Pharmaceutical vs. Duque PDF

Republic of the Philippines
SUPREME COURT
Manila
EN BANC
G.R. No. 173034 October 9, 2007
PHARMACEUTICAL AND HEALTH CARE
ASSOCIATION OF THE PHILIPPINES, petitioner,
vs.
HEALTH SECRETARY FRANCISCO T. DUQUE
III; HEALTH UNDER SECRETARIES DR.
ETHELYN P. NIETO, DR. MARGARITA M.
GALON, ATTY. ALEXANDER A. PADILLA, & DR.
JADE F. DEL MUNDO; and ASSISTANT
SECRETARIES DR. MARIO C. VILLAVERDE, DR.
DAVID J. LOZADA, AND DR. NEMESIO T. GAKO,
respondents.
DECISION
AUSTRIA-MARTINEZ, J.:
The Court and all parties involved are in agreement that
the best nourishment for an infant is mother's milk. There
is nothing greater than for a mother to nurture her
beloved child straight from her bosom. The ideal is, of
course, for each and every Filipino child to enjoy the
unequaled benefits of breastmilk. But how should this
end be attained?
Before the Court is a petition for certiorari under Rule
65 of the Rules of Court, seeking to nullify
Administrative Order (A.O.) No. 2006-0012 entitled,
Revised Implementing Rules and Regulations of
Executive Order No. 51, Otherwise Known as The
"Milk Code," Relevant International Agreements,
Penalizing Violations Thereof, and for Other Purposes
(RIRR). Petitioner posits that the RIRR is not valid as it
contains provisions that are not constitutional and go
beyond the law it is supposed to implement.
Named as respondents are the Health Secretary,
Undersecretaries, and Assistant Secretaries of the
Department of Health (DOH). For purposes of herein
petition, the DOH is deemed impleaded as a
co-respondent since respondents issued the questioned
RIRR in their capacity as officials of said executive
agency.1
Executive Order No. 51 (Milk Code) was issued by
President Corazon Aquino on October 28, 1986 by virtue
of the legislative powers granted to the president under
the Freedom Constitution. One of the preambular clauses
of the Milk Code states that the law seeks to give effect
to Article 112 of the International Code of Marketing of
Breastmilk Substitutes (ICMBS), a code adopted by the
World Health Assembly (WHA) in 1981. From 1982 to
2006, the WHA adopted several Resolutions to the effect
that breastfeeding should be supported, promoted and
protected, hence, it should be ensured that nutrition and
health claims are not permitted for breastmilk substitutes.
In 1990, the Philippines ratified the International
Convention on the Rights of the Child. Article 24 of said
instrument provides that State Parties should take
appropriate measures to diminish infant and child
mortality, and ensure that all segments of society,
specially parents and children, are informed of the
advantages of breastfeeding.
On May 15, 2006, the DOH issued herein assailed RIRR
which was to take effect on July 7, 2006.
However, on June 28, 2006, petitioner, representing its
members that are manufacturers of breastmilk substitutes,
filed the present Petition for Certiorari and Prohibition
with Prayer for the Issuance of a Temporary Restraining
Order (TRO) or Writ of Preliminary Injunction.
The main issue raised in the petition is whether
respondents officers of the DOH acted without or in
excess of jurisdiction, or with grave abuse of discretion
amounting to lack or excess of jurisdiction, and in
violation of the provisions of the Constitution in
promulgating the RIRR.3
On August 15, 2006, the Court issued a Resolution
granting a TRO enjoining respondents from
implementing the questioned RIRR.
After the Comment and Reply had been filed, the Court
set the case for oral arguments on June 19, 2007. The
Court issued an Advisory (Guidance for Oral Arguments)
dated June 5, 2007, to wit:
The Court hereby sets the following issues:
1. Whether or not petitioner is a real party-in-interest;
2. Whether Administrative Order No. 2006-0012 or the
Revised Implementing Rules and Regulations (RIRR)
issued by the Department of Health (DOH) is not
constitutional;
2.1 Whether the RIRR is in accord with the provisions of
Executive Order No. 51 (Milk Code);
2.2 Whether pertinent international agreements1 entered
into by the Philippines are part of the law of the land and
may be implemented by the DOH through the RIRR; If
in the affirmative, whether the RIRR is in accord with
the international agreements;
2.3 Whether Sections 4, 5(w), 22, 32, 47, and 52 of the
RIRR violate the due process clause and are in restraint
of trade; and
2.4 Whether Section 13 of the RIRR on Total Effect
provides sufficient standards.
_____________
1 (1) United Nations Convention on the Rights of the
Child; (2) the WHO and Unicef "2002 Global Strategy
on Infant and Young Child Feeding;" and (3) various
World Health Assembly (WHA) Resolutions.
The parties filed their respective memoranda.
The petition is partly imbued with merit.
On the issue of petitioner's standing
With regard to the issue of whether petitioner may
prosecute this case as the real party-in-interest, the Court
adopts the view enunciated in Executive Secretary v.
Court of Appeals,4 to wit:
The modern view is that an association has standing to
complain of injuries to its members. This view fuses the
legal identity of an association with that of its members.
An association has standing to file suit for its workers
despite its lack of direct interest if its members are
affected by the action. An organization has standing
to assert the concerns of its constituents.
xxxx
x x x We note that, under its Articles of Incorporation,
the respondent was organized x x x to act as the
representative of any individual, company, entity or
association on matters related to the manpower
recruitment industry, and to perform other acts and
activities necessary to accomplish the purposes embodied
therein. The respondent is, thus, the appropriate party
to assert the rights of its members, because it and its
members are in every practical sense identical. x x x
The respondent [association] is but the medium
through which its individual members seek to make
more effective the expression of their voices and the
redress of their grievances. 5 (Emphasis supplied)
which was reasserted in Purok Bagong Silang
Association, Inc. v. Yuipco,6 where the Court ruled that
an association has the legal personality to represent its
members because the results of the case will affect their
vital interests.7
Herein petitioner's Amended Articles of Incorporation
contains a similar provision just like in Executive
Secretary, that the association is formed "to represent
directly or through approved representatives the
pharmaceutical and health care industry before the
Philippine Government and any of its agencies, the
medical professions and the general public."8 Thus, as an
organization, petitioner definitely has an interest in
fulfilling its avowed purpose of representing members
who are part of the pharmaceutical and health care
industry. Petitioner is duly authorized9 to take the
appropriate course of action to bring to the attention of
government agencies and the courts any grievance
suffered by its members which are directly affected by
the RIRR. Petitioner, which is mandated by its Amended
Articles of Incorporation to represent the entire industry,
would be remiss in its duties if it fails to act on
governmental action that would affect any of its industry
members, no matter how few or numerous they are.
Hence, petitioner, whose legal identity is deemed fused
with its members, should be considered as a real
party-in-interest which stands to be benefited or injured
by any judgment in the present action.
On the constitutionality of the provisions of the RIRR
First, the Court will determine if pertinent international
instruments adverted to by respondents are part of the
law of the land.
Petitioner assails the RIRR for allegedly going beyond
the provisions of the Milk Code, thereby amending and
expanding the coverage of said law. The defense of the
DOH is that the RIRR implements not only the Milk
Code but also various international instruments10
regarding infant and young child nutrition. It is
respondents' position that said international instruments
are deemed part of the law of the land and therefore the
DOH may implement them through the RIRR.
The Court notes that the following international
instruments invoked by respondents, namely: (1) The
United Nations Convention on the Rights of the Child; (2)
The International Covenant on Economic, Social and
Cultural Rights; and (3) the Convention on the
Elimination of All Forms of Discrimination Against
Women, only provide in general terms that steps must be
taken by State Parties to diminish infant and child
mortality and inform society of the advantages of
breastfeeding, ensure the health and well-being of
families, and ensure that women are provided with
services and nutrition in connection with pregnancy and
lactation. Said instruments do not contain specific
provisions regarding the use or marketing of breastmilk
substitutes.
The international instruments that do have specific
provisions regarding breastmilk substitutes are the
ICMBS and various WHA Resolutions.
Under the 1987 Constitution, international law can
become part of the sphere of domestic law either by
transformation or incorporation.11 The transformation
method requires that an international law be transformed
into a domestic law through a constitutional mechanism
such as local legislation. The incorporation method
applies when, by mere constitutional declaration,
international law is deemed to have the force of domestic
law.12
Treaties become part of the law of the land through
transformation pursuant to Article VII, Section 21 of
the Constitution which provides that "[n]o treaty or
international agreement shall be valid and effective
unless concurred in by at least two-thirds of all the
members of the Senate." Thus, treaties or conventional
international law must go through a process prescribed
by the Constitution for it to be transformed into
municipal law that can be applied to domestic conflicts.13
The ICMBS and WHA Resolutions are not treaties as
they have not been concurred in by at least two-thirds of
all members of the Senate as required under Section 21,
Article VII of the 1987 Constitution.
However, the ICMBS which was adopted by the WHA in
1981 had been transformed into domestic law through
local legislation, the Milk Code. Consequently, it is the
Milk Code that has the force and effect of law in this
jurisdiction and not the ICMBS per se.
The Milk Code is almost a verbatim reproduction of the
ICMBS, but it is well to emphasize at this point that the
Code did not adopt the provision in the ICMBS
absolutely prohibiting advertising or other forms of
promotion to the general public of products within the
scope of the ICMBS. Instead, the Milk Code expressly
provides that advertising, promotion, or other
marketing materials may be allowed if such materials
are duly authorized and approved by the
Inter-Agency Committee (IAC).
On the other hand, Section 2, Article II of the 1987
Constitution, to wit:
SECTION 2. The Philippines renounces war as an
instrument of national policy, adopts the generally
accepted principles of international law as part of the
law of the land and adheres to the policy of peace,
equality, justice, freedom, cooperation and amity with all
nations. (Emphasis supplied)
embodies the incorporation method.14
In Mijares v. Ranada,15 the Court held thus:
[G]enerally accepted principles of international law, by
virtue of the incorporation clause of the Constitution,
form part of the laws of the land even if they do not
derive from treaty obligations. The classical formulation
in international law sees those customary rules accepted
as binding result from the combination [of] two elements:
the established, widespread, and consistent practice on
the part of States; and a psychological element known as
the opinion juris sive necessitates (opinion as to law or
necessity). Implicit in the latter element is a belief that
the practice in question is rendered obligatory by the
existence of a rule of law requiring it.16 (Emphasis
supplied)
"Generally accepted principles of international law"
refers to norms of general or customary international law
which are binding on all states,17 i.e., renunciation of war
as an instrument of national policy, the principle of
sovereign immunity,18 a person's right to life, liberty and
due process,19 and pacta sunt servanda,20 among others.
The concept of "generally accepted principles of law"
has also been depicted in this wise:
Some legal scholars and judges look upon certain
"general principles of law" as a primary source of
international law because they have the "character of
jus rationale" and are "valid through all kinds of
human societies." (Judge Tanaka in his dissenting
opinion in the 1966 South West Africa Case, 1966 I.C.J.
296). O'Connell holds that certain priniciples are part of
international law because they are "basic to legal
systems generally" and hence part of the jus gentium.
These principles, he believes, are established by a
process of reasoning based on the common identity of all
legal systems. If there should be doubt or disagreement,
one must look to state practice and determine whether
the municipal law principle provides a just and
acceptable solution. x x x 21 (Emphasis supplied)
Fr. Joaquin G. Bernas defines customary international
law as follows:
Custom or customary international law means "a general
and consistent practice of states followed by them from a
sense of legal obligation [opinio juris]." (Restatement)
This statement contains the two basic elements of
custom: the material factor, that is, how states behave,
