Republic of the
Supreme Court
EN BANC
PHARMACEUTICAL and HEALTH G.R. NO.
173034
CARE
ASSOCIATION of the
Petitioner,
Present:
PUNO,
C.J.
QUISUMBING,
YNARES-SANTIAGO,
SANDOVAL-GUTIERREZ,
CARPIO,
- versus - AUSTRIA-MARTINEZ,
CARPIO-MORALES,
AZCUNA,
TINGA,
CHICO-NAZARIO,
GARCIA,
VELASCO,
JR.,
NACHURA,
and
REYES,
JJ.
HEALTH
SECRETARY
FRANCISCO
T. DUQUE III;
HEALTH
UNDERSECRETARIES
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, Promulgated:
Respondents.
x-
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - x
D E C I S I O N
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
In
1990, the
On
However,
on
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
After
the Comment and Reply had been filed, the Court set the case for oral arguments
on
The Court hereby sets the
following issues:
1. Whether or not petitioner
is a real party-in-interest;
2. Whether Administrative
Order No. 2006-0012 or the Revised Implementing Rules and Regulations (RIRR)
issued by the Department of Health (DOH) is not constitutional;
2.1 Whether the RIRR is in accord with the
provisions of Executive Order No. 51 (Milk Code);
2.2 Whether pertinent international
agreements1 entered into by the
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.
x x x x
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
authorized[9]
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 instruments[10] 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
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.
x
x x x
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
x
x x x
Duration
therefore is not the most important element.
More important is the consistency and the generality of the
practice. x x
x
x
x x x
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 63[25] 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.
Rańada[37] 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
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
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:
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MILK CODE |
RIRR |
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WHEREAS, in order to ensure that safe and adequate nutrition for infants is provided, there is a need to protect and promote breastfeeding and to inform the public about the proper use of breastmilk substitutes and supplements and related products through adequate, consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes, supplements and related products; SECTION 4(e). “Infant” means a person falling within
the age bracket of 0-12 months. |
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. 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). |
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”:
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MILK CODE |
RIRR |
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WHEREAS, in order to ensure that safe and adequate nutrition for infants is provided, there is a need to protect and promote breastfeeding and to inform the public about the proper use of breastmilk substitutes and supplements and related products through adequate, consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes, supplements and related products; |
Section 4. Declaration of Principles – The following are the underlying principles from which the revised rules and regulations are premised upon: a. Exclusive breastfeeding is for infants from 0 to six (6) months. b. There is no substitute or replacement for breastmilk. |
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:
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MILK CODE |
RIRR |
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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. |
Section 4. Declaration of Principles – The following are the underlying principles from which the revised rules and regulations are premised upon: x x x x f. Advertising, promotions,
or sponsor-ships of infant formula, breastmilk
substitutes and other related products are prohibited. 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 or make the product appear to be as good or equal to breastmilk or breastfeeding in the advertising concept. It must not in any case undermine breastmilk or breastfeeding. The “total effect” should not directly or indirectly suggest that buying their product would produce better individuals, or resulting in greater love, intelligence, ability, harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim. Section 15. Content of Materials. - The following shall not be included in advertising, promotional and marketing materials: a. Texts, pictures, illustrations or information which discourage or tend to undermine the benefits or superiority of breastfeeding or which idealize the use of breastmilk substitutes and milk supplements. In this connection, no pictures of babies and children together with their mothers, fathers, siblings, grandparents, other relatives or caregivers (or yayas) shall be used in any advertisements for infant formula and breastmilk supplements;
b. The term “humanized,” “maternalized,” “close to mother's milk” or similar words in describing breastmilk substitutes or milk supplements; c. Pictures or texts that idealize the use of infant and milk formula. Section 16. All health and nutrition claims for products within the scope of the Code are absolutely prohibited. For this purpose, any phrase or words that connotes to increase emotional, intellectual abilities of the infant and young child and other like phrases shall not be allowed. |
4. The RIRR imposes additional labeling
requirements not found in the Milk Code:
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MILK CODE |
RIRR |
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SECTION
10. Containers/Label. – (a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products, and in such a way as not to discourage breastfeeding. (b) Each container shall have a clear, conspicuous and easily readable and understandable message in Pilipino or English printed on it, or on a label, which message can not readily become separated from it, and which shall include the following points: (i) the words “Important Notice” or their equivalent; (ii)
