Pharmaceutical and Health Care Association of The Philippines vs. Duque III, 535 SCRA 265

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 11 2 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 agreements 1 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.
Article 21. The Health Assembly shall have authority to 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:
Article 23. The Health Assembly shall have authority to 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 ensure that safe Section 2. Purpose – These Revised
and adequate nutrition for infants is Rules and Regulations are hereby
provided, there is a need to protect and promulgated to ensure the provision of
promote breastfeeding and to inform the safe and adequate nutrition for infants and
public about the proper use of breastmilk young children by the promotion, protectio
substitutes and supplements and related and support of breastfeeding and by
products through adequate, consistent and ensuring the proper use of breastmilk
objective information and appropriate substitutes, breastmilk supplements and
regulation of the marketing and distribution related products when these are medically
of the said substitutes, supplements and indicated and only when necessary, on the
related products; basis of adequate information and through
appropriate marketing and distribution.
SECTION 4(e). "Infant" means a person
falling within the age bracket of 0-12 Section 5(ff). "Young Child" means a
months. 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

Section 4. Declaration of Principles
WHEREAS, in order to ensure that safe – The following are the underlying
and adequate nutrition for infants is principles from which the revised rules and
provided, there is a need to protect and regulations are premised upon:
promote breastfeeding and to inform the
public about the proper use of breastmilk a. Exclusive breastfeeding is for
substitutes and supplements and related infants from 0 to six (6) months.
products through adequate, consistent and
objective information and appropriate b. There is no substitute or replacement fo
regulation of the marketing and distribution breastmilk.
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 Public and Section 4. Declaration of Principles
Mothers. – – The following are the underlying
principles from which the revised rules and
(a) No advertising, promotion or other regulations are premised upon:
marketing materials, whether written, audio
or visual, for products within the scope of xxxx
this Code shall be printed, published,
distributed, exhibited and broadcast unless f. Advertising, promotions, or sponsor-
such materials are duly authorized and ships of infant formula, breastmilk
approved by an inter-agency substitutes and other related products are
committee created herein pursuant to the prohibited.
applicable standards provided for in this
Code. 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.
Section 13. "Total Effect" - Promotion of

products within the scope of this Code
must be objective and should not equate o
make the product appear to be as good or
equal to breastmilk or breastfeeding in the
advertising concept. It must not in any cas
undermine breastmilk or breastfeeding.
The "total effect" should not directly or
indirectly suggest that buying their produc
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. Containers/Label. – Section 26. Content – Each
container/label shall contain such
(a) Containers and/or labels shall be message, in both Filipino and English
designed to provide the necessary languages, and which message cannot be
information about the appropriate use of readily separated therefrom, relative the
the products, and in such a way as not to following points:
discourage breastfeeding.
(a) The words or phrase "Important Notice
(b) Each container shall have a clear, or "Government Warning" or their
conspicuous and easily readable and equivalent;
understandable message in Pilipino or
English printed on it, or on a label, which (b) A statement of the superiority of
message can not readily become breastfeeding;
separated from it, and which shall include
the following points: (c) A statement that there is no substitute
for breastmilk;
(i) the words "Important Notice" or their
equivalent; (d) A statement that the product shall be
used only on the advice of a health worker
(ii) a statement of the superiority of as to the need for its use and the proper
breastfeeding; methods of use;
(iii) a statement that the product shall be (e) Instructions for appropriate prepara-
used only on the advice of a health worker tion, and a warning against the health
as to the need for its use and the proper
methods of use; and hazards of inappropriate preparation; and
(iv) instructions for appropriate preparation, (f) The health hazards of unnecessary or
and a warning against the health hazards improper use of infant formula and other
of inappropriate preparation. related products including information that
powdered infant formula may contain
pathogenic microorganisms 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 System. – Section 22. No manufacturer, distributor,
or representatives of products covered by
(b) No facility of the health care system the Code shall be allowed to conduct or be
shall be used for the purpose of promoting involved in any activity on breastfeeding
infant formula or other products within the promotion, education and production of
scope of this Code. This Code does not, Information, Education and Communicatio
however, preclude the dissemination of (IEC) materials on breastfeeding, holding
information to health professionals as of or participating as speakers in classes o
provided in Section 8(b). seminars for women and children activities
and to avoid the use of these venues to
SECTION 8. Health Workers. - market their brands or company names.
(b) Information provided by manufacturers SECTION 16. All health and nutrition
and distributors to health professionals claims for products within the scope of the
regarding products within the scope of this Code are absolutely prohibited. For this
Code shall be restricted to scientific and purpose, any phrase or words that
factual matters and such information shall connotes to increase emotional, intellectua
not imply or create a belief that bottle- abilities of the infant and young child and
feeding is equivalent or superior to other like phrases shall not be allowed.
breastfeeding. It shall also include the
information specified in 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 Workers – Section 4. Declaration of Principles –
(e) Manufacturers and distributors of The following are the underlying principles
products within the scope of this Code may from which the revised rules and
assist in the research, scholarships and regulations are premised upon:
continuing education, of health
professionals, in accordance with the rules i. Milk companies, and their
and regulations promulgated by the representatives, should not form part of
Ministry of Health. any 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 Communicatio
(IEC) materials on breastfeeding, holding
of or participating as speakers in classes o
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 breastfeedin
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 Public and Section 51. Donations Within the Scope
Mothers. – of This Code - Donations of products,
materials, defined and covered under the
(f) Nothing herein contained shall prevent Milk Code and these implementing rules
donations from manufacturers and and regulations, shall be strictly prohibited
distributors of products within the scope of
this Code upon request by or with the Section 52. Other Donations By Milk
approval of the Ministry of Health. Companies Not 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, juridica
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 recal
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 compan
for the infraction.
For purposes of determining whether or no