and the psychological or subjective factor, that is, why
they behave the way they do.
xxxx
The initial factor for determining the existence of custom
is the actual behavior of states. This includes several
elements: duration, consistency, and generality of the
practice of states.
The required duration can be either short or long. x x x
xxxx
Duration therefore is not the most important element.
More important is the consistency and the generality of
the practice. x x x
xxxx
Once the existence of state practice has been established,
it becomes necessary to determine why states behave the
way they do. Do states behave the way they do because
they consider it obligatory to behave thus or do they do
it only as a matter of courtesy? Opinio juris, or the
belief that a certain form of behavior is obligatory, is
what makes practice an international rule. Without it,
practice is not law.22 (Underscoring and Emphasis
supplied)
Clearly, customary international law is deemed
incorporated into our domestic system.23
WHA Resolutions have not been embodied in any local
legislation. Have they attained the status of customary
law and should they then be deemed incorporated as part
of the law of the land?
The World Health Organization (WHO) is one of the
international specialized agencies allied with the United
Nations (UN) by virtue of Article 57,24 in relation to
Article 6325 of the UN Charter. Under the 1946 WHO
Constitution, it is the WHA which determines the
policies of the WHO,26 and has the power to adopt
regulations concerning "advertising and labeling of
biological, pharmaceutical and similar products moving
in international commerce,"27 and to "make
recommendations to members with respect to any matter
within the competence of the Organization."28 The legal
effect of its regulations, as opposed to recommendations,
is quite different.
Regulations, along with conventions and agreements,
duly adopted by the WHA bind member states thus:
Article 19. The Health Assembly shall have authority to
adopt conventions or agreements with respect to any
matter within the competence of the Organization. A
two-thirds vote of the Health Assembly shall be required
for the adoption of such conventions or agreements,
which shall come into force for each Member when
accepted by it in accordance with its constitutional
processes.
Article 20. Each Member undertakes that it will,
within eighteen months after the adoption by the Health
Assembly of a convention or agreement, take action
relative to the acceptance of such convention or
agreement. Each Member shall notify the
Director-General of the action taken, and if it does not
accept such convention or agreement within the time
limit, it will furnish a statement of the reasons for
non-acceptance. In case of acceptance, each Member
agrees to make an annual report to the Director-General
in accordance with Chapter XIV.
adopt regulations concerning: (a) sanitary and quarantine
requirements and other procedures designed to prevent
the international spread of disease; (b) nomenclatures
with respect to diseases, causes of death and public
health practices; (c) standards with respect to diagnostic
procedures for international use; (d) standards with
respect to the safety, purity and potency of biological,
pharmaceutical and similar products moving in
international commerce; (e) advertising and labeling of
biological, pharmaceutical and similar products moving
in international commerce.
Article 22. Regulations adopted pursuant to Article 21
shall come into force for all Members after due notice
has been given of their adoption by the Health Assembly
except for such Members as may notify the
Director-General of rejection or reservations within the
period stated in the notice. (Emphasis supplied)
On the other hand, under Article 23, recommendations
of the WHA do not come into force for members, in
the same way that conventions or agreements under
Article 19 and regulations under Article 21 come into
force. Article 23 of the WHO Constitution reads:
make recommendations to Members with respect to any
matter within the competence of the Organization.
(Emphasis supplied)
The absence of a provision in Article 23 of any
mechanism by which the recommendation would come
into force for member states is conspicuous.
The former Senior Legal Officer of WHO, Sami Shubber,
stated that WHA recommendations are generally not
binding, but they "carry moral and political weight, as
they constitute the judgment on a health issue of the
collective membership of the highest international body
in the field of health."29 Even the ICMBS itself was
adopted as a mere recommendation, as WHA Resolution
No. 34.22 states:
"The Thirty-Fourth World Health Assembly x x x adopts,
in the sense of Article 23 of the Constitution, the
International Code of Marketing of Breastmilk
Substitutes annexed to the present resolution." (Emphasis
supplied)
The Introduction to the ICMBS also reads as follows:
In January 1981, the Executive Board of the World
Health Organization at its sixty-seventh session,
considered the fourth draft of the code, endorsed it, and
unanimously recommended to the Thirty-fourth World
Health Assembly the text of a resolution by which it
would adopt the code in the form of a
recommendation rather than a regulation. x x x
(Emphasis supplied)
The legal value of WHA Resolutions as
recommendations is summarized in Article 62 of the
WHO Constitution, to wit:
Art. 62. Each member shall report annually on the action
taken with respect to recommendations made to it by the
Organization, and with respect to conventions,
agreements and regulations.
Apparently, the WHA Resolution adopting the ICMBS
and subsequent WHA Resolutions urging member states
to implement the ICMBS are merely recommendatory
and legally non-binding. Thus, unlike what has been
done with the ICMBS whereby the legislature enacted
most of the provisions into law which is the Milk
Code, the subsequent WHA Resolutions,30 specifically
providing for exclusive breastfeeding from 0-6
months, continued breastfeeding up to 24 months,
and absolutely prohibiting advertisements and
promotions of breastmilk substitutes, have not been
adopted as a domestic law.
It is propounded that WHA Resolutions may constitute
"soft law" or non-binding norms, principles and practices
that influence state behavior.31
"Soft law" does not fall into any of the categories of
international law set forth in Article 38, Chapter III of
the 1946 Statute of the International Court of Justice.32 It
is, however, an expression of non-binding norms,
principles, and practices that influence state behavior.33
Certain declarations and resolutions of the UN General
Assembly fall under this category.34 The most notable is
the UN Declaration of Human Rights, which this Court
has enforced in various cases, specifically, Government
of Hongkong Special Administrative Region v. Olalia,35
Mejoff v. Director of Prisons,36 Mijares v. Rañada37 and
Shangri-la International Hotel Management, Ltd. v.
Developers Group of Companies, Inc..38
The World Intellectual Property Organization (WIPO), a
specialized agency attached to the UN with the mandate
to promote and protect intellectual property worldwide,
has resorted to soft law as a rapid means of norm
creation, in order "to reflect and respond to the changing
needs and demands of its constituents."39 Other
international organizations which have resorted to soft
law include the International Labor Organization and the
Food and Agriculture Organization (in the form of the
Codex Alimentarius).40
WHO has resorted to soft law. This was most evident at
the time of the Severe Acute Respiratory Syndrome
(SARS) and Avian flu outbreaks.
Although the IHR Resolution does not create new
international law binding on WHO member states, it
provides an excellent example of the power of "soft
law" in international relations. International lawyers
typically distinguish binding rules of international
law-"hard law"-from non-binding norms, principles,
and practices that influence state behavior-"soft law."
WHO has during its existence generated many soft law
norms, creating a "soft law regime" in international
governance for public health.
The "soft law" SARS and IHR Resolutions represent
significant steps in laying the political groundwork for
improved international cooperation on infectious
diseases. These resolutions clearly define WHO member
states' normative duty to cooperate fully with other
countries and with WHO in connection with infectious
disease surveillance and response to outbreaks.
This duty is neither binding nor enforceable, but, in the
wake of the SARS epidemic, the duty is powerful
politically for two reasons. First, the SARS outbreak has
taught the lesson that participating in, and enhancing,
international cooperation on infectious disease controls is
in a country's self-interest x x x if this warning is heeded,
the "soft law" in the SARS and IHR Resolution could
inform the development of general and consistent state
practice on infectious disease surveillance and outbreak
response, perhaps crystallizing eventually into customary
international law on infectious disease prevention and
control.41
In the Philippines, the executive department
implemented certain measures recommended by WHO to
address the outbreaks of SARS and Avian flu by issuing
Executive Order (E.O.) No. 201 on April 26, 2003 and
E.O. No. 280 on February 2, 2004, delegating to various
departments broad powers to close down
schools/establishments, conduct health surveillance and
monitoring, and ban importation of poultry and
agricultural products.
It must be emphasized that even under such an
international emergency, the duty of a state to implement
the IHR Resolution was still considered not binding or
enforceable, although said resolutions had great political
influence.
As previously discussed, for an international rule to be
considered as customary law, it must be established that
such rule is being followed by states because they
consider it obligatory to comply with such rules (opinio
juris). Respondents have not presented any evidence to
prove that the WHA Resolutions, although signed by
most of the member states, were in fact enforced or
practiced by at least a majority of the member states;
neither have respondents proven that any compliance by
member states with said WHA Resolutions was
obligatory in nature.
Respondents failed to establish that the provisions of
pertinent WHA Resolutions are customary international
law that may be deemed part of the law of the land.
Consequently, legislation is necessary to transform the
provisions of the WHA Resolutions into domestic law.
The provisions of the WHA Resolutions cannot be
considered as part of the law of the land that can be
implemented by executive agencies without the need
of a law enacted by the legislature.
Second, the Court will determine whether the DOH may
implement the provisions of the WHA Resolutions by
virtue of its powers and functions under the Revised
Administrative Code even in the absence of a domestic
law.
Section 3, Chapter 1, Title IX of the Revised
Administrative Code of 1987 provides that the DOH
shall define the national health policy and implement a
national health plan within the framework of the
government's general policies and plans, and issue
orders and regulations concerning the
implementation of established health policies.
It is crucial to ascertain whether the absolute prohibition
on advertising and other forms of promotion of
breastmilk substitutes provided in some WHA
Resolutions has been adopted as part of the national
health policy.
Respondents submit that the national policy on infant and
young child feeding is embodied in A.O. No. 2005-0014,
dated May 23, 2005. Basically, the Administrative Order
declared the following policy guidelines: (1) ideal
breastfeeding practices, such as early initiation of
breastfeeding, exclusive breastfeeding for the first six
months, extended breastfeeding up to two years and
beyond; (2) appropriate complementary feeding, which is
to start at age six months; (3) micronutrient
supplementation; (4) universal salt iodization; (5) the
exercise of other feeding options; and (6) feeding in
exceptionally difficult circumstances. Indeed, the
primacy of breastfeeding for children is emphasized as a
national health policy. However, nowhere in A.O. No.
2005-0014 is it declared that as part of such health
policy, the advertisement or promotion of breastmilk
substitutes should be absolutely prohibited.
The national policy of protection, promotion and support
of breastfeeding cannot automatically be equated with a
total ban on advertising for breastmilk substitutes.
In view of the enactment of the Milk Code which does
not contain a total ban on the advertising and promotion
of breastmilk substitutes, but instead, specifically creates
an IAC which will regulate said advertising and
promotion, it follows that a total ban policy could be
implemented only pursuant to a law amending the Milk
Code passed by the constitutionally authorized branch of
government, the legislature.
Thus, only the provisions of the Milk Code, but not
those of subsequent WHA Resolutions, can be validly
implemented by the DOH through the subject RIRR.
Third, the Court will now determine whether the
provisions of the RIRR are in accordance with those of
the Milk Code.
In support of its claim that the RIRR is inconsistent with
the Milk Code, petitioner alleges the following:
1. The Milk Code limits its coverage to children 0-12
months old, but the RIRR extended its coverage to
"young children" or those from ages two years old and
beyond:
MILK CODE RIRR

