Ethical guidelines for

good practice in the

health care professions

Protecting the Public and Guiding the Professions

Ethical guidelines for good practice
in the health care professions
The following Booklets are separately available:

Booklet 1: General ethical guidelines for health care professions 3

Booklet 2: Ethical and professional rules of the Health Professions Council of South Africa as
promulgated in government gazette R717/2006 20

Booklet 3: National Patients’ Rights Charter 79

Booklet 4: Seeking patients’ informed consent: The ethical considerations 86

Booklet 5: Confidentiality: Protecting and providing information 103

Booklet 6: Guidelines for the management of patients with HIV infection or AIDS 119

Booklet 7: Guidelines withholding and withdrawing treatment 133

Booklet 8: Guidelines on Reproductive Health management 146

Booklet 9: Guidelines on Patient Records 162

Booklet 10: Guidelines for the practice of Telemedicine 173

Booklet 11: Guidelines on over servicing, perverse incentives and related matters 193

Booklet 12: Guidelines for the management of health care waste 208

Booklet 13: General ethical guidelines for health researchers 262

Booklet 14: Ethical Guidelines for Biotechnology Research in South Africa 278

Booklet 15: Research, development and the use of the chemical, biological and nuclear weapons 294

Booklet 16: Ethical Guidelines on Social Media 307

Booklet 17: Ethical Guidelines on Palliative Care 320

 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

GENERAL ETHICAL GUIDELINES FOR THE

HEALTH CARE PROFESSIONS

BOOKLET 1

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship

of mutual trust between patients and health care practitioners. The

term “profession” means “a dedication, promise or commitment

publicly made”.1 To be a good health care practitioner, requires a

life-long commitment to sound professional and ethical practices

and an overriding dedication to the interests of one’s fellow human

beings and society. In essence, the practice of health care

professions is a moral enterprise. In this spirit the HPCSA presents

the following ethical guidelines to guide and direct the practice of

health care practitioners. These guidelines form an integral part of

the standards of professional conduct against which a complaint of

professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines

refers to persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).
 ii

TABLE OF CONTENTS

Acknowledgements ......................................................................................................................... iii

1. Introduction ....................................................................................................................... 1
2. Core ethical values and standards for good practice ......................................................... 2
3. How to resolve ethical dilemmas ....................................................................................... 3
4. What it means to have a duty ............................................................................................ 4
5. Duties to patients .............................................................................................................. 5
6. Duties to colleagues and other health care practitioners ................................................. 10
7. Duties to patients of other health care practitioners ......................................................... 10
8. Duties to themselves ....................................................................................................... 11
9. Duties to society .............................................................................................................. 11
10. Duties to the health care profession ................................................................................ 12
11. Duties to the environment................................................................................................ 12
 iii

ACKNOWLEDGEMENTS

The Health Professions Council of South Africa wishes to thank the following persons for
their contributions towards the revision of the guidelines:

 The Committee for Human Rights, Ethics and Professional Practice of the Health
Professions Council of South Africa for initiating and advising the review process.
 Ms RM Kekana (Chairperson), Prof A. Dhai, Prof D J. McQuoid-Mason, Ms V
Amrit, Rev G Moerane, Dr C Vincent-Lambert, Mr R Mjethu and Dr TKS Letlape,
 Prof A. Dhai, Prof D.J. McQuoid-Mason, Dr N Msomi and LIFElab for the
development of the ethical guidelines for Biotechnology Research in South Africa.
 Prof D. J McQuoid-Mason for his editorial advice on the booklets
 Adv Mathibeli as the legal advisor, Ms N Manciya as Committee coordinator and
Mr N Sipeka as the Council secretariat.
 GENERAL ETHICAL GUIDELINES FOR THE HEALTH CARE PROFESSIONALS

1. INTRODUCTION

1.1 Being registered as a health care professional with the Health Professions Council of
South Africa (HPCSA) confers on us the right and privilege to practise our
professions. Correspondingly, practitioners have moral or ethical duties to others and
society. These duties are generally in keeping with the principles of the South African
Constitution (Act No. 108 of 1996) and the obligations imposed on health care
practitioners by law.

1.2 This first booklet on general ethical guidelines contains value-oriented principles and
express the most honourable ideals to which members of the health care profession
should subscribe in terms of their conduct

1.3 More specific ethical guidelines and rules are derived from these general ethical
guidelines. They offer more precise guidance and direction for action in concrete
situations. They also make it possible for the HPCSA to implement sanctions against
transgressors.

1.4 It is impossible, however, to develop a complete set of specific ethical prescriptions

applicable to all conceivable real-life situations. In concrete cases, health care
professionals may have to work out for themselves what course of action can best be
defended ethically. This requires ethical reasoning.
1.5 This booklet lists thirteen core ethical values and standards that underlie professional
and ethical practice in health care professions, and gives a short explanation of how
one makes practical decisions through ethical reasoning. It then explains what a duty
is, and catalogues the general ethical duties of health care professionals

[Note: In this booklet, the expressions “professional” or ‘”practitioner” are used

interchangeably to refer to health care practitioners].

[Note: Environmental Health Practitioners do not see patients]

 2

2. CORE ETHICAL VALUES AND STANDARDS FOR GOOD PRACTICE

2.1 Everything ethically required of a professional to maintain good professional practice is

grounded in core ethical values and standards – the latter are the directives that follow the
core values. These core values and standards are presented as a linear list for the sake of
simplicity.

2.2 In concrete cases, the demands of these core values and standards may clash, thus
making competing demands on health care practitioners. The only way to address such
clashes is through ethical reasoning.

2.3 The core ethical values and standards required of health care practitioners include the
following:

2.3.1 Respect for persons: Health care practitioners should respect patients as persons,
and acknowledge their intrinsic worth, dignity, and sense of value.

2.3.2 Best interests or well-being: Non-maleficence: Health care practitioners should not
harm or act against the best interests of patients, even when the interests of the latter
conflict with their own self-interest.

2.3.3 Best interest or well-being: Beneficence: Health care practitioners should act in the
best interests of patients even when the interests of the latter conflict with their own
personal self-interest.

2.3.4 Human rights: Health care practitioners should recognise the human rights of all
individuals.

2.3.5 Autonomy: Health care practitioners should honour the right of patients to self-
determination or to make their own informed choices, and to live their lives by their own
beliefs, values and preferences.

2.3.6 Integrity: Health care practitioners should incorporate these core ethical values and
standards as the foundation for their character and practice as responsible health care
professionals.

2.3.7 Truthfulness: Health care practitioners should regard the truth and truthfulness as the
basis of trust in their professional relationships with patients.

2.3.8 Confidentiality: Health care practitioners should treat personal or private information
as confidential in professional relationships with patients - unless overriding reasons
confer a moral or legal right to disclosure.

2.3.9 Compassion: Health care practitioners should be sensitive to, and empathise with, the
individual and social needs of their patients and seek to create mechanisms for
providing comfort and support where appropriate and possible.

2.3.10 Tolerance: Health care practitioners should respect the rights of people to have
different ethical beliefs as these may arise from deeply held personal, religious or
cultural convictions.

2.3.11 Justice: Health care practitioners should treat all individuals and groups in an
impartial, fair and just manner.
 3
2.3.12 Professional competence and self-improvement: Health care practitioners should
continually endeavour to attain the highest level of knowledge and skills required within
their area of practice.

2.3.13 Community: Health care practitioners should strive to contribute to the betterment of
society in accordance with their professional abilities and standing in the community.

3. HOW TO RESOLVE ETHICAL DILEMMAS

3.1 The core values and standards referred to above are the foundation that grounds the
general ethical guidelines in these booklets. Being general, such guidelines may be
applied to many different concrete cases.

3.2 Questions arise as to how health care practitioners may use these guidelines to make
practical decisions or choices about the provision of health care. For example, how
does a guideline apply in a specific case? And, how do health care practitioners
handle difficult situations where two (or more) principles appear to be in conflict?

3.3 Briefly, what is needed is ethical reasoning. In general, such ethical reasoning
proceeds in four steps:

3.3.1 Formulating the problem: Determine whether the issue at hand is an ethical
one once this has been done it must be decided whether there is a better way
of understanding it.

3.3.2 Gathering information: All the relevant information must be collected - such
as clinical, personal and social data. Consult authoritative sources such as
these guidelines, practitioner associations, respected colleagues and see how
practitioners generally deal with such matters.

3.3.3 Considering options: Consider alternative solutions in light of the principles

and values they uphold.

3.3.4 Making a moral assessment: The ethical content of each option should be
weighed by asking the following questions:

3.3.4.1 What are the likely consequences of each option?

3.3.4.2 What are the most important values, duties, and rights? Which
weighs the heaviest?

3.3.4.3 What are the weaknesses of the health care practitioner’s individual
view concerning the correct option?

3.3.4.4 How would the health care practitioner himself or herself want to be
treated under similar circumstances. –

3.3.4.5 How does the health care practitioner think that the patient would
want to be treated in the particular circumstances?

3.3.5 Discuss your proposed solution with those whom it will affect
3.3.6 Act on your decision with sensitivity to others affected
3.3.7 Evaluate your decision and be prepared to act differently in the future

(Adopted from WMA – Medical Ethics Manual)

 4

4. WHAT IT MEANS TO HAVE A DUTY

4.1 Ethical guidelines express duties. A duty is an obligation to do or refrain from doing
something.

4.2 If we have a duty to another person, it means we are bound to that person in some
respect and for some reason. We owe that person something, while he or she holds a
corresponding right or claim against us.

4.3 An example of a right with a corresponding duty is the following: Suppose a health
care practitioner reaches an agreement with a colleague that the latter will do a locum
for him while he is away on family business: The colleague has a duty to do the locum
and the health care practitioner has a right to the colleague’s services. At the same
time the colleague has a right to fair remuneration and the health care practitioner has
a duty to compensate her/him.

4.4 To have a duty is to ask the question “What do I owe others?” To have a right is to
ask the question “What do others owe me?”

4.5 Duties may be ethical, legal or both at once, and operate in the personal, social,
professional or political spheres of our lives.

4.6 Healthcare practitioners fulfil different roles. Accordingly, they have different kinds of
duties:

4.6.1 As human beings we have “natural duties”, namely unacquired general

duties simply because we are members of the human community - for
example the natural duties to refrain from doing harm, to promote the good, or
to be fair and just. As is the case with everyone, health care professionals owe
these duties to all other people, whether patients or not, and quite
independently of our professional qualifications.

4.6.2 As professionals we have “moral obligations”, namely general duties we

acquire by being qualified and licensed as professionals, that is, professionals
entering into contractual relationships with patients - for example the
professional duties to provide health care, relieve pain, gain informed consent,
respect confidentiality, and be truthful.

4.6.3 Institutional duties: Institutional duties are imposed upon health care
practitioners working in specific institutions. They are specific to the health
care practitioner’s particular institutionalised role, for example the duties of a
practitioner employed by a company, a health care practitioner working in a
governmental research agency, or a doctor engaged in private practice. These
duties are contained in employment contracts, job descriptions, conventional
expectations etc. Institutional duties must be consistent with the ethical and
legal duties of health care practitioners.

4.6.4 Legal duties: Legal duties are duties imposed by the common law and by
statute law (for example, the National Health Act (Act No. 61 of 2003) or the
Health Professions Act, 1974) that require health care practitioners to follow
certain procedures and to use particular skill and care when dealing with
patients.
 5

4.7 The duties listed in these general guidelines mostly fall into the second category – the
general but acquired duties of a health care practitioner as a professional.

4.8 No duty is absolute or holds without exception irrespective of time, place or

circumstance. This is not surprising, since different duties may prescribe quite
opposite decisions and actions in a specific concrete or real-life situation.For
example, our duties to our patients may compete with our duties to our employer. Or
our duty to respect a patient’s confidentiality may clash with our duty to protect
innocent third parties from harm. (HIV/AIDS examples are particularly perplexing.)
These are instances of conflicts of interest or dual loyalties.

4.9 No list of such duties is ever complete, but the catalogue of duties below presents a
fairly comprehensive picture of what it is, in general, that binds any health care
provider as a professional to his or her patients, as well as to others. However, it
should be noted that these duties, if not honoured without justification, may constitute
the basis for sanctions being imposed on professionals by the Health Professions
Council of South Africa.

4.10 Any classification of duties is arbitrary, because specific duties may be owed to
different parties simultaneously. Therefore, the classifications used below should be
viewed only as a rough guide. However, underlying these duties is a set of core
ethical values and standards of good practice that are regarded as basic ethical
principles.
(see above para 2).

5. DUTIES TO PATIENTS

5.1 PATIENTS’ BEST INTERESTS OR WELL-BEING

Health care practitioners should:

5.1.1 Always regard concern for the best interests or well-being of their patients as
their primary professional duty.

5.1.2 Honour the trust of their patients.

5.1.3 Be mindful that they are in a position of power over their patients and avoid
abusing their position.

5.1.4 Within the normal constraints of their practice, be accessible to patients when
they are on duty, and make arrangements for access when they are not on
duty.

5.1.5 Make sure that their personal beliefs do not prejudice their patients’ health
care. Beliefs that might prejudice care relate to patients’ race, culture,
ethnicity, social status, lifestyle, perceived economic worth, age, gender,
disability, communicable disease status, sexual orientation, religious or
spiritual beliefs, or any condition of vulnerability.

5.1.6 If they feel that their beliefs might affect the treatment they provide, they must
explain this to their patients, and inform them of their right to see another
health care practitioner.
 6
5.1.7 Not refuse or delay treatment because they believe that patients’ actions
have contributed to their condition, or because they – the health care
practitioners - may be putting their own health at risk.

5.1.8 Apply their mind when making diagnoses and considering appropriate
treatment.

5.1.9 Respond appropriately to protect patients from any risk or harm

5.1.10 Respond to criticism and complaints promptly and constructively.

5.1.11 Not employ any intern, health care provider in community service, or health
care practitioner with restricted registration with the HPCSA, as a locum
tenens - or otherwise - in their own or any associated health care practice.

5.1.12 Inform their patients if they are in the employ of, in association with, linked to,
or have an interest in any organisation or facility that could be interpreted by
an average person as potentially creating a conflict of interest or dual loyalty
in respect of their patient care.

5.1.13 In emergency situations, provide health care within the limits of their practice
and according their education and/ or training, experience and competency
under proper conditions and in appropriate surroundings. If unable to do so,
refer the patient to a colleague or an institution where the required care can
be provided.

Adequately educated and/or trained

To qualify as adequately educated and/or trained:

i. The individual practitioner must have successfully completed an educational

training programme approved and accredited by the HPCSA within the field
of practice and category of registration.

ii. The individual practitioner must have successfully completed a training

programme in a training entity/institution/hospital that has been accredited by
the professional board, for training in that particular profession or discipline
and for that particular competency.

iii. The individual practitioner must, in order to be regarded as trained, have

undergone an initial training period under the supervision, as defined in
clause (i) above, of an entity accredited by the professional board for such
purposes, and been credentialed in the successful completion of such
training as defined.

iv. The individual practitioner must have completed undergraduate or

postgraduate training, the duration of which was laid down by the
professional board.

v. The individual practitioner must be evaluated and credentialed as having met

the requirements of the training programme by an entity accredited by the
Professional board (e.g. Colleges of Medicine, Universities, etc).

vi. A short course will serve to enhance or maintain skills that have been
credentialed and registered by the professional board.
 7
vii. The application of such training in care of the patient will be judged by the
professional board by the standards and norms considered reasonable for
the circumstances under which the intervention took place.

b. Sufficiently experienced

To be regarded as sufficiently experienced, a practitioner must:

i. Have performed a minimum number of interventions annually to remain

proficient, taking into account and judged by the standards and norms
considered reasonable by the professional board, for the circumstances
under which the intervention took place.

ii. With regard to the introduction of new interventions within the practitioners’
scope of professional practice, have undergone further appropriate training
and credentialing as approved by the professional board.”

c. Under proper conditions and appropriate surroundings

All interventions shall take place under appropriate conditions and surroundings.
These are subject to judgment by the professional board as to what is considered
reasonable in the circumstances and conditions, under which the intervention took
place. No practitioner must embark upon an intervention unless it is in the patient’s
interest, and that it would be considered safe to do so, under the prevailing conditions
and surroundings. The practitioner will be judged on what requirements would be
reasonable to ensure that patient safety was protected.

5.2 RESPECT FOR PATIENTS

Health care practitioners should:

5.2.1 Respect the privacy, confidentiality and dignity of patients.

5.2.2 Treat patients politely and with consideration.

5.2.3 Listen to their patients and respect their opinions.

5.2.4 Avoid improper relationships with their patients and those who are
accompanying the patient (for example, sexual relationships or exploitative
financial arrangements).

5.2.5 Guard against human rights violations of patients, and not allow, participate
in or condone any actions that lead to violations of the rights of patients.

5.2.6 inform the patient of the choice of having a chaperone in the room during an
intimate examination

5.2.7 inform the patient if the practitioner will be having a chaperone in the room
during an intimate examination
 8

5.3 INFORMED CONSENT

Health care practitioners should:

5.3.1 Give their patients the information they ask for or need about their condition,
its treatment and prognosis.

5.3.2 Give information to their patients in the way they can best understand it. The
information must be given in a language that the patient understands and in
a manner that takes into account the patient’s level of literacy,
understanding, values and belief systems.

5.3.3 Refrain from withholding from their patients any information, investigation,
treatment or procedure the health care practitioner knows would be in the
patient’s best interests.

5.3.4 Apply the principle of informed consent as an on-going process

5.3.5 Allow patients access to their medical records

For detailed information consult the HPCSA Ethical Booklet on Informed Consent

5.4 PATIENT CONFIDENTIALITY

Health care practitioners should:

5.4.1 Recognise the right of patients to expect that health care practitioners will not
disclose any personal and confidential information they acquire in the course
of their professional duties, unless the disclosure thereof is:
made in accordance with patient’s consent;
made in accordance with the court order to that effect;
required by law; or
In the interest of the patient. Section 14 and 15 of the NHA.

5.4.2 Not breach confidentiality without sound reason and without the knowledge
of their patients

5.4.3 When claiming from medical schemes explain to patients the significance of
ICD-10 coding and get the permission of patients to breach confidentiality
when making a medical scheme claim.

For detailed information consult the HPCSA Ethical Booklet 5 on confidentiality: Protecting
and Providing information

5.5 PATIENT PARTICIPATION IN THEIR OWN HEALTH CARE

Health care practitioners should:

5.5.1 Respect the right of patients to be fully involved in decisions about their
treatment and care even if they are not legally competent to give the
necessary consent.

5.5.2 Respect the right of patients to refuse treatment or to take part in teaching or
research.
 9

5.5.3 Inform their patients that they have a right to seek a second opinion without
prejudicing their future treatment.

For detailed information consult the HPCSA Ethical Booklet 3 on the National Patients’’ Rights
Charter

5.6 IMPARTIALITY AND JUSTICE

Health care practitioners should be aware of the rights and laws concerning unfair
discrimination in the management of patients or their families on the basis of race, culture,
ethnicity, social status, lifestyle, perceived economic worth, age, gender, disability,
communicable disease status, sexual orientation, religious or spiritual beliefs, or any condition
vulnerability.

For detailed information consult the HPCSA Ethical Booklet 3 on National Patients’’ Rights
Charter

5.7 ACCESS TO CARE

Health care practitioners should:

5.7.1 Promote access to health care. If they are unable to provide a service, they
should refer the patient to another health care practitioner or to a health care
facility where the required service can be obtained, provided that in an
emergency situation practitioners shall be obliged to provide care in order to
stabilize the patient and then to arrange for an appropriate referral to another
practitioner or facility. Section 5 of the NHA

For detailed information consult the HPCSA Ethical Booklet 3 on Patients’’ Rights Charter

5.8 POTENTIAL CONFLICTS OF INTEREST

Health care practitioners should:

5.8.1 Always seek to give priority to the investigation and treatment of patients
solely on the basis of clinical need.

5.8.2 Avoid over-servicing: They should recommend or refer patients for necessary
investigations and treatment only, and should prescribe only treatment, drugs
or appliances that serve the needs of their patients. Rule 23A of the Ethical
Rules of Conduct

5.8.3 Declare to their patients – verbally and by a displayed notice – any financial
interest they may have in institutions, diagnostic equipment, or the like to
which they make referrals, if the holding of such interest is permitted by the
HPCSA. Rule 24 of the Ethical Rules of Conduct

5.8.4 Refrain from coercing patients or their family members to provide them
(health practitioners) with gifts or any other undue benefit.
 10

6. DUTIES TO COLLEAGUES AND OTHER HEALTH CARE PRACTITIONERS

6.1 REFERRALS TO COLLEAGUES AND POTENTIAL CONFLICTS OF INTEREST

Health care practitioners should:

6.1.1 Act in their patients’ best interests when making referrals and providing or
arranging treatment or care. They should not ask for, or accept, any undue
inducement or incentive, from colleagues to whom they refer patients
because it may affect or be seen to affect the health care practitioner’s
judgement.

6.1.2 Treat patients referred to them in the same manner in which they would treat
their own patients.

6.1.3 Not service a patient in more than one capacity or charge fees based
on more than one consultation where health practitioners are
registered with more than one statutory council or professional board
or in one or more categories within the same professional board.

Adhere to the guideline on self-referral and other referrals mentioned in Booklet 11 on

Guideline on Over – Servicing, Perverse incentives and Related Matters (par 3.5).

6.2 WORKING WITH COLLEAGUES

Health care practitioners should:

6.2.1 Work with and respect other health-care professionals in pursuit of the best
health care possible for all patients.

6.2.2 Not discriminate against colleagues, including health care practitioners

applying for posts, because of their views of their race, culture, ethnicity,
social status, lifestyle, perceived economic worth, age, gender, disability,
communicable disease status, sexual orientation, religious or spiritual beliefs,
or any condition of vulnerability.

6.2.3 Refrain from speaking ill of colleagues or other health care practitioners. Rule
12 of the ethical Rules of conduct
.
6.2.4 Not make a patient doubt the knowledge or skills of colleagues by making
comments about them that cannot be fully justified.

6.2.5 Support colleagues who uphold the core values and standards embodied in
these guidelines.

6.2.6 Advise colleagues who are impaired to seek professional assistance.

7. DUTIES TO PATIENTS OF OTHER HEALTH CARE PRACTITIONERS

Health care practitioners should:

7.1 Act quickly to protect patients from risk due to any reason.
 11
7.2 Report violations and seek redress in circumstances where they have a good
or persuasive reason to believe that the rights of patients are being violated.
7.3 Report impaired colleagues who are a danger to the health of their patients
in order that such colleagues may be provided with the necessary support to
overcome their impairment and prevented from harming patients (See
HPCSA Booklet 2 on Ethical and Professional Rules of the HPCSA Rule 25)

For detailed information consult the HPCSA Ethical Booklet 11 on Guideline on Over –
Servicing, Perverse incentives and Related Matters.

8. DUTIES TO THEMSELVES

8.1 KNOWLEDGE AND SKILLS

Health care practitioners should:

Maintain and improve the standard of their performance by keeping their professional
knowledge and skills up to date throughout their working life. In particular, they should
regularly take part in educational activities that would enhance their provision of
health services.

Acknowledge the limits of their professional knowledge and competence. They should
not pretend to know everything.

Observe and keep up to date with the laws that affect professional health care
practice in general and their practice in particular (for example, the provisions of the
National Health Act (Act No. 61 of 2003)).

Update their skills and knowledge of ethics, human rights and health law as provided
for in accredited Continuing Professional Development programmes.

For detailed information consult the HPCSA Ethical Booklet 16 on Continuing Professional
Development.

8.2 MAINTAINING A PROFESSIONAL PRACTICE

Health care practitioners should:

8.2.1 Keep their equipment in good working order.

8.2.2 Maintain proper hygiene in their working environment.

8.2.3 Keep accurate and up-to-date patient records

8.2.4 Refrain from engaging in activities that may affect their health and lead to
impairment.

8.2.5 Ensure that staff members employed by them are trained to respect patients’
rights; in particular the right to confidentiality
 12

9. DUTIES TO SOCIETY

9.1 ACCESS TO SCARCE RESOURCES

Health care practitioners should:

9.1.1 Deal responsibly with scarce health care resources.

9.1.2 Refrain from providing a service that is not needed.

9.1.3 Refrain from unnecessary wastage, and from participating in improper

financial arrangements, especially those that escalate costs and
disadvantage individuals or institutions unfairly.

9.2 HEALTH-CARE POLICY DEVELOPMENT

Health care practitioners should include ethical considerations, legal requirements and human
rights in the development of health care policies.
Do they have a responsibility to develop policy?

10. DUTIES TO THE HEALTH CARE PROFESSION

10.1 REPORTING MISCONDUCT

Health care practitioners should:

10.1.1 Report violations and seek redress in circumstances where they have good
or persuasive reason to believe that the rights of patients are being violated
and / or where the conduct of the practitioner is unethical

10.1.2 Where it is in their power, protect people who report misconduct from
victimisation or intimidation.

10.2 ACCESS TO APPROPRIATE HEALTH CARE

Health care practitioners should promote access to health care. If they are unable to provide a
health service, they should refer the patient to another health care practitioner or health care
facility that can provide the service.

11. DUTIES TO THE ENVIRONMENT

11.1 CONSERVATION OF NATURAL RESOURCES

Health care practitioners should recognise that they have a responsibility to ensure that in the
conduct of their affairs they do not in any way contribute to environmental degradation.

11.2 DISPOSAL OF HEALTH CARE WASTE

Health care practitioners should protect the environment and the public by ensuring that health

care waste is disposed off legally and in an environmentally friendly manner

 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

ETHICAL AND PROFESSIONAL RULES OF THE HEALTH

PROFESSIONS COUNCIL OF SOUTH AFRICA

BOOKLET 2

PRETORIA
SEPTEMBER 2016

1
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za

2
 ETHICAL AND PROFESSIONAL RULES

Practice as a health care professional is based on a relationship of

mutual trust between patients and health care practitioners. The

term “profession” means “a dedication, promise or commitment

publicly made”.1 To be a good health care practitioner, requires a

life-long commitment to sound professional and ethical practices

and an overriding dedication to the interests of one’s fellow human

beings and society.

In the course of their professional work health care practitioners

are required to subscribe to certain rules of conduct. To this end

the Health Professional Council of South Africa has formulated a

set of rules regarding professional conduct against which

complaints of professional misconduct will be evaluated. These

rules are reproduced in this booklet.

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).
 4

TABLE OF CONTENTS

SCHEDULE .................................................................................................................................... 7
DEFINITIONS ................................................................................................................................. 7
INTERPRETATION AND APPLICATION ....................................................................................... 9
ADVERTISING AND CANVASSING OR TOUTING........................................................................ 9
INFORMATION ON PROFESSIONAL STATIONERY .................................................................. 10
NAMING OF A PRACTICE ........................................................................................................... 10
ITINERANT PRACTICE ................................................................................................................ 11
FEES AND COMMISSION ............................................................................................................ 11
PARTNERSHIP AND JURISTIC PERSONS ................................................................................. 11
SHARING OF ROOMS ................................................................................................................. 12
COVERING ................................................................................................................................... 12
SUPERSESSION .......................................................................................................................... 12
IMPEDING A PATIENT ................................................................................................................. 13
PROFESSIONAL REPUTATION OF COLLEAGUES ................................................................... 13
PROFESSIONAL CONFIDENTIALITY ......................................................................................... 13
RETENTION OF HUMAN ORGANS ............................................................................................. 13
SIGNING OF OFFICIAL DOCUMENTS ........................................................................................ 14
CERTIFICATES AND REPORTS.................................................................................................. 14
ISSUING OF PRESCRIPTIONS .................................................................................................... 15
PROFESSIONAL APPOINTMENTS ............................................................................................. 15
SECRET REMEDIES .................................................................................................................... 15
DEFEATING OR OBSTRUCTING THE COUNCIL OR BOARD IN
THEPERFORMANCE OF ITS DUTIES ......................................................................................... 15
PERFORMANCE OF PROFESSIONAL ACTS ............................................................................. 16
EXPLOITATION ............................................................................................................................ 16
MEDICINE AND MEDICAL DEVICES .......................................................................................... 16
FINANCIAL INTERESTS IN HOSPITALS .................................................................................... 17
REFERRAL OF PATIENTS TO HOSPITALS ............................................................................... 18
REPORTING OF IMPAIRMENT OR OF UNPROFESSIONAL, ILLEGAL OR
UNETHICAL CONDUCT ............................................................................................................... 18
RESEARCH, DEVELOPMENT AND USE OF CHEMICAL, BIOLOGICAL AND
NUCLEAR CAPABILITIES ........................................................................................................... 19

4
 5

MULTIPLE REGISTRATION......................................................................................................... 19
MAIN RESPONSIBILITIES OF HEALTH PRACTITIONERS ........................................................ 20
REPEAL........................................................................................................................................ 20
ANNEXURES ................................................................................................................................ 21

5
 6

ETHICAL AND PROFESSIONAL RULES OF THE HEALTH

PROFESSIONS COUNCIL OF SOUTH AFRICA

NOTE

This Booklet contains the Draft Regulations concerning the ethical and professional rules
that the Health Professions Council of South Africa (HPCSA) has recommended to the
Minister of Health.

Health care practitioners who decide not to follow the guidance in this Booklet (including
the Annexure), must be prepared to explain and justify their actions and decisions to
patients and their families, their colleagues and, if necessary, to the courts and the
HPCSA.

6
 7

GOVERNMENT NOTICE

DEPARTMENT OF HEALTH

No. R. 717 4 August 2006

as amended by Government Notice No. R 68 of 2 February 2009.

HEALTH PROFESSIONS ACT, 1974 (ACT NO. 56 OF 1974)

ETHICAL RULES OF CONDUCT FOR PRACTITIONERS REGISTERED UNDER THE

HEALTH PROFESSIONS ACT, 1974

The Health Professions Council of South Africa, in consultation with the professional
boards, has, under section 49 of the Health Professions Act, 1974 (Act No. 56 of 1974),
made the rules in the Schedule.

SCHEDULE

Definitions

1. In these rules, any word or expression to which a meaning has been assigned in
the Act shall bear such meaning and, unless the context indicates otherwise -

“Act” means the Health Professions Act, 1974 (Act No. 56 of 1974);

“annexure” means an annexure to these rules;

“association” means a form of where two or more practitioners practise for their
own account, but share communal assets or facilities;

“board” means a professional board established in terms of section 15 of the Act;

“canvassing” means conduct which draws attention, either verbally or by means of

printed or electronic media, to one’s personal qualities, superior knowledge, quality
of service, professional guarantees or best practice;

“close collaboration” means consultation by a practitioner at one stage or another

in the treatment of a patient with another practitioner and the furnishing by the latter
practitioner, at the end of such treatment, of a report on the treatment to the
practitioner whom he or she consulted;

“dental specialist” means a dentist who has been registered as a specialist in a

speciality or subspeciality in dentistry in terms of the Regulations relating to the
Specialities and Subspecialities in Medicine and Dentistry, published under
Government Notice No. R. 590 of 29 June 2001;

7
 8

“dispensing optician” means a person registered as such in terms of the Act and
the Rules for the registration of Dispensing Opticians, published under Government
Notice No. R. 2339 of 3 December 1976;

“impairment” means a mental or physical condition which affects the competence,

attitude, judgement or performance of professional acts by a registered practitioner;

“independent practice” means a practice where a registered health profession is

conducted by a health practitioner without the supervision of another health
practitioner;

“itinerant practice” means a practice which a practitioner conducts on a regular

basis at a location other than at his or her resident practice address;

"'medical device' means a medical device as defined in section 1 of the Medicines

and Related Substances Act, 1965 (Act No. 101 of 1965);

“medical scientist” means a person registered under the Act as a biomedical

engineer, clinical biochemist, genetic counsellor, medical biological scientist or
medical physicist;

“medical specialist” means a medical practitioner who has been registered as a

specialist in a speciality or subspeciality in medicine in terms of the Regulations
relating to the Specialities and Subspecialities in Medicine and Dentistry, published
under Government Notice No. R. 590 of 29 June 2001;

“optometrist” means a person registered as such under the Act;

“pharmaceutical concern” means a company registered as such under the

Pharmacy Act, 1974 (Act No. 53 of 1974);

“practitioner” means a person registered as such under the Act and, in the
application of rules 5, 6 and 9 of these rules, also a juristic person exempted from
registration in terms of section 54A of the Act;

“private practice” means the practice of a health practitioner who practises for his
or her own account, either in solus practice, or as a partner in a partnership, or as
an associate in an association with other practitioners, or as a director of a
company established in terms of section 54A of the Act;

“public company” means a company registered as such under the Companies

Act, 1973 (Act No. 61 of 1973);

“public service” means a service rendered by the state at the national, provincial
or local level of government and includes organizations which function under its
auspices or are largely subsidized by the state or recognized by a board for the
purposes of these rules;

“resident practice” means a place where a registered health practitioner conducts

his or her practice on a daily basis;

8
 9

”rooms” means a physical structure, with an exclusive entrance and walled all
round for the privacy of patients, the preservation of their confidentiality and the
safe keeping of records, where a practitioner conducts his or her practice;

“section” means a section of the Act;

“specialist” means a practitioner who is registered as a specialist in a speciality or

subspeciality (if any) in terms of the Regulations relating to the Specialities and
Subspecialities in Medicine and Dentistry, published under Government Notice No.
R. 590 of 29 June 2001, and who confines his or her practice to such speciality or
subspeciality;

“supervision” means the acceptance of liability by a supervising practitioner for

the acts of another practitioner; and

“touting” means conduct which draws attention, either verbally or by means of

printed or electronic media, to one's offers, guarantees or material benefits that do
not fall in the categories of professional services or items, but are linked to the
rendering of a professional service or designed to entice the public to the
professional practice.

Interpretation and application

2. (1) Failure by a practitioner to comply with any conduct determined in these rules
or an annexure to these rules shall constitute an act or omission in respect of
which the board concerned may take disciplinary steps in terms of Chapter IV
of the Act.
(2) Conduct determined in these rules or an annexure to these rules shall not be
deemed to constitute a complete list of conduct and the board concerned may
therefore inquire into and deal with any complaint of unprofessional conduct
which may be brought before such board.
(3) At an inquiry referred to in subrule (2) the board concerned shall be guided by
these rules, annexures to these rules, ethical rulings or guidelines and policy
statements which the board concerned or council makes from time to time.

Advertising and canvassing or touting

3. (1) A practitioner shall be allowed to advertise his or her services or permit,

sanction or acquiesce to such advertisement: Provided that the advertisement
is not unprofessional, untruthful, deceptive or misleading or causes
consumers unwarranted anxiety that they may be suffering from any health
condition.
(2) A practitioner shall not canvass or tout or allow canvassing or touting to be
done for patients on his or her behalf.

9
 10

Information on professional stationery

4. (1) A practitioner shall print or have printed on letterheads, account forms and
electronic stationery information pertaining only to such practitioner’s –
(a) name;
(b) profession;
(c) registered category;
(d) speciality or subspeciality or field of professional practice (if any);
(e) registered qualifications or other academic qualifications or honorary
degrees in abbreviated form;
(f) registration number;
(g) addresses (including email address);
(h) telephone and fax numbers;
(i) practice or consultation hours;
(j) practice code number; and
(k) dispensing licence number (if any).

(2) A group of practitioners practising as a juristic person which is exempted from

registration in terms of section 54A of the Act or a group of practitioners
practising in partnership, shall print or have printed on letterheads, account
forms and electronic stationery information pertaining only to such juristic
person or partnership practitioners’ -

(a) name;
(b) profession;
(c) registered category;
(d) speciality or subspeciality or field of professional practice (if any);
(e) registered qualifications or other academic qualifications or honorary
degrees in abbreviated form;
(f) registration number;
(g) addresses (including email address);
(h) telephone and fax numbers;
(i) business hours;
(j) practice code number;
(k) exemption from registration in terms of section 54A of the Act; and
(l) dispensing licence number (if any).

(3) A practitioner shall not use prescription forms or envelopes on which the name
or address of a pharmacist is printed.

Naming of a practice

5. (1) A practitioner shall use his or her own name or the name of a registered
practitioner or practitioners with whom he or she is in partnership or with
whom he or she practises as a juristic person, as a name for his or her private
practice.
(2) A practitioner referred to in subrule (1) may retain the name of such private
practice even if another practitioner, partner of such partnership or member of
such juristic person is no longer part of such private practice: Provided that the
express consent of the past practitioner or, in the case of a deceased

10
 11

practitioner the consent of the executor of his or her estate or his or her next-
of-kin, has been obtained.
(3) A practitioner shall not use, in the name of his or her private practice, the
expression “hospital”, “clinic” or “institute” or any other expression which may
give the impression that such private practice forms part of, or is in association
with, a hospital, clinic or institute.

Itinerant practice

6. A practitioner may conduct a regularly recurring itinerant practice at a place where

another practitioner is established if, in such itinerant practice, such practitioner
renders the same level of service to patients, at the same fee as the service which
he or she would render in the area in which he or she is conducting a resident
practice.

Fees and commission

7. (1) A practitioner shall not accept commission or any material consideration,

(monetary or otherwise) from a person or from another practitioner or
institution in return for the purchase, sale or supply of any goods, substances
or materials used by him or her in the conduct of his or her professional
practice.

(2) A practitioner shall not pay commission or offer any material consideration,
(monetary or otherwise) to any person for recommending patients.

(3) A practitioner shall not offer or accept any payment, benefit or material
consideration (monetary or otherwise) which is calculated to induce him or her
to act or not to act in a particular way not scientifically, professionally or
medically indicated or to under-service, over-service or over-charge patients.

(4) A practitioner shall not share fees with any person or with another practitioner
who has not taken a commensurate part in the services for which such fees are
charged.

(5) A practitioner shall not charge or receive fees for services not personally
rendered, except for services rendered by another practitioner in his or her
employment or with whom he or she is associated as a partner, shareholder or
locum tenens.

(6) A practitioner shall explain to the patients the benefits, costs and consequences
associated with each service option offered.

Partnership and juristic persons

8. (1) A practitioner may practise in partnership or association with or employ only a

practitioner who is registered under the Act and who is not prohibited under
any of the annexures to these rules or any ethical rulings from entering into
such partnership or association or being so employed: Provided that, in the
case of employment, the practitioner so employed either provides a supportive

11
 12

health care service to complete or supplement the employing practitioner's

healthcare or treatment intervention or is in the same professional category as
the employing practitioner.

(2) A practitioner shall practise in or as a juristic person who is exempted from

registration in terms of section 54A of the Act only if such juristic person
complies with the conditions of such exemption.

(3) A practitioner shall practise in a partnership, association or as a juristic person

only within the scope of the profession in respect of which he or she is
registered under the Act.

(4) A practitioner shall not practise in any other form of practice which has
inherent requirements or conditions that violate or potentially may violate one
or more of these rules or an annexure to these rules.

Sharing of Rooms

8. A practitioner shall not share his or her rooms with a person or entity not registered in
terms of the Act.

Covering

9. (1) A practitioner shall employ as a professional assistant or locum tenens, or in

any other contractual capacity and, in the case of locum tenens for a period
not exceeding six months, only a person -
(a) who is registered under the Act to practise in independent practice;
(b) whose name currently appears on the register kept by the registrar in
terms of section 18 of the Act; and
(c) who is not suspended from practising his or her profession.

(2) A practitioner shall help or support only a person registered under the Act, the
Pharmacy Act, 1974 (Act No. 53 of 1974), the Nursing Act, 1978 (Act No. 50
of 1978), the Social Service Professions Act, 1978 (Act No. 110 of 1978), the
Dental Technicians Act, 1979 (Act No. 19 of 1979), or the Allied Health
Professions Act, 1982 (Act No. 63 of 1982), if the professional practice or
conduct of such person is legal and within the scope of his or her profession.

Supersession

10. A practitioner shall not supersede or take over a patient from another practitioner if
he or she is aware that such patient is in active treatment of another practitioner,
unless he or she –

(a) takes reasonable steps to inform the other practitioner that he or she has taken
over the patient at such patient’s request; and

(b) establishes from the other practitioner what treatment such patient previously
received, especially what medication, if any, was prescribed to such patient

12
 13

and in such case the other practitioner shall be obliged to provide such
required information.

Impeding a patient

11. A practitioner shall not impede a patient, or in the case of a minor, the parent or
guardian of such minor, from obtaining the opinion of another practitioner or from
being treated by another practitioner.

Professional reputation of colleagues

12. A practitioner shall not cast reflections on the probity, professional reputation or skill
of another person registered under the Act or any other Health Act.

Professional confidentiality

13. (1) A practitioner shall divulge verbally or in writing information regarding a patient
which he or she ought to divulge only -
(a) in terms of a statutory provision;
(b) at the instruction of a court of law; or
(c) where justified in the public interest.

(2) Any information other than the information referred to in subrule (1) shall be
divulged by a practitioner only –

(a) with the express consent of the patient;

(b) in the case of a minor under the age of 12 years, with the written consent
of his or her parent or guardian; or

(c) in the case of a deceased patient, with the written consent of his or her
next-of-kin or the executor of such deceased patient’s estate.

Retention of human organs

14. (1) A practitioner shall only for research, educational, training or prescribed
purposes retain the organs of a deceased person during an autopsy.

(2) The retention of organs referred to in subrule (1) shall be subject –

(a) to the express written consent given by the patient concerned during his or
her lifetime;

(b) in the case of a minor under the age of 14 years, to the written consent of
such minor’s parent or guardian; or

13
 14

(c) in the case of a deceased patient who had not previously given such
written consent, to the written consent of his or her next-of-kin or the
executor of his or her estate.

Signing of official documents

15. A student, intern or practitioner who, in the execution of his or her professional
duties, signs official documents relating to patient care, such as prescriptions,
certificates (excluding death certificates), patient records, hospital or other reports,
shall do so by signing such document next to his or her initials and surname printed
in block letters.

Certificates and reports

16. (1) A practitioner shall grant a certificate of illness only if such certificate contains
the following information –

(a) the name, address and qualification of such practitioner;

(b) the name of the patient;

(c) the employment number of the patient (if applicable);

(d) the date and time of the examination;

(e) whether the certificate is being issued as a result of personal

observations by such practitioner during an examination, or as a result of
information which has been received from the patient and which is
based on acceptable medical grounds;

(f) a description of the illness, disorder or malady in layman’s terminology

with the informed consent of the patient: Provided that if such patient is
not prepared to give such consent, the practitioner shall merely specify
that, in his or her opinion based on an examination of such patient, such
patient is unfit to work;

(g) whether the patient is totally indisposed for duty or whether such patient
is able to perform less strenuous duties in the work situation;

(h) the exact period of recommended sick leave;

(i) the date of issue of the certificate of illness; and

(j) the initial and surname in block letters and the registration number of the
practitioner who issued the certificate.

(2) A certificate of illness referred to in subrule (1) shall be signed by a

practitioner next to his or her initials and surname printed in block letters.
(3) If preprinted stationery is used, a practitioner shall delete words which are not
applicable.

14
 15

(4) A practitioner shall issue a brief factual report to a patient where such patient
requires information concerning himself or herself.

Issuing of prescriptions

17. (1) A practitioner authorized in terms of the Medicines and Related Substances
Act, 1965 (Act No. 101 of 1965), to prescribe medicines shall issue
typewritten, handwritten, computer-generated, pre-typed, pre-printed or
standardized prescriptions for medicine scheduled in Schedules I, 2, 3 and 4
of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965),
subject thereto that such prescriptions may be issued only under his or her
personal and original signature.

(2) A practitioner authorized in terms of the Medicines and Related Substances

Act, 1965 (Act No. 101 of 1965), to prescribe medicines shall issue
handwritten prescriptions for medicine scheduled in Schedules 5, 6, 7 and 8 of
the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965),
under his or her personal and original signature.

Professional appointments

18. (1) A practitioner shall accept a professional appointment or employment from

employers approved by the council only in accordance with a written contract
of appointment or employment which is drawn up on a basis which is in the
interest of the public and the profession.

(2) A written contract of appointment or employment referred to in subrule (1)

shall be made available to the council at its request.

Secret remedies

19. A practitioner shall in the conduct and scope of his or her practice, use only –
(a) a form of treatment, apparatus or health technology which is not secret and
which is not claimed to be secret; and
(b) an apparatus or health technology which proves upon investigation to be
capable of fulfilling the claims made in regard to it.

Defeating or obstructing the council or board in the performance of its duties

20. A practitioner shall at all times cooperate and comply with any lawful instruction,
directive or process of the council, a board, a committee of such board or an official
of council and in particular, shall be required, where so directed to –

(a) respond to correspondence and instructions from the council, such board, a
committee of such board or an official of council within the stipulated time
frames; and

(b) attend consultation at the time and place stipulated by the council, such board,
a committee of such board or an official of council.

15
 16

Performance of professional acts

21. A practitioner shall perform, except in an emergency, only a professional act -

(a) for which he or she is adequately educated, trained and sufficiently
experienced; and

(b) under proper conditions and in appropriate surroundings.

Exploitation

22. A practitioner shall not permit himself or herself to be exploited in any manner.

Medicine and medical devices

23. (1) A practitioner shall not participate in the manufacture for commercial
purposes, or in the sale, advertising or promotion of any medicine or medical
device or in any other activity that amounts to selling medicine or medical
devices to the public or keeping an open shop or pharmacy,

(2) A practitioner shall not engage in or advocate the preferential use or

prescription of any medicine or medical device which, save for the valuable
consideration he or she may derive from such preferential use or prescription,
would not be clinically appropriate or the most cost-effective option.

(3) The provisions of subrules (1) and (2) shall not prohibit a practitioner from -

(a) owning shares in a listed company;

(b) manufacturing or marketing medicines whilst employed by a

pharmaceutical concern;

(c) whilst employed by a pharmaceutical concern in any particular capacity,

performing such duties as are normally in accordance with such
employment; or

(d) dispensing in terms of a licence issued in terms of the Medicines and

Related Substances Act, 1965.

(4) A practitioner referred to in subrule (3) shall display a conspicuous notice in

his or her waiting room and also duly inform his or her patient about the fact
that he or she -

(a) owns shares or has a financial interest in a listed public company that
manufactures or markets the medicine or medical device prescribed for that
patient; or

(b) is in the employ of or contractually engaged by the pharmaceutical or

medical device company that manufactures such medicine or medical device,

16
 17

and shall, subject to subrule (5), obtain the patient's informed written consent
prior to prescribing such medicine or medical device for that patient."; and

(5) A practitioner may prescribe or supply medicine or a medical device to a

patient: Provided that such practitioner has ascertained the diagnosis of the
patient concerned through a personal examination of the patient or by virtue of
a report by another practitioner under whose treatment the patient is or has
been and such medicine or medical device is clinically indicated, taking into
account the diagnosis and the individual prognosis of the patient, and affords
the best possible care at a cost-effective rate compared to other available
medicines or medical devices and the patient is informed of such other
available medicines or medical devices,

(6) In the case of a patient with a chronic disease the provision of subrule (5) shall
not apply.

Financial interests in hospitals

23A. A practitioner may have a direct or indirect financial interest or shares in a hospital
or any other health care institution: Provided that -

(a) such interests or shares are purchased at market-related prices in arm's length
transactions;

(b) the purchase transaction or ownership of such interest or shares does not impose
conditions or terms upon the practitioner that will detract from the good, ethical
and safe practice of his or her profession;

(c) the returns on investment or payment of dividends is not based on patient

admissions or meeting particular targets in terms of servicing patients;

(d) such practitioner does not over-service patients and to this end establishes
appropriate peer review and clinical governance procedures for the treatment and
servicing of his or her patients at such hospital or health care institution;

(e) such practitioner does not participate in the advertising or promotion of the
hospital or health care institution, or in any other activity that amounts to such
advertising or promotion;

(f) such practitioner does not engage in or advocate the preferential use of such
hospital or health care institution;

(g) the purchase agreement is approved by the council based on the criteria listed in
paragraphs (a) to (f) above; and

17
 18

(h) such practitioner annually submit a report to the council indicating the number of
patients referred by him or her or his or her associates or partners to such
hospital or health care institution and the number of patients referred to other
hospitals in which he or she or his or her associates or partners hold no shares.
Referral of patients to hospitals

24. (1) A practitioner who has a direct or indirect financial interest or shares in a
private clinic or hospital shall refer a patient to such clinic or hospital only if
a conspicuous notice is displayed in his or her waiting room indicating that
he or she has a financial interest or shares in that clinic or hospital and the
patient is duly informed about the fact that the practitioner has an interest
or shares in the clinic or hospital to which the patient is referred and the
patient's informed written consent is obtained prior to such referral.

(2) Deleted

(3) Deleted

(4) Deleted

(5) Deleted

(6) A practitioner may admit a patient to such private clinic or hospital:

Provided that such practitioner -

(a) has ascertained the diagnosis of the patient concerned through a

personal examination of such patient or by virtue of a report by another
practitioner under whose treatment such patient is or has been;

(a) has informed such patient that such admission in such private clinic or
hospital was necessary for his or her treatment; and

(b) has obtained such patient’s consent for admission to such private clinic
or hospital.

Reporting of impairment or of unprofessional, illegal or unethical conduct

25. (1) A student, intern or practitioner shall -

(a) report impairment in another student, intern or practitioner to the board if

he or she is convinced that such student, intern or practitioner is
impaired;

(b) report his or her own impairment or suspected impairment to the board
concerned if he or she is aware of his or her own impairment or has
been publicly informed, or has been seriously advised by a colleague to
act appropriately to obtain help in view of an alleged or established
impairment, and

18
 19

(c) report any unprofessional, illegal or unethical conduct on the part of

another student, intern or practitioner.

Research, development and use of chemical, biological and nuclear capabilities

26. (1) A practitioner who is or becomes involved in research, development or use of

defensive chemical, biological or nuclear capabilities shall obtain prior written
approval from the board concerned to conduct such research, development or
use.

(2) In applying for written approval referred to in subrule (1), such practitioner
shall provide the following information to the board concerned:

(a) Full particulars of the nature and scope of such research, development
or use;

(b) whether the clinical trials pertaining to such research have been passed
by a professionally recognized research ethics committee;

(c) that such research, development or use is permitted in terms of the

provisions of the World Medical Association’s Declaration on Chemical
and Biological Weapons; and

(d) that such research, development or use is permitted in terms of the

provisions of the applicable international treaties or conventions to which
South Africa is a signatory.

Multiple registration

27. A health practitioner who holds registration with more than one statutory council or
professional board or in one or more categories within the same professional board
shall at all times ensure that -

(a) no conflict of interest arises from such multiple registration in the

rendering of health services to patients;

(b) patients are clearly informed at the start of the consultation of the
profession in which the practitioner is acting;

(c) informed consent regarding the profession referred to in paragraph (b) is

obtained from the said patient;

(d) patients are not consulted in more than one capacity or charged fees
based on more than one such consultation; and

19
 20

(e) no patients may be serviced by the same health practitioner in more

than one capacity

(f) the ethical rules applicable at a given moment to the profession in which
the practitioner is acting, are strictly adhered to.

Main responsibilities of health practitioners

27A. A practitioner shall at all times

(a) act in the best interests of his or her patients;

(b) respect patient confidentiality, privacy, choices and dignity;

(c) maintain the highest standards of personal conduct and integrity;

(d) provide adequate information about the patient's diagnosis, treatment

options and alternatives, costs associated with each such alternative and
any other pertinent information to enable the patient to exercise a choice in
terms of treatment and informed decision-making pertaining to his or her
health and that of others;

(e) keep his or her professional knowledge and skills up to date;

(f) maintain proper and effective communication with his or her patients and
other professionals;

(g) except in an emergency, obtain informed consent from a patient or, in the
event that the patient is unable to provide consent for treatment himself or
herself, from his or her next of kin; and

(h) keep accurate patient records.

Repeal

28. The Rules Specifying the Acts or Omissions in respect of which Disciplinary Steps
may be taken by a Professional Board and the Council, published under
Government Notice No. R. 2278 of 3 December 1976 and Government Notice No.
R. 1379 of 12 August 1994, as amended by Government Notice No. R. 1405 of 22
December 2000 are hereby repealed.