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 2 42 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 3 45 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

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 5.58 (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 2 60 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

following points: x x x (5) where needed, the proper use of infant formula,
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. (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 Industry ------------------- Member

Minister of Justice ------------------- Member
Minister of Social Services and ------------------- Member

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
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

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,
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 of 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.
xxxx
SECTION 8. Health Workers. –

xxxx

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 bottle feeding is equivalent or superior to
breastfeeding. It shall also include the information specified in Section
5(b).
xxxx
(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.
Footnotes
1
Section 11, Rule 3, 1997 Rules of Civil Procedure which provides:
Section 11. Misjoinder and non-joinder of parties. - Neither

misjoinder nor non-joinder of parties is ground for dismissal of an
action. Parties may be dropped or added by order of the
court on motion of any party or on its own initiative at any stage
of the action and on such terms as are just. x x x (Emphasis
supplied)
2
Article 11. Implementation and monitoring
11.1 Governments should take action to give effect to the principles

and aim of this Code, as appropriate to their social and legislative
framework, including the adoption of national legislation,
regulations or other suitable measures. For this purpose,
governments should seek, when necessary, the cooperation of
WHO, UNICEF and other agencies of the United Nations system.
National policies and measures, including laws and regulations,
which are adopted to give effect to the principles and aim of this
Code should be publicly stated, and should apply on the same
basis to all those involved in the manufacture and marketing of
products within the scope of this Code.
xxxx
3
Petition, rollo, p. 12.
4
G.R. No. 131719, May 25, 2004, 429 SCRA 81.
5
Id. at 96-97.
6
G.R. No. 135092, May 4, 2006, 489 SCRA 382.
7
Id. at 396.
8
Annex "G", Petitioner's Memorandum dated July 19, 2007.
9
Annexes "H", "I", and "J" of Petitioner's Memorandum executed by Wyeth
Philippines, Inc., Bristol Myers Squibb (Phil.), Inc., and Abbott
Laboratories, Inc., respectively.
10
a) The UN Convention on the Rights of the Child (CRC); b) the
International Code of Marketing Breastmilk Substitutes (ICMBS); c) the
International Covenant on Economic, Social and Cultural Rights (CSCR);
d) the Convention on the Elimination of All Forms of Discrimination Against
Women (CEDAW); e) the Global Strategy for Infant and Young Child
Nutrition (Global Strategy); and f) various resolutions adopted by the
World Health Assembly.
Joaquin G. Bernas, S.J., Constitutional Structure and Powers of

11
Government (Notes and Cases) Part I ( 2005).
12
Id.
Joaquin G. Bernas, S.J., An Introduction to Public International Law,

13
2002 Ed., p. 57.
14
According to Fr. Bernas, the Austrian Constitution (Art. 9) and the
Constitution of the Federal Republic of Germany (Art. 25) also use the
incorporation method.
15
G.R. No. 139325, April 12, 2005, 455 SCRA 397.
16
Id. at 421.
Merlin M. Magallona, Fundamentals of Public International Law, 2005