WHEREAS, in order to Section 2. Purpose – These
ensure that safe and adequate Revised Rules and
nutrition for infants is Regulations are hereby
provided, there is a need to promulgated to ensure the
protect and promote provision of safe and
breastfeeding and to inform adequate nutrition for infants
the public about the proper and young children by the
use of breastmilk substitutes promotion, protection and
and supplements and related support of breastfeeding and
products through adequate, by ensuring the proper use of
consistent and objective breastmilk substitutes,
information and appropriate breastmilk supplements and
regulation of the marketing related products when these
and distribution of the said are medically indicated and
substitutes, supplements and only when necessary, on the
related products; basis of adequate information
and through appropriate
SECTION 4(e). "Infant" marketing and distribution.
means a person falling within
the age bracket of 0-12 Section 5(ff). "Young Child"
months. means a person from the age
of more than twelve (12)
months up to the age of three
(3) years (36 months).
2. The Milk Code recognizes that infant formula may be

a proper and possible substitute for breastmilk in certain
instances; but the RIRR provides "exclusive
breastfeeding for infants from 0-6 months" and declares
that "there is no substitute nor replacement for
breastmilk":
MILK CODE RIRR

WHEREAS, in order to Section 4. Declaration of
ensure that safe and adequate Principles – The following
nutrition for infants is are the underlying principles
provided, there is a need to from which the revised rules
protect and promote and regulations are premised
breastfeeding and to inform upon:
the public about the proper
use of breastmilk substitutes a. Exclusive breastfeeding is
and supplements and related for infants from 0 to six (6)
products through adequate, months.
consistent and objective b. There is no substitute or
information and appropriate replacement for breastmilk.
regulation of the marketing
and distribution of the said
substitutes, supplements and
related products;
3. The Milk Code only regulates and does not impose

unreasonable requirements for advertising and promotion;
RIRR imposes an absolute ban on such activities for
breastmilk substitutes intended for infants from 0-24
months old or beyond, and forbids the use of health and
nutritional claims. Section 13 of the RIRR, which
provides for a "total effect" in the promotion of products
within the scope of the Code, is vague:
MILK CODE RIRR

SECTION 6. The General Section 4. Declaration of
Public and Mothers. – Principles – The following
are the underlying principles
(a) No advertising, promotion from which the revised rules
or other marketing materials, and regulations are premised
whether written, audio or upon:
visual, for products within the
scope of this Code shall be xxxx
printed, published,
distributed, exhibited and f. Advertising, promotions, or
broadcast unless such sponsor-ships of infant
materials are duly authorized formula, breastmilk
and approved by an substitutes and other related
inter-agency committee products are prohibited.
created herein pursuant to the
applicable standards provided Section 11. Prohibition – No
for in this Code. advertising, promotions,
sponsorships, or marketing
materials and activities for
breastmilk substitutes
intended for infants and
young children up to
twenty-four (24) months,
shall be allowed, because they
tend to convey or give
subliminal messages or
impressions that undermine
breastmilk and breastfeeding
or otherwise exaggerate
breastmilk substitutes and/or
replacements, as well as
related products covered
within the scope of this Code.
Section 13. "Total Effect" -
Promotion of products within
the scope of this Code must
be objective and should not
equate or make the product
appear to be as good or equal
to breastmilk or breastfeeding
in the advertising concept. It
must not in any case
undermine breastmilk or
breastfeeding. The "total
effect" should not directly or
indirectly suggest that buying
their product would produce
better individuals, or resulting
in greater love, intelligence,
ability, harmony or in any
manner bring better health to
the baby or other such
exaggerated and
unsubstantiated claim.
Section 15. Content of
Materials. - The following
shall not be included in
advertising, promotional and
marketing materials:
a. Texts, pictures, illustrations
or information which
discourage or tend to
undermine the benefits or
superiority of breastfeeding or
which idealize the use of
breastmilk substitutes and
milk supplements. In this
connection, no pictures of
babies and children together
with their mothers, fathers,
siblings, grandparents, other
relatives or caregivers (or
yayas) shall be used in any
advertisements for infant
formula and breastmilk
supplements;
b. The term "humanized,"
"maternalized," "close to
mother's milk" or similar
words in describing
breastmilk substitutes or milk
supplements;
c. Pictures or texts that
idealize the use of infant and
milk formula.
Section 16. All health and
nutrition claims for products
within the scope of the Code
are absolutely prohibited. For
this purpose, any phrase or
words that connotes to
increase emotional,
intellectual abilities of the
infant and young child and
other like phrases shall not be
allowed.
4. The RIRR imposes additional labeling requirements