20
 21

ANNEXURES

ANNEXURE 1

PROFESSIONAL BOARD FOR DENTAL THERAPY AND ORAL HYGIENE

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSIONS OF

DENTAL THERAPY,

ORAL HYGIENE AND DENTAL ASSISTANTS

A dental therapist, student in dental therapy, an oral hygienist, a student in oral hygiene
and a dental assistant shall adhere to the following rules of conduct in addition to the rules
of conduct referred to in rules 2 to 27. Failure by such dental therapist, student in dental
therapy, oral hygienist and student in oral hygiene to comply with the rules of conduct
listed herein shall constitute an act or omission in respect of which the board may take
disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by dental therapist

1. A dental therapist –
(a) shall confine himself or herself to clinical diagnosis and practice in the field of
dental therapy in which he or she was educated and trained and in which he or
she has gained experience, regard being had to both the extent and the limits
of his or her professional expertise;
(b) shall communicate and co-operate with dentists, dental specialists, dental
therapists and other registered practitioners in the diagnosis and treatment of a
patient;
(c) shall not conduct a private practice unless he or she has met the requirements
of the board and practised for at least one year under the control and
supervision of a dentist or another dental therapist approved by the board;
(d) shall refer the following cases to a dentist or dental specialist for treatment:
(i) Pulpal exposure, excluding the emergency treatment thereof;
(ii) impacted teeth; and

21
 22

(iii) oral diseases and dental abnormalities, such as tumours, mucosal

diseases, developmental defects and infections;
(e) shall not remove the roots of teeth by any way other than the use of hand
instruments or make any incision into the soft tissues during such removal; and
(f) shall not manufacture or repair dentures or other dental appliances which
involve the taking of impressions.

Performance of professional acts by oral hygienist

2. An oral hygienist –
(a) shall confine himself or herself to clinical practice in the field of oral hygiene in
which he or she was educated and trained and in which he or she has gained
experience, regard being had to both the extent and the limits of his or her
professional expertise;
(b) shall communicate and cooperate with dentists, dental therapists and other
registered practitioners in the treatment of a patient; and
(c) shall not conduct a private practice unless he or she has met the requirements
of the board.

Performance of professional acts by dental assistant

3. A dental assistant shall perform professional acts only under the supervision of a
registered practitioner and shall limit such acts to acts directly related to his or her
education and training in dental assistance.

Performance of professional acts by student in dental therapy

4. A student in dental therapy shall perform professional acts only under the supervision
of a registered practitioner and shall limit such acts to acts directly related to his or
her education and training in dental therapy.

Performance of professional acts by student in oral hygiene

22
 23

5. A student in oral hygiene shall perform professional acts only under the supervision
of a dentist, dental therapist, an oral hygienist or other registered practitioner and
shall limit such acts to acts directly related to his or her education and training in oral
hygiene.

23
 24

ANNEXURE 2

PROFESSIONAL BOARD FOR DIETETICS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

DIETETICS

A dietitian, food service manager, nutritionist, student in dietetics, student in food service
management and student in nutrition shall adhere to the following rules of conduct in
addition to the rules of conduct referred to in rules 2 to 27. Failure by such dietitian, food
service manager, nutritionist, student in dietetics, student in food service management and
student in nutrition to comply with the rules of conduct listed herein shall constitute an act
or omission in respect of which the board may take disciplinary steps in terms of Chapter IV
of the Act.

Performance of professional acts by a dietitian

1. A dietitian –
(a) shall confine himself or herself to the performance of professional acts in the
field of dietetics in which he or she was educated and trained and in which he
or she has gained experience; and
(b) shall not fail to communicate and cooperate with other registered practitioners
in the treatment of a patient.

Performance of professional acts by assistant dietitian

2. An assistant dietitian -
(a) shall perform professional acts in dietetics only under the supervision of a
dietitian or nutritionist;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his
or her education and training in dietetics; and
(c) shall not conduct a private practice.

24
 25

Performance of professional acts by food service manager

3. A food service manager shall confine himself or herself to the performance of

professional acts in the field of food service management in which he or she was
educated and trained and in which he or she has gained experience.

Performance of professional acts by nutritionist

4. A nutritionist –
(a) shall perform professional acts only under the supervision of a registered
practitioner and shall limit such acts to acts directly related to his or her
education and training; and
(b) shall not conduct a therapeutic private practice.

Performance of professional acts by assistant nutritionist

5. An assistant nutritionist -
(a) shall perform professional acts in nutrition only under the supervision of a
nutritionist or dietitian;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training; and
(c) shall not conduct a private practice.

Performance of professional acts by student in dietetics

6. A student in dietetics shall perform professional acts only under the supervision of a
registered practitioner and shall limit such acts to acts directly related to his or her
education and training.

Performance of professional acts by student in food service management

25
 26

7. A student in food service management shall perform professional acts only under
the supervision of a registered practitioner and shall limit such acts to acts directly
related to his or her education and training.

Performance of professional acts by student in nutrition

8. A student in nutrition shall perform professional acts only under the supervision of a
registered practitioner and shall limit such acts to acts directly related to his or her
education and training.

26
 27

ANNEXURE 3

PROFESSIONAL BOARD FOR EMERGENCY CARE PRACTITIONERS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

EMERGENCY CARE

A basic ambulance assistant, an emergency care assistant, ambulance emergency

assistant, operational emergency orderly, a paramedic student basic ambulance
assistant, student emergency care assistant, student ambulance emergency assistant or
student paramedic shall adhere to the following rules of conduct in addition to the rules of
conduct referred to in rules 2 to 27. Failure by such basic ambulance assistant, emergency
care assistant, ambulance emergency assistant, operational emergency orderly and
paramedic or student basic ambulance assistant, student emergency care assistant,
student ambulance emergency assistant, student operational emergency orderly or student
paramedic to comply with the additional rules of conduct listed herein shall constitute an act
or omission in respect of which the board may take disciplinary steps in terms of Chapter IV
of the Act.

Performance of professional acts by basic ambulance assistant, emergency care

assistant, ambulance emergency assistant, operational emergency orderly or
paramedic

1. Notwithstanding the provisions of rule 21, a basic ambulance assistant, an

emergency care assistant, ambulance emergency assistant, operational emergency
orderly or a paramedic –
(a) shall not perform any professional act or exercise any capability in respect of
any incident, other than the acts set out in the relevant protocol or annexure
to such protocol approved by the board; and
(b) shall not hand over the responsibility for the treatment of a patient to any
person who is less qualified or experienced than himself or herself, unless
such basic ambulance assistant, emergency care assistant, ambulance
emergency assistant, operational emergency care orderly or paramedic
assumes full responsibility for the acts falling within his or her scope of
practice.

27
 28

Performance of professional acts by student basic ambulance assistant, student

emergency care assistant, student ambulance emergency assistant or student paramedic

2. A student basic ambulance assistant shall perform professional acts only under the
supervision of a registered emergency care assistant and, in the case of a student
emergency care assistant, student ambulance emergency assistant, student
operational emergency care orderly or student paramedic only under the
supervision of a medical practitioner or a paramedic and shall limit such acts to
acts directly related to his or her education and training.

28
 29

ANNEXURE 4

PROFESSIONAL BOARD FOR ENVIRONMENTAL HEALTH PRACTITIONERS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

ENVIRONMENTAL HEALTH

An environmental health practitioner, environmental health assistant, a food inspector and

a student in environmental health shall adhere to the following rules of conduct in addition
to the rules of conduct referred to in rules 2 to 27. Failure by such environmental health
practitioner, environmental health assistant, food inspector and student in environmental
health to comply with the rules of conduct listed herein shall constitute an act or omission in
respect of which the board may take disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by environmental health practitioner

1. An environmental health practitioner –

(a) shall confine himself or herself to practising in the field of environmental
health in which he or she was educated and trained; and
(b) shall not conduct a private practice without meeting the requirements of the
board.

Performance of professional acts by environmental health assistant

2. An environmental health assistant –

(a) shall perform professional acts only under supervision of an environmental
health practitioner;
(b) shall confine himself or herself to practising in the field of environmental
health in which he or she was educated and trained; and
(c) shall not conduct a private practice.

Performance of professional acts by food inspector

29
 30

3. A food inspector –
(a) shall perform professional acts only under the supervision of an
environmental health practitioner;
(b) shall confine himself or herself to practising in the field of environmental
health in which he or she was educated and trained; and
(c) shall not conduct a private practice.

Performance of professional acts by student in environmental health

4. A student in environmental health shall perform professional acts only under the
supervision of an environmental health practitioner.

30
 31

ANNEXURE 5

PROFESSIONAL BOARD FOR MEDICAL TECHNOLOGY

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

MEDICAL TECHNOLOGY

A medical technologist, medical technician, an intern medical technologist and a student in

biomedical technology shall adhere to the following rules of conduct in addition to the rules
of conduct referred to in rules 2 to 27. Failure by such medical technologist, medical
technician, intern medical technologist and student in biomedical technology to comply with
the rules of conduct listed herein shall constitute an act or omission in respect of which the
board may take disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by medical technologist

1. A medical technologist –
(a) shall confine himself or herself to practising in the specific discipline of
medical technology in which he or she was educated, trained and registered;
(b) shall not conduct a private practice without obtaining -
(i) postgraduate experience of at least two years; and
(ii) prior written approval from the board; and
(c) shall, if he or she does not comply with the provisions of paragraph (b), perform
professional acts only under the direction of a medical practitioner or medical
scientist who is registered in the relevant discipline: Provided that this
prohibition shall apply only to acts excluded, as determined by the board.

Performance of professional acts by medical technician

2. A medical technician –
(a) shall confine himself or herself to practising in the specific discipline of
medical technology in which he or she was educated, trained and registered;
(b) shall perform professional acts only under the supervision of a medical
practitioner or medical technologist who is registered in the relevant
discipline; and

31
 32

(c) shall not conduct a private practice.

Performance of professional acts by intern medical technologist

3. An intern medical technologist –

(a) shall perform professional acts only under the supervision of a practitioner
who is registered in the relevant discipline;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training as part of the formal internship in his or her
discipline of study;
(c) shall not conduct a private practice; and
(d) if he or she has completed his or her internship, shall not perform any
professional acts until he or she has satisfied all the academic requirements
for registration as a medical technologist and has been registered as such.

Performance of professional acts by student in medical technology

4. A student in medical technology –

(a) shall perform professional acts only under the supervision of a practitioner
who is registered in the relevant discipline; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in his or her discipline of study.

Performance of professional acts by laboratory assistant

5. A laboratory assistant –
(a) shall confine himself or herself to performing acts in the specific discipline of
medical technology in which he or she is educated, trained and registered;
(b) shall perform professional acts only under the supervision of a medical
practitioner or
medical technologist who is registered in the relevant discipline; and
(c) shall not conduct a private practice.

32
 33

ANNEXURE 6

MEDICAL AND DENTAL PROFESSIONS BOARD

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE MEDICAL AND

DENTAL PROFESSIONS

A medical practitioner, dentist, medical specialist, dental specialist, biomedical engineer,

clinical biochemist, genetic counsellor, medical biological scientist, medical physicist, an
intern in biomedical engineering, intern in clinical biochemistry, intern in genetic
counselling, intern in medical biological science and intern in medical physics shall adhere
to the following rules of conduct in addition to the rules of conduct referred to in rules 2 to
27. Failure by such medical practitioner, dentist, medical specialist, dental specialist,
biomedical engineer, clinical biochemist, genetic counsellor, medical biological scientist,
medical physicist, intern in biomedical engineering, intern in clinical biochemistry, intern in
genetic counselling, intern in medical biological science and intern in medical physics to
comply with the rules of conduct listed herein shall constitute an act or omission in respect
of which the board may take disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by medical practitioner or medical specialist

1. A medical practitioner or medical specialist -

(a) shall perform professional acts only in the field of medicine in which he or she
was educated and trained and in which he or she has gained experience,
regard being had to both the extent and the limits of his or her professional
expertise;
(b) shall not fail to communicate and cooperate with medical practitioners, medical
specialists and other health practitioners in the diagnosis and treatment of a
patient; and
(c) shall not sign official documents such as reports, certificates or prescriptions
unless his or her name is printed next to his or her signature.

33
 34

Performance of professional acts by dentist or dental specialist

2. A dentist or dental specialist –

(a) shall perform professional acts only in the field of dentistry in which he or she
was educated and trained and in which he or she has gained experience,
regard being had to both the extent and the limits of his or her professional
expertise;
(b) shall not fail to communicate and cooperate with dentists, dental specialists and
other health practitioners in the diagnosis and treatment of a patient; and
(c) shall not sign official documents such as reports, certificates or prescriptions
unless his or her name is printed next to his or her signature.

Partnerships and juristic persons

3. (1) Where a patient is seen -

(a) by both a medical specialist or a dental specialist and a medical
practitioner or a dentist practising as specified in rule 8(3), such
specialist and medical practitioner or dentist shall charge the fees
applicable to either the medical practitioner or the dentist and not those
applicable to a medical specialist or a dental specialist; and
(b) by a medical specialist or a dental specialist only, the fees applicable to
such specialist may be charged.

(2) The provisions in rule 8 (3) shall be limited in that -

(a) a medical specialist who practises in one of the prescribed related
specialities in medical pathology shall be excluded from the concession
to form an incorporated practice in terms of section 54A, or to form a
partnership or association with a medical practitioner, a medical
specialist or another practitioner who does not practise in one of the
related specialities in medical pathology;
(b) a medical specialist who practises in diagnostic radiology shall be
excluded from the concession to form an incorporated practice in terms
of section 54A, or to form a partnership or association with a medical

34
 35

practitioner, medical specialist or another practitioner who does not

practise in the speciality diagnostic radiology;
(c) the only exception to the restriction pertaining to specialities in medical
pathology referred to in paragraph (a) hereof shall be that a pathologist
shall be permitted to form an incorporated practice, partnership or
association with a medical technologist registered in the relevant
discipline in view of the fact that the said two professions are related to
each other in terms of the nature of the field of professional practice;
and
(d) the only exception to the restriction pertaining to radiology referred to in
paragraph (b) hereof shall be that a radiologist shall be permitted to
form an incorporated practice, partnership or association with a nuclear
physician or a radiographer registered in the relevant discipline in view
of the fact that the said two medical professions are related to each
other in terms of the nature of their field of professional practice.

Medical specialist and dental specialist

4. A medical specialist and a dental specialist shall adhere to the Regulations

relating to the Specialities and Subspecialities in Medicine and Dentistry,
published under Government Notice No. R. 590 of 29 June 2001.

Performance of professional acts by biomedical engineer, clinical biochemist,

genetic counsellor, medical biological scientist, medical physicist

5. A biomedical engineer, a clinical biochemist, a genetic counsellor, a medical

biological scientist and a medical physicist –
(a) shall perform professional acts only at the request of and in consultation with a
medical practitioner or dentist;
(b) shall perform professional acts directly related to the treatment or diagnosis of
a patient, in close cooperation with the medical practitioner or dentist
concerned with the diagnosis or treatment of such patient; and

35
 36

(c) shall not sign official documents such as reports, certificates or prescriptions,
unless his or her name is printed next to his or her signature.

Performance of professional acts by intern in medicine

6. An intern in medicine -
(a) shall perform acts as part of a structured internship training programme at an
approved facility only under the supervision of a medical practitioner as
prescribed for this purpose and in accordance with the guidelines of the board;
(b) shall limit acts referred to in (a) to acts related to his or her education and
training as part of a structured internship programme;
(c) shall not conduct a private practice;
(d) shall not act as a locum or perform professional acts in a private practice;
(e) if he or she has completed his or her internship, shall not perform any
professional act until he or she has satisfied all the academic requirements for
registration as a medical practitioner and has been registered as such; and
(f) shall not sign official documents such as reports, certificates or prescriptions,
unless his or her name is printed next to his or her signature.

Performance of professional acts by interns in biomedical engineering, clinical

biochemistry, genetic counselling, medical biological science or medical physics

7. An intern in biomedical engineering, clinical biochemistry, genetic counselling,

medical biological science or medical physics –
(a) shall perform professional acts as part of a structured internship training
programme at an approved facility only under the supervision of a practitioner
as prescribed for this purpose and in accordance with the guidelines of the
board;

(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training as part of a structured internship programme in his or her
discipline of study;
(c) shall not conduct a private practice;

36
 37

(d) shall not act as a locum or perform professional acts in a private practice;
(e) if he or she has completed his or her internship, shall not perform any
professional act until he or she
has satisfied all the academic requirements for registration as a medical
scientist and has
been registered as such; and
(f) shall not sign official documents such as reports, certificates or prescriptions,
unless his or her
name is printed next to his or her signature.

Performance of professional acts by student in medicine or dentistry

8. A student in medicine or dentistry -

(a) shall perform professional acts only under the supervision of a practitioner
approved for this purpose by the board;
(b) shall limit acts referred to in (a) to acts related to his or her education and
training;
(c) shall not conduct a private practice; and
(d) shall not act as a locum or perform professional acts in a private practice.

37
 38

ANNEXURE 7

PROFESSIONAL BOARD FOR OCCUPATIONAL THERAPY AND

MEDICAL ORTHOTICS OR PROSTHETICS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

OCCUPATIONAL THERAPY AND MEDICAL ORTHOTICS OR PROSTHETICS

An occupational therapist, occupational therapy assistant, occupational therapy technician,

a student in occupational therapy, an arts therapist, student in arts therapy, medical
orthotist or prosthetist, an orthopaedic footwear technician, assistant medical orthotist or
prosthetist, leatherworker and student in medical orthotics or prosthetics shall adhere to the
following rules of conduct in addition to the rules of conduct referred to in rules 2 to 27.
Failure by such occupational therapist, occupational therapyassistant, occupational therapy
technician, student in occupational therapy, arts therapist, student in arts therapy, medical
orthotist or prosthetist, orthopaedic footwear technician, assistant medical orthotist or
prosthetist, leatherworker and student in medical orthotics or prosthetics to comply with the
rules of conduct listed herein shall constitute an act or omission in respect of which the
board may take disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by an occupational therapist

1. An occupational therapist –
(a) shall perform professional acts only in the field of occupational therapy in
which he or she was educated and trained and in which he or she has gained
experience, regard being had to both the extent and the limits of his or her
professional expertise;
(b) shall communicate and cooperate with medical practitioners and other
registered health practitioners in the diagnosis and treatment of a patient; and
(c) in private practice may not employ any person as an occupational therapy
assistant or an occupational therapy technician without the prior written
approval of the board: Provided that this prohibition shall not apply in the case
of a full-time or part-time appointment in the public service.

38
 39

Performance of professional acts by occupational therapy assistant

2. An occupational therapy assistant –

(a) shall perform professional acts only under the supervision of an occupational
therapist or appropriately qualified registered practitioner: Provided that in the
case of supervision under an appropriately qualified registered practitioner,
such supervision shall not extend for a period of more that six months;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in his or her discipline of study;
(c) shall not accept employment without the prior written approval of the board:
Provided that this prohibition shall not apply in the case of a full-time or part-
time appointment in the public service; and
(d) shall not conduct a private practice.

Performance of professional acts by occupational therapy technician

3. An occupational therapy technician –

(a) shall perform professional acts only under the supervision of an occupational
therapist or an appropriately qualified registered practitioner: Provided that in
the case of supervision under an appropriately qualified registered practitioner,
such supervision shall not extend for a period of more than six months;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in his or her discipline of study;
(c) shall not accept an appointment without the prior written approval of the
board: Provided that this prohibition shall not apply in the case of a full-time or
part-time appointment in the public service; and
(d) shall not conduct a private practice.

39
 40

Performance of professional acts by student in occupational therapy

4. A student in occupational therapy –

(a) shall perform professional acts only under the supervision of an occupational
therapist or appropriately qualified registered practitioner: Provided that in the
case of supervision under an appropriately qualified registered practitioner,
such supervision shall not extend for a period of more than six months; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in occupational therapy.

Performance of professional acts by arts therapist

5. An arts therapist –
(a) shall perform professional acts only in the specific registered category of arts
therapy;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in which he or she has gained experience, regard
being had to both the extent and the limits of his or her professional expertise;
(c) shall not fail to communicate and cooperate, where appropriate, with medical
practitioners and other registered health practitioners in the diagnosis and
treatment of a patient; and
(d) shall not employ an occupational therapy assistant or an occupational therapy
technician without the prior written approval of the board: Provided that this
prohibition shall not apply in the case of a full-time or part-time appointment in
the public service.
Performance of professional acts by student in arts therapy

6. A student in arts therapy –

(a) shall perform professional acts only under the supervision of an arts therapist;
and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in the specific category of arts therapy.

40
 41

Performance of professional acts by medical orthotist or prosthetist

7. A medical orthotist or prosthetist –

(a) shall perform professional acts only in the field of medical orthotics or
prosthetics;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in which he or she has gained experience, regard
being had to both the extent and the limits of his or her professional expertise;
(c) shall not fail to communicate and cooperate, where appropriate, with medical
practitioners and other registered health practitioners in the diagnosis and
treatment of a patient; and
(d) shall not give any treatment in connection with or advice or assistance
preparatory to or for the purpose of the manufacture, repair, supply, fitting or
fixing of artificial limbs or other similar assistive devices, whether for gain or
not, where such devices are supplied or are to be supplied to the patient by a
person who is not a medical orthotist or prosthetist.

Performance of professional acts by orthopaedic footwear technician

8. An orthopaedic footwear technician –

(a) shall perform professional acts only under the supervision of a medical
orthotist or prosthetist;
(b) shall not conduct a private practice; and
(c) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in his or her discipline of study.

Performance of professional acts by assistant medical orthotist or prosthetist and

leatherworker

41
 42

9. An assistant medical orthotist or prosthetist and leatherworker –

(a) shall perform professional acts only under the supervision of a medical
orthotist or prosthetist;
(b) shall not conduct a private practice; and
(c) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in his or her discipline of study
Performance of professional acts by student in medical orthotics or prosthetics

10. A student in medical orthotics or prosthetics –

(a) shall perform professional acts only under the supervision of a medical
orthotist or prosthetist; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in medical orthotics or prosthetics.

42
 43

ANNEXURE 8

PROFESSIONAL BOARD FOR OPTOMETRY AND DISPENSING OPTICIANS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

OPTOMETRY AND DISPENSING OPTICIANS

An optometrist, a student in optometry, dispensing optician and dispensing optician student

shall adhere to the following rules of conduct in addition to the rules of conduct referred to
in rules 2 to 27. Failure by such optometrist, student in optometry, dispensing optician and
dispensing optician student to comply with the rules of conduct listed herein shall constitute
an act or omission in respect of which the board may take disciplinary steps in terms of
Chapter IV of the Act.

Performance of professional acts by optometrist

1. (1) An optometrist –
(a) shall provide only optometric services, including the prescription of spectacle
lenses, contact lenses and visual aids or appliances. In cases where
pathology of the visual system is detected or suspected, or where the patient
cannot attain normal single or binocular vision with the aid of corrective
lenses or other methods of correction, the optometrist should work in close
collaboration with a medical practitioner who has received adequate
education and training as approved by the board for this purpose; and
(b) shall , only in the treatment of a patient, use a scheduled substance subject to
the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965).

(2) Notwithstanding the requirements relating to the naming of practices referred

to in rule 5, an optometrist may make use of a practice name: Provided that -
(a) he or she obtains prior approval for the use of the practice name from the
board;
(b) such name or the use thereof is not indecent, misleading or deceptive and is
in keeping with the professional image or dignity of the profession and that
such practice name does not claim prominence for a registered optometrist;
and

43
 44

(c) the names of the responsible practitioners are displayed together with or
alongside the practice name.

Performance of professional acts by student in optometry

2. A student in optometry –
(a) shall perform professional acts only under the supervision of an optometrist or
medical practitioner; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in optometry.

Performance of professional acts by dispensing optician

3. A dispensing optician shall not dispense in any way spectacles to any person
except on a prescription written and signed by a medical practitioner or an optometrist:
Provided that this rule shall not apply to the repair or replacement of such spectacles or
lenses or frames for such spectacles.

Performance of professional acts by dispensing optician student

4. A dispensing optician student –

(a) shall perform professional acts only under the supervision of a dispensing
optician, optometrist or medical practitioner; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her training in optical dispensing.

44
 45

ANNEXURE 9

PROFESSIONAL BOARD FOR PHYSIOTHERAPY, PODIATRY AND BIOKINETICS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

PHYSIOTHERAPY, PODIATRY AND BIOKINETICS

A physiotherapist, physiotherapy assistant, student in physiotherapy, podiatrist, student in

podiatry, biokineticist and student in biokinetics shall adhere to the following rules of
conduct in addition to the rules of conduct referred to in rules 2 to 27. Failure by such
physiotherapist, physiotherapy assistant, student in physiotherapy, podiatrist, student in
podiatry, biokineticist and student in biokinetics to comply with the rules of conduct listed
herein shall constitute an act or omission in respect of which the board may take
disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by physiotherapist

1. A physiotherapist –
(a) shall confine himself or herself to clinical diagnoses and practising in the field
of physiotherapy in which he or she was educated and trained and in which
he or she has gained experience, regard being had to both the extent and the
limits of his or her professional expertise;
(b) shall not fail to communicate and cooperate, where appropriate with medical
practitioners in the diagnosis and treatment of a patient;
(c) shall refer a patient to a practitioner when the patient's problems and needs
are beyond the scope of physiotherapy; and
(d) shall not employ a physiotherapy assistant without the prior written approval
of the council: Provided that this prohibition shall not apply in the case of full-
time or part-time employment in the public service.

Performance of professional acts by physiotherapy assistant

2. A physiotherapy assistant shall not accept an appointment in private practice

without the prior written approval of the council: Provided that this prohibition shall
not apply in the case of a full-time or part-time appointment in the public service.

45
 46

Performance of professional acts by physiotherapy technician

3. A physiotherapy technician shall not accept an appointment in private practice

without the prior written approval of the council: Provided that this prohibition shall
not apply in the case of a full-time or part-time appointment in the public service.

Performance of professional acts by student in physiotherapy

4. A student in physiotherapy –
(a) shall perform professional acts pertaining to physiotherapy only under the
supervision of a physiotherapist or a medical practitioner; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in physiotherapy.

Performance of professional acts by podiatrist

5. A podiatrist –
(a) shall investigate and treat only disorders which fall within the scope of the
profession of podiatry;
(b) shall, in the treatment of any person, use only medicines or surgery which
have been specifically approved for that purpose by the board;
(c) shall administer local anaesthetic only for the purpose of relieving pain, the
specific medicine for which shall have been approved by the board and the
regulatory authority on medicines; and
(d) shall perform professional acts requiring general anaesthetic only in close
collaboration with a medical practitioner.

Performance of professional acts by student in podiatry

6. A student in podiatry –
(a) shall perform professional acts pertaining to podiatry only under the

46
 47

supervision of a podiatrist or a medical practitioner; and

(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in podiatry.

Performance of professional acts by biokineticist

7. A biokineticist –
(a) shall confine himself or herself to functional and clinical diagnoses, and
practising in the field of biokinetics in which he or she was educated and
trained and in which he or she has gained experience, regard being had to
both the extent and the limits of his or her professional expertise;
(b) shall not fail to communicate and cooperate, where appropriate, with medical
practitioners and other practitioners in the diagnosis and treatment of a
patient; and
(c) shall refer a patient to a practitioner when the patient's problems and needs
are beyond the scope of biokinetics.

Performance of professional acts by student in biokinetics

8. A student in biokinetics –
(a) shall perform professional acts pertaining to biokinetics only under the
supervision of a biokineticist or a medical practitioner; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in biokinetics.

47
 48

ANNEXURE 10

PROFESSIONAL BOARD FOR RADIOGRAPHY AND CLINICAL TECHNOLOGY

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

RADIOGRAPHY AND CLINICAL TECHNOLOGY

A radiographer, an assistant radiographer, a radiation laboratory technologist, student in

radiography, student radiation laboratory technologist, graduate clinical technologist or
clinical technologist (registered prior to 1 April 2002), clinical technologist (registered after
31 March 2002), an assistant clinical technologist, electroencephalography technician, a
student in clinical technology and a student electro-encephalography technician shall
adhere to the following rules of conduct in addition to the rules of conduct referred to in
rules 2 to 27. Failure by such radiographer, assistant radiographer, radiation laboratory
technologist, student in radiography, student radiation laboratory technologist, graduate
clinical technologist or clinical technologist (registered prior to 1 April 2002), clinical
technologist (registered after 31 March 2002), assistant clinical technologist,
electroencephalography technician, student in clinical technology and student electro-
encephalography technician to comply with the rules of conduct listed herein shall
constitute an act or omission in respect of which the board may take disciplinary steps in
terms of Chapter IV of the Act.

Performance of professional acts by radiographer

1. A radiographer –
(a) shall perform professional acts only at the written request and under the
supervision of a practitioner approved by the board for such purpose: Provided
that this prohibition shall not apply in respect of –
(i) acts pertaining to the profession of radiography determined by the
board for such purpose;
(ii) a radiographer who complies with the conditions set by the board in this
regard and who in the opinion of such board is competent to perform
professional acts without supervision at the written request of such
practitioner; and

48
 49

(iii) a request from such practitioner which in the opinion of the radiographer
was based on good and sufficient grounds: Provided that such request
was in writing and signed by the person making the request;
(b) shall consult in regard to any work performed by him or her in his or her
profession only with a practitioner approved by the board at whose instance
such work was undertaken;
(c) shall not interpret radiographical investigations, report thereon or furnish
information in regard to any work performed by him or her in his or her
profession to any person other than a practitioner approved by the board at
whose request such work was undertaken; and
(d) shall not in his or her practice exceed the limits of the category or categories
in which he or she is registered.

Performance of professional acts by assistant radiographer

2. An assistant radiographer –
(a) shall perform professional acts in radiography only under the supervision of a
registered practitioner approved by the board or radiographer;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in radiography;
(c) shall not conduct a private practice; and
(d) shall not perform any diagnostic X-ray examination in any place other than a
hospital or facility in the public service or operated by the South African
Chamber of Mines or such other facility as may be approved by the board for
a specific purpose.

49
 50

Performance of professional acts by radiation laboratory technologist

3. A radiation laboratory technologist -

(a) shall perform professional acts in radiation laboratory technology only under
the supervision of a registered practitioner approved by the board or a
radiographer;
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in radiation laboratory technology; and
(c) shall not conduct a private practice.

Performance of professional acts by student in radiography

4. A student in radiography –
(a) shall perform professional acts in radiography only under the supervision of a
registered practitioner approved by the board or a radiographer; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in radiography.

Performance of professional acts by student radiation laboratory technologist

5. A student radiation laboratory technologist –

(a) shall perform professional acts in radiation laboratory technology only under
the supervision of a registered practitioner approved by the board or a
radiographer; and
(b) shall limit the acts referred to in paragraph (a) to acts directly related to his or
her education and training in radiation laboratory technology.

Performance of professional acts by graduate clinical technologist or clinical

technologist registered prior to 1 April 2002

50
 51

6. A graduate clinical technologist or clinical technologist registered prior to 1 April

2002 –

(a) shall confine himself or herself to the performance of professional acts in the
field of clinical technology in which he or she was educated and trained and in
which he or she has gained experience, regard being had to both the extent
and the limits of his or her professional expertise;
(b) shall not fail to communicate and cooperate, where appropriate, with
registered practitioners approved by the board in the treatment of a patient;
and
(c) shall perform professional acts only in collaboration with a registered
practitioner approved by the board or a specialist.

Performance of professional acts by clinical technologist qualified after 31 March

2002

7. A clinical technologist who qualified as such after 31 March 2002 –

(a) shall perform professional acts only under the supervision of or in
collaboration with a registered practitioner approved by the board or a
specialist;
(b) shall confine himself or herself to the performance of professional acts in the
field of clinical technology in which he or she was educated and trained and in
which he or she has gained experience, regard being had to both the extent
and the limits of his or her professional expertise;
(c) shall not conduct a private practice; and
(d) shall not fail to communicate and cooperate, where appropriate, with
registered practitioners approved by the board in the treatment of a patient.

Performance of professional acts by assistant clinical technologist

8. An assistant clinical technologist -

(a) shall perform professional acts only in collaboration with clinical technologists,
specialists or practitioners approved by the board for such purpose;

51
 52

(b) shall confine himself or herself to the performance of professional acts in the
field of clinical technology in which he or she was educated and trained and in
which he or she has gained experience, regard being had to both the extent
and the limits of his or her professional expertise;
(c) shall not conduct a private practice; and
(d) shall not fail to communicate and cooperate, where appropriate, with
registered practitioners approved by the board in the treatment of a patient.

Performance of professional acts by electroencephalography technician

9. An electroencephalography technician –
(a) shall perform professional acts only under the supervision of clinical
technologists, specialists or practitioners approved by the board for such
purpose;
(b) shall limit the acts referred to in paragraph (a) to acts related to his or her
education and training in electroencephalography;
(c) shall not conduct a private practice; and
(d) shall not fail to communicate and cooperate, where appropriate, with
registered practitioners approved by the board in the treatment of a patient.

Performance of professional acts by student in clinical technology

10. A student in clinical technology –

(a) shall perform professional acts only under the supervision of clinical
technologists, specialists or practitioners approved by the board for such
purpose; and
(b) shall limit the acts referred to in paragraph (a) to acts related to his or her
education and training in clinical technology.

Performance of professional acts by student electroencephalography technician

11. A student electroencephalography technician –

52
 53

(a) shall perform professional acts only under the supervision of clinical
technologists, specialists or practitioners approved by the board for such
purpose; and
(b) shall limit the acts referred to in paragraph (a) to acts related to his or her
education and training in electroencephalography technology.

53
 54

ANNEXURE 11

PROFESSIONAL BOARD FOR SPEECH, LANGUAGE AND HEARING

PROFESSIONS

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE SPEECH, LANGUAGE

AND HEARING PROFESSIONS

A speech therapist, an audiologist, an audiometrician, a hearing aid acoustician, speech

and hearing correctionist, speech and hearing community worker, speech and hearing
assistant, student in speech profession, student in language profession and student in
hearing profession shall adhere to the following rules of conduct in addition to the rules of
conduct referred to in rules 2 to 27. Failure by such speech therapist, audiologist,
audiometrician, hearing aid acoustician, speech and hearing correctionist, speech and
hearing community worker, speech and hearing assistant, student in speech profession,
student in language profession and student in hearing profession to comply with the rules
of conduct listed herein shall constitute an act or omission in respect of which the board
may take disciplinary steps in terms of Chapter IV of the Act.

Performance of professional acts by speech therapist or audiologist

1. A speech therapist or an audiologist -

(a) shall confine himself or herself to clinical diagnoses, and practising in the field
of speech-language therapy or audiology in which he or she was educated and
trained and in which he or she has gained experience, with due regard to both
the extent and the limits of his or her professional expertise;
(b) shall not fail to communicate and cooperate, where appropriate, with medical
practitioners and other practitioners in the diagnosis and treatment of a patient;
and
(c) shall refer a patient to a practitioner or educational professional when the
patient's problems and needs are beyond the scope of speech-language
therapy or audiology.

54
 55

Performance of professional acts by audiometric Ian

2. An audiometrician -
(a) shall practice only in the appropriate fields in which he or she has been
trained and in which he or she has gained experience, with due regard to
both the extent and the limits of his or her professional expertise; and
(b) shall perform any work in audiometry only -
(i) under the supervision of an audiologist; or
(ii) with the prior written approval of the board, under the direction and
supervision of a medical practitioner or other practitioners approved by
the board.

Performance of professional acts by hearing aid acoustician

3. A hearing aid acoustician -

(a) shall confine himself or herself to practising in the appropriate fields in which
he or she has been trained and in which he or she has gained experience,
with due regard to both the extent and the limits of his or her professional
expertise;
(b) shall refer a patient to a practitioner when the patient’s problem is beyond the
scope of the practice of the hearing aid acoustician;
(c) shall not diagnose a person's hearing ability;
(d) shall not select and fit a hearing aid to children under the age of 10 years, or
to persons with multiple handicaps; and
(e) shall not affix his or her nameplate at the entrance of a pharmacy, unless he or
she is also registered as a pharmacist.

Performance of professional acts by speech and hearing correctionist

4. A speech and hearing correctionist –

(a) shall confine himself or herself to practising in the appropriate fields in which
he or she has been trained and in which he or she has gained experience,

55
 56

with due regard to both the extent and the limits of his or her professional
expertise;
(b) shall not perform any speech or language therapy or audiology, except in a
primary school, nursery school or school for the deaf or hearing impaired
controlled by the government or the provincial Department of Education
concerned or in such other institution as may be approved for this purpose by
the board;
(c) shall not perform any speech or language therapy or audiology, in assessment
and treatment clinics associated with education departments or other institutions,
except under the direct supervision of a speech therapist or audiologist; and
(d) shall not conduct a private practice.

Performance of professional acts by speech and hearing community worker

5. A speech and hearing community worker –

(a) shall confine himself or herself to the appropriate fields in which he or she has
been trained and in which he or she has gained experience, with due regard
to both the extent and the limits of his or her professional expertise;
(b) shall not perform any speech or language and hearing community work, except
when employed by an institution or establishment recognised by the board;
(c) shall not perform any speech or language and hearing community work in an
institution or establishment where a speech therapist or audiologist is employed
except under the direction of such speech therapist and/or audiologist;
(d) shall not perform any speech or language and hearing community work,
except in consultation with a general medical practitioner or, in cases
involving oral conditions, in consultation with a dentist;
(e) shall not perform any speech or language and hearing community work where
supervision by a speech therapist and/or an audiologist is possible, or regard
being had to geographical proximity where such supervision is not possible, in
consultation with a speech therapist or an audiologist; and
(f) shall not conduct a private practice.

56
 57

Performance of professional acts by speech and hearing assistant

6. A speech and hearing assistant –

(a) shall confine himself or herself to practising in the appropriate fields in which
he or she has been trained and in which he or she has gained experience,
with due regard to both the extent and the limits of his or her professional
expertise;
(b) shall perform professional acts only-
(i) under the direction and supervision or in the employment of a speech
therapist or an audiologist in the health or education sectors; and
(ii) with the approval of the board under the direction and supervision of a
general medical practitioner or other practitioner registered with the
board;
(c) shall not accept employment without the prior written approval of the board:
Provided that this prohibition shall not apply in the case of a full-time or part-
time appointment in the health or education sectors in the public service; and
(d) shall not conduct a private practice.

Performance of professional acts by student in the speech, language and hearing

professions

7. A student in the speech, language and hearing professions –

(a) shall perform professional acts only under supervision of a practitioner; and
(b) shall limit the acts referred to in paragraph (a) to acts related to his or her
education and training in the profession concerned.

57
 58

ANNEXURE 12

PROFESSIONAL BOARD FOR PSYCHOLOGY

RULES OF CONDUCT PERTAINING SPECIFICALLY TO THE PROFESSION OF

PSYCHOLOGY

A psychologist shall adhere to the following rules of conduct in addition to the rules of
conduct referred to in rules 2 to 27. Failure by such psychologist to comply with the rules
of conduct listed herein shall constitute an act or omission in respect of which the board
may take disciplinary steps in terms of Chapter IV of the Act.

1. Definitions

In these rules, any word or expression to which a meaning has been assigned in the Act
shall bear such meaning and, unless the context otherwise indicates - “Act” means the
Health Professions Act, 1974(Act No.56 of 1974); “barter” means the acceptance of
goods, services or other non- monetary remuneration from clients in return for
psychological services;

“board” means the Professional Board for Psychology established in terms of section 15
of the Act;
“children” means persons 14 years and younger and the word “child” has a similar
meaning;
“client” means a user of psychological services, irrespective of whether the recipient of
such services is an individual, a family, a group, an organisation or a community;
“competency” means the ability to conduct the psychological acts in which a
psychologist was trained and in which he obtained a qualification as prescribed in terms
of the Act; “
confidential information” means any information conveyed in confidence to a
psychologist by a client, colleague, collateral source or another professional;
“health committee” means a committee established by the council in terms of section
10(1) and the regulations made under section 51 of the Act;

58
 59

“intern” means a person registered as an intern in psychology under the Act;

“psychological services” means the acts of psychological assessment, diagnosis and
intervention rendered to a client;
“psychologist” includes a person registered under the Act as a psychologist, registered
counsellor, psychometrist, psycho-technician, intern in psychology or student in
professional psychology;
“psychometrist” means a person registered as a psychometrist in terms of the Act;
“psycho-technician” means a person registered as a psycho-technician in terms of the
Act; “registered counsellor” means a person registered as a registered counsellor in
terms of the Act; “section” means a section of the Act;
“sexual harassment” means any act of sexual solicitation, physical advances, or verbal
or nonverbal conduct that is sexual in nature that is committed by a psychologist in the
course of his or her professional activities and that is unwelcome or offensive or creates
an untenable situation in the workplace or educational environment;
“student” means a person registered under the Act as a student in professional
psychology;
“test data” means the test protocols, record forms, scores and notes regarding an
individual’s responses to test items in any medium;
“the code” means these rules.

59
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

NATIONAL PATIENTS’ RIGHTS CHARTER

BOOKLET 3

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

ETHICAL AND PROFESSIONAL RULES

Practice as a health care professional is based on a relationship of mutual

trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society.

In the course of their professional work health care practitioners are

required to subscribe to certain rules of conduct. To this end the Health

Professional Council of South Africa has formulated a set of rules

regarding professional conduct against which complaints of professional

misconduct will be evaluated. These rules are reproduced in this booklet.

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
 ii

TABLE OF CONTENTS

PREAMBLE .................................................................................................................................... 1

1 INTRODUCTION ............................................................................................................... 1

2 PATIENTS’ RIGHTS ......................................................................................................... 1

3 RESPONSIBILITIES OF THE PATIENT ........................................................................... 3

 1

NATIONAL PATIENTS’ RIGHTS CHARTER

PREAMBLE

The Department of Health, in consultation with various other bodies, developed a National
Patients’ Rights Charter.

The document contained herein was launched by the Minister of Health and agreed to by the
HPCSA. It has since been included in the Board’s Handbook for Interns, Accredited facilities and
Health Authorities.

NATIONAL PATIENTS’ RIGHTS CHARTER

1. INTRODUCTION

1.1 For many decades the vast majority of the South African population has experienced
either a denial or violation of fundamental human rights, including rights to health care
services.

1.2 To ensure the realisation of the right of access to health care services as guaranteed in
the Constitution of the Republic of South Africa, 1996 (Act No. 109 of 1996), the
Department of Health is committed to upholding, promoting and protecting this right and,
therefore, proclaims this PATIENTS’ RIGHTS CHARTER as a common standard for
achieving the realisation of this right.

1.3 Equally, Practitioners should adhere to the stipulations of this charter as it relates to them.

2. PATIENTS’ RIGHTS

2.1 HEALTHY AND SAFE ENVIRONMENT

Everyone has a right to a healthy and safe environment that will ensure their physical and
mental health or well-being, including adequate water supply, sanitation and waste
disposal, as well as protection from all forms of environmental danger, such as pollution,
ecological degradation or infection.

2.2 PARTICIPATION IN DECISION-MAKING

Every citizen has the right to participate in the development of health policies, whereas
everyone has the right to participate in decision-making on matters affecting one’s own
health.
 2
2.3 ACCESS TO HEALTH CARE

Everyone has the right to access to health care services that include -

a. receiving timely emergency care at any health care facility that is open,
regardless of one’s ability to pay;

b. treatment and rehabilitation that must be made known to the patient to enable
the patient to understand such treatment or rehabilitation and the consequences
thereof;

c. provision for special needs in the case of newborn infants, children, pregnant
women, the aged, disabled persons, patients in pain, persons living with HIV or
AIDS patients;

d. counselling without discrimination, coercion or violence on matters such as

reproductive health, cancer or HIV/AIDS;

e. palliative care that is affordable and effective in cases of incurable or terminal

illness;

f. a positive disposition displayed by health care providers that demonstrates

courtesy, human dignity, patience, empathy and tolerance;

g. health information that includes information on the availability of health services

and how best to use such services, and such information shall be in the language
understood by the patient.

2.4 KNOWLEDGE OF ONE’S HEALTH INSURANCE/MEDICAL AID SCHEME

A member of a health insurance or medical aid scheme is entitled to information about

that health insurance or medical aid scheme and to challenge, where necessary, the
decision of such health insurance or medical aid scheme relating to the member.

2.5 CHOICE OF HEALTH SERVICES

Everyone has a right to choose a particular health care provider for services or a particular
health facility for treatment, provided that such choice shall not be contrary to the ethical
standards applicable to such health care provider or facility.

2.6 TREATED BY A NAMED HEALTH CARE PROVIDER

Everyone has a right to know the person that is providing health care and, therefore, must
be attended to by only clearly identified health care providers.

2.7 CONFIDENTIALITY AND PRIVACY

Information concerning one’s health, including information concerning treatment may only
be disclosed with informed consent, except when required in terms of any law or any
order of court.

2.8 INFORMED CONSENT

Everyone has a right to be given full and accurate information about the nature of one’s
illnesses, diagnostic procedures, the proposed treatment and risks associated therewith
and the costs involved.
 3

2.9 REFUSAL OF TREATMENT

A person may refuse treatment and such refusal shall be verbal or in writing, provided that
such refusal does not endanger the health of others.

2.10 A SECOND OPINION

Everyone has the right on request to be referred for a second opinion to a health provider
of one’s choice.

2.11 CONTINUITY OF CARE

No one shall be abandoned by a health care professional who or a health facility which
initially took responsibility for one’s health without appropriate referral or hand-over.

2.12 COMPLAINTS ABOUT HEALTH SERVICES

Everyone has the right to complain about health care services, to have such complaints
investigated and to receive a full response on such investigation.

3. RESPONSIBILITIES OF THE PATIENT

Every patient or client has the following responsibilities:

3.1 To take care of his or her own health.

3.2 To care for and protect the environment.

3.3 To respect the rights of other patients and health care providers.

3.4 To utilise the health care system properly and not to abuse it.

3.5 To know his or her local health services and what they offer.

3.6 To provide health care providers with relevant and accurate information for diagnostic,
treatment, rehabilitation or counselling purposes.

3.7 To advise health care providers of his or her wishes with regard to his or her death.

3.8 To comply with the prescribed treatment or rehabilitation procedures.

3.9 To enquire about the related costs of treatment and/or rehabilitation and to arrange for
payment.

3.10 To take care of the health records in his or her possession.

 THE HEALTH CARE PROFESSIONS COUNCIL OF SOUTH
AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

SEEKING PATIENTS’ INFORMED CONSENT:

THE ETHICAL CONSIDERATIONS

BOOKLET 4

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the HPCSA presents the following ethical guidelines to guide and direct

the practice of health care practitioners. These guidelines form an

integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation on
p. 148).
 2

TABLE OF CONTENTS

1. GUIDANCE TO HEALTH CARE PRACTITIONERS ......................................................... 3

2. INTRODUCTION ............................................................................................................... 3
3. CONSENT TO INVESTIGATION AND TREATMENT ....................................................... 3
3.1 PROVIDING SUFFICIENT INFORMATION ...................................................................... 3
3.2 RESPONDING TO QUESTIONS ...................................................................................... 5
3.3 WITHHOLDING INFORMATION....................................................................................... 6
3.4 PRESENTING INFORMATION TO PATIENTS ................................................................. 6
4. WHO OBTAINS CONSENT? ............................................................................................ 7
5. THE RIGHT OF PATIENTS TO INFORMATION ............................................................... 7
6. ENSURING VOLUNTARY DECISION MAKING ............................................................... 8
7 EMERGENCIES ................................................................................................................ 8
8 ESTABLISHING CAPACITY TO MAKE DECISIONS ....................................................... 9
8.1 ASSESSING MENTAL CAPACITY .................................................................................. 9
8.2 FLUCTUATING CAPACITY .............................................................................................. 9
8.3 MENTALLY INCAPACITATED PATIENTS ...................................................................... 9
8.4 THIRD PARTY NOMINATIONS IN REGARD TO CONSENT ......................................... 10
8.5 CHILDREN...................................................................................................................... 10
9. THE “BEST INTERESTS” PRINCIPLE .......................................................................... 11
10. APPLYING TO THE COURT .......................................................................................... 12
11. FORMS OF CONSENT ................................................................................................... 12
12. EXPRESS CONSENT ..................................................................................................... 12
13. STATUTORY REQUIREMENTS ..................................................................................... 13
14. IMPLIED CONSENT ....................................................................................................... 13
15. REVIEWING CONSENT ................................................................................................. 13
16. CONSENT TO SCREENING AND TESTING .................................................................. 13
18. ICD10 CODING AND INFORMED CONSENT ................................................................ 14
18.1 PROVIDER RESPONSIBILITIES: ICD-10 ...................................................................... 14
18.2 INFORMED CONSENT FOR INTER-COUNCIL INTERACTION OF HEALTH
PROFESSIONALS AS MEMBERS OF A HEALTH CARE TEAM ................................................ 15

2
 3

SEEKING PATIENTS’ INFORMED CONSENT: THE ETHICAL

CONSIDERATIONS

1. GUIDANCE TO HEALTH CARE PRACTITIONERS

Being registered under the Health Professions Act, 1976 (Act No. 56 of 1974), gives health care
practitioners certain rights and privileges. In return, you must meet the standards of competence,
care and conduct set by the Health Professions Council of South Africa.

This booklet sets out the principles of good practice which all health care practitioners are
expected to follow when seeking patients' informed consent to investigations, treatment, screening
or research.

2. INTRODUCTION

2.1 Successful relationships between health care practitioners and patients depend upon
mutual trust. To establish that trust practitioners must respect patients' autonomy - their
right to decide whether or not to undergo any medical intervention, even where a refusal
may result in harm to themselves or in their own death. Patients must be given sufficient
information in a way that they can understand, to enable them to exercise their right to
make informed decisions about their care. This is what is meant by an informed consent

2.2 The right to an informed consent flows from the South African Constitution, the National
Health Act, various other statutes, the common law and the HPCSA Guidelines. Health
care practitioners are expected to be aware of the law in this regard. The law prescribes
the minimum requirements when seeking informed consent from patients.

2.3 Effective communication is the key to enabling patients to make informed decisions.
Health care practitioners must take appropriate steps to find out what patients want to
know and ought to know about their condition and its treatment. Such dialogue with
patients leads to clarity of objectives and understanding, and strengthens the quality of the
relationship between health care practitioners and patients. It provides an agreed
framework within which health care practitioners can respond effectively to the individual
needs of patients. Patients who make properly informed decisions about their health care
are more likely to co-operate fully with the agreed management of their conditions.

3. CONSENT TO INVESTIGATION AND TREATMENT

3.1 PROVIDING SUFFICIENT INFORMATION

3.1.1 Patients have a right to information about their condition and the treatment options
available to them. The amount of information that must be given to each patient will vary
according to factors such as the nature of the condition, the complexity of the treatment, the
risks associated with the treatment or procedure, and the patient's own wishes. For
example, patients may need more information to make an informed decision about a
procedure which carries a high risk of failure or adverse side effects, or about an
investigation for a condition which, if present, could have serious implications for the
patient's employment, social or personal life.

3.1.2 The National Health Act requires patients to be given information about:

3
 4
3.1.2.1 Their patient’s health status except in circumstances where there is substantial
evidence that the disclosure of the patient’s health status would be contrary to the
best interests of the patient;

3.1.2.2 The range of diagnostic procedures and treatment options generally available to
the patient;

3.1.2.3 The benefits, risks costs and consequences generally associated with each
option; and

3.1.2.4 The patient’s right to refuse health services and explain the implications, risks
and obligations of such refusal.

3.1.3 Patients have a right to information about any condition or disease from which they are
suffering. This information should be presented in a language that the patient
understands. The information which patients want or ought to know, before deciding
whether to consent to treatment or an investigation, includes:

3.1.3.1 Details of the diagnosis and prognosis, and the likely prognosis if the condition is
left untreated;

3.1.3.2 Uncertainties about the diagnosis, including options for further investigation prior
to treatment;

3.1.3.3 Options for treatment or management of the condition, including the option not to
treat;

3.1.3.4 The purpose of a proposed investigation or treatment; details of the procedures

or therapies involved, including subsidiary treatment such as methods of pain
relief; how the patient should prepare for the procedure; and details of what the
patient might experience during or after the procedure including common and
serious side effects;

3.1.3.5 For each option, explanations of the likely benefits and the probabilities of
success; and discussion of any serious or frequently occurring risks, and of any
lifestyle changes which may be caused or necessitated by the treatment;

3.1.3.6 Advice about whether a proposed treatment is experimental;

3.1.3.7 How and when the patient's condition and any side effects will be monitored or
re-assessed;

3.1.3.8 The name of the doctor who will have overall responsibility for the treatment and,
where appropriate, names of the senior members of his or her team;

3.1.3.9. Whether students will be involved, and the extent to which students may be
involved in an investigation or treatment;

3.1.3.10 A reminder that patients can change their minds about a decision at any time;

3.1.3.11 A reminder that patients have a right to seek a second opinion;

3.1.3.12 Details of costs or charges which the patient may have to meet.

3.1.4 When providing information, health care practitioners must do their best to find out about
patients' individual needs and priorities. For example, patients' beliefs, culture, occupation
or other factors may have a bearing on the information they need in order to reach a

4
 5
decision. Health care practitioners should not make assumptions about patients' views,
but discuss these matters with them and ask them whether they have any concerns about
the treatment or the risks it may involve. Health care practitioners should provide patients
with appropriate information, which should include an explanation of any risks to which
they may attach particular significance. Patients should be asked whether they have
understood the information and whether they would like more before making a decision.