a statement of the superiority of breastfeeding; (iii)
a statement that the product shall be used only on the advice of a health
worker as to the need for its use and the proper methods of use; and (iv)
instructions for appropriate preparation, and a
warning against the health hazards of inappropriate preparation. |
Section 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: (a) The words or phrase “Important Notice” or “Government Warning” or their equivalent; (b) A statement of the superiority of breastfeeding; (c) A statement that there is no substitute for breastmilk; (d) 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; (e) Instructions for appropriate prepara-tion, and a warning against the health hazards of inappropriate preparation; and (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. |
5. The Milk Code allows dissemination of
information on infant formula to health professionals; the RIRR totally
prohibits such activity:
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MILK CODE |
RIRR |
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SECTION
7. Health Care System. – (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). SECTION 8. Health Workers. - (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 bottle-feeding is equivalent or superior to breastfeeding. It shall also include the information specified in Section 5(b). |
Section 22. No manufacturer, distributor, or representatives of products covered by the Code shall be allowed to conduct or be involved in any activity on breastfeeding promotion, education and production of Information, Education and Communication (IEC) materials on breastfeeding, holding of or participating as speakers in classes or seminars for women and children activities and to avoid the use of these venues to market their brands or company names. SECTION 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. |
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.
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MILK CODE |
RIRR |
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SECTION 8. Health Workers – (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
4. Declaration of Principles – The following are the underlying principles from which the revised rules and regulations are premised upon: i. Milk companies, and their representatives, should
not form part of 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 Communication (IEC) materials on breastfeeding, holding of or participating as speakers in classes or seminars for women and children activities and to avoid the use of these venues to market their brands or company names. SECTION 32. Primary Responsibility of Health Workers - It is the primary
responsibility of the health workers to promote, protect and support
breastfeeding and appropriate infant and young child feeding. Part of this responsibility is to continuously
update their knowledge and skills on breastfeeding. No assistance, support, logistics or
training from milk companies shall be permitted. |
7. The Milk Code regulates the giving of donations;
RIRR absolutely prohibits it.
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MILK CODE |
RIRR |
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SECTION
6. The General Public and Mothers. – (f) Nothing herein contained shall prevent donations from manufacturers and distributors of products within the scope of this Code upon request by or with the approval of the Ministry of Health.
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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. 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. |
8. The RIRR provides for administrative sanctions
not imposed by the Milk Code.
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MILK CODE |
RIRR |
|
|
Section 46. Administrative Sanctions. – The following administrative sanctions shall be imposed upon any person, juridical or natural, found to have violated the provisions of the Code and its implementing Rules and Regulations: a) 1st violation – Warning; b) 2nd
violation – Administrative fine of a minimum of Ten Thousand ( c) 3rd
violation – Administrative Fine of a minimum of Sixty Thousand ( d) 4th
violation –Administrative Fine of a minimum of Two Hundred Thousand ( e) 5th and
succeeding repeated violations – Administrative Fine of One Million ( f) An additional penalty
of Two Thou-sand Five Hundred ( For purposes of determining whether or not there is “repeated” violation, each product violation belonging or owned by a company, including those of their subsidiaries, are deemed to be violations of the concerned milk company and shall not be based on the specific violating product alone. |
9. The RIRR provides for repeal of existing laws to
the contrary.
The
Court shall resolve the merits of the allegations of petitioner seriatim.
1.
Petitioner
is mistaken in its claim that the Milk Code's coverage is limited only to
children 0-12 months old. Section 3 of
the Milk Code states:
SECTION
3. Scope of the Code – The Code applies to the marketing, and
practices related thereto, of the following products: breastmilk
substitutes, including infant formula; other milk products, foods and
beverages, including bottle-fed complementary foods, when marketed or otherwise
represented to be suitable, with or without modification, for use as a partial
or total replacement of breastmilk; feeding bottles
and teats. It also applies to their
quality and availability, and to information concerning their use.
Clearly, the coverage of the Milk Code is not
dependent on the age of the child but on the kind of product being
marketed to the public. The law treats infant formula, bottle-fed
complementary food, and breastmilk substitute as separate and distinct product
categories.
Section
4(h) of the Milk Code defines infant
formula as “a breastmilk substitute x x x to satisfy the
normal nutritional requirements of infants up to between four to six months of
age, and adapted to their physiological characteristics”; while under
Section 4(b), bottle-fed complementary food refers to “any food, whether
manufactured or locally prepared, suitable as a complement to breastmilk or infant formula, when either becomes
insufficient to satisfy the nutritional requirements of the infant.” An infant under Section 4(e) is a person falling within the age bracket
0-12 months. It is the nourishment of
this group of infants or children aged 0-12 months that is sought to be
promoted and protected by the Milk Code.
But there is another target group. Breastmilk
substitute is defined under Section 4(a) as “any food being marketed or otherwise presented
as a partial or total replacement for breastmilk, whether or not suitable for
that purpose.” This section conspicuously lacks reference
to any particular age-group of children. Hence, the provision of the Milk Code cannot
be considered exclusive for children aged
0-12 months. In other words, breastmilk substitutes may also be intended for young children more than 12 months of age.
Therefore, by regulating breastmilk
substitutes, the Milk Code also intends to protect and promote the nourishment
of children more than 12 months old.
Evidently, as long as what is being marketed
falls within the scope of the Milk Code as provided in Section 3, then it can
be subject to regulation pursuant to said law, even if the product is to be
used by children aged over 12 months.
There is, therefore, nothing objectionable with
Sections 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 4[46]
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 –
x x x x
(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.
x x x x
(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-ŕ-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 –
x x x x
(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.
x x x x
(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 Code[54]
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 13[55] on “total effect” and 26[56] 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 16[57] 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 -
x
x x x
(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.[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
x 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: x x x (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. (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
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 Development ----------- Member
The members may designate their duly
authorized representative to every meeting of the Committee.
The Committee shall have the following powers and
functions:
(1) To review and examine
all advertising. promotion or other marketing
materials, whether written, audio or visual, on products within the scope of
this Code;
(2) To approve or
disapprove, delete objectionable portions from and prohibit the printing,
publication, distribution, exhibition and broadcast of, all advertising
promotion or other marketing materials, whether written, audio or visual, on
products within the scope of this Code;
(3) To prescribe the
internal and operational procedure for the exercise of its powers and functions
as well as the performance of its duties and responsibilities; and
(4) To promulgate such
rules and regulations as are necessary or proper for the implementation of
Section 6(a) of this Code. x x x (Emphasis supplied)
However, Section
11 of the RIRR, to wit:
SECTION 11. Prohibition – No advertising, promotions, sponsorships, or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty-four (24) months, shall be allowed, because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements, as well as related products covered within the scope of this Code.
prohibits
advertising, promotions, sponsorships or marketing materials and activities for
breastmilk substitutes in line with the RIRR’s declaration of principle under Section 4(f), to wit:
SECTION 4. Declaration of Principles –
x x x
x
(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
SOLICITOR
GENERAL DEVANADERA:
x x x x
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.
x x x x
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.
x x x x
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.
x x x x
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?
SOLICITOR
GENERAL DEVANADERA:
Your Honor, please, it is provided
that the Inter-Agency Committee, Your Honor.
x x x x
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?
SOLICITOR
GENERAL DEVANADERA:
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.
x x x x
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?
SOLICITOR
GENERAL DEVANADERA:
Yes, your
Honor.
ASSOCIATE
JUSTICE NAZARIO:
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?
SOLICITOR
GENERAL DEVANADERA:
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.
x x x x
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.
ASSOCIATE
JUSTICE NAZARIO:
So in short, will you please clarify
there's no absolute ban on advertisement regarding milk substitute regarding
infants two (2) years below?
SOLICITOR
GENERAL DEVANADERA:
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:
SECTION 5. Information
and Education –
x
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 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.
x x
x x
SECTION 8. Health Workers. –
x x x x
(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 bottle feeding is equivalent or superior to breastfeeding. It shall also include the information specified in Section 5(b).
x x
x x
SECTION
10. Containers/Label –
(a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products, and in such a way as not to discourage breastfeeding.