not found in the Milk Code:
MILK CODE RIRR

SECTION 10. Section 26. Content – Each
Containers/Label. – container/label shall contain
such message, in both Filipino
(a) Containers and/or labels and English languages, and
shall be designed to provide
the necessary information which message cannot be
about the appropriate use of readily separated therefrom,
the products, and in such a relative the following points:
way as not to discourage
breastfeeding. (a) The words or phrase
"Important Notice" or
(b) Each container shall have "Government Warning" or
a clear, conspicuous and their equivalent;
easily readable and
understandable message in (b) A statement of the
Pilipino or English printed on superiority of breastfeeding;
it, or on a label, which (c) A statement that there is
message can not readily no substitute for breastmilk;
become separated from it, and
which shall include the (d) A statement that the
following points: product shall be used only on
the advice of a health worker
(i) the words "Important as to the need for its use and
Notice" or their equivalent; the proper methods of use;
(ii) a statement of the (e) Instructions for
superiority of breastfeeding; appropriate prepara-tion, and
(iii) a statement that the a warning against the health
product shall be used only on hazards of inappropriate
the advice of a health worker preparation; and
as to the need for its use and (f) The health hazards of
the proper methods of use; unnecessary or improper use
and of infant formula and other
(iv) instructions for related products including
appropriate preparation, and a information that powdered
warning against the health infant formula may contain
hazards of inappropriate pathogenic microorganisms
preparation. and must be prepared and
used appropriately.
5. The Milk Code allows dissemination of information

on infant formula to health professionals; the RIRR
totally prohibits such activity:
MILK CODE RIRR

SECTION 7. Health Care Section 22. No manufacturer,
System. – distributor, or representatives
of products covered by the
(b) No facility of the health Code shall be allowed to
care system shall be used for conduct or be involved in any
the purpose of promoting activity on breastfeeding
infant formula or other promotion, education and
products within the scope of production of Information,
this Code. This Code does Education and
not, however, preclude the Communication (IEC)
dissemination of information materials on breastfeeding,
to health professionals as holding of or participating as
provided in Section 8(b). speakers in classes or
SECTION 8. Health seminars for women and
Workers. - children activities and to
avoid the use of these venues
(b) Information provided by to market their brands or
manufacturers and company names.
distributors to health
professionals regarding SECTION 16. All health and
products within the scope of nutrition claims for products
this Code shall be restricted to within the scope of the Code
scientific and factual matters are absolutely prohibited. For
and such information shall not this purpose, any phrase or
imply or create a belief that words that connotes to
bottle-feeding is equivalent or increase emotional,
intellectual abilities of the
superior to breastfeeding. It infant and young child and
shall also include the other like phrases shall not be
information specified in allowed.
Section 5(b).
6. The Milk Code permits milk manufacturers and

distributors to extend assistance in research and
continuing education of health professionals; RIRR
absolutely forbids the same.
MILK CODE RIRR

SECTION 8. Health Section 4. Declaration of
Workers – Principles –
(e) Manufacturers and The following are the
distributors of products within underlying principles from
the scope of this Code may which the revised rules and
assist in the research, regulations are premised
scholarships and continuing upon:
education, of health
professionals, in accordance i. Milk companies, and their
with the rules and regulations representatives, should not
promulgated by the Ministry form part of any
of Health. policymaking body or entity
in relation to the advancement
of breasfeeding.
SECTION 22. No
manufacturer, distributor, or
representatives of products
covered by the Code shall be
allowed to conduct or be
involved in any activity on
breastfeeding promotion,
education and production of
Information, Education and
Communication (IEC)
materials on breastfeeding,
holding of or participating as
speakers in classes or
seminars for women and
children activities and to
avoid the use of these venues
to market their brands or
company names.
SECTION 32. Primary
Responsibility of Health
Workers - It is the primary
responsibility of the health
workers to promote, protect
and support breastfeeding and
appropriate infant and young
child feeding. Part of this
responsibility is to
continuously update their
knowledge and skills on
breastfeeding. No assistance,
support, logistics or training
from milk companies shall be
permitted.
7. The Milk Code regulates the giving of donations;

RIRR absolutely prohibits it.
MILK CODE RIRR

SECTION 6. The General Section 51. Donations
Within the Scope of This
Public and Mothers. – Code - Donations of
products, materials, defined
(f) Nothing herein contained and covered under the Milk
shall prevent donations from Code and these implementing
manufacturers and rules and regulations, shall be
distributors of products within strictly prohibited.
the scope of this Code upon
request by or with the Section 52. Other Donations
approval of the Ministry of By Milk Companies Not
Health. Covered by this Code. -
Donations of products,
equipments, and the like, not
otherwise falling within the
scope of this Code or these
Rules, given by milk
companies and their agents,
representatives, whether in
kind or in cash, may only be
coursed through the Inter
Agency Committee (IAC),
which shall determine
whether such donation be
accepted or otherwise.
8. The RIRR provides for administrative sanctions not

imposed by the Milk Code.
MILK CODE RIRR

Section 46. Administrative
Sanctions. – The following
administrative sanctions shall
be imposed upon any person,
juridical or natural, found to
have violated the provisions
of the Code and its
implementing Rules and
Regulations:
a) 1st violation – Warning;
b) 2nd violation –
Administrative fine of a
minimum of Ten Thousand
(P10,000.00) to Fifty
Thousand (P50,000.00)
Pesos, depending on the
gravity and extent of the
violation, including the recall
of the offending product;
c) 3rd violation –
Administrative Fine of a
minimum of Sixty Thousand
(P60,000.00) to One Hundred
Fifty Thousand (P150,000.00)
Pesos, depending on the
gravity and extent of the
violation, and in addition
thereto, the recall of the
offending product, and
suspension of the Certificate
of Product Registration
(CPR);
d) 4th violation
–Administrative Fine of a
minimum of Two Hundred
Thousand (P200,000.00) to
Five Hundred (P500,000.00)
Thousand Pesos, depending
on the gravity and extent of
the violation; and in addition
thereto, the recall of the
product, revocation of the
CPR, suspension of the
License to Operate (LTO) for
one year;
e) 5th and succeeding repeated
violations – Administrative
Fine of One Million
(P1,000,000.00) Pesos, the
recall of the offending
product, cancellation of the
CPR, revocation of the
License to Operate (LTO) of
the company concerned,
including the blacklisting of
the company to be furnished
the Department of Budget and
Management (DBM) and the
Department of Trade and
Industry (DTI);
f) An additional penalty of
Two Thou-sand Five Hundred
(P2,500.00) Pesos per day
shall be made for every day
the violation continues after
having received the order
from the IAC or other such
appropriate body, notifying
and penalizing the company
for the infraction.
For purposes of determining
whether or not there is
"repeated" violation, each
product violation belonging
or owned by a company,
including those of their
subsidiaries, are deemed to be
violations of the concerned
milk company and shall not
be based on the specific
violating product alone.
9. The RIRR provides for repeal of existing laws to the

