In the very fresh en banc constitutional case of PHARMACEUTICAL and HEALTH CARE ASSOCIATION of the PHILIPPINES vs. HEALTH SECRETARY FRANCISCO T. DUQUE III, et. al., G.R. NO. 173034, October 9, 2007, the Philippine Supreme Court PARTIALLY GRANTED the petition by declaring NULL AND VOID Sections 4(f), 11 and 46 of Administrative Order No. 2006-0012, dated May 12, 2006, for being ultra vires and prohibited the Department of Health from implementing the said provisions.
With regard to the issue of whether petitioner may prosecute the case as the real party-in-interest, the Court held that 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.
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 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 however held that the 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; however, they do not contain specific provisions regarding the use or marketing of breastmilk substitutes. The international instruments that 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. 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.
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.
The Court held that 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, according to the Court, 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 the Court noted that the Milk 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).
Section 2, Article II of the 1987 Constitution provides that the Philippines renounces war as an instrument of national policy, adopts the generally accepted principles of international law as part of the law of the land and adheres to the policy of peace, equality, justice, freedom, cooperation and amity with all nations. The provisions embodies the incorporation method.
Generally 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.
“Generally accepted principles of international law” refers to norms of general or customary international law which are binding on all states, i.e., renunciation of war as an instrument of national policy, the principle of sovereign immunity, a person's right to life, liberty and due process, and pacta sunt servanda, among others. The concept of “generally accepted principles of law” has also been depicted in this wise:
Customary international means “a general and consistent practice of states followed by them from a sense of legal obligation [opinio juris].” 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. 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. 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.
It is propounded that WHA Resolutions may constitute “soft law” or non-binding norms, principles and practices that influence state behavior. “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. It is, however, an expression of non-binding norms, principles, and practices that influence state behavior. Certain declarations and resolutions of the UN General Assembly fall under this category. 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, Mejoff v. Director of Prisons, Mijares v. Rañada and Shangri-la International Hotel Management, Ltd. v. Developers Group of Companies, Inc.
The Court stressed that 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). However, according to the Court, the 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.
May 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.
The crucial issue was whether the absolute prohibition on advertising and other forms of promotion of breastmilk substitutes provided in some WHA Resolutions has been adopted as part of the national health policy.
Respondents submit that the national policy on infant and young child feeding is embodied in A.O. No. 2005-0014, dated May 23, 2005. Basically, the Administrative Order declared the following policy guidelines: (1) ideal breastfeeding practices, such as early initiation of breastfeeding, exclusive breastfeeding for the first six months, extended breastfeeding up to two years and beyond; (2) appropriate complementary feeding, which is to start at age six months; (3) micronutrient supplementation; (4) universal salt iodization; (5) the exercise of other feeding options; and (6) feeding in exceptionally difficult circumstances. Indeed, the primacy of breastfeeding for children is emphasized as a national health policy. However, nowhere in A.O. No. 2005-0014 is it declared that as part of such health policy, the advertisement or promotion of breastmilk substitutes should be absolutely prohibited. Hence, the Court held that the national policy of protection, promotion and support of breastfeeding cannot automatically be equated with a total ban on advertising for breastmilk substitutes. The Milk Code 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. 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. The Court emphasized that 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.
The Court held that the Sec. 3 of the Milk Code's coverage is not limited only to children 0-12 months old. Section 3 of the Milk Code. 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.
To resolve the question of whether the labeling requirements and advertising regulations under the RIRR are valid, the Court had to discuss the nature, purpose, and depth of the regulatory powers of the DOH, as defined in general under the 1987 Administrative Code, 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.. 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. 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.” 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.” 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. Further, DOH is authorized by the Milk Code to control the content of any information on breastmilk vis-à-vis breastmilk substitutes, supplement and related products. 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 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.
Nonetheless, the Court held that the framers of the constitution were well aware that trade must be subjected to some form of regulation for the public good. 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. Free enterprise does not call for 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. 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.
In fine, the Court held that 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.
Atty. MANUEL J. LASERNA JR.
Oct. 14, 2007