17
Ed., p. 526.
18
Id. at 525.
Government of Hong Kong Special Administrative Region v. Olalia, G.R.

19
No. 153675, April 19, 2007.
20
Tañada v. Angara, 338 Phil. 546, 592 (1997).
Louis Henkin, Richard C. Pugh, Oscar Schachter, Hans

21
Smit, International Law, Cases and Materials, 2nd Ed., p. 96.
22
Supra note 13, at 10-13.
23
Minucher v. Court of Appeals, 445 Phil. 250, 269 (2003).
24
Article 57. The various specialized agencies, established by
intergovernmental agreement and having wide international
responsibilities, as defined in their basic instruments, in economic, social,
cultural, educational, health, and related fields, shall be brought into
relationship with the United Nations in accordance with the provisions of
Article 63.
Such agencies thus brought into relationship with the United Nations are
hereinafter referred to as specialized agencies.
Article 63. The Economic and Social Council may enter into agreements
25
with any of the agencies referred to in Article 57, defining the terms on
which the agency concerned shall be brought into relationship with the
United Nations. Such agreements shall be subject to approval by the
General Assembly.
It may coordinate the activities of the specialized agencies through

consultation with and recommendations to such agencies and through
recommendations to the General Assembly and to the Members of the
United Nations.
Article 18. The functions of the Health Assembly shall be: (a) to
26
determine the policies of the Organization x x x. (Emphasis supplied)
27
Article 21. The Health Assembly shall have authority to adopt regulations
concerning: x x x (e) advertising and labeling of biological, pharmaceutical
and similar products moving in international commerce. (Emphasis
supplied)
28
Article 23. The Health Assembly shall have authority to make
recommendations to Members with respect to any matter within the
competence of the Organization. (Emphasis supplied)
29
See David Fidler, Developments Involving SARS, International Law, and
Infectious Disease Control at the Fifty-Sixth Meeting of the World Health
Assembly, June 2003, ASIL.
In Resolution No. 34.22 (May 21, 1981), the WHA, acting under Article
30
23 of the WHO Constitution, adopted the ICBMS.
(a) In Resolution No. 35.26 (May 1982), the WHA urged member
states to implement the ICBMS as a "minimum requirement".
(b) In Resolution No. 39.28 (May 16, 1986), the WHA requested
the WHO Director General to direct the attention of member states
to the fact that any food or drink given before complementary
feeding is nutritionally required may interfere with the initiation or
maintenance of breastfeeding and therefore should neither be
promoted nor encouraged for us by infants during this period.
(c) In Resolution No. 43.3 (May 14, 1990), the WHA urged
member states to protect and promote breastfeeding as an
essential component of nutrition policies so as to enable infants to
be exclusively breastfed during the first four to six months of life.
(d) In Resolution No. 45.34 (May 14, 1992), the WHA urged
member states to implement the targets of the Innocenti
Declaration specifically, to give effect to the ICMBS.
(e) In Resolution No. 46.7 (May 10, 1993), the WHA urged
member states to strive to eliminate under-nutrition, malnutrition
and nutritional deficiency among children.
(f) In Resolution No. 47.5 (May 9, 1994), the WHA urged member
states to ensure that there are no donations of supplies of
breastmilk substitutes and other products covered by the ICMBS in
any part of the health care system.
(g) In Resolution No. 49.15 (May 25, 1996), the WHA urged
member states to ensure that complementary foods are not
marketed for or used in ways that undermine exclusive and
sustained breastfeeding.
(h) In Resolution No. 54.2 (May 2002), the WHA, noting that
"despite the fact that the International Code of Marketing of
Breastmilk Substitutes and relevant subsequent World Health
Assembly resolutions state that there should be no advertising or
other forms of promotion of products within its scope, new modern
communication methods including electronic means, are currently
increasingly being used to promote such products; and conscious
of the need for the Codex Alimentarius Commission to take the
International Code and subsequent relevant Health Assembly
resolutions into consideration in dealing with health claims in the
development of food standards and guidelines x x x," urged
member states to develop new approaches to protect, promote and
support exclusive breastfeeding for six months as a global public
health recommendation.
(i) In Resolution No. 55.25 (May 15, 2002), the WHA requested
the Codex Alimentarius Commission to ensure that labelling of
processed foods for infants and young children be consistent with
the WHO policy under the ICBMS.
(j) In Resolution No. 58.32 (May 25, 2005), the WHA urged
member states to continue to protect and promote exclusive
breastfeeding for six months.
(k) In Resolution No. 59.21 (May 27, 2006), the WHA reiterated its
support for the Gobal strategy for Infant and Young Child Feeding.
31
David Fidler, supra note 29.
32
Article 38. 1. The Court, whose function is to decide in accordance with
international law such disputes as are submitted to it, shall apply: a)
international conventions, whether general or particular, establishing rules
expressly recognized by the contesting states; b) international custom, as
evidence of a general practice accepted as law; c) the general principles
of law recognized by civilized nations; d) subject to the provisions of Article
59, judicial decisions and the teachings of the most highly qualified
publicists of the various nations, as subsidiary means for the
determination of rules of law.
33
Supra note 29.
34
Louis Henkin, et al., International Law, Cases and Materials, 2nd Ed.,
supra note 21, at 114-136.
35
Supra note 19.
36
90 Phil. 70 (1951).
37
Supra note 15.
38
G.R. No. 159938, March 31, 2006, 486 SCRA 405.
39
Edward Kwakwa, Some Comments on Rulemaking at the World
Intellectual Property Organization, www.law.duke.edu/shell/cite;
September 13, 2007, 12:33, citing the 1999 WIPO Resolution Concerning
Provisions on the Protection of Well-Known Marks, 2000 WIPO
Recommendation Concerning Trademark Licenses, and 2001 WIPO
Recommendation Concerning Provisions on the Protection of Marks and
other Industrial Property Rights in Signs on the Internet.
40
Id.
41
Supra note 29.
42
Section 2. Purpose – These Revised Rules and Regulations are hereby
promulgated to ensure the provision of safe and adequate nutrition for
infants and young children by the promotion, protection and support of
breastfeeding and by ensuring the proper use of breastmilk substitutes,
breastmilk supplements and related products when these are medically
indicated and only when necessary, on the basis of adequate information
and through appropriate marketing and distribution. (Underscoring
supplied)
43
Section 5(ff). "Young Child" means a person from the age of more than
twelve (12) months up to the age of three (3) years (36
months). (Underscoring supplied)
44
G.R. No. 144218, July 14, 2006, 495 SCRA 42, 55.
45
See pp. 19-21.
46
See p. 21.
Executive Order No. 292, made effective on November 23, 1989 by