contrary.
The Court shall resolve the merits of the allegations of
petitioner seriatim.
1. Petitioner is mistaken in its claim that the Milk Code's
coverage is limited only to children 0-12 months old.
Section 3 of the Milk Code states:
SECTION 3. Scope of the Code – The Code applies to
the marketing, and practices related thereto, of the
following products: breastmilk substitutes, including
infant formula; other milk products, foods and beverages,
including bottle-fed complementary foods, when
marketed or otherwise represented to be suitable, with or
without modification, for use as a partial or total
replacement of breastmilk; feeding bottles and teats. It
also applies to their quality and availability, and to
information concerning their use.
Clearly, the coverage of the Milk Code is not dependent
on the age of the child but on the kind of product being
marketed to the public. The law treats infant formula,
bottle-fed complementary food, and breastmilk substitute
as separate and distinct product categories.
Section 4(h) of the Milk Code defines infant formula as
"a breastmilk substitute x x x to satisfy the normal
nutritional requirements of infants up to between four to
six months of age, and adapted to their physiological
characteristics"; while under Section 4(b), bottle-fed
complementary food refers to "any food, whether
manufactured or locally prepared, suitable as a
complement to breastmilk or infant formula, when either
becomes insufficient to satisfy the nutritional
requirements of the infant." An infant under Section 4(e)
is a person falling within the age bracket 0-12 months. It
is the nourishment of this group of infants or children
aged 0-12 months that is sought to be promoted and
protected by the Milk Code.
But there is another target group. Breastmilk substitute is
defined under Section 4(a) as "any food being marketed
or otherwise presented as a partial or total replacement
for breastmilk, whether or not suitable for that purpose."
This section conspicuously lacks reference to any
particular age-group of children. Hence, the provision
of the Milk Code cannot be considered exclusive for
children aged 0-12 months. In other words, breastmilk
substitutes may also be intended for young children more
than 12 months of age. Therefore, by regulating
breastmilk substitutes, the Milk Code also intends to
protect and promote the nourishment of children more
than 12 months old.
Evidently, as long as what is being marketed falls within
the scope of the Milk Code as provided in Section 3, then
it can be subject to regulation pursuant to said law, even
if the product is to be used by children aged over 12
months.
There is, therefore, nothing objectionable with Sections
242 and 5(ff)43 of the RIRR.
2. It is also incorrect for petitioner to say that the RIRR,
unlike the Milk Code, does not recognize that breastmilk
substitutes may be a proper and possible substitute for
breastmilk.
The entirety of the RIRR, not merely truncated portions
thereof, must be considered and construed together. As
held in De Luna v. Pascual,44 "[t]he particular words,
clauses and phrases in the Rule should not be studied as
detached and isolated expressions, but the whole and
every part thereof must be considered in fixing the
meaning of any of its parts and in order to produce a
harmonious whole."
Section 7 of the RIRR provides that "when medically
indicated and only when necessary, the use of
breastmilk substitutes is proper if based on complete
and updated information." Section 8 of the RIRR also
states that information and educational materials should
include information on the proper use of infant formula
when the use thereof is needed.
Hence, the RIRR, just like the Milk Code, also
recognizes that in certain cases, the use of breastmilk
substitutes may be proper.
3. The Court shall ascertain the merits of allegations 345
and 446 together as they are interlinked with each other.
To resolve the question of whether the labeling
requirements and advertising regulations under the RIRR
are valid, it is important to deal first with the nature,
purpose, and depth of the regulatory powers of the DOH,
as defined in general under the 1987 Administrative
Code,47 and as delegated in particular under the Milk
Code.
Health is a legitimate subject matter for regulation by the
DOH (and certain other administrative agencies) in
exercise of police powers delegated to it. The sheer span
of jurisprudence on that matter precludes the need to
further discuss it..48 However, health information,
particularly advertising materials on apparently non-toxic
products like breastmilk substitutes and supplements, is a
relatively new area for regulation by the DOH.49
As early as the 1917 Revised Administrative Code of the
Philippine Islands,50 health information was already
within the ambit of the regulatory powers of the
predecessor of DOH.51 Section 938 thereof charged it
with the duty to protect the health of the people, and
vested it with such powers as "(g) the dissemination of
hygienic information among the people and especially
the inculcation of knowledge as to the proper care of
infants and the methods of preventing and combating
dangerous communicable diseases."
Seventy years later, the 1987 Administrative Code tasked
respondent DOH to carry out the state policy pronounced
under Section 15, Article II of the 1987 Constitution,
which is "to protect and promote the right to health of the
people and instill health consciousness among them."52
To that end, it was granted under Section 3 of the
Administrative Code the power to "(6) propagate health
information and educate the population on important
health, medical and environmental matters which have
health implications."53
When it comes to information regarding nutrition of
infants and young children, however, the Milk Code
specifically delegated to the Ministry of Health
(hereinafter referred to as DOH) the power to ensure that
there is adequate, consistent and objective information on
breastfeeding and use of breastmilk substitutes,
supplements and related products; and the power to
control such information. These are expressly provided
for in Sections 12 and 5(a), to wit:
SECTION 12. Implementation and Monitoring –
xxxx
(b) The Ministry of Health shall be principally
responsible for the implementation and enforcement of
the provisions of this Code. For this purpose, the
Ministry of Health shall have the following powers and
functions:
(1) To promulgate such rules and regulations as are
necessary or proper for the implementation of this Code
and the accomplishment of its purposes and objectives.
xxxx
(4) To exercise such other powers and functions as may
be necessary for or incidental to the attainment of the
purposes and objectives of this Code.
SECTION 5. Information and Education –
(a) The government shall ensure that objective and
consistent information is provided on infant feeding, for
use by families and those involved in the field of infant
nutrition. This responsibility shall cover the planning,
provision, design and dissemination of information, and
the control thereof, on infant nutrition. (Emphasis
supplied)
Further, DOH is authorized by the Milk Code to control
the content of any information on breastmilk vis-à-vis
breastmilk substitutes, supplement and related products,
in the following manner:
SECTION 5. x x x
(b) Informational and educational materials, whether
written, audio, or visual, dealing with the feeding of
infants and intended to reach pregnant women and
mothers of infants, shall include clear information on all
the following points: (1) the benefits and superiority of
breastfeeding; (2) maternal nutrition, and the preparation
for and maintenance of breastfeeding; (3) the negative
effect on breastfeeding of introducing partial
bottlefeeding; (4) the difficulty of reversing the decision
not to breastfeed; and (5) where needed, the proper use
of infant formula, whether manufactured industrially or
home-prepared. When such materials contain
information about the use of infant formula, they shall
include the social and financial implications of its use;
the health hazards of inappropriate foods or feeding
methods; and, in particular, the health hazards of
unnecessary or improper use of infant formula and
other breastmilk substitutes. Such materials shall not
use any picture or text which may idealize the use of
breastmilk substitutes.
SECTION 8. Health Workers –
xxxx
(b) Information provided by manufacturers and
distributors to health professionals regarding products
within the scope of this Code shall be restricted to
scientific and factual matters, and such information
shall not imply or create a belief that bottlefeeding is
equivalent or superior to breastfeeding. It shall also
include the information specified in Section 5(b).
SECTION 10. Containers/Label –
(a) Containers and/or labels shall be designed to provide
the necessary information about the appropriate use of
the products, and in such a way as not to discourage
breastfeeding.
xxxx
(d) The term "humanized," "maternalized" or similar
terms shall not be used. (Emphasis supplied)
The DOH is also authorized to control the purpose of the
information and to whom such information may be
disseminated under Sections 6 through 9 of the Milk
Code54 to ensure that the information that would reach
pregnant women, mothers of infants, and health
professionals and workers in the health care system is
restricted to scientific and factual matters and shall not
imply or create a belief that bottlefeeding is equivalent or
superior to breastfeeding.
It bears emphasis, however, that the DOH's power under
the Milk Code to control information regarding
breastmilk vis-a-vis breastmilk substitutes is not
absolute as the power to control does not encompass the
power to absolutely prohibit the advertising, marketing,
and promotion of breastmilk substitutes.
The following are the provisions of the Milk Code that
unequivocally indicate that the control over information
given to the DOH is not absolute and that absolute
prohibition is not contemplated by the Code:
a) Section 2 which requires adequate information and
appropriate marketing and distribution of breastmilk
substitutes, to wit:
SECTION 2. Aim of the Code – The aim of the Code is
to contribute to the provision of safe and adequate
nutrition for infants by the protection and promotion of
breastfeeding and by ensuring the proper use of
breastmilk substitutes and breastmilk supplements when
these are necessary, on the basis of adequate information
and through appropriate marketing and distribution.
b) Section 3 which specifically states that the Code
applies to the marketing of and practices related to
breastmilk substitutes, including infant formula, and to
information concerning their use;
c) Section 5(a) which provides that the government shall
ensure that objective and consistent information is
provided on infant feeding;
d) Section 5(b) which provides that written, audio or
visual informational and educational materials shall not
use any picture or text which may idealize the use of
breastmilk substitutes and should include information on
the health hazards of unnecessary or improper use of said
product;
e) Section 6(a) in relation to Section 12(a) which creates
and empowers the IAC to review and examine
advertising, promotion, and other marketing materials;
f) Section 8(b) which states that milk companies may
provide information to health professionals but such
information should be restricted to factual and scientific
matters and shall not imply or create a belief that
bottlefeeding is equivalent or superior to breastfeeding;
and
g) Section 10 which provides that containers or labels
should not contain information that would discourage
breastfeeding and idealize the use of infant formula.
It is in this context that the Court now examines the
assailed provisions of the RIRR regarding labeling and
advertising.
Sections 1355 on "total effect" and 2656 of Rule VII of the
RIRR contain some labeling requirements, specifically: a)
that there be a statement that there is no substitute to
breastmilk; and b) that there be a statement that
powdered infant formula may contain pathogenic
microorganisms and must be prepared and used
appropriately. Section 1657 of the RIRR prohibits all
health and nutrition claims for products within the scope
of the Milk Code, such as claims of increased emotional
and intellectual abilities of the infant and young child.
These requirements and limitations are consistent with
the provisions of Section 8 of the Milk Code, to wit:
SECTION 8. Health workers -
xxxx
scientific and factual matters, and such information
shall not imply or create a belief that bottlefeeding is
include the information specified in Section 5.58
(Emphasis supplied)
and Section 10(d)59 which bars the use on containers and
labels of the terms "humanized," "maternalized," or
similar terms.
These provisions of the Milk Code expressly forbid
information that would imply or create a belief that there
is any milk product equivalent to breastmilk or which is
humanized or maternalized, as such information would
be inconsistent with the superiority of breastfeeding.
It may be argued that Section 8 of the Milk Code refers
only to information given to health workers regarding
breastmilk substitutes, not to containers and labels
thereof. However, such restrictive application of Section
8(b) will result in the absurd situation in which milk
companies and distributors are forbidden to claim to
health workers that their products are substitutes or
equivalents of breastmilk, and yet be allowed to display
on the containers and labels of their products the exact
opposite message. That askewed interpretation of the
Milk Code is precisely what Section 5(a) thereof seeks to
avoid by mandating that all information regarding
breastmilk vis-a-vis breastmilk substitutes be consistent,
at the same time giving the government control over
planning, provision, design, and dissemination of
information on infant feeding.
Thus, Section 26(c) of the RIRR which requires
containers and labels to state that the product offered is
not a substitute for breastmilk, is a reasonable means of
enforcing Section 8(b) of the Milk Code and deterring
circumvention of the protection and promotion of
breastfeeding as embodied in Section 260 of the Milk
Code.
Section 26(f)61 of the RIRR is an equally reasonable
labeling requirement. It implements Section 5(b) of the
Milk Code which reads:
SECTION 5. x x x
xxxx
the following points: x x x (5) where needed, the proper
use of infant formula, whether manufactured industrially
or home-prepared. When such materials contain
the health hazards of inappropriate foods or feeding
unnecessary or improper use of infant formula and
other breastmilk substitutes. Such materials shall not use
any picture or text which may idealize the use of
breastmilk substitutes. (Emphasis supplied)
The label of a product contains information about said
product intended for the buyers thereof. The buyers of
breastmilk substitutes are mothers of infants, and Section
26 of the RIRR merely adds a fair warning about the
likelihood of pathogenic microorganisms being present
in infant formula and other related products when these
are prepared and used inappropriately.
Petitioner’s counsel has admitted during the hearing on
June 19, 2007 that formula milk is prone to
contaminations and there is as yet no technology that
allows production of powdered infant formula that
eliminates all forms of contamination.62
Ineluctably, the requirement under Section 26(f) of the
RIRR for the label to contain the message regarding
health hazards including the possibility of contamination
with pathogenic microorganisms is in accordance with
Section 5(b) of the Milk Code.
The authority of DOH to control information regarding
breastmilk vis-a-vis breastmilk substitutes and
supplements and related products cannot be questioned.
It is its intervention into the area of advertising,
promotion, and marketing that is being assailed by
petitioner.
In furtherance of Section 6(a) of the Milk Code, to wit:
SECTION 6. The General Public and Mothers. –
(a) No advertising, promotion or other marketing
materials, whether written, audio or visual, for products
within the scope of this Code shall be printed, published,
distributed, exhibited and broadcast unless such materials
are duly authorized and approved by an inter-agency
committee created herein pursuant to the applicable
standards provided for in this Code.
the Milk Code invested regulatory authority over
advertising, promotional and marketing materials to an
IAC, thus:
SECTION 12. Implementation and Monitoring -
(a) For purposes of Section 6(a) of this Code, an
inter-agency committee composed of the following
members is hereby created:
Minister of Health ------------------- Chairman

