Pharmaceutical and Health Care Association of the Philippines vs.

Duque III

Nature: Special Civil Action in the Supreme Court. Certiorari

Petitioner: Pharmaceutical and Healthcare Association of the Philippines
Respondents: DOH Sec. Francisco Duque III, DOH Undersecretaries Dr. Ethelyn Nieto, Dr. Margarita
Galon, Atty. Alexander Padilla and Dr. Jade Del Mundo; and Asst. Secretaries Dr. Mario Villaverde, Dr.
David Lozada and Dr. Nemesio Gako, DOH as co-respondent

Facts:
 1981 - ICMBS
 Oct. 28, 1986 - Executive Order No. 51 (The Milk Code – TMC – AO 2005-0014) was issued by
Pres. Aquino by virtue of the legislative powers granted to her under the Freedom Constitution.
o Preambular clauses of TMC – the law seeks to give effect to Article 11 of the
International Code of Marketing of Breastmilk Substituttes (ICMBS), World Health
Assembly) in 1981.
 1990, the Philippine ratified the International Convention on the Rights of the Child.
o Art. 24 of the instrument mandates that States should take measure to diminish infant
mortality and
o should ensure that all segments of society are informed of the advantages of
breastfeeding.
 1982 – 2006, the WHA adopted several resolutions to the effect that breastfeeding should be
supported, promoted and protected, hence, it should be ensured that nutrition and health
claims are not permitted for breastmilk substitutes.
 May 15, 2006 – DOH issues the assailed RIRR (Revised Implementing Rules and Regulations of
E.O. 51 or A.O. No. 2006-0012) which was to take effect on July 7, 2006.
o The RIRR imposes a ban on all advertisements of breastmilk substitutes
 June 28, 2006 – Petitioner filed the present Petition for Certiorari and Prohibition with Prayer
for the Issuance of a TRO or Writ of Preliminary injunction.
o Issues raised:
 WON respondents acting without or in excess of juris, or with grave abuse of
discretion amounting to lack or excess of juris.
 WON provisions of RIRR are unconstitutional.
o Petitioner assails the RIRR for going beyond the provisions of TMC thereby amending
and expanding the coverage of the said law.
o DOH meanwhile contends that the RIRR implements not only TMC but also various
international instruments regarding infant and young child nutrition. They posit that the
said international instruments are deemed part of the law of the land and therefore may
be implemented by the DOH in the RIRR.
 August 15, 2006 – the Court issued a Resolution granting the TRO, enjoining the respondents
from implementing the assailed RIRR.
 June 5, 2007 – court issued Guidance for Oral Arguments (set for June 19, 2007); raising ff.
issues:
o WON petitioner is a real party interest
o WON AO 2006-0012 (RIRR) is unconstitutional
o WON RIRR is in accord with EO # 51 (TMC)
o WON pertinent international agreements entered into by PH are part of the law of the
land and may be implemented by the DOH through the RIRR
  If so, WON RIRR is in accord with international agreements.
o WON Sec 4, 5(w), 22, 32, 47, 54 of RIRR violate due process clause and are restraint of
trade
o WON Sec 13 of RIRR on Total Effect provides sufficient standards.

Milk
12 mos
Chemicals are ok sub
Ads should be authorized
Added labelling ok
Can tell doctors the contents
IRR
2 y o (mas madami di pwede iadvert – not favor company)
<6 mos dapat exclusive breast milk, no sub.
ads prohibited for subs (gusto real thing talaga)
label needs to specifically say (walang real sub, may contain patho organisms)
bawal

Held: No. However what may be implemented is the RIRR based on the Milk Code which in turn is based
on the ICMBS as this is deemed part of the law of the land. The other WHA Resolutions however cannot
be imposed as they are not deemed part of the law of the land.

Ratio:
1. W/n the petitioner is the real party in interest? YES.

- 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. (Exec Sec vs CA)
- The Court has rules that an association has the legal personality to represent its members because
the results of the case will affect their vital interests. (Purok Bagong Silang Association Inc. vs.
Yuipco)
- In the petitioner’s Amended Articles of Incorporation, it states 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.”
- Therefore, the petitioner, as an organization, 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 to bring to the attention of the government agencies and courts
any grievance suffered by its members which are directly affected by the assailed RIRR.
- The petitioner, whose legal identity is deemed fused with its members, should be considered as a
legal party-in-interest which stands to be benefited or injured by any judgment in the case.