3.1.5 Health care practitioners must not exceed the scope of the authority given by a patient,
except in an emergency. Therefore, health care practitioners providing treatment or
undertaking investigations, must give the patient a clear explanation of the scope of
consent being sought. This will apply particularly where:

3.1.5.1 Treatment will be provided in stages with the possibility of later adjustments;

3.1.5.2 Different health care practitioners provide particular elements of an investigation

or treatment (for example anaesthesia during surgery);

3.1.5.3 A number of different investigations or treatments are involved;

3.1.5.4 Uncertainty about the diagnosis or about the appropriate range of options for
treatment may be resolved only in the light of findings once an investigation or
treatment is underway, and when the patient may be unable to participate in
decision making.

3.1.6 In the cases referred to in para 3.1.5 above, health care practitioners should explain how
decisions will be made about whether or when to move from one stage or one form of
treatment to another. There should be a clear agreement about whether the patient
consents to all or only parts of the proposed plan of investigation or treatment, and
whether further consent will have to be sought at a later stage.

3.1.7 Health care practitioners should raise with patients the possibility of additional problems
emerging during a procedure when the patient is unconscious or otherwise unable to
make a decision. They should seek consent to treat any problems which they think may
arise and ascertain whether there are any procedures to which the patient would object, or
prefer to give further thought to before they proceed. Health care practitioners must abide
by patients' decisions on these issues. If in exceptional circumstances health care
practitioners decide, while the patient is unconscious, to treat a condition which falls
outside the scope of the patient's consent, their decision may be challenged in the courts,
or be the subject of a complaint to their employers or the HPCSA. Health care
practitioners should therefore seek the views of an experienced colleague, wherever
possible, before providing the treatment. They must be prepared to explain and justify
their decisions based on such consideration as preservation of life. Health care
practitioners must tell the patient what they have done and why, as soon as the patient is
sufficiently recovered to understand.

3.2 RESPONDING TO QUESTIONS

Health care practitioners must respond honestly to any questions the patient raises and,
as far as possible, answer as fully as the patient wishes. In some cases, a patient may
ask about other treatments that are unproven or ineffective. Some patients may want to
know whether any of the risks or benefits of treatment are affected by the choice of
institution or doctor providing the care. Health care practitioners must answer such
questions as fully, accurately and objectively as possible.

5
 6

3.3 WITHHOLDING INFORMATION

3.3.1 Health care practitioners should not withhold information necessary for decision making
unless they judge that disclosure of some relevant information would cause the patient
serious harm. In this context, serious harm does not mean the patient would become
upset or decide to refuse treatment.

3.3.2 The South African courts have held that patients must be informed of all “material risks” in
order to give a proper informed consent. A risk is “material” if:

3.3.2.1 A reasonable person in the position of the patient, if warned of the risk, would
attach significance to it; and

3.3.2.2 The health care practitioner should reasonably be aware that the patient, if
warned of the risk, would attach significance to it.

3.3.3 No-one may make decisions on behalf of a mentally competent adult. If patients ask health
care practitioners to withhold information and make decisions on their behalf, or nominate a
relative or third party to make decisions for them, the health care practitioner should explain
the importance of patients knowing the options open to them, and what the treatment they
may receive will involve. If patients insist they do not want to know in detail about their
condition and its treatment, the health care practitioner should still provide basic information
about the treatment. If a relative asks a health care practitioner to withhold information, the
latter must seek the views of the patient. Again, health care practitioners should not
withhold relevant information unless they judge that it would cause the patient serious
harm.

3.3.4 The National Health Act provides that health care practitioners must provide patients (i.e.
patients) with information about their health status unless “there is substantial evidence that
the disclosure of the patient’s health status would be contrary to the best interests of the
patients”.

3.3.5 In any case where health care practitioners withhold relevant information from the patient
they must record this, and the reason for doing so, in the patient's medical records and they
must be prepared to explain and justify their decision.

3.4 PRESENTING INFORMATION TO PATIENTS

3.4.1 Obtaining informed consent cannot be an isolated event. It involves a continuing dialogue
between health care practitioners and their patients which keeps them abreast of changes
in the condition of patients and the treatment or investigation the practitioners propose.
Whenever possible, health care practitioners should discuss treatment options at a time
when the patient is best able to understand and retain the information.

3.4.2 To be sure that their patients understand, health care practitioners should give clear
explanations and give the patients time to ask questions. In particular, health care
practitioners should:

3.4.2.1 Use up-to-date written material, visual and other aids to explain complex aspects
of the investigation, diagnosis or treatment where appropriate and practicable;

3.4.2.2 Make arrangements, wherever possible, to meet particular language and

communication needs, for example through translations, independent
interpreters, people who sign on behalf of patients, or the patient's
representative;

6
 7
3.4.2.3 Where appropriate, discuss with patients the possibility of being accompanied by
a relative or friend,

3.4.2.4 Explain the probabilities of success, or the risk of failure of, or harm associated
with options for treatment, using accurate data;

3.4.2.5 Ensure that information which patients may find distressing is given to them in a
considerate way. Provide patients with information about counseling services and
patient support groups, where appropriate;

3.4.2.6 Allow patients sufficient time to reflect, before and after making a decision,
especially where the information is complex or the severity of the risks is great.
Where patients have difficulty understanding information, or there is a lot of
information to absorb, it may be appropriate to provide it in manageable amounts,
with appropriate written or other back-up material, over a period of time, or to
repeat it;

3.4.2.7 Involve nursing or other members of the health care team in discussions with the
patient, where appropriate. They may have valuable knowledge of the patient's
background or particular concerns, for example in identifying what risks the
patient should be told about );

3.4.2.8 Ensure that, where treatment is not to start until sometime after consent has been
obtained, patients are given clear instructions on how to review their decision with
the health care practitioner providing the treatment.

3.4.2.9 Consent will not be informed if it was given as a result of duress, coercion,
manipulation, misrepresentation or mental impairment (e.g. under the influence of
alcohol, drugs, including premedication in the theatre).

4. WHO OBTAINS CONSENT?

4.1 A health care practitioner providing treatment or undertaking an investigation, has the
responsibility to discuss it with the patient and obtain consent, as the practitioner will have a
comprehensive understanding of the procedure or treatment, how it is to be carried out, and
the risks attached to it. Where this is not practicable, health care practitioners may delegate
these tasks provided they ensure that the person to whom they delegate:

4.1.1 Is suitably educated, trained and qualified;

4.1.2 Has sufficient knowledge of the proposed investigation or treatment and understands the
risks involved; and

4.1.3 Acts in accordance with the guidance in this Booklet.

4.2 A health care practitioner will remain responsible for ensuring that, before he or she starts
any treatment, the patient has been given sufficient time and information to make an
informed decision, and has given consent to the investigation or procedure

5. THE RIGHT OF PATIENTS TO INFORMATION

5.1 Patients have a right to information about the health care services available to them,
presented in a way that is easy to follow and use.

7
 8
5.2 The National Health Act provides that health care providers (this includes health care
practitioners) must inform users (patients) of the following:

5.2.1 The user’s health status except in circumstances where there is substantial evidence that
the disclosure of the user’s health status would be contrary to the best interests of the user;

5.2.2 The range of diagnostic procedures and treatment options generally available to the user;

5.2.3 The benefits, risks costs and consequences generally associated with each option; and

5.2.4 The user’s right to refuse health services and explain the implications, risks and obligations
of such refusal.

6. ENSURING VOLUNTARY DECISION MAKING

6.1 It is for the patient, not the health care practitioner, to determine what is in the patient's own
best interests. Nonetheless, practitioners may wish to recommend a treatment or a course of
action to patients, but they must not put pressure on patients to accept their advice. In
discussions with patients, health care practitioners should:

6.1.1 Give a balanced view of the options;

6.1.2 Explain the need for informed consent.

6.2 Health care practitioners must declare any potential conflicts of interest, for example where
they or their organisation benefit financially from the use of a particular drug or treatment, or
treatment at a particular institution if permitted by the HPCSA.

6.3 Pressure may be put on patients by employers, insurance companies or others to undergo
particular tests or accept treatment. Health care practitioners should do their best to ensure
that patients have considered the options and reached their own decision. Health care
practitioners should take appropriate action if they believe patients are being offered
inappropriate or unlawful financial or other rewards.

6.4 Patients who are detained by the police or immigration authorities, or are in prison, and those
detained under the provisions of any mental health legislation may be particularly vulnerable.
Where such patients have a right to decline treatment, health care practitioners should do
their best to ensure that they know this and are able to exercise this right.

7 EMERGENCIES

7.1 In an emergency, where consent cannot be obtained, health care practitioners may provide
medical treatment to anyone who needs it, provided the treatment is limited to what is
immediately necessary to save life or avoid significant deterioration in the patient's health.

7.2 However, health care practitioners must respect the terms of any valid advance refusal by
the patient which they know about, or which is drawn to their attention.

7.3 After the emergency health care practitioners should tell the patient what has been done and
why, as soon as the patient is sufficiently recovered to understand.

8
 9

8 ESTABLISHING CAPACITY TO MAKE DECISIONS

8.1 ASSESSING MENTAL CAPACITY

8.1.1 Health care practitioners must work on the presumption that every adult has the capacity to
decide whether to consent to, or refuse, proposed medical intervention, unless it is shown
that they cannot understand information presented in a clear way.

8.1.2 If a patient's choice appears irrational, or does not accord with the health care practitioner’s
view of what is in the patient's best interests, this is not evidence in itself that the patient
lacks competence. In such circumstances it may be appropriate to review with the patient
whether all reasonable steps have been taken to identify and meet their information needs.

8.1.3 Where health care practitioners need to assess a patient's capacity to make a
decision, they should consult the guidance issued by the relevant professional bodies.

8.1.4 In the case of children who have legal capacity to give consent in terms of the Child Care Act
(Act No.74 of 1983) or the Choice on Termination of Pregnancy Act (Act No.92 of 1996)
health care practitioners should make sure that the children are sufficiently mentally mature
to understand the nature and effect of the treatment or procedure to which they are
consenting (see below para 8.5).

8.2 FLUCTUATING CAPACITY

8.2.1 Where patients have difficulty retaining information, or are only intermittently competent to
make a decision health care practitioners should provide any assistance they might need to
reach an informed decision.

8.2.2 Health care practitioners should record any decision made while the patients were
competent, including the key elements of the consultation.

8.2.3 Health care practitioners should review any decision made whilst the patients were
competent, at appropriate intervals before treatment starts, to establish that their views are
consistently held and can be relied on.

8.3 MENTALLY INCAPACITATED PATIENTS

8.3.1 The National Health Act makes provision for certain persons to consent on behalf of mentally
incompetent patients to an operation or medical treatment where such patients are unable to
give the necessary consent and have not mandated - while still mentally competent-
somebody else in writing to give consent on their behalf.

8.3.2 The Act sets out a priority list of persons who may consent in such circumstances:

8.3.2.1 A person authorized by the court (e.g. a curator); or

8.3.2.2 In order of priority, the patient's spouse, partner, parent, grandparent, major child
or brother or sister.

8.3.3 Health care practitioners should also consult the provisions of the Mental Health Care Act
(Act No.17 of 2002) when dealing with mentally ill patients.

9
 10

8.4 THIRD PARTY NOMINATIONS IN REGARD TO CONSENT

8.4.1 The National Health Act allows patients – while still mentally competent - to mandate another
person in writing to give consent on their behalf

8.4.2 If health care practitioners are treating a patient who has lost the capacity to consent to or
refuse treatment, for example through the onset or progress of a mental disorder or other
disability, they should try to find out whether:

8.4.2.1 The patient has previously mandated someone else in writing to make decisions on
their behalf; or

8.4.2.2 Have indicated preferences in an advance statement (e.g. an “advance directive” or

“living will”).

8.4.3 Health care practitioners must respect any refusal of treatment given when the patient was
competent, provided the decision in the advance statement is clearly applicable to the
present circumstances, and there is no reason to believe that the patient has changed his or
her mind. Where an advance statement of this kind is not available, the patient's known
wishes should be taken into account

8.5 CHILDREN

The ages as stipulated in this document are a reflection of the Children’s Act, 2005 (Act No. 38 of
2005)

8.5.1 Health care practitioners must assess a child's capacity to decide whether to consent to or
refuse a proposed investigation or treatment before they provide it.

8.5.2 In general, a competent child will be able to understand the nature, purpose and possible
consequences of the proposed investigation or treatment, as well as the consequences of
non-treatment.

8.5.3 A health care practitioner’s assessment must take account of the following:

8.5.3.1 A person over the age of 18years is an adult and is legally competent to decide
on all forms of treatment and medical procedures (Children’s Act, 2005).

8.5.3.2 A child who is 12 years of age is legally competent to consent to medical

treatment if the child is of sufficient maturity and has the mental capacity to
understand the benefits, risks, social and other implications of the treatment
(Children’s Act, 2005 (Act No. 38 of 2005) section 129(2)).

8.5.3.3 Where a child is under 12 years of age or not of sufficient maturity and does not
have the necessary mental capacity his or her parent, guardian or care-giver may
give consent to medical treatment (Children’s Act, 2005 section 129(4)).

8.5.3.4 A child who is 12 years of age is legally competent to consent to a surgical

operation if the child is of sufficient maturity, has the mental capacity to
understand the benefits, risks, social and other implications of the surgical
operation, and is duly assisted by his or her parent or guardian (Children’s Act,
2005 section 129(3)).

10
 11
8.5.3.5 Where a child is under 12 years of age or not of sufficient maturity and does not
have the necessary mental capacity his or her parent or guardian may give
consent to a surgical procedure (Children’s Act, 2005 section 129(5)).

8.5.3.6 The superintendent of a hospital or the person in charge of the hospital in the
absence of the superintendent may consent to the medical treatment of or a
surgical operation on a child if the treatment or operation is necessary to
preserve the life of the child or to save the child from serious or lasting physical
injury or disability; and the need for the treatment or operation is so urgent that it
cannot be deferred for the purpose of obtaining consent that would otherwise
have been required (Children’s Act, 2005 section 129(6)).

8.5.3.7 The Minister of Health may consent to the medical treatment of or surgical
operation on a child if the parent or guardian of the child unreasonably refuses to
give consent or to assist the child in giving consent, is incapable of giving consent
or of assisting the child in giving consent, cannot readily be traced, or is
deceased (Children’s Act, 2005 section 129(7)).

8.5.3.8 The Minister may consent to the medical treatment of or surgical operation on a
child if the child unreasonably refuses to give consent (Children’s Act, 2005
section 129(8)).

8.5.3.9 A High Court or children’s court may consent to the medical treatment of or a
surgical operation on a child in all instances where another person that may give
consent refuses or is unable to give such consent (Children’s Act, 2005 section
129(9)).

8.5.3.10 No parent, guardian or care-giver of a child may refuse to assist a child or

withhold consent by reason only of religious or other beliefs, unless that parent or
guardian can show that there is a medically accepted alternative choice to the
medical treatment or surgical operation concerned (Children’s Act, 2005 section
129(10)).

8.5.3.11 A female of any age is legally competent to consent to a termination of

pregnancy (Choice on Termination of Pregnancy Act, 1996 (Act No. 92 of 1996))
provided she has the necessary mental capacity to give an informed consent by
understanding and appreciating the benefits, risks, social and other implications
of the termination of pregnancy.

9. THE “BEST INTERESTS” PRINCIPLE

9.1 In deciding what options may be reasonably considered as being in the best interests of a
patient who lacks capacity to decide, health care practitioners should take into account:

9.1.1 The options for investigation or treatment which are clinically indicated;

9.1.2 Any evidence of the patient's previously expressed preferences, including an advance
statement;

9.1.3 Their own and the health care team's knowledge of the patient's background, such as
cultural, religious or employment considerations;

11
 12
9.1.4 Views about the patient's preferences given by a third party who may have other
knowledge of the patient, for example, the patient's partner, family, carer, or a person with
parental responsibility;

9.1.5 Which option least restricts the patient's future choices, where more than one option
(including non-treatment) seems reasonable in the patient's best interests.

9.2 The South African Constitution provides that “a child’s best interests are paramount in every
matter concerning a child”.

10. APPLYING TO THE COURT

10.1 Where a patient's capacity to consent is in doubt, or where differences of opinion about his
or her best interests cannot be resolved satisfactorily, health care practitioners should
consult more experienced colleagues and, where appropriate, seek legal advice on whether
it is necessary to apply to the court for a ruling.

10.2 Health care practitioners should seek the court where a patient lacks capacity to consent to
a medical intervention and the situation is contentious for example, parents withholding
consent to life-saving treatment for children under the age of 12 years.

10.3 Where health care practitioners decide to apply to a court they should, as soon as possible,
inform the patient, or his or her representative of their decision and of his or her right to be
represented at the hearing.

11. FORMS OF CONSENT

To determine whether patients have given informed consent to any proposed investigation or
treatment, health care practitioners must check how well the patients have understood the
details and implications of what is proposed, and not simply rely on the form in which their
consent has been expressed or recorded – especially where the initial consent was obtained
by a third party.

12 EXPRESS CONSENT

12.1 Patients can indicate their informed consent either orally or in writing.

12.2 In some cases, the nature of the risks to which the patient might be exposed makes it
important that a written record is available of the patient's consent and other wishes in
relation to the proposed investigation and treatment. This helps to ensure later
understanding between health care practitioner, the patient and anyone else involved in
carrying out the procedure or providing care.

12.3 Except in an emergency, where the patient has the capacity to give consent, health care
practitioners should obtain written consent in the following cases, although this list is not
exhaustive:

12.3.1 The treatment or procedure is complex or involves significant risks and/or side
effects;

12.3.2 Providing clinical care is not the primary purpose of the investigation or
examination;

12
 13
12.3.3 There may be significant consequences for the patient's employment,
social or personal life;

12.3.4 The treatment is part of a research programme.

12.4 Health care practitioners must use the patient's case notes or the consent form to detail the
key elements of the discussion with the patient, including the nature of information provided,
specific requests by the patient, and details of the scope of the consent given.

13. STATUTORY REQUIREMENTS

Some statutes require particular forms of consent to be obtained for specific procedures
(for example, sterilizations (Sterilization Act (Act No. 44 of 1998), terminations of
pregnancy (Choice on Termination of Pregnancy Act (No.92 of 1996) and removal of
organs from dead people (National Health Act, 2003. Health care practitioners need to
consult the law in this regard when carrying out such procedures.

14. IMPLIED CONSENT

Health care practitioners should be careful about relying on a patient's apparent

compliance with a procedure as a form of consent. Submission in itself may not
necessarily indicate consent. For example, the fact that a patient lies down on an
examination couch does not indicate that the patient has understood what the health care
practitioner proposes to do and why. Consent must at all times be expressed and not
implied.

15. REVIEWING CONSENT

15.1 A signed consent form is not sufficient evidence that a patient has given, or still gives,
informed consent to the proposed treatment in all its aspects. Health care practitioners
must review the patient's decision close to the time of treatment, and especially where:

16.1.1 Significant time has elapsed between when the consent was obtained and the
start of treatment;

16.1.2 There have been material changes in the patient's condition, or in any aspects of
the proposed treatment plan, which might invalidate the patient's existing consent;

16.1.3 New, potentially relevant information has become available, for example about
the risks of the treatment or about other treatment options.

16. CONSENT TO SCREENING AND TESTING

16.1 Screening or testing of healthy or asymptomatic people to detect genetic predispositions or

early signs of debilitating or life threatening conditions can be an important tool in providing
effective care. However, the uncertainties involved in screening or testing may be great, for
example the risk of false positive or false negative results. Some findings may potentially
have serious medical, social or financial consequences not only for the individuals, but for
their relatives. In some cases the fact of having been screened or tested may itself have
serious implications.

16.2 Health care practitioners must ensure that anyone considering whether to consent to
screening or testing can make a properly informed decision. As far as possible, practitioners

13
 14
should ensure that screening or testing is not contrary to the individual's interests. Health
care practitioners must pay particular attention to ensuring that the information the person
wants or ought to have is identified and provided. Practitioners should be careful to explain
clearly:

16.2.1 The purpose of the screening or test;

16.2.2 The likelihood of positive or negative findings and the possibility of false positive
or negative results;

16.2.3 The uncertainties and risks attached to the screening or testing process;

16.2.4 Any significant medical, social or financial implications of screening or testing for
the particular condition or predisposition;

16.2.5 Follow up plans, including the availability of counseling and support services.

17. ICD10 CODING AND INFORMED CONSENT

Informed consent is an exercise of an informed choice by a patient who has the capacity to give
consent:-

a) in instances where there are multiple options or alternatives to treatment; or

b) in making a decision whether to withhold or disclose information or allow someone else
to disclose information on their medical condition to a defined third party; or
c) in making a decision for purposes of reimbursement by a Medical Scheme,

based on adequate information and a detailed analysis or unpacking of each of the options or
alternatives as well as the legislative requirements for disclosure of such information.

This means there must be a full and frank disclosure of all the material facts to enable the patient
to decide from an informed basis. With regards to ICD 10, for instance, the patient should be given
information as to who will access their information, for what purpose and what would be the
implications of the utilization of such information etc.

17.1 PROVIDER RESPONSIBILITIES: ICD-10

Health care providers have the following obligations, the list not being exhaustive as any other
ethical obligation in handling and dealing with patient information and respecting their
confidentiality will be required:-

a) to provide information to the patients about the legislative requirement of supplying ICD-
10 codes to the medical schemes for purposes of reimbursements and the inevitable
consequences of the medical scheme becoming aware of the diagnosis of the
patient/member;

b) to procure patient consent to release ICD-10 coding to the medical scheme and/or
(where required) to the other health professional (within the health care team);

c) to advise the patient of their choice not to have their ICD-10 coding divulged to the
medical scheme which would mean the patient has to settle the provider’s account
directly; and

d) to indicate that the practitioner does not have control over the management and
utilization of this information once divulged over to the medical scheme and that the

14
 15
medical scheme takes responsibility for any further disclosure or utilization of such
information for whatever purpose.

It is strongly suggested that written consent be procured from the patients by the providers in order
to safeguard the interests of both parties. Consent by a patient may be once-off in relation to the
treatment of a similar condition provided there is a verbal reminder to the patient about their initial
commitment to confirm if they are still comfortable with the disclosure. It would be advisable for a
provider to note the verbal reminder on that patient’s file. Where a patient presents with a new or
different condition, a fresh consent should be obtained from the patient and appropriately
documented.

Providers without a direct patient contact like pathologists and radiologists act on referrals from
other providers. Their responsibility would be to ensure that the referring provider has procured
consent for that other provider (in this case a pathologist or radiologist) to access and also disclose
the information to the medical scheme for reimbursement purposes.

17.2 INFORMED CONSENT FOR INTER-COUNCIL INTERACTION OF HEALTH

PROFESSIONALS AS MEMBERS OF A HEALTH CARE TEAM

Sharing of information with members of a health care team providing a health service to a patient
would be permissible to the extent that it is necessary to enhance the quality of care to be provided
to that patient and the patient has given consent to treatment and disclosure of such information to
another healthcare practitioner. This would include members beyond the HPCSA.

15
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE IN THE HEALTH CARE

PROFESSIONS

CONFIDENTIALITY: PROTECTING AND

PROVIDING INFORMATION

BOOKLET 5

PRETORIA
SEPTEMBER 2016
 Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the HPCSA presents the following ethical guidelines to guide and direct

the practice of health care practitioners. These guidelines form an

integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).

i
 ii

TABLE OF CONTENTS

1. INTRODUCTION .......................................................... ERROR! BOOKMARK NOT DEFINED.

2. DEFINITIONS .......................................................................................................................... 1

3. PATIENTS’ RIGHT TO CONFIDENTIALITY ........................................................................... 2

4. RETAINING CONFIDENTIALITY ............................................................................................ 3

5. PROTECTING INFORMATION ............................................................................................... 3

6. THE RIGHT OF PATIENTS TO INFORMATION ..................................................................... 3

7. DISCLOSURE OF INFORMATION TO OTHERS PROVIDING CARE .................................... 4

8. DISCLOSURE OF INFORMATION OTHER THAN FOR TREATMENT OF INDIVIDUAL

PATIENTS ............................................................................................................................... 5

9. PUTTING THE PRINCIPLES INTO PRACTICE ...................................................................... 6

10. DISCLOSURE IN CONNECTION WITH JUDICIAL OR OTHER STATUTORY

PROCEEDINGS .................................................................................................................... 11

11. ELECTRONIC PROCESSING OF INFORMATION ............................................................... 11

ii
 1

CONFIDENTIALITY: PROVIDING AND PROTECTING INFORMATION

1. PRE-AMBLE

1.1 Being registered under the Health Professions Act, 1974 (Act No. 56 of 1974), gives
health care practitioners certain rights and privileges. In return, they have the duty to meet
the standards of competence, care and conduct set by the Health Professions Council of
South Africa and its Professional Boards.

1.2 Health care practitioners hold information about patients that is private and sensitive. The
National Health Act (Act No. 61 of 2003) provides that this information must not be given
to others, unless the patient consents or the health care practitioner can justify the
disclosure. Practitioners are responsible for ensuring that clerks, receptionists and other
staff respect confidentiality in their performance of their duties. Guidelines on when
disclosures may be justified are provided in this booklet.

1.3 When a health care provider is satisfied that information should be released, he or she
should act promptly to disclose all relevant information. This is often essential to protect
the best interests of the patient, or to safeguard the well-being of others.

1.4 These guidelines on confidentiality are the result of extensive discussion and debate with
professional and patient groups and the provisions of the National Health Act. They place
new responsibilities on health care practitioners regarding the obtaining of consent for and
keeping patients informed about the disclosure of information concerning them. The
guidelines set out a framework for respecting patients' rights, while ensuring that
information needed to maintain and improve health care for individual patients and society
is disclosed to those who need it for such purposes.

1.5 The additional duties on health care practitioners to obtain consent and to anonymise data
are consistent with the provisions of the National Health Act. These guidelines ensure
privacy-friendly relationships between patients and practitioners and should assist health
care practitioners to comply with their ethical and legal obligations.

1.6 These guidelines are based upon international ethical codes, the South African
Constitution (Act No. 108 of 1996) and the National Health Act (Act No. 61 of 2003).

2. DEFINITIONS

This section defines the terms used in this document.

2.1 “Anonymised data” means data from which the patient cannot be identified by the
recipient of the information. The name, address, and full postal code must be removed,
together with any other information which, in conjunction with other data held by or
disclosed to the recipient, could identify the patient. Patient reference numbers or other
unique numbers may be included only if recipients of the data do not have access to the
'key' to trace the identity of the patient using that number.

1
 2
2.2 “Consent” in terms of the National Health Act means consent for the provision of a
specified health service given by a person with legal capacity. A person older than 12
years may consent to medical and surgical treatment subject to being sufficiently mature
to provide the consent, (Children’s Act (Act No. 38 of 2005) and a female of any age may
consent to a termination of pregnancy (Choice on Termination of Pregnancy Act (Act No.
92 of 1996)). For more information on Consent consult Booklet 9 on Seeking patients’
informed consent: Ethical considerations.

2.3 “Express consent” means consent which is expressed orally or in writing (except where
patients cannot write or speak, when other forms of communication may be sufficient).

2.4 “Health care personnel” in terms of the National Health Act includes both health care
providers and health workers (i.e. the health care team that provide clinical services for
users or patients, and the administrative staff who support these services). The Act
includes health care practitioners under the term “health care providers”. For the purposes
of these guidelines the term “health care practitioners” refers to practitioners registered
with the HPCSA.

2.5 “Patients” are referred to as “users” in the National Health Act. A “user” is a person
receiving treatment in a health establishment, including receiving blood or blood products,
or using a health service. “User” includes persons who are authorised to give consent in
terms of the National Health Act where the patient is incompetent to give consent (see
Booklet 9 on Seeking patients’ informed consent: Ethical considerations).

2.6 “Personal information” means information about people that health care practitioners learn
in a professional capacity and from which individuals can be identified.

2.7 “Public interest” mean the interests of the community as a whole, or individuals or a group
within the community.

3. PATIENTS’ RIGHT TO CONFIDENTIALITY

3.1 The National Health Act (Act No. 61 of 2003) states that all patients have a right to
confidentiality and this is consistent with the right to privacy in the South African
Constitution (Act No. 108 of 1996).

3.2 Rule 13 of the Ethical Rules of the HPCSA states that a practitioner may divulge
information regarding a patient only if this is done:

3.2.1 In terms of a Statutory provision,

3.2.2 At the instruction of a court,

3.2.3 In the public interest,

3.2.4 With the express consent of the patient,

3.2.5 With the written consent of a parent or guardian of a minor under the age of 12
years,

2
 3
3.2.6 In the case of a deceased patient with the written consent of the next of kin or the
executor of the deceased’s estate.

3.3 Disclosures in the public interest would include but not be limited to situations where the
patient or other persons would be prone to harm as a result of risk related contact.

4. RETAINING CONFIDENTIALITY

4.1 Patients have a right to expect that information about them will be held in confidence by
health care practitioners. Confidentiality is central to trust between practitioners and
patients. Without assurances about confidentiality, patients may be reluctant to give
practitioners the information they need in order to provide good care.

4.2 Where health care practitioners are asked to provide information about patients, they
should :

4.2.1 Seek the consent of patients to disclosure of information wherever possible,

whether or not the patients can be identified from the disclosure; Comprehensive
information must be made available to patients with regard to the potential for a
breach of confidentiality with ICD10 coding.

4.2.2 Anonymise data where unidentifiable data will serve the purpose;

4.2.3 Keep disclosures to the minimum necessary.

4.3 Health care practitioners must always be prepared to justify their decisions in accordance
with these guidelines.

5. PROTECTING INFORMATION

5.1 The National Health Act requires that health care providers (which includes health care
practitioners) and health care establishments are responsible for personal information
about their patients and must make sure that such information is effectively protected
against improper disclosure at all times. For example, this means that employees such as
clerks and receptionists must also be trained to respect the confidentiality of patients
when dealing with personal information.

5.2 Many improper disclosures are unintentional. Health care practitioners should not discuss
information about patients where they can be overheard or leave patients' records where
they are vulnerable to disclosure, either on paper or electronically, where they can be
seen by other patients, unauthorised health care personnel or the public. Health care
practitioners should endeavour to ensure that their consultations with patients are private.

6. THE RIGHT OF PATIENTS TO INFORMATION

6.1 Patients have a right to information about the health care services available to them,
presented in a way that is easy to follow and use.

6.2 The National Health Act provides that health care providers (this includes health care
practitioners) must inform patients (patients) of the following:

3
 4
6.2.1 The patient’s health status except in circumstances where there is substantial evidence
that the disclosure of the patient’s health status would be contrary to the best interests of
the patients;

6.2.2 The range of diagnostic procedures and treatment options generally available to the
patients;

6.2.3 The benefits, risks costs and consequences generally associated with each option; and

6.2.4 The patient’s right to refuse health services and explain the implications, risks and
obligations of such refusal.

6.3 Patients also have a right to information about any condition or disease from which they
are suffering. Such information should be presented in a manner easy to follow and use,
and should include information about the diagnosis, prognosis, treatment options,
outcomes of treatment, common and serious side-effects of treatment, the likely time-
frames of treatment, and the expected costs, where relevant.

6.4 Health care practitioners should always give patients basic information about the
treatment they propose to provide, but should respect the wishes of any patient who asks
not to be given detailed information. The latter requests place a considerable onus upon
health care providers because, without such information, patients cannot make proper
choices as partners in the health care process.

7. DISCLOSURE OF INFORMATION TO OTHERS PROVIDING CARE

7.1 Health care practitioners should make sure that patients are aware that personal
information about them will be shared within the health care team - and patients must be
told the reasons for this. It is particularly important to check that patients understand what
will be disclosed if it is necessary to share personal information with anyone employed by
another organisation or agency providing health or social care. Practitioners cannot treat
patients safely, nor provide continuity of care, without having relevant information about
the patient's condition and medical history.

7.2 In some circumstances where patients have consented to treatment, express consent
(orally or in writing) is not usually needed before relevant personal information is shared to
enable the treatment to be provided. For example, express consent is not needed before
a general practitioner discloses relevant personal information to a medical secretary so
that she can type a referral letter. In such circumstances, when the practitioner informs the
patient that he or she is referring the patient to somebody else, the patient is assumed to
have given implied consent to such disclosure being made to the secretary.

7.3 The health care practitioner must make sure that any recipient to whom personal
information about patients is disclosed, understands that it is given to them in confidence,
which they must respect. Anyone receiving personal information in order to provide care is
bound by the legal duty of confidentiality - whether or not they have contractual or
professional obligations to protect confidentiality.

7.4 Circumstances may arise where a patient cannot be informed about the sharing of
information, for example because of a medical emergency. In these cases the health care
practitioner should disclose the relevant information promptly to those providing the
patients' care, and explain the situation to the patient after the emergency has passed.

4
 5

8. DISCLOSURE OF INFORMATION OTHER THAN FOR TREATMENT OF INDIVIDUAL

PATIENTS

8.1 PRINCIPLES

8.1.1 Information about patients is requested for a wide variety of purposes including education,
research, monitoring and epidemiology, public health surveillance, clinical audit,
administration and planning, insurance and employment. Health care practitioners have a
duty to protect the privacy of patients and respect their autonomy. When asked to provide
information health care practitioners should adhere to the principles in para 4.2 above.

8.1.2 The paragraphs below deal with obtaining consent for disclosure of information and what
to do where consent is unobtainable, or where it is impracticable to seek consent for
disclosure of information.

8.2 OBTAINING CONSENT FOR DISCLOSURE

8.2.1 Seeking consent of patients to disclosure is part of good communication between health
care practitioners and patients and is an essential part of respect for the autonomy and
privacy of patients. The following principles should be applied:

8.2.2 Obtaining consent where the disclosures will have personal consequences for patients:

8.2.2.1 Health care practitioners must obtain express consent where patients may be
personally affected by the disclosure, for example when disclosing personal
information to a patient's employer or to a medical scheme for ICD-10 coding.

8.2.2.2 When seeking express consent, health care practitioners must make sure that
patients are given enough information on which to base their decision, the
reasons for the disclosure and the likely consequences of the disclosure.

8.2.2.3 Health care practitioners should also explain how much information will be
disclosed and to whom it will be given.

8.2.2.4 If the patient withholds consent the health care practitioner should first attempt to
persuade the patient to consent.

8.2.2.5 If the patient continues to refuse consent, or consent cannot be obtained, the
consequences of disclosure and non-disclosure should be explained to the
patient. Disclosures may be made only where they can be justified in the public
interest.

8.2.3 Obtaining consent where the disclosure is made for research, educational, training,
efficient administration of health services or clinical audit purposes:

8.2.3.1 If identifiable data is to be used this can only be done with informed consent of
the patient

8.2.3.2 Use of identifiable patient data is permitted for purposes of the efficient
administration of health services and for clinical audit, with the proviso that only
information relevant to the purpose of disclosure is revealed, and disclosure is
only made to personnel with a direct interest in that information.

5
 6
8.2.3.3 Where de-identified information can serve any of the above purposes, it is
incumbent on the health care provider to de-identify these data as soon as
possible before making use of the data.

8.2.3.4 Where health care practitioners have control of personal information about
patients, they must not allow anyone access to that information for study,
research or medical audit unless the person obtaining access has been properly
trained and authorised by a health establishment, a health care provider or
comparable body and is subject to a duty of confidentiality in their employment or
because of their registration with a statutory regulatory body.

8.2.4 Disclosures in the public interest:

8.2.4.1 In cases where health care practitioners have considered all the available means
of obtaining consent, but are satisfied that it is not practicable to do so, or that
patients are not competent to give consent, or exceptionally, in cases where
patients withhold consent, personal information may be disclosed in the public
interest where the benefits to an individual or to society of the disclosure
outweigh the public and the patient's interest in keeping the information
confidential, (e.g. endangered third parties such as the spouse or partner of a
patient who is HIV positive, who after counselling refuses to disclosure his or her
status to such spouse or partner; or reporting a notifiable disease).

8.2.4.2 In all such cases the health care practitioner must weigh the possible harm (both
to the patient, and the overall trust between practitioners and patients) against
the benefits that are likely to arise from the release of information.

8.2.4.3 Examples of circumstances to protect the patient or other persons from death or
serious harm, include, but are not limited to:

a. Access to prophylactic treatment for a person who has had contact with an
infectious disease, or
b. An employee with a health condition which may render him or her unable to
work safely posing a danger to co-workers or clients
c. A driver of a vehicle who requires medication to control an illness that might
impair his or her driving ability.

9. PUTTING THE PRINCIPLES INTO PRACTICE

The remainder of this booklet deals with circumstances in which health care practitioners are most
frequently asked to disclose information, and provides advice on how the principles should be
applied.

9.1 DISCLOSURES WHICH BENEFIT PATIENTS INDIRECTLY

9.1.1 Monitoring public health and the safety of medicines and devices:

9.1.1.1 Professional organisations and Government regulatory bodies that monitor the
public health or the safety of medicines or devices, as well as registries of
notifiable conditions, rely on information from patients' records for their
effectiveness in safeguarding public health. For example, the effectiveness of the
system of notifiable conditions depends on information provided by clinicians.
Health care practitioners must co-operate by providing relevant information

6
 7
wherever possible. The notification of some communicable diseases is required
by law and in other cases health care practitioners should provide information in
anonymised form, when that would be sufficient.

9.1.1.2 Where personal information is needed, health care practitioners should seek
express consent before disclosing information, whenever that is practicable. For
example, where patients are receiving treatment there will usually be an
opportunity for a health care practitioner to discuss disclosure of information with
them.

9.1.1.3 Personal information may sometimes be sought about patients with whom health
care practitioners are not in regular contact. Practitioners should therefore make
sure that patients are given information about the possible value of their data in
protecting public health in the longer-term, at the initial consultation or at another
suitable occasion when they attend a health establishment.. It should be clear
that they may object to disclosures at any point. The health care practitioner must
record any objections so that patients' wishes can be respected. In such cases,
the practitioner may pass on anonymised information if asked to do so.

9.1.1.4 Where patients have not expressed an objection, health care practitioners should
assess the likely benefit of the disclosure to the public and commitment to
confidentiality of the organisation requesting the information. If there is little or no
evident public benefit, they should not disclose information without the express
consent of the patient.

9.1.1.5 Where it is not practicable to seek the consent of patients for disclosure of
personal information for these purposes, or where patients are not competent to
give consent, health care practitioners must consider whether the disclosures
would be justified in the public interest, by weighing the benefits to public health
of the disclosure against the possible detriment to the patient.

9.1.1.6 The automatic transfer of personal information to a registry, whether by electronic

or other means, before informing the patient that information will be passed on, is
unacceptable, save in the most exceptional circumstances. These would be
where a court has already decided that there is such an overwhelming public
interest in the disclosure of information to a registry that rights of patients to
confidentiality are overridden; or where health care practitioners are willing and
able to justify the disclosure, potentially before a court or to the HPCSA, on the
same grounds.

9.1.2 Administration and financial audit:

9.1.2.1 Health care practitioners should record financial or other administrative data
separately from clinical information and provide it in anonymised form wherever
possible.

9.1.2.2 Decisions about the disclosure of clinical records for administrative or financial
audit purposes, for example where medical scheme staff seek access to patients'
records as part of the arrangements for medical benefit payments, are unlikely to
breach the ethical rules of the HPCSA, provided that, before allowing access to
patients' records, they follow the guidelines as set out in this booklet.. Only the
relevant part of the record should be made available for scrutiny.

7
 8

9.1.3 Medical research:

Where research projects depend upon using identifiable information or samples, and it is
not practicable to contact patients to seek their consent, the data should be anonymised
and this should be drawn to the attention of a research ethics committee.

9.1.4 Publication of case-histories and photographs:

Health care practitioners must obtain express consent from patients before publishing
personal information about them in media to which the public has access, for example in
journals or text books, whether or not the practitioners believe the patients can be
identified. Express consent must, therefore, be sought to the publication of, for example
case-histories about or photographs of patients. Where health care practitioners wish to
publish information about a patient who has died, they should take into account the
guidelines in this booklet before deciding whether or not to do so.

9.2 DISCLOSURES WHERE HEALTH CARE PRACTITIONERS HAVE DUAL

RESPONSIBILITIES

9.2.1 Situations arise where health care practitioners have contractual obligations to third
parties, such as companies or organisations, as well as obligations to patients. Such
situations occur, for example when practitioners:

9.2.1.1 Provide occupational health services or medical care for employees of a

company or organisation;

9.2.1.2 Are employed by an organisation such as an insurance company;

9.2.1.3 Work for an agency assessing claims for benefits;

9.2.1.4 Provide medical care to patients and are subsequently asked to provide medical
reports or information for third parties about them;

9.2.1.5 Work as district medical officers or forensic pathologists;

9.2.1.6 Work in the armed forces; or

9.2.1.7 Work in correctional services.

9.2.2 If health care practitioners are asked to write a report about or examine a patient, or to
disclose information about a patient from existing records for a third party to whom the
practitioners have contractual obligations, they must:

9.2.2.1 Be satisfied that the patient has been told at the earliest opportunity about the
purpose of the examination or disclosure; the extent of the information to be
disclosed; and the fact that relevant information cannot be concealed or withheld.
Health care practitioners should show the form to the patient before they
complete it to ensure that the patient understands the scope of the information
requested;

8
 9
9.2.2.2 Obtain, or have seen, written consent to the disclosure from the patient or a
person properly authorised to act on the patient's behalf.

9.2.2.3 Disclose only information relevant to the request for disclosure.

9.2.2.4 Include only factual information that they can substantiate, and ensure that it is
presented in an unbiased manner;

9.2.2.5 Patients may wish to see reports written about them before they are disclosed, In
all circumstances health care practitioners should check whether patients wish to
see their reports - unless patients have clearly and specifically stated that they do
not wish to do so.

9.2.3 Disclosures without patients’ consent to employers, or any other relevant third party, can
be justified only in exceptional circumstances, for example when they are necessary to
protect others from risk of death or serious harm.

9.3 DISCLOSURES TO PROTECT THE PATIENT OR OTHERS

9.3.1 Disclosure of personal information without consent may be justified where failure to do so
may expose the patient or others to risk or death or serious harm. Where third parties are
exposed to a risk so serious that it outweighs the patient's right to confidentiality, health
care practitioners should seek consent to disclosure where practicable. If it is not
practicable, they should disclose information promptly to an appropriate person or
authority. They should generally inform the patient before disclosing the information.

9.3.2 Such circumstances may arise, for example:

9.3.1.1 A colleague who is placing patients at risk as a result of illness or some other
medical condition (eg. an impaired colleague): If health care practitioners are in
doubt about whether such disclosure is justified they should consult an
experienced colleague, or seek advice from a professional organisation. The
safety of patients must come first at all times;

9.3.1.2 A patient who continues to drive, against medical advice, when unfit to do so: In
such circumstances health care practitioners should consider disclosing the
relevant information to the patient’s next-of-kin or the traffic authorities or police.
Where such a patient is employed as a professional driver the employer should
be informed.

9.3.1.3 A disclosure that may assist in the prevention or detection of a serious crime: In
this context serious crimes, means crimes that will put someone at risk of death
or serious harm, and will usually be crimes against the person, such as abuse of
children.

9.4 CHILDREN AND OTHER PATIENTS WHO MAY LACK COMPETENCE TO GIVE
CONSENT

9.4.1 Problems may arise if health care practitioners consider that a patient is incapable of
giving consent to treatment or disclosure because of immaturity, illness or mental
incapacity. If such patients ask them not to disclose information to a third party, the health
care practitioners should try to persuade them to allow an appropriate person to be
involved in the consultation.

9.4.1.1 If patients refuse to give consent and health care practitioners are convinced that
it is essential, in the patients’ medical interests, they may disclose relevant

9
 10
information to an appropriate person or authority. In such cases the health care
practitioner must tell the patient before disclosing any information, and seek the
consent of the person legally designated to give such consent in terms of the
National Health Act.

9.4.1.2 The National Health Act provides that if no person has been mandated or legally
appointed to give consent, then in the following order of precedence, a spouse or
partner, parent, grandparent, adult child or adult brother or sister may give
consent.

9.4.1.3 Health care practitioners should document in the patient's record the steps they
took to obtain consent and the reasons for deciding to disclose information.

9.4.2 If health care practitioners believe a child or other legally incompetent patient to be a victim
of neglect or physical, sexual or emotional abuse and that the patient cannot give or
withhold consent to disclosure, they should give information promptly to an appropriate
responsible person or statutory agency, where they believe that the disclosure is in the
patient's best interests.

9.4.2.1 Health care practitioners should inform the patient that they intend to disclose the
information before doing so. Such circumstances may arise in relation to children.
Where child abuse is suspected the law requires the health care provider to
report the alleged abuse to the relevant authorities.

9.4.2.2 Where appropriate, health care practitioners should inform those with parental
responsibility about the disclosure. If, for any reason, practitioners believe that
disclosure of information to the parents or guardians is not in the best interests of
an abused or neglected patient, they must be prepared to justify their decision
(e.g. where the parents or guardians are suspected of abusing the child).

9.4.2.3 The ages are as stipulated in this document are a reflection of the Children’s Act,
2005 (Act No. 38 of 2005).

For detailed information consult the HPCSA Ethical Booklet 4 on Seeking patients’ informed
consent: The ethical considerations

9.5 DISCLOSURE AFTER A PATIENT'S DEATH

9.5.1 Health care practitioners still have an obligation to keep personal information confidential
after a patient dies. The extent to which confidential information may be disclosed after a
patient's death will depend upon the circumstances. These include the nature of the
information, whether that information is already public knowledge or can be anonymised,
and the intended use to which the information will be put. Health care practitioners should
also consider whether the disclosure of information may cause distress to, or be of benefit
to, the patient's partner or family.

9.5.2 There are a number of circumstances in which health care practitioners may be asked to
disclose, or wish to use, information about patients who have died:

9.5.2.1 To assist in connection with an inquest. In these circumstances, practitioners are

required to provide the relevant information;

9.5.2.2 As part of a clinical audit or for education or research with the approval of a
research ethics committee. The publication of properly anonymised case studies
would not be improper in these contexts;

10
 11
9.5.2.3 On death certificates. The law requires health care practitioners to complete
death certificates honestly and fully;

9.5.2.4 To obtain information relating to public health surveillance that is approved by a

research ethics committee. Anonymised information should be used, unless
identifiable data is essential to the study.

9.5.3 Particular difficulties may arise when there is a conflict of interest between parties affected
by the patient's death. For example, if an insurance company seeks information in order to
decide whether to make a payment under a life assurance policy, health care practitioners
should only release information with consent from the next-of-kin or the executor of the
deceased’s estate, or if the deceased had consented to such release before his or her
death.

10. DISCLOSURE IN CONNECTION WITH JUDICIAL OR OTHER STATUTORY

PROCEEDINGS

10.1 Health care practitioners may be required to disclose information to satisfy a specific
statutory requirement, such as notification of a notifiable disease or suspected child or
elder abuse.

10.2 Health care practitioners must also disclose information if ordered to do so by a judge or
presiding officer of a court. They should object to the judge or the presiding officer if
attempts are made to compel them to disclose what appear to them to be irrelevant
matters, for example matters relating to relatives or partners of the patient, who are not
parties to the proceedings.

10.3 Health care practitioners should not disclose personal information to a third party such as
a lawyer, police officer or officer of a court without the patient's express consent, except in
the circumstances described in paras 9.3, 9.4.2 and 9.5.2.

10.4 Health care practitioners may disclose personal information in response to an official
request from a statutory regulatory body for any of the health care professions, where that
body determines that this is necessary in the interests of justice and for the safety of other
patients. Wherever practicable they should discuss this with the patient. There may be
exceptional cases where, even though the patient objects, disclosure is justified.

10.5 In all cases, should health care practitioners decide to disclose confidential information
they must be prepared to explain and justify their decisions.

11. ELECTRONIC PROCESSING OF INFORMATION

11.1 Health care practitioners must be satisfied that there are appropriate arrangements for the
security of personal information when it is stored, sent or received by fax, computer, e-
mail or other electronic means.

11.2 If necessary, health care practitioners should take appropriate authoritative professional
advice on how to keep information secure before connecting to a network. They should
record the fact that they have taken such advice.

11.3 Health care practitioners must make sure that their own fax machine and computer
terminals are in secure areas. If they send data by fax, they should satisfy themselves, as
far as is practicable, that the data cannot be intercepted or seen by anyone other than the
intended recipient.

11
 12

11.4.1 When deciding whether and in what form to transmit personal information, health
care practitioners should note that information sent by e-mail through the internet
may be intercepted.

For detailed information consult the HPCSA Ethical Booklet 10 on Telemedicine.

12
 i

HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE IN

THE HEALTH CARE PROFESSIONS

ETHICAL GUIDELINES FOR GOOD PRACTICE

WITH REGARD TO HIV

BOOKLET 6

PRETORIA
SEPTEMBER 2016
 ii

Health Professions Council of South Africa

Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 iii

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the HPCSA presents the following ethical guidelines to guide and direct

the practice of health care practitioners. These guidelines form an

integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
 iv

TABLE OF CONTENTS

1 PREAMBLE .......................................................................................................................................... 1

2. HIV INFECTION AND AIDS ................................................................................................................. 1

3 MODES OF TRANSMISSION OF HIV ................................................................................................. 2

4 RESPONSIBILITIES OF HEALTH CARE PRACTITIONERS TO HIV POSITIVE PATIENTS ........... 2

5 CONFIDENTIALITY ............................................................................................................................. 3

6 HIV TESTING ....................................................................................................................................... 3

7. KNOWLEDGE OF THE HIV STATUS OF PATIENTS IN THE HEALTH CARE ENVIRONMENT ..... 4

8. REFUSAL TO HAVE BLOOD TESTED FOR HIV ANTIBODIES ....................................................... 4

9. PARTNER DISCLOSURE .................................................................................................................... 5

10 OCCUPATIONAL TRANSMISSION OF HIV, COMPENSATION AND INSURANCE ........................ 6

11. HEALTH CARE PRACTITIONER’S INFECTED WITH HIV ................................................................ 7

 1

GUIDELINES FOR THE MANAGEMENT OF PATIENTS WITH HIV

INFECTION OR AIDS

1 PREAMBLE

1.1 While the guidelines focus on HIV and AIDS, many of the concerns reflected are
applicable to other communicable diseases and other health issues that carry similar
burdens of stigma and discrimination. However, given the enormity of the HIV and AIDS
epidemic and the specific social, economic and ethical conundrums associated with HIV,
these guidelines concentrate on assisting South African health care practitioners to deal
with the problems associated with HIV and AIDS. This was the last paragraph

1.1 The HIV/AIDS epidemic has emerged as the most challenging health matter of modern
times, causing intense debate and discussion in the fields of medicine, ethics, law,
sociology, politics and economics. More so than any other disease in the history of
humankind, HIV and AIDS have forced society and health care practitioners to re-consider
important values relating to human rights, stigma, discrimination and public health.

1.2 South Africa has one of the most rapidly progressing HIV epidemics in the world. The HIV
epidemic is undoubtedly increasing the huge burden of disease facing our country and
poses a major challenge to our health and social services and to the economy of the
country.

1.3 As health care providers committed to maximising human health and well-being, we
should do all in our power to promote the prevention of HIV as well as providing access to
the best possible preventive, promotional, curative and rehabilitative care.

1.4 These guidelines are the product of consultations with stakeholders and the revisions are
consistent with international best practice, such as is contained in guidelines from the
United Nations Joint Programme on HIV/AIDS (UNAIDS), the World Health Organisation
(WHO) and the Department of Health (DoH) comprehensive document on HIV and AIDS.

2. HIV INFECTION AND AIDS

2.1.1 The human immuno virus is responsible for the epidemic facing South Africa
andmanyother countries. For the most part initial infection with the virus in the main, is a
non-event. The majority of people infected with the virus only become aware of their
status by voluntarily choosing to have a HIV test. Otherwise they remain totally unaware
of their HIV infection until presenting several years later with a disease associated with
AIDS.

