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Pharmaceutical and Health Care Association of the Philippines vs. Duque III

G.R. No. 173034. October 9, 2007.* PHARMACEUTICAL and HEALTH CARE ASSOCIATION of the PHILIPPINES, petitioner, vs. 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, respondents.

Judicial Review; Locus Standi; Associations; An organization has standing to assert the concerns of its constituents—it 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.—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, 429 SCRA 81 (2004), 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

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* EN BANC.

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Pharmaceutical and Health Care Association of the Philippines vs. Duque III

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 (Emphasis supplied), which was reasserted in Purok Bagong Silang Association, Inc. v. Yuipco, 489 SCRA 382 (2006), 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.

International Law; Treaties; Doctrine of Incorporation and Doctrine of Transformation; Words and Phrases; Under the 1987 Constitution, international law can become part of the sphere of domestic law either by transformation or incorporation; Treaties become part of the law of the land through transformation pursuant to Article VII, Section 21 of the Constitution.—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.

Same; Same; Same; Milk Code (E.O. No. 51); World Health Assembly (WHA); International Code of Marketing of Breastmilk Substitutes (ICMBS); Advertisements; While the International Code of

Marketing of Breastmilk Substitutes (ICMBS) and World Health Assembly (WHA) Resolutions are not treaties as they have not been concurred in by at least two-thirds of all members of the Senate, the International Code of Marketing of Breastmilk Substitutes (ICMBS) which was adopted by the World Health Assembly (WHA) in 1981 had been transformed into domestic law through local legislation, the

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Pharmaceutical and Health Care Association of the Philippines vs. Duque III

Milk Code; The Milk Code is almost a verbatim reproduction of the International Code of Marketing of Breastmilk Substitutes (ICMBS), but the Code did not adopt the provision in the International Code of Marketing of Breastmilk Substitutes (ICMBS) absolutely prohibiting advertising or other forms of promotion to the general public of products within the scope of the International Code of Marketing of Breastmilk Substitutes (ICMBS).—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).

Same; Same; Same; Generally Accepted Principles of Law; Section 2, Article II of the 1987 Constitution, whereby the Philippines adopts the generally accepted principles of international law as part of the law of the land, embodies the incorporation method.—Section 2, Article II of the 1987 Constitution, to wit: “SECTION 2. The Phil-ippines renounces war as an instrument of national policy, adopts the generally

justice. Generally accepted principles of international law. and pacta sunt servanda. a person’s right to life. by virtue of the incorporation clause of the Constitution. Same. Duque III immunity. a person’s right to life. and a psychological element known as the opinion juris sive necessitates (opinion as to law or necessity). and consistent practice on the part of States. the principle of sovereign immunity. among others. equality. liberty and due process. by virtue of the incorporation clause of the Constitution.accepted principles of international law as part of the law of the land and adheres to the policy of peace. Ranada. cooperation and amity with all nations (Emphasis supplied). 455 SCRA 399 (2005) the Court held thus: [G]enerally accepted principles of international law. the principle of sovereign 268 268 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. widespread. Same.e. i. 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 . Same. “Generally accepted principles of international law” refers to norms of general or customary international law which are binding on all states.. (Emphasis supplied) “Generally accepted principles of international law” refers to norms of general or customary international law which are binding on all states.. form part of the laws of the land even if they do not derive from treaty obligations. liberty and due process. 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. and pacta sunt servanda. i. The classical formulation in international law sees those customary rules accepted as binding result from the combination [of] two elements: the established. Words and Phrases. among others.—In Mijares v. renunciation of war as an instrument of national policy. freedom. renunciation of war as an instrument of national policy. form part of the laws of the land even if they do not derive from treaty obligations. Same.e.” embodies the incorporation method.

Custom or customary international law means “a general and consistent practice of states followed by them from a sense of legal obligation *opinio juris+. The required duration can be either short or long. and generality of the practice of states. that is.C. x x x x x x x Once the existence of state practice has been established. 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. If there should be doubt or disagreement. how states behave. consistency. how states behave. x x x x x x x Duration therefore is not the most important element. Same. that is. that is. OCTOBER 9. x x x x The initial factor for determining the existence of custom is the actual behavior of states. 296). that is. 2007 269 Pharmaceutical and Health Care Association of the Philippines vs. why they behave the way they do. More important is the consistency and the generality of the practice.” (Restatement) This statement contains the two basic elements of custom: the material factor. he believes. This includes several elements: duration. the psychological or subjective factor. 1966 I. 535. why they behave the way they do. These principles. Customary international law is deemed incorporated into our domestic system.” which statement contains the two basic elements of custom: the material factor. are established by a process of reasoning based on the common identity of all legal systems. and. Same. Same. one must look to state practice and determine whether the municipal law principle provides a just and acceptable solution. and the psychological or subjective factor. Joaquin G. Bernas defines customary 269 VOL. Same. Customary International Law.rationale” and are “valid through all kinds of human societies. it becomes necessary to determine why states behave the way they do.J. x x x (Emphasis supplied) Same.—Fr. Do states . Duque III 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+.” (Judge Tanaka in his dissenting opinion in the 1966 South West Africa Case.

International Code of Marketing of Breastmilk Substitutes (ICMBS). Without it. under Article 23.— The WHA Resolution adopting the ICMBS and subsequent WHA Resolutions urging member states to . Article 23 of the WHO Constitution reads: Article 23. have not been adopted as a domestic law. recommendations of the WHA do not come into force for members. Same. Same. World Health Assembly (WHA). Same. duly adopted by the World Health Assembly (WHA) bind member states. Duque III Same. (Italics and Emphasis supplied) Clearly customary international law is deemed incorporated into our domestic system.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. along with conventions and agreements. Same. Same. is what makes practice an international rule. 51). Same. Milk Code (E. 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. continued breastfeeding up to 24 months. No. duly adopted by the WHA bind member states thus: x x x On the other hand. and absolutely prohibiting advertisements and promotions of breast-milk substitutes. in the same way that conventions or agreements under Article 19 and regulations under Article 21 come into force. Same. 270 270 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.— Regulations. While regulations. or the belief that a certain form of behavior is obligatory. Same. the subsequent World Health Assembly (WHA) Resolutions. practice is not law. recommendations of the World Health Assembly (WHA) do not come into force for members. in the same way that conventions or agreements and regulations come into force.O. Unlike what has been done with the International Code of Marketing of Breastmilk Substitutes (ICMBS) whereby the legislature enacted most of the provisions into law which is the Milk Code. along with conventions and agreements. specifically providing for exclusive breastfeeding from 0-6 months. Same.

“Soft law” does not fall into any of the categories of international law set forth in Article 38. Same. Soft Law. Same. 486 SCRA 405 (2006). 455 SCRA 397 (2005). and absolutely prohibiting advertisements and promotions of breastmilk substitutes. Same. specifically providing for exclusive breastfeeding from 0-6 months. and practices that influence state behavior. however. which this Court has enforced in various cases. Inc. an expression of non-binding norms.implement the ICMBS are merely recommendatory and legally non-binding. unlike what has been done with the ICMBS whereby the legislature enacted most of the provisions into law which is the Milk Code. specifically. and Shangri-la International Hotel Management. Words and Phrases. While “soft law” does not fall into any of the categories of international law set forth in Article 38. Mijares v. 2007 271 Pharmaceutical and Health Care Association of the Philippines vs. Administrative Law. Certain declarations and resolutions of the UN General Assembly fall under this category. Government of Hongkong Special Administrative Region v. Rañada. Olalia. Same. Chapter III of the 1946 Statute of the International Court of Justice. it is. an expression of non-binding norms.. Duque III Same. have not been adopted as a domestic law. 70. continued breastfeed-ing up to 24 months. Same. Thus. 271 VOL. the subsequent WHA Resolutions. Same. It is. principles. Same. Same. however. Same. and practices that influence state behavior. OCTOBER 9. principles. Same.—It is propounded that WHA Resolutions may constitute “soft law” or non-binding norms. Same. Developers Group of Companies. Same. The most notable is the UN Declaration of Human Rights. 535. Ltd. 90 Phil. Director of Prisons. Same. Chapter III of the 1946 Statute of the International Court of Justice. 521 SCRA 470 (2007). Mejoff v. The provisions of the World Health Assembly (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.—Respondents failed to establish that the provisions of pertinent WHA Resolutions are customary international law that . principles and practices that influence state behavior. v.

However. Administrative Law. (3) micronutrient supplementation. Duque III . can be validly implemented by the Department of Health (DOH). Health. Indeed. the legislature—only the provisions of the Milk Code. extended breastfeeding up to two years and beyond. the advertisement or promotion of breastmilk substitutes should be absolutely prohibited. Milk Code.O. the primacy of breastfeeding for children is emphasized as a national health policy.O. Consequently. No. Breastfeeding. No. 2005-0014 is it declared that as part of such health policy.—Respondents submit that the national policy on infant and young child feeding is embodied in A. but not those of subsequent World Health Assembly (WHA) Resolutions. No.O. Breast-milk Substitutes. the advertise- 272 272 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. promotion and support of breast-feeding cannot automatically be equated with a total ban on advertising for breastmilk substitutes. (2) appropriate complementary feeding. 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 primacy of breastfeeding for children is emphasized as a national health policy but nowhere in A. such as early initiation of breastfeed-ing. dated May 23. and (6) feeding in exceptionally difficult circumstances. No. (5) the exercise of other feeding options. 2005-0014 is it declared that as part of such health policy. Advertisements. exclusive breastfeeding for the first six months. In view of the enactment of the Milk Code which does not contain a total ban on the advertising and promotion of breastmilk substitutes. which is to start at age six months. legislation is necessary to transform the provisions of the WHA Resolutions into domestic law.may be deemed part of the law of the land. National Health Policy (A. Basically. nowhere in A. The national policy of protection.O. the Administrative Order declared the following policy guidelines: (1) ideal breastfeeding practices. 2005-0014). 2005. 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. 2005-0014. (4) universal salt iodization.