2. WON the provisions if the RIRR are unconstitutional. NO

1.1. Are the international instruments referred to by the respondents part of the law of the land?
YES.

Petitioners: The RIRR goes beyond TMC, amending and expanding its coverage.
Respondents: RIRR not just TMC, but also other international instruments in child nutrition, which
hare part of land and therefore implementable thru RIRR.

- The various international instruments invoked by respondents are (being going beyond TMC)
(1) The UN Conventions on the Rights of the Child
 (2) The International Convenant on Economic, Social, and Cultural Rights
(3) Convention on the Elimination of All Forms of Discrimination Against Women
 These instruments only provide general terms of the steps that States must take to prevent
child mortality, inform society of adv of breastfeeding, ensure wellbeing of fams and
women. Hence, they do not have anything about the use and marketing of breastmilk
substitute.
 The ICMBS and other WHA Resolutions however, are the international instruments which
have specific provisions on breastmilk substitutes
- Under the 1987 Constitution, international law can become part of domestic law in 2 ways:
- Transformation – an international law is transformed into a domestic law through a
constitutional mechanism such as local legislation, or concurred upon by 2/3 of Senate
 Treaties become part of law of the land through this method, pursuant to Art 7, Sec 21 –
wherein “no treaty or international agreement shall be valid.. unless concurred by at least
2/3 of Senate”
 The ICMBS and WHA Resolutions are NOT treaties as they haven’t been concurred in
by the required 2/3 vote.
 HOWEVER, the ICMBS has been transformed into domestic law through local legislation
that is TMC.
 Therefore, it is not the ICMBS per se that has the force of law but it’s TMC.
 While TMC is almost a verbatim reproduction of the ICMBS, it did not adopt the ICMBS’s
provision on the absolute prohibition on advertising of products within the scope of the
ICMBS.
 Instead the MC provides that advertising promotion or other marketing materials
may be allowed if such materials are approved by a committee.
- Incorporation – by mere constitutional declaration, international law is deemed to have the
force of domestic law
 This is found under Art 2, Sec 2 – The Philippines… adopts generally accepted principles of
international law as part of the law of the land
 In Mihares v. Ranada: International law becomes customary rules accepted as binding as a
result of two elements:
 Established, widespread, and consistent practice on part of the state
 Opinion juris sive necessitates (opinion as to law or necessity)
o Implicitly states that practice in question is rendered obligatory by existence of a
rule of law requiring it.
 Generally accepted principles of international law refer to norms of general or customary
international law which are binding on all states (i.e. principle of sovereign immunity, right
to life, liberty, and due process, pacta sunt servanda, etc.), valid through all kinds of human
societies, and basic to legal systems generally.
 Customary international law has two factors (Bernas):
1.) Material factor – how states behave
 Duration (short or long), consistency and the generality of the practice
2.) Psychological or subjective factor – why they behave the way they do
 Obligatory? Courtesy? or opinio juris (the belief that a certain type of behavior is
obligatory)
 When a law satisfies the two factors it becomes part of customary international law which
is then incorporated into our domestic system
 1.1.1. Since the WHA Resolutions (breastfeeding should be supported, promoted and protected,
hence, it should be ensured that nutrition and health claims are not permitted for
breastmilk substitutes) have not been embodied in any local legislation, have they
attained the status of customary law and hence part of our law of the land? NO.