2.1.2 Presently there is no cure for HIV but understanding the impact of the virus on the human
body has made it possible to develop effective management programmes that provides
great hope for people living with HIV and AIDS. This has made HIV and AIDS a medically
manageable condition – a far cry from a few years ago when despondency and
depression prevailed amongst HIV positive people and their carers.
 2

3 MODES OF TRANSMISSION OF HIV

3.1 HIV is transmitted primarily in three ways:

3.1.1 Through unprotected heterosexual or homosexual intercourse;

3.1.2 During pregnancy or at birth from the infected pregnant woman to the foetus or
infant; and

3.1.3 Through infected blood (e.g. in drug addicts who share needles, occupational
needle stick injuries or exposure to infected blood and blood transfusions).

3.2 The modes of transmission referred to in para 3.1 above may be effectively prevented, and
health care practitioners can play and important role in this regard.

3.3 Much has been said of ‘high risk groups or individuals’ but given the complexities
associated with the modes of transmission, human relationships and sexuality
generalisation around the issue should not be encouraged.

4 RESPONSIBILITIES OF HEALTH CARE PRACTITIONERS TO HIV POSITIVE

PATIENTS

4.1 The primary responsibility of health care practitioners is to their patients.

4.2 It is against all ethical and professional rules for a health care practitioner to refuse to treat
a patient solely on the grounds of the latter’s perceived or actual HIV status. Treatment
should never be suboptimal because of a perceived potential HIV risk to the health care
practitioner. Unilateral decisions not to resuscitate patients with HIV are violations of
fundamental rights.

4.3 It is ethically and legally mandatory, to get informed consent before a health care
practitioner tests a patient for HIV – by law this always applies except in a medical
emergency, or in the case of a child where a parent or guardian is required to give
consent.

4.4 The diagnosis of HIV, without further examination and investigation provides only the most
basic information about a person’s prognosis or actual state of health. It is imperative that
the health care practitioner continues counselling and conducts further investigations once
a patient has been diagnosed as HIV positive.

4.5 In the management of an HIV positive patient it is important that the health care
practitioner gives due consideration to other health care professionals who are also
involved in the management of the same patient (e.g. where necessary, and with the
patient’s consent, informing them of the HIV status of the patient).

4.6 Health care practitioners must support all measures aimed at preventing HIV infection.
Such measures include appropriate education regarding HIV infection; alteration of
lifestyle; improved management of predisposing and aggravating factors (including other
sexually transmitted diseases); mobilising support from the community; and disseminating
information regarding preventive measures.
 3

5 CONFIDENTIALITY

5.1 Ethics, the South African Constitution (Act 108 of 1996) and the law recognise the
importance of maintaining the confidentiality of the HIV status of a patient.

5.2 The test results of HIV positive patients should be treated with the highest possible level
of confidentiality.

5.3 Confidentiality regarding a patient’s HIV status extends to other health care practitioners.
Other health care professionals may not be informed of a patient’s HIV status without that
patient’s consent unless the disclosure is clinically indicated. For treatment and care to be
in the best interests of the patient, the need for disclosure of clinical data, (including HIV
and related test results), to health care practitioners directly involved in the care of the
patient, should be discussed with the patient.

5.4 The decision to divulge information relating to the HIV status of a patient must always be
done in consultation with the patient

5.5 The report of HIV test results by a laboratory, as is the case with all laboratory test results,
should be considered confidential information. A breach of confidentiality is more likely to
occur in the ward, hospital or health care practitioner’s reception area than in the
laboratory. It is, therefore, essential that health care institutions, pathologists and health
care practitioners formulate a clear policy as to how such laboratory results will be
communicated and how confidentiality of the results will be maintained.

6 HIV TESTING

6.1 HIV testing must only take place with the voluntary, informed consent of the patient. The
South African Constitution (Act 108 of 1996) and the law recognises that testing for HIV is
unlike testing for any other medical condition and that special conditions apply.

6.2 The attention of health care practitioners is drawn to the potential abuse of HIV test kits
that are currently available on the market. Health care professionals must be aware of the
reliability and safety of such kits in order to provide the necessary counselling and
information to patients. New forms of HIV testing must only be adopted if they meet
acceptable scientific standards.

6.3 In order to obtain an informed consent, the patient should be given information regarding
the purpose of the laboratory test; what advantages or disadvantages testing may hold for
him or her as a patient; why the health care practitioner wants this information; what
influence the result of such a test will have on his or her treatment; and how his or her
medical protocol will be altered by this information. The psychosocial impact of a positive
test result should also be addressed.

6.4 All communications between the health care practitioner and the patient concerning HIV
testing should be conducted in a language that is easily understood by the patient.

6.5 The patient must clearly understand the information provided, so that he or she agrees to
the HIV test, based on a proper understanding. The importance of the patient’s ability to
understand the information means that if posters are displayed in an attempt to inform
patients about HIV testing, these must be supplemented by verbal pre-test counselling of
 4

the patient by the health care practitioner in order to obtain an informed consent.

6.6 A requirement of informed consent in respect of HIV testing is that if the patient is found to
be HIV-positive, post-test counselling will follow. The health care provider must, therefore,
ensure that the patient is directed to appropriate facilities that will oversee his or her
further care and, where relevant, counsel his or her family and sexual partners.

7. KNOWLEDGE OF THE HIV STATUS OF PATIENTS IN THE HEALTH CARE

ENVIRONMENT

7.1 Health care practitioners should be aware that there are factors that make it unrealistic to
rely solely on HIV testing either in everyday practise or when dealing with a person who
has been occupationally exposed.

7.2 Health care practitioners must appreciate the significance of the window period of
infectivity; the prevalence of HIV infection in the community (and therefore in their
patients); the different tests available; and, where applicable, the time frames necessary
to obtain a reliable HIV test result.

7.3 There is no evidence that knowledge of the HIV status of patients protects health care
practitioners or reduces the risk of needle stick injuries. However, given the high incidence
of HIV infection, in all instances health care establishments should ensure that universal
precautions are used to provide protection against HIV infection.

7.4 Where certain well-defined high risk or exposure-prone procedures are contemplated, the
patient should be informed of the concerns and asked to consent to HIV testing. All patients
have a right to refuse testing, and where a patient refuses to test for HIV under such
circumstances, the patient may not be refused treatment on this basis. Should a patient
decline to be tested for HIV, such patient should be managed by health care practitioners
as if he or she was HIV positive.

7.5 “High risk” procedures may require the use of “extended” universal precautions such as
special gloves, clothing and face masks. “High risk” procedures include, for example, the
palpation of a needle-tip in a body cavity; the simultaneous presence of the health care
practitioner’s fingers and a needle or other sharp object in a poorly visualised or highly
confined anatomic cavity; and orthopaedic and other procedures where there is an
aerosol of blood, bone fragments or bloody fluids.

7.6 It should be emphasised that permitting pre-operative or pre-treatment HIV testing with
informed consent where high-risk procedures are contemplated, or under specific
circumstances, should not be misinterpreted or abused to justify routine HIV testing of all
patients, nor is it permissible for patients to be told that pre-HIV testing is mandatory in
such circumstances.

8. REFUSAL TO HAVE BLOOD TESTED FOR HIV ANTIBODIES

8.1 It is not justifiable to test for HIV without the patient's consent, except in the circumstances
set out in the National Policy on Testing for HIV, (e.g. as part of unlinked and anonymous
testing for epidemiological purposes undertaken by the national, or a provincial or local
health authority, or an agency authorised by any of these bodies - provided that HIV
testing for epidemiological purposes is carried out in accordance with national, legal and
ethical provisions regarding such testing.
 5

8.2 Where the health care practitioner has sustained a risk-bearing incident such as a needle
stick injury because immediate post-exposure measures may be beneficial to the health
care professional, information as to the HIV status of the source patient may be obtained
in the following ways:

8.2.1 Testing any existing blood specimen from the source patient. This should be
done with the source patient's consent, but if consent is withheld, the specimen
may nevertheless be tested, but only after informing the source patient that the
test will be performed and providing for the protection of privacy.

8.2.2 If there is no existing blood specimen and the patient still refuses to consent to an
HIV test the patient should be treated as HIV positive and prophylaxis should be
initiated in respect of the health care practitioner who has been placed at risk of
HIV infection.

8.2.3 If the patient is unable to give informed consent and is likely to remain unable to
do so for a significant length of time every reasonable attempt should be made to
obtain appropriate proxy consent. Proxy consent means consent by a person
legally able to give such consent in terms of the National Health Act (Act No. 61
of 2003) – i.e. in order of precedence, a spouse or partner, a parent, a
grandparent, an adult child or a brother or sister of the patient, or in terms of the
Children’s Act (Act No. 38 of 2005) the clinical manager in the absence of such
persons in the case of a child.

8.3 It must be emphasised that with regard to HIV testing there should be no medical
emergency situation and it may be difficult legally to justify such a situation on the basis
that testing without consent was necessary in order to save a person’s life.

9. PARTNER DISCLOSURE

9.1 Health care practitioners should try to encourage their HIV positive patients to disclose
their status to their sexual partners so as to encourage them to undergo VCT and access
treatment if necessary. This is consistent with good clinical practice.

9.2 If the patient refuses consent, the health care practitioner should use his or her discretion
when deciding whether or not to divulge the information to the patient’s sexual partner,
taking into account the possible risk of HIV infection to the sexual partner and the risks to
the patient (e.g. through violence) that may follow such disclosure. The decision must be
made with great care, and consideration must be given to the rights of all the parties
concerned. If the health care practitioner decides to make the disclosure against the
patient’s wishes, the practitioner must do so after explaining the situation to the patient
and accepting full responsibility at all times. The following steps are recommended – the
health care practitioner must:

9.2.1 Counsel the patient on the importance of disclosing to his or her sexual partner
and on taking other measures to prevent HIV transmission.

9.2.2 Provide support to the patient to make the disclosure.

9.2.3 If the patient still refuses to disclose his or her HIV status or refuses to consider
other measures to prevent infection, counsel the patient on the health care
practitioner’s ethical obligation to disclose such information.

9.2.4 If the patient still refuses, disclose information on the patient’s HIV status to the
sexual partner and assist them to undergo VCT and access treatment if
necessary.
 6

9.2.5 After disclosure, follow up with the patient and the patient’s partner to see if
disclosure has resulted in adverse consequences or violence for the patient, and,
if so, intervene to assist the patient appropriately.

9.3 Health care practitioners must recognise the major ethical dilemma when confronted with
a person who is HIV positive and who refuses, despite counselling, to inform his/her
partner or partners.

9.4 When health care practitioners are expected to record diagnostic information for patients
on medical insurance for the purposes of processing claims, or in line with the rules of the
medical scheme, the patient must give informed consent for such information to be placed
on the account (e.g. ICD-codes).

10 OCCUPATIONAL TRANSMISSION OF HIV, COMPENSATION AND INSURANCE

10.1 There is a slight risk of transmission of HIV infection in the health care environment (e.g.
from patient- to-patient, patient-to-health care practitioner, and from health care
practitioner-to-patient) through the exchange of infected blood or other body fluids –
although scientifically the risk has been shown to be small. The risk can be reduced to
negligible levels by effective infection control and hygiene measures. Nonetheless health
care practitioners need to remain vigilant regarding the risk of occupational exposure to
HIV.

10.2 Universal precautions must be practised at all times by all health care practitioners and
health institutions in the health care environment.

10.3 Post-exposure treatment of a health care practitioner or a patient must be available where
the possibility of an exchange of blood or body fluids has taken place. There can be no
excuse for any health institution and practise not to have a clear and concise policy on
such treatment.

10.4 Health practitioners working in the health care industry must make their employers aware
of the importance of HIV. They should assist in the development and formulation of a
comprehensive HIV and AIDS policy that covers prevention, treatment and care, as well
as non-discrimination and non-stigmatisation. In developing a policy it should not be
forgotten that a number of health care practitioners are themselves infected with HIV – the
ethos of a caring profession should apply to fellow health care professionals. It is also
imperative for employers in the health care industry to familiarise themselves with their
constitutional, legal and ethical obligations when dealing with HIV and AIDS.

10.5 Students in faculties of health sciences, who are not legally recognised employees, and
who face the possibility of occupational HIV exposure should be insured - either by their
University or by the hospital where they are undergoing training.

10.6 There is consensus that adherence to universal precautions is the most important
preventative action that will significantly protect health care practitioners against infection
by HIV and other blood borne pathogens.

10.7 For the above reasons the following must be in place:

10.7.1 All employers must make available to health care practitioners the tools and
systems necessary for the latter to practise universal precautions.

10.7.2. The necessary universal precaution tools and systems must also be provided to
paramedical personnel, auxiliary and unskilled workers who handle patients (or
 7

could be exposed to contaminated materials), and health science students who

may be potentially exposed to the risk of HIV infection.

11. HEALTH CARE PRACTITIONER’S INFECTED WITH HIV

11.1 Health care practitioners cannot be obliged to disclose their HIV status to an employer nor
may any health care practitioner be unfairly discriminated against or dismissed as a result
of his or her HIV status.

11.2 Health care practitioners are expected to be aware of the benefits of voluntary HIV testing
and are encouraged to consider VCT. Where the health care practitioner tests positive for
HIV, they should attend further counselling.

11.3 Restrictions that cannot be scientifically justified, should not be imposed on HIV positive
health care practitioners.

11.4 Universal precautions should always be used when undertaking invasive procedures in
order to minimise transmission from health practitioners to patients.

11.5 Patients should be made aware by health care practitioners that HIV infection can affect
everybody including health care practitioners.
 8

ANNEXURE

1. BASIC ELEMENTS OF PRACTICALLY APPLICABLE AND

UNIVERSAL PRECAUTIONS

1.1 Universal precautions are designed to prevent:

1.1.1 Penetration of the skin by contaminated sharp objects; and

1.1.2 Contamination of the skin, especially non-intact skin and mucous membranes, in
particular the conjunctivae.

1.2 As a general principle, disposable instruments should only be used once, and re-usable
items should be sterilised.

2. BODY FLUIDS WHICH SHOULD BE HANDLED WITH THE SAME PRECAUTIONS AS

BLOOD

2.1 The following body fluids should be handled with the same precautions as blood:

2.1.1Cerebrospinal fluid
2.1.2 Peritoneal fluid
2.1.3 Pleural fluid
2.1.4 Pericardial fluid
2.1.5 Synovial fluid
2.1.6 Amniotic fluid
2.1.7 Semen
2.1.8 Vaginal secretions
2.1.9Breast milk

2.2. The following other body fluids and tissues should also be treated like blood:

2.2.1 Any other body fluid which is blood stained.

2.2.2 Saliva in association with dentistry.
2.2.3 Unfixed tissues and organs.

3. BODY FLUIDS SUCH AS URINE, SWEAT AND SALIVA

Body fluids such as urine, sweat and saliva do not pose any risk.

4. AVOIDANCE OF INJURIES WITH “SHARPS”

Health care practitioners should avoid injuries with “sharps” by:

4.1 Recognising risky objects, not only needles and knives, but less obvious ones such as
towel-clips, suction drain introducers, bone spicules, etc.

4.2 Never allowing a sharp object, especially a contaminated one, to come near one's fingers
(e.g. they should not resheath needles and should use instruments to load and unload
scalpel blades, etc.)

4.3 Being personally responsible for the immediate safe disposal of all “sharps” that they use
into an approved container.

4.4 Never handling a “sharp” without looking at it.

 9

4.5 Never puting down a”'sharp” except in an agreed neutral area.

4.6 Using the safest “sharp” that will do the job (e.g. knives and sharp needles only for skin;
scissors and blunt (round-nosed) needles for tissues).

4.7 Never feeling for a needle point (or other sharp object) with their fingers.

4.8 Never putting their fingers in an area or wound where someone else is using a “'sharp”.

4.9 Avoiding the use of wire sutures.

4.10 Using heavy-duty gloves (ring-link or similar) in dangerous situations (e.g. where there are
broken bones, sharp foreign bodies).

5. AVOIDANCE OF SKIN and MUCOUS MEMBRANE CONTAMINATION

5.1 Three risks have been identified regarding skin and mucous membrane contamination,
namely from:

5.1.1 Blood or body fluid on the hands;

5.1.2 Spillage of blood or body fluid on the health care practitioner’s body;

5.1.3 Spray-aerosol of blood or body fluid to eyes and face.

5.2 Health care practitioners should never have contact with patients’ soiled linen, etc. if the
skin of their hands is not intact (e.g. from cuts, eczema, etc.) unless the lesions can be
completely isolated by impermeable adhesive tape.

5.3 Health care practitioners should use make careful use of gloves:

5.3.1 Latex gloves should be used by every health care provider handling blood or
body fluid.

5.3.2 Torn gloves should be removed immediately and contamination washed away.

5.3.3 Double gloving reduces skin contamination during operations by 80%, and may
reduce the risk associated with “sharps” injuries.

5.4. In respect of spillage health care practitioners should:

5.4.1 Use plastic aprons and impermeable boots where the risk of spillage exists,

5.4.2 Ensure that all spillage is immediately cleaned.

5.4.3 Double seal all containers of blood and body fluid.

5.5 In respect of spray-aerosol health care practitioners should:

5.5.1 Use face or eye protection (e.g. face shields, eye-goggles) where the risk of
spray-aerosol contamination exists.

5.5.1 Should continuously aspirate laser and fulguration smoke by suction.

 10

Note: Routine implementation of these simple, logical measures, that are not time consuming, nor
significantly expensive, by all members of the health care team, should reduce the risk of infection
of health care practitioners by patients, and of patients by health care practitioners to very nearly
zero. Disciplined implementation of these precautions in dealing with all patients should make pre-
treatment determination of a patient's HIV status irrelevant in terms of the safety of health care
practitioners.
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR THE WITHHOLDING AND

WITHDRAWING OF TREATMENT

BOOKLET 7

PRETORIA
SEPTEMBER 2016
 i

Health Professions Council of South Africa

Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 ii

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly

made”.[1] To be a good health care practitioner, requires a life-long

commitment to sound professional and ethical practices and an overriding

dedication to the interests of one’s fellow human beings and society. In

essence, the practice of health care professions is a moral enterprise. In

this spirit the HPCSA presents the following ethical guidelines to guide

and direct the practice of health care practitioners. These guidelines

form an integral part of the standards of professional conduct against

which a complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

 iii

[1]
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
TABLE OF CONTENTS

1 INTRODUCTION ....................................................................................................................................... 1

2 GOOD PRACTICE FRAMEWORK: PROCEDURES TO BE FOLLOWED .............................................. 2

3 CLINICAL RESPONSIBILITY FOR DECISIONS...................................................................................... 2

4 DIAGNOSIS AND PROGNOSIS ............................................................................................................... 3

5 OPTIONS FOR TREATMENT ................................................................................................................... 3

6 EMERGENCIES ........................................................................................................................................ 3

7 CHOOSING BETWEEN OPTIONS: PATIENTS WHO CAN DECIDE FOR THEMSELVES .................. 3

8 CHOOSING BETWEEN OPTIONS: PATIENTS WHO CANNOT DECIDE FOR THEMSELVES ........... 5

9 WITHHOLDING TREATMENT DUE TO SCARCITY OF RESOURCES AND ALLOCATION OF

SCARCE RESOURCES ............................................................................................................................ 6

10 COMMUNICATING DECISIONS ............................................................................................................... 6

11 RECORDING DECISIONS ........................................................................................................................ 6

12 REVIEWING DECISIONS.......................................................................................................................... 7

13 AUDIT ........................................................................................................................................................ 7

14 CHILDREN................................................................................................................................................. 7
 GUIDELINES FOR THE WITHHOLDING AND
WITHDRAWING OF TREATMENT

1 INTRODUCTION

1.1 Health care practitioners have a responsibility to make the care of their patients their
first concern. This is essential when considering any of the growing range of life-saving
or life-prolonging treatments which make it possible to extend the lives of patients who,
through organ or system failure, might otherwise die. The benefits of modern
techniques such as cardiopulmonary resuscitation, renal dialysis, artificial ventilation,
and artificial nutrition and hydration are considerable. However, life has a natural end
and the existence of such techniques of life support may, in certain cases, sustain life
artificially for many years for patients for whom there is little hope of recovery. The
quality of life which may follow some treatments might raise questions as to whether it is
in the best interests of the patient to start or continue treatment.

1.2 The guidance which follows is intended to provide an ethical framework of good practice
for health care practitioners in circumstances where they are faced with making a
decision on whether to withhold or withdraw life-prolonging treatment. It is based on
those areas of broad consensus so far established and recognises the need to ensure
that patients can die with dignity and that their families and others close to them are
appropriately involved in their care. It takes account of existing law in this area, that
allowing for withholding and withdrawing of life sustaining treatments and that which
prohibits killing, active euthanasia, and assisted suicide. It is, therefore, based on the
premise that any medical intervention where the health care professional’s primary
intention is to end the patient’s life is both contrary to the ethics of health care and
unlawful.

1.3 The health care professional may alleviate the suffering of a terminally-ill patient by
withholding treatment, i.e. allowing the natural process of death to follow its course,
provided there is consultation with another health care practitioner who is an expert in
the field, and where available, discussions with the closest relatives.The withholding of
treatment does not exempt the health care professional from the duty to assist the dying
person by providing him or her with the necessary medication in order to alleviate the
terminal phase of illness. The health care professional shall refrain from employing
unusual methods of treatment which are of no benefit to the patient.”

1.4 The HPCSA also expects health care practitioners to observe the provisions of the
World Medical Association Declaration on Terminal Illness.

1.5 Health care practitioners have a duty to give priority to patients on the basis of clinical
need, while seeking to make the best use of resources and using up to date evidence
about the clinical efficacy of treatments. Health care practitioners must not allow their
views about, for example, a patient’s age, disability, race, colour, culture, beliefs,
sexuality, gender, lifestyle, social or economic status or other irrational grounds to
prejudice the choices of treatment offered or the general standard of care provided. A
non-discriminatory policy also applies to patients infected with HIV. In any event a
diagnosis of HIV infection, without further examination, provides only incomplete
information about a person’s prognosis or actual state of health.
 2
2 GOOD PRACTICE FRAMEWORK: PROCEDURES TO BE FOLLOWED

2.1 The National Health Act (Act No. 61 of 2003) allows patients in writing to mandate a
person to act on their behalf when they are no longer able to do so. Therefore, patients
should be encouraged to appoint in writing a person to make decisions on their behalf
when they are no longer capable of doing so. The patient-selected proxy decision-
maker must then be regarded as the substitute for the patient whenever reference is
made to the patient in these provisions.

2.2 Patients and their families, unless a contrary wish is expressed, must be kept informed
of treatment, treatment alternatives and outcome probabilities.

2.3 Patients should be given the opportunity and be encouraged to indicate their wishes
regarding further treatment and to place in writing their directives for future care in
possible critical circumstances, (e.g. permanent coma or terminal illness). An
appropriately drafted “living will” may be used for this purpose. These instructions can
also be set out in the mandate to a third party mentioned in para 2.1 above. Patients
should also be given the opportunity to reconsider their directives from time to time and
to alter instructions, should they wish to do so.

2.4 When the patient is incapable of being involved in making a decision related to
treatment and no advance directive or other information regarding the patient’s wishes
is available, close family must be consulted and a decision taken in what are considered
to be the patient’s best interests.

2.5 Before taking definitive action, the responsible health team should carefully consider
and discuss the issue, obtain the advice of other health care practitioners, the family,
patient (if possible) and a person with a background in ethics. Health care practitioners
should always involve the family and patient (where practicable) in the discussions, and
should never act in haste.

2.6 When the patient or the family request continued treatment against health advice that
considers such treatment to be futile, the patient or the family must be given the choice
of transferring to another institution where such treatment is available. If this option is
refused and the health team considers treatment to be futile, and this is confirmed by an
independent health care practitioner, treatment may be withheld or withdrawn.

2.7 All decisions should be fully and clearly documented in the notes, including the reasons
for the decision and the procedure adopted in the decision-making process. Where
significant disagreement arises about a patient’s best interests, health care practitioners
should seek a clinical and / or ethical review, independent of the health care team. If
this fails to resolve the disagreement, they must seek legal advice on whether it is
necessary to apply to the court for a ruling.

3 CLINICAL RESPONSIBILITY FOR DECISIONS

A decision to withhold or withdraw life-prolonging treatment should be made only by the

senior clinician in charge of a patient’s care, taking account of the views of the patient or
those close to the patient.
 3
4 DIAGNOSIS AND PROGNOSIS

Before a decision is made to withhold or withdraw treatment, the treating health care
practitioner must carry out a thorough assessment of the patient’s condition and the
likely prognosis, taking account of current guidance on good clinical practice. The
practitioner should always consider seeking a second opinion. Health care practitioners
must seek a second opinion in cases where they are not sufficiently experienced or
knowledgeable.

5 OPTIONS FOR TREATMENT

5.1 Health care practitioners should only identify treatment options as being appropriate if
based on up-to-date clinical evidence about efficacy, side-effects and other risks, while
also referring to any relevant clinical guidelines on the treatment and management of
the patient’s condition, or of patients with similar underlying risk factors.

5.2 Health care practitioners must reach a considered judgment on the likely benefits,
burdens and risks (including non-clinical ones) for the particular patient of each of the
treatment (or non-treatment) options identified. They should always consult a clinician
with relevant experience in cases where:

5.2.1 The health care practitioner and the health care team have limited experience
of a condition; or

5.2.2 The health care practitioner is in doubt about the range of options or the
benefits, burdens and risks of a particular option for the individual patient; or

5.2.3 The health care practitioner is considering withholding or withdrawing artificial

nutrition and hydration.

6 EMERGENCIES

6.1 In an acute life threatening emergency where any delay might prejudice the outcome
and where it is impossible to obtain all relevant information or hold any consultations
required - or where there is uncertainty about the diagnosis or the likelihood of recovery,
health care practitioners should start treatment which may be of some benefit to the
patient until a clearer assessment can be made.

6.2 If the treatment referred to in para 6.1 above, was done without the consent of the
patient the health care practitioner should inform the patient about the procedures that
were done – as soon as the patient is mentally capable of understanding such
information.

7 CHOOSING BETWEEN OPTIONS: PATIENTS WHO CAN DECIDE FOR

THEMSELVES

7.1 SEEKING THE PATIENT’S VIEWS

7.1.1 Where a patient is competent to participate in decision-making, health care

practitioners must discuss with the patient their conclusions about diagnosis,
prognosis and which options they consider may be in the patient’s best
interests. It is for the patient to judge what might be acceptable; what weight or
priority to give to any burden or risks; and to decide which of the options would
be in his or her best interests.
 4

7.1.2 Health care practitioners should bear in mind that the decisions of competent
adult patients to refuse a particular medical intervention must be respected,
even where this would result in serious harm to them or in their own death.

7.1.3 Where the possibility of withholding or withdrawing of life-prolonging treatment

is being considered as an option, health care practitioners should discuss with
the patient how his or her care would be managed if such a decision were
made. This should include arrangements for providing basic care and other
appropriate treatment; and what might be his or her palliative or terminal care
needs and how these would be met. In addition the patient’s preferences
about who should be involved in decision-making or in providing additional
support if he or she becomes incapacitated should also be discussed.

7.1.4 Discussions of the sort in the above paragraph will allow patients the
opportunity they need to decide what arrangements should be made to
manage the final stages of their illness; and to attend to personal and other
concerns which are important in ensuring that patients can die with dignity.

7.1.5 Discussions about the possibility of withholding or withdrawing a potentially life-

prolonging treatment may be difficult and distressing. However, this does not
mean that such discussions should be avoided. Instead, the discussions
should be handled sensitively and with appropriate support being provided to
the patient. Health care practitioners should also consult with those close to the
patient about the best means of withholding or withdrawing treatment where
this is appropriate.

7.1.6 Where patients clearly indicate that they do not wish to know or discuss the
details, health care practitioners should still provide the patient with sufficient
information about his or her condition and its treatment to enable the patient to
make an informed decision.

7.1.7 A linguistic or cultural barrier may exist between health care practitioners and
the patient. Under these circumstances, an interpreter fluent in the language
used by the patient should be present in order to facilitate communication
when discussions are held and decisions regarding the treatment of the patient
are to be made.

7.2 TIMING OF DISCUSSIONS WITH THE PATIENT

7.2.1 Health care practitioners should hold discussions at a time when the patient is
best able to understand and retain information. They should allow the patient
sufficient time to reflect and ask questions before deciding.

7.2.2 Health care practitioners should also discuss the patient’s right to change his
or her mind about the decision. Where a patient has an existing condition and
the likely progression of the disorder is known, the health care practitioner
should consider formulating an advance management plan with the patient and
the clinical team.
 5

8 CHOOSING BETWEEN OPTIONS: PATIENTS WHO CANNOT DECIDE FOR

THEMSELVES

8.1 ASSESSING CAPACITY TO DECIDE

8.1.1 In most cases where the dying process itself affects the patient’s mental
capacity, the correct course of action for the patient should have been decided
previously. Where no such advance management plan had been agreed, or
the plan has not been reviewed recently, or is not relevant to the patient’s
current condition, health care practitioners are advised as follows:.

8.1.2 Where patients have difficulty retaining information, communicating their views,
or are only intermittently competent, health care practitioners should provide
any assistance a patient might need to enable him or her to reach and
communicate a decision.

8.1.3 Where there are doubts about a patient’s capacity at making a decision, health
care practitioners should consult with the relevant health care practitioner taking
into account any legal tests of capacity.

8.2 MAKING DECISIONS FOR THE PATIENT

8.2.1 Where a patient lacks the capacity to decide, health care practitioners must
respect any valid advance refusal of treatment.

8.2.2 Where there is no advance refusal of treatment the senior clinician responsible
for the patient’s care must make the decision about what course of action would be in
the patient’s best interests:

8.2.2.1 The senior clinician should consult the patient’s authorised

representative if such a person was appointed.

8.2.2.2 The clinician should also consult the health care team and the
patient’s authorised representative and, wherever possible, those
close to the patient. The latter may be able to provide insights into the
patient’s preferences, and be able to offer an opinion on what would
be in the patient’s best interests.

8.2.2.3 Health care practitioners should pay due regard to any previous
wishes of the patient about not disclosing information to particular
individuals.

8.2.2.4 If the patient is new to the health care practitioner at the time
decisions are needed, the health care practitioner must satisfy himself
or herself whether or not such consultations have previously been
carried out and if so, find out what had been agreed.

8.2.3 The health care practitioner should consider what support could be provided to
family members and others close to the patient.
 6
8.3 REACHING CONSENSUS

The consultations between the clinician and the health care team and those close to the patient
should aim to achieve consensus on what course of action would be in the best interests of the
patient. The factors considered in assessing best interests should take into account guidance
from the HPCSA, pertinent ethical principles and relevant statutory requirements,

9 WITHHOLDING TREATMENT DUE TO SCARCITY OF RESOURCES AND

ALLOCATION OF SCARCE RESOURCES

9.1 There are circumstances when withholding treatment, even if it is not in the best interest
of the patient is permissible. This will apply to continued care in special units such as
critical care and chronic dialysis units for end stage kidney failure.

9.2 A health care institution has the right to limit life-sustaining interventions without the
consent of a patient or surrogate by restricting admission to these units. However, such
restriction must be based on national admission criteria agreed upon by the expert
professional bodies in the relevant speciality, as well as the HPCSA.

9.3 A health care institution is, however, obliged to provide the appropriate palliative care
and follow up when specialised care is withheld.

9.4 If, however, the patient does satisfy all the criteria for admission, but cannot be admitted
because of limited resources at a particular institution, the health care practitioner must
transfer the patient to another institution where such resources exist. However, this
should be done only after the necessary emergency treatment has been instituted.

9.5 The HPCSA considers it unethical to continue with life-prolonging treatment for the sole
purpose of financial gain. Moreover, it is unacceptable that patients are transferred to
state institutions after all their funding has been exhausted as a result of prolonging
futile treatments.

10 COMMUNICATING DECISIONS

10.1 Whatever decision is made, health care practitioners must ensure that all those
consulted, and especially those responsible for delivering care, are informed of the
decision and are clear about the goals and the agreed management plan.

10.2 It is particularly important where treatment is to be withheld or withdrawn that everyone

involved is clear about the arrangements for providing appropriate palliative or terminal
care and about their own roles.

10.3 Health care practitioners should discuss what the role of the family or other carers will
be and what support they will receive from the health care team.

11 RECORDING DECISIONS

11.1 Health care practitioners must ensure that decisions are properly documented, including
the relevant clinical findings; details of discussions with the patient, health care team or
others involved in decision-making; and details of treatment or other significant factors
which may affect future care.

11.2 Health care practitioners should record the information at the time of the events
described or soon thereafter. The record should be legible, clear, accurate and
 7
unambiguous. It should, for example, avoid abbreviations or other
terminology that may cause confusion to those providing care.

11.3 Health care practitioners should ensure that the records are appropriately accessible to
team members and others involved in providing care to the patient.

12 REVIEWING DECISIONS

12.1 Health care practitioners must review their decisions at appropriate intervals during the
agreed treatment or the period of palliative or terminal care to determine whether the
goals of treatment or the management plan remain appropriate.

12.2 Health care practitioners should seek a second opinion where, for example the patient’s
condition is not progressing as expected.

13 AUDIT

13.1 As in other areas of decision making, health care practitioners must carry out clinical
audits of the process which can improve their own and others’ knowledge about the
outcomes of different treatment and non-treatment decisions.

13.2 Where possible health care practitioners should help to disseminate best practice, for
example, by contributing to the education of students and colleagues about good
practice in the area concerned.

14 CHILDREN

14.1 The general principles of good practice set out in this framework also apply to decision-
making in cases involving children - including premature babies where the decisions
may be particularly difficult for everyone involved.

14.2 Health care practitioners should respect the decisions of children who have the legal
capacity to make decisions about refusing health care – except in cases where the
practitioners believe that it is not in the child’s best interests – in which case they should
approach the court for a decision.

14.3 In all cases, health care practitioners and others who make decisions on behalf of a
child have to consider only those options that are in the best interest of the child.

14.4 If the child does not have the legal capacity to make a decision, but is sufficiently
mentally mature to understand the procedures to be adopted, he or she should be
consulted during the decision-making process.
 8

ANNEXURE

World Medical Association Declaration on Terminal Illness

Adopted by the 35th World Medical Assembly Venice, Italy, October 1983
and Revised by the WMA General Assembly, Pilanesberg, South Africa, October 2006
Preface

1. When addressing the ethical issues associated with end-of-life care, questions
regarding euthanasia and physician-assisted suicide inevitably arise. The World
Medical Association condemns as unethical both euthanasia and physician-assisted
suicide. It should be understood that WMA policy on these issues is fully applicable in
the context of this Statement on Terminal Illness.

Preamble

2. When a patient's medical diagnosis precludes the hope of health being restored or
maintained, and the death of the patient is inevitable, the physician and the patient
are often faced with a complex set of decisions regarding medical interventions.
Advances in medical science have improved the ability of physicians to address
many issues associated with end-of-life care. However, it is an area of medicine that
historically has not received the attention it deserves. While the priority of research to
cure disease should not be compromised, more attention must be paid to developing
palliative treatments and improving the ability of physicians to assess and address
the medical and psychological components of symptoms in terminal illness. The
dying phase must be recognized and respected as an important part of a person's
life. As public pressure increases in many countries to consider physician assisted
suicide and euthanasia as acceptable options to end suffering in terminal patients,
the ethical imperative to improve palliative treatment in the terminal phase of life
comes into sharp focus.

3. The World Medical Association recognizes that attitudes and beliefs toward death
and dying vary widely from culture to culture and among different religions. In
addition, many palliative and life-sustaining measures require technologies and/or
financial resources that are simply not available in many places. The approach to
medical care of the terminally ill will be influenced significantly by these factors, and
thus attempting to developing detailed guidelines on terminal care that can be
universally applied is neither practical nor wise. Therefore, the World Medical
Association articulates the following core principles to assist physicians and National
Medical Associations with decision-making related to terminal care.

Principles

4. The duty of physicians is to heal, where possible, to relieve suffering and to protect
the best interests of their patients. There shall be no exception to this principle even
in the case of incurable disease.

5. In the care of terminal patients, the primary responsibilities of the physician are to
assist the patient in maintaining an optimal quality of life through controlling
symptoms and addressing psychosocial needs, and to enable the patient to die with
dignity and in comfort. Physicians should inform patients of the availability, benefits
and other potential effects of palliative care.

6. The patient's right to autonomy in decision-making must be respected with regard to

decisions in the terminal phase of life. This includes the right to refuse treatment and
to request palliative measures to relieve suffering but which may have the additional
effect of accelerating the dying process. However, physicians are ethically prohibited
 9
from actively assisting patients in suicide. This includes administering any treatments
whose palliative benefits, in the opinion of the physician, do not justify the additional
effects.

7. The physician must not employ any means that would provide no benefit for the
patient.

8. . Physicians should recognise the right of patients to develop written advance

directives that describe their wishes regarding care in the event that they are unable
to communicate and that designate a substitute decision-maker to make decisions
that are not expressed in the advance directive. In particular, physicians should
discuss the patient's wishes regarding the approach to life-sustaining interventions as
well as palliative measures that might have the additional effect of accelerating
death. Whenever possible, the patient's substitute decision-maker should be included
in these conversations.

9. Physicians should endeavour to understand and address the psychosocial needs of

their patients, especially as they relate to patients' physical symptoms. Physicians
should try to ensure that psychological and spiritual resources are available to
patients and their families to help them deal with the anxiety, fear and grief
associated with terminal illness.

10. The clinical management of pain in terminal patients is of paramount importance in

terms of alleviating suffering. Physicians and National Medical Associations should
promote the dissemination and sharing of information regarding pain management to
ensure that all physicians involved in terminal care have access to best practice
guidelines and the most current treatments and methods available. Physicians
should be able to pursue clinically appropriate aggressive pain management without
undue fear of regulatory or legal repercussions.

11. National Medical Associations should encourage governments and research

institutions to invest additional resources in developing treatments to improve end-of-
life care. Medical school curricula should include the teaching of palliative medical
care. Where it does not exist, the establishment of palliative medicine as a medical
specialty should be considered.

12. National Medical Associations should advocate for the development of networks
among institutions and organizations involved in palliative care in order to foster
communication and collaboration

13. Physicians may, when the patient cannot reverse the final process of cessation of
vital functions, apply such artificial means as are necessary to keep organs active for
transplantation provided that they act in accordance with the ethical guidelines
established in the World Medical Association Declaration of Sydney on the
Determination of Death and the Recovery of Organs.
 1

HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

GENERAL ETHICAL GUIDELINES FOR

REPRODUCTIVE HEALTH

BOOKLET 8

PRETORIA
SEPTEMBER 2016
 2

Health Professions Council of South Africa

Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 3

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a

relationship of mutual trust between patients and health care

practitioners. The term “profession” means “a dedication,

promise or commitment publicly made”.1 To be a good health

care professional requires a life-long commitment to sound

professional and ethical practices and an overriding dedication

to the interests of one’s fellow human beings and society. In

essence, practice as a health care professional is a moral

enterprise. In this spirit the Health Professions Council of

South Africa presents the following ethical guidelines.

[Note: The term “health care practitioner” in these guidelines

refers to persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000;
13(2):147-149 (quotation on p. 148).
 4

TABLE OF CONTENTS

1. PREAMBLE ..................................................................................................... 5
2. THE ROLE OF THE HEALTH PRACTITIONERS AS ADVOCATES FOR ..... 6
WOMEN’S HEALTH ....................................................................................... 6
3. INTIMATE EXAMINATIONS …………………………………………………5
4. VIOLENCE AGAINST WOMEN ...................................................................... 8
5. DOMESTIC VIOLENCE………………………………………………………8
6. CONTRACEPTION ....................................................................................... 10
7. ETHICAL CONSIDERATIONS IN STERILIZATION ..................................... 11
8. INDUCED ABORTION FOR NON-HEALTHCARE PRACTITIONER
REASONS .......................................................................................................... 13
9. SEX SELECTION .......................................................................................... 14
10. SURROGATE MOTHERHOOD .................................................................... 14
11. PREVENTING IATROGENIC MULTIPLE PREGNANCY ............................. 15
12. ETHICAL GUIDELINES REGARDING THE PROCEDURE ......................... 15
OF COLLECTION OF CORD BLOOD .......................................................... 15
 5

1. PREAMBLE

The concept of reproductive health will play a crucial role in improving

women’s health and rights in the country. While reproductive health is an
important component of health for both women and men, it is more critical,
however, for women. A major burden of disease in females is related to their
reproductive function and reproductive potential, and the way in which society
treats or mistreats women because of their gender. The concept of
reproductive health offers a comprehensive and integrated approach to health
needs related to reproduction. It puts women at the centre of the process, and
recognizes respects and responds to the needs of women 1. Women have a
unique vulnerability because of their reproductive function and role. Social
discrimination and abuse based on gendered undervaluing of women may
further compromise women’s health. Concern for family welfare may take
precedence over individual health and also increase their health risk.
However, whatever the social norms, these should not be allowed to impact
negatively on women’s health.

The concept of reproductive health received great attention and was endorsed
at the United Nations International Conference on Population and
Development held in Cairo in 1994. The definition of reproductive health
adopted at the conference reads as follows:

“Reproductive health is a state of complete physical, mental and social well-

being and not merely the absence of disease and infirmity, in all matters
relating to the reproductive system and to its functions and processes.
Reproductive health therefore implies that people are able to have a satisfying
and safe sex life and that they have the capability to reproduce and the
freedom to decide if, when and how to do so. Implicit in this last condition are
the right of men and women to be informed and to have access to safe,
effective, affordable and acceptable methods of family planning of their
choice, as well as other methods of their choice for regulation of fertility which
are not against the law, and the right of access to appropriate health care
service that will enable women top go safely through pregnancy and
childbirth.. .”2 This would serve to provide women with the best chance of
having a healthy infant.

In the delivery of health care to women, justice requires that all women are
treated with equal consideration, irrespective of their socioeconomic status 3.
Allocation must therefore be based on clinical needs and be in line with the
Bill of Rights of the Constitution. Moreover, women’s rights to bodily integrity
must always be respected and the unequal power relationship between men
and women must be taken into account when facilitating women in making
their own choices.
L ISIN WOMEN’S HEALTHDVOCACY
1. Cook RJ, Dickens BM, Fathalla MF eds. Reproductive Health and Human Rights. Oxford University Press.
2003.
2. UN Department of Public Information, Platform For Action and Beijing Declaration. Fourth World
Conference on Women, Beijing, China, 4-15 September 1995. (New York: UN, 1995), Para94.
3. November 2003. Recommendations on Ethical Issues in Obstetrics and Gynaecology by the FIGO
Committee on the Ethical Aspects on Human Reproduction and Women’s Health. http://www.figo.org.
These guidelines have in the main been drawn from the FIGO recommendations.
 6

2. THE ROLE OF THE HEALTH PRACTITIONERS AS ADVOCATES FOR

WOMEN’S HEALTH

As advocates for women’s health:

2.1 Health practitioners have an ethical duty to be advocates for women’s

health care. The HPCSA places an obligation on health practitioners to
advocate for improvements in the health and social status of women.
This is because the knowledge base and social standing of
practitioners places them in a position with potential to influence
policies regarding women’s health.

2.2 Health practitioners are obliged individually and as a profession to

monitor and publicise indices of reproductive health and provide data to
sensitise the public to health issues and rights of women. The
informative function should not be limited to quantifying the problem,
but they should also identify social and cultural causes in order to
develop appropriate strategies for improvement.

2.3 Failure to advocate policies that will improve women’s health care and
advance women’s rights broadly will deleteriously influence the health
care of the individual patients.

2.4 Practitioners should inform the community about problems of sexual

and reproductive health and promote a wide debate in order to
influence health practices and legislation. The debate should include a
broad spectrum of society such as healthcare practitioner associations,
women’s organizations, legislators and educators. Health professionals
are also obliged to organize themselves and other professional groups
to ensure that essential health services are available for
disadvantaged, impoverished and underprivileged women.

3. INTIMATE EXAMINATIONS2

Complaints of sexual impropriety against health care practitioners are

escalating. Professionalism in the practitioner-patient relationship and the
role-based trust in health care do not allow crossing of sexual boundaries.
Communication with patients is key to prevent erroneous allegations of sexual
misconduct. The intimate examination is difficult to define. A chaperone
present during an intimate examination protects the patient and practitioner
and should be considered a risk reduction strategy in practice.

2This section is based on extracts from Ames Dhai, Jillian Gardner, Yolande Guidozzi,
Graham Howarth, Merryll Vorster “Professionalism and the intimate examination – are
chaperones the answer?” S Afr Med J 2011;110:814-816.
 7

3.1 Sexual misconduct may be categorised as “sexual impropriety”

Behavior, gestures or expressions that are sexually suggestive,
Seductive or disrespectful of a patient’s privacy or sexually demeaning
to a patient; and “sexual violation” refers to physical sexual contact
between a doctor and a patient, whether or not it was consensual
and/or Initiated by the patient.

3.2 The Healthcare practitioner Protection Society (MPS) defines intimate

examinations
as including, but not limited to, examination of the breasts, genitalia
and rectum, and any examination where it is necessary to touch the
patient in close proximity, and cautions practitioners to be
vigilant in situations of vulnerability, e.g. when listening to the chest,
taking blood pressure using a cuff and palpating the apex beat, as
these could involve touching the breast area.

3.3 Sexual involvement with a patient could affect the practitioner’s

healthcare practitioner judgment and thereby harm the patient. Sexual
relationships between patients and practitioners are considered
unethical and a form of professional misconduct by the HPCSA.
Because of the unequal power
relationship and the dependence of the patient on the practitioner,
even a consenting sexual relationship does not relieve the practitioner
of the HPCSA’s ethical prohibition.

3.4 The following framework for the conduct of intimate examinations is

recommended:

i. Ensure the intimate examination is necessary and will assist in

the patient’s care.

ii. Explain to the patient that an intimate examination needs to be

done and why.

iii. Explain what the examination will involve.

iv. Obtain the patient’s permission - verbal permission and the

co-operation of the patient to adopt an appropriate state of
undress and position may provide sufficient authorisation.

v. Offer all patients who are to undergo intimate examination a

chaperone, irrespective of the gender of the practitioner.

vi. Should the patient wish to have a chaperone, the presence of

the chaperone and the chaperone’s identity should be noted at
the time.

vii. Should the patient decline a chaperone, this should be noted at

the time.
 8

viii. Should the patient decline the offer of a chaperone and the
practitioner prefers to have one present, this should be
communicated to the patient. If the patient still declines the
offer of a chaperone, the practitioner should probably not
perform the examination.

ix. Give the patient privacy to undress and dress.

x. Adequate and appropriate draping should be used when the

patient is undressed.

xi. Keep the discussion relevant and avoid unnecessary personal

comments.

xii. Encourage questions and discussion.

4. VIOLENCE AGAINST WOMEN

Violence against women is a reflection of the unequal power relationship

of men and women in societies. The HPCSA condemns violence against
women, whether it occurs in a societal setting (such as virginity testing) or a
domestic setting (such as spousal abuse). It is not a private or family matter.
Violence against women is not acceptable whatever the setting and therefore
practitioners treating women are ethically obligated to:

4.1 Inform themselves about the manifestations of violence and recognize

cases. Documentation must take into account the need for confidentiality to
avoid potential harmful consequences for the woman, and this may need
separate, non-identifiable compilation of data.

i. Treat the physical and psychological results of the violence.

ii. Affirm to their patients that violent acts towards them are not
acceptable.

iii. Advocate for social infrastructures to provide women the

choice of seeking secure refuge and ongoing counselling.

4.2 The physical, financial and social vulnerabilities of women are

fundamentally harmful to the future of a society. Not redressing them fails to
prevent harm to subsequent generations and contributes to the cycle of
violence. Practitioners treating women therefore have an obligation to:

i. Affirm women’s rights to be free of physical and psychological

violence, particularly sexual violence including sexual
intercourse without consent within marriage.

ii. Advocate for non-violent resolutions in relationships by

Enlisting the aid of social workers and other health care
workers where appropriate.

iii. Make themselves and others, in particular men, aware of the

 9

harmful effects of the embedded discrimination against

women in social systems.

4.3 There is a need for wider awareness of the magnitude of the problem
of violence against women. Practitioners are uniquely placed to assist in this.
Only if a problem is recognized can it be addressed. There is therefore a duty
for professional societies and practitioners to publicize information about the
frequency of types of violence against women.

5. DOMESTIC VIOLENCE3

5.1 “Domestic violence” is defined by the Domestic Violence Act as: “Any
controlling, abusive, fear-inducing act that threatens to harm the health,
well-being or safety of a person in a domestic relationship” , while the
United Nations defines it as: “Any act of gender-based violence that results
in, or is likely to result in, physical, sexual or psychological harm or
suffering to women, including threats of such acts, coercion or arbitrary
deprivations of liberty, whether occurring in public or private life”. Domestic
Violence is a form of Gender-based violence or interpersonal violence and
does not preclude men and children as victims.
5.2 According to the United Nations “Gender-based violence” is any harmful
act that is perpetrated against a person’s will and that is based on socially
ascribed (gender) differences between males and females and is usually
regarded as interchangeable with "violence against women.” It highlights
the relationship between the subordinate status of women in society and
their increased vulnerability to violence. Men and boys may also be
survivors of gender-based violence, especially sexual violence.
5.3 Health care professionals must be responsive to domestic violence by the
following actions:

I. Screening: Ask gently about violent and/or controlling

behavior and believe response.

ii. Assess Risk: Conduct a risk assessment in all cases of

domestic violence to identify imminent danger – especially
where the patient still has contact with the perpetrator.

iii. Supportive care: Provide supportive bio-psycho-social care.

iv. Document: Document any evidence of abuse on a Domestic

Violence examination form.

v. Inform: Inform patients of their rights, services and the legal

remedies, including how to obtain a protection order under the
Domestic Violence Act, and whether they want to report the
case to the police. Explain the implications of domestic

3
Based on the Domestic Violence Screening Protocol Prepared by the Professional Board for
Emergency Care.
 10

violence, including the risk of HIV and in the case of a sexual

offence their right to get free HIV treatment under the Sexual
Offences Act.

vi. Refer responsibly: Refer clients to appropriate resources and

identify their support system.

5.4 When conducting a risk assessment in situations where the patient is

uncertain about reporting continued dangerous domestic violence to the
police, health care professionals should establish the following in order to
develop a safety plan:

i. Has the violence increased?

ii. Does the perpetrator use alcohol and drugs?

iii. Has the perpetrator threatened to kill the patient?

iv. Does the perpetrator have access to weapons?

v. Is the patient afraid to go home?

vi. Has the patient or perpetrator thought about killing themselves?

6. CONTRACEPTION

Women have the right to make a choice on whether or not to reproduce and
should therefore have access to legal, safe, effective and affordable methods
of contraception. Responsible control of procreation enjoys wide social
acceptance. However, none of the current methods of fertility control fully
satisfies the ideal of safety, effectiveness, reversibility, ease and religious
acceptance. Contraceptive counseling and the rendering of contraceptive care
are clear examples of healthcare practitioner care requested for other than the
treatment of disease.

6.1 The principle of beneficence requires that contraceptive methods must

be safe, effective, and acceptable to women.

6.2 In introducing contraceptive methods, healthcare practitioner

practitioners must be guided by respect for an individual’s
autonomy.

6.3 The same respect for autonomy requires that standards especially
relevant to the introduction of methods of fertility regulation should
include both facilitating informed choice and delivering quality care.
 11

6.4 There are 2 major aspects to delivering quality of care: healthcare

practitioner quality requirements and the need to take into account the
woman’s express wishes. Healthcare practitioner quality requirements
include that a range of appropriate contraceptive methods is offered, that
appropriate support counseling services are available and that
providers are technically competent. Interpersonal relations with
healthcare personnel must be respectful and take into account
women’s inputs and opinions.

6.5 Nobody may refuse to sell condoms to a child over the age of 12 years, or
provide a child over the age of 12 years with condoms on request where
condoms are provided or distributed free of charge (Children’s Act, 2005
section 134(1)) .

6.6 Contraceptives other than condoms may be provided to a child on

request by the child and without the consent of the parent or care-giver
of the child if the child is at least 12 years of age, proper medical advice
is given to the child, and a medical examination is carried out on the
child to determine whether there are any medical reasons why a specific
contraceptive should not be provided to the child (Children’s Act, 2005
section 134(2)).

6.7 A child who is legally competent to obtain condoms, contraceptives or

contraceptive advice entitled to confidentiality in this respect (Children’s
Act, 2005 section 134(3)).