Same. The entirety of the Revised Implementing Rules and Regulations (RIRR). Pascual. clauses and phrases in the Rule should not be studied as detached and isolated expressions. also recognizes that in certain cases. Same. 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. promotion and support of breastfeeding cannot automatically be equated with a total ban on advertising for breastmilk substitutes. OCTOBER 9. must be considered and construed together—the particular words. In view of the enactment of the Milk Code which does not contain a total ban on the advertising and promotion of breastmilk substitutes. Same. 2007 . Same. not merely truncated portions thereof. the use of breastmilk substitutes may be proper. the legislature.ment or promotion of breastmilk substitutes should be absolutely prohibited. specifically creates an IAC which will regulate said advertising and promotion. Thus.” Section 7 of the RIRR provides that “when medically indicated and only when 273 VOL. Same. “*t+he particular words. The Revised Implementing Rules and Regulations (RIRR). clauses and phrases in the Rule should not be studied as detached and isolated expressions. can be validly implemented by the DOH through the subject RIRR. bottle-fed complementary food. does not recognize that breastmilk substitutes may be a proper and possible substitute for breastmilk. Same. 535. unlike the Milk Code. but not those of subsequent WHA Resolutions. only the provisions of the Milk Code.—It is also incorrect for petitioner to say that the RIRR. but instead. The entirety of the RIRR. and breastmilk substitute as separate and distinct product categories. 495 SCRA 42 (2006). Same. 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.—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. Same. Statutory Construction. As held in De Luna v. must be considered and construed together. not merely truncated portions thereof. Same. Same. 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 national policy of protection. 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. just like 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. also recognizes that in certain cases.—When it comes to information regarding nutrition of infants and young children. Police Power. in the following manner: x x x 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 274 . the RIRR. to wit: x x x Further. particularly advertising materials on apparently nontoxic products like breastmilk substitutes and supplements. Same. supplement and related products. particularly advertising materials on apparently non-toxic products like breast-milk substitutes and supplements. Duque III necessary. Health is a legitimate subject matter for regulation by the Department of Health (DOH) (and certain other administrative agencies) in exercise of police powers delegated to it. Same. supplements and related products. The sheer span of jurisprudence on that matter precludes the need to further discuss it. is a relatively new area for regulation by the DOH. Same. and promotion of breastmilk substitutes. the use of breastmilk substitutes is proper if based on complete and updated information. Same. the use of breastmilk substitutes may be proper.However. Same. Advertisements. marketing. Same.273 Pharmaceutical and Health Care Association of the Philippines vs. and the power to control such information. just like the Milk Code. Same. Same. Same. is a relatively new area for regulation by the Department of Health (DOH). Same. Same. The Department of Health’s (DOH’s) power under the Milk Code to control information regarding breastmilk vis-à-vis breastmilk substitutes is not absolute as the power to control does not encompass the power to absolutely prohibit the advertising. health information. consistent and objective information on breastfeeding and use of breastmilk substitutes. These are expressly provided for in Sections 12 and 5(a). DOH is authorized by the Milk Code to control the content of any information on breastmilk vis-à-vis breastmilk substitutes. Hence. the Milk Code specifically delegated to the Ministry of Health (hereinafter referred to as DOH) the power to ensure that there is adequate. Health 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.

Same. Same. The requirement under Section 26(f) of the Revised Implementing Rules and Regulations (RIRR) for the label to contain the message regarding health . and yet be allowed to display on the containers and labels of their products the exact opposite message. Same. 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. Duque III would reach pregnant women. Same.—It may be argued that Section 8 of the Milk Code refers only to information given to health workers regarding breastmilk substitutes. and promotion of breastmilk substitutes. at the same time giving the government control over planning. Same. not to containers and labels thereof. That askewed interpretation of the Milk Code is precisely what Section 5(a) thereof seeks to avoid by mandating that all information regarding breast-milk vis-à-vis breastmilk substitutes be consistent.274 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Section 26(c) of the Revised Implementing Rules and Regulations (RIRR) which requires containers and labels to state that the product offered is not a substitute for breastmilk. Same. Same. Thus. Same. and dissemination of information on infant feeding. Same. Same. provision. mothers of infants. Same. 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. 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 of the Milk Code. that the DOH’s power under the Milk Code to control information regarding breastmilk vis-à-vis breastmilk substitutes is not absolute as the power to control does not encompass the power to absolutely prohibit the advertising. marketing. however. Section 26(c) of the RIRR which requires containers and labels to state that the product offered is not a substitute for breastmilk. However. It bears emphasis. design. Same. 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 of the Milk Code.

hazards including the possibility of contamination with pathogenic microorganisms is in accordance with Section 5(b) of the Milk Code. 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. to wit: “SECTION 11. Same. Ineluctably.—x x x x (f) Advertising. 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. as well as related products covered within the scope of this Code. Same. 2007 275 Pharmaceutical and Health Care Association of the Philippines vs. The Department of Health (DOH) evidently arrogated to itself not only the regulatory authority given to the Inter-Agency Committee (IAC) but also imposed absolute prohibition on advertising. or sponsorships of infant formula. promotions. The DOH. through its co-respondents. Same. or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty-four (24) months. sponsorships. The buyers of breastmilk substitutes are mothers of infants. shall be allowed. Same. and marketing. sponsorships or marketing materials and activities for breastmilk substitutes in line with the RIRR’s declaration of principle under Section 4(f).” prohibits advertising. promotions. Petitioner’s counsel has admitted during the hearing on June 19. breastmilk substitutes and other related products are prohibited.—No advertising. because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements. Declaration of Principles. OCTOBER 9. Same. 2007 that formula milk is prone to contaminations and there is as yet no technology that allows production of powdered infant formula that eliminates all forms of contamination. promotions. Prohibition. 535.—The label of a product contains information about said product intended 275 VOL. promotion. Same. evidently arrogated to itself not only the . to wit: SECTION 4.—Section 11 of the RIRR. Duque III for the buyers thereof.

Information and Education. 8(b). or other marketing materials. Duque III which is authorized to promulgate rules and regulations for the approval or rejection of advertising.—Section 12(b) of the Milk Code designates the DOH as the principal implementing agency for the enforcement of the provisions of the Code. Same. Same. Section 5(a) of the Milk Code states that: SECTION 5. by which the Inter-Agency Committee (IAC) shall screen advertising. at the risk of being repetitious. although it is the IAC 276 276 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Same.regulatory authority given to the IAC but also imposed absolute prohibition on advertising. Sections 11 and 4(f) of the Revised Implementing Rules and Regulations (RIRR) are clearly violative of the Milk Code. oddly enough. promotional. 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. marketing and promotional materials prior to dissemination. Same. provision. Same. Same. and 10 of the Code. and marketing. Same. This responsibility shall cover the planning. Yet. However. Same. and 10 of the Milk Code.—(a) The government shall ensure that objective and consistent information is provided on infant feeding. . promotional. Same. promotion. Section 12 of the RIRR reiterated the requirement of the Milk Code in Section 6 thereof for prior approval by IAC of all advertising. which. In relation to such responsibility of the DOH.—Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code. for use by families and those involved in the field of infant nutrition.” Said standards are set forth in Sections 5(b). The Department of Health (DOH) has the significant responsibility to translate into operational terms the standards set forth in Sections 5. or other marketing materials under Section 12(a) of the Milk Code. and for easy reference. Same. Same. Same. 8.

promotional and marketing materials on breastmilk vis-à-vis breastmilk substitutes. 2007 277 Pharmaceutical and Health Care Association of the Philippines vs. Same. Same. 8. It also sets a viable standard against which the IAC may screen such materials before they are made public. the DOH has the significant responsibility to translate into operational terms the standards set forth in Sections 5. 535. The “total effect” should not directly or indirectly suggest that buying their product would produce better indi- 277 VOL. and 10 of the Milk Code. promotion. intelligence.”—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. by which the IAC shall screen advertising. or resulting in greater love. Duque III viduals. supplements and other related products. promotional. and marketing. (Emphasis supplied) Thus. It must not in any case undermine breast-milk or breastfeeding. and marketing. The “total effect” standards set out in Section 13 of the Revised Implementing Rules and Regulations (RIRR) bind the Inter-Agency Committee (IAC) in formulating its rules and regulations on advertising. Same. harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim. promotion. or other marketing materials. . OCTOBER 9. the DOH exercises control over the information content of advertising. Same.design and dissemination of information.—It is pursuant to such responsibility that the DOH correctly provided for Section 13 in the RIRR which reads as follows: SECTION 13. ability. on infant nutrition. “Total Effect. and the control thereof. Through that single provision. Such standards bind the IAC in formulating its rules and regulations on advertising. Same. Same.

Section 22 of the Revised Implementing Rules and Regulations (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. Same. Same. economy and welfare. Same.” and “simplicity. Education and Communication (IEC) materials regarding breastfeeding that are intended for women and children. education and production of Information. Said provision cannot be construed to encompass even the dissemination of information to health professionals. What it prohibits is the involvement of the manufacturer and distributor of the products covered by the Code in activities for the promotion. Duque III . Same. Same. in the past. Same. Same.Same. Inc. correct information as to infant feeding and nutrition is infused with public interest and welfare. It is the Department of Health (DOH) which is principally responsible for the implementa- 278 278 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Same. the Court held: x x x [T]his Court had. Same. as restricted by the Milk Code. Same. Same.” In this case. 502 SCRA 295 (2006). Department of Foreign Affairs. vs. Same. Correct information as to infant feeding and nutrition is infused with public interest and welfare. Same.” “public convenience and welfare.” “justice and equity. Same. Education and Communication (IEC) materials regarding breastfeeding that are intended for women and children.—Section 22 of the RIRR does not prohibit the giving of information to health professionals on scientific and factual matters. Same. accepted as sufficient standards the following: “public interest.—In Equi-Asia Placement. Same.