- The World Health Organization (WHO) is one of the international specialized agencies of the UN.
 According to the WHO Constitution, it’s the WHA which determines the policies of the
WHO, the former also has the power to “adopt regulations concerning advertising and
labeling of pharmaceutical and similar products” and “to make recommendations to
members on any matter within the Organization’s competence”
 Note that the legal effect of a regulation as opposed to recommendation is quite
different
 Regulations which are duly adopted by the WHA are binding on member states
 Art 19. The health assembly shall have authority to adopt conventions or
agreements with respect to any matter within the competence of the Org.
 [READ MORE PROVISIONS FROM TEXT]
 Recommendations (Art 23) of the WHA do not come into force for its members unlike
regulations. Rather, they carry moral and political weight as they constitute the judgment
on a health issue of the collective membership of the highest body in the field of health.
- The WHA resolution adopting the ICMBS and the subsequent WHA resolutions urging states to
implement the ICMBS are merely recommendatory and legally non-binding.
 Unlike the ICMBS which has become TMC through legislative enactment, the subsequent
WHA Resolutions, which provide for exclusive breastfeeding (0-6 mos to 24 mos) and
prohibition on advertisements and promotions of breastmilk have not been adopted as
domestic law.
- WHA Resolutions have been viewed to constitute “soft law” or non-binding norms, which influence
state behavior.
 Soft law has been noted to be a rapid means of norm creation, in order to reflect and
respond to the changing needs and demands of constituents (of the UN.)
 Not fall into any categories of international law, but an expression of non-binding
norms, principles, practices/ state behavior.
 Say, certain declarations and resos of UN General Assembly (UN declaration of
human rights)
 WHO also resorted to soft law (i.e. Severe Acute Respiratory Syndrome and Avian
Flue outbreaks), which the PH adopted/domesticized via EO 201 and 280.
- For international rule to be considered customary law, it must be followed by states because it is
considered obligatory (opinio juris).
 In the case at bar, respondents have failed to:
 presented any evidence to prove that the WHA Resolutions are in fact enforced or
practice by member states.
 Establish that provisions of pertinent WHA Resolutions are customary international
law that may be deemed part of law of the land.
 Hence, legislation is necessary to transform the WHA resolutions into domestic law.
 They cannot thus be implemented by executive agencies without the need of a law
to be enacted by legislature.
 1.2. WON DOH may implement provisions of WHA Resolutions by virtue of its powers and
functions under Revised Administrative Code, even in absence of domestic law. NO.

- DOH shall define national health policy, issue orders and regulations concerning implementation of
established health policies.
 Need to know whether absolute prohibitions on ads and promotion of breastmilk
substitutes WHA Resos have been adopted as national health policy.

Respondents: national health policy on infant and young child feeding is embodied in AO # 2005-
0014:
 [REFER TO READINGS PAGE 301].

- NOWHERE in AO… said that ads and promotions of breastmilk subs should be absolutely
prohibited.
- Total ban can only be enacted by amending TMC.
- Thus, only TMC, NOT WHA resos can be validly implemented by DOH thru RIRR.

3. W/n the DOH has the power to implement the WHA Resolutions under the Revised Administrative
Code even in the absence of a domestic law? Only the provisions of the Milk Code. (as per the
discussion above). NO.
- Section 3, Chapter 1, Title IX of the RAC of 1987 provides that the DOH shall define the national
health policy and can issue orders and regulations concerning the implementation of established
health policies.
- A.O. No 2005 -0014 which provides the national policy on infant and young child feeding does not
say that advertisement or promotion of breastmilk substitutes should be absolutely prohibited.
- Only the provisions of the Milk Code, but not those of the subsequent WHA Resolutions, can be
validly implemented by the DOH through the subject RIRR.

1.3. W/n the provisions of the RIRR are in accordance with the Milk Code? Not all of them.

PETITIONER: Assailed provisions: [1] extending the coverage to young children (2 y.o. up from 0-12
mos); [2] imposing exclusive breastfeeding for infants from 0-6 months, and saying there is no
substitute of replacement for breastmilk; [3] imposes an absolute ban on advertising and
promotion for breastmilk substitutes, and total effect in promotion of products provision is vague;
[4] requiring additional labeling requirements; [5] prohibits the dissemination of information on
infant formula to health professionals; [6] forbids milk manufacturers and distributors to extend
assistance in research and continuing education of health profs; [7] prohibiting donations of
products and materials; [8] providing admin sanctions; [9] repealing existing laws to contrary.

COURT’S CORRECTIONS ON PETITIONERS’ ARGUMENTS:

1. Milk code is not limited to age of child (0-12 mos.), but kind of product.
a. Infant formula, bottle-fed food, breastmilk subs are separate and distinct.
b. Breastmilk subs section has no mention of any age group, and thus can be extended to
beyond 12 mos.
c. As long as what is being marketed falls under the scope of TMC, it is subject to
regulation, regardless of age group.
2. Wrong to say that RIRR does not recognize that breastmilk subs are proper subs.
 a. Read the entire provision as a whole, not just parts.
b. If medically necessary, use of breastmilk subs is proper if based on complete and
updated info.
3. [READ PAGE 315]
4. RIRR does not prohibit dissemination of into to health profs on scientific and factual matters.
a. It prohibits involvement of manufacturer and dis of products covered by Code in
activities for promotion, education, production of info, education, communication.
5. RIRR does not pertain to research assistance to or continuing education of health and
professionals.
a. But to breastfeeding promotion and education for women and children.
6. Re. donations, also consistent; donations of breastmilk subs may be done upon approval or
request of DOH. It is purely discretion of DOH.

UNCONSTITUTIONAL PROVISIONS:

- Although the DOH (RIRR) has the power under the Milk Code to control information regarding
breastmilk vis-à-vis breastmilk substitutes, this power is not absolute because it has no power to
impose an absolute prohibition in the marketing, promotion and advertising of breastmilk
substitutes. Several provisions of the Milk Code attest to the fact that such power to control
information is not absolute.
- Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code because such provisions
impose an absolute prohibition on advertising, promotion and marketing of breastmilk substitutes,
which is not provided for in the Milk Code.
- Section 46 is violative of the Milk Code because the DOH has exceeded its authority in imposing
such fines or sanctions when the Milk Code does not do so.
- Neither Milk nor Revised Ad allows DOH to fix fines.

Section 46. Administrative Sanctions – The following admin 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:
1) Ist violation – Warning;
2) 2nd – administrative fine of min P10K to max P50k, depending on gravity and extent of
violation, including the recall of the offending product;
3) 3rd – P60k – P150k, depending on gravity and extent; addition to recall of the offending
product, and suspension of certificate of product registration (CPR).
4) 4th – [CONTINUE READING 340].

- ***Section 7 (b) allows dissemination of info to health profs, but ONLY for scientific and factual
matters.
- Other assailed provisions are in accordance with the Milk Code.

2. W/n Section 13 of the RIRR provides a sufficient standard? YES.

- Questioned provision, in addition to Section 26 of Rule VII provide labeling requirements for
breastmilk substitutes  found to be in consonance with the Milk Code
- The provisions in question provide reasonable means of enforcing related provisions in the Milk
Code.
3. W/n Section 57 of the RIRR repeals existing laws?

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.

- Section in question only repeals orders, issuances and rules and regulations, not laws. The
provision is valid as it is within the DOH’s rule-making power.
- An administrative agency has quasi-legislative or rule-making power.
- Includes power to amend, revise, alter, repeal, for flexibility of admin agencies in formulating
and adjusting details and manner of implementation.
- but limited to making rules and regulation subjected to the boundaries set by the granting
statute and the Constitution.
- Also subject to the doctrine of non-delegability and separability of powers. The power, which
includes amending, revising, altering or repealing, is granted to allow for flexibility in the
implementation of the laws.

4. W/n On Section 4, 5(w), 11, 22, 32, 47 and 52 violates the due process clause of the Constitution
(Article III Section 1)?

- Despite the fact that the 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
- free enterprise does not call for the removal of protective regulations.
- It must be clearly explained and proven by competent evidence just exactly how such protective
regulation would result in the restraint of trade .
- Section 4 – proscription of milk manufacturers’ participation in any policymaking body;
- Section 22 – classes and seminars for women and children;
- Section 32 – giving of assistance, support and logistics or training;
- Section 52 – prohibiting giving of donations to government (DOH).
- In the instant case, petitioner failed to show how the aforementioned sections hamper the trade of
breastmilk substitutes. They also failed to establish that these activities are essential and
indispensable to their trade.

Disposition: The Petition is Partially Granted. Only sections 4(f), 11 and 46 of A.O. 2006-0014 are
declared null and void for being ultra vires. The TRO is lifted insofar as the rest of the provisions of
A.O. 2006-0012 is concerned.