7. ETHICAL CONSIDERATIONS IN STERILIZATION

Decisions about sterilization involve personal values and therefore may be

subject to inappropriate practitioner bias. Ethical considerations evolve from
these unique and controversial aspects of fertility control.

Sterilization differs from other contraceptive methods because in theory it

eliminates any further option to procreate. The intention of permanency
underscores the need for patients and practitioners to consider a special set
of ethical issues and the well-documented possibility of later regret by the
patient
The obvious relationship of sterilization to procreation, the potential
irreversibility of the procedure, and its usually elective nature require that
certain ethical considerations receive special emphasis. Although these
considerations involve matters of private and individual choice, they may also
have societal implications.

7.1 Specific ethical considerations in sterilization

7.1.1 Because a patient’s ability to procreate may significantly affect the lives
of others, the practitioner should encourage the patient to include other
appropriate persons including her partner in the counseling process.
However, the partner’s consent must not be obligatory.
 12

7.1.2 The withholding of other healthcare practitioner care by linking it to the

patient’s agreement to undergo sterilization is coercive and unacceptable.

7.1.3 The physician’s personal values or sense of societal objectives should

never be a basis for urging sterilization. Ethnic, racial or socioeconomic
factors should never be grounds for limiting a patient’s choices about
sterilization.

7.1.4 The physician’s personal values should not limit counseling, services or
referral.

7.1.5 The rights of mentally handicapped and other vulnerable persons,

whether institutionalized or not, should be carefully protected. Even if a
person is unable to make their own decision because of mental
incapacity or mental retardation, nevertheless they must be involved in
the decision-making process to the fullest extent their capacity allows,
and their best interests must be taken into account.

7.1.6 Hysterectomy solely for the purpose of sterilization is inappropriate

because of the disproportionate risks and costs.

7.1.7 Special informed consent considerations inherent in sterilization

counselling include:

a) Sterilization is intended to be permanent;

b) Life circumstances may change;

c) The patient may later regret her sterility;

d) Male sterilization may be an appropriate alternative;

e) There is a measurable failure rate with any sterilization procedure.

7.1.8 No minimum or maximum number of children may be used as a criteria

for access to sterilisation.

7.1.9 At a public policy level, the profession has a duty to be a voice of

reason and compassion, pointing out when legislative and regulatory
measures interfere with personal choice and appropriate healthcare
practitioner care.

7.1.10 Practitioners may also encounter situations in which, according to their

best judgement, sterilization would not be appropriate. It is the right of
these practitioners to abstain from the performance of the sterilizing
procedures.

(See the Sterilization Act No 44 of 1998)

7.1.11 In terms of the Constitution practitioners may refuse to participate in a

sterilization procedure because of their conscience or religious beliefs
 13

(Constitution of the Republic of South Africa, 1996 section 15) provided

it is not an emergency situation.

8. TERMINATION OF PREGNANCY FOR NON-MEDICAL REASONS

8.1 Abortion is very widely considered to be ethically justified when

undertaken for medical reasons to protect the life and health of the
mother.

8.2 The use of abortion for other social reasons remains very controversial
because of the ethical dilemmas it presents to both women and the
healthcare team. Women frequently agonise over their difficult choice,
making what they regard in the circumstances to be the least worse
decision. Health care providers wrestle with the moral values of
preserving life, of providing care to women and of avoiding unsafe
abortions.

8.3 Every effort must be made to improve women’s rights, status and
health and to prevent unintended pregnancies by education,
counseling, making available reliable information and services on family
planning. Abortion should never be promoted as a method of family
planning.

8.4 Providing the process of a properly informed consent has been carried
out a woman’s right to autonomy coupled with the need to prevent unsafe
abortion, justifies the provision of safe abortion.

8.5 Where practitioners feel that abortion for non-healthcare practitioner

reasons is not permissible whatever the circumstances, respect for
their autonomy means that they should not be expected to advise or
perform abortions against their personal convictions. Their careers
should not be prejudiced as a result. Such practitioners are obliged to
refer the woman to a colleague who is not in principle opposed to
the abortion.

8.6 Practitioners do not have the right to impose their religious or cultural
convictions regarding abortion on those whose attitudes are different.
Counseling should include objective information. Post abortion
counseling on fertility control should always be provided.

8.7 After appropriate counseling, a woman has the right to have access to
healthcare practitioner or surgically induced abortion, and the health
care service has an obligation to provide such services as safely as
possible.

8.8 A female child of any age is legally competent to consent to a

termination of pregnancy (Choice on Termination of Pregnancy Act,
1996 (Act No. 92 of 1996)) provided she has the necessary mental
capacity to give an informed consent by understanding and
 14

appreciating the benefits, risks, social and other implications of the

termination of pregnancy.

8.9 Practitioners are urged to facilitate access by female children seeking a

termination of pregnancy to appropriate non-directive education,
counseling and family planning services.

9. SEX SELECTION

Deeply-rooted discrimination based on gender and sex is still prevalent in

many societies. Selective abortion of a fetus based on gender (e.g female
fetus) is another manifestation of this social injustice.

9.1 The ethical principles of protection of the vulnerable and justice are
violated by sex selection abortion (whether male or female). No fetus
should be sacrificed because of its sex alone.

9.2 The use of preconceptional sex selection to avoid sex-linked genetic

disorders is completely justifiable on healthcare practitioner grounds.

9.3 Preconceptional sex selection should never be used as a tool for sex
discrimination against either sex, especially female.

10. SURROGATE MOTHERHOOD

10.1 Surrogacy can be applied only in cases of very limited special

indications.

10.2 Special attention has to be made to the ethical principle of protection of

the surrogate mother who can be exploited because of her
socioeconomic status.

10.3 The autonomy of the surrogate mother should be respected and the
surrogate arrangement should not be commercialized.

10.4 Surrogacy should be practiced strictly under healthcare practitioner

supervision, taking into consideration full regard of ethics and the law.
Participants should be fully informed of the legal position.

10.5 All surrogacy agreements must be approved by the High Court

(Children’s Act No. 38 of 2005, section 292) and practitioners should
ensure that this has been done before engaging in surrogacy
procedures.

10.6 In terms of the Constitution practitioners may refuse to participate in a

surrogacy procedure because of their conscience or religious beliefs
(Constitution of the Republic of South Africa, 1996 section 15) provided
it is not an emergency situation.
 15

11. PREVENTING IATROGENIC MULTIPLE PREGNANCY

The use of ovulation inducing drugs and of multiple embryo transfer in the
treatment of infertility has led to a dramatic increase in multiple pregnancies.
The need for infertility treatment has also been rising sharply due to factors
which include the trend towards pregnancy at later ages, and the impact of
sexually transmitted diseases.

11.1 Multiple pregnancy has very serious implications for the mother and
her offspring, for the family and the community, and for health service
resources.

11.2 The misuse of drugs for the induction of ovulation is responsible for a
great deal of iatrogenic multiple pregnancies. Therefore those
prescribing these drugs should be appropriately trained and familiar
with the indications for their use, their adverse side effects, and the
methods of monitoring and preventing iatrogenic multiple pregnancy.

11.3 Assisted reproductive technologies whether by the induction of

ovulation, transfer of gametes, pre-embryos or embryos should only be
performed by those practitioners qualified to do so and should aim to
achieve singleton pregnancies. Under optimal conditions, not more
than two pre-embryos or embryos should be transferred.

11.4 Centers offering assisted reproductive technologies should be

accredited to ensure a uniformly high standard.

11.5 The risks for both mother and her resulting children with triplets and
higher order pregnancies are sufficiently great to justify consideration
by the couple and their healthcare practitioner advisors of the use of
fetal reduction.

11.6 Couples seeking treatment for infertility must be fully informed of the
risks of multiple pregnancy both to the woman and to their potential
progeny.

12. ETHICAL GUIDELINES REGARDING THE PROCEDURE

OF COLLECTION OF CORD BLOOD

The discovery that umbilical cord-blood provided a rich source of

haemopoietic stem cells used in transplantation in diseases such as
leukaemia, has led to the organised collection of blood from this source and
its retention in cord-blood banks until required. Altruistic non directed
donations for public cord blood storage is currently not practiced in South
Africa. Directed donations can be for “at risk families or “low risk families”. No
major controversy exists regarding directed donations in “at risk families”.
However, with “low risk families” the chance of using personal cord blood
before the age of 20 years is low with estimates varying between 1 in 2 700
and 1 in 20 000. Currently, it is very expensive to store umbilical cord blood in
 16

private banks. Hence, patients end up compromising themselves financially

as the likelihood of them ever requiring the cells is very low. The vulnerability
of parents at this emotional period in their lives need to be recognized and
protected. Any advertising and marketing of cord blood storage must be done
responsibly and must not exploit parents’ vulnerabilities.

12.1 It is ethically necessary for the mother to give informed consent (before
delivery) for the collection of cord-blood for banking where indicated.

12.2 The information that blood in the placenta is no longer of use to the
baby and this “waste blood” may help to save another person’s life is
incomplete and does not permit informed consent.

12.3 The timing of informed consent from the mother is crucial in order to
ensure an understanding and appreciation of the procedure. Moreover,
she needs to be made aware of not only the benefits of the collection
but also the associated risks which include the possibility of insufficient
harvesting of the stem cells and the chance of using the blood before
the age of 20 may be very low. Accordingly, consent should be taken
early in the antenatal period. The taking of informed consent during
active labour and delivery does not lend itself to an ethically and legally
valid and binding decision. Moreover, during this confusing and
emotional period the ability of the woman to make a rational decision is
highly unlikely.

12.4 Early clamping of the umbilical cord following vaginal delivery is likely
to deprive the newborn infant of at least a third of its normal circulating
blood volume, and it will also cause a haemodynamic disturbance.
These factors may result in serious morbidity.

12.5 For consent to be informed the harmful effects of early cord clamping
should be disclosed and the mother assured that the collection of cord-
blood will not involve early clamping.

12.6 Permission to collect blood from the cord for banking should not lead to
clamping of the cord earlier than 20-30 seconds after delivery of the
baby.

12.7 Any payment to the health care practitioner by the company for cord
blood collection is viewed by the HPCSA as a “finder’s fee” and
therefore unethical.

12.8 There should be no alteration on the usual management of the third

stage of labour

12.9 The HPCSA advises that there is insufficient evidence to recommend

directed cord blood collection and storage in “low risk families”. Hence,
private cord blood banking cannot be recommended as a routine for
everyone.
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

GUIDELINES ON THE KEEPING OF PATIENT RECORDS

BOOKLET 9

PRETORIA
SEPTEMBER 2016
 ii

Health Professions Council of South Africa

Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za

ii
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly

made”.1 To be a good health care practitioner, requires a life-long

commitment to sound professional and ethical practices and an

overriding dedication to the interests of one’s fellow human beings and

society. In essence, the practice of health care professions is a moral

enterprise. In this spirit the HPCSA presents the following ethical

guidelines to guide and direct the practice of health care practitioners.

These guidelines form an integral part of the standards of professional

conduct against which a complaint of professional misconduct will be

evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1 Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).
i
 ii

TABLE OF CONTENTS

1 DEFINITION OF A HEALTH RECORD ......................................................................... 1

2 WHAT CONSTITUTES A HEALTH RECORD? ............................................................ 1
3 WHY DOCUMENTS OR MATERIALS SHOULD BE RETAINED ................................. 1
4 COMPULSORY KEEPING OF RECORDS ................................................................... 2
5 SIGNING OF OFFICIAL DOCUMENTS ........................................................................ 2
6 CERTIFICATES AND REPORTS.................................................................................. 3
7 ISSUING OF PRESCRIPTIONS .................................................................................... 3
8 ALTERATION OF RECORDS....................................................................................... 4
9 DURATION FOR THE RETENTION OF HEALTH RECORDS ...................................... 4
10 OWNERSHIP OF RECORDS ........................................................................................ 5
11 ACCESS TO RECORDS ............................................................................................... 6
12 RETENTION OF PATIENT RECORDS ON CD-ROM ................................................... 7
13 CHECKLIST FOR HEALTH RECORD-KEEPING ......................................................... 7

ii
 GUIDELINES ON THE KEEPING OF PATIENT RECORDS
These guidelines are applicable to health care practitioners in private practice (including
managed health care organisations), as well as to those in the employ of the public service.

1. DEFINITION OF A HEALTH RECORD

A health record may be defined as any relevant record made by a health care practitioner at the
time of or subsequent to a consultation and / or examination or the application of health
management.2

A health record contains the information about the health of an identifiable individual recorded by
a health care professional, either personally or at his or her direction.3

2. WHAT CONSTITUTES A HEALTH RECORD?

2.1 The following documents can be regarded as the essential components of a health
record, obviously depending on the nature of the individual case:

2.1.1 Hand-written contemporaneous notes taken by the health care practitioner.

2.1.2 Notes taken by previous practitioners attending health care or other health care
practitioners, including a typed patient discharge summary or summaries.

2.1.3 Referral letters to and from other health care practitioners.

2.1.4 Laboratory reports and other laboratory evidence such as histology sections,
cytology slides and printouts from automated analysers, X-ray films and
reports, ECG races, etc.

2.1.5 Audiovisual records such as photographs, videos and tape-recordings.

2.1.6 Clinical research forms and clinical trial data.

2.1.7 Other forms completed during the health interaction such as insurance forms,
disability assessments and documentation of injury on duty.

2.1.8 Death certificates and autopsy reports.

2.2 The above records may be archived on microfilm, microfiche or magnetic data files.

3. WHY DOCUMENTS OR MATERIALS SHOULD BE RETAINED

3.1 Documents and materials should be retained in order to:

3.1.1 Further the diagnosis or ongoing clinical management of the patient;

3.1.2 Conduct clinical audits;
3.1.3 Promote teaching and research;

2 de Klerk A. The right of patients to have access to their medical records: the position in South African law. Medical Law,
Vol 12, 1993, pp. 77 - 83
3 Making and keeping medical records. MPS Casebook 13 (International), July 2000, 6-8
 3.1.4 Be used for administrative or other purposes;
3.1.5 Be kept as direct evidence in litigation or for occupational disease or injury
compensation purposes;
3.1.6 Be used as research data;
3.1.7 Be kept for historical purposes;
3.1.8 Promote good clinical and laboratory practices;
3.1.9 Make case reviews possible;
3.1.10 Serve as the basis for accreditation.4

4. COMPULSORY KEEPING OF RECORDS

4.1 Health care practitioners should enter and maintain at least the following information for
each patient consulted:

4.1.1 Personal (identifying) particulars of the patient.

4.1.2 The bio-psychosocial history of the patient, including allergies and
idiosyncrasies.
4.1.3 The time, date and place of every consultation.
4.1.4 The assessment of the patient’s condition.
4.1.5 The proposed clinical management of the patient.
4.1.6 The medication and dosage prescribed.
4.1.7 Details of referrals to specialists, if any.
4.1.8 The patient’s reaction to treatment or medication, including adverse effects.
4.1.9 Test results.
4.1.10 Imaging investigation results.
4.1.11 Information on the times that the patient was booked off from work and the
relevant reasons.
4.1.12 Written proof of informed consent, where applicable.

4.2 Records should be kept in non-erasable ink and erasure fluid should not be used.

5. SIGNING OF OFFICIAL DOCUMENTS

Rule 15 of the HPCSA’s ethical rules states that:

“Any student, intern or practitioner who, in the execution of his or her professional
duties, signs official documents relating to patient care, such as prescriptions,
certificates(excluding death certificates) patient records, hospital or other reports,
shall do so by signing such document next to his or her initials and surname in block
letters.”

4 Royal College of Pathologists, Marks and Spencer Publications Unit. The retention and storage of pathological records and
Archives, London, Royal College of Pathologists, 1995
2
6. CERTIFICATES AND REPORTS

According to Rule 16 of the ethical guidelines:

“(1) A practitioner shall only grant a certificate of illness if such certificate contains the
following information, namely -

(a) the name, address and qualification of the practitioner;

(b) the name of the patient;

(c) the employment number of the patient (if applicable);

(d) the date and time of the examination;

(e) whether the certificate is being issued as a result of personal observations

by the practitioner during an examination, or as the result of information
received from the patient and which is based on acceptable medical
grounds;

(f) a description of the illness, disorder or malady in layman's terminology with

the informed consent of the patient: Provided that if the patient is not
prepared to give such consent, the medical practitioner or dentist shall
merely specify that, in his or her opinion based on an examination of the
patient, the patient is unfit to work;

(g) whether the patient is totally indisposed for duty or whether the patient is
able to perform less strenuous duties in the work situation;

(h) the exact period of recommended sick leave;

(i) the date of issuing the certificate of illness; and

(j) a clear indication of the identity of the practitioner who issued the certificate
which shall be personally and originally signed by him or her next to his or
her initials and surname in printed or block letters.

(2) If preprinted stationery is used, a practitioner shall delete words which are irrelevant.

(3) A practitioner shall issue a brief factual report to a patient where such
a patient, requires information concerning himself or herself.”

7. ISSUING OF PRESCRIPTIONS

On the issuing of prescriptions, Rule 17 states that:

“A practitioner -

(a) shall be permitted to issue typewritten, computer-generated, pre-typed, pre-

printed or standardised prescriptions for medicine scheduled in schedules I,
II, III and IV of the Medicines and Related Substances Control Act, 1965
(Act No. 101 of 1965), subject thereto that such prescriptions may only be
issued under his or her personal and original signature;

(b) shall issue handwritten prescriptions for medicine scheduled in schedules

5,6,7 and 8 above of the Act referred to in paragraph (a) under his or her
3
 personal and original signature (see also rule 14).”

8. ALTERATION OF RECORDS

8.1 No information or entry may be removed from a health record.

8.2 An error or incorrect entry discovered in the record may be corrected by placing a line
through it with ink and correcting it. The date of change must be entered and the
correction must be signed in full. The original record must remain intact and fully legible.

8.3 Additional entries added at a later date must be dated and signed in full.

8.4 The reason for an amendment or error should also be specified on the record.

9. DURATION FOR THE RETENTION OF HEALTH RECORDS

9.1 Health records should be stored in a safe place and if they are in electronic format,
safeguarded by passwords. Practitioners should satisfy themselves that they
understand the HPCSA’s guidelines with regard to the retention of patient records on
computer compact discs.

9.2 Health records should be stored for a period of not less than six (6) years as from the
date they became dormant.

9.3 In the case of minors and those patients who are mentally incompetent, health care
practitioners should keep the records for a longer period:

9.3.1 For minors under the age of 18 years health records should be kept until the
minor’s 21ST birthday because legally minors have up to three years after they
reach the age of 18 years to bring a claim. This would apply equally for
obstetric records.

9.3.2 For mentally incompetent patients the records should be kept for the duration
of the patient’s lifetime.

9.4 In terms of the Occupational Health and Safety Act (Act No. 85 of 1993) health records
must be kept for a period of 20 years after treatment.

9.5 Notwithstanding the provisions in paras 9.3 and 9.4 above, the health records kept in a
provincial hospital or clinic shall only be destroyed if such destruction is authorised by
the Deputy Director-General concerned.

9.6 In addition to the time periods mentioned above there are a number of other factors that
may require health records to be kept for longer periods, but no clear-cut rules exist in
this regard. For instance, certain health conditions take a long period to manifest
themselves, (e.g.asbestosis), and records of patients who may have been exposed to
such conditions, should be kept for a sufficient period of time. The HPCSA recommends
that this should not be less than 25 years.

9.7 A balance must be reached between the costs of (indefinite) retention of records (in
terms of space, equipment, etc.) and the occasional case where the practitioners’
defence of a case of negligence is handicapped by the absence of records. The value
of the record for academic or research purposes, and the risks resulting from the
handling or complications of the case, are additional considerations.
4
9.8 Where there are statutory obligations that prescribe the period for which patient records
should be kept, a practitioner must comply with these obligations.

10. OWNERSHIP OF RECORDS

10.1 In the case of state institutions, where records e.g radiographs are the property of the
institution, original records and images should be retained by the institution. Copies
must however, be made available to the patient (or referring practitioner) on request for
which a reasonable fee may be charged in terms of the Promotion of Access to
Information Act (Act No. 2 of 2000);

10.2 In cases where patients are required to pay for records and images (e.g. private
patients or patients in private hospitals) such patients must be allowed to retain such
records - unless the health care practitioners deem it necessary to retain such records
for purpose of monitoring treatment for a given period. Should the patient however
require the records and / or images to further or protect an interest (e.g. such as
consulting with another practitioner) he or she must be allowed to obtain the originals
for these purposes.

10.3 As the ownership of records in a multi-disciplinary practice depends on the legal

structure of the practice, the governing body of such multi-disciplinary practice should
ensure that these guidelines and the provisions of the Promotion of the Access to
Information Act relating to health records are adhered to. The Act requires public
institutions to appoint information officers to administer access to information, and
similar provisions apply to private bodies.

10.4 Should a health care practitioner in private practice (both in a single practice and in a
partnership) pass away, his or her estate, which includes the records, will be
administered by the executor of the estate:

10.4.1 Should a practice be taken over by another health care practitioner, the
executor shall carry over the records to the new health care professional. The
new health care practitioner is obliged to take reasonable steps to inform all
patients regarding the change in ownership and that the patient could remain
with the new health care practitioner or could request that his or her records be
transferred to another health care practitioner of his or her choice.

10.4.2 Should the practice not be taken over by another health care practitioner the
executor should inform all patients in writing accordingly and transfer those
records to other health care practitioners as requested by individual patients.
The remaining files should be kept in safe keeping by the executor for a period
of at least twelve (12) months with full authority to further deal with the files as
he or she may deem appropriate - provided the provisions of the rules on
professional confidentiality are observed.

10.4.3 It should be noted that certain partnership agreements may make specific
provision for the management of a deceased partner’s share in the partnership
after the death of a partner and such management would include dealing with
patient records.

10.5 If health care practitioners in private practice decide to close their practice for whatever
reason they shall within three months of closure inform all their patients in writing that:

10.5.1 The practice is being closed as from a specific date;

5
 10.5.2 Requests may be made that records are transferred to other health care
practitioners of their choice;

10.5.3 After the date concerned, the records will be kept in safe-keeping for a period
of at least twelve (12) months by an identified health care practitioner or health
institution with full authority to deal with the files as he or she may deem
appropriate, provided the provisions of the rules on professional confidentiality
are observed.

11. ACCESS TO RECORDS

11.1 In terms of the law the following principles apply in regard to access to information in
health records:

11.1.1 A health care practitioner shall provide any person of age 12 years and older
with a copy or abstract or direct access to his or her own records regarding
medical treatment on request (Children’s Act (Act No. 38 of 2005)).

11.1.2 Where the patient is under the age of 16 years, the parent or legal guardian
may make the application for access to the records, but such access should
only be given on receipt of written authorization by the patient (Access to
Information Act (Act No. 2 of 2000)).

11.1.3 Information about termination of a pregnancy may not be divulged to any party,
except the patient herself, regardless of the age of the patient (Choice on
Termination of Pregnancy Act (Act No. 92 of 1996)).

11.1.4 No health care practitioner shall make information available to any third party
without the written authorisation of the patient or a court order or where non-
disclosure of the information would represent a serious threat to public health
(National Health Act (Act 61 of 2003)).

11.2 A health care practitioner may make available the records to a third party without the
written authorisation of the patient or his or her legal representative under the following
circumstances:

11.2.1 Where a court orders the records to be handed to the third party;

11.2.2 Where the third party is a health care practitioner who is being sued by a
patient and needs access to the records to mount a defence.

11.2.3 Where the third party is a health care practitioner who has had disciplinary
proceedings instituted against him or her by the HPCSA and requires access to
the records to defend himself or herself.

11.2.4 Where the health care practitioner is under a statutory obligation to disclose
certain medical facts, (e.g. reporting a case of suspected child abuse in terms
of the Children’s Act, (Act No. 38 of 2005)).

11.2.5 Where the non-disclosure of the medical information about the patient would
represent a serious threat to public health (National Health Act (Act No. 61 of
2003)).

11.3 In provincial hospitals medical records must be kept under the care and control of the
clinical manager. Access to such records shall be subject to compliance with the

6
 requirements of the Access to Information Act and such conditions as may be approved
by the superintendent.

12. RETENTION OF PATIENT RECORDS ON CD-ROM

12.1 Storage of clinical records on computer compact disc (CD-ROM) is permissible,

provided that protective measures are in place:

12.1.1 Only CD-ROM technology that is designed to record a CD once only, so that
old information cannot be overwritten, but new information can be added is
used;

12.1.2 All clinical records stored on computer compact disc and copies thereof are to
be encrypted and protected by a password in order to prevent unauthorised
persons to have access to such information;

12.1.3 A copy of the CD-ROM to be used in the practitioner’s rooms will be in a read-
only format;

12.1.4 A back-up copy of the CD-ROM must be kept and stored in a physically
different site in order that the two discs can be compared in the case of any
suspicion of tampering;

12.1.5 Effective safeguards against unauthorised use or retransmission of confidential

patient information must be assured before such information was entered on
the computer disc. The right of patients to privacy, security and confidentiality
must be protected at all times.

13. CHECKLIST FOR HEALTH RECORD-KEEPING

Good notes imply good practice and the following checklist may serve to guide health care
practitioners in the appropriate keeping of patient records:5

13.1 Records should be complete, but concise.

13.2 Records should be consistent.
13.3 Self-serving or disapproving comments should be avoided in patient records.
Unsolicited comments should be avoided (i.e. the facts should be described, and
conclusions only essential for patient care made).
13.4 A standardised format should be used (e.g. notes should contain in order the history,
physical findings, investigations, diagnosis, treatment and outcome.).
13.5 If the record needs alteration in the interests of patient care, a line in ink should be put
through the original entry so that it remains legible; the alterations should be signed in
full and dated; and, when possible, a new note should refer to the correction without
altering the initial entry.
13.6 Copies of records should only be released after receiving proper authorisation.
13.7 Billing records should be kept separate from patient care records.
13.8 Attached documents such as diagrams, laboratory results, photographs, charts, etc.
should always be labelled. Sheets of paper should not be identified simply by being
bound or stapled together – each individual sheet should be labelled.

5 Adapted from Torres, A, Proper S.: Medico-legal developments and the Dermatologist. Advances in Dermatology, Vol 12,
1987
7
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTHCARE PROFESSIONS

GENERAL ETHICAL GUIDELINES FOR

GOOD PRACTICE IN TELEMEDICINE

DEVELOPED BY THE HUMAN RIGHTS, ETHICS AND

PROFESSIONAL PRACTICE COMMITTEE

Booklet No: 10

PRETORIA
AUG 2014 [APPROVED BY COUNCIL]
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly

made”.1 To be a good health care practitioner, requires a life-long

commitment to sound professional and ethical practices and an

overriding dedication to the interests of one’s fellow human beings and

society. In essence, the practice of health care professions is a moral

enterprise. In this spirit the HPCSA presents the following ethical

guidelines to guide and direct the practice of health care practitioners.

These guidelines form an integral part of the standards of professional

conduct against which a complaint of professional misconduct will be

evaluated.

[Note: The term “health care practitioner” in these guidelines refers

to persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).
TABLE OF CONTENTS

1. Introduction 3
2. Purpose 4
3. Definition of concepts 4
3.1. Telemedicine 4
3.2. Health Establishment 5
3.3 Healthcare Practitioner 5
3.4 The Consulting healthcare practitioner 5
3.5 The servicing healthcare practitioner 5
3.6 The Requesting patient 5
3.7 Other Terms relate to consultation 5
4. Ethical guidelines 6
4.1. Competence, registration and authorisation 6
4.2. Healthcare practitioner –patient relationship 7
4.3. Assumption of primary responsibility 7
4.4. Evaluation and treatment of patient 8
4.5 Professional duties 8
4.6. Duty to inform and informed consent 8
4.7 Patient confidentiality 10
4.8. Routine, specialists and emergency consultations 12
4.9. Quality, security and safety 13
5. Sources consulted 16

4
1. INTRODUCTION

1.1 The objective of the South African Telemedicine System as established by the
National Department of Health is to deliver healthcare services at a distance to
South African communities in under-served areas. The system has been established
to alleviate the human resource crisis as experienced and is geared to improve the
links and communication between developed healthcare facilities and the
underdeveloped rural areas. Different categories of Health Care Practitioners will be
involved.

1.2 The Health Professions Council of South Africa (HPCSA) has a mandate to regulate
healthcare provision by ensuring that services are provided by qualified and skilled
healthcare practitioners. This regulatory mandate applies to healthcare practitioner
in both state and privately-owned health care institutions. It is the mandate of the
HPCSA to protect the “patient” against possible abuse by healthcare practitioner on
one hand and to provide guidance for good practice to the professions.

1.3 All Telemedicine services should involve a healthcare provider where there is an
actual face-to-face consultation and physical examination of the patient in a clinical
setting. The consulting practitioner will communicate the information to the servicing
practitioner, who will then provide the necessary assistance.

Note: These guidelines must be read as a whole and not piece-meal as the overall
purpose may be lost. The guidelines must further be read in conjunction with
other ethical booklets of the HPCSA which include but are not limited to:

Booklet No 1: General ethical guidelines for healthcare professions

Booklet No 9: Seeking patients’ informed consent
Booklet No 10: Confidentiality

5
2. PURPOSE

The purpose of these guidelines is twofold:

(a) Firstly to provide an ethical framework that draws from the core values and
standards in Booklet No 1 and pertinent laws.

(b) Secondly, to provide guidelines to Healthcare Practitioners engaged in

telemedicine practices within and outside the South Africa.

3. DEFINITION OF CONCEPTS

These guidelines first provide definitions of telemedicine and other related terminology
as used in the guidelines.

3.1 Telemedicine

For the purposes of these guidelines, “telemedicine” is defined as:

The practice of medicine using electronic communications, information

technology or other electronic means between a healthcare practitioner in one
location and a healthcare practitioner in another location for the purpose of
facilitating, improving and enhancing clinical, educational and scientific
healthcare and research, particularly to the under serviced areas in the Republic
of South Africa.
Note:

1. Telemedicine involves secure videoconferencing or similar forms of technology

which enable healthcare practitioners to replicate the interaction of traditional face-
to-face consultations between healthcare practitioners and the patient.

6
 2. Telemedicine as defined refers to where information is exchanged electronically
either on or off-line, formally, informally or as a need for a second opinion.

3.2 Health establishment

“Health establishment” means the whole or part of a public or private institution, facility,
building or place, whether for profit or not, that is designed to provide inpatient or
outpatient treatment, and diagnostic or therapeutic interventions

3.3 Healthcare practitioner

“Healthcare practitioner” means a person providing health services, registered in terms

of the Health Professions Act No 56 of 1974, to include any other appropriate disciplines
as defined in the National Health Act No 61 of 2003.

3.4 The consulting healthcare practitioner

The “consulting healthcare practitioner” refers to the practitioner who conducts a “face-
to-face” interview or examination with the patient or refers patient’s information to a
remote location for further advice or intervention.

3.5 The servicing healthcare practitioner

The “servicing healthcare practitioner” refers to the practitioner who offers advice or
intervention or patient information from a remote location.

3.6 The requesting patient

The “requesting patient” is the patient who requests to be treated by the servicing
healthcare practitioner. This applies only where there is already an existing relationship
between the patient and the healthcare practitioner.

7
3.7 Other terms that relate to consultation

Other terms relate to consultation as used in telemedicine as described by the World

Medical Association:
3.7.1 Asynchronous: Refers to data transmission that involves a mechanism where the
patient information from the consulting healthcare practitioner's site is temporarily
stored and then retransmitted to the servicing healthcare practitioner's site or vice
versa. A common asynchronous transmission includes the transmission of
patient information via email.

3.7.2 Synchronous: Refers to the continuous, uninterrupted transmission of patient

information from the consulting health care practitioner's site to the consultant
health care practitioner's site, or vice versa. The flow of patient information does
not include any storage or intended delay in the transmission of the patient data.

4. ETHICAL GUIDELINES

Although telemedicine has become an essential tool in alleviating human resource

crises and supporting primary healthcare services, particularly those of vulnerable
communities in South Africa. It also raises important ethical and legal issues.

4.1 Competence, registration and authorisation

4.1.1 According to the Health Professions Act, No 56 of 1974, registration is a

prerequisite for practising a profession in terms of which a professional board has
been established, where such practice is for gain within South Africa, or for any
other health profession the scope which has been defined by the Minister in
terms of the Act, unless a practitioner is registered in terms of the Act in respect
of such profession.

4.1.2 Only practitioners who have been deemed competent and are registered in their
respective professions are authorised to participate in telemedicine practice in
8
 South Africa either as consulting healthcare practitioners or servicing healthcare
practitioners.

4.1.3 In the case of telemedicine across country borders, practitioners serving South
African patients should be registered with the regulating bodies in their original
states as well as with the HPCSA.
4.1.4 Consulting healthcare practitioners are responsible for ensuring that the servicing
healthcare practitioner is competent according to South African healthcare
standards.
4.1.5 Consulting healthcare practitioners and servicing healthcare practitioners are
held to the same standards of medical practice as healthcare practitioners who
conduct face-to-face consultations.

4.2 Healthcare practitioner-patient relationship

4.2.1 The relationship between the patient and the healthcare practitioner is
established when the practitioner agrees to treat the patient and the patient
agrees to be treated.

4.2.2 In telemedicine the practice of medicine occurs where the patient is located at
the time telemedicine technologies are used.

4.2.3 The relationship between the patient and the healthcare practitioner must be
based on mutual trust and respect, and this applies to both servicing and
consulting practitioners.

4.2.4 Core ethical values as outlined in the HPCSA guidelines for Healthcare
practitioners are also applicable in telemedicine practice and the fact that a
patient’s information can be moved using electronic means does not alter the
ethical duties of health care practitioner.

9
4.2.5 The professional discretion of healthcare practitioners engaging in telemedicine
regarding the diagnosis, scope of care or treatment should not be limited or
influenced by non-clinical considerations of telemedicine technologies.

4.3 Assumption of primary responsibility

4.3.1 The World Medical Association (WMA) makes a distinction between telemedicine
consulting and the servicing practitioners regarding where the primary
responsibility lies.

4.3.2 According to the WMA:

(a) The consulting practitioner remains responsible for the treatment, decisions and
other recommendations given to the patient, as well as for keeping detailed
records of the patient’s condition and information transmitted and received from
the servicing practitioner.

(b) The servicing practitioner must keep detailed records of the advice he or she
delivers as well as the information he or she receives and on which the advice is
based.

(c) The servicing practitioner must further ensure that the advice or treatment
suggestions given were understood by the consulting practitioner or the patient.

4.4 Evaluation and treatment of patient

4.4.1 A documented medical evaluation must be done and the relevant clinical history
necessary to diagnose underlying conditions as well as any contra-indications
regarding the recommended treatment must be obtained before providing
treatment, including issuing prescriptions, electronically or otherwise.

10
4.4.2 Treatment, including issuing a prescription based solely on an online
questionnaire does not constitute an acceptable standard of care.

4.4.3 When prescribing care using telemedicine consulting practitioners should ensure
that informed consent is taken in accordance with the standards practice used in
face-to-face issuing of prescriptions.

4.5 Professional duties

4.5.1 Healthcare practitioners engaging in telemedicine must observe the professional

duties imposed in the HPCSA’s General Ethical Guidelines for Good Practice.

4.5.2 Duties to patients include, but are not limited to, always acting in the best interest
or well-being of the patient, respecting patients’ privacy and dignity, giving
patients the information they need about their conditions, and maintaining
confidentiality at all times as required by the National Health Act No 61 of 2003
and the SA National Patients’ Rights Charter.

4.5.3 Healthcare practitioners should not give medical advice or provide treatment
using telemedicine without obtaining proper informed consent from the patient for
both the treatment to be given and the use of telemedicine technology.

4.5.4 The consulting and servicing healthcare practitioners they should verify:
(a) The location of the consulting or servicing healthcare practitioner;
(b) The identity and qualifications of the consulting or servicing healthcare
practitioner; and
(c) The identity of the patient.

11
4.6 Duty to inform and informed consent

4.6.1 This section must be read in conjunction with HPCSA guidelines regarding
informed consent in Booklet 9 and the provisions of the National Health Act.

4.6.2 Informed consent for the use of telemedicine technologies must be obtained in
writing.

4.6.3 Informed consent documentation for telemedicine practice should include the
following:

(a) The identities of the patient and the servicing healthcare practitioner.
(b) The servicing healthcare practitioner’s practice number.
(c) The types of transmissions consented to using telemedicine technologies
(e.g. prescriptions, refills, appointment scheduling, patient education etc.).
(d) Agreement by the patient that the servicing practitioner will decide whether or
not the condition being diagnosed or treated is appropriate for a telemedicine
consultation.
(e) Details of the security measures taken with the use of telemedicine
technologies, such as encrypting data, password protected screen savers and
data files, or the use of other reliable authentication techniques.
(f) Any material risks to confidentiality arising from the use of telemedicine
technologies that may influence the patient’s decision to consent.
(g) The patient’s express consent to the transmission of the patient’s personal
medical information to a consulting healthcare practitioner or other
appropriate third parties.

4.6.3 When telemedicine is used the patient should be informed regarding who will
access their information, the purpose of the telemedicine service, the cost of the service
and what the implications of the use of such information will be.

12
4.6.4 It is the duty and responsibility of the consulting practitioner to obtain informed
consent for telemedicine purposes.

4.6.5 The documentation regarding informed consent for telemedicine practice should
include the following:

(a) The patient’s name and address and the location or site of consultation;

(b) The consulting practitioner’s name, practice address and number, and location;

(c) The servicing practitioner’s or practitioner’s names, practice addresses and

numbers, and location;

(d) A brief explanation of telemedicine;

(e) The types of transmissions consented to using telemedicine technologies (e.g.

prescriptions, refills, appointment scheduling, patient education etc.).

(f) Details of the security measures taken with the use of telemedicine technologies,
such as encrypting data, password protected screen savers and data files, or the
use of other reliable authentication techniques.

(g) Any material risks to confidentiality arising from the use of telemedicine
technologies that may influence the patient’s decision to consent.

(h) The expected risks, possible benefits of and alternatives to telemedicine;

(i) Agreement by the patient that the servicing practitioner will decide whether or not
the condition being diagnosed or treated is appropriate for a telemedicine
consultation.

(j) The patient’s agreement, after a full explanation was given, including the
patient’s express consent to the transmission of the patient’s personal medical
information to a consulting healthcare practitioner or other appropriate third
parties.

(k) The signature of patient, the patient’s parent, the patient’s guardian or the
patient’s caregiver - the relationship to the patient should be specified;

(l) The signature of the witness.

13
4.6.6 A copy of the consent form should be kept with patient’s records and a duplicate
given to the patient.
4.6.7 In the case of videoconference consultations, the patient must be aware of the
presence of other people on the other side, and that the patient’s identity may be
revealed to such people, and must consent to this.

4.7 Patient confidentiality

4.7.1 The patient must at all times be assured that their confidentiality is protected.
4.7.2 Patient confidentiality should be ensured at both the consulting and servicing
practitioners’
sites and should follow the provisions of the Constitution, the National Health Act
No 61 of 2003, the Promotion of Access to Information Act No 2 of 2000, the
Protection of Personal Information Act No 4 of 2013, the Common law and the
HPCSA’s ethical guidelines on patient confidentiality in Booklet 10 which
generally state that it is every practitioner’s duty to make sure that information is
effectively protected against improper disclosure at all times.
4.7.3 HPCSA’s booklet on Confidentiality further provides guidelines on how patient
information may be disclosed for example, in the case of research, education,
clinical audit, financial audit or even for the publication of case histories and
photographs].
4.7.4 Policies and procedures for documentation, maintenance and transmission of
records regarding telemedicine consultations should be maintained at the same
standard of care as face-to-face consultations.
4.7.5 Policies and procedures for telemedicine should deal with: (a) Confidentiality; (b)
Healthcare personnel apart from the healthcare practitioners who will process the
electronic information; (c) Hours of operation; (d) Types of transactions that are
permitted electronically; (e) Required patient information to be included in
electronic communications (e.g. name, identification number and type of
transaction); (f) Archival and retrieval oversight mechanisms; and (g) Quality
oversight mechanisms.

14
4.7.6 Electronic transmissions, (e.g. email, prescriptions and laboratory results) must
be secure within existing technology (e.g. password protected, encrypted
electronic prescriptions or other reliable authentication techniques). It is the
responsibility of the healthcare practitioners to ensure that these non-healthcare
personnel do not violate patient confidentiality.
4.7.7 All patient-practitioner electronic communications must be stored and filed in the
patient’s medical record file in line with traditional record-keeping policies and
procedures.

4.8 Routine, specialists and emergency consultations

There is a need to provide guidelines on routine, emergency or specialist consultations

using telemedicine technologies.

4.8.1 Routine telemedicine

(a) Patient-initiated or second opinion telemedicine should be restricted to situations

in which a previously existing healthcare-patient relationship enables the
healthcare practitioner to gather sufficient knowledge of the patient’s clinical
condition to be able to render a proper and clinically justifiable diagnosis,
treatment or recommendation.

(b) This recommendation is in line with the WMA’s regulations that telemedicine is
only used as an adjunct to normal medical practice, and only replaces face-to-
face services where the quality and safety of patient care is not compromised
and the best available resources are used in securing and transmitting patient
information.

15
4.8.2 Specialist telemedicine

(a) Specialist telemedicine consultations form the bulk of telemedicine practice in

South Africa because of human resource capacity challenges – particularly in
rural areas.
(b) These challenges do not however mean that patients should be over- or under-
serviced.
(c) The ethical guidelines for good practice as well as the ethical rules of conduct for
practitioners registered with the HPCSA should be taken into consideration at all
times.

4.8.3 Emergency telemedicine

(a) Emergency telemedicine involves judgements by the healthcare practitioner often

based on sub-optimal patient information.
(b) In emergencies, the health and wellbeing of the patient are the determining
factors with regard to stabilising the patient and having the patient referred for
thorough medical care.
(c) The practitioner must provide the patient with emergency instructions when the
care provided by telemedicine indicates that a referral to an acute care or
emergency facility is necessary for the immediate treatment of the patient.
(d) The emergency instructions should be in writing and appropriate to the services
being rendered via telemedicine.

4.9 Quality, security and safety of patient information and records

Rules on confidentiality and security of patient information applies to telemedicine as

well, especially with regard to transmission and storage.

4.9.1 Every registered healthcare practitioner engaging in telemedicine practices takes

responsibility for the quality of service delivered as well as confidentiality, security
and safety of patients’ information.
16
4.9.2 Patient information and records should consist of copies of all patient-related
electronic communications, including:
(a) Patient-practitioners communications;
(b) Prescriptions;
(c) Laboratory and test results;
(d) Evaluations and consultations;
(e) Records of past care;
(f) Instructions obtained or produced in connection telemedicine technologies;
and
(g) Signed informed consents to treatment and use of telemedicine.

4.9.3 The patient’s records established during the use of telemedicine must be
accessible and documented for both the healthcare practitioners involved and
their patients.

4.9.4 It is the registered healthcare practitioner’s responsibility to ensure that non-

registered personnel who may be offering auxiliary or technical services, are
aware of the need for such quality, security and safety and that they adhere to
the stipulated guidelines.

4.9.5 Quality assurance

(a) Healthcare practitioners, both from the consulting and servicing sites, should not
practice telemedicine without ensuring that the equipment and accessories used
are optimally operational.
(b) Periodical quality control tests and servicing of equipment should be carried out
and records kept for verification.
(c) The quality and quantity of patient information received should be sufficient and
relevant for the patient’s clinical condition in order to ensure that accurate
medical decisions and recommendations are made for the benefit of the patient.
(d) Good communication contributes to quality patient information being transmitted
from one practitioner to the other.
17
 (e) Quality should further be ascertained in the manner of documenting patient
information.
(f) A standardised manner of documentation is recommended to ensure that all
healthcare practitioners adhere to the same protocol in terms of history taking,
reporting on findings, creation of reserves and hard copies where necessary.
(g) Where images are transmitted from one location to the other, it is the
responsibility of both the consulting and servicing practitioner to ensure that there
is no critical loss of image resolution from acquisition to final display.

4.9.6 Security

(a) Patient information should only be transmitted from one site to the other and
stored, with the full knowledge and approval of the patient, in line with the informed
consent guidelines.
(b) Only the information that is relevant to the clinical history of the patient should be
transmitted electronically.
(c) To protect the identity of the patient when information is transmitted between
sites, it is essential that personal identification should be removed and the
transmitted information is encrypted.
(d) All personal computers of the telemedicine service should be accessed by
authorised personnel only through the use of a login password.
(e) There are three factors central to the security of patient information, namely:
i) Privacy: Who can access it?
ii) Authenticity: Who sends the information?
iii) Integrity: Has the information been altered during its transmission
through the public networks?
(f) Access to information by other healthcare practitioner, patients or third party
should be authorised by the healthcare provider in charge of the patient and be
carried out according to the rules and regulations as outlined in the Promotion of
Access to Information Act, of 2000.

18
4.9.7 Safety
Health care practitioners using telemedicine should:

(a) Avoid accidental damage and loss of patient information;

(b) Provide safe procedures to avoid any alteration or elimination of patient data;
(c) Ensure that patient information obtained electronically is kept in line with the
HPCSA’s guidelines on the keeping of patients’ records in Booklet 15;
(d) Comply with the legal requirements for data messages in the Electronic
Communications and Transactions Act No 25 of 2002 regarding the protection of
information and the principles regarding the electronic collection of personal
information.

19
5. SOURCES CONSULTED

1. Department of Health. A Telemedicine Strategy for South Africa. 2010 – 2015

Extending Better Healthcare. Version 3
2. Federation of State Medical Boards. Policy Guidelines for the Safe Practice of
Telemedicine. 2014. Available from
www.fsmb.org/pdf/FSMB_Telemedicine_Policy.pdf 29 April 2014.
3. World Health Organisation. Telemedicine. Opportunities and developments in
Member States. Report on the Second Global Survey on eHealth. Global
Observatory for eHealth Series. 2010. Vol 2. Available from:
http://www.who.int/goe/publications/goe_telemedicine_2010.pdf Accessed on
06/02/2013.
4. World Medical Association. Ethics Unit. What’s New? Available from:
http://www.wma.net/e/ethics/whats_new.htm Accessed on 02/01/2008, Issued
November 2007.
5. HPCSA Act No 56 of 1974 and related Guidelines Booklets.
6. Ontario Association of Radiologists. 2007. New OAR Teleradiology Standard
Approved. OAR board approves new teleradiology standard. Available from:
http://www.oar.info/pdf/NewOARTeleradiologyStandards.pdf Accessed on
04/01/2008
7. Telemedicine Information Exchange. Informed consent and Evaluation forms.
March 9, 2007. Available from:
http://www.tie.telemed.org/telemed101/policy_forms_links.asp Accessed on
03/02/2008
8. White, P. Legal Issues in Teleradiology- distant thoughts. British Journal of
Radiology. 75 (2002), 201-206.
9. Kekana M, Noe P & Mkhize B. The Practice of telemedicine and challenges to
the Regulatory Authorities. December 2010. SAJBL. Vol 3. No 1.
10. Mars M & Jack C. Why Telemedicine is a challenge to the Regulators.
December 2010. SAJBL. Vol 3.No 2.

20
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE IN THE HEALTH CARE

PROFESSIONS

GUIDELINES ON OVERSERVICING, PERVERSE INCENTIVES

AND RELATED MATTERS

BOOKLET 11

PRETORIA
SEPTEMBER 2016
 2

Health Professions Council of South Africa

Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za

2
 i
THE SPIRIT OF PROFESSIONAL POLICY GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the HPCSA presents the following ethical policy guidelines to guide and

direct the practice of health care practitioners. These guidelines form

an integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).

i
 ii

TABLE OF CONTENTS

1 INTRODUCTION ..................................................................................................... 2

2 DEFINING OF CONCEPTS .................................................................................... 3

3 OVERSERVICING, PERVERSE INCENTIVES AND RELATED MATTERS ......... 6

3.1 OVERSERVICING RULE 7 ............................................................................................... 6

3.2 MANUFACTURING RULE 23 ........................................................................................... 6

3.3 ADVERTISING RULE 3 .................................................................................................... 7

3.4 PREFERENTIAL USAGE OR PRESCRIPTIONS RULE 23 .............................................. 7

3.5 REFERRALS RULE 24 ..................................................................................................... 7

3.6 TECHNOLOGICAL EQUIPMENT ..................................................................................... 7

3.7 FINANCIAL INTEREST IN HOSPITALS RULE 23A....................................................... 78

3.8 RENTALS AS PERVERSE INCENTIVES ......................................................................... 8

3.9 COMMISSION RULE 7 ..................................................................................................... 8

3.10 CHARGING OR RECEIVING FEES RULE 7 .................................................................... 9

3.11 SHARING OF FEES ......................................................................................................... 9

3.12 CONTRACTS .................................................................................................................... 9

3.13 CONTINUING PROFESSIONAL DEVELOPMENT ........................................................... 9

ii
 THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.2

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence, the

practice of health care professions is a moral enterprise. In this spirit

the HPCSA presents the following ethical guidelines to guide and direct

the practice of health care practitioners. These guidelines form an

integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

2
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
 GUIDELINES REGARDING OVER SERVICING, PERVERSE INCENTIVES
AND RELATED MATTERS CONCERNING HEALTH CARE
PROFESSIONALS
APPLICABLE TO ALL HEALTH CARE PROFESSIONALS

PREAMBLE

WHEREAS SECTION 49(1) of the Health Professions Act, 1974 (Act No. 56 of 1974) (“the Act”)
provides that the council shall, in consultation with a professional board, from time to time make
rules specifying the acts or omissions in respect of which the professional board may take
disciplinary steps under this Chapter: Provided that the powers of a professional board to inquire
into and deal with any complaint, charge or allegation relating to a health profession under this
Chapter, shall not be limited to the acts or omissions so specified;
AND WHEREAS council has made the rules in terms of section 49(1) of the Act;
NOW THEREFORE the HPCSA issues the following guidelines in respect of some of the above
rules:

1 INTRODUCTION

1.1 The Health Professions Council of South Africa (HPCSA) requires that health care
practitioners should at all times act in the best interests of their patients and regard the
clinical needs of their patients as paramount. To this end, a health care practitioner
should always try to avoid potential conflicts of interest and maintain professional
autonomy, independence and a commitment to the relevant professional and ethical rules
and policies applicable. Any conflicts of interest, incentives or forms of inducement that
threaten such autonomy, independence or commitment to the appropriate professional
and ethical rules and policies or that do not accord first priority to the clinical needs of
patients, are unacceptable. The ownership and use of high technology equipment creates
a special problem, not only because of its inappropriate use by health care practitioners
who are not properly qualified, but also due to overservicing by appropriately qualified
health care professionals. In general these guidelines cover the problems related to the
use of high technology equipment. In particular, it needs to be emphasised, that over
servicing of any kind is unacceptable.

1.2 In these guidelines, the HPCSA seeks to identify incentive schemes and forms of
inducement that it finds unacceptable. It must be clearly stated that the perverse
incentives or potential conflicts of interest set out in this document should not in any way
be regarded as an exhaustive list. The principles underlying these listed perverse
incentives apply in every case of alleged unprofessional conduct on the part of a health
care practitioner, and where breached will lead to an investigation by an appropriate
health care authority or the HPCSA.

1.3 These guidelines regarding over servicing, perverse incentives and related matters shall
be applicable to health care practitioners in both the public and private sectors.

1.4 It should further be noted that in terms of these guidelines, it is an offence either to offer a
perverse incentive or to accept one.

2
1.5 In addition to any action that the HPCSA may take in terms of other legislation that
governs the health professions, the HPCSA may, at its own discretion and where it
believes such action is warranted, lay a charge against any person, or corporate body or
other legal entity in terms of the Prevention and Combating of Corrupt Activities Act, 2004
(Act No. 12 of 2004 , should the actions or omissions of such person, body or other legal
entity be in breach of the provisions of that Act.

2 DEFINING OF CONCEPTS

For the purpose of these guidelines, the following concepts will have the meanings
described below, unless the context indicates otherwise. It should be noted that these
concepts have not been defined for legal purposes, but merely to clarify the meaning of
the guidelines. It should further be noted that some of these definitions have been based
on those in certain Acts of Parliament in the Medicine and Substance Related Act, 1965
(Act No. 101 of 1965

2.1 “Advertise” in relation to any health establishment or orthodox medicine, complementary

medicine, veterinary medicine, medical device or scheduled substance or health related
product or health related service, means any written, pictorial, visual or other descriptive
matter or verbal statement or reference in respect thereof:

2.1.1 Appearing in any newspaper, magazine, pamphlet or other publication; or

2.1.2 Distributed to members of the public; or

2.1.3 Brought to the notice of members of the public in any manner whatsoever,

That is intended to promote the sale of that orthodox medicine, complementary medicine,
veterinary medicine, medical device or scheduled substance or health related product or
to attract patients to any particular health establishment or health related service.