—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. petitioner’s argument against this particular provision must be struck down. 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. and with certain disclosure requirements imposed on the milk company and on the recipient of the research award. Same. rather. thus. Same. Sections 9 and 10 of the Revised Implementing Rules and Regulations (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.tion and enforcement of the provisions of said Code—it is entirely up to the Department of Health (DOH) to decide which entities to call upon or allow to be part of policymaking bodies on breastfeeding. Same. it is the DOH which shall be principally responsible for the implementation and enforcement of the provisions of said Code. Said sections of the RIRR provide that research assistance for health workers and researchers may be allowed upon approval of an ethics committee. Same. It is Sections 9 and 10 of the RIRR which govern research assistance. Section 22 of the RIRR does not pertain to research assistance to or the continuing education of health professionals. 535. Same. Therefore.—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. 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 279 VOL. OCTOBER 9. Note that under Section 12(b) of the Milk Code. The Milk Code endows the Department of Health (DOH) with the power to determine how research or educational assistance may be given by milk companies or under what conditions health workers may accept the assistance. It is entirely up to the DOH to decide which entities to call upon or allow to be part of policymaking bodies on breastfeeding. it deals with breastfeeding promotion and education for women and children. hence. 2007 279 . Nothing in Section 22 of the RIRR prohibits milk companies from giving assistance for research or continuing education to health professionals. The Court finds nothing in said provisions which contravenes the Milk Code.

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. Same. Perez v. the Court upheld the Department of Energy (DOE) Circular No.—As to the RIRR’s prohibition on donations. Same. 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. 33 and R. LPG Refillers Association of the Philippines. therefore.A. Same. 7638 to impose fines or penalties.Pharmaceutical and Health Care Association of the Philippines vs. The law does not proscribe the refusal of donations made by manufacturers and distributors of breastmilk substitutes—the Milk Code leaves it purely to the discretion of the Department of Health (DOH) whether to request or accept such donations. no real inconsistency between the RIRR and the law because the Milk Code does not prohibit the DOH from refusing donations.—In a more recent case. Same. said provisions are also consistent with the Milk Code. For that matter.) Blg. 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.P. The law does not proscribe the refusal of donations. Same. As reasoned out by respondents. Thus. Since neither the Milk Code nor the Revised Administrative Code grants the Department of Health (DOH) the authority to fix or impose administrative fines. Duque III may accept the assistance. The Court found that nothing in the circular contravened the law because the DOE was expressly authorized by B.P.. no person or entity can be forced to accept a donation. 2000-06-10 implementing Batas Pambansa (B. The DOH then appropriately exercised its discretion through Section 51 of the RIRR which sets forth its policy not to request or approve donations from manufacturers and distributors of breastmilk substitutes. 492 SCRA 638 (2006). Blg. the DOH is not mandated by the Milk Code to accept donations. The circular provided for fines for the commission of prohibited acts. 33. Same. Administrative Penalties. In the 280 280 . Inc. No. then the Department of Health (DOH) cannot provide for such fines in the Revised Implementing Rules and Regulations (RIRR). Same. The Milk Code leaves it purely to the discretion of the DOH whether to request or accept such donations. There is.

revise. Same. as held in Association of Philippine Coconut Desiccators v. Hence. without any express grant of power to fix or impose such fines. It is a standard provision in administrative rules that prior issuances of administrative agencies that are inconsistent therewith are declared repealed or modified. alter. Fertilizer and Pesticide Authority. The express grant of rule-making power to an administrive agency necessarily includes the power to amend. and subject to the doctrine of non-delegability and separability of powers. the DOH cannot provide for those fines in the RIRR. Same. it is a standard provision in administrative rules that prior issuances of administrative agencies that are inconsistent therewith are declared repealed or modified. Non-Delegation of Powers. Thus. Such express grant of rule-making power necessarily includes the power to amend. An administrative agency like respondent possesses quasilegislative 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. 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. issuances and rules and regulations. revise. Duque III present case. the DOH again exceeded its authority by providing for such fines or sanctions in Section 46 of the RIRR. or repeal the same. it . it was held thus: x x x Furthermore.SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Public interest must be upheld over business interests.—Section 57 of the RIRR does not provide for the repeal of laws but only orders. Same. alter. said provision is valid as it is within the DOH’s rule-making power. In Pest Management Association of the Philippines v. null and void. Same. neither the Milk Code nor the Revised Administrative Code grants the DOH the authority to fix or impose administrative fines. or repeal the same. Philippine Coconut Authority. therefore.—The framers of the constitution were well aware that trade must be subjected to some form of regulation for the public good. In this regard. Same. Regulation of Trade. despite the fact that “our present Constitution enshrines free enterprise as a policy. 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. Thus. 516 SCRA 360 (2007). in order to make it more responsive to the times. Said provision is.

Since all the regulatory provisions under the Milk Code apply equally to both manufacturers and distributors. 535. the Court sees no harm in the Revised Implementing Rules and Regulations (RIRR) providing for just one term to encompass both entities—the definition of “milk company” in the Revised Implementing Rules and Regulations (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. Same. Thus. Duque III nonetheless reserves to the government the power to intervene whenever necessary to promote the general welfare.’ ” 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. in the aforecited case. what is used is the phrase “products within the scope of this Code. . the Court declared that “free enterprise does not call for removal of ‘protective regulations. 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.281 VOL.” 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. OCTOBER 9. 2007 281 Pharmaceutical and Health Care Association of the Philippines vs. as defined under the Milk Code. the Court sees no harm in the RIRR providing for just one term to encompass both entities.—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. [Emphasis and italics supplied] Same. Since all the regulatory provisions under the Milk Code apply equally to both manufacturers and distributors. Words and Phrases.” Those are the only differences between the definitions given in the Milk Code and the definition as restated in the RIRR.” There can be no question that the unregulated use or proliferation of pesticides would be hazardous to our environment.

Concurring and Separate Opinion: Freedom of Expression. No. To begin with. C.— Central Hudson provides a four-part analysis for evaluating the validity of regulations of commercial speech.O. 282 282 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Next.. Justice Ma. the commercial speech must “concern lawful activity and not be misleading” if it is to be protected under the First Amendment. it must next be determined whether the state . Same. Same. This is a separate category of speech which is not accorded the same level of protection as that given to other constitutionally guaranteed forms of expression but is nonetheless entitled to protection.—I fully concur with the well-written and comprehensive ponencia of my esteemed colleague. 2006-0012 (RIRR) should be struck down. Duque III speech that proposes an economic transaction—a separate category of speech which is not accorded the same level of protection as that given to other constitutionally guaranteed forms of expression but is nonetheless entitled to protection.J.PUNO. Commercial Speech. If both of these requirements are met. the asserted governmental interest must be substantial. Breastmilk Substitutes. Alicia Austria-Martinez. Four-Part Analysis for Evaluating Validity of Regulations of Commercial Speech. The advertising and promotion of breastmilk substitutes properly falls within the ambit of the term commercial speech—that is. speech that proproses an economic transaction. The advertising and promotion of breastmilk substitutes properly falls within the ambit of the term commercial speech—that is. I write to elucidate another reason why the absolute ban on the advertising and promotion of breastmilk substitutes found under Sections 4(f) and 11 of A. Ms. Same.

overarching ban. Reyes for petitioner. and whether it is not more extensive than is necessary to serve that interest. The facts are stated in the opinion of the Court. for instance. Duque III SPECIAL CIVIL ACTION in the Supreme Court. 2007 283 Pharmaceutical and Health Care Association of the Philippines vs. It ought to be self-evident. . Certiorari. Ma. Sandra Marie Olaso-Coronel and Grace Veronica C. Same. Felicitas Aquino Arroyo.regulation directly advances the governmental interest asserted. Pilar Martinez-Caedo. 535. The absolute ban on advertising prescribed under Sections 4(f) and 11 of the Revised Implementing Rules and Regulations (RIRR) is unduly restrictive and is more than necessary to further the avowed governmental interest of promoting the health of infants and young children. that the dvertisement of such products which are strictly informative cuts too deep on free speech. OCTOBER 9.—I proffer the humble view that the absolute ban on advertising prescribed under Sections 4(f) and 11 of the RIRR is unduly restrictive and is more than necessary to further the avowed governmental interest of promoting the health of infants and young children. The laudable concern of the respondent for the promotion of the health of infants and young children cannot justify the absolute. Same. 283 VOL. Same.

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. Rosales. Maria Paz Luna for herself and movant/intervenors Pia Denise Ducay. J.V. 51. and for Other Purposes (RIRR). Bazar for Arugaan.” Relevant International Agreements. Leonen for himself and movant/inter-venors Karol Ruiz Austria. There is nothing greater than for a mother to nurture her beloved child straight from her bosom. Revised Implementing Rules and Regulations of Executive Order No. Inc. seeking to nullify Administrative Order (A.O. Otherwise Known as The “Milk Code.F. et al. AUSTRIA-MARTINEZ. Penalizing Violations Thereof. The ideal is. et al. But how should this end be attained? Before the Court is a petition for certiorari under Rule 65 of the Rules of Court. 284 284 .: The Court and all parties involved are in agreement that the best nourishment for an infant is mother’s milk. Bernas Law Offices for respondents-in-intervention and Theresia Hontiveros-Baraquel and Loreta Ann P.) No.The Solicitor General for respondents. for each and every Filipino child to enjoy the unequaled benefits of breastmilk. of course. Maria Shiela M. Marvic M. 2006-0012 entitled.