47
Proclamation No. 495.
48
Jacobson v. Massachusetts, 197 US 11 (1905); Beltran v. Secretary of
Health G.R. No. 133640, November 25, 2005, 476 SCRA 168, 196; St.
Lukes’s Medical Center Employees Association- AFW v. National Labor
Relations Commission, G.R. No. 162053, March 7, 2007; Tablarin v.
Gutierrez, G.R. No. L-78164, July 31, 1987, 152 SCRA 730, 741; Pollution
Adjudication Board v. Court of Appeals, G.R. No. 93891, March 11, 1991,
195 SCRA 112, 123-124; Rivera v. Campbell, 34 Phil. 348, 353-354
(1916); Lorenzo v. Director of Health, 50 Phil. 595, 597 (1927).
49
As early as People v. Pomar, 46 Phil. 440, 445 (1924), we already noted
that "advancing civilization is bringing within the scope of police
power of the state today things which were not thought of as being
with in such power yesterday. The development of civilization, the
rapidly increasing population, the growth of public opinion, with [an
increasing] desire on the part of the masses and of the government to look
after and care for the interests of the individuals of the state, have brought
within the police power of the state many questions for regulation which
formerly were not so considered."
50
Act No. 2711, approved on March 10, 1917.
51
Known then as Public Health Service
52
Section 1, Chapter I, Title IX, Executive Order No. 292.
53
Id. at Section 3.
54
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.
(b) Manufacturers and distributors shall not be permitted to give,

directly or indirectly, samples and supplies of products within the
scope of this Code or gifts of any sort to any member of the general
public, including members of their families, to hospitals and other
health institutions, as well as to personnel within the health care
system, save as otherwise provided in this Code.
(c) There shall be no point-of-sale advertising, giving of samples or

any other promotion devices to induce sales directly to the
consumers at the retail level, such as special displays, discount
coupons, premiums, special sales, bonus and tie-in sales for the
products within the scope of this Code. This provision shall not
restrict the establishment of pricing policies and practices intended
to provide products at lower prices on a long-term basis.
(d) Manufactures and distributors shall not distribute to pregnant

women or mothers of infants any gifts or articles or utensils which
may promote the use of breastmilk substitutes or bottlefeeding, nor
shall any other groups, institutions or individuals distribute such
gifts, utensils or products to the general public and mothers.
(e) Marketing personnel shall be prohibited from advertising or

promoting in any other manner the products covered by this Code,
either directly or indirectly, to pregnant women or with mother of
infants, except as otherwise provided by this Code.
(f) Nothing herein contained shall prevent donations from

manufacturers and distributors or products within the scope of this
Code upon request by or with the approval of the Ministry of
Health.
SECTION 7. Health Care System –
(a) The Ministry of Health shall take appropriate measures to

encourage and promote breastfeeding. It shall provide objective
and consistent information, training and advice to health workers
on infant nutrition, and on their obligations under this Code.
(b) No facility of the health care system shall be used for the
purpose of promoting infant formula or other products within the
scope of this Code. This Code does not, however, preclude the
dissemination of information to health professionals as provided in
Section 8(b).
(c) Facilities of the health care system shall not be used for the
display of products within the scope of this Code, or for placards or
posters concerning such products.
(d) The use by the health care system of "professional service"

representatives, "mothercraft nurses" or similar personnel, provided
or paid for by manufacturers or distributors, shall not be permitted.
(e) In health education classes for mothers and the general public,
health workers and community workers shall emphasize the
hazards and risks of the improper use of breastmilk substitutes
particularly infant formula. Feeding with infant formula shall be
demonstrated only to mothers who may not be able to breastfeed
for medical or other legitimate reasons.
SECTION 8. Health Workers –
(a) Health workers shall encourage and promote breastfeeding and

shall make themselves familiar with objectives and consistent
information on maternal and infant nutrition, and with their
responsibilities under this Code.

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
(c) No financial or material inducements to promote products within

the scope of this Code shall be offered by manufacturers or
distributors to health workers or members of their families, nor shall
these be accepted by the health workers or members of their
families, except as otherwise provided in Section 8(e).
(d) Samples of infant formula or other products within the scope of

this Code, or of equipment or utensils for their preparation or use,
shall not be provided to health workers except when necessary for
the purpose of professional evaluation or research in accordance
with the rules and regulations promulgated by the Ministry of
Health. No health workers shall give samples of infant formula to
pregnant women and mothers of infants or members of their
families.
(e) Manufacturers and distributors of products within the scope of

this Code may assist in the research, scholarships and continuing
education, of health professionals, in accordance with the rules and
regulations promulgated by the Ministry of Health.
SECTION 9. Persons employed by Manufacturers and Distributors –
Personnel employed in marketing products within the scope of this Code
shall not, as part of their job responsibilities, perform educational functions
in relation to pregnant women or mothers of infants.
55
See p. 20.
56
See p. 21.
57
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.
58
See p. 30.
59
xxxx
(d) The term "humanized", "maternalized" or similar terms shall not

be used.
60
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.
61
SECTION 26. Content – Each container/label shall contain such
message, in both Filipino and English languages, and which message
cannot be readily separated therefrom, relative the following points:
xxxx
(f) The health hazards of unnecessary or improper use of infant

formula and other related products including information that
powdered infant formula may contain pathogenic microorganisms
and must be prepared and used appropriately.
62
TSN of the hearing of June 19, 2007, pp. 114-120.
TSN of June 19, 2007 hearing, pp. 193-194, 198, 231, 237-240, 295-
63
300.
64
G.R. No. 152214, September 19, 2006, 502 SCRA 295.
65
Id. at 314.
66
SECTION 7. Health Care System –
xxxx
(b) No facility of the health care system shall be used for the
purpose of promoting infant formula or other products within the
scope of this Code. This Code does not, however, preclude the
dissemination of information to health professionals as provided in
Section 8(b).
67
SECTION 8. Health Workers. -
xxxx

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
68
SECTION 8. Health Workers -
xxxx
(e) Manufacturers and distributors of products within the scope of