Minister of Trade and ------------------- Member
Industry
Minister of Justice ------------------- Member
Minister of Social ------------------- Member
Services and
Development
The members may designate their duly authorized
representative to every meeting of the Committee.
The Committee shall have the following powers and
functions:
(1) To review and examine all advertising. promotion or
other marketing materials, whether written, audio or
visual, on products within the scope of this Code;
(2) To approve or disapprove, delete objectionable
portions from and prohibit the printing, publication,
distribution, exhibition and broadcast of, all advertising
promotion or other marketing materials, whether written,
audio or visual, on products within the scope of this
Code;
(3) To prescribe the internal and operational procedure
for the exercise of its powers and functions as well as the
performance of its duties and responsibilities; and
(4) To promulgate such rules and regulations as are
necessary or proper for the implementation of Section
6(a) of this Code. x x x (Emphasis supplied)
However, Section 11 of the RIRR, to wit:
SECTION 11. Prohibition – No advertising, promotions,
sponsorships, or marketing materials and activities for
breastmilk substitutes intended for infants and young
children up to twenty-four (24) months, shall be allowed,
because they tend to convey or give subliminal messages
or impressions that undermine breastmilk and
breastfeeding or otherwise exaggerate breastmilk
substitutes and/or replacements, as well as related
products covered within the scope of this Code.
prohibits advertising, promotions, sponsorships or
marketing materials and activities for breastmilk
substitutes in line with the RIRR’s declaration of
principle under Section 4(f), to wit:
SECTION 4. Declaration of Principles –
xxxx
(f) Advertising, promotions, or sponsorships of infant
formula, breastmilk substitutes and other related products
are prohibited.
The DOH, through its co-respondents, evidently
arrogated to itself not only the regulatory authority given
to the IAC but also imposed absolute prohibition on
advertising, promotion, and marketing.
Yet, oddly enough, Section 12 of the RIRR reiterated the
requirement of the Milk Code in Section 6 thereof for
prior approval by IAC of all advertising, marketing and
promotional materials prior to dissemination.
Even respondents, through the OSG, acknowledged the
authority of IAC, and repeatedly insisted, during the oral
arguments on June 19, 2007, that the prohibition under
Section 11 is not actually operational, viz:
SOLICITOR GENERAL DEVANADERA:
xxxx
x x x Now, the crux of the matter that is being questioned
by Petitioner is whether or not there is an absolute
prohibition on advertising making AO 2006-12
unconstitutional. We maintained that what AO 2006-12
provides is not an absolute prohibition because Section
11 while it states and it is entitled prohibition it states
that no advertising, promotion, sponsorship or marketing
materials and activities for breast milk substitutes
intended for infants and young children up to 24 months
shall be allowed because this is the standard they tend to
convey or give subliminal messages or impression
undermine that breastmilk or breastfeeding x x x.
We have to read Section 11 together with the other
Sections because the other Section, Section 12, provides
for the inter agency committee that is empowered to
process and evaluate all the advertising and promotion
materials.
xxxx
What AO 2006-12, what it does, it does not prohibit the
sale and manufacture, it simply regulates the
advertisement and the promotions of breastfeeding milk
substitutes.
xxxx
Now, the prohibition on advertising, Your Honor, must
be taken together with the provision on the Inter-Agency
Committee that processes and evaluates because there
may be some information dissemination that are straight
forward information dissemination. What the AO 2006 is
trying to prevent is any material that will undermine the
practice of breastfeeding, Your Honor.
xxxx
ASSOCIATE JUSTICE SANTIAGO:
Madam Solicitor General, under the Milk Code, which
body has authority or power to promulgate Rules and
Regulations regarding the Advertising, Promotion and
Marketing of Breastmilk Substitutes?
Your Honor, please, it is provided that the Inter-Agency
Committee, Your Honor.
xxxx
ASSOCIATE JUSTICE SANTIAGO:
x x x Don't you think that the Department of Health
overstepped its rule making authority when it totally
banned advertising and promotion under Section 11
prescribed the total effect rule as well as the content of
materials under Section 13 and 15 of the rules and
regulations?
Your Honor, please, first we would like to stress that
there is no total absolute ban. Second, the Inter-Agency
Committee is under the Department of Health, Your
Honor.
xxxx
ASSOCIATE JUSTICE NAZARIO:
x x x Did I hear you correctly, Madam Solicitor, that
there is no absolute ban on advertising of breastmilk
substitutes in the Revised Rules?
Yes, your Honor.
But, would you nevertheless agree that there is an
absolute ban on advertising of breastmilk substitutes
intended for children two (2) years old and younger?
It's not an absolute ban, Your Honor, because we have
the Inter-Agency Committee that can evaluate some
advertising and promotional materials, subject to the
standards that we have stated earlier, which are- they
should not undermine breastfeeding, Your Honor.
xxxx
x x x Section 11, while it is titled Prohibition, it must be
taken in relation with the other Sections, particularly 12
and 13 and 15, Your Honor, because it is recognized that
the Inter-Agency Committee has that power to evaluate
promotional materials, Your Honor.
So in short, will you please clarify there's no absolute
ban on advertisement regarding milk substitute regarding
infants two (2) years below?
We can proudly say that the general rule is that there is a
prohibition, however, we take exceptions and standards
have been set. One of which is that, the Inter-Agency
Committee can allow if the advertising and promotions
will not undermine breastmilk and breastfeeding, Your
Honor.63
Sections 11 and 4(f) of the RIRR are clearly violative of
the Milk Code.
However, although it is the IAC which is authorized to
promulgate rules and regulations for the approval or
rejection of advertising, promotional, or other marketing
materials under Section 12(a) of the Milk Code, said
provision must be related to Section 6 thereof which in
turn provides that the rules and regulations must be
"pursuant to the applicable standards provided for in this
Code." Said standards are set forth in Sections 5(b), 8(b),
and 10 of the Code, which, at the risk of being repetitious,
and for easy reference, are quoted hereunder:
xxxx
the following points: (1) the benefits and superiority of
breastfeeding; (2) maternal nutrition, and the preparation
for and maintenance of breastfeeding; (3) the negative
effect on breastfeeding of introducing partial
bottlefeeding; (4) the difficulty of reversing the decision
not to breastfeed; and (5) where needed, the proper use
of infant formula, whether manufactured industrially or
home-prepared. When such materials contain
the health hazards of inappropriate foods of feeding
unnecessary or improper use of infant formula and other
breastmilk substitutes. Such materials shall not use any
picture or text which may idealize the use of breastmilk
substitutes.
xxxx
SECTION 8. Health Workers. –
xxxx
scientific and factual matters and such information shall
not imply or create a belief that bottle feeding is
include the information specified in Section 5(b).
xxxx
SECTION 10. Containers/Label –
(a) Containers and/or labels shall be designed to provide
the necessary information about the appropriate use of
the products, and in such a way as not to discourage
breastfeeding.
(b) Each container shall have a clear, conspicuous and
easily readable and understandable message in Pilipino
or English printed on it, or on a label, which message can
not readily become separated from it, and which shall
include the following points:
(i) the words "Important Notice" or their equivalent;
(ii) a statement of the superiority of breastfeeding;
(iii) a statement that the product shall be used only on the
advice of a health worker as to the need for its use and
the proper methods of use; and
(iv) instructions for appropriate preparation, and a
warning against the health hazards of inappropriate
preparation.
Section 12(b) of the Milk Code designates the DOH as
the principal implementing agency for the enforcement
of the provisions of the Code. In relation to such
responsibility of the DOH, Section 5(a) of the Milk Code
states that:
(a) The government shall ensure that objective and
consistent information is provided on infant feeding, for
use by families and those involved in the field of infant
nutrition. This responsibility shall cover the planning,
provision, design and dissemination of information, and
the control thereof, on infant nutrition. (Emphasis
supplied)