including the adoption of national legislation. when necessary.SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. x x x (Emphasis supplied) 2 Article 11. National policies and . the DOH is deemed impleaded as a corespondent since respondents issued the questioned RIRR in their capacity as officials of said executive agency. regulations or other suitable measures. For purposes of herein petition. 1986 by virtue of the legislative powers granted to the president under the Freedom Constitution. the cooperation of WHO. Misjoinder and non-joinder of parties. 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. Implementation and monitoring 11. Under-secretaries. UNICEF and other agencies of the United Nations system. For this purpose.1 Governments should take action to give effect to the principles and aim of this Code. 1997 Rules of Civil Procedure which provides: Section 11. as appropriate to their social and legislative framework. the WHA adopted several Resolutions to the effect that breastfeeding should be sup- _______________ 1 Section 11.—Neither misjoinder nor non-joinder of parties is ground for dismissal of an action. Rule 3. and Assistant Secretaries of the Department of Health (DOH). governments should seek.1 Executive Order No. 51 (Milk Code) was issued by President Corazon Aquino on October 28. Duque III Named as respondents are the Health Secretary. One of the preambular clauses of the Milk Code states that the law seeks to give effect to Article 112 of the International Code of Marketing of Breastmilk Substitutes (ICMBS). From 1982 to 2006. a code adopted by the World Health Assembly (WHA) in 1981.

are informed of the advantages of breastfeeding. the DOH issued herein assailed RIRR which was to take effect on July 7. petitioner. it should be ensured that nutrition and health claims are not permitted for breastmilk substitutes. specially parents and children. 2007 285 Pharmaceutical and Health Care Association of the Philippines vs. xxxx 285 VOL. 535. including laws and regulations. filed the present Petition for Certiorari and Prohibition with Prayer for the Issuance of a Temporary Restraining Order (TRO) or Writ of Preliminary Injunction. 2006. 2006. representing its members that are manufacturers of breastmilk substitutes. Article 24 of said instrument provides that State Parties should take appropriate measures to diminish infant and child mortality. which are adopted to give effect to the principles and aim of this Code should be publicly stated. Duque III ported. the Philippines ratified the International Convention on the Rights of the Child.measures. hence. and ensure that all segments of society. on June 28. promoted and protected. 2006. OCTOBER 9. In 1990. However. . and should apply on the same basis to all those involved in the manufacture and marketing of products within the scope of this Code. On May 15.

p. the Court set the case for oral arguments on June 19. Rollo. 2007. or with grave abuse of discretion amounting to lack or excess of jurisdiction. Whether Administrative Order No.3 On August 15. and in violation of the provisions of the Constitution in promulgating the RIRR. 12. to wit: “The Court hereby sets the following issues: 1. 286 286 SUPREME COURT REPORTS ANNOTATED . After the Comment and Reply had been filed. the Court issued a Resolution granting a TRO enjoining respondents from implementing the questioned RIRR. _______________ 3 Petition. Whether or not petitioner is a real party-in-interest.The main issue raised in the petition is whether respondents officers of the DOH acted without or in excess of jurisdiction. 2006-0012 or the Revised Implementing Rules and Regulations (RIRR) issued by the Department of Health (DOH) is not constitutional. The Court issued an Advisory (Guidance for Oral Arguments) dated June 5. 2006. 2. 2007.

Whether Sections 4. and 52 of the RIRR violate the due process clause and are in restraint of trade. The petition is partly imbued with merit. 2.Pharmaceutical and Health Care Association of the Philippines vs. ____________ 1 (1) United Nations Convention on the Rights of the Child. whether the RIRR is in accord with the international agreements.3. (2) the WHO and Unicef “2002 Global Strategy on Infant and Young Child Feeding.4.1. 32. 5(w). and 2. the Court adopts the view enunciated in Executive Secretary v. Whether pertinent international agreements1 entered into by the Philippines are part of the law of the land and may be implemented by the DOH through the RIRR. This view fuses the legal identity of an association with that of its members.” and (3) various World Health Assembly (WHA) Resolutions. If in the affirmative.2. 47. An association has standing to file suit for its workers despite its lack of direct interest if its members are affected by the action. Whether the RIRR is in accord with the provisions of Executive Order No. xxxx . 51 (Milk Code). An organization has standing to assert the concerns of its constituents.4 to wit: “The modern view is that an association has standing to complain of injuries to its members. Court of Appeals. The parties filed their respective memoranda. 2. Whether Section 13 of the RIRR on Total Effect provides sufficient standards. Duque III 2. 22. 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.

7 . Inc. 2007 287 Pharmaceutical and Health Care Association of the Philippines vs. v. No. 535.6 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.R. May 25. The respondent is. 131719. thus. because it and its members are in every practical sense identical. and to perform other acts and activities necessary to accomplish the purposes embodied therein. OCTOBER 9. 287 VOL.”5 (Emphasis supplied) which was reasserted in Purok Bagong Silang Association. company. Duque III individual. the respondent was organized x x x to act as the representative of any _______________ 4 G. Yuipco. 2004. under its Articles of Incorporation.x x x We note that. the appropriate party to assert the rights of its members. 429 SCRA 81. 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. entity or association on matters related to the manpower recruitment industry.

May 4. 6 G.Herein petitioner’s Amended Articles of Incorporation contains a similar provision just like in Executive Secretary.. at p. Inc. respectively. at pp... 9 Annexes “H. Inc. 7 Id.). Bristol Myers Squibb (Phils.” and “J” of Petitioner’s Memorandum executed by Wyeth Philippines.R. and Abbott Laboratories. 2007.” “I. 8 Annex “G. would be remiss in its duties if it fails to act _______________ 5 Id. 489 SCRA 382. 288 288 SUPREME COURT REPORTS ANNOTATED . 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. petitioner definitely has an interest in fulfilling its avowed purpose of representing members who are part of the pharmaceutical and health care industry.. which is mandated by its Amended Articles of Incorporation to represent the entire industry. Petitioner. Inc. the medical professions and the general public. 2006. 396. 135092.”8 Thus. Petitioner is duly authorized9 to take the appropriate course of action to bring to the attention of government agencies and the courts any grievance suffered by its members which are directly affected by the RIRR. as an organization.. 96-97.” Petitioner’s Memorandum dated July 19. No.

The Court notes that the following international instruments invoked by respondents. Petitioner assails the RIRR for allegedly going beyond the provisions of the Milk Code. Social and Cultural Rights. e) the Global Strategy for Infant and Young Child Nutrition (Global Strategy). The defense of the DOH is that the RIRR implements not only the Milk Code but also various international instruments10 regarding infant and young child nutrition. It is respondents’ position that said international instruments are deemed part of the law of the land and therefore the DOH may implement them through the RIRR. petitioner. and (3) the Convention on the Elimination of All Forms of Discrimination Against Women. b) the International Code of Marketing Breastmilk Substitutes (ICMBS). ensure the health and well-being of families. d) the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW). Hence. should be considered as a real party-in-interest which stands to be benefited or injured by any judgment in the present action. c) the International Covenant on Economic. . the Court will determine if pertinent international instruments adverted to by respondents are part of the law of the land. _______________ 10 a) The UN Convention on the Rights of the Child (CRC). whose legal identity is deemed fused with its members. no matter how few or numerous they are. and f) various resolutions adopted by the World Health Assembly. Social and Cultural Rights (CSCR). Duque III on governmental action that would affect any of its industry members.Pharmaceutical and Health Care Association of the Philippines vs. On the constitutionality of the provisions of the RIRR First. thereby amending and expanding the coverage of said law. (2) The International Covenant on Economic. namely: (1) The United Nations Convention on the Rights of the Child. 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.

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.289 VOL. The international instruments that do have specific provisions regarding breastmilk substitutes are the ICMBS and various WHA Resolutions. international law is deemed to have the force of domestic law. Duque III and ensure that women are provided with services and nutrition in connection with pregnancy and lactation. international law can become part of the sphere of domestic law either by transformation or incorporation.12 Treaties become part of the law of the land through transformation pursuant to Article VII. 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 incorporation method applies when.” Thus. by mere constitutional declaration.11 The transformation method requires that an international law be transformed into a domestic law through a constitutional mechanism such as local legislation. 535. Said instruments do not contain specific provisions regarding the use or marketing of breastmilk substitutes. OCTOBER 9. Under the 1987 Constitution. 2007 289 Pharmaceutical and Health Care Association of the Philippines vs.

12 Id. An Introduction to Public International Law. ..J. 290 290 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Bernas. 57. p. Consequently. Duque III that has the force and effect of law in this jurisdiction and not the ICMBS per se.. 2002 Ed. S.The ICMBS and WHA Resolutions are not treaties as they have not been concurred in by at least twothirds of all members of the Senate as required under Section 21. it is the Milk Code _______________ 11 Joaquin G. Constitutional Structure and Powers of Government (Notes and Cases) Part I (2005). Article VII of the 1987 Constitution. the Milk Code. However.J. the ICMBS which was adopted by the WHA in 1981 had been transformed into domestic law through local legislation. Bernas.. 13 Joaquin G. S.

15 the Court held thus: “*G+enerally accepted principles of international law. equality. or other marketing materials may be allowed if such materials are duly authorized and approved by the Inter-Agency Committee (IAC).R. . adopts the generally accepted principles of international law as part of the law of the land and adheres to the policy of peace. the Austrian Constitution (Art. April 12. 25) also use the incorporation method. Article II of the 1987 Constitution. No. 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. justice. and a psychological element known as the opinion juris sive necessitates (opinion as to law or necessity).The Milk Code is almost a verbatim reproduction of the ICMBS. freedom. form part of the laws of the land even if they do not derive from treaty obligations. Implicit in the latter element is a belief that the _______________ 14 According to Fr. The Philippines renounces war as an instrument of national policy. 455 SCRA 397. widespread. the Milk Code expressly provides that advertising. and consistent practice on the part of States. Section 2. 2005. The classical formulation in international law sees those customary rules accepted as binding result from the combination [of] two elements: the established. 9) and the Constitution of the Federal Republic of Germany (Art. 139325. Ranada. by virtue of the incorporation clause of the Constitution.14 In Mijares v. promotion. 15 G. Bernas. (Emphasis supplied) embodies the incorporation method. cooperation and amity with all nations. On the other hand. Instead. to wit: “SECTION 2.

renunciation of war as an instrument of national policy.. 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 . 1966 I.291 VOL. 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.17 i. OCTOBER 9. 296).C. 2007 291 Pharmaceutical and Health Care Association of the Philippines vs.” (Judge Tanaka in his dissenting opinion in the 1966 South West Africa Case. These principles. If there should be doubt or disagreement. Duque III practice in question is rendered obligatory by the existence of a rule of law requiring it. 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.19 and pacta sunt servanda.20 among others.”16 (Emphasis supplied) “Generally accepted principles of international law” refers to norms of general or customary international law which are binding on all states. 535. one must look to state practice and determine whether the municipal law principle provides a just and acceptable solution. he believes.J.e.18 a person’s right to life. liberty and due process. are established by a process of reasoning based on the common identity of all legal systems. x x x”21 (Emphasis supplied) Fr. the principle of sovereign immunity. Joaquin G.