this Code may assist in the research, scholarships and continuing
education, of health professionals, in accordance with the rules and
regulations promulgated by the Ministry of Health.
69
SECTION 4. Declaration of Principles – The following are the underlying
principles from which the revised rules and regulations are premised upon:
xxxx
(i) Milk companies, and their representatives, should not form part
of any policymaking body or entity in relation to the advancement of
breastfeeding.
70
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.
71
SECTION 9. Research, Ethics Committee, Purpose - The DOH shall
ensure that research conducted for public policy purposes, relating to
infant and young child feeding should, at all times, be free form any
commercial influence/bias; accordingly, the health worker or researcher
involved in such must disclose any actual or potential conflict of interest
with the company/person funding the research. In any event, such
research and its findings shall be subjected to independent peer review. x
x x.
72
SECTION 10. Public Disclosure – For transparency purposes, a
disclosure and/or disclaimer of the sponsoring company should be done
by the company itself, health worker, researcher involved through verbal
declaration during the public presentation of the research and in print upon
publication.
73
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.
74
Supra note 68.
75
SECTION 51. Donations Within the Scope of This Code - Donations of
products, materials, defined and covered under the Milk Code and these
implementing rules and regulations, shall be strictly prohibited.
76
159-A Phil. 142 (1975).
77
G.R. No. 159149, June 26, 2006, 492 SCRA 638.
Smart Communications, Inc. v. National Telecommunications

78
Commission, 456 Phil. 145, 155-156 (2003).
79
Yazaki Torres Manufacturing, Inc. v. Court of Appeals, G.R. No. 130584,
June 27, 2006, 493 SCRA 86, 97.
80
Supra note 78, at 156.
81
Petitioner's Memorandum.
82
SECTION 4. Declaration of Principles – The following are the underlying
principles from which the revised rules and regulations are premised upon:
xxxx
(f) Advertising, promotions, or sponsorships of infant formula,

breastmilk substitutes and other related products are prohibited.
83
SECTION 4. Declaration of Principles – x x x
(i) Milk companies, and their representatives, should not form part
of any policymaking body or entity in relation to the advancement of
breastfeeding.
84
SECTION 5. x 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;
x x x.
85
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
86
Supra note 70.
87
Supra note 73.
88
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.
89
SECTION 52. Other Donations By Milk Companies Not 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.
90
Eastern Assurance & Surety Corporation v. Land Transportation
Franchising and Regulatory Board, 459 Phil. 395, 399 (2003).
91
G.R. No. 156041, February 21, 2007

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Republic of the Philippines

G.R. No. 173034 October 9, 2007

PHARMACEUTICAL AND HEALTH CARE ASSOCIATION OF THE

Named as respondents are the Health Secretary, Undersecretaries, and Assistant

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

2.2 Whether pertinent international agreements 1 entered into by the

2.4 Whether Section 13 of the RIRR on Total Effect provides sufficient

The petition is partly imbued with merit.

On the issue of petitioner's standing

The modern view is that an association has standing to complain of

x x x We note that, under its Articles of Incorporation, the respondent was

Herein petitioner's Amended Articles of Incorporation contains a similar provision

On the constitutionality of the provisions of the RIRR

The Court notes that the following international instruments invoked by

The international instruments that do have specific provisions regarding

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

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

"Generally accepted principles of international law" refers to norms of general or

Fr. Joaquin G. Bernas defines customary international law as follows:

Custom or customary international law means "a general and

The required duration can be either short or long. x x x

Duration therefore is not the most important element. More important is

Once the existence of state practice has been established, it becomes

Clearly, customary international law is deemed incorporated into our domestic

The World Health Organization (WHO) is one of the international specialized

Regulations, along with conventions and agreements, duly adopted by the

Article 22. Regulations adopted pursuant to Article 21 shall come into

Article 23. The Health Assembly shall have authority to make

The absence of a provision in Article 23 of any mechanism by which the

"The Thirty-Fourth World Health Assembly x x x adopts, in the sense of

In January 1981, the Executive Board of the World Health Organization at

The legal value of WHA Resolutions as recommendations is summarized in

It is propounded that WHA Resolutions may constitute "soft law" or non-binding

The World Intellectual Property Organization (WIPO), a specialized agency

In the Philippines, the executive department implemented certain measures

As previously discussed, for an international rule to be considered as customary

Respondents failed to establish that the provisions of pertinent WHA Resolutions

Consequently, legislation is necessary to transform the provisions of the WHA

Section 3, Chapter 1, Title IX of the Revised Administrative Code of 1987

It is crucial to ascertain whether the absolute prohibition on advertising and other

The national policy of protection, promotion and support of breastfeeding cannot

MILK CODE RIRR

MILK CODE RIRR

Section 13. "Total Effect" - Promotion of

Section 15. Content of Materials. - The

a. Texts, pictures, illustrations or

b. The term "humanized," "maternalized,"

c. Pictures or texts that idealize the use of

Section 16. All health and nutrition claims

MILK CODE RIRR

5. The Milk Code allows dissemination of information on infant formula to

MILK CODE RIRR

6. The Milk Code permits milk manufacturers and distributors to extend