Thus, the DOH has the significant responsibility to
translate into operational terms the standards set
forth in Sections 5, 8, and 10 of the Milk Code, by
which the IAC shall screen advertising, promotional,
or other marketing materials.
It is pursuant to such responsibility that the DOH
correctly provided for Section 13 in the RIRR which
reads as follows:
SECTION 13. "Total Effect" - Promotion of products
within the scope of this Code must be objective and
should not equate or make the product appear to be as
good or equal to breastmilk or breastfeeding in the
advertising concept. It must not in any case undermine
breastmilk or breastfeeding. The "total effect" should not
directly or indirectly suggest that buying their product
would produce better individuals, or resulting in greater
love, intelligence, ability, harmony or in any manner
bring better health to the baby or other such exaggerated
and unsubstantiated claim.
Such standards bind the IAC in formulating its rules and
regulations on advertising, promotion, and marketing.
Through that single provision, the DOH exercises control
over the information content of advertising, promotional
and marketing materials on breastmilk vis-a-vis
breastmilk substitutes, supplements and other related
products. It also sets a viable standard against which the
IAC may screen such materials before they are made
public.
In Equi-Asia Placement, Inc. vs. Department of Foreign
Affairs,64 the Court held:
x x x [T]his Court had, in the past, accepted as sufficient
standards the following: "public interest," "justice and
equity," "public convenience and welfare," and
"simplicity, economy and welfare."65
In this case, correct information as to infant feeding and
nutrition is infused with public interest and welfare.
4. With regard to activities for dissemination of
information to health professionals, the Court also finds
that there is no inconsistency between the provisions of
the Milk Code and the RIRR. Section 7(b)66 of the Milk
Code, in relation to Section 8(b)67 of the same Code,
allows dissemination of information to health
professionals but such information is restricted to
scientific and factual matters.
Contrary to petitioner's claim, Section 22 of the RIRR
does not prohibit the giving of information to health
professionals on scientific and factual matters. What it
prohibits is the involvement of the manufacturer and
distributor of the products covered by the Code in
activities for the promotion, education and production of
Information, Education and Communication (IEC)
materials regarding breastfeeding that are intended for
women and children. Said provision cannot be
construed to encompass even the dissemination of
information to health professionals, as restricted by
the Milk Code.
5. Next, petitioner alleges that Section 8(e)68 of the Milk
Code permits milk manufacturers and distributors to
extend assistance in research and in the continuing
education of health professionals, while Sections 22 and
32 of the RIRR absolutely forbid the same. Petitioner
also assails Section 4(i)69 of the RIRR prohibiting milk
manufacturers' and distributors' participation in any
policymaking body in relation to the advancement of
breastfeeding.
Section 4(i) of the RIRR provides that milk companies
and their representatives should not form part of any
policymaking body or entity in relation to the
advancement of breastfeeding. The Court finds nothing
in said provisions which contravenes the Milk Code.
Note that under Section 12(b) of the Milk Code, it is the
DOH which shall be principally responsible for the
implementation and enforcement of the provisions of
said Code. It is entirely up to the DOH to decide which
entities to call upon or allow to be part of policymaking
bodies on breastfeeding. Therefore, the RIRR's
prohibition on milk companies’ participation in any
policymaking body in relation to the advancement of
breastfeeding is in accord with the Milk Code.
Petitioner is also mistaken in arguing that Section 22 of
the RIRR prohibits milk companies from giving
reasearch assistance and continuing education to health
professionals. Section 2270 of the RIRR does not
pertain to research assistance to or the continuing
education of health professionals; rather, it deals with
breastfeeding promotion and education for women and
children. Nothing in Section 22 of the RIRR prohibits
milk companies from giving assistance for research or
continuing education to health professionals; hence,
petitioner's argument against this particular provision
must be struck down.
It is Sections 971 and 1072 of the RIRR which govern
research assistance. Said sections of the RIRR provide
that research assistance for health workers and
researchers may be allowed upon approval of an
ethics committee, and with certain disclosure
requirements imposed on the milk company and on
the recipient of the research award.
The Milk Code endows the DOH with the power to
determine how such research or educational assistance
may be given by milk companies or under what
conditions health workers may accept the assistance.
Thus, Sections 9 and 10 of the RIRR imposing
limitations on the kind of research done or extent of
assistance given by milk companies are completely in
accord with the Milk Code.
Petitioner complains that Section 3273 of the RIRR
prohibits milk companies from giving assistance, support,
logistics or training to health workers. This provision is
within the prerogative given to the DOH under Section
8(e)74 of the Milk Code, which provides that
manufacturers and distributors of breastmilk substitutes
may assist in researches, scholarships and the continuing
education, of health professionals in accordance with the
rules and regulations promulgated by the Ministry of
Health, now DOH.
6. As to the RIRR's prohibition on donations, said
provisions are also consistent with the Milk Code.
Section 6(f) of the Milk Code provides that donations
may be made by manufacturers and distributors of
breastmilk substitutes upon the request or with the
approval of the DOH. The law does not proscribe the
refusal of donations. The Milk Code leaves it purely to
the discretion of the DOH whether to request or accept
such donations. The DOH then appropriately exercised
its discretion through Section 5175 of the RIRR which
sets forth its policy not to request or approve donations
from manufacturers and distributors of breastmilk
substitutes.
It was within the discretion of the DOH when it provided
in Section 52 of the RIRR that any donation from milk
companies not covered by the Code should be coursed
through the IAC which shall determine whether such
donation should be accepted or refused. As reasoned out
by respondents, the DOH is not mandated by the Milk
Code to accept donations. For that matter, no person or
entity can be forced to accept a donation. There is,
therefore, no real inconsistency between the RIRR and
the law because the Milk Code does not prohibit the
DOH from refusing donations.
7. With regard to Section 46 of the RIRR providing for
administrative sanctions that are not found in the Milk
Code, the Court upholds petitioner's objection thereto.
Respondent's reliance on Civil Aeronautics Board v.
Philippine Air Lines, Inc.76 is misplaced. The glaring
difference in said case and the present case before the
Court is that, in the Civil Aeronautics Board, the Civil
Aeronautics Administration (CAA) was expressly
granted by the law (R.A. No. 776) the power to impose
fines and civil penalties, while the Civil Aeronautics
Board (CAB) was granted by the same law the power to
review on appeal the order or decision of the CAA and to
determine whether to impose, remit, mitigate, increase or
compromise such fine and civil penalties. Thus, the
Court upheld the CAB's Resolution imposing
administrative fines.
In a more recent case, Perez v. LPG Refillers Association
of the Philippines, Inc.,77 the Court upheld the
Department of Energy (DOE) Circular No. 2000-06-10
implementing Batas Pambansa (B.P.) Blg. 33. The
circular provided for fines for the commission of
prohibited acts. The Court found that nothing in the
circular contravened the law because the DOE was
expressly authorized by B.P. Blg. 33 and R.A. No. 7638
to impose fines or penalties.
In the present case, neither the Milk Code nor the
Revised Administrative Code grants the DOH the
authority to fix or impose administrative fines. Thus,
without any express grant of power to fix or impose such
fines, the DOH cannot provide for those fines in the
RIRR. In this regard, the DOH again exceeded its
authority by providing for such fines or sanctions in
Section 46 of the RIRR. Said provision is, therefore, null
and void.
The DOH is not left without any means to enforce its
rules and regulations. Section 12(b) (3) of the Milk Code
authorizes the DOH to "cause the prosecution of the
violators of this Code and other pertinent laws on
products covered by this Code." Section 13 of the Milk
Code provides for the penalties to be imposed on
violators of the provision of the Milk Code or the rules
and regulations issued pursuant to it, to wit:
SECTION 13. Sanctions –
(a) Any person who violates the provisions of this Code
or the rules and regulations issued pursuant to this
Code shall, upon conviction, be punished by a penalty of
two (2) months to one (1) year imprisonment or a fine of
not less than One Thousand Pesos (P1,000.00) nor more
than Thirty Thousand Pesos (P30,000.00) or both.
Should the offense be committed by a juridical person,
the chairman of the Board of Directors, the president,
general manager, or the partners and/or the persons
directly responsible therefor, shall be penalized.
(b) Any license, permit or authority issued by any
government agency to any health worker, distributor,
manufacturer, or marketing firm or personnel for the
practice of their profession or occupation, or for the
pursuit of their business, may, upon recommendation of
the Ministry of Health, be suspended or revoked in the
event of repeated violations of this Code, or of the rules
and regulations issued pursuant to this Code. (Emphasis
supplied)
8. Petitioner’s claim that Section 57 of the RIRR repeals
existing laws that are contrary to the RIRR is frivolous.
Section 57 reads:
SECTION 57. Repealing Clause - All orders, issuances,
and rules and regulations or parts thereof inconsistent
with these revised rules and implementing regulations
are hereby repealed or modified accordingly.
Section 57 of the RIRR does not provide for the repeal of
laws but only orders, issuances and rules and regulations.
Thus, said provision is valid as it is within the DOH's
rule-making power.
An administrative agency like respondent possesses
quasi-legislative or rule-making power or the power to
make rules and regulations which results in delegated
legislation that is within the confines of the granting
statute and the Constitution, and subject to the doctrine
of non-delegability and separability of powers.78 Such
express grant of rule-making power necessarily includes
the power to amend, revise, alter, or repeal the same.79
This is to allow administrative agencies flexibility in
formulating and adjusting the details and manner by
which they are to implement the provisions of a law,80 in
order to make it more responsive to the times. Hence, it
is a standard provision in administrative rules that prior
issuances of administrative agencies that are inconsistent
therewith are declared repealed or modified.
In fine, only Sections 4(f), 11 and 46 are ultra vires,
beyond the authority of the DOH to promulgate and in
contravention of the Milk Code and, therefore, null and
void. The rest of the provisions of the RIRR are in
consonance with the Milk Code.
Lastly, petitioner makes a "catch-all" allegation that:
x x x [T]he questioned RIRR sought to be implemented
by the Respondents is unnecessary and oppressive, and
is offensive to the due process clause of the
Constitution, insofar as the same is in restraint of
trade and because a provision therein is inadequate to
provide the public with a comprehensible basis to
determine whether or not they have committed a
violation.81 (Emphasis supplied)
Petitioner refers to Sections 4(f),82 4(i),83 5(w),84 11,85
22,86 32,87 46,88 and 5289 as the provisions that suppress
the trade of milk and, thus, violate the due process clause
of the Constitution.
The framers of the constitution were well aware that
trade must be subjected to some form of regulation for
the public good. Public interest must be upheld over
business interests.90 In Pest Management Association of
the Philippines v. Fertilizer and Pesticide Authority,91 it
was held thus:
x x x Furthermore, as held in Association of Philippine
Coconut Desiccators v. Philippine Coconut Authority,
despite the fact that "our present Constitution
enshrines free enterprise as a policy, it nonetheless
reserves to the government the power to intervene
whenever necessary to promote the general welfare."
There can be no question that the unregulated use or
proliferation of pesticides would be hazardous to our
environment. Thus, in the aforecited case, the Court
declared that "free enterprise does not call for removal
of ‘protective regulations’." x x x It must be clearly
explained and proven by competent evidence just
exactly how such protective regulation would result in
the restraint of trade. [Emphasis and underscoring
supplied]
In this case, petitioner failed to show that the proscription
of milk manufacturers’ participation in any policymaking
body (Section 4(i)), classes and seminars for women and
children (Section 22); the giving of assistance, support
and logistics or training (Section 32); and the giving of
donations (Section 52) would unreasonably hamper the
trade of breastmilk substitutes. Petitioner has not
established that the proscribed activities are
indispensable to the trade of breastmilk substitutes.
Petitioner failed to demonstrate that the aforementioned
provisions of the RIRR are unreasonable and oppressive
for being in restraint of trade.
Petitioner also failed to convince the Court that Section
5(w) of the RIRR is unreasonable and oppressive. Said
section provides for the definition of the term "milk
company," to wit:
SECTION 5 x x x. (w) "Milk Company" shall refer to the
owner, manufacturer, distributor of infant formula,
follow-up milk, milk formula, milk supplement,
breastmilk substitute or replacement, or by any other
description of such nature, including their representatives
who promote or otherwise advance their commercial
interests in marketing those products;
On the other hand, Section 4 of the Milk Code provides:
(d) "Distributor" means a person, corporation or any
other entity in the public or private sector engaged in the
business (whether directly or indirectly) of marketing at
the wholesale or retail level a product within the scope of
this Code. A "primary distributor" is a manufacturer's
sales agent, representative, national distributor or broker.
xxxx
(j) "Manufacturer" means a corporation or other entity in
the public or private sector engaged in the business or
function (whether directly or indirectly or through an
agent or and entity controlled by or under contract with it)
of manufacturing a products within the scope of this
Code.
Notably, the definition in the RIRR merely merged
together under the term "milk company" the entities
defined separately under the Milk Code as "distributor"
and "manufacturer." The RIRR also enumerated in
Section 5(w) the products manufactured or distributed by
an entity that would qualify it as a "milk company,"
whereas in the Milk Code, what is used is the phrase
"products within the scope of this Code." Those are the
only differences between the definitions given in the
Milk Code and the definition as re-stated in the RIRR.
Since all the regulatory provisions under the Milk Code
apply equally to both manufacturers and distributors, the
Court sees no harm in the RIRR providing for just one
term to encompass both entities. The definition of "milk
company" in the RIRR and the definitions of
"distributor" and "manufacturer" provided for under the
Milk Code are practically the same.
The Court is not convinced that the definition of "milk
company" provided in the RIRR would bring about any
change in the treatment or regulation of "distributors"
and "manufacturers" of breastmilk substitutes, as defined
under the Milk Code.
Except Sections 4(f), 11 and 46, the rest of the provisions
of the RIRR are in consonance with the objective,
purpose and intent of the Milk Code, constituting
reasonable regulation of an industry which affects public
health and welfare and, as such, the rest of the RIRR do
not constitute illegal restraint of trade nor are they
violative of the due process clause of the Constitution.
WHEREFORE, the petition is PARTIALLY
GRANTED. Sections 4(f), 11 and 46 of Administrative
Order No. 2006-0012 dated May 12, 2006 are declared
NULL and VOID for being ultra vires. The Department
of Health and respondents are PROHIBITED from
implementing said provisions.
The Temporary Restraining Order issued on August 15,
2006 is LIFTED insofar as the rest of the provisions of
Administrative Order No. 2006-0012 is concerned.
SO ORDERED.
Puno, (Chief Justice), Quisumbing, Ynares-Santiago,
Sandoval-Gutierrez, Carpio, Corona, Carpio-Morales,
Azcuna, Tinga, Chico-Nazario, Garcia, Velasco, Jr.,
Nachura, Reyes, JJ., concur.

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Republic of the Philippines

MILK CODE RIRR

2. The Milk Code recognizes that infant formula may be

MILK CODE RIRR

3. The Milk Code only regulates and does not impose

MILK CODE RIRR

4. The RIRR imposes additional labeling requirements

MILK CODE RIRR

5. The Milk Code allows dissemination of information

MILK CODE RIRR

6. The Milk Code permits milk manufacturers and

MILK CODE RIRR

7. The Milk Code regulates the giving of donations;

MILK CODE RIRR

8. The RIRR provides for administrative sanctions not

MILK CODE RIRR

9. The RIRR provides for repeal of existing laws to the

Minister of Health ------------------- Chairman

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