. Duque III . 592. Fundamentals of Public International Law. G. 17 Merlin M. p. p.R. at p. 292 292 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Hans Smit. 2nd Ed. Pugh.. 546._______________ 16 Id. 2005 Ed. 526. No. 96. 338 Phil. 19 Government of Hong Kong Special Administrative Region v. 272 SCRA 18 (1997)... Olalia. 20 Tañada v. 21 Louis Henkin. at p. 18 Id. Oscar Schachter. Angara. 421. 153675. Richard C. 521 SCRA 470. April 19. International Law. 2007. 525. Cases and Materials. Magallona.

xxxx The initial factor for determining the existence of custom is the actual behavior of states. and generality of the practice of states. x x x xxxx Duration therefore is not the most important element. why they behave the way they do. More important is the consistency and the generality of the practice. This includes several elements: duration.” (Restatement) This statement contains the two basic elements of custom: the material factor. and the psychological or subjective factor.23 WHA Resolutions have not been embodied in any local legislation. x x x xxxx Once the existence of state practice has been established. The required duration can be either short or long. Have they attained the status of customary law and should they then be deemed incorporated as part of the law of the land? . how states behave.obligation *opinio juris+.”22 (Italics and Emphasis supplied) Clearly. is what makes practice an international rule. Without it. or the belief that a certain form of behavior is obligatory. practice is not law. that is. consistency. it becomes necessary to determine why states behave the way they do. that is. customary international law is deemed incorporated into our domestic system. 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.

250. in economic. OCTOBER 9. 535. is quite different. Duque III 6325 of the UN Charter. . Under the 1946 WHO Constitution. 445 Phil.”28 The legal effect of its regulations. 24 Article 57. 23 Minucher v. pharmaceutical and similar products moving in international commerce. established by intergovernmental agreement and having wide international responsibilities. The various specialized agencies. at pp.24 in relation to Article _______________ 22 Supra note 13. 397 SCRA 244. as opposed to recommendations. 10-13. 269.The World Health Organization (WHO) is one of the international specialized agencies allied with the United Nations (UN) by virtue of Article 57. social. 2007 293 Pharmaceutical and Health Care Association of the Philippines vs.”27 and to “make recommendations to members with respect to any matter within the competence of the Organization. as defined in their basic instruments. 259-260 (2003). Court of Appeals. 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. 293 VOL.

The Health Assembly shall have authority to adopt conventions or agreements with respect to any matter within _______________ cultural.Regulations. and related fields. The Health Assembly shall have authority to adopt regulations concerning: x x x (e) advertising and labeling of biological. The Economic and Social Council may enter into agreements with any of the agencies referred to in Article 57. pharmaceutical and similar products moving in international commerce. (Emphasis supplied) 27 Article 21. Such agreements shall be subject to approval by the General Assembly. defining the terms on which the agency concerned shall be brought into relationship with the United Nations. health. 26 Article 18. educational. 25Article 63. The functions of the Health Assembly shall be: (a) to determine the policies of the Organization x x x. along with conventions and agreements. shall be brought into relationship with the United Nations in accordance with the provisions of Article 63. 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. duly adopted by the WHA bind member states thus: Article 19. (Emphasis supplied) . Such agencies thus brought into relationship with the United Nations are hereinafter referred to as specialized agencies.

take action relative to the acceptance of such convention or agreement. (b) nomenclatures with respect to diseases. it will furnish a statement of the reasons for non-acceptance. purity and potency of biological. Duque III the competence of the Organization. In case of acceptance. (e) advertising and labeling of biological. causes of death and public health practices. and if it does not accept such convention or agreement within the time limit. pharmaceutical and similar products moving in international commerce. . Article 21. (d) standards with respect to the safety. Each Member undertakes that it will. which shall come into force for each Member when accepted by it in accordance with its constitutional processes. (c) standards with respect to diagnostic procedures for international use. 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. (Emphasis supplied) 294 294 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. within eighteen months after the adoption by the Health Assembly of a convention or agreement. pharmaceutical and similar products moving in international commerce.28 Article 23. Article 20. Each Member shall notify the Director-General of the action taken. each Member agrees to make an annual report to the Director-General in accordance with Chapter XIV. A two-thirds vote of the Health Assembly shall be required for the adoption of such conventions or agreements. The Health Assembly shall have authority to make recommendations to Members with respect to any matter within the competence of the Organization.

Sami Shubber. recommendations of the WHA do not come into force for members. 2007 295 Pharmaceutical and Health Care Association of the Philippines vs. 34. 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. The Health Assembly shall have authority to make recommendations to Members with respect to any matter within the competence of the Organization.”29 Even the ICMBS itself was adopted as a mere recommendation. as they constitute the judgment on a health issue of the collective membership of the highest international body in the field of health. The former Senior Legal Officer of WHO. OCTOBER 9. as WHA Resolution No.22 states: .Article 22. Article 23 of the WHO Constitution reads: Article 23. in the same way that conventions or agreements under Article 19 and regulations under Article 21 come into force. but they “carry moral and political weight. 535. stated that WHA recommendations are generally not binding. (Emphasis supplied) On the other hand. Duque III The absence of a provision in Article 23 of any mechanism by which the recommendation would come into force for member states is conspicuous. under Article 23. (Emphasis supplied) 295 VOL.

in the sense of Article 23 of the Constitution. x x x” (Emphasis supplied) The legal value of WHA Resolutions as recommendations is summarized in Article 62 of the WHO Constitution.“The Thirty-Fourth World Health Assembly x x x adopts. Each member shall report annually on the action taken with respect to recommendations made to it by the Organization. 62. to wit: “Art. the WHA Resolution adopting the ICMBS and subsequent WHA Resolutions urging member states to implement the ICMBS are merely recommendatory and legally _______________ 29 See David Fidler. ASIL. International Law. agreements and regulations. the Executive Board of the World Health Organization at its sixty-seventh session. the International Code of Marketing of Breastmilk Substitutes annexed to the present resolution.” Apparently. endorsed it. June 2003. and unanimously recommended to the Thirtyfourth 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. 296 296 . Developments Involving SARS. and Infectious Disease Control at the Fifty-Sixth Meeting of the World Health Assembly. and with respect to conventions.” (Emphasis supplied) The Introduction to the ICMBS also reads as follows: “In January 1981. considered the fourth draft of the code.

22 (May 21. the WHA urged member states to implement the ICBMS as a “minimum requirement. Duque III non-binding. (f) In Resolution No. (e) In Resolution No. 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. Thus. the WHA.” (b) In Resolution No. 47. 1992). 34.26 (May 1982). (a) In Resolution No. 43.3 (May 14. acting under Article 23 of the WHO Constitution. (c) In Resolution No. the WHA urged member states to implement the targets of the Innocenti Declaration specifically. 1993). 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. 35.SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. to give effect to the ICMBS. 46.28 (May 16. the subsequent WHA Resolutions. 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. adopted the ICBMS. 39. continued _______________ 30 In Resolution No.5 (May 9. 1990). 1981). (d) In Resolution No. unlike what has been done with the ICMBS whereby the legislature enacted most of the provisions into law which is the Milk Code.7 (May 10. 45.34 (May 14. the WHA urged member states to strive to eliminate undernutrition. malnutrition and nutritional deficiency among children. 1986). 1994). .30 specifically providing for exclusive breastfeeding from 0-6 months.

31 “Soft law” does not fall into any of the categories of international law set forth in Article 38. the WHA. 49. 2007 297 Pharmaceutical and Health Care Association of the Philippines vs. the WHA urged member states to ensure that complementary foods are not marketed for or used in ways that undermine exclusive and sustained breastfeeding. Chapter III of the 1946 Statute of the International Court of Justice. are currently increasingly being used to promote such products. 54. Duque III breastfeeding up to 24 months. and conscious of the need for the Codex Alimentarius . however. OCTOBER 9.2 (May 2002). new modern communication methods including electronic means.15 (May 25. 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. _______________ (h) In Resolution No. 535. have not been adopted as a domestic law.32 It is. It is propounded that WHA Resolutions may constitute “soft law” or non-binding norms.(g) In Resolution No. 297 VOL. principles and practices that influence state behavior. and absolutely prohibiting advertisements and promotions of breastmilk substitutes. 1996).

32 (May 25. (i) In Resolution No.” urged member states to develop new approaches to protect.33 Certain declarations and resolutions of the UN General Assembly fall under this category.21 (May 27. the WHA reiterated its support for the Gobal strategy for Infant and Young Child Feeding. the WHA urged member states to continue to protect and promote exclusive breastfeeding for six months. 2002). 58. promote and support exclusive breastfeeding for six months as a global public health recommendation. (k) In Resolution No. supra note 29. The Court.35 Mejoff v. 55. principles. 32 Article 38. Director of Prisons. 2006). Government of Hongkong Special Administrative Region v. (j) In Resolution No. 59.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. 1. Olalia. whose function is to decide in accordance with international law such disputes as are submitted to it. 298 298 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.36 . specifically. which this Court has enforced in various cases. 31 David Fidler. 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. and practices that influence state behavior.34 The most notable is the UN Declaration of Human Rights.25 (May 15. Duque III an expression of non-binding norms. 2005).