2.2 “Complementary medicine” means any substance, or mixture of substance, which:

2.2.1 Originates from a plant, mineral or animal, and which may be, but is not limited to
being classified as herbal, homeopathic, ayurvedic or nutritional; and

2.2.2 Is used or intended to be used for, or manufactured or sold for use in, or
purported to be useful in, complementing the healing power of a human or animal
body or for which there is a claim regarding its effect in complementing the
healing power of a human or animal body in the treatment, modification,
alleviation or prevention of a disease, abnormal physical or mental state or the
symptoms thereof in a human being or animal; and

2.2.3 Is used in, but not limited to, the disciplines of Western herbal, African traditional,
traditional Chinese, Homeopathy, Ayurveda, Unani, Antroposophy, Aromatherapy
and Nutritional supplementation; or

2.2.4 Because of its origin, intended use or use in a discipline, is determined by the
Authority, by notice in the Gazette, to be a complementary medicine.

2.3 “Device” see definition of “Medical device”.

2.4 “Dual Practice” means a situation where a practitioner combines clinical practice in the
public service with a clinical practice in the private sector. For practitioners employed in
the Public Service, the equivalent of Dual Practice is referred to as Remunerative Work
Outside Public Service (RWOPS). For practitioners in Private practice this refers to a

3
 situation where a practitioner is employed in the public service either on sessional or part
time basis.

2.4 “Endorse” means any action whereby a person or body attaches approval to or sanctions
any health establishment or orthodox medicine, complementary medicine, veterinary
medicine, medical device or scheduled substance or other health related product or health
related service with a view to encouraging or promoting the preferential use or preferential
sale thereof for the purpose of financial gain or other valuable consideration.

2.5 “Health care professional” means any person registered in terms of the applicable Act
which governs the functioning of any of the Councils that form part of the Forum of
Statutory Health Councils. This includes persons registered by the Health Professions
Council of South Africa. The term also includes registered student health care
practitioners.

2.6 “Health care practitioner” means any person registered with the HPCSA.

2.7 “Health establishment” means an institution, facility, building or place where persons
receive treatment, diagnostic or therapeutic interventions or other allopathic or
complementing health services and it includes facilities such as a clinic, mobile clinic,
hospital, community health centre, maternity home or unattached delivery suite,
convalescent home, consulting room, dispensary of health related treatment or aids and
appliances, first aid station, orthopaedic workshop, dental laboratory or workshop,
ambulance, unattached operating theatre, sanatorium, laboratory, pharmacy, occupational
health clinic, radiological clinic, and health spa or hydro.

2.8 “Health related product” means any commodity other than orthodox medicine,
complementary medicine, veterinary medicine, medical device or scheduled substance
which is produced by human effort or some mechanical, chemical, electrical or other
human engineered process for medicinal purposes or other preventive, curative,
therapeutic or diagnostic purposes in connection with human health.

2.9 “Improper financial gain or other valuable consideration” means money, or any other form
of compensation, payment, reward or benefit which is not legally due or which is given on
the understanding, whether express, implied or tacit, that the recipient will engage or
refrain from engaging in certain behaviour in a manner which is either:

2.9.1 Illegal; and/or

2.9.2 Contrary to ethical or professional rules; and/or

2.9.3 Which, in the opinion of a the HPCSA, may adversely affect the interests of a
patient or group of patients,

In order to procure some direct or indirect advantage, benefit, reward or payment for the
person offering or giving the said money, compensation, payment, reward or benefit, and
“perverse incentive” has the same meaning.

2.10 “Medicinal purposes” in relation to a scheduled substance, means the purpose of

treatment or prevention of a disease or some other definite curative or therapeutic
purpose, but does not include the satisfaction or relief of a habit or a craving for the
substance used or for any other scheduled substance, except where the substance is
administered or used in a hospital or similar institution maintained wholly or partly by the
Government or a provincial administration, or approved for that purpose by the Minister of
Health.

4
2.11 “Medicine” means any substance or mixture of substances intended to be used by, or
administered to human beings, for any of the following therapeutic purposes, namely:

2.11.1 Treating, preventing or alleviating symptoms of disease, abnormal physical or

mental state or the symptoms thereof;

2.11.2 Diagnosing disease or ascertaining the existence, degree or extent of a

physiological condition;

2.11.3 Otherwise preventing or interfering with the normal operation of physiological

function, whether permanently or temporarily and whether by way of terminating,
reducing, postponing or increasing or accelerating the operation of that function.

And “orthodox medicine” has the same meaning.

2.12 “Medical device” means any instrument, appliance, material, machine, apparatus, implant
or diagnostic reagent or any other article, whether used alone or in combination, including
software necessary for its proper application used for or purporting to be suitable for use
or manufactured or sold for use in or on a human or animal body:

2.12.1 In the diagnosis, prevention, monitoring, treatment or alleviation of disease; or

2.12.2 In diagnosis, monitoring, treatment, alleviation of or compensation for an injury or

handicap; or

2.12.3 In investigation, replacement or modification of the anatomy or of a physiological

process; or

2.12.4 In the diagnosis of pregnancy, or the control of conception or termination of

pregnancy,

And which does not achieve its principal intended action in or on the human body by
chemical, pharmacological, immunological or metabolic means, but which may be
assisted in its function by such means: and “device” has the same meaning.

2.13 “Orthodox medicine” see definition of “Medicine”.

2.14 “Overservicing” means the supply, provision, administration, use or prescription of any
treatment or care (including diagnostic and other testing, medicines and medical devices)
which is medically and clinically not indicated, unnecessary or inappropriate under the
circumstances or which is not in accordance with the recognised treatment protocols and
procedures, without due regard to both the financial and health interests of the patient.

2.15 “Perverse incentive” see definition of “improper financial gain or other valuable
consideration”.

2.16 “Promote” means any action taken by a person or body or allowed to be taken by such
person or body to further or to encourage the preferential use of any health establishment
or orthodox medicine, complementary medicine, veterinary medicine, medical device or
scheduled substance or health related product or health related service or to further or to
encourage the preferential sale of any such product or service for the purpose of financial
gain or other valuable consideration: This definition does, however, not prohibit the
practice of those professions where, in terms of their scopes of practice, it is appropriate
to sell such product or service at market related prices.

5
2.17 “Scheduled substance” means any medicine or other substance prescribed by the
Minister under section 22A; of the Medicines and Related Substances Act (Act No. 101 of
1965).

2.18 “Spouse” means a person’s partner in marriage and includes for the purpose of this policy
statement, a person with whom another person lives as if they were married or with whom
one habitually cohabits.

2.19 “Trade” means an act or instance of buying, selling or purchasing goods and services for
the purpose of financial gain or other valuable consideration.

2.20 “Veterinary medicine” means any substance or mixture of substances intended or

manufactured for use in connection with animals for diagnosis, treatment, alleviation,
modification or prevention of disease or unhealthy physical conditions, for the
improvement of growth, production or working capacity, for the lasting capacity of
carcasses, for curing, correcting or modifying behaviour or for humane euthanasia, but
does not include foodstuffs.

3 OVERSERVICING, PERVERSE INCENTIVES AND RELATED MATTERS

The following acts or omissions are not permissible for any health care practitioner, nor is
it ethical for any health related body to encourage health care professionals to engage in
any of them:

3.1 OVERSERVICING RULE 7

Health care practitioners shall not:

3.1.1 Provide a service or perform or direct certain procedures to be performed on a

patient that are neither indicated nor scientific or have been shown to be
ineffective, harmful or inappropriate through evidence-based review.

3.1.2 Refer a patient to another health care practitioner for a service or a procedure
that is neither indicated nor scientific or has been shown to be ineffective, harmful
or inappropriate through evidence-based review.

[Note: Over servicing by ordering or providing more tests, procedures or care than is
strictly necessary, is a common problem in modern medicine. Health care
practitioners must therefore not engage in any act that would constitute over
servicing of patients].

3.2 MANUFACTURING RULE 23

Health care practitioners shall not manufacture or participate in the manufacture, for
commercial purposes or trade, of orthodox medicine, complementary medicine, veterinary
medicine, a medical device or a scheduled substance or a health related product, except
where such medicine or device or substance or product forms an integral part of the
normal scope of practice of the health care practitioner concerned and where explicit
permission was granted to a health care professional by the HPCSA to manufacture or to
participate in the manufacture of such medicine, device, substance or product.

6
3.3 ADVERTISING RULE 3

Health care practitioners shall not advertise or endorse or encourage the use of any
health establishment or orthodox medicine, complementary medicine, veterinary
medicine, medical device or scheduled substance or health related product or health
related service in a manner that unfairly promotes the practice of a particular health care
practitioner or a health care facility for the purpose of financial gain or other valuable
consideration.

3.4 PREFERENTIAL USAGE OR PRESCRIPTIONS RULE 23

Health care practitioners shall not engage in or advocate the preferential use of any health
establishment or medical device or health related service or prescribe any orthodox
medicine, complementary medicine, veterinary medicine or scheduled substance, if any
financial gain or other valuable consideration is derived from such preferential usage or
prescription or the advocacy of preferential usage by the health care professional.

3.5 REFERRALS RULE 24

3.5.1 Self-referrals

Health care practitioners may only refer their clients or patients to any health
establishment in which such health care practitioner or a close family member or business
associate has a financial interest or a potential conflict of interest if such interest has been
declared to and approved by the HPCSA and on condition that such interest is discussed
and agreement reached with the patient prior to the referral for the patient’s consent.

3.5.2 Other referrals

Health care practitioners shall not refer their clients or patients to any health establishment
or to any other health care professionals if such referral would constitute overservicing.

3.5.3 Practitioners must not consult with one patient in more than one capacity.

3.6 TECHNOLOGICAL EQUIPMENT

3.6.1 Health care practitioners shall only own and use technological equipment if it forms an
integral part of their scope of the profession and practice and on condition that the health
care practitioner concerned has received appropriate training in using and managing such
equipment.

3.6.2 Health care practitioners shall not over-use equipment for procedures, tests and other
applications that are not indicated, scientific or based on evidence. This constitutes
overservicing and is prohibited.

3.6.3 Health care professionals shall not use technological equipment, health care products or
devices for profiteering and must refrain from charging patients fees for the use of such
products or devices that are not market related.

3.7 FINANCIAL INTEREST IN HOSPITALS RULE 23A

7
A practitioner may have a direct or indirect financial interest or shares in a hospital or any other
health care institution: Provided that -

(a) such interests or shares are purchased at market-related prices in arm's length
transactions;
(b) the purchase transaction or ownership of such interest or shares does not impose
conditions or terms upon the practitioner that will detract from the good, ethical and safe
practice of his or her profession;
(c) the returns on investment or payment of dividends is not based on patient admissions or
meeting particular targets in terms of servicing patients;
(d) such practitioner does not over-service patients and to this end establishes appropriate
peer review and clinical governance procedures for the treatment and servicing of his or her
patients at such hospital or health care institution;
(e) such practitioner does not participate in the advertising or promotion of the hospital or
health care institution, or in any other activity that amounts to such advertising or
promotion;
(f) such practitioner does not engage in or advocate the preferential use of such hospital or
health care institution;
(g) the purchase agreement is approved by the council based on the criteria listed in
paragraphs (a) to (f) above; and
(h) such practitioner annually submit a report to the council indicating the number of patients
referred by him or her or his or her associates or partners to such hospital or health care
institution and the number of patients referred to other hospitals in which he or she or his or
her associates or partners hold no shares.

3.8 RENTALS AS PERVERSE INCENTIVES

Health care practitioners shall not:

3.8.1 Pay rentals in lease agreements between health care practitioners and health
establishments that are not market related or are at preferential rates.

3.8.2 Enter into lease agreements with health establishments or services that wish to rent their
consulting rooms at rates conditional on the health care practitioner achieving a certain
turnover or targets such as admission of a specific number of patients at a private health
care facility.

3.8.3 Rent consulting rooms from health establishments or services under financial arrangements
that are not openly available to other similarly qualified health care practitioners.

3.9 COMMISSION RULE 7

3.9.1 Accepting commission

Health care practitioners shall not accept commission or any financial gain or other
valuable consideration from any person or body or service in return for the purchase, sale
or supply of any goods, substances or materials used by the health care professional in
his or her practice.

3.9.2 Paying commission

8
 Health care practitioners shall not pay commission or render any financial gain or other
valuable consideration to any person for recommending patients.

3.10 CHARGING OR RECEIVING FEES RULE 7

3.10.1 For referring patients

Health care practitioners shall not charge a fee or receive any financial gain or other
valuable consideration for referring patients to the other health professional or for
participation in drug trials or other research trials of a similar nature.

3.10.2 For seeing representatives

Health care practitioners shall not charge a fee or receive any financial gain or other
valuable consideration for seeing medical representatives

3.10.3 For services not personally rendered

Health care practitioners shall not charge or receive fees for services not personally
rendered by either a health care professional himself or herself or by an unregistered
person in his or her employ, except for services rendered by another health care
practitioner or person registered in terms of the Health Professions Act (Act No. 56 of
1974), that regulates the particular profession, with whom the health care practitioner is
associated as a partner, shareholder or locum tenens.

3.10.4 Charging consultation fee for an appointment that was not honoured (Rule 7)

A practitioner shall not charge or receive fees for services not rendered. An appointment
that was not honoured by the patient is equivalent to services not rendered, and for that, a
practitioner may not charge or receive fees

3.11 SHARING OF FEES

Health care practitioners shall not share fees with any person or health care professional
who has not taken a commensurate part in the service for which the fees are charged.

3.12 CONTRACTS

3.12.1 Health care practitioners shall not enter into a contract to work in a particular health
establishment or service on the understanding that the health care professional generates
a particular amount of revenue for such health establishment or service.

[Note: A health establishment or service that equips a theatre, ward or other facility for a specific
health care practitioner according to his or her specifications may enter into a contractual
agreement with such health care professional on condition that such health establishment
or service may not stipulate any turnover targets for the health care practitioner
concerned].

3.13 CONTINUING PROFESSIONAL DEVELOPMENT

With regard to continuing professional development (CPD), the HPCSA wishes to state
the following:

9
3.13.1 Collaborative efforts

Historically there has been a close collaboration between health care practitioners and the
pharmaceutical and health supply industry that extended particularly to CPD. Health care
is to a large extent self-governing and practitioners must ensure that their participation in
such collaborative efforts is in keeping with their ethical duties towards patients and
society.

3.13.2 Educational needs of targeted group

Continuing professional development activities should address the educational needs of

the targeted health care group.

3.13.3 Health care provider organisations

The decision on content and choice of continuing professional development activities, as

well as funding arrangements lies ultimately with the health care provider organisations
such as professional associations, their branches and groups who should not be in a
position of conflict of interest by virtue of any relationship with the funding body. The
organisers may acknowledge financial or other aid received, but should not identify any
specific products. Generic names of products should be used rather than trade names in
the course of continuing professional development activities.

3.13.4 Funding

Funds for continuing professional development activities should preferably be in the form
of an educational grant payable to the health care provider organisation arranging the
activity.

3.13.5 Travel, lodging and other expenses with regard to the attendance of CPD events

No travel or lodging costs or other expenses should be paid by the industry directly to the
individual health care practitioners to attend a CPD event. However indirect funding or
scholarship of CPD events may be permissible in instances where, such sponsorships are
paid to the organisers of the CPD events who in turn will identify, through a transparent
selection process, deserving candidates based on such factors as historically
disadvantaged individuals status, gender, geographical location in terms of rural and
inaccessible locations, young practitioners and developing practitioners etc. The
organisers may extend reasonable honoraria and imbursement for travel, lodging and
meal expenses to speakers. The principal event should at all times centre around
education and not around meals, entertainment or other hospitality, the cost of which
should not exceed that level at which the recipients might reasonably be expected to incur
for themselves under similar circumstances.

3.13.6 Travel, lodging and other expenses with regard to the attendance of international
conferences

3.13.6.1 It is a well established practice and an acknowledged fact that health care
practitioners and educators should be exposed to new knowledge and insights
into their respective professions and disciplines by attendance at international
conferences, either locally or overseas. It is, however, also of the utmost
importance that young and upcoming health care practitioners and educators and
those from disadvantaged backgrounds be given an equal opportunity to expand
their knowledge and understanding with regard to their respective professions
and disciplines by attendance at international conferences.

10
 3.13.6.2 It will, therefore, be permissible for companies to sponsor delegates to attend
international conferences, either directly or through professional associations or
societies, with the proviso that a fair and transparent process should be followed
in the election and sponsoring of delegates to attend such events, especially with
regard to the attendance of such conferences by young and upcoming health
care professionals and educators and those from disadvantaged backgrounds.

3.13.6.3 Sponsorships should be earmarked for specific educational events and

conferences and not for holiday purposes.

3.13.7 Distinction between education, training and product promotion

A distinction should be made between education and training on the one hand and
product promotion on the other. Health care practitioners cannot earn CEUs for attending
product launches or other product promotion events. No travel, lodging or other expenses
of health care practitioners should be paid for attendance at product promotion events or
product launches. However, modest meals may be provided.

3.14 Dual Practice

3.14.1 Health Care PR actioners employed in the Public Service place their undivided attention,
time and skills at the disposal of the Public Service as employer. Practitioners engaging in
Remunerative Work Outside Public Service (RWOPS) shall do so in line with the approval
by the executing authority; and in so doing, practitioners place the health and wellbeing of
their patients as first priority.

3.14.2 Practitioners abusing RWOPS must be reported to Council.

11
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE IN THE HEALTH CARE

PROFESSIONS

GUIDELINES FOR THE MANAGEMENT OF HEALTH CARE

WASTE

BOOKLET 12

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care practitioner, requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the HPCSA presents the following ethical guidelines to guide and direct

the practice of health care practitioners. These guidelines form an

integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
 ii
TABLE OF CONTENTS

GUIDELINES FOR GOOD PRACTICE IN THE HEALTH CARE PROFESSIONS ......................... 1

1 MOTIVATION OF THE NEED FOR THESE GUIDELINES ............................................... 1

2 DEFINITION OF HEALTH CARE WASTE ........................................................................ 1

3 TYPES OF HAZARDOUS HEALTH CARE WASTE ......................................................... 1

4 HAZARDOUS PROPERTIES OF HEALTH CARE WASTE .............................................. 2

5 REASONS WHY HEALTH CARE WASTE IS A SIGNIFICANT DANGER TO

SOCIETY .......................................................................................................................... 2

6 MANAGEMENT OF HEALTH CARE WASTE BY HEALTH CARE

PRACTITIONERS ............................................................................................................. 2

7 CONTACT DETAILS OF AUTHORITIES WHERE FURTHER ADVICE MAY BE

OBTAINED ....................................................................................................................... 4

8 REFERENCES .................................................................................................................. 5

1 SCOPE AND FIELD OF APPLICATION ........................................................................... 3

2 DEFINITIONS ................................................................................................................... 3

3 REFERENCE DOCUMENTS ............................................................................................ 8

4 OCCUPATIONAL HAZARDS AND HEALTH RISKS ....................................................... 9

5 GENERAL PROVISIONS................................................................................................ 10

5.1 SEGREGATION OF WASTES ........................................................................................ 10

5.2 IN-HOUSE CONTROL .................................................................................................... 10
5.3 CLOSURE AND BAGGING OF WASTE-HOLDING PLASTIC BAGS ............................ 11
5.4 INTERMEDIATE AND FINAL STORAGE AREAS.......................................................... 11
5.5 MOVEMENT OF WASTE ................................................................................................ 11
5.6 DISPOSAL OF WASTE .................................................................................................. 12
5.7 MAINTENANCE AND CLEANING OPERATIONS ......................................................... 12

5.7.1.1 PROTECTIVE APPAREL ............................................................................................... 12

5.7.1.2 RUBBER BOOTS. .......................................................................................................... 12

5.7.1.3 REUSABLE WASTE CONTAINERS AND WASTE-MOVEMENT CARTS ..................... 12

5.7.2 STORAGE SITES ........................................................................................................... 13

5.8 SPILL OR ACCIDENT CLEANUPS ................................................................................ 13

6 SPECIFIC PROVISIONS FOR DEALING WITH THE DIFFERENT TYPES OF

HEALTH CARE WASTE ................................................................................................. 14
 iii
6.4 THE FOLLOWING CATEGORIES OF HEALTH CARE WASTE ARE ADDRESSED
IN THE STANDARD: ...................................................................................................... 14
6.4.1 HUMAN/ANIMAL ANATOMICAL WASTE...................................................................... 14
6.4.2 INFECTIOUS NON-ANATOMICAL WASTE ................................................................... 14
6.4.3 SHARPS AND SIMILAR WASTE ................................................................................... 14
6.4.4 CHEMICAL/PHARMACEUTICAL WASTE ..................................................................... 15
6.4.5 RADIOACTIVE WASTE .................................................................................................. 15
6.4.6 PRESSURISED CONTAINER WASTE ........................................................................... 16
6.4.7 GENERAL WASTE ......................................................................................................... 16
 1

GUIDELINES FOR THE MANAGEMENT OF HEALTH CARE WASTE BY

HEALTH CARE PRACTITIONERS

1 MOTIVATION OF THE NEED FOR THESE GUIDELINES

The HPCSA views the proper disposal of health care waste by health care practitioners as an
essential element of good professional practice. These guidelines are issued to remind
practitioners of their ethical and professional obligations to their patients and to the community.
They also serve to assist practitioners to meet the HPCSA’s mandate to protect the public and the
requirements of the South African Constitution (Act No.108 of 1996) regarding the preservation
and protection of the environment.

2 DEFINITION OF HEALTH CARE WASTE

Health care waste may be defined as any undesirable or superfluous by-product, emission, residue
or remainder generated by in the course of health care by healthcare professionals, healthcare
facilities and other non-healthcare professionals, which is discarded, accumulated and stored with
the purpose of eventually discarding it, or is stored with the purpose of recycling, re-using or
extracting a usable product from such matter. Health care waste may, if handled improperly, have
the potential to harm people, property or the environment. In this regard, all human anatomical
waste, blood and body fluids are considered to be potentially hazardous. The unsafe disposal of
such waste could have detrimental effects for people who might come into contact with health care
waste.

3 TYPES OF HAZARDOUS HEALTH CARE WASTE

For the purpose of these guidelines, the following would be considered to be hazardous health
care waste:

3.1 Infectious waste.

3.2 Pathological waste, including body fluids, secretions and surgical specimens.

3.3 Sharps, especially contaminated sharps.

3.4 Pharmaceutical waste.

3.5 Chemical waste.

3.6 Heavy metals.

3.7 Radioactive waste.

3.8 Genotoxic waste.

3.9 Cytotoxic agents

3.10 Pressurised containers.

 2
4 HAZARDOUS PROPERTIES OF HEALTH CARE WASTE

Health care waste may be hazardous because it contains infectious, radioactive or toxic (including
genotoxic, immunotoxic and cytotoxic) materials. Health care waste may also contain hazardous
chemicals or pharmaceuticals and could be responsible for traumatic injury and other forms of
physical hazard.

5 REASONS WHY HEALTH CARE WASTE IS A SIGNIFICANT DANGER TO SOCIETY

Health care waste is a significant danger to society because:

5.1 Unsafe management of hazardous health care waste, particularly in its disposal,
may increase the risk of needle stick injuries, transmission of infectious agents and
expose unsuspecting parties to unnecessary and entirely preventable risks. The severity
of the risk associated with such exposures may be difficult to quantify, and such
exposures should be prevented.

5.2 Health care waste entering the normal domestic waste stream will end up being
disposed of in municipal landfill sites. When health care waste is placed in landfills or
buried, contamination of groundwater may occur and may result in the spread of E-Coli
and unacceptably high COD readings.

5.3. Many smaller landfill sites are not fenced off and have poor security. This results in
unwanted tip-face picking and scavenging. If health care waste is disposed on such a
site, there is a risk of exposure to people scavenging on the sites.

5.4 The irresponsible and illegal dumping of hazardous health care waste in South
Africa, as intermittently reported in the media, is a matter or serious concern. It also
places an unacceptably high financial and human resources burden on health authorities
to manage the problem.

5.5 The burning of health care waste as opposed to incineration is not recommended as
it pollutes the environment, especially through the formation of dioxins. Incineration should
only be used where it meets specifications that avoid secondary pollutant emissions.

6 MANAGEMENT OF HEALTH CARE WASTE BY HEALTH CARE PRACTITIONERS

6.1 It is the responsibility of all health care practitioners to have a health care waste
management system in place or to have access to such a system. Such a system
should be provided by an accredited waste service provider and be conducted in
accordance with relevant SANS code, such as 10248 -1- 2008 as updated. Such a
system should deal comprehensively with measures for waste minimization,
segregation, packaging, labeling, storage and removal under circumstances that do
not pose a threat to human health or the environment, both for routine
circumstances and in the event of an accident resulting in contamination with health
care waste.

6.2 Independent practitioners should be able to provide demonstrable evidence of

compliance with an acceptable protocol for the management of health care waste.
Such a protocol should provide for an audit trail of the management of waste
generated by the practice.

6.3 Where a health care practitioner is in the employ of a health care institution and is
not directly responsible for the management policies of the facility, there is an
 3
obligation on practitioners to insist that the management comply with the provisions
of these guidelines. Where management is unable or unwilling to meet the
requirements for safe management of health care waste, the practitioner should
report the matter to the HPCSA and the Department of Health for appropriate follow
up.

6.4 Provincial and local government health authorities should, wherever possible, by
mutual agreement and taking into account the cost implications, make their facilities
for the management of health care waste available to independent health care
practitioners in the area.

6.5 Where a health care practitioner is responsible for the management of a health care
facility, he or she must ensure that the facility has a documented waste
management policy with sufficient resources and suitably trained team members to
implement safe management of health care waste generated by the facility and its
staff.

6.6 Health care practitioners should aim at all times to minimize the amount of health
care waste generated in the process of health care delivery and to ensure that they
are familiar with methods to minimize, segregate and store health care waste safely.

6.7 It is the responsibility of health care practitioners to ensure that, if necessary, they
should keep up to date with the latest scientific knowledge on the safe management
of health care waste by undergoing further training in waste management.

6.8 All medical sharps should be considered hazardous healthcare waste whether or
not contaminated with infectious agents. The proper use and disposal of suitable
sharps containers contributes to the minimization of injuries and transmission of
potentially harmful agents. It is important that the health care practitioner make use
of sharp containers that are suited for the purposes of disposing of sharps. Such
containers should not puncture easily, should be stable and durable enough to
withstand a fall onto a hard surface.

6.9 When using sharps containers for discarded needles and other sharp health care
waste, health care practitioners should ensure that the containers are not filled
beyond their fill capacity, and are maintained upright throughout their use during
handling, storage and transport. Sharps that contain cytotoxic, genotoxic or
radioactive waste should be treated as per their waste categories and not mixed
with general sharp items. Do not reuse sharps containers designed, manufactured
and intended for single-use purposes.

6.10 Health care practitioners have an obligation to report evidence of unsafe disposal or
management of health care waste by other persons, including any health care
practitioners, to the HPCSA and the Department of Health, should such unsafe
practice come to their attention.

6.11 The Code of Practice of the South Africa Bureau of Standards on the Handling and
Disposal of Waste Material within Health Care Facilities (SANS 10248 -1- 2008) or
updates, should it be amended, should be used as a supplement to these official
guidelines of the HPCSA for the management of health care waste by health care
practitioners (see Annexure below).

6.12 Failure to adhere to these guidelines will be considered to be unprofessional

conduct on the part of the health care practitioners concerned.
 4
7 CONTACT DETAILS OF AUTHORITIES WHERE FURTHER ADVICE MAY BE
OBTAINED

7.1 The Director-General 7.7 Environmental Health Office

Department of Health Department of Health
Private Bag X828 Private Bag X517
PRETORIA BLOEMFONTEIN
0001 9300
Tel: (012) 312-0921 Tel: (051) 405-5021
Fax: (012) 323-0094 Fax: (051) 448-1150

7.2 Provincial Environmental Health Office 7.8 Environmental Health Office

Department of Health Department of Health and Welfare
Private Bag X0038 Private Bag X2068
BISHO MMABATHO
5609 2735
Tel: (040) 609-3701 Tel: (018) 387-5096
Fax: (040) 635-0115 Fax: (018) 387-5332

7.3 Environmental Health Office 7.9 Environmental Health Office

Department of Health Department of Health
Private Bag X11285 P O Box 62302
NELSPRUIT MARSHALLTOWN
1200 2107
Tel: (013) 752-8085 x 2043 Tel: (011) 355-3829
Fax: (013) 755-3549 Fax: (011) 355-3154

7.4 Environmental Health Office 7.10 Environmental Health Office

Department of Health Department of Health
Private Bag X9051 P O Box 648
PIETERMARITZBURG CAPE TOWN
3201 8000
Tel: (033) 395-2772 Tel: (021) 483-3737
Fax: (033) 342-1405 Fax: (021) 483-2786

7.5 Environmental Health Office 7.11 The Director General

Department of Welfare Department of Environmental Affairs
Private Bag X5048 and Tourism
KIMBERLEY Fedsure Forum
8300 315 Pretorius Street
Tel: (053) 830-0654 Private Bag X477
Fax: (053) 830-0655 PRETORIA
0001

7.6 Environmental Health Office 7.12 The President

Department of Health and Welfare South African Institute of
Private Bag X9302 Environmental Health
POLOKWANE P O Box 23
0700 NIGEL
Tel: (015) 290-9057 1490
Fax: (015) 291-2925
 5
8 REFERENCES

8.1 Mudgal, S; De Toni, A; Lockwood, S; Salês, K; Backhaus,T & Sorensen, BH. Study on the
environmental risks of medicinal products – Final Report. December 2013. Available from:
http://ec.europa.eu/health/files/environment/study_environment.pdf [Accessed on19 May
2015]

8.2 Mathee A. Environment and Health in South Africa: Gains, Losses and Opportunities.
Journal of Public Health Policy. 2011. 32, s37- s43. DOI: 10.1057/jphp.2011.21

8.3 South African National Standards (A division of SABS): Management of healthcare waste.
Part 1: Management of healthcare Risk Waste from a Healthcare facility. SANS Code
10248-1-2008, Pretoria. 2008.

8.4 Gabela, S D. Health Care Waste Management in Public Clinics in the ILembe District. A
Situational Analysis and Intervention Strategy. Health Systems Trust, University of
Kwazulu Natal. National Department of Health. 2007. http://www.hst.org.za [accessed
on16 May 2015]

8.5 Oelofse, S & Musee, N. Hazardous Waste Management and Emerging Waste Streams: A
Consideration of Key Emmerging Issues that may Impact the State of the Environment.
CSIR, Natural Resources and the Environment. March 2008.
ISBN No: 978-0-9814178-3-7
 I suggest we replace with SANS 10248-1-2008 with annexures
A.B, D & F

ANNEXURE

ABRIDGED VERSION
UDC 725.5:628.4.04 SABS 0248:1993

SOUTH AFRICAN BUREAU OF STANDARDS

CODE OF PRACTICE

for the

HANDLING AND DISPOSAL OF WASTE MATERIALS WITHIN HEALTH CARE

FACILITIES

(Incorporating CAN/CSA-Z317.10-88, Handling of waste materials within health care

facilities, with modifications)

Abridged by the
Health Professions Council of South Africa
as part of the
Guidelines for the Management of Health Care Waste by Medical Practitioners, Dentists
and Medical Scientists

The detailed document is

obtainable from the

SA BUREAU OF STANDARDS
Private Bag X191
Pretoria
Republic of South Africa
0001

Tel: (012) 428-6561

Fax: (012) 344-1568
 2

NOTICE

The detailed standard was approved by the Council of the South African Bureau of Standards on
25 February 1993. It remains under revision and should, therefore, be obtained from the Bureau in
full if required for verification of specific provisions.

NOTES

1. In terms of the Regulations promulgated under the Standards Act, 1982 (Act No. 30 of
1982), it is a punishable offence for any person to falsely claim compliance with the
provisions of a code of practice published by the South African Bureau of Standards.

2. Authorities who wish to incorporate any part of this code of practice into any legislation in
the manner intended by section 33 of the Act, should consult the South African Bureau of
Standards regarding the implications.

3. As the standard will be revised when necessary in order to keep abreast of progress,
comment will be welcomed by the Bureau and will be considered when the standard is
revised.

FOREWORD

The standard establishes specific guidelines for the segregation, collection, movement and storage
of waste materials within health care facilities. The main objective is to decrease injury to
personnel and the possible risks of spreading infection due to the improper handling of waste
materials.

The main features of the standard are as follows:

1. A series of waste categories based on the World Health Organisation’s Report

Management of Waste from Hospitals has been introduced.

2. A clause on pharmaceutical waste appears in the standard.

3. A classification system for waste containers has been developed.

4. Various procedures reflect modern current infection control practices.

5. The standard has been written in such a way as to reflect the practical aspects of handling
waste.

INTRODUCTION

In many guidelines, all waste contaminated with blood or body fluids are classified as infectious
waste. This enormously increases the volume of waste requiring expensive handling and disposal.
Identical items of waste are disposed of from homes with no special handling or decontamination.
For these reasons, this issue received detailed consideration during the preparation of the
standard.

The identification of every patient who carries a blood borne pathogen such as Hepatitis B or
Human Immunodeficiency Virus (HIV, leading to AIDS) is both impractical and inappropriate. The
modern trend in hospital infection control is to build safe practices into ALL clinical procedures; the
precaution taken is dictated by the risk accompanying the procedure, not by the diagnosis.
 3

Two premises have been incorporated throughout the standard:

1. The simple presence of viable organisms does not constitute a hazard; a mechanism by
which these organisms can infect a host must coexist. Since Hepatitis B and HIV are
usually transmitted by inoculation, the concern with blood alone, for example, is
misplaced. The emphasis should more appropriately be applied to the category of clinical
sharps. Infections acquired by waste handlers are rare, but almost always associated
with trauma. Vigorous efforts directed toward the prevention of these injuries deserve
high priority; the incidence of both the wounds and accompanying infections can be
reduced dramatically by adherence to safe procedures.

2. Absolute elimination of all risk is impossible. A realistic goal is the attainment of a

reasonable degree of safety at all times without needlessly compromising efficiency.

Note: The scope of the standard is restricted to the health care site, but the responsible person
for the health care facility still bears the ultimate responsibility for the safe disposal of
waste (generated on site) outside the site.

1 SCOPE AND FIELD OF APPLICATION

1.1 The standard includes criteria for the segregation, collection, movement, storage,
and on-site disposal of waste materials within health care and biological research
facilities.

1.2 The standard does not deal with the disposal of waste once it has been removed
from the site of the health care facility. Such matters are the subject of national,
provincial, regional and municipal legislation and regulations.

1.3 The standard does not address special precautions in national and provincial
legislation which may apply to infectious substances (or the transportation thereof).

1.4 In the standard, “shall” indicates a mandatory requirement; “should” indicates a

recommendation, or that which is advised but not mandatory.

1.5 Notes accompanying the clauses do not include mandatory or alternative

requirements. The purpose of a note accompanying a clause is to separate it from
the text as being explanatory or informative material that is not properly a part of the
standard. Notes to the table are considered to be part of the table and are written
as mandatory requirements.

2 DEFINITIONS

The following definitions apply to the standard and are included herein for information and clarity:

2.1 Chemical waste: Comprises discarded solid, liquid and gaseous chemicals, e.g.
from diagnostic or experiential work, or from cleaning, housekeeping or disinfecting
procedures. Chemical waste may be hazardous or non-hazardous. For the
purposes of choosing the most appropriate waste-handling method, hazardous
chemical waste is considered to be waste that is -

2.1.1 Toxic;

2.1.2 Corrosive (acids of pH < 2,0 and bases of pH > 12,0);

 4
2.1.3 Flammable;

2.2.4 Reactive (explosive, water reactive, shock sensitive); or

2.2.5 Genotoxic (carcinogenic, mutagenic, teratogenic or otherwise capable of

altering genetic material).

[Note: Non-hazardous chemical waste consists of chemicals other than those described here,
such as sugars, amino acids, and certain organic and inorganic salts].

2.2 Clinical glass: Glass possibly contaminated with blood and body fluids or
chemicals, (e.g. blood collection tubes, laboratory glass, medication vials).

2.3 Collection: The accumulation of wastes from several primary or intermediate

storage sites for movement to a waste-holding area or from several waste-holding
areas for movement to a final storage area.

2.4 Colour-coding: The application of colour to a container in order to identify the

category of waste for which it is to be used.

2.5 Container: Any receptacle for the storage of wastes. Containers can be classified
into two subgroups as follows:

2.5.1 Reusable waste container.

2.5.2 Single-use waste container.

2.5.1. Reusable waste container: A waste container that is:

2.5.1.1 Reusable;

2.5.1.2 Fabricated of metal or rigid plastics;

2.5.1.3 Resistant to burning, impact and corrosion;

2.5.1.4 Suitable for the waste it is to contain; and

2.5.1.4 Colour-coded or identified according to the type of waste for which it

is intended (see table 1) by one of the following methods:

1. If the container is made of plastics, the plastics may be dyed in the

appropriate colour; or

2. A band of colour not less than 50 mm in width may be applied to the

container. Reusable waste containers shall be inspected for holes or
leaks every time they are emptied, and their colour-coding renewed if
necessary.

[Note: Such containers are used for the:

a. Collection;

b. Transportation; or

c. Storage of waste, e.g. garbage cans and storage bins].

2.5.2 Single-use waste container: A waste container that can be one of the
following:
 5

2.5.2.1 Sharps container.

2.5.2.2 Waste-holding plastic bag.

2.5.2.3 Cardboard container.

2.5.2.4 Specialised container.

2.5.3 Sharps container: A container that:

2.5.3.1 Is sturdy enough to resist puncture under usage conditions and to the
point of disposal;

2.5.3.2 Is clearly identified as containing sharps, e.g. by the use of the word
SHARPS or a symbol recognised by the facility;

2.5.3.4 Has lid(s) capable of being tightly secured; and

2.5.3.5 If used for containing cytotoxic wastes, has the cytotoxic hazard
symbol displayed clearly and visibly.

[Notes:

1. Other useful features of sharps containers include -

a. A fill line;

b. Unauthorised withdrawal prevention;

c. Handles; and

d. A wall bracket and lock.

2. Containers selected should be compatible with and appropriate to the type of waste they
are to contain.

3. Where practical, the same type of container should be used throughout a facility.
Standardisation of the containers will encourage greater use and enhance identifiability
among users].

2.5.4 Waste-holding plastic bag container: A plastics bag used as a container

and that is:

2.5.4.1 Colour-coded or identified according to the type of waste for which it

is intended (see table 1); and

2.5.4.2 Sturdy enough to resist puncture, leaking and breaking under

individual usage conditions and to the point of disposal, except
where:

a. Provincial regulations governing the off-site disposal of waste

require bags of a specific thickness;

b. Municipal or other local authorities responsible for sanitary

landfill sites require bags of a specific thickness; or

c. Facility administrators have established procedures involving

specified bag thicknesses.
 6

[Note: It is inappropriate to specify a minimum thickness of plastic bags or plastic sharps

containers since polymeric materials vary extensively in their physical and mechanical
properties. It is quite possible that a 25 mm thick film of one polymeric material will be
more puncture, impact and abrasion resistant than a 50 mm thick film of a different
polymeric material. These properties can be further affected by the manufacturing
process, i.e. extrusion and injection moulding. The most appropriate manner of
determining the suitability of a particular container in respect of its ability to resist
puncture, leaking and breaking under individual usage conditions is to subject the
container to those usage conditions].

2.5.5 Cardboard container: A container made from cardboard and that is:

2.5.5.1 Colour-coded or identified according to the type of waste for

which it is intended (see table 1);

2.5.5.2 Rigid; and

2.5.5.3 Leak resistant.

2.5.6 Specialised containers (e.g. paint cans): Specialised containers colour-

coded or identified according to the type of waste for which they are
intended.

2.6 Cytotoxic: Having a deleterious effect upon cells; commonly used in reference to
pharmaceuticals used in the treatment of cancer, (e.g. antineoplastics,
chemotherapy agents).

2.7 Disposal: The removal of waste from the site of the health care facility or the on-
site incineration of waste.

2.8 General waste: Waste that:

2.8.1 Has not been included in the other waste categories; and

2.8.2 Does not pose a disease-related risk or threat to people or the environment.
The general waste category includes:

2.8.2.1 Office waste;

2.8.2.2 Kitchen waste;

2.8.2.3 Non-clinical glass waste; and

2.8.2.4 All other similar wastes.

2.9 Hazardous: Referring to any material or substance that, if handled improperly, has
the potential to harm people, property or the environment.

[Note: All human anatomical waste such as blood and body fluids are potentially hazardous.

2.10 Human/animal anatomical waste:

2.10.1 Waste consisting of:

2.10.1.1 Tissues;

2.10.1.2 Organs;
 7

2.10.1.3 Body parts;

2.10.1.4 Products of conception; and

2.10.1.5 Animal carcasses.

2.10.2 This waste category is divided into the subcategories of:

2.10.2.1 Human anatomical waste;

` 2.10.2.2 Infectious animal anatomical waste; or

2.10.2.3 Non-infectious animal anatomical waste.

[Note: The following are considered to be non-anatomical wastes:

a. Blood and body fluids.

b. Extracted teeth.

c. Nail clippings.

d. Hair].

2.11 Health care facilities: Health care facilities are all places (sites) where
professional health services are dispensed to human patients or biological
research is carried out and includes, inter alia, hospitals, clinics,
rehabilitation centres, sick bays (old age homes), free-standing operating
theatres, day units, clinics (mobile and stationary) and doctor’s consulting
rooms.

2.12 Infectious non-anatomical waste: Any waste contaminated with viable

micro-organisms capable of transmitting, and reasonably likely to transmit,
disease.

[Note: This may include -

a. All microbiology lab wastes that have not been decontaminated;

b. Waste from surgeries and autopsies performed on patients with infectious

diseases; and

c. All contaminated waste from patients].

2.13 Movement: Transfer of waste material between storage areas within the
health care facility.

2.14 Non-clinical glass: Glass from maintenance and kitchen areas, (e.g.
broken window panes and discarded glass bottles, unless visibly
contaminated with blood).

2.15 Pharmaceutical waste: Pharmaceutical products such as drugs and

medicinal chemicals that are:

2.15.1 No longer usable in patient treatment and have been returned from
patient care areas, have become outdated or contaminated, have
been stored improper; or
 8
2.15.2 No longer required.

2.16 Pressurised container waste: Consists of aerosol cans or disposable

compressed gas containers that may explode if incinerated or accidentally
punctured.

2.17 Refrigerated storage: Storage of waste at a temperature of 4ºC or lower.

2.18 Segregation: The separation of waste according to classification (see Table

1) prior to storage.

2.19 Sharps and similar waste: These include:

2.19.1 Needles;

2.19.2 Syringes;

2.19.3 Blades;

2.19.4 Clinical glass; and

2.19.5 Any other clinical items capable of causing a cut or puncture.

2.20 Soiled utility room: An intermediate storage room within the facility where
waste from the patient’s bedside is temporarily stored.

2.21 Storage: The accumulation of waste after segregation in a specified

container in a predetermined location.

2.22 Storage areas:

2.22.1 Final storage area: The area of the facility where waste is stored
just before being disposed of;

2.22.2 Intermediate storage area: The area of the facility where waste is
stored following its collection from the primary storage area and
before being removed to the final storage area. This will necessarily
include the means by which the waste is transported;

2.22.3 primary storage area: The area of the facility where waste
originates, e.g. a consulting room, patient room and laboratory.

2.23 System: The waste management system belonging to the health care
facility.

2.24 Waste holding: The storage of waste collected from all primary storage
areas such as a laboratory wing, a block of operating rooms, or a floor of
patient rooms.

3 REFERENCE DOCUMENTS

3.1 The following documents should be referred to when handling and disposing of
waste materials:

3.1.1 Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965).
 9
3.1.2. Human Tissue Act, 1983 (Act No. 56 of 1983), as amended.

3.1.3 Compulsory specification for biological safety cabinets (Classes I, II and III),
published by Government Notice No. 1318 (Government Gazette No. 12517)
of 15 June 1990.

3.1.4 SABS 1186, Symbolic safety signs.

3.1.5 SABS 0226, The installation, post-installation tests and maintenance of

biological safety cabinets.

3.1.6 BS 5252, Framework for colour coordination for building purposes.

4 OCCUPATIONAL HAZARDS AND HEALTH RISKS

4.1 To minimise the occupational health risks associated with the handling and disposal
of health care waste, occupational health care programmes should:

4.1.1 Introduce safe or less hazardous substitutes for chemical agents with
exposure hazards;

4.1.2 Require closed storage for volatile agents, traces of which, or brief exposure
to which, cause a health hazard;

4.1.3 Require the use of proper venting and exhausting in accordance with the
established principles of occupational hygiene;

4.1.4 Provide appropriate personal protective equipment with disinfection and

disposal arrangements for workers involved in various stages of waste
handling and disposal;

4.1.5 Include an assessment of waste management procedures on a regular

basis, to assure compliance with the standard and applicable national,
provincial, regional and municipal regulations and legislation;

4.1.6 Include a training programme for all persons handling wastes;

4.1.7 Include appropriate protective equipment and handwashing facilities; and

4.1.8 Include a written procedure to handle and report needle-stick injuries and
other injuries sustained whilst engaged in waste disposal.

4.2 Health care facilities shall have freely available to all personnel concerned, written
policies and procedures which include requirements for at least:

4.2.1 The cautionary labeling of all containers of hazardous materials;

4.2.2 Material safety data sheets;

4.2.3 Appropriate worker training for each system element;

4.2.4 Protection of proprietary information; and

4.2.5 When applicable, compliance with relevant national and local regulations.
 10
5 GENERAL PROVISIONS

All waste needs to be handled so as to ensure that it is segregated at source, contained in

packaging that holds the contents to the point of disposal, and disposed of in a manner that is
practical and efficient yet minimises any hazard. By minimising the handling of waste, fewer
people will be exposed to it. Potentially offensive unrefrigerated waste should be timeously
removed.

There are certain classes of waste that need to be handled in specific ways. They are specified n
the standard to ensure proper handling.

5.1 SEGREGATION OF WASTES

Wastes shall be segregated according to the following categories that are further detailed
in Table 1 (see below page 16):

5.1.1 Human/animal anatomical waste.

5.1.2 Infectious non-anatomical waste.

5.1.3 Sharps and similar waste.

5.1.4 Chemical/pharmaceutical waste.

5.1.5 Radioactive waste.

5.1.6 Pressurised container waste.

5.1.7 General waste.

5.2 IN-HOUSE CONTROL

5.2.1 Each generator of biohazardous waste shall prepare, maintain and

implement a written plan to identify and handle all waste generated within
the facility and shall provide a training programme for all staff to familiarise
them with:

5.2.1.1 Procedures for the segregation, collection, storage, labeling and

movement of waste specified by the standard;

5.2.1.2 Personal hygiene, especially handwashing; and

5.2.1.3 The hazards of those materials to which workers may be exposed.

Such training shall be continuously assessed and reinforced.

5.2.2 An inspection programme shall be established to ensure that the procedures

specified by the standard are followed.

5.2.3 The final disposal of hazardous waste remains the responsibility of the waste
generator.

[Note: The in-house control of waste produced by health care facilities should be
managed in accordance with the provisions of the standard, under the supervision of
the facility’s infection control committee or a designated department].
 11
5.3 CLOSURE AND BAGGING OF WASTE-HOLDING PLASTIC BAGS

5.3.1 Bags containing waste, no matter how they are closed, shall be such that
their contents are prevented from escaping.

5.3.2 A single bag is normally adequate if it is impervious and sturdy (i.e. not
easily penetrated) and if the article can be placed in the bag without
contaminating the outside of the bag. Otherwise, double bagging should be
used.

5.4 INTERMEDIATE AND FINAL STORAGE AREAS

5.4.1 All waste-storage areas shall meet the requirements of the National Building
Regulations.

5.4.2 Intermediate and final storage areas shall:

5.4.2.1 Be totally enclosed;

5.4.2.2 Be separate from supply rooms or food preparation areas;

5.4.2.3 Have provision for being locked; and

5.4.2.4 Have access restricted to authorised personnel only.

5.4.3 Health care facilities that refrigerate stored waste shall use:

5.4.3.1 A lockable, closed cold storage facility; or

5.4.3.2 A lockable, domestic-type freezer unit that is dedicated to the

accumulation of waste for disposal This waste shall be stored at a
temperature of 4ºC or lower, with freezing being the preferred
method of storage.

5.4.4 Health care facilities shall prepare a contingency plan for dealing with the
storage of refrigerated waste in the event of excess waste being produced,
incineration facilities or refrigeration/freezing facilities becoming inoperative.

5.4.5 Health care facilities shall prepare a contingency plan to deal with the
disposal of waste in the event of a disruption of disposal services.

5.4.6 Users of the standard shall refer to the National Building Regulations for
information regarding the ventilation of waste-storage areas.

5.5 MOVEMENT OF WASTE

5.5.1 Manual handling of waste materials shall be minimised.

5.5.2 Carts used for carrying waste shall be:

5.5.2.1 Capable of containing the waste;

5.5.2.2 Designed to prevent spills; and

 12
5.5.2.3 Constructed of materials that permit effective cleaning and
disinfection.

[Note: Open carts may be used to transfer waste contained within waste
containers].

5.5.3 Waste containers shall be moved only when properly closed.

5.5.4 Specific routes for the movement of waste shall be planned in order to
minimise its passage through patient care and other clean areas.

5.5.5 Waste disposal chutes should be avoided, but if they are provided, shall be
used for general waste purposes only. Such disposal chutes shall comply
with all applicable building and fire codes and regulations.

5.5.6 The compacting of waste destined for landfill sites shall be determined by
the individual health care facility in accordance with national, provincial,
regional and municipal legislation and regulations.

5.6 DISPOSAL OF WASTE

The health care facility shall dispose of all waste in accordance with national, provincial,
regional and municipal regulations and legislation.

5.7 MAINTENANCE AND CLEANING OPERATIONS

5.7.1.1 Protective apparel

The following protective apparel shall be worn, as necessary, by any personnel engaged
in the cleaning of reusable waste containers, waste-movement carts, or final storage
areas:

5.7.1.1 Water-resistant coveralls.

5.7.1.2 Rubber boots.

5.7.1.3 Heavy-duty waterproof gloves.

5.7.1.4 Protective goggles or face shields.

[Note: When not in use, protective apparel shall be stored in an area designated for
this purpose].

5.7.1.3 Reusable waste containers and waste-movement carts

5.7.2.1 Reusable waste containers and waste-movement carts shall be thoroughly

cleaned in accordance with the facility’s established procedures.

5.7.2.2 The frequency of cleaning operations shall be in accordance with the

facility’s established procedures.

5.7.2.3 Reusable waste containers and waste-movement carts shall be thoroughly

cleaned before any maintenance work is performed on them.
 13

5.7.2 Storage sites

Floors, walls and ceilings of intermediate and final storage areas shall be thoroughly
cleaned in accordance with the facility’s established procedures.

5.8 SPILL OR ACCIDENT CLEANUPS

5.8.1 Every possible effort should be made to avoid the escape of any hazardous material in the
course of normal operations. Minor spills involving loss or release into the air of small
volumes of material are most likely to result from faulty transfer techniques. Major spills or
accidents usually involve container rupture, caused by equipment malfunction or careless
handling.

5.8.2 As in the handling of all hazardous substances, the most important elements in dealing
with a major spill are common sense and a contingency plan prepared and learned in
advance.

5.8.3 Health care facilities shall have a documented policy and procedure for managing spills of
a hazardous substance.

5.8.4 The procedure for managing a spill shall include the following:

5.8.4.1 All staff shall be trained and educated in -

a. The management of hazardous substances; and

b.. The recognition and management of a spill condition.

5.8.4.2 A method for the containment and isolation of each type of spill shall be
prepared.

5.8.4.3 Should a spill occur, the person or persons designated for spill cleanup shall be
notified immediately. These persons shall have specific training in the
management of spills.

5.8.4.4 Information concerning individual substances and their cleanup shall be readily
accessible to all staff and available on a 24 hour basis.

5.8.4.5 Proper equipment shall be made available for:

a. Spill cleanups; and

b. The protection of employees.

5.8.4.6 The procedures for each type of spill shall be documented and made available in
the area where the spill is likely to occur.

5.8.4.7 Procedures for the proper disposal of waste spills according to the waste-
management policy of the facility shall be prepared.

5.8.4.8 All incidents shall be documented for the purpose of record keeping.

5.8.4.9 Any employee exposed to a spill shall be treated and monitored by the facility.
 14
5.8.4.10 If necessary, evacuation and internal disaster plans shall be implemented.

6 SPECIFIC PROVISIONS FOR DEALING WITH THE DIFFERENT TYPES OF HEALTH

CARE WASTE

6.1 After dealing with the above general provisions, the standard goes on to deal separately
with each of the various categories of health care and general waste.

6.2 Readers who require more detailed information on dealing with the relevant categories of
waste, are advised to contact the South African Bureau of Standards (SABS) for such
information as the standard for dealing with health care waste is constantly under review
and being updated as required.

6.3 At the invitation of the SABS, a member of the HPCSA’s Committee for Human Rights,
Ethics and Professional Practice has been nominated to serve on the relevant Committee
of the SABS. The HPCSA appreciates this invitation and trusts that it will result in close
cooperation between the SABS and the HPCSA in dealing with this important aspect of
health care management and protection of the public.

6.4 The following categories of health care waste are addressed in the standard:

6.4.1 Human/animal anatomical waste

The standard deals with Its definition and the following subcategories:

6.4.1.1 Human anatomical waste

The item deals with the containment, collection, final storage areas and disposal of human
anatomical waste.

6.4.1.2 Animal anatomical waste

The item deals with the containment, collection, final storage areas and disposal of animal
anatomical waste.

6.4.2 Infectious non-anatomical waste

The standard deals with the definition, containment, collection, final storage areas and
disposal of infectious non-anatomical waste.

6.4.3 Sharps and similar waste

The standard deals with the definition of sharps and similar waste which includes:

6.4.3.1 Needles;

6.4.3.2 Syringes;

6.4.3.3 Blades;

6.4.3.4 Clinical glass; and

6.4.3.5 Any other clinical items capable of causing a cut or puncture; and
 15
their containment, collection and disposal.

6.4.4 Chemical/pharmaceutical waste

The standard on chemical waste deals mainly with hazardous and pharmaceutical
chemicals, their definition, basic safety guidelines, basic waste disposal guidelines, the
handling and disposal of pharmaceuticals other than cytotoxics, and the handling and
disposal of cytotoxic pharmaceuticals.

6.4.5 Radioactive waste

The handling and disposal of radioactive wastes are subject to the Nuclear Energy Act,
1982 (Act No. 92 of 1982).
 16

6.4.6 Pressurised container waste

The standard again deals with the definition, containment, collection and disposal of
pressurised container waste.

6.4.7 General waste

The standard deals with the definition, containment, collection and disposal of general
waste and briefly addresses the issues of kitchen waste and non-clinical glass waste.
 17

TABLE 1 - SUMMARY OF COLOUR-CODING/LABELING REQUIREMENTS

1 2 3 4

Waste category Waste subcategory Colour-coding/labeling Clause

1(a) Human anatomical RED 6.2

1(b) Infectious animal ORANGE**, OR RED 6.3

1. Human/animal*)
anatomical
anatomical waste
1(c) Non-infectious animal BLUE 6.3
anatomical

2. Infectious*) non-
YELLOW 7
anatomical waste

3. Sharps and “SHARPS” or recognised 8

similar waste symbol

4. Chemical/ Chemical waste 9.1/9.2

pharmaceutical
Pharmaceutical waste BLACK, DARK GREEN, or 9.3/9.3.4
waste
excluding cytotoxic recognised coding
pharmaceutical waste
9.3.5
Cytotoxic pharmaceutical Cytotoxic hazard symbol
waste

5. Radioactive waste Radiation hazard symbol 10

6. Pressurised BLACK or DARK GREEN 11

container waste

7. General waste 7(a) Office waste BLACK or DARK GREEN 12

7(b) Kitchen waste BLACK or DARK GREEN 12.4
7(c) Non-clinical glass BLACK or DARK GREEN 12.5
waste
7(d) Non-infectious non- 12
BLACK or DARK GREEN
anatomical waste

*) Chemical or radioactive solutions containing human/animal anatomical and infectious non-

anatomical wastes should be considered as chemical or radioactive wastes respectively.
**) ORANGE - 06E53 in BS 5252 (MUNSELL Ref 5YR7/15).
 `

HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

GENERAL ETHICAL GUIDELINES FOR

HEALTH RESEARCHERS

BOOKLET 13

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care professional requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the Health Professions Council of South Africa presents the following

ethical guidelines.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).

i
 ii

TABLE OF CONTENTS

1. PREAMBLE ..................................................................................................................... 1
2. INTRODUCTION ............................................................................................................ 1
3. ETHICAL GUIDELINES IN HEALTH RESEARCH ......................................................... 2
4. BASIC ETHICAL PRINCIPLES IN HEALTH RESEARCH.............................................. 2
5. THE SOCIAL VALUE OF RESEARCH .......................................................................... 3
6. DUTIES TO RESEARCH PARTICIPANTS .................................................................... 3
7. DUTIES TO RESEARCH COLLEAGUES AND OTHER PROFESSIONALS ................. 8
8. DUTIES TO HEALTH RESEARCHERS THEMSELVES ................................................ 8
9. DUTIES TO SOCIETY ................................................................................................... 9
10. DUTIES TO THE HEALTH CARE PROFESSION ....................................................... 10
11. DUTIES TO ANIMALS ................................................................................................. 11
12. DUTIES TO THE ENVIRONMENT............................................................................... 11
13. DATA AND SPECIMEN STORAGE AND TRANSFER ................................................ 11

ii
 GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCHERS

1. PREAMBLE

Biomedical research has made spectacular strides during the past century. That medical research
has increased the well being of humans in much of the world is without doubt but the power to
save human lives and ameliorate disease has also raised concerns about how this is achieved and
how its fruits will be distributed. South Africa with its scientific expertise, advanced infrastructure,
developing country burden of disease and large number of vulnerable populations provides fertile
ground for research. Moreover the country is still recovering from its many years under apartheid.
Hence the misuse of power in research cannot be ignored. The following guidelines should serve
as a reference to research institutions, organisation and researchers registered with the HPCSA

2. INTRODUCTION

2.1 Being registered as a health practitioner under the Health Professions Act, 1974 (Act No.
56 of 1974), confers certain rights and privileges. Corresponding to these rights and
privileges are the ethical duties a health practitioner owes to individuals and society.
2.2 This booklet contains general ethical guidelines for health researchers. General ethical
guidelines embody the ideals to which members of professions should aspire and
subscribe. A failure to do so may result in disciplinary action by the HPCSA and legal
consequences.
2.3 The ethical guidelines contained herein are drawn from a variety of sources, including the
South African Constitution, the Department of Health’s Ethics in Health Research:
Principles, Structures and Processes, the South African Medical Research Council’s
Guidelines for Ethics in Medical Research and the Declaration of Helsinki.

Definitions

2.4 The following definitions apply:

2.4.1 ‘Health researcher’ refers to all scientific investigators engaged in health research.

2.4.2 Research participant’ refers to a person who subjects himself or herself to a process of
scientific or health research.

2.4.3 Health research,’ as defined in the National Health Act (Act No. 61 of 2003), includes
any research that contributes to the knowledge of:

i) The biological, clinical psychological or social processes in human beings;

ii) Improved methods for the provision of health services;
iii) Human pathology;
iv) The causes of diseases;
v) The effects of the environment on the human body;
vi) The development or new application of pharmaceuticals, medicines and related
substances; and
vii) The development of new applications of health technology.

2.4.4 ‘Research ethics committee’ refers to a Committee established in terms of

section 69(1) of the National Health Act;

1
 2.4.5 ‘Clinical trial’ refers to a systematic study involving human participants that aims to answer
specific questions about the safety or efficacy of a medicine or method of treatment.
2.4.6 According to the UNAIDS definition, ‘Vulnerable communities’ refers to those communities
that have some or all of the following characteristics

i) Limited economic development

ii) Inadequate protection of human rights and discrimination on the basis of
health status
iii) Inadequate community/cultural experience with the understanding of
scientific research
iv) Limited availability of health care and treatment options
v) Limited ability of individuals in the community to provide informed consent
vi) Being a junior or subordinate member of a hierarchical group
vii) Limited literacy levels

3. ETHICAL GUIDELINES IN HEALTH RESEARCH

3.1 Researchers conducting health research involving human participants need to consider
the possible adverse impacts of their research on vulnerable groups and thus have a duty
to observe the highest possible standards to protect the rights of research participants.

3.2 Responsible health research not only makes a scientific contribution for the good of
humans or animals, but is also conducted in an ethical manner.

3.3 For research to be ethical, guidelines need to be followed. Such guidelines flow from
underlying ethical values, standards, and principles. Effective guidelines contribute to
achieving health research that is scientifically, ethically and legally sound.

3.4 Health research ethics committees use a protocol review procedure to consider all ethical
questions regarding human and animal health research proposals and protocols. In terms
of the National Health Act (Act No. 61 of 2003), all health research proposals and
protocols require approval by an accredited health research ethics committee before the
research may commence.

4. BASIC ETHICAL PRINCIPLES IN HEALTH RESEARCH

4.1 Some core ethical values and standards have the status of basic ethical principles.

4.1.1. The principle of best interest or well-being

The principle of non-maleficence: risks and harms of research to participants must be

minimised.

The principle of beneficence: The benefits of health research must outweigh the risks to
the research participants.

4.1.2. The principle of respect for persons:

The principle of autonomy: participants that are capable of deliberation about personal
choices should be treated with respect for their capacity of self determination and be
afforded the opportunity to make informed decisions with regard to their participation in
research. Therefore there must be special protections for those with diminished or
impaired autonomy i.e. dependant and or vulnerable participants need to be afforded
safeguards against harm or abuse.

2
 The principle of confidentiality: A participant’s right to both privacy and confidentiality
must be protected. The researcher must ensure that where personal information about
research participants or a community is collected, stored, used or destroyed, this is done
in ways that respect the privacy or confidentiality of participants or the community and any
agreements made with the participants or the community

4.1.3. The principle of justice

Justice imposes an ethical obligation to treat each person in accordance with what is right
and proper. In research this is primarily distributive justice whereby there should be
equitable distribution of both burdens and benefits of research participation. It is an
ethical imperative that the study should leave the participant and or community better off
or no worse off. Researchers have an obligation to justify their choice of research
questions and to ensure that such questions are neither gratuitous nor result in the
exploitation of study participants. The selection, recruitment, exclusion and inclusion of
research participants must be just and fair, based on sound scientific and ethical
principles. No persons may be inappropriately or unjustly excluded on the basis of race,
age, sex, sexual orientation, disability, education, religious beliefs, pregnancy, marital
status, ethnic or social origin, conscience, belief or language.

Where research involves participants from vulnerable communities, added protections will
be necessary to safeguard their vulnerabilities. There needs to be justification for doing
research in vulnerable communities. Moreover, the research should be responsive to their
particular vulnerabilities. Enhanced or added consent procedures would be necessary
where appropriate. Vulnerable communities should not be targeted for research just
because of administrative and logistical ease of availability.

5. THE SOCIAL VALUE OF RESEARCH

5.1 Research in South Africa should be responsive to the health needs of our communities
and in line with our national health research priorities as outlined in section 70 of the National
Health Act. The following factors should be taken into consideration:

5.1.1 The burden of disease;

5.1.2 The cost-effectiveness of interventions aimed at reducing the burden of
disease;
5.1.3 The availability of human and institutional resources for the implementation of
an intervention at the level closest to the affected communities;
5.1.4 The health needs of vulnerable groups such as women, older persons, children
and people with disabilities; and
5.1.5 The health needs of communities.

6. DUTIES TO RESEARCH PARTICIPANTS

6.1 ACTING IN THE BEST INTERESTS OF RESEARCH PARTICIPANTS

In order to always act in the best interests of research participants, health researchers should
always:

6.1.1 Place the life, well being, health, privacy and dignity of their research participants
before all other interests.

6.1.2 Honour the trust that research participants place in them.

3
 6.1.3 Recognise that they are in a position of power over research participants and
should avoid abusing their position.

6.1.4 Abstain from engaging in research projects involving human research participants
unless they are in no doubt that the risks involved have been adequately assessed
and can be satisfactorily managed throughout the duration of the project.

6.1.5 Stop the involvement of research participants if continuation of the research may
be harmful to them or where it becomes obvious that the risks are outweighing the
benefits.

6.1.6 Be accessible to research participants in the course of their investigations.

6.1.7 Ensure that their personal beliefs do not influence their choice of research
participants. Such beliefs may prejudice choices regarding the lifestyle, culture,
beliefs, race, colour, gender, sexual orientation, age, social status, or perceived
economic worth of research participants, and will be unethical.

6.1.8 Respond to criticism and complaints promptly and constructively.

6.1.9 Report violations and seek redress, if possible, in circumstances where they
believe that violations of the rights of research participants are taking place.

6.1.10 Ensure that research participants are compensated for all reasonable expenses or
loss of income incurred as a result of their participation in research and such
compensation should be specified in the relevant research protocol or proposal.

6.1.11 Ensure that all research participants are compensated for trial related injuries and
that there is adequate insurance cover for research participants. .

6.1.12 Ensure that no undue inducements are offered to participants to encourage them
to participate in the research by exploiting their unfavourable socio – economic
status.

6.1.13 Ensure at the end of a drug trial that on-going treatment where needed/necessary
is available to research participants.

6.2 RESPECT FOR RESEARCH PARTICIPANTS

In order to demonstrate respect for their research participants, health researchers should always:

6.2.1 Respect the privacy and dignity of research participants.

6.2.2 Treat research participants politely and with consideration.

6.2.3 Listen to the research participants and respect their opinions.

6.2.4 Respect the right of research participants to safeguard their integrity.

6.2.5 Avoid improper relations with research participants, their friends or family
members.

6.2.6 Remember that contemporary societal reactions to particular diseases may place
research participants at risk and this must be taken into account when selecting
research participants.

4
 6.2.7 Guard against human-rights violations and avoid participating in any actions that
violate the rights of others.

6.3 INFORMED CONSENT

Health researchers should always:

6.3.1 Give research participants sufficient information about the nature and effect of the
research - in particular the effect of the research on the participants including its
consequences, risks and benefits - to enable them to make an informed choice
about their participation.

6.3.2 Give research participants the information they ask for and need about their
research participation.

6.3.4 Remember that responsibility for the well-being of research participants always
rests with the health researcher - not the research participants - even though the
latter have given consent.

6.3.5 Give information to research participants in a language that the participant

understands and in a manner that takes into account the participant’s level of
literacy, understanding, values and personal belief systems. Participation at all
times should be voluntary and not coerced.

6.3.6 Use caution when obtaining informed consent where the research participant is in
a dependent relationship with the health researcher or is in a situation where he
or she may consent under duress. In such cases, informed consent should be
obtained by a well-informed health care practitioner who is not engaged in the
research and who is completely independent of this relationship.

6.3.7 Refrain from purposefully withholding from research participants any information,
investigation or procedure that health care practitioners know is in the best
interests of the participants.

6.3.8 Obtain the consent of legally authorised representatives in cases of research

participants who cannot consent for themselves, e.g. children, mentally
challenged, elderly and the unconscious. These groups should not be included in
research unless the research is necessary to promote the health of the
population represented and unless this research cannot instead be performed on
legally competent persons.

6.3.9 Remember that the principle of informed consent should be viewed as an on-
going process in that research participants are entitled to change their minds.
Moreover, the consent process should be reinforced during the trial.

6.3.10 Inform research participants of their right to abstain from participating in the
study, or to withdraw from participating in the study - by revoking their consent -
at any time, without suffering prejudice or reprisal.

6.3.11 Allow competent research participant’s unimpeded access throughout the

research period to information concerning the research.

6.3.12 Inform participants of the limits to the confidentially of the information about them
gathered during the research - e.g. bodies such as the National Health Research

5
 Ethics Council, the HPCSA, and the Medicines Control Council may review or
inspect data.

6.3.13 Adhere to the principle of informed consent by keeping proper documentation.

After ensuring that the research participant understands the information, the
health researcher should obtain the participant’s freely given informed consent in
writing. If the consent cannot be obtained in writing, the non-written consent must
be fully documented and witnessed. Both verbal and written informed consent
must be obtained unless there are good reasons for not doing so. Where the
research participant is not literate verbal consent should be obtained in the
presence of an independent literate witness who should verify this in writing.
Where the independent witness is not literate, the consent process should be
audio-visually recorded.

6.4 RESEARCH PARTICIPANT CONFIDENTIALITY

Health researchers should always:

6.4.1 Recognise the right of research participants to expect that health researchers will
not pass on any personal and confidential information that the latter learn in the
course of their professional duties, unless the research participants agree.

6.4.2 Not breach confidentiality without sound reason and without the knowledge and
consent of the research participants.

6.4.3 Protect the confidentiality of research data or other disclosures made by research
participants.

6.5 IMPARTIALITY AND JUSTICE

Health researchers must always:

6.5.1 Be aware of the rights and laws concerning unfair discrimination in the
management of research participants or their families on the basis of race,
culture, ethnicity, social status, lifestyle, perceived economic worth, age, gender,
disability, communicable disease status, sexual orientation, religious or spiritual
beliefs, or any condition of vulnerability such as contained in health-rights
legislation.

6.5.2 Not discriminate in the selection and recruitment of participants by including or

excluding them on the grounds of race, culture, ethnicity, social status, lifestyle,
perceived economic worth, age, gender, disability, communicable disease status,
sexual orientation, religious or spiritual beliefs, or any condition of vulnerability,
except where the exclusion or inclusion of particular groups is critical to the
research purpose and scientific design.

6.5.3 Design research projects so that the selection, recruitment, exclusion or inclusion
of research participants is fair and equitable.

6.5.4 Balance the burdens and benefits of research within different population groups.

6.5.5. Avoid imposing an unfair burden of research participation on particular groups

and communities, who are likely to be subject to over-researching.

6
6.6 HEALTH RESEARCH AND MEDICAL HEALTH CARE

Health care should not be assumed to refer to drug treatments only. It extends to considerations of
all other aspects of health care under the control of the investigator.

In all instances, health researchers should:

6.6.1 Combine health research with medical care only to the extent that the research is
justified by its potential prophylactic, diagnostic or therapeutic value.

6.6.2 Test the benefits and burdens, risks and effectiveness of new methods against
those of the best current prophylactic, diagnostic and therapeutic methods. This
does not exclude the use of placebo, or no treatment, in studies where no proven
prophylactic, diagnostic and therapeutic method exists.

6.6.3 At the conclusion of their study, ensure that research participants have access to
the best proven prophylactic, diagnostic and therapeutic methods identified by
the study.

6.6.4 Fully inform research participants about which aspects of medical care, if any, are
related to health research, and clearly distinguish between therapeutic
interventions and health research processes.

6.6.5 Ensure that research participants understand that the health researcher’s role as a
researcher differs from their role as health care practitioners.

6.6.6 Promote access to health care. Should health researchers be unable to provide
the required research related health care for research participants they should
refer the research participants to another health care practitioner or healthcare
facility. The costs of this care should be the responsibility of the researcher and
sponsor.

6.6.7 Ensure that in multi-centre and multi-national studies, equal standards of care are
applied across countries to all research participants

6.7 POTENTIAL CONFLICTS OF INTEREST

All health researchers should:

6.7.1 Declare to all research participants any conflicts of interest they may have in
institutions, equipment, research sponsors etc. This includes the need to declare
whether the research is being conducted for academic purposes.

6.7.2 Disclose any potential conflicts of interest to their research ethics committee
before the research commences.

6.7.3 Design their research to exclude any potential conflicts of interest with sponsors
or collaborators.

7
7. DUTIES TO RESEARCH COLLEAGUES AND OTHER PROFESSIONALS

Health researchers should always:

7.1 Work with and respect other health care practitioners in pursuit of the best health care
possible for all research participants.

7.2 Not discriminate against colleagues because of their race, culture, ethnicity, social status,
lifestyle, perceived economic worth, age, gender, disability, communicable disease status,
sexual orientation, religious or spiritual beliefs, or any condition of vulnerability.

7.3 Not allow research participants to doubt the knowledge or skills of colleagues by making
unnecessary or unsubstantiated comments about them.

7.4 Refrain from unjustifiably hindering other colleagues who wish to conduct research in
similar fields.

8. DUTIES TO HEALTH RESEARCHERS THEMSELVES

8.1 KNOWLEDGE AND SKILLS

8.1.1 Health researchers who are suitably qualified should conduct health research
studies. In all cases including multi-national collaborative research the local
primary investigator must be a South African based researcher (i.e. a person who
is permanently based in South Africa). The Principal Investigator must be
registered with the HPCSA and must be responsible for the ethical management
of study.

8.1.2 All health researchers should always:

8.1.2.1 Maintain and improve the standard of their performance by keeping their
professional knowledge and skills up to date throughout their working life. In
particular, they should regularly take part in educational activities that
enhance their scientific and research ethics knowledge.

8.1.2.2 Acknowledge the limits of their professional knowledge and competence.

8.1.2.3 Observe and keep up to date with the ethical and regulatory frameworks that
affect health research.

8.2 EQUIPMENT, HYGIENE, AND RECORD KEEPING

Health researchers should always:

8.2.1 Keep their research equipment in good working order.

8.2.2 Maintain proper hygiene in their working environment.

8.2.3 Keep accurate and up-to-date records about research participants.

8
9. DUTIES TO SOCIETY

9.1. RESPECT FOR LIFE

9.1.1 Health researchers should treat all living objects - humans, animals and plants -
with the necessary and appropriate respect.
9.1.2 Animals should not be used in research requiring them to be harmed or sacrificed
where alternative methods such as computer-generated models can be used to
achieve the same results.

9.2 REPORTING SCIENTIFIC MISCONDUCT

Health researchers should report evidence of fraud and other crimes or scientific misconduct in
research to the HPCSA.

9.2.1 Scientific misconduct is defined as fabrication, falsification, or plagiarism in

proposing, performing, or reviewing research, or in reporting research results.

9.2.2 Fabrication is making up data or results and recording or reporting them

9.2.3 Falsification is manipulating research material, equipment, or processes, or

changing or omitting data or results such that the research is not accurately
represented in the research record.

9.2.4 Plagiarism is the appropriation of another person’s ideas, processes, results, or

words without giving appropriate credit

9.2.5 Scientific misconduct does not include honest error or honest difference of opinion
Definition available at http://www.ostp.gov/html/001207_3.htm

9.2.6 Scientific misconduct also includes but is not limited to:

 Failure of obtaining informed consent

 Inappropriate disclosure of research participant data
 Deviation from approved protocol
 Falsification of credentials
 Deception in the research proposal

9.3 ACCESS TO SCARCE RESOURCES

Health researchers should always:

9.3.1 Deal responsibly with scarce health care resources, and should refrain from
research that duplicates other research unnecessarily.

9.3.2 Refrain from any form of resource wastage in carrying out their research.

9.3.3 Refrain from participating in improper financial arrangements that escalate costs
or disadvantage research participants, patients or institutions unfairly.

9.3.4 Design and conduct research to include or provide the use of appropriate
facilities, in order to manage any rising contingencies.

9.3.5 Avoid research that impacts adversely on public health facilities.

9
9.4 LEGAL REQUIREMENTS

Health researchers should always:

9.4.1 Conform to relevant legal requirements and ensure that their research is lawful.

9.4.2 Adhere to ethical guidelines. Where the ethical guidelines prescribe a higher
standard than the law, health researchers should conform to the higher standard.

9.4.3 Ensure that at all times research is conducted or supervised by experienced,

qualified, competent and ethical health researchers who are approved by all the
legally required bodies.

10. DUTIES TO THE HEALTH CARE PROFESSION

10.1 REVIEW PROCESSES

The following research guidelines are applicable to all health care practitioners registered with the
HPCSA irrespective of where they conduct their research.

Health researchers should:

10.1.1 Receive approval for their research projects from all the relevant committees
before beginning the project. This includes bodies like the MCC, Provincial and
hospital authorities and the National Department of Health where applicable.

10.1.2 Notify all relevant reviewing bodies if the risks to research participants are found
to be disproportionate to the benefits during the course of the trial.

10.1.3 Inform relevant reviewing bodies and institutions of any changes to their research
protocol.

10.1.4 Ensure that the health research institutions with which they work are accredited
by the National Health Research Ethics Council (NHREC) and have established
or provided access to an accredited health research ethics committee which is
registered with the NHREC.

10.1.5 Report inadequate or inappropriate reviews of research protocols to the HPCSA.

10.1.6 Prematurely terminate a study where:

 the research question has been answered;

 the research proves harmful to participants

10
11. DUTIES TO ANIMALS

Health researchers should:

11.1 Accept responsibility for the care of animals used in health research and respect their
welfare.

11.2 Demonstrate that their research is justifiable and scientifically based on literature reviews,
prior observations, approved studies and, when applicable, laboratory and animal
studies.

11.3 Follow the ethical and regulatory guidelines established at institutional level regarding the
use of animals by professional associations, and by governmental authorities.

11.4 Use, when appropriate, inanimate materials and processes instead of animals.

11.5 When the use of an animal species is scientifically necessary, use lower animal species
that may be less susceptible to pain and suffering - without compromising the integrity of
the research.

11.6 When designing the research protocol, use the minimum number of animals necessary to
yield valid answers to the research hypothesis.

11.7 Take active measures to use procedures that minimise both the incidence and severity of
the pain and suffering experienced by animals.

12. DUTIES TO THE ENVIRONMENT

Health researchers should:

12.1.1 Ensure that the research does not impact on the environment in a manner that is
harmful to the health and well-being of the population, nature and the
environment. In all instances health researchers must ensure that the
environment is protected for the benefit of present and future generations as is
required by the South African Constitution.

12.1.2 Recognise that natural resources are limited and guard against their exploitation.

12.1.3 Health researchers should protect the environment and the public by assuring
that health care waste is disposed off legally and in an environmentally friendly
manner

13. DATA AND SPECIMEN STORAGE AND TRANSFER

13.1 Data and specimens obtained as a result of research activity should be securely stored.

13.2 Data, including tape recordings should be stored for a minimum of 2 years after
publication or 6 years in the absence of publication.

13.3 There must be justifiable reasons and benefits for the country which should be provided to
Research Ethics Committees for data and specimens to leave the country. This should

11
 only be done after a Material Transfer Agreement has been signed and submitted to the
local Research Ethics Committee.

13.4 The Protection of Personal Information Act 4 of 2013 (Act No. 4 of 2013) protects personal
information by restricting how it can be used and collected by individuals and
organisations by providing that:

13.4.1 The party processing the personal information must comply with the Act (s 8);
13.4.2 The processing of personal information must be done so that it does not infringe
the privacy of the data subject (the individual whose data is collected) (ss 9-12);
13.4.3 The personal information must only be collected for a specific purpose and the
data subject must be told about this (s 13);
13.4.4 The records may not be held longer than is necessary to achieve the purpose for
which they were collected (s 14);
13.4.5 Further processing of the information must be in line with the purpose of
collecting it (s 15);
13.4.6 The party holding the personal information must ensure that it is complete,
accurate, not misleading and updated when required (s 16);
13.4.7 The party holding the data must ensure that the data subject knows that the
personal information has been collected and the purpose of the collection (s 18);
(h) the party holding the personal information must secure the personal data
under their control (s 19);
` 13.4.8 The party holding the information must inform the data subject if there is a
breach of security (ss 21 and 22);
13.4.9 A data subject may enquire whether a person or organisation holds their personal
information and what the information is (s 23);
13.4.10 The data subject may request the correction or deletion of personal information
that is inaccurate, irrelevant, excessive, out of date, incomplete, misleading or
obtained unlawfully (s 24).

12
 `

HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

GENERAL ETHICAL GUIDELINES FOR

HEALTH RESEARCHERS

BOOKLET 14

PRETORIA
SEPTEMBER 2016
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care practitioners. The term

“profession” means “a dedication, promise or commitment publicly made”.1

To be a good health care professional requires a life-long commitment to

sound professional and ethical practices and an overriding dedication to

the interests of one’s fellow human beings and society. In essence,

practice as a health care professional is a moral enterprise. In this spirit

the Health Professions Council of South Africa presents the following

ethical guidelines.

[Note: The term “health care practitioner” in these guidelines refers to

persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).
 ii

TABLE OF CONTENTS

1. PREAMBLE ..................................................................................................................... 1
2. INTRODUCTION ............................................................................................................ 1
3. ETHICAL GUIDELINES IN HEALTH RESEARCH ......................................................... 2
4. BASIC ETHICAL PRINCIPLES IN HEALTH RESEARCH.............................................. 2
5. THE SOCIAL VALUE OF RESEARCH .......................................................................... 3
6. DUTIES TO RESEARCH PARTICIPANTS .................................................................... 3
7. DUTIES TO RESEARCH COLLEAGUES AND OTHER PROFESSIONALS ................. 8
8. DUTIES TO HEALTH RESEARCHERS THEMSELVES ................................................ 8
9. DUTIES TO SOCIETY ................................................................................................... 8
10. DUTIES TO THE HEALTH CARE PROFESSION ....................................................... 10
11. DUTIES TO ANIMALS ................................................................................................. 10
12. DUTIES TO THE ENVIRONMENT............................................................................... 11
13. DATA AND SPECIMEN STORAGE............................................................................. 11
 1
GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCHERS

1. PREAMBLE

Biomedical research has made spectacular strides during the past century. That medical research
has increased the well being of humans in much of the world is without doubt but the power to
save human lives and ameliorate disease has also raised concerns about how this is achieved and
how its fruits will be distributed. South Africa with its scientific expertise, advanced infrastructure,
developing country burden of disease and large number of vulnerable populations provides fertile
ground for research. Moreover the country is still recovering from its many years under apartheid.
Hence the misuse of power in research cannot be ignored. The following guidelines should serve
as a reference to research institutions, organisation and researchers registered with the HPCSA

2. INTRODUCTION

2.1 Being registered as a health practitioner under the Health Professions Act, 1974 (Act No.
56 of 1974), confers certain rights and privileges. Corresponding to these rights and
privileges are the ethical duties a health practitioner owes to individuals and society.
2.2 This booklet contains general ethical guidelines for health researchers. General ethical
guidelines embody the ideals to which members of professions should aspire and
subscribe. A failure to do so may result in disciplinary action by the HPCSA and legal
consequences.
2.3 The ethical guidelines contained herein are drawn from a variety of sources, including the
South African Constitution, the Department of Health’s Ethics in Health Research:
Principles, Structures and Processes, the South African Medical Research Council’s
Guidelines for Ethics in Medical Research and the Declaration of Helsinki.

Definitions

2.4 The following definitions apply:

2.4.1 ‘Health researcher’ refers to all scientific investigators engaged in health research.

2.42 ‘Research participant’ refers to a person who subjects himself or herself to a process of
scientific or health research.

2.4.3 ‘Health research,’ as defined in the National Health Act (Act No. 61 of 2003), includes any
research that contributes to the knowledge of:

i The biological, clinical psychological or social processes in human beings;

ii Improved methods for the provision of health services;
iii Human pathology;
iv The causes of diseases;
v The effects of the environment on the human body;
vi The development or new application of pharmaceuticals, medicines and related
substances; and
vii The development of new applications of health technology.

2.4.4 ‘Research ethics committee’ refers to a Committee established in terms of

section 69(1) of the National Health Act;
 2

2.4.5 ‘Clinical trial’ refers to a systematic study involving human participants that aims to answer
specific questions about the safety or efficacy of a medicine or method of treatment.
2.4.6 According to the UNAIDS definition, ‘Vulnerable communities’ refers to those communities
that have some or all of the following characteristics

i. Limited economic development

ii. Inadequate protection of human rights and discrimination on the basis of health
status
iii. Inadequate community/cultural experience with the understanding of scientific
research
iv. Limited availability of health care and treatment options
v. Limited ability of individuals in the community to provide informed consent
vi. Being a junior or subordinate member of a hierarchical group
vii. Limited literacy levels

3. ETHICAL GUIDELINES IN HEALTH RESEARCH

3.1 Researchers conducting health research involving human participants need to consider
the possible adverse impacts of their research on vulnerable groups and thus have a duty
to observe the highest possible standards to protect the rights of research participants.

3.2 Responsible health research not only makes a scientific contribution for the good of
humans or animals, but is also conducted in an ethical manner.

3.3 For research to be ethical, guidelines need to be followed. Such guidelines flow from
underlying ethical values, standards, and principles. Effective guidelines contribute to
achieving health research that is scientifically, ethically and legally sound.

3.4 Health research ethics committees use a protocol review procedure to consider all ethical
questions regarding human and animal health research proposals and protocols. In terms
of the National Health Act (Act No. 61 of 2003), all health research proposals and
protocols require approval by an accredited health research ethics committee before the
research may commence.

4. BASIC ETHICAL PRINCIPLES IN HEALTH RESEARCH

4.1 Some core ethical values and standards have the status of basic ethical principles.

4.1.1. The principle of best interest or well-being

The principle of non-maleficence: risks and harms of research to participants must be

minimised.

The principle of beneficence: The benefits of health research must outweigh the risks to
the research participants.

4.1.2. The principle of respect for persons:

The principle of autonomy: participants that are capable of deliberation about personal
choices should be treated with respect for their capacity of self determination and be
afforded the opportunity to make informed decisions with regard to their participation in
research. Therefore there must be special protections for those with diminished or
impaired autonomy i.e. dependant and or vulnerable participants need to be afforded
safeguards against harm or abuse.
 3

The principle of confidentiality: A participant’s right to both privacy and confidentiality

must be protected. The researcher must ensure that where personal information about
research participants or a community is collected, stored, used or destroyed, this is done
in ways that respect the privacy or confidentiality of participants or the community and any
agreements made with the participants or the community

4.1.3. The principle of justice

Justice imposes an ethical obligation to treat each person in accordance with what is right
and proper. In research this is primarily distributive justice whereby there should be
equitable distribution of both burdens and benefits of research participation. It is an
ethical imperative that the study should leave the participant and or community better off
or no worse off. Researchers have an obligation to justify their choice of research
questions and to ensure that such questions are neither gratuitous nor result in the
exploitation of study participants. The selection, recruitment, exclusion and inclusion of
research participants must be just and fair, based on sound scientific and ethical
principles. No persons may be inappropriately or unjustly excluded on the basis of race,
age, sex, sexual orientation, disability, education, religious beliefs, pregnancy, marital
status, ethnic or social origin, conscience, belief or language.

Where research involves participants from vulnerable communities, added protections will
be necessary to safeguard their vulnerabilities. There needs to be justification for doing
research in vulnerable communities. Moreover, the research should be responsive to their
particular vulnerabilities. Enhanced or added consent procedures would be necessary
where appropriate. Vulnerable communities should not be targeted for research just
because of administrative and logistical ease of availability.

5. THE SOCIAL VALUE OF RESEARCH

5.1 Research in South Africa should be responsive to the health needs of our communities
and in line with our national health research priorities as outlined in section 70 of the National
Health Act. The following factors should be taken into consideration:

5.1.1 The burden of disease;

5.1.2 The cost-effectiveness of interventions aimed at reducing the burden of
disease;
5.1.3 The availability of human and institutional resources for the implementation of
an intervention at the level closest to the affected communities;
5.1.4 The health needs of vulnerable groups such as women, older persons, children
and people with disabilities; and
5.1.5 The health needs of communities.

6. DUTIES TO RESEARCH PARTICIPANTS

6.1 ACTING IN THE BEST INTERESTS OF RESEARCH PARTICIPANTS

In order to always act in the best interests of research participants, health researchers should
always:

6.1.1 Place the life, well being, health, privacy and dignity of their research participants
before all other interests.

6.1.2 Honour the trust that research participants place in them.

 4

6.1.3 Recognise that they are in a position of power over research participants and
should avoid abusing their position.

6.1.4 Abstain from engaging in research projects involving human research participants
unless they are in no doubt that the risks involved have been adequately assessed
and can be satisfactorily managed throughout the duration of the project.

6.1.5 Stop the involvement of research participants if continuation of the research may
be harmful to them or where it becomes obvious that the risks are outweighing the
benefits.

6.1.6 Be accessible to research participants in the course of their investigations.

6.1.7 Ensure that their personal beliefs do not influence their choice of research
participants. Such beliefs may prejudice choices regarding the lifestyle, culture,
beliefs, race, colour, gender, sexual orientation, age, social status, or perceived
economic worth of research participants, and will be unethical.

6.1.8 Respond to criticism and complaints promptly and constructively.

6.1.9 Report violations and seek redress, if possible, in circumstances where they
believe that violations of the rights of research participants are taking place.

6.1.10 Ensure that research participants are compensated for all reasonable expenses or
loss of income incurred as a result of their participation in research and such
compensation should be specified in the relevant research protocol or proposal.

6.1.11 Ensure that all research participants are compensated for trial related injuries and
that there is adequate insurance cover for research participants. .

6.1.12 Ensure that no undue inducements are offered to participants to encourage them
to participate in the research by exploiting their unfavourable socio – economic
status.

6.1.13 Ensure at the end of a drug trial that on-going treatment where needed/necessary
is available to research participants.

6.2 RESPECT FOR RESEARCH PARTICIPANTS

In order to demonstrate respect for their research participants, health researchers should always:

6.2.1 Respect the privacy and dignity of research participants.

6.2.2 Treat research participants politely and with consideration.

6.2.3 Listen to the research participants and respect their opinions.

6.2.4 Respect the right of research participants to safeguard their integrity.

6.2.5 Avoid improper relations with research participants, their friends or family
members.

6.2.6 Remember that contemporary societal reactions to particular diseases may place
research participants at risk and this must be taken into account when selecting
research participants.
 5

6.2.7 Guard against human-rights violations and avoid participating in any actions that
violate the rights of others.

6.3 INFORMED CONSENT

Health researchers should always:

6.3.1 Give research participants sufficient information about the nature and effect of the
research - in particular the effect of the research on the participants including its
consequences, risks and benefits - to enable them to make an informed choice
about their participation.

6.3.2 Give research participants the information they ask for and need about their
research participation.

6.3.4 Remember that responsibility for the well-being of research participants always
rests with the health researcher - not the research participants - even though the
latter have given consent.

6.3.5 Give information to research participants in a language that the participant

understands and in a manner that takes into account the participant’s level of
literacy, understanding, values and personal belief systems. Participation at all
times should be voluntary and not coerced.

6.3.6 Use caution when obtaining informed consent where the research participant is in
a dependent relationship with the health researcher or is in a situation where he
or she may consent under duress. In such cases, informed consent should be
obtained by a well-informed health care practitioner who is not engaged in the
research and who is completely independent of this relationship.

6.3.7 Refrain from purposefully withholding from research participants any information,
investigation or procedure that health care practitioners know is in the best
interests of the participants.

6.3.8 Obtain the consent of legally authorised representatives in cases of research

participants who cannot consent for themselves, e.g. children, mentally
challenged, elderly and the unconscious. These groups should not be included in
research unless the research is necessary to promote the health of the
population represented and unless this research cannot instead be performed on
legally competent persons.

6.3.9 Remember that the principle of informed consent should be viewed as an on-
going process in that research participants are entitled to change their minds.
Moreover, the consent process should be reinforced during the trial.

6.3.10 Inform research participants of their right to abstain from participating in the
study, or to withdraw from participating in the study - by revoking their consent -
at any time, without suffering prejudice or reprisal.

6.3.11 Allow competent research participants unimpeded access throughout the

research period to information concerning the research.

6.3.12 Inform participants of the limits to the confidentially of the information about them
gathered during the research - e.g. bodies such as the National Health Research
 6
Ethics Council, the HPCSA, and the Medicines Control Council may review or
inspect data.

6.3.13 Adhere to the principle of informed consent by keeping proper documentation.

After ensuring that the research participant understands the information, the
health researcher should obtain the participant’s freely given informed consent in
writing. If the consent cannot be obtained in writing, the non-written consent must
be fully documented and witnessed. Both verbal and written informed consent
must be obtained unless there are good reasons for not doing so. Where the
research participant is not literate verbal consent should be obtained in the
presence of an independent literate witness who should verify this in writing.
Where the independent witness is not literate, the consent process should be
audio-visually recorded.

6.4 RESEARCH PARTICIPANT CONFIDENTIALITY

Health researchers should always:

6.4.1 Recognise the right of research participants to expect that health researchers will
not pass on any personal and confidential information that the latter learn in the
course of their professional duties, unless the research participants agree.

6.4.2 Not breach confidentiality without sound reason and without the knowledge and
consent of the research participants.

6.4.3 Protect the confidentiality of research data or other disclosures made by research
participants.

6.5 IMPARTIALITY AND JUSTICE

Health researchers must always:

6.5.1 Be aware of the rights and laws concerning unfair discrimination in the
management of research participants or their families on the basis of race,
culture, ethnicity, social status, lifestyle, perceived economic worth, age, gender,
disability, communicable disease status, sexual orientation, religious or spiritual
beliefs, or any condition of vulnerability such as contained in health-rights
legislation.

6.5.2 Not discriminate in the selection and recruitment of participants by including or

excluding them on the grounds of race, culture, ethnicity, social status, lifestyle,
perceived economic worth, age, gender, disability, communicable disease status,
sexual orientation, religious or spiritual beliefs, or any condition of vulnerability,
except where the exclusion or inclusion of particular groups is critical to the
research purpose and scientific design.

6.5.3 Design research projects so that the selection, recruitment, exclusion or inclusion
of research participants is fair and equitable.

6.5.4 Balance the burdens and benefits of research within different population groups.

6.5.5. Avoid imposing an unfair burden of research participation on particular groups

and communities, who are likely to be subject to over-researching.
 7
6.6 HEALTH RESEARCH AND MEDICAL HEALTH CARE

Health care should not be assumed to refer to drug treatments only. It extends to considerations of
all other aspects of health care under the control of the investigator.

In all instances, health researchers should:

6.6.1 Combine health research with medical care only to the extent that the research is
justified by its potential prophylactic, diagnostic or therapeutic value.

6.6.2 Test the benefits and burdens, risks and effectiveness of new methods against
those of the best current prophylactic, diagnostic and therapeutic methods. This
does not exclude the use of placebo, or no treatment, in studies where no proven
prophylactic, diagnostic and therapeutic method exists.

6.6.3 At the conclusion of their study, ensure that research participants have access to
the best proven prophylactic, diagnostic and therapeutic methods identified by
the study.

6.6.4 Fully inform research participants about which aspects of medical care, if any, are
related to health research, and clearly distinguish between therapeutic
interventions and health research processes.

6.6.5 Ensure that research participants understand that the health researcher’s role as a
researcher differs from their role as health care practitioners.

6.6.6 Promote access to health care. Should health researchers be unable to provide
the required research related health care for research participants they should
refer the research participants to another health care practitioner or healthcare
facility. The costs of this care should be the responsibility of the researcher and
sponsor.

6.6.7 Ensure that in multi-centre and multi-national studies, equal standards of care are
applied across countries to all research participants

6.7 POTENTIAL CONFLICTS OF INTEREST

All health researchers should:

6.7.1 Declare to all research participants any conflicts of interest they may have in
institutions, equipment, research sponsors etc. This includes the need to declare
whether the research is being conducted for academic purposes.

6.7.2 Disclose any potential conflicts of interest to their research ethics committee
before the research commences.

6.7.3 Design their research to exclude any potential conflicts of interest with sponsors
or collaborators.
 8
7. DUTIES TO RESEARCH COLLEAGUES AND OTHER PROFESSIONALS

Health researchers should always:

7.1 Work with and respect other health care practitioners in pursuit of the best health care
possible for all research participants.

7.2 Not discriminate against colleagues because of their race, culture, ethnicity, social status,
lifestyle, perceived economic worth, age, gender, disability, communicable disease status,
sexual orientation, religious or spiritual beliefs, or any condition of vulnerability.

7.3 Not allow research participants to doubt the knowledge or skills of colleagues by making
unnecessary or unsubstantiated comments about them.

7.4 Refrain from unjustifiably hindering other colleagues who wish to conduct research in
similar fields.

8. DUTIES TO HEALTH RESEARCHERS THEMSELVES

8.1 KNOWLEDGE AND SKILLS

8.1.1 Health researchers who are suitably qualified should conduct health research studies. In all
cases including multi-national collaborative research the local primary investigator must be
a South African based researcher (i.e. a person who is permanently based in South Africa).
The Principal Investigator must be registered with the HPCSA and must be responsible for
the ethical management of study.

8.1.2 All health researchers should always:

8.1.2.1 Maintain and improve the standard of their performance by keeping their
professional knowledge and skills up to date throughout their working life. In
particular, they should regularly take part in educational activities that
enhance their scientific and research ethics knowledge.

8.1.2.2 Acknowledge the limits of their professional knowledge and competence.

8.1.2.3 Observe and keep up to date with the ethical and regulatory frameworks that
affect health research.

8.2 EQUIPMENT, HYGIENE, AND RECORD KEEPING

Health researchers should always:

8.2.1 Keep their research equipment in good working order.

8.2.2 Maintain proper hygiene in their working environment.

8.2.3 Keep accurate and up-to-date records about research participants.

9. DUTIES TO SOCIETY

9.1. RESPECT FOR LIFE

 9
9.1.1 Health researchers should treat all living objects - humans, animals and plants - with the
necessary and appropriate respect.
9.1.2 Animals should not be used in research requiring them to be harmed or sacrificed where
alternative methods such as computer-generated models can be used to achieve the same
results.

9.2 REPORTING SCIENTIFIC MISCONDUCT

Health researchers should report evidence of fraud and other crimes or scientific misconduct in
research to the HPCSA.

9.2.1 Scientific misconduct is defined as fabrication, falsification, or plagiarism in proposing,

performing, or reviewing research, or in reporting research results.

9.2.2 Fabrication is making up data or results and recording or reporting them

9.2.3 Falsification is manipulating research material, equipment, or processes, or changing or

omitting data or results such that the research is not accurately represented in the research
record.

9.2.4 Plagiarism is the appropriation of another person’s ideas, processes, results, or words
without giving appropriate credit

9.2.5 Scientific misconduct does not include honest error or honest difference of opinion
Definition available at http://www.ostp.gov/html/001207_3.htm

9.2.6 Scientific misconduct also includes but is not limited to:

 Failure of obtaining informed consent

 Inappropriate disclosure of research participant data
 Deviation from approved protocol
 Falsification of credentials
 Deception in the research proposal

9.3 ACCESS TO SCARCE RESOURCES

Health researchers should always:

9.3.1 Deal responsibly with scarce health care resources, and should refrain from research that
duplicates other research unnecessarily.

9.3.2 Refrain from any form of resource wastage in carrying out their research.

9.3.3 Refrain from participating in improper financial arrangements that escalate costs or
disadvantage research participants, patients or institutions unfairly.

9.3.4 Design and conduct research to include or provide the use of appropriate facilities, in
order to manage any rising contingencies.

9.3.5 Avoid research that impacts adversely on public health facilities.

 10
9.4 LEGAL REQUIREMENTS

Health researchers should always:

9.4.1 Conform to relevant legal requirements and ensure that their research is lawful.

9.4.2 Adhere to ethical guidelines. Where the ethical guidelines prescribe a higher
standard than the law, health researchers should conform to the higher standard.

9.4.3 Ensure that at all times research is conducted or supervised by experienced,

qualified, competent and ethical health researchers who are approved by all the
legally required bodies.

10. DUTIES TO THE HEALTH CARE PROFESSION

10.1 REVIEW PROCESSES

The following research guidelines are applicable to all health care practitioners registered with the
HPCSA irrespective of where they conduct their research.

Health researchers should:

10.1.1 Receive approval for their research projects from all the relevant committees
before beginning the project. This includes bodies like the MCC, Provincial and
hospital authorities and the National Department of Health where applicable.

10.1.2 Notify all relevant reviewing bodies if the risks to research participants are found
to be disproportionate to the benefits during the course of the trial.

10.1.3 Inform relevant reviewing bodies and institutions of any changes to their research
protocol.

10.1.4 Ensure that the health research institutions with which they work are accredited by
the National Health Research Ethics Council (NHREC) and have established or
provided access to an accredited health research ethics committee which is
registered with the NHREC.

10.1.5 Report inadequate or inappropriate reviews of research protocols to the HPCSA.

10.1.6 Prematurely terminate a study where:

 the research question has been answered;

 the research proves harmful to participants

11. DUTIES TO ANIMALS

Health researchers should:

11.1 Accept responsibility for the care of animals used in health research and respect their
welfare.
 11
11.2 Demonstrate that their research is justifiable and scientifically based on literature reviews,
prior observations, approved studies and, when applicable, laboratory and animal
studies.

11.3 Follow the ethical and regulatory guidelines established at institutional level regarding the
use of animals by professional associations, and by governmental authorities.

11.4 Use, when appropriate, inanimate materials and processes instead of animals.

11.5 When the use of an animal species is scientifically necessary, use lower animal species
that may be less susceptible to pain and suffering - without compromising the integrity of
the research.

11.6 When designing the research protocol, use the minimum number of animals necessary to
yield valid answers to the research hypothesis.

11.7 Take active measures to use procedures that minimise both the incidence and severity of
the pain and suffering experienced by animals.

12. DUTIES TO THE ENVIRONMENT

Health researchers should:

12.1.1 Ensure that the research does not impact on the environment in a manner that is harmful
to the health and well-being of the population, nature and the environment. In all instances
health researchers must ensure that the environment is protected for the benefit of
present and future generations as is required by the South African Constitution.

12.1.2 Recognise that natural resources are limited and guard against their exploitation.

12.1.3 Health researchers should protect the environment and the public by assuring that health
care waste is disposed off legally and in an environmentally friendly manner

13. DATA AND SPECIMEN STORAGE AND TRANSFER

13.1 Data and specimens obtained as a result of research activity should be securely stored.

13.2 Data, including tape recordings should be stored for a minimum of 2 years after
publication or 6 years in the absence of publication.

13.3 There must be justifiable reasons and benefits for the country which should be provided to
Research Ethics Committees for data and specimens to leave the country. This should
only be done after a Material Transfer Agreement has been signed and submitted to the
local Research Ethics Committee.

13.4 The Protection of Personal Information Act 4 of 2013 (Act No. 4 of 2013) protects personal
information by restricting how it can be used and collected by individuals and
organisations by providing that:

13.4.1 The party processing the personal information must comply with the Act (s 8);
13.4.2 The processing of personal information must be done so that it does not infringe
the privacy of the data subject (the individual whose data is collected) (ss 9-12);
 12
13.4.3 The personal information must only be collected for a specific purpose and the
data subject must be told about this (s 13);
13.4.4 The records may not be held longer than is necessary to achieve the purpose for
which they were collected (s 14);
13.4.5 Further processing of the information must be in line with the purpose of
collecting it (s 15);
13.4.6 The party holding the personal information must ensure that it is complete,
accurate, not misleading and updated when required (s 16);
13.4.7 The party holding the data must ensure that the data subject knows that the
personal information has been collected and the purpose of the collection (s 18);
(h) the party holding the personal information must secure the personal data
under their control (s 19);
` 13.4.8 The party holding the information must inform the data subject if there is a
breach of security (ss 21 and 22);
13.4.9 A data subject may enquire whether a person or organisation holds their personal
information and what the information is (s 23);
13.4.10 The data subject may request the correction or deletion of personal information
that is inaccurate, irrelevant, excessive, out of date, incomplete, misleading or
obtained unlawfully (s 24).
 HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

RESEARCH, DEVELOPMENT AND USE OF CHEMICAL AND

BIOLOGICAL WEAPONS

BOOKLET 15

PRETORIA
SEPTEMBER 2016

1
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax:(012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za

2
 i

THE SPIRIT OF PROFESSIONAL GUIDELINES

Practice as a health care professional is based upon a relationship of

mutual trust between patients and health care Healthcare Healthcare

Practitioners. The term “profession” means “a dedication, promise or

commitment publicly made”.1 To be a good health care Healthcare

Healthcare Practitioner, requires a life-long commitment to sound

professional and ethical practices and an overriding dedication to the

interests of one’s fellow human beings and society. In essence, practice

as a health care professional is a moral enterprise. In this spirit the

HPCSA presents the following ethical guidelines to guide and direct the

practice of health care Healthcare Practitioners. These guidelines form

an integral part of the standards of professional conduct against which a

complaint of professional misconduct will be evaluated.