(b) Each container shall have a clear, conspicuous and easily readable and understandable message in Pilipino or English printed on it, or on a label, which message can not readily become separated from it, and which shall include the following points:
(i) the words “Important Notice” or their
equivalent;
(ii) a statement of the superiority of breastfeeding;
(iii) a statement that the product shall be used only on
the advice of a health worker as
to the need for its use and the proper methods of use; and
(iv) instructions for appropriate preparation, and a warning against the health hazards of
inappropriate preparation.
Section 12(b) of the Milk Code designates the DOH as the principal implementing agency for the
enforcement of the provisions of the Code. In relation to such responsibility of the DOH,
Section 5(a) of the Milk Code states that:
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)
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 22[70]
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 9[71]
and 10[72]
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 32[73]
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 51[75]
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 52[89]
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.
x x x x
(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
The Temporary Restraining Order
issued on
SO ORDERED.
MA. ALICIA
AUSTRIA-MARTINEZ
Associate Justice
WE
CONCUR:
REYNATO S. PUNO
Chief Justice
|
LEONARDO A.
QUISUMBING Associate Justice |
CONSUELO YNARES-SANTIAGO Associate
Justice |
|
ANGELINA SANDOVAL-GUTIERREZ Associate Justice |
ANTONIO
T. CARPIO Associate Justice |
|
RENATO
C. CORONA Associate Justice |
CONCHITA
CARPIO-MORALES Associate
Justice |
|
ADOLFO S. AZCUNA Associate Justice |
DANTE O. TINGA Associate Justice |
|
MINITA V.
CHICO-NAZARIO Associate Justice |
CANCIO C.
GARCIA Associate Justice |
|
PRESBITERO J. VELASCO, JR. Associate Justice |
ANTONIO EDUARDO B.
NACHURA Associate Justice |
RUBEN T. REYES
Associate Justice
C E R T I F I C A T I O N
Pursuant
to Section 13, Article VIII of the Constitution, it is hereby certified that
the conclusions in the above Decision had been reached in consultation before
the case was assigned to the writer of the opinion of the Court.
REYNATO S. PUNO
Chief Justice
[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.
x x x x
[3] Petition, rollo, p. 12.
[4] G.R. No. 131719,
[5]
[6] G.R. No. 135092,
[7]
[8] Annex “G”, Petitioner's Memorandum
dated
[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.
[11] Joaquin G. Bernas, S.J., Constitutional
Structure and Powers of Government (Notes and Cases) Part I ( 2005).
[12]
[13] Joaquin G. Bernas, S.J., An
Introduction to Public International Law, 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,
[16]
[17] Merlin M. Magallona, Fundamentals of Public International Law, 2005 Ed., p. 526.
[18]
[19] Government
of
[20] Tańada v.
[21] Louis Henkin, Richard C. Pugh, Oscar Schachter, Hans 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.
[25] Article 63. The Economic and Social Council may enter
into agreements 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.
[26] Article 18. The functions of the Health
Assembly shall be: (a) to
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.
[30] In Resolution No. 34.22 (May
21, 1981), the WHA, acting under Article 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 (
(k)
In Resolution No. 59.21 (
[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,
[39] Edward Kwakwa, Some Comments
on Rulemaking at the World Intellectual Property Organization, www.law.duke.edu/shell/cite;
[40]
[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,
[45] See pp. 19-21.
[46] See p. 21.
[47] Executive
Order No. 292, made effective on
[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
[51] Known then as Public Health Service
[52] Section 1, Chapter I, Title IX, Executive Order No. 292.
[53]
[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.
(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).
(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]
SECTION 10. Containers/Label –
x x x x
(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:
x
x x x
(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
[63] TSN of
[64]
G.R. No. 152214,
[65]
[66] SECTION 7. Health
Care System –
x x x x
(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. -
x x x
x
(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).
[68] SECTION 8. Health Workers -
x x x
x
(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:
x
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.
[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,
[78] Smart Communications, Inc. v. National Telecommunications
Commission, 456 Phil. 145, 155-156 (2003).
[79] Yazaki
Torres Manufacturing, Inc. v. Court of Appeals, G.R. No. 130584,
[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:
x x x x
(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 covered within the scope of this Code.
[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,