33 Supra note 29. a specialized agency attached to the UN with the mandate to promote and protect intellectual property worldwide. 38 G. 2006. judicial decisions and the teachings of the most highly qualified publicists of the various nations. 36 90 Phil.R. 37 Supra note 15. Rañada 37 and Shangri-La International Hotel Management. establishing rules expressly recognized by the contesting states. 486 SCRA 405.”39 Other international organizations which have resorted to soft law include the International _______________ shall apply: a) international conventions.Mijares v. 114-136. Developers Group of Companies. 35 Supra note 19. has resorted to soft law as a rapid means of norm creation. 70 (1951). Inc. 2nd Ed. as evidence of a general practice accepted as law. v. as subsidiary means for the determination of rules of law. International Law. whether general or particular. in order “to reflect and respond to the changing needs and demands of its constituents. No. Ltd. d) subject to the provisions of Article 59. Cases and Materials. b) international custom. at pp. . 159938. 34 Louis Henkin. 38 The World Intellectual Property Organization (WIPO). supra note 21. et al. March 31. c) the general principles of law recognized by civilized nations...

it provides an excellent example of the power of “soft law” in international relations.” WHO has during its existence generated many soft law norms. 299 VOL. The “soft law” SARS and IHR Resolutions represent significant steps in laying the political groundwork for improved international cooperation on infectious diseases. OCTOBER 9. 2000 WIPO Recommendation Concerning Trademark Licenses. principles. Some Comments on Rulemaking at the World Intellectual Property Organization. 2007. “Although the IHR Resolution does not create new international law binding on WHO member states.law. 535. September 13.duke. Duque III Labor Organization and the Food and Agriculture Organization (in the form of the Codex Alimentarius). and 2001 WIPO Recommendation Concerning Provisions on the Protection of Marks and other Industrial Property Rights in Signs on the Internet. . and practices that influence state behavior—”soft law. 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. www. citing the 1999 WIPO Resolution Concerning Provisions on the Protection of Well-Known Marks. 12:33.40 WHO has resorted to soft law. creating a “soft law regime” in international governance for public health. This was most evident at the time of the Severe Acute Respiratory Syndrome (SARS) and Avian flu outbreaks. 2007 299 Pharmaceutical and Health Care Association of the Philippines vs. International lawyers typically distinguish binding rules of international law—”hard law”—from non-binding norms.39 Edward Kwakwa.edu/shell/cite.

300 300 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. the executive department implemented certain measures recommended by WHO to address the outbreaks of SARS and Avian flu by issuing Executive Order (E.”41 In the Philippines. and enhancing. 201 on April 26.O. 280 on Febru- _______________ 40 Id. but. No. 2003 and E. perhaps crystallizing eventually into customary international law on infectious disease prevention and control. 41 Supra note 29.O. international cooperation on infectious disease controls is in a country’s self-interest x x x if this warning is heeded. in the wake of the SARS epidemic. Duque III . the duty is powerful politically for two reasons. 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. the SARS outbreak has taught the lesson that participating in.This duty is neither binding nor enforceable. First.) No.

the duty of a state to implement the IHR Resolution was still considered not binding or enforceable. neither have respondents proven that any compliance by member states with said WHA Resolutions was obligatory in nature. 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 poli- 301 . delegating to various departments broad powers to close down schools/establishments. 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. 2004. although signed by most of the member states. It must be emphasized that even under such an international emergency. Second. although said resolutions had great political influence. As previously discussed. were in fact enforced or practiced by at least a majority of the member states. Chapter 1. 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. Section 3. and ban importation of poultry and agricultural products. for an international rule to be considered as customary law. Respondents have not presented any evidence to prove that the WHA Resolutions. it must be established that such rule is being followed by states because they consider it obligatory to comply with such rules (opinio juris). Consequently. legislation is necessary to transform the provisions of the WHA Resolutions into domestic law.ary 2. 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. conduct health surveillance and monitoring.

No. the Administrative Order declared the following policy guidelines: (1) ideal breastfeeding practices. Basically. 2005-0014 is it declared that as part of such health policy. Respondents submit that the national policy on infant and young child feeding is embodied in A. 2005.O. Indeed. and (6) feeding in exceptionally difficult circumstances. which is to start at age six months. 2005-0014. However.O. OCTOBER 9. the primacy of breastfeeding for children is emphasized as a national health policy. 2007 301 Pharmaceutical and Health Care Association of the Philippines vs. In view of the enactment of the Milk Code which does not contain a total ban on the advertising and promotion of breastmilk substitutes. the legislature. exclusive breastfeeding for the first six months. 535. dated May 23. the advertisement or promotion of breastmilk substitutes should be absolutely prohibited. nowhere in A. but instead. (3) micronutrient supplementation. (2) appropriate complementary feeding. (5) the exercise of other feeding options. No. promotion and support of breastfeeding cannot automatically be equated with a total ban on advertising for breastmilk substitutes. 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. The national policy of protection. 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. extended breastfeeding up to two years and beyond.VOL. Duque III cies and plans. (4) universal salt iodization. specifically creates an IAC which will regulate said advertising and promotion. such as early initiation of breastfeeding. . and issue orders and regulations concerning the implementation of established health policies.

Thus. 302 302 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. can be validly implemented by the DOH through the subject RIRR. but not those of subsequent WHA Resolutions. The Milk Code limits its coverage to children 0-12 months old. only the provisions of the Milk Code. In support of its claim that the RIRR is inconsistent with the Milk Code. Duque III Third. the Court will now determine whether the provisions of the RIRR are in accordance with those of the Milk Code. but the RIRR extended its coverage to “young children” or those from ages two years old and beyond: MILK CODE RIRR . petitioner alleges the following: 1.

“Infant” means a person falling within the age bracket of 0-12 months. Purpose.WHEREAS. 2. “Young Child” means a person from the age of more than twelve (12) months up to the age of three (3) years (36 months). SECTION 4(e). but the RIRR provides “exclusive breast- 303 VOL. protection and support of breastfeeding and by ensuring the proper use of breastmilk substitutes. OCTOBER 9. Section 2. 2007 303 . 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. Section 5(ff). consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes. breastmilk supplements and related products when these are medically indicated and only when necessary. The Milk Code recognizes that infant formula may be a proper and possible substitute for breastmilk in certain instances. supplements and related products. on the basis of adequate information and through appropriate marketing and distribution. in order to ensure that safe and adequate nutrition for infants is provided.—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. 535.

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.Pharmaceutical and Health Care Association of the Philippines vs. Duque III feeding for infants from 0-6 months” and declares that “there is no substitute nor replacement for breastmilk:” MILK CODE RIRR WHEREAS. consistent and objective information and appropriate regulation of the marketing and distribution of the said substitutes. There is no substitute or replacement for breastmilk. The Milk Code only regulates and does not impose unreasonable requirements for advertising and promotion. 3. is vague: . in order to ensure that safe and adequate nutrition for infants is provided. which provides for a “total effect” in the promotion of products within the scope of the Code. Section 4. supplements and related products.—The following are the underlying principles from which the revised rules and regulations are premised upon: a. Section 13 of the RIRR. and forbids the use of health and nutritional claims. Exclusive breastfeeding is for infants from 0 to six (6) months. RIRR imposes an absolute ban on such activities for breastmilk substitutes intended for infants from 0-24 months old or beyond. b. Declaration of Principles.

—The following are the underlying principles from which the revised rules and regulations are premised upon: x x x x 304 304 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. published. The General Public and Mothers.MILK CODE RIRR SECTION 6. promotion or other marketing materials. f. for products within the scope of this Code shall be printed.—(a) No advertising. promotions. distrib Section 4. Declaration of Principles. Duque III uted. audio or visual. Advertising. or sponsor-ships . exhibited and broadcast unless such materials are duly authorized and approved by an interagency committee created herein pursuant to the applicable standards provided for in this Code. whether written.

as well as related products covered within the scope of this Code. “Total Effect. shall be allowed. It must not in any case undermine breastmilk . Section 11. or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty. Prohibition.”—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. Section 13.of infant formula.—No advertising. sponsorships.four (24) months. breastmilk substitutes and other related products are prohibited. promotions. because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements.

illustrations or information which discourage or tend to undermine the benefits or superiority of breastfeed. or resulting in greater love. Texts. 535. ability. 305 VOL. Duque III Section 15. grandparents. other relatives or caregivers (or yayas) shall be used in any advertisements for infant formula and breastmilk supplements. 2007 305 Pharmaceutical and Health Care Association of the Philippines vs.—The following shall not be included in advertising. fathers. pictures. harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim. promotional and marketing materials: a. siblings. Content of Materials. In this connection. .or breast-feeding.ing or which idealize the use of breastmilk substitutes and milk supplements. intelligence. The “total effect” should not directly or indirectly suggest that buying their product would produce better individuals. no pictures of babies and children together with their mothers. OCTOBER 9.

c. All health and nutrition claims for products within the scope of the Code are absolutely prohibited. Pictures or texts that idealize the use of infant and milk formula. The term “humanized.” “maternalized.” “close to mother’s milk” or similar words in describing breastmilk substitutes or milk supplements. For this purpose. Duque III . intellectual abilities of the infant and young child and other like phrases shall not be allowed. 306 306 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.b. any phrase or words that connotes to increase emotional. Section 16.

4.— (a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products. (iii) a statement that the product shall be used only onthe advice of a health worker as to the need for its use and the proper methods of use. and which shall include the follow-ing points: (i) the words “Important Notice” or their equivalent. or on a label. (b) A statement of the superiority of breastfeeding. and a warning against the health hazards of inappropriate preparation. (c) A statement that there is no substitute for breastmilk. Content. conspicuous and easily readable and understandable message in Pilipino or English printed on it. and in such a way as not to discourage breastfeeding.—Each container/label shall contain such message. and (iv) instructions for appropriate preparation. (ii) a statement of the superiority of breastfeeding. relative the following points: (a) The words or phrase “Im-portant Notice” or “Government Warning” or their equivalent. The RIRR imposes additional labeling requirements not found in the Milk Code: MILK CODE RIRR SECTION 10. and which message cannot be readily separated therefrom. (b) Each container shall have a clear. in both Filipino and English languages. . (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. Section 26. which message can not readily become separated from it. Containers/ Label.