[Note: The term “health care Healthcare Practitioner” in these guidelines

refers to persons registered with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149 (quotation
on p. 148).

i
 ii

TABLE OF CONTENTS

1 PREAMBLE .........................................................................................................................1

2 GLOBAL CONCERNS ........................................................................................................1

3 TYPES OF CBW RESEARCH AND ETHICAL OBLIGATIONS OF HEALTH CARE

HEALTHCARE HEALTHCARE PRACTITIONERS ............................................................2

4 ADOPTION OF THE WMA DECLARATIONS ON CHEMICAL AND BIOLOGICAL

WEAPONS BY THE HPCSA ...............................................................................................3

ANNEXURE 1 ....................................................................................................................................4

ANNEXURE 2 ....................................................................................................................................6

ii
 1

RESEARCH, DEVELOPMENT AND USE OF CHEMICAL AND

BIOLOGICAL WEAPONS: POLICY ON INVOLVEMENT OF HEALTH
CARE HEALTHCARE PRACTITIONERS

1 PREAMBLE

1.1 The development of chemical and biological weapons (CBWs) is a major threat to global
security and to the safety and health of the world’s peoples. A number of countries around
the world have continued to pursue scientific programmes to develop such capabilities
despite international efforts to control the proliferation of these weapons of mass
destruction.

1.2 As confirmed by the Truth and Reconciliation Commission (TRC), the South African
military authorities under the apartheid government sustained a covert programme for the
development of chemical and biological weapons, and recruited health care Healthcare
Practitioners and scientists to staff the programme. The evidence that emerged in the
TRC’s investigations into this clandestine project has pointed to the importance of
developing clear guidelines for the health professions in regard to participation in such
programmes. It was particularly evident that the secrecy surrounding the apartheid
government’s CBW programme enabled health professional scientists to conduct
research outside of any ethical oversight.

1.3 Health care Healthcare Practitioners are committed to the preservation of life and the
alleviation of human suffering. It is completely contrary to the fundamental principles of the
ethics of the health professions for a health care Healthcare Healthcare Practitioner to
participate in research activities directed at generating materials intended to cause harm
to human health and well-being. As stated in the Declaration of Geneva health care
Healthcare Practitioners are expected to adhere to the following principle:

‘I will maintain the utmost respect for human life from its beginning even under
threat and I will not use my medical knowledge contrary to the laws of humanity;’

2 GLOBAL CONCERNS

2.1 Fears of the consequences of the use of chemical and biological weapons (CBWs) has
been exacerbated by the perception of an upsurge in global terrorism. Regrettably this
concern has resulted in increased secrecy and restrictions of civil liberties in several
countries around the world. This, in turn, creates a climate in which covert work on CBWs
may take place under the pretext of developing defenses. Secrecy and restrictions on civil
liberties are both factors that help to fuel an environment of covert activities

2..2 The danger of clandestine work on CBWs and the risk they pose to human rights makes it
imperative that the health professions strongly condemn the development of CBWs and
the participation of health care Healthcare Practitioners in their development and use.

2.3 The World Medical Association (WMA) in its Declaration on Chemical and Biological
Warfare in 1990 declared that it would be “unethical for a health care Healthcare
Practitioner whose missions are the preservation of life, and the provision and promotion
of health care - to participate in the research, development and use of the chemical,
biological and nuclear capabilities aimed at destroying life” (see below Annexure 1) In the
WMA Declaration of Washington on Biological Weapons in 2002, the WMA reconfirmed
its position that “research specifically for the purposes of creating biological weapons is to
be condemned” (see below Annexure 2).

1
 2

2.4 Article 1 of the Biological and Toxins Weapons Convention precludes health care
professionals and scientists from ever undertaking to develop, produce, acquire or retain:
(a) microbial or other biological agents, or toxins whatever their origin or method of
production, of types and in quantities that have no justification for prophylactic, protective
or other peaceful purposes; (b) weapons, equipment or means of delivery designed to use
such agents or toxins for hostile purposes or in armed conflict - the Convention renders all
such actions illegal.

3 TYPES OF CBW RESEARCH AND ETHICAL OBLIGATIONS OF HEALTH CARE

HEALTHCARE HEALTHCARE PRACTITIONERS

3.1 All research to develop CBWs designed to inflict harm on humans is unethical and health
care Healthcare care Practitioners find themselves in dual loyalty situations where they
are coerced or experience pressure or threats to comply from the military or other
authorities, they should appeal to the HPCSA or any other appropriate professional body
for support in resisting such pressures.

3.2 No distinction should be made between what have been called “defensive” and “offensive”
CBWs. Weapons that have the capacity to inflict harm should be treated as offensive
weapons, notwithstanding any claims or intentions that they will be used for non-offensive
purposes. Where technologies are being developed to protect military or civilian personnel
against CBWs, such research should be subject to open peer review and ethical oversight
by a suitably appointed independent body, as indicated below.

3.3 A Healthcare Practitioner who is or becomes involved in research related to combating the
effects of CBWs, shall obtain prior permission from the relevant professional board of the
HPCSA to conduct such research and, for that purpose the Healthcare Healthcare
Practitioner shall:

3.3.1 Provide full particulars of the nature and scope of the envisaged research,
development and use;

3.3.2 Specify whether the protocols pertaining to such research have been passed by
a professionally recognised research ethics committee;

3.3.3 Specify how such research, development and use shall be permissible within the
provisions of the World Medical Association’s Declaration on Chemical and
Biological Weapons (1990); and

3.3.4 Specify how such research, development or use is permitted in terms of the
provisions of applicable international treaties or conventions to which South
Africa is a signatory.

3.4 It is recommended that where military secrecy restricts civilian access to the research for
reasons of military security, an ethics committee be established by the military authorities
which includes suitably qualified civilian participants with expertise in human rights and
ethics, to provide ethical oversight over any CBW-related research, consistent with the
provisions of these guidelines and the relevant WMA Declarations.

3.5 Notwithstanding the condemnation of direct participation in CBW research, and the
restrictions on research involving protection against CBW agents, there is a third category
of research attracting ethical concerns. This relates to the misuse of bona fide
biotechnology research for purposes of producing weapons from biological agents,
particularly biological agents created through genetic manipulation of micro-organisms to
increase virulence and pathogenicity. This type of research may be conducted by

2
 3
researchers who have no connection to CBW programmes or who intend to allow their
research to be used for such purposes, but who are not aware of or able to control the
uses to which their research findings are put. Such research has been labeled “dual-use”
research because it has peaceful intentions but may be used for non-peaceful purposes.
Dual-use research requires careful evaluation for its ethical implications and demands
added ethical oversight prior to approval of the research. Health care Healthcare
Practitioners involved in such research must therefore ensure that no such research is
conducted without ethical consideration of the possible misuse of the study findings to
develop CBW agents.

3.6 Health care Healthcare Practitioners are required to ensure that they are familiar with the
provisions of the Non-Proliferation of Weapons of Mass Destruction Act, which are
consistent with these guidelines.

4 ADOPTION OF THE WMA DECLARATIONS ON CHEMICAL AND BIOLOGICAL

WEAPONS BY THE HPCSA

4.1 The HPCSA has adopted the WMA’s Declaration on Chemical and Biological Weapons
(1990) and the WMA Declaration of Washington on Biological Weapons (2002) which
have been reproduced below as Annexures 1 and 2 respectively.

4.2 The term “physician” as used in the Declarations refers to health care Healthcare
Practitioners and, for the purposes of the HPCSA, should be understood to include all
health care Healthcare Practitioners who fall under the jurisdiction of the HPCSA.

4.3 Health care Healthcare Practitioners who breach the above guidelines or the provisions of
the WMA Declarations of 1990 or 2002 as reproduced in Annexures 1 and 2 below may
face disciplinary action by the HPCSA.

3
 4

ANNEXURE 1

WORLD MEDICAL ASSOCIATION

DECLARATION ON
CHEMICAL AND BIOLOGICAL WEAPONS (1990)

[Adopted by the 42nd World Medical Assembly, Rancho Mirage, CA, USA, October 1990]

1. The World Medical Association draws the attention of the medical profession throughout
the world to the dangers presented by chemical and biological weapons. Among other,
more obvious dangers, it should be noted as follows:

a. The use of such weapons would have a devastating effect on civilian populations
in addition to military personnel, and not only in the target area, but also in distant
places, perhaps beyond the national boundaries of the combatants.

b. The effects of exposure to chemical and biological weapons present a continuing

threat to the health of human beings on a long term basis, possibly causing
illness, injury, disease and defects in the population over a long period of time.

c. The effects of exposure to chemical and biological weapons may also result in
permanent, complex and unpredictable changes in the natural environment,
including animals, plant life and water supply, thus destroying the food source of
human beings and resulting in extensive morbidity.

d. Existing health care services, technology and manpower may be helpless to

relieve the suffering caused by exposure to chemical and biological weapons.

2. The World Medical Association Declaration of Geneva asks physicians to consecrate their
lives to the service of humanity, to pledge that the health of the patient will be the
physician’s first consideration, and that the physician will not use medical knowledge
contrary to the laws of humanity.

3. The World Medical Association Declaration of Helsinki states that it is the mission of the
physician to safeguard the health of the people. The physician’s knowledge and
conscience are dedicated to the fulfillment of this mission.

4. The World Medical Association Declaration of Tokyo begins with the following statement:

“It is the privilege of the medical health care Healthcare Practitioner to practice
medicine in the service of humanity, to preserve and restore bodily and mental
health without distinction as to persons, to comfort and ease the suffering of his
or her patients. The utmost respect for human life is to be maintained even under
threat, and no use made of any medical knowledge contrary to the laws of
humanity”.

5. Therefore, the World Medical Association considers that it would be unethical for the
physician, whose mission is to provide health care, to participate in the research and
development of chemical and biological weapons, and to use his or her personal and
scientific knowledge in the conception and manufacture of such weapons.

6. Furthermore, the World Medical Association -

4
 5

a. Condemns the development and use of chemical and biological weapons;

b. Asks all Governments to refrain from the development and use of chemical and
biological weapons;

c. Asks all National Medical Associations to join the World Medical Association in
actively supporting this Declaration.

5
 6

ANNEXURE 2

THE WMA DECLARATION OF WASHINGTON ON BIOLOGICAL

WEAPONS

[Adopted by the WMA General Assembly, Washington 2002]

A. INTRODUCTION
1. The World Medical Association recognizes the growing threat that biological
weapons might be used to cause devastating epidemics that could spread
internationally. All countries are potentially at risk. The release of organisms
causing smallpox, plague, anthrax or other diseases could prove
catastrophic in terms of the resulting illnesses and deaths compounded by
the panic such outbreaks would generate. At the same time, there is a
growing potential for production of new microbial agents, as expertise in
biotechnology grows and methods for genetic manipulation of organisms
become simpler. These developments are of special concern to medical and
public health professionals because it is they who best know the potential
human suffering caused by epidemic disease and it is they who will bear
primary responsibility for dealing with the victims of biological weapons.
Thus, the World Medical Association believes that medical associations and
all who are concerned with health care bear a special responsibility to lead in
educating the public and policy makers about the implications of biological
weapons and to mobilize universal support for condemning research,
development, or use of such weapons as morally and ethically unacceptable.

2. Unlike the use of nuclear, chemical, and conventional weapons, the

consequences of a biological attack are likely to be insidious. Their impact
might continue with secondary and tertiary transmission of the agent, weeks
or months after the initial epidemic. The consequences of a successful
biological attack, especially if the infection were readily communicable, could
far exceed those of a chemical or even a nuclear event. Given the ease of
travel and increasing globalization, an outbreak anywhere in the world could
be a threat to all nations.
3. A great many severe, acute illnesses occurring over a short span of time
would almost certainly overwhelm the capacities of most health systems in
both the developing and industrialized world. Health services throughout the
world are struggling to meet the demands created by HIV/AIDS and
antimicrobial-resistant organisms, the problems created by civil strife,
refugees and crowded, unsanitary urban environments as well as the
increased health needs of aging populations. Coping over a short period of
time with large numbers of desperately ill persons could overwhelm entire
health systems.
4. Actions can be taken to diminish the risk of biological weapons as well as the
potentially harmful consequences of serious epidemics whatever their origin.
International collaboration is needed to build a universal consensus that

6
 7
condemns the development, production, or use of biological weapons.
Programs of surveillance are needed in all countries for the early detection,
identification, and response to serious epidemic disease; health education
and training is needed for professionals, civic leaders, and the public alike;
and collaborative programs of research are needed to improve disease
diagnosis, prevention, and treatment.
5. The proliferation of technology and scientific progress in biochemistry,
biotechnology, and the life sciences provides the opportunity to create novel
pathogens and diseases and simplified production methods for bio-weapons.
The technology is relatively inexpensive and, because production is similar to
that used in biological facilities such as vaccine manufacturing, it is easy to
obtain. Capacity to produce and effectively disperse biological weapons
exists globally, allowing extremists (acting collectively or individually) to
threaten governments and endanger peoples around the world. Non
proliferation and arms control measures can diminish but cannot completely
eliminate the threat of biological weapons. Thus, there is a need for the
creation of and adherence to a globally accepted ethos that rejects the
development and use of biological weapons.
B. STRENGTHENING PUBLIC HEALTH AND DISEASE SURVEILLANCE SYSTEMS

6. A critical component in dealing with epidemic disease is a strong public

health infrastructure. Investment in public health systems will enhance
capacity to detect and to contain expeditiously, rare or unusual disease
outbreaks, whether deliberately induced or naturally occurring. Core public
health functions (disease surveillance and supporting laboratory services)
are needed as a foundation for detection, investigation, and response to all
epidemic threats. A more effective global surveillance program will improve
response to naturally occurring infectious diseases and will permit earlier
detection and characterization of new or emerging diseases.

7. It is especially important that physicians be alert to the occurrence of cases

or clusters of unusual infectious diseases, to seek help from infectious
disease specialists in diagnosis, and to report cases promptly to public health
authorities. Because any physician may see only one or a few cases and
may not recognize that an outbreak is occurring, cooperation between
primary care physicians and public health authorities is especially important.
8. Public health officials, dealing with an epidemic, will require the cooperation
of emergency management agencies, law enforcement officials, healthcare
facilities, and a variety of community service organizations. For these
different groups to work together effectively, advance planning will be
important. In addition to developing surveillance activities for early detection
and reporting, public health efforts should be directed toward educating
primary caregivers and public health staff about potential agents that might
be used, building laboratory capacity for rapid identification of biological
agents, providing medical and hospital services as well as vaccines and
drugs to control the epidemic.
C. ENHANCEMENT OF MEDICAL PREPAREDNESS AND RESPONSE CAPACITY

7
 8
9. The first indication that a biological weapon may have been disseminated is
likely to be the appearance of patients in the offices of practicing physicians,
especially those in acute care settings. Physicians thus play a critical role in
early detection of an outbreak and must be prepared to recognize and deal
with diseases resulting from the use of biological weapons as well as other
infectious disease agents and to promptly report suspicious illnesses and
diseases to public health officials.

10. In the course of an epidemic, physicians will be directly involved with mass
patient care, with mass immunization and antibiotic prophylaxis, with
providing information to the public, and in a variety of hospital and
community efforts to control the epidemic. Thus, physicians should
participate with local and national health authorities to develop and
implement disaster preparedness and response plans for intentional and
natural infectious disease outbreaks.
D. BIOWEAPONS RESEARCH AND MEDICAL ETHICS

11. Rapid advances in microbiology, molecular biology, and genetic engineering

have created extraordinary opportunities for biomedical research and hold
great promise for improving human health and the quality of life. Better and
more rapid diagnostic tools, novel vaccines, and therapeutic drugs can be
foreseen. At the same time, there is concern about the possible misuse of
research for the development of more potent biological weapons and the
spread of new infectious diseases. It may be difficult to distinguish legitimate
biomedical research from research by unscrupulous scientists with the
malign purpose of producing more effective biological weapons.

12. All who participate in biomedical research have a moral and ethical obligation
to consider the implications of possible malicious use of their findings.
Through deliberate or inadvertent means, genetic modification of
microorganisms could create organisms that are more virulent, are antibiotic-
resistant, or have greater stability in the environment. Genetic modification of
microorganisms could alter their immunogenicity, allowing them to evade
natural- and vaccine-induced immunity. Advances in genetic engineering and
gene therapy may allow modification of the immune response system of the
target population to increase or decrease susceptibility to a pathogen or
disrupt the functioning of normal host genes.
13. Research specifically for the purposes of creating biological weapons is to be
condemned. As scientists and humanitarians, physicians have a societal
responsibility to decry scientific research for the development and use of
biological weapons and to express abhorrence for the use of biotechnology
and information technologies for potentially harmful purposes.
14. Physicians and medical organizations have important societal roles in
demanding a global prohibition on biological weapons and stigmatizing their
use, guarding against unethical and illicit research, and mitigating civilian
harm from use of biological weapons.

E. RECOMMENDATIONS

8
 9
15. That the World Medical Association and National Medical Associations
worldwide take an active role in promoting an international ethos
condemning the development, production, or use of toxins and biological
agents that have no justification for prophylactic, protective, or other peaceful
purposes.
16. That the World Medical Association, National Medical Associations and
healthcare workers worldwide promote, with the World Health Organization,
the United Nations, and other appropriate entities, the establishment of an
international consortium of medical and public health leaders to monitor the
threat of biological weapons, to identify actions likely to prevent bioweapons
proliferation, and to develop a coordinated plan for monitoring the worldwide
emergence of infectious diseases. This plan should address: (a) international
monitoring and reporting systems so as to enhance the surveillance and
control of infectious disease outbreaks throughout the world; (b) the
development of an effective verification protocol under the UN Biological and
Toxin Weapons Convention; (c) education of physicians and public health
workers about emerging infectious diseases and potential biological
weapons; (d) laboratory capacity to identify biological pathogens; (e)
availability of appropriate vaccines and pharmaceuticals; and (f) financial,
technical, and research needs to reduce the risk of use of biological weapons
and other major infectious disease threats.
17. That the World Medical Association urge physicians to be alert to the
occurrence of unexplained illnesses and deaths in the community and
knowledgeable of disease surveillance and control capabilities for
responding to unusual clusters of diseases, symptoms, or presentations.
18. That the World Medical Association encourage physicians, National Medical
Associations and other medical societies to participate with local, national,
and international health authorities in developing and implementing disaster
preparedness and response protocols for acts of bioterrorism and natural
infectious disease outbreaks. These protocols should be used as the basis
for physician and public education.
19. That the World Medical Association urge all who participate in biomedical
research to consider the implications and possible applications of their work
and to weigh carefully in the balance the pursuit of scientific knowledge with
their ethical responsibilities to society.

9
HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

ETHICAL GUIDELINES ON SOCIAL MEDIA

EDITED BY THE HUMAN RIGHTS, ETHICS AND PROFESSIONAL PRACTICE

BOOKLET 16

2019

1
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za

2
 THE INTENT OF PROFESSIONAL GUIDELINES

Practicing as a health care professional is based upon a relationship

of mutual trust between patients and health care practitioners. The

term “profession” means “a dedication, promise or commitment

publicly made”.1 To be a good health care practitioner, requires a

life-long commitment to sound professional and ethical practices and

an overriding dedication to the interests of one’s fellow human

beings and society. In essence, the practice of health care

professions is a moral enterprise. The HPCSA presents the following

ethical guidelines to guide and direct the practice of health care

practitioners. These guidelines form an integral part of the

standards of professional conduct against which a complaint of

professional misconduct will be evaluated.

[Note: The term “health care practitioner” in these guidelines

refers to persons registered as such with the HPCSA].

TABLE OF CONTENTS

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).

3
ACKNOWLEDGEMENTS
1 ABOUT THESE GUIDELINES
2 INTRODUCTION
3 DEFINITION OF SOCIAL MEDIA
4 CONTEXT IN RELATION TO HPCSA
5 WHO NEEDS TO USE THESE GUIDELINES?
6 OBLIGATIONS IN RELATION TO SOCIAL MEDIA
7 PATIENT CONFIDENTIALITY AND PRIVACY
8 THE PRACTITIONER-PATIENT RELATIONSHIP
9 THE HEALTH PRACTITIONER’S IMAGE
10 CONFLICT OF INTEREST
11 PRECAUTIONARY MEASURES WHEN USING SOCIAL MEDIA
12 REFERENCES

ACKNOWLEDGEMENTS

4
The Health Professions Council of South Africa wishes to thank the following persons for
their contributions towards the compiling of these guidelines:

Dr N Tsotsi for the first draft, and Ms Nerissa Naidoo and Prof DJ McQuoid-Mason
for the second and third drafts.
Prof A Dhai for reviewing the first and third drafts.
The Committee for Human Rights, Ethics and Professional Practice of the Health
Professions Council of South Africa for initiating and advising the review process:
Dr S Balton (Chairperson), Prof D J. McQuoid-Mason, Dr N Tsotsi, Prof B Pillay,
Prof N Gwele, Prof N Mekwa, Prof S Hanekom.
Adv Mathibeli as the legal advisor, Ms N Manciya as Committee coordinator and Mr
N Sipeka as the Council secretariat.

1 ABOUT THESE GUIDELINES

5
The guideline was developed to help health practitioners understand their obligations
when using social media. The guideline applies to all health practitioners registered
with the Health Professions Council of South Africa.

2 INTRODUCTION

2.1 The use of social medial is expanding rapidly as individuals and organisations
are embracing user-generated content through social networks, internet
forums and personal blogs.

2.2 Irrespective of whether online content is accessible to the public at large or is

limited to specific health practitioners, there is a need to maintain high
professional and ethical standards in using social media.

2.3 Health professionals need to be aware that there are potential risks involved
in the sharing of information via social media, even if the consequences are
unintended.

2.4 The General Ethical and Professional Rules of Conduct set out in Booklet 2:
Ethical Rules of Conduct for Practitioners Registered Under the Health
Professions Act, 1974 as published under Government Notice R7171 in
Government Gazette 29079 of 4 August 2006 and as amended.

3 DEFINITION OF SOCIAL MEDIA

3.1 Social media describes the online tools and electronic platforms that people
use to share content such as opinions, information, photos, videos and audio.

3.2 Social media includes social networks (e.g. Facebook, Twitter, WhatsApp and
LinkedIn), content-sharing platforms (e.g. YouTube and Instagram), personal
and professional blogs (including email, SMS, electronic journals as well as
those published anonymously), internet discussion forums, and the comment
sections of websites.

4 CONTEXT IN RELATION TO HPCSA

6
4.1 A key objective of the HPCSA and its Professional Boards is to guide the
profession and protect the public.

4.2 Health practitioners may find social media beneficial as it allows them to keep
updated on the latest healthcare developments through reputable user-
generated content, build a professional support network as well as
communicate and share health-related information with the public and other
health practitioners.

4.3 These guidelines must be read in conjunction with the other HPCSA Ethical
Guidelines Booklets and other applicable publications.

5 OBLIGATIONS IN RELATION TO SOCIAL MEDIA

5.1 Just as with all aspects of professional behaviour, health practitioners should
be aware of their obligations under the HPCSA Ethical and Professional
Rules, the Professional Board’s scope of practice and other relevant
legislation, such as the Promotion of Access to Justice Act 3 of 2000, the
Protection of Personal Information Act 4 of 2013, and the common law.

5.2 There are ethical obligations and responsibilities imposed on health

practitioners regarding their relationships with their patients and each other,
such as those set out in Booklet 1 General Ethical Guidelines for Health Care
Professionals and Booklet 5 Confidentiality: Protecting and Providing
Information.

5.3 Obligations relating to the electronic storage and transmission of patient and
client data for professional purposes are found in Booklet 10 General Ethical
Guidelines for Good Practice in Telemedicine.

6 PATIENT CONFIDENTIALITY AND PRIVACY

6.1 All patients are entitled to privacy and confidentiality, which is enshrined under
the human right to privacy in the South African Constitution and the National
Health Act.

6.2 Disclosure of a patient’s information may only be in accordance with a court

order, patients consent and in terms of the law.

7
6.2.1 Health practitioners can share confidential information with other members of
the health care team involved in the patient’s care and with individuals who
have the patient’s consent.

6.2.2 Health practitioners can also share information if it is justified in the public
interest, or if failure to do so will result in harm to the patient.

6.3 Health practitioners must obtain the written consent of the patient before
publishing information (e.g. case histories and photographs) about them in
media to which the public has access, whether or not the health care
practitioner believes the patient can be identified by the data.

6.4 If the patient is a minor under the age of 12 years old, the health care
practitioner will require the written consent of the patient’s parent or guardian
and assent of the minor.

6.5 Health practitioners sharing information or data for the sake of diagnosis,
treatment or education and training through social media must ensure that the
recipient of the information is not able to identify the patient from the data
disclosed.

6.5.1 Health practitioners must ensure that the recipient of patient information via
social media understands that such information is given to them in
confidence, which they must respect.

6.6 Disclosure of information on social media must be kept to the minimum

necessary in order to protect the rights of patients.

6.7 Health practitioners must be aware that there is always a risk that the
information can be disseminated, even in so-called “invisible” groups, (i.e.
people you do not know are reading the information or who you did not know
could read the information).

6.8 The obligation to keep patient information confidential remains even after the
patient dies.

7 THE PRACTITIONER-PATIENT RELATIONSHIP

8
7.1 Interaction between health practitioners and their patients on social media can
blur the boundaries of the professional practitioner-patient relationship.

7.2 Health practitioners are advised not to interact with patients via social media
platforms as a failure to maintain strictly professional relationships with
patients could result in other ethical dilemmas.

7.3 The Protection of Personal Information Act outlaws the acquisition of data
about an individual’s health or sex life outside the healthcare setting, and by
having access to patients’ social media profiles, health care practitioners may
find themselves privy to personal patient information that has not been shared
in the healthcare setting.

7.4 Health practitioners may choose to share personal information about

themselves with their patients during face-to-face consultations, but social
media does not offer a similar level of control over the extent and type of
content shared.

7.5 If the health practitioner performs a non-medical role in their community,

maintaining appropriate professional boundaries may be difficult as they may
receive requests on social media from patient’s they know in a non-
professional capacity. In these instances, health practitioners should consider
the circumstances and implications before accepting these requests.

7.6 Should the health practitioner receive an inappropriate message from a

patient via social media, they should politely re-establish professional
boundaries and explain their reasons for doing so.

7.7 Except in an emergency or life-threatening situation, if a patient is seeking

health care advice over social media, the health care practitioner should
politely request them to set up an appointment in-person.

7.8 If a patient persists in contacting the health practitioner, the practitioner should
keep a log of all contacts and seek advice from the HPCSA.

7.9 Providing health advice over social media to individuals with whom the health
practitioner does not have a practitioner-patient relationship is discouraged
and should be done with the outmost discretion.

7.10 If health advice is shared online, it must be evidence based , scientifically

sound and generic and the recipient must be directed to consult with a health
practitioner in person before following through.

7.11 Health practitioners should separate their professional and personal social
media accounts to help maintain the appropriate professional boundaries.

9
 8 THE HEALTH PROFESSION’S IMAGE

8.1 If the health care practitioner uses social media in their personal capacity,
their online activity may nevertheless bring the profession into disrepute.

8.2 The media routinely monitor online activity to research stories or potential
stories. Information posted online may be disseminated, whether intended or
not, to a larger audience, and may be taken out of context.

8.3 Content posted on social media may also harm the health practitioner’s
employability and recruitment, limiting professional development and
advancement. Employers often monitor the social media profiles of
prospective employees, and are known to turn away applicants based on
questionable digital behaviour.

8.4 Social media activities health practitioners should avoid for example include:

8.4.1 Taking photographs during surgery and other forms of care or treatment;
8.4.2 Making unsubstantiated negative comments about individuals or
organisations;
8.4.3 Making informal and derogatory comments about patients;
8.4.4 Making comments that can be perceived as racist, sexist, homophobic or
otherwise prejudiced, even if meant in jest or as satire.

8.5 Health practitioners may engage fully in debates on health matters, however
they must be aware that the laws regarding defamation, hate speech and
copyright also extend to content shared via social media.

8.6 Health practitioners must not post their opinions on the probity, skill or
professional reputation of their colleagues on social media, lest the public lose
faith in the health care profession.

8.7 Online relationships between practitioners of varying levels of training should

only be initiated upon consideration of the purpose of the relationship. In the
case of senior staff receiving social media requests from students (or vice
versa), the purpose might be mentorship, research or career advice.
Regardless of intent, the traditional boundaries of the trainee-teacher
relationship apply even in interactions via social media. These boundaries
also extend to staff and other health practitioners.

8.8 If a colleague makes derogatory or inappropriate comments on social media,

health practitioners are advised to bring it to their attention discreetly, and not
to engage or respond publicly on the social media platform.

10
8.9 Health practitioners are advised to include disclaimers in their social media
profiles, indicating that the views expressed therein are their own and not
those of the health profession or the health establishment they represent.
However, this does not absolve the health care practitioner from the above
rules.

9 CONFLICTS OF INTEREST

9.1 Social media is also a popular tool for the advertisement and promotion of
goods and services, with the growing online market being one of the most
emphasised in business practice.

9.2 When using social media, even if via personal or anonymous blogs, health
care practitioners must comply with the HPCSA rules on advertising practice,
(including not engaging in active or passive touting and canvassing or
allowing others to do so on their behalf), and must make sure that they
declaring their financial interests in hospitals (see Booklet 2 Ethical and
Professional Rules of the Health Professions Council of South Africa and
Booklet 11 Guidelines on Overservicing, Perverse Incentives and Related
Matters).

9.3 Touting involves drawing attention to one’s professional goods or services by

offering guarantees or benefits that fall outside one’s scope of practice. An
example is advertising free WiFi services to patients while waiting for their
consultations.

9.4 Canvassing involves the promotion of one’s professional goods and services
by drawing attention to one’s personal qualities, superior knowledge, quality of
service, professional guarantees, or best practice. An example of canvassing
is a health care practitioner declaring on social media or posting patient
reviews that state he or she is ‘the best health care practitioner in the country’.
9.5 Health practitioners may not advertise, endorse or encourage the use of any
hospital, medicine or health-related product on social media in a manner that
unfairly promotes the practice of a particular health practitioner or
establishment for the purposes of financial gain or other valuable
consideration.

9.6 A failure to follow these guidelines when using social media will undermine
public trust in the health profession.

10 PRECAUTIONARY MEASURES WHEN USING SOCIAL MEDIA

11
11.1 Health practitioners must be aware that, even with a pseudonym, anonymity
on social media platforms is never guaranteed. The identity and location of the
user can be traced through their linked accounts or IP address.

11.2 If health practitioners use social media in their personal capacity, they are
advised to adjust their privacy settings to restrict public access. However,
even with advanced security measures and end-to-end encryption, complete
privacy on social media cannot be guaranteed. There is always the risk that
the content can be shared beyond the scope of the health practitioner’s
personal network.

11.3 Once content is shared online, it is difficult to remove, and health practitioners
must use social media on the understanding that the information they post will
remain on the internet permanently.

11.4 Even if a health practitioner deletes a post on a social media site, this does
not necessarily mean the content has been removed. Content may be copied
or reproduced by other users before it has been deleted, and many websites
and internet browsers use cache and cookie systems that inconspicuously
store data.
11.5 Health practitioners should avoid using social media when stressed, tired,
upset or under the influence of alcohol.

11.6 Health practitioners are advised to err on the side of caution when using social
media. If uncertain about whether it is ethically and legally permissible to
share particular content via social media, it is best not to do so until advice
has been obtained.

12 REFERENCES

12.1 American Medical Association Policy: Professionalism in the Use of Social

Media (2012) https://mededu.jmir.org/article/downloadSuppFile/4886/28296.
12.2 British Medical Association: Social media, ethics and professional
(2017) https://www.bma.org.uk/advice/employment/ethics/social-media-
guidance-for-doctors.
12.3 General Medical Council: Doctors Use of Social Media
(2013) https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-
doctors/doctors-use-of-social-media.
12.4 South African Medical Association: Guidelines for doctors using social media
(2015) https://www.samedical.org/files/Guideline%20for%20Drs%20Using%2
0Social%20Media%20febr015.pdf.

12
12.5 Grobler C, Dhai A. Social Media in the healthcare context: Ethical challenges
and recommendations. S Afr J BL 2016; 9(1): 22-25.
12.6 National Department of Health. National Policy Framework and Strategy on
Palliative Care 2017-2022.

13
 COUNCIL OF SOUTH AFRICA

GUIDELINES FOR GOOD PRACTICE

IN THE HEALTH CARE PROFESSIONS

ETHICAL GUIDELINES ON PALLIATIVE CARE

EDITED BY THE HUMAN RIGHTS, ETHICS AND PROFESSIONAL PRACTICE

BOOKLET 17
2019
Health Professions Council of South Africa
Post Office Box 205
Pretoria 0001

Telephone: (012) 338 9300

Fax: (012) 328 4863

E-mail: [email protected]

Website: http://www.hpcsa.co.za
 `3

THE INTENT OF PROFESSIONAL GUIDELINES

Practicing as a health care professional is based upon a relationship

of mutual trust between patients and health care practitioners. The

term “profession” means “a dedication, promise or commitment

publicly made”.1 To be a good health care practitioner, requires a

life-long commitment to sound professional and ethical practices and

an overriding dedication to the interests of one’s fellow human

beings and society. In essence, the practice of health care

professions is a moral enterprise. The HPCSA presents the following

ethical guidelines to guide and direct the practice of health care

practitioners. These guidelines form an integral part of the

standards of professional conduct against which a complaint of

professional misconduct will be evaluated.

[Note: The term “health practitioner” in these guidelines refers to

persons registered as such with the HPCSA].

1
Pellegrino, ED. Medical professionalism: Can it, should it survive? J Am Board Fam Pract 2000; 13(2):147-149
(quotation on p. 148).
 `4

TABLE OF CONTENTS

ACKNOWLEDGEMENTS
1 PREAMBLE
2 WHEN PALLIATIVE CARE IS USED
3 WHY PALLIATIVE CARE IS USED
4 WHO PROVIDES PALLIATIVE CARE?
5 WHERE PALLIATIVE CARE IS USED
6 HOW PALLIATIVE CARE IS USED
7 PATIENT AUTONOMY AND PALLIATIVE CARE
8 BENEFICENCE AND PALLIATIVE CARE
9 NON-MALEFICENCE AND PALLIATIVE CARE
10 JUSTICE OR FAIRNESS AND PALLIATIVE CARE
11 REFERENCES
 `5

ACKNOWLEDGEMENTS

The Health Professions Council of South Africa wishes to thank the following persons for
their contributions towards the revision of the guidelines:

Ms. Nerissa Naidoo and Prof D J. McQuoid-Mason for drafting the document, and
Prof A Dhai and the SA Hospice Association for reviewing it.
The Committee for Human Rights, Ethics and Professional Practice of the Health
Professions Council of South Africa for initiating and advising the review process:
Dr S Balton (Chairperson), Prof D J. McQuoid-Mason, Dr N Tsotsi, Prof B Pillay,
Prof N Gwele, Prof N Mekwa, Prof S Hanekom.
. Adv Mathibeli as the legal advisor, Ms N Manciya as Committee coordinator and Mr
N Sipeka as the Council secretariat.
 `6

1 PREAMBLE

1.1 The World Health Organisation (WHO) defines palliative care as ‘an approach
that improves the quality of life of patients and their families facing the
problem associated with life-threatening illness, through the prevention and
relief of suffering by means of early identification and impeccable assessment
and treatment of pain and other problems, physical, psychosocial and
spiritual’.
1.2 Palliative care:
1.2.1 provides relief from pain and other distressing symptoms;
1.2.2 affirms life and regards dying as a normal process;
1.2.3 intends neither to hasten or postpone death;
1.2.4 integrates the psychological and spiritual aspects of patient care;
1.2.5 offers a support system to help patients live as actively as possible
until death;
1.2.6 offers a support system to help the family cope during the patient’s
illness and in their own bereavement;
1.2.7 uses a team approach to address the needs of patients and their
families, including bereavement counselling, if indicated;
1.2.8 will enhance quality of life, and may also positively influence the
course of illness;
1.2.9 is applicable early in the course of illness, in conjunction with other
therapies that are intended to prolong life, such as chemotherapy or
radiation therapy, and includes those investigations needed to better
understand and manage distressing clinical complications.’
1.3 With the spread of HIV, South Africa shoulders a significant disease burden,
and the Department of Health’s National Policy Framework and Strategy on
Palliative Care 2017–2022 acknowledges the importance of integrating
palliative care as an essential component of health service delivery.

2 WHEN IS PALLIATIVE CARE PROVIDED

2.1 Palliative care is provided to those living with and dying from any advanced,
progressive and incurable condition regardless of age or setting.
2.2 Palliative care is provided throughout the journey, from diagnosis to end of
life.
 `7

2.3 As the patient’s disease progresses, the need for palliative care will increase
and the level of curative treatment will decrease.
2.4 The WHO recognises that palliative care is required for a wide range of
diseases, including but not limited to:
2.4.1 Cardiovascular disease;
2.4.2 Cancer;
2.4.3 Chronic respiratory diseases;
2.4.4 AIDS;
2.4.5 Diabetes;
2.4.6 Kidney failure;
2.4.7 Chronic liver disease;
2.4.8 Multiple sclerosis;
2.4.9 Parkinson’s;
2.4.10 Rheumatoid arthritis;
2.4.11 Neurological disease;
2.4.12 Dementia;
2.4.13 Congenital anomalies;
2.4.14 Drug-resistant tuberculosis

3 WHY IS PALLIATIVE CARE PROVIDED

3.1 Palliative care is recognised by the United Nations as part of the human right
to health.
3.2 The goal of palliative care is the achievement of the best possible quality of
life for patients and their families, even if life expectancy is short.
3.3 Palliative care is an extension of the South African Constitutional rights of
human dignity and access to healthcare.
3.4 The Constitution also guarantees the right to basic healthcare for children
which includes the provision of paediatric palliative care, and not merely
access to such care, as is the case with adults.
3.5 Evidence suggests that palliative care can reduce unnecessary hospitalisation
and use of health care services, which lessens the costs of the health system.

4 WHO PROVIDES PALLIATIVE CARE?

4.1 Palliative care is provided by all health practitioners and other health care
professionals working with people with life-threatening conditions.
 `8

4.2 Health practitioners providing palliative care should possess the requisite
knowledge, skills and attitudes to meet the physical, psychological, practical,
social and spiritual needs of their patients.
4.3 Health practitioners providing palliative care should keep their skills up to
date.
4.4 As a result of the current inadequate provision of palliative care services in the
country, the National Department of Health has developed a strategy to
increase the scope of palliative care services in its National Policy Framework
and Strategy on Palliative Care 2017-2022.
4.5 It is imperative that all healthcare professionals play an advocacy role on the
importance of palliative care services in the public health sector and for
palliative care to be included in the curriculum of health practitioners.

5 WHERE IS PALLIATIVE PROVIDED

5.1 Palliative care can be provided in public, private facilities and patient’s homes.
5.2 According to the National Department of Health National Policy Framework
and Strategy on Palliative Care the different palliative care service delivery
settings, are:
5.2.1 Home-based palliative care;
5.2.2 Mobile outreach services;
5.2.3 Outpatient care;
5.2.4 Inpatient palliative care facilities;
5.2.5 Hospital based palliative care teams;
5.2.6 Day care palliative services;
5.2.7 Frail care and other care homes;
5.2.8 Workplace programs; and
5.2.9 Correctional services.

6 HOW PALLIATIVE CARE IS USED

 `9

6.1 Health practitioners must deliver care in a manner that upholds these
principles, and the rights and values of the patient and their family, even in the
midst of a dehumanising environment or in noisy facilities/areas”
6.2 Health practitioners providing palliative care should apply the bioethical
principles of autonomy, beneficence, non-maleficence and justice that require
respect for the worth, dignity and human rights of their patients when
managing them.
6.3 Patients and their families faced with life-threatening illnesses, are likely to be
vulnerable and anxious during this time, health practitioners providing
palliative care will find the bioethical principles helpful in guiding decision-
making.
6.4 Health practitioners must establish trust in the patient and their family through
availability, listening, providing honest answers, and having a non-judgmental
attitude.
6.5 In administering palliative care, health practitioners should also adhere to the
HPCSA’s general ethical guidelines and the National Department of Health’s
National Policy Framework and Strategy on Palliative Care 2017–2022.

7 PATIENT AUTONOMY AND PALLIATIVE CARE

7.1 MEANING OF PATIENT AUTONOMY

7.1.1 Patient autonomy recognises the ability of patients to make decisions for
themselves regarding palliative care, and is in accordance with the
constitutional rights to human dignity and bodily and psychological integrity.
7.1.2 Patient autonomy presumes that patients have the required information and
capacity to make rational decisions about palliative care and that the
circumstances allow them to give an informed consent.
7.1.3 When obtaining informed consent from patient’s health practitioners providing
palliative care must comply with the National Health Act 61 of 2003 and the
HPCSA’s guidelines on Seeking Patients’ Informed Consent: The Ethical
Considerations (Booklet 9).
 `10

7.2 CAPACITY TO CONSENT TO PALLIATIVE CARE

7.2.1 Health practitioners providing palliative care should assume that every
mentally competent adult patient and every sufficiently mature child patient
over the age of 12 years have legal capacity to consent to, or oppose, medical
interventions - unless it is shown that they clearly cannot understand the
information given to them.
7.2.2 It is for the patient, and not the health practitioner providing palliative care, to
determine what is in the patient’s best interests.
7.2.3 Although health practitioners providing palliative care may recommend a
course of treatment, they may not pressurize or manipulate the patient into
accepting their advice.
7.2.4 Health practitioners providing palliative care must understand and respect that
a patient’s decision-making may be guided by values, customs and beliefs
different from the practitioner’s.
7.2.5 If a mentally and legally competent patient, who is fully informed of the
benefits and risks of treatment, consents to or refuses a particular course of
treatment, their decision must be respected, even if the health practitioner
providing palliative care believes it will result in serious harm or even death.
7.2.6 Respecting patient autonomy, however, does not mean that patients are
entitled to illegal, unethical or medically inappropriate treatment simply
because they have requested it.
7.2.7 Health practitioners providing palliative care should only recommend and
provide treatment options that are both scientifically grounded, and are, in
their best medical judgement, reasonably expected to yield the intended
benefits.
7.2.8 Should a patient request illegal, unethical or medically inappropriate
treatment, the health practitioner providing palliative care should reassure
them and their family of the sound treatment options available to the patient -
subject to consent by the latter or his or her surrogate.

7.3 ADVANCED PALLIATIVE CARE PLANNING

 `11

7.3.1 Patient autonomy includes the need to protect patients with diminished
autonomy.

7.3.2 Health practitioners providing palliative care should encourage competent

patients to indicate their wishes regarding treatment options in an advance
directive, such as a living will, and in such a document or a written nomination
of a surrogate in terms of the National Health Act, to mandate a person to
make decisions on their behalf if they become incapacitated.
7.3.3 An advance directive helps ensure consideration of the patient’s values and
preferences, even when they lack the capacity to express them.
7.3.4 Health practitioners providing palliative care should record any conversations
with a competent patient regarding their goals for care in their medical
records, and should review such goals regularly and as circumstances
change.
7.3.5 The advance directive or other records of the patient’s wishes should be kept
inside the patient’s file, with stickers indicating that the advance directive is
available for ease of reference.
7.3.6 The Patient’s Rights Charter introduced by the National Department of Health
requires patients to advise their healthcare provider of their wishes regarding
death, and to take care of any medical records in their possession – see
HPSCA National Patient’s Rights Charter (Booklet 3).
7.3.7 An advance directive should include the following:

7.3.7.1 the patient’s wishes and preferences with regard to future treatment;
7.3.7.2 any beliefs or values that may influence the patient’s decisions and
preferences;
7.3.7.3 the family members or surrogates that should be involved in decision-
making;
7.3.7.4 any interventions that should be considered and implemented in case of
emergency, such as CPR;
7.3.7.5 the patient’s preferred place of care; and
7.3.7.6 the patient’s need for religious, spiritual, and other personal support.

7.3.8 As is the case with life-threatening illness, towards the end-of-life, it is not
uncommon for a patient’s mental capacity to be impaired.

7.3.9 When a patient becomes mentally incompetent, and an advance directive is

available, health practitioners providing palliative care should give effect to the
patient’s wishes – provided that the directive is applicable to the present
circumstances and represents the patient’s current wishes.
 `12

7.3.10 If no advance directive is available, and no surrogate has been appointed, the
health practitioner providing palliative care must, in consultation with the
patient’s family, determine the treatment option that is in the patient’s best
interest.
7.3.11 In determining an incapacitated patient’s best interests during the decision-
making process, the health practitioner providing palliative care must
consider:
7.3.11.1 the medically appropriate treatment options available;
7.3.11.2 any previous requests of the patient when he or she was mentally
competent;
7.3.11.3 what the practitioner knows about the background and preferences of
the patient, in consultation with the patient’s healthcare team;
7.3.11.4 information regarding the patient’s values, beliefs and preferences
from third parties who may have other knowledge of the patient due to
their relationship (e.g. a parent, sibling, child or spouse);
7.3.11.5 where more than one treatment option is reasonably in the patient’s
best interests, the practitioner must, in consultation with the patient or
the patient’s surrogate, choose the option that least restricts the
patient’s future choices.
7.3.12 The health practitioner providing palliative care must take appropriate
action in the case of illegal, unethical or inappropriate behaviour that
jeopardises the best interests of the patient.

7.4 COMMUNICATION

7.4.1 Health practitioners providing palliative care must communicate effectively

and timeously with the patient and their family, and the rest of the palliative
care team.
7.4.2 Health practitioners providing palliative care must take into account the
emotional toll that the circumstances regarding the use of palliative care may
have on the patient and their family, and should communicate with them in an
empathic and understandable manner.
7.4.3 If a patient’s communication skills are compromised by their illness, health
practitioners providing palliative care must communicate with the patient
through verbal and non-verbal means.
7.4.4 Irrespective of the patient’s level of consciousness, health practitioners
providing palliative care should communicate any proposed interventions to
the patient, based on the understanding that hearing is the last sense to die.
 `13

8 BENEFICENCE AND PALLIATIVE CARE

8.1 MEANING OF BENEFICENCE

8.1.1 The principle of beneficence requires the health practitioner providing

palliative care to do good for their patients.
8.1.2 The health practitioner providing palliative care must weigh up the costs, risks
and benefits of particular forms of palliative care and recommend those that
are most beneficial to the patient, while leaving the final decision to the patient
or their surrogate.
8.1.3 From the moment of diagnosis of a life-threatening condition, the health
practitioner providing palliative care must monitor the patient and keep
abreast of relevant medical advancements, and ensure that their knowledge
and understanding of palliative care is up to date.
8.1.3 If the health practitioner providing palliative care is not able to manage severe
or refractory symptoms, it is important for such practitioner to refer the patient
to a health practitioner who is qualified to do so.

8.2 WITHHOLDING OR WITHDRAWAL OF TREATMENT

8.2.1 The health practitioner providing palliative care is required to balance the
intended benefits of palliative care against the risks and burdens of treatment.
8.2.2 In some instances, the quality of life which follows palliative treatment may
raise questions as to whether such treatment is in the best interests of the
patient.
8.2.3 Treatment can legally and ethically be withheld or withdrawn if the patient
refuses further treatment, further treatment is futile, or if it is no longer in the
patient’s best interests (e.g. when treatment merely prolongs the dying
process).
 `14

8.2.4 The decision to withhold or withdraw treatment must not be taken lightly, and
must be considered by the health practitioner providing palliative care in
consultation with the patient and their family.
8.2.5 When the possibility of withholding or withdrawal of treatment arises, the
health practitioner providing palliative care should discuss with the patient and
their family, arrangements for basic care and other appropriate treatments.
8.2.6 At end-of-life, discussions about withholding or withdrawal of treatment should
include plans to manage the final stages of the lives of patients, before they
are incapacitated, and include personal matters such as wills, as well as any
other concerns that patients believe are important to ensure that they die with
dignity.
8.2.7 When dealing with end-of-life decisions health practitioners providing palliative
care must approach the withholding or withdrawal of treatment in a manner
consistent with the HPSCA’s Guidelines for the Withholding and Withdrawal of
Treatment (Booklet 7).

9 NON-MALEFICENCE AND PALLIATIVE CARE

9.1 Non-maleficence requires health practitioners providing palliative care not to

harm their patients and complements beneficence and the balancing of risks
and benefits.
9.2 Euthanasia and doctor-assisted suicide are often perceived as inconsistent
with the principle of non-maleficence.
9.3 Euthanasia and doctor-assisted suicide are presently prohibited under South
African law, and the courts frequently do not distinguish between the two
when it comes to culpability.
9.4 Euthanasia is the employment of any medical intervention primarily aimed at
ending a patient’s life (e.g. giving a patient lethal drug or injection).
9.5 Doctor-assisted suicide occurs when the health practitioner provides the
means necessary to enable the patient to end their own life (e.g. handing a
patient a lethal drug or prescribing a lethal drug for a patient).
9.5 At present, South African courts have acknowledged that both euthanasia and
doctor-assisted suicide are fundamentally incompatible with a practitioner’s
role as a healer, and a practitioner guilty of either is regarded as having acted
unethically and unlawfully.
 `15

9.6 Due to the stress of extreme pain and the prospect of facing a life-threatening
illness, a patient may request a health practitioner providing palliative care to
end their life.
9.7 The role of the health practitioner providing palliative care in this instance is to
discuss the concerns and fears that have led to the patient’s request, and to
provide alternate approaches to address these issues.

9.8 When medical treatment relieves suffering - but has the effect of accelerating
the dying process - the health practitioner providing palliative care must
consider whether the palliative benefits justify the shortened life expectancy
before pursuing that course of treatment.
9.9 Palliative care treatment where life is shortened as a side effect, is not
regarded as unlawful or unethical – provided the patient or their surrogate has
given informed consent.

10 JUSTICE OR FAIRNESS AND PALLIATIVE CARE

10.1 The World Health Organisation (WHO) states that ‘palliative care needs to be
provided in accordance with the principles of universal health coverage’.
10.2 This means that everyone, ‘irrespective of income, disease type or age,
should have access to a nationally determined set of basic health services,
including palliative care’ and is consistent with the South African Constitution.
10.3 The WHO also states that ‘financial and social protection systems need to
take into account the human right to palliative care for poor and marginalized
population groups’.
10.4 Palliative care should be available to all patients from birth until death, and
should be accessible at all levels of the health care service and this is what
the National Department of Health’s National Policy Framework and Strategy
on Palliative Care 2017–2022 aspires to do.
10.5 Health practitioners providing palliative care must treat patients equally and
without discrimination.
10.6 According to the National Department of Health’s National Policy Framework
and Strategy on Palliative Care 2017–2022 health practitioners providing
palliative care must give special consideration to the following groups of
people in their provision of palliative care services:
 `16

10.6.1 Persons with disabilities;

10.6.2 Children (including neonates and adolescents);
10.6.3 Older persons including those living in residential care settings and
frail care facilities;
10.6.4 Asylum seekers and refugees;
10.6.5 Inmates of correctional services; and
10.6.6 Persons in long term care facilities such as TB and psychiatric
hospitals or residential care facilities.
10.6 Palliative care practitioners should use the country’s limited health care
resources responsibly, fairly and effectively to ensure all patients receive
appropriate palliative care.

11 REFERENCES

11.1 National Department of Health. National Policy Framework and Strategy on

Palliative Care 2017-2022.
11.2 National Health Service Scotland. Scottish Palliative Care Guidelines (2014).
http://www.palliativecareguidelines.scot.nhs.uk/guidelines/about-the-
guidelines.aspx.
11.3 American Medical Association. Opinions on Caring for Patients at End of Life
(2016). https://www.ama-assn.org/sites/default/files/media-browser/code-of-
medical-ethics-chapter-5.pdf.
11.4 General Medical Council. Treatment and Care towards End of Life: Good
Practice in Decision-Making (2010). https://www.gmc-uk.org/ethical-
guidance/ethical-guidance-for-doctors/treatment-and-care-towards-the-end-of-
life.
11.5 Irish National Clinical Programme for Palliative Care: Palliative Care Needs
Assessment Guidance
(2014). https://www.hse.ie/eng/services/publications/clinical-strategy-and-
programmes/palliative-care-needs-assessment-guidance.pdf.

11.6 Republic of Kenya Ministry of Health. National Palliative Care Guidelines

(2013). http://kehpca.org/wp-content/uploads/National-Palliative-Care-
Guidelines-02.10.pdf.
11.7 Australian Medical Association. Position Statement on End of Life Care and
Advance Care Planning (2014). https://ama.com.au/position-statement/end-
life-care-and-advance-care-planning-2014.
11.8 Canadian Medical Association. Palliative Care National Call to Action
(2015). https://www.cma.ca/Assets/assets-
library/document/en/advocacy/palliative-care-report-online-e.pdf.