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Pharmaceutical and Health Care Association of the Philippines vs.

Duque III (Austria-Martinez, October 9, 2007) 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 Facts: - Executive Order No. 51 (The Milk Code - TMC) was issued by Pres. Aquino on Oct. 28, 1986 by virtue of the legislative powers granted to her under the Freedom Constitution. (1) One of the preambular clauses of TMC the law seeks to give effect to Article 11 of the International Code of Marketing of Breastmilk Substituttes (ICMBS), a code adopted by the WHA (World Health Assembly) in 1981. - In 1990, the Philippine ratified the International Convention on the Rights of the Child. Art. 24 of the instrument mandates that States should take measure to diminish infant mortality and should ensure that all segments of society are informed of the advantages of breastfeeding. From 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. 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. August 15, 2006 the Court issued a Resolution granting the TRO, enjoining the respondents from implementing the assailed RIRR. Petitioner assails the RIRR for going beyond the provisions of TMC thereby amending and expanding the coverage of the said law. - 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. Issue: W/n the RIRR is unconstitutional? Sub-issue(s): W/n the RIRR is in accord with TMC? W/n pertinent international agreements entered into by the Philippines are part of the law of the land and may thus be implemented through an RIRR, if so, is the RIRR in accord with such international agreements?

Note: I focused on the parts on international law. The other matters (in case maam asks) are at the bottom of the digest. 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. Are the international instruments referred to by the respondents part of the law of the land? The various international instruments invoked by respondents are: (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. Hence, they do not have anything about the use and marketing of breastmilk substitutes

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: (1) Transformation an international law is transformed into a domestic law through a constitutional mechanism such as local legislation 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 havent 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 its TMC. o While TMC is almost a verbatim reproduction of the ICMBS, it did not adopt the latters 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. (2) 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: 1.) Established, widespread, and consistent practice on part of the state 2.) Opinion juris sive necessitates (opinion as to law or necessity. Generally accepted principles of international law refer to norms of general or customary international law which are binding on all states, valid through all kinds of human societies, and basic to legal systems generally Fr. Bernas has a definition similar to the one above. Customary international law has two factors: 1.) Material factor how states behave The consistency and the generality of the practice 2.) Psychological or subjective factor why they behave the way they do Once state practice has been established, now determine why they behave they do. Is it ouor of 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

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.) As previously discussed, for an international rule to be considered customary law, it must be established that such rule is followed by states because it is considered obligatory (opinio juris). In the case at bar, respondents have not presented any evidence to prove that the WHA Resolutions are in fact enforced or practice by member states. Further, they failed to 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.

2. -

Since the WHA Resolutions 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? The World Health Organization (WHO) is one of the international specialized agencies of the UN. According to the WHO Constitution, its 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 Organizations competence Note that the legal effect of a regulation as opposed to recommendation is quite different (1) Regulations which are duly adopted by the WHA are binding on member states (2) On the other hand, recommendations 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. Hence, unlike the ICMBS which has become TMC through legislative enactment, the subsequent WHA Resolutions, which provide for exclusive breastfeeding and prohibition on advertisements and promotions of breastmilk have not been adopted as domestic law.

On other issues: 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 of 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 petitioners 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. 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) 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 declare that as part of its policy, the 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. -

W/n the provisions of the RIRR being in accordance with the Milk Code? Not all of them - Assailed provisions: [1] extending the coverage to young children; [2] imposing exclusive breastfeeding for infants from 0-6 months; [3] imposes an absolute ban on advertising and promotion for breastmilk substitutes; [4] requiring additional labeling requirements; [5] prohibits the dissemination of information on infant formula; [6] forbids milk manufacturers and distributors to extend assistance in research and continuing education Although the DOH has the power under the Milk Code to control information regarding breastmilk vis--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. Other assailed provisions are in accordance with the Milk Code. W/n Section 13 of the RIRR providing 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. W/n Section 57 of the RIRR repeals existing laws? Section in question only repeals orders, issuances and rules and regulations, not laws. The provision is valid as it is within the DOHs rule-making power. An administrative agency has quasi-legislative or rule-making power. However, such power is limited to making rules and regulation subjected to the boundaries set by the granting statute and the Constitution. The power is 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. 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 giving of donations 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.