(e) Instructions for appropria te preparation, 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.

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5. The Milk Code allows dissemination of information on infant formula to health professionals; the RIRR totally prohibits such activity:

MILK CODE

RIRR

SECTION 7. Health Care System.— (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

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 prem-ised 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 manufact urer, 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 breast-feeding, 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 Work-ers.—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

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MILK CODE RIRR SECTION 6. shall be strictly prohibited. defined and covered under the Milk Code and these implementing rules and regulations.— (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. Other Donations By Milk Companies .Pharmaceutical and Health Care Association of the Philippines vs. 7. Section 52. The General Public and Mothers. Donations Within the Scope of This Code. materials. RIRR absolutely prohibits it. The Milk Code regulates the giving of donations. Duque III shall be permitted.—Donations of products. Section 51.

—Donations of products. MILK CODE RIRR Section 46. 8. juridical or natural. found to have violated the 310 310 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.Not Covered by this Code. not otherw ise falling within the scope of this Code or these Rules. may only be coursed through the Inter Agency Committee (IAC). Duque III .—The following administrative sanctions shall be imposed upon any person. Administrative Sanctions. which shall determine whether such donation be accepted or otherwise. and the like. The RIRR provides for administrative sanctions not imposed by the Milk Code. equipments. given by milk companies and their agents. whether in kind or in cash. representatives.

000.00) to Five Hundred (P500. 2007 311 Pharmaceutical and Health Care Association of the Philippines vs.000.00) Pesos. depending on the gravity and extent of the violation. and suspension of the Certificate of Product Registration (CPR). suspension of the License to Operate (LTO) for one year.00) Pesos. the recall of the offending product. the recall of the offending product. OCTOBER 9.00) to Fifty Thousand (P50. e) 5th and succeeding repeated violations—Adminis-trative Fine of One Million (P1.00) to One Hundred Fifty Thousand (P150.000.000. c) 3rd violation—Adminis-trative Fine of a minimum of Sixty Thousand (P60.000. 311 VOL. depending on the gravity and extent of the violation. and in addition thereto.00) Thousand Pesos. including the recall of the offending product. 535. d) 4th violation—Admin-istrative Fine of a minimum of Two Hundred Thousand (P200. and in addition thereto. depending on the gravity and extent of the violation. the recall of the product. Duque III .provisions of the Code and its implementing Rules and Regulations: a) 1st violation—Warning.000.00) Pesos.000. revocation of the CPR.000. b) 2nd violation—Adminis-trative fine of a minimum of Ten Thousand (P10.

cancellation of the CPR, revocation of the License to Operate (LTO) of the company concerned, including the black-listing 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 Thousand 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 “re-peated” 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:

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“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

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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 242 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 infor-mation.” Section 8 of the RIRR also states that information

_______________

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. (Italics supplied)

the RIRR. purpose. as defined in general under the 1987 Administrative Code. 3. “Young Child” means a person from the age of more than twelve (12) months up to the age of three (3) years (36 months). just like the Milk Code. 314 314 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Duque III and educational materials should include information on the proper use of infant formula when the use thereof is needed. 2006. 495 SCRA 42. (Italics supplied) 44 G. it is important to deal first with the nature. the use of breastmilk substitutes may be proper. Hence. 144218. 55. To resolve the question of whether the labeling requirements and advertising regulations under the RIRR are valid. July 14.47 and as delegated in particular under the Milk Code. also recognizes that in certain cases. .R. No. The Court shall ascertain the merits of allegations 345 and 446 together as they are interlinked with each other. and depth of the regulatory powers of the DOH.43 Section 5(ff).

1991. 535. Lorenzo v. No. 445 (1924). OCTOBER 9. Massachusetts. 49 As early as People v. made effective on November 23. L-78164. No.Health is a legitimate subject matter for regulation by the DOH (and certain other administrative agencies) in exercise of police powers delegated to it. 195 SCRA 112. July 31. 741. G.R. 197 US 11 (1905). Campbell. 495. 440. Tablarin v. 1987. 93891. National Labor Relations Commission. health information. 353354 (1916). Gutierrez. 2007 . G. 50 Phil. 123-124. G. 21. 133640. 2007. 476 SCRA 168. 46 Phil. 162053. Court of Appeals. Lukes’s Medical Center Employees Association-AFW v. particularly advertising materials on apparently non-toxic products like breastmilk substitutes and supplements. 2005.R. Director of Health. Pomar. The sheer span of jurisprudence on that matter precludes the need to further discuss it.R. March 11. 196. 152 SCRA 730. 19-21.48 However. November 25. March 7. No. 46 See p. 597 (1927). 595. Secretary of Health. 34 Phil. is a relatively new area for regulation by the DOH. 348. 517 SCRA 677. Beltran v. G. St.R. Rivera v. 47 Executive Order No.49 _______________ 45 See pp. 48 Jacobson v. 292. Pollution Adjudication Board v. 1989 by Proclamation No. we already noted that “advancing civilization is bringing within the 315 VOL. No.

50 health information was already within the ambit of the regulatory powers of the predecessor of DOH. the rapidly increasing population. 2711. medical and environmental matters which have health implications. supplements and related products.315 Pharmaceutical and Health Care Association of the Philippines vs.”53 When it comes to information regarding nutrition of infants and young children.” 50 Act No. 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. the growth of public opinion. however. 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. Article II of the 1987 Constitution. Duque III As early as the 1917 Revised Administrative Code of the Philippine Islands. consistent and objective information on breastfeeding and use of breast-milk substitutes. have brought within the police power of the state many questions for regulation which formerly were not so considered. 1917.51 Section 938 thereof charged it with the duty to protect the health of the people. approved on March 10.” Seventy years later. the Milk Code specifically delegated to the Ministry of Health (hereinafter referred to as DOH) the power to ensure that there is adequate. The development of civilization. it was granted under Section 3 of the Administrative Code the power to “(6) propagate health information and educate the population on important health. the 1987 Administrative Code tasked respondent DOH to carry out the state policy pronounced under Section 15. which is “to protect and promote the right to health of the people and instill health consciousness among them. . and the _______________ scope of police power of the state today things which were not thought of as being with in such power yesterday.”52 To that end.

the Ministry of Health shall have the following powers and functions: . These are expressly provided for in Sections 12 and 5(a). 53 Id. Implementation and Monitoring— xxxx (b) The Ministry of Health shall be principally responsible for the implementation and enforcement of the provisions of this Code. 316 316 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.. at Section 3. Duque III power to control such information. Executive Order No. 52 Section 1. Title IX. 292. to wit: SECTION 12.51 Known then as Public Health Service. For this purpose. Chapter I.

2007 . (3) the negative effect on breastfeeding of introducing partial bottlefeeding. or visual. Information and Education— (a) The government shall ensure that objective and consistent information is provided on infant feeding. provision. 535. SECTION 5. whether manufactured industrially or 317 VOL. dealing with the feeding of infants and intended to reach pregnant women and mothers of infants. This responsibility shall cover the planning. (4) the difficulty of reversing the decision not to breastfeed. on infant nutrition. the proper use of infant formula. and (5) where needed. xxxx (4) To exercise such other powers and functions as may be necessary for or incidental to the attainment of the purposes and objectives of this Code. (2) maternal nutrition. and the control thereof. (Emphasis supplied) Further. design and dissemination of information. x x x (b) Informational and educational materials. whether written. shall include clear information on all the following points: (1) the benefits and superiority of breastfeeding. in the following manner: “SECTION 5.(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. OCTOBER 9. DOH is authorized by the Milk Code to control the content of any information on breastmilk visà-vis breastmilk substitutes. supplement and related products. and the preparation for and maintenance of breastfeeding. for use by families and those involved in the field of infant nutrition. audio.

the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes. and.317 Pharmaceutical and Health Care Association of the Philippines vs. Duque III home-prepared. they shall include the social and financial implications of its use. (Emphasis supplied) . the health hazards of inappropriate foods or feeding methods.— (a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products. xxxx (d) The term “humanized. When such materials contain information about the use of infant formula.” “maternalized” or similar terms shall not be used. SECTION 10. Containers/Label. and in such a way as not to discourage breastfeeding. and such information shall not imply or create a belief that bot-tlefeeding is equivalent or superior to breastfeeding.— xxxx (b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters. It shall also include the information specified in Section 5(b). Such materials shall not use any picture or text which may idealize the use of breastmilk substitutes. Health Workers. in particular. SECTION 8.

published. mothers of infants.— (a) No advertising. for products within the scope of this Code shall be printed. whether written. 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. distributed. directly or indirectly. samples and supplies of products within the scope of this Code or gifts of any sort to 318 318 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. (b) Manufacturers and distributors shall not be permitted to give. audio or visual.The DOH is also authorized to control the purpose of the information and to whom such information may be disseminated under Sections 6 through 9 of the Milk Code54 to ensure _______________ 54 SECTION 6. The General Public and Mothers. promotion or other marketing materials. and health professionals and workers in _______________ . Duque III that the information that would reach pregnant women.

2007 . 319 VOL. premiums. to hospitals and other health institutions. special sales. (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. giving of samples or any other promotion devices to induce sales directly to the consumers at the retail level. nor shall any other groups. Health Care System. (c) There shall be no point-of-sale advertising. This provision shall not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long-term basis. (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. (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. and on their obligations under this Code. This Code does not. either directly or indirectly. 535. discount coupons. such as special displays. training and advice to health workers on infant nutrition.— (a) The Ministry of Health shall take appropriate measures to encourage and promote breastfeeding. OCTOBER 9.any member of the general public. including members of their families. institutions or individuals distribute such gifts. It shall provide objective and consistent information. except as otherwise provided by this Code. SECTION 7. utensils or products to the general public and mothers. to pregnant women or with mother of infants. however. (e) Marketing personnel shall be prohibited from advertising or promoting in any other manner the products covered by this Code. save as otherwise provided in this Code. bonus and tie-in sales for the products within the scope of this Code. as well as to personnel within the health care system.

Health Workers. (d) The use by the health care system of “professional service” representatives.— (a) Health workers shall encourage and promote breast-feeding and shall make themselves familiar with objectives and consistent information on maternal and infant nutrition.319 Pharmaceutical and Health Care Association of the Philippines vs. Duque III the health care system is restricted to scientific and factual matters and shall not imply or create a belief that bottlefeed-ing is equivalent or superior to breastfeeding. “mothercraft nurses” or similar personnel. (e) In health education classes for mothers and the general public. shall not be permitted. (c) Facilities of the health care system shall not be used for the display of products within the scope of 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. provided or paid for by manufacturers or distributors. _______________ preclude the dissemination of information to health professionals as provided in Section 8(b). health workers and community workers shall emphasize the hazards and risks of the improper use of breast-milk 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. or for placards or posters concerning such products. SECTION 8. and with their responsibilities under this Code. It shall also include the information specified in Section 5(b).

that the DOH’s power under the Milk Code to control information regarding breastmilk vis-à-vis breastmilk substitutes is not absolute as the power to control does not encompass the power to absolutely prohibit the advertising. Duque III It bears emphasis. Aim of the Code. 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. or of equipment or utensils for their 320 320 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. nor shall these be accepted by the health workers or members of their families. and promotion of breastmilk substitutes. except as otherwise provided in Section 8(e). (d) Samples of infant formula or other products within the scope of this Code. to wit: “SECTION 2. however.(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. marketing.—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 .

321 VOL. 2007 321 Pharmaceutical and Health Care Association of the Philippines vs. and to information concerning their 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. . of health professionals.—Personnel employed in marketing products within the scope of this Code shall not. in accordance with the rules and regulations promulgated by the Ministry of Health. (e) Manufacturers and distributors of products within the scope of this Code may assist in the research. 535.proper use of breastmilk substitutes and breastmilk supplements when these are necessary. Duque III b) Section 3 which specifically states that the Code applies to the marketing of and practices related to breastmilk substitutes. as part of their job responsibilities. perform educational functions in relation to pregnant women or mothers of infants. including infant formula. OCTOBER 9. SECTION 9. No health workers shall give samples of infant formula to pregnant women and mothers of infants or members of their families. on the basis of adequate information and through appropriate marketing and distribution. Persons employed by Manufacturers and Distributors.” _______________ preparation or use. scholarships and continuing education.

and g) Section 10 which provides that containers or labels should not contain information that would discourage breast-feeding and idealize the use of infant formula.c) Section 5(a) which provides that the government shall ensure that objective and consistent information is provided on infant feeding. 21. 20. 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. Sections 1355 on “total effect” and 2656 of Rule VII of the RIRR contain some labeling requirements. promotion. and b) that there be a statement that powdered infant formula may contain pathogenic microorganisms and must be _______________ 55 See p. specifically: a) that there be a statement that there is no substitute to breastmilk. and other marketing materials. It is in this context that the Court now examines the assailed provisions of the RIRR regarding labeling and advertising. e) Section 6(a) in relation to Section 12(a) which creates and empowers the IAC to review and examine advertising. 322 322 . 56 See p. 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.

Health workers— xxxx (b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters. such as claims of increased emotional and intellectual abilities of the infant and young child. Section 1657 of the RIRR prohibits all health and nutrition claims for products within the scope of the Milk Code. Duque III prepared and used appropriately. It shall also include the information specified in Section 5. 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. These requirements and limitations are consistent with the provisions of Section 8 of the Milk Code.SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. as such information would be inconsistent with the superiority of breastfeeding.”58 (Emphasis supplied) and Section 10(d)59 which bars the use on containers and labels of the terms “humanized.” or similar terms. . and such information shall not imply or create a belief that bottlefeed-ing is equivalent or superior to breastfeeding.” “maternalized. to wit: “SECTION 8.

Duque III . 30. any phrase or words that connotes to increase emotional. 2007 323 Pharmaceutical and Health Care Association of the Philippines vs.It may be argued that Section 8 of the Milk Code refers only to information given to health workers regarding breast- _______________ 57 SECTION 16. For this purpose. 535. intellectual abilities of the infant and young child and other like phrases shall not be allowed.— xxxx (d) The term “humanized. OCTOBER 9. 58 See p. All health and nutrition claims for products within the scope of the Code are absolutely prohibited. 59 SECTION 10. 323 VOL.” “maternalized” or similar terms shall not be used. Containers/Label.

in both Filipino and English languages.—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. 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. design. and which message cannot be readily separated therefrom. not to containers and labels thereof. Section 26(f)61 of the RIRR is an equally reasonable labeling requirement. 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 260 of the Milk Code. Thus. That askewed interpretation of the Milk Code is precisely what Section 5(a) thereof seeks to avoid by mandating that all information regarding breast-milk vis-à-vis breastmilk substitutes be consistent. Content. on the basis of adequate information and through appropriate marketing and distribution. relative the follow-ing points: xxxx (f) The health hazards of unnecessary or improper use of infant formula and other related products including information that . 61 SECTION 26. and dissemination of information on infant feeding.milk substitutes. However. at the same time giving the government control over planning. Aim of the Code. It implements Section 5(b) of the Milk Code which reads: _______________ 60 SECTION 2. provision.—Each container/label shall contain such message. Section 26(c) of the RIRR which requires containers and labels to state that the product offered is not a substitute for breastmilk.

2007 that formula milk is prone to contaminations and there is as yet no technology that allows production of powdered infant formula that eliminates all forms of contamination. whether written. or visual. Duque III “SECTION 5. 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. x x x xxxx (b) Informational and educational materials. shall include clear information on all the following points: x x x (5) where needed. the health hazards of inappropriate foods or feeding methods. The buyers of breast-milk substitutes are mothers of infants. in particular. the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes. When such materials contain information about the use of infant formula. Such materials shall not use any picture or text which may idealize the use of breastmilk substitutes. Petitioner’s counsel has admitted during the hearing on June 19. whether manufactured industrially or home-prepared.62 . and. audio. they shall include the social and financial implications of its use. (Emphasis supplied) The label of a product contains information about said product intended for the buyers thereof.324 324 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. the proper use of infant formula. dealing with the feeding of infants and intended to reach pregnant women and mothers of infants.

62 TSN of the hearing of June 19. _______________ powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately. promotion. 535. In furtherance of Section 6(a) of the Milk Code. 2007 325 Pharmaceutical and Health Care Association of the Philippines vs. 114-120. to wit: . Duque III The authority of DOH to control information regarding breastmilk vis-à-vis breastmilk substitutes and supplements and related products cannot be questioned. 325 VOL. and marketing that is being assailed by petitioner.Ineluctably. It is its intervention into the area of advertising. 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. 2007. OCTOBER 9. pp.

............ Chairman Minister of Trade and Industry .....SECTION 6. for products within the scope of this Code shall be printed..... whether written........ audio or visual....... 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...... ..... thus: SECTION 12. Member Minister of Justice ...... Implementation and Monitoring...... published....— (a) No advertising......... an inter-agency committee composed of the following members is hereby created: Minister of Health ........... The General Public and Mothers........ distributed...........................— (a) For purposes of Section 6(a) of this Code.. promotion or other marketing materials...................................... the Milk Code invested regulatory authority over advertising.. promotional and marketing materials to an IAC........

... promotion or other marketing materials. Member The members may designate their duly authorized representative to every meeting of the Committee.. exhibition and broadcast of... distribution.... on products within the scope of this Code..... whether written. publication. The Committee shall have the following powers and functions: (1) To review and examine all advertising. delete objectionable portions from and prohibit the printing. Duque III . 326 326 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.. audio or visual. all advertising promotion or other marketing materials.. on products within the scope of this Code. whether written. audio or visual.Member Minister of Social Services and Development .. (2) To approve or disapprove..

promotions. because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements. promotions. Section 11 of the RIRR. promotions. or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty-four (24) months.” The DOH. Declaration of Principles. oddly enough. promotion. shall be allowed. to wit: “SECTION 11. Yet. and (4) To promulgate such rules and regulations as are necessary or proper for the implementation of Section 6(a) of this Code. marketing and promotional materials prior to dissemination.—No advertising. Section 12 of the RIRR reiterated the requirement of the Milk Code in Section 6 thereof for prior approval by IAC of all advertising. breastmilk substitutes and other related products are prohibited.” prohibits advertising. Prohibition.(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.— xxxx (f) Advertising. or sponsorships of infant formula. and marketing. through its co-respondents. evidently arrogated to itself not only the regulatory authority given to the IAC but also imposed absolute prohibition on advertising. sponsorships or marketing materials and activities for breastmilk substitutes in line with the RIRR’s declaration of principle under Section 4(f). as well as related products covered within the scope of this Code. x x x (Emphasis supplied) However. to wit: “SECTION 4. . sponsorships.

535. 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. during the oral argu- 327 VOL. 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.Even respondents. viz. Duque III ments on June 19. that the prohibition under Section 11 is not actually operational. We have to read Section 11 together with the other Sections because the other Section. and repeatedly insisted. provides for the inter agency committee that is empowered to process and evaluate all the advertising and promotion materials. 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. 2007 327 Pharmaceutical and Health Care Association of the Philippines vs. through the OSG. acknowledged the authority of IAC.: SOLICITOR GENERAL DEVANADERA: xxxx x x x Now. . OCTOBER 9. promotion. 2007. Section 12.

must be taken together with the provision on the InterAgency Committee that processes and evaluates because there may be some information dissemination that are straight forward information dissemination. Your Honor. which body has authority or power to promulgate Rules 328 328 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Duque III . xxxx Now. Your Honor. under the Milk Code. the prohibition on advertising. it does not prohibit the sale and manufacture. it simply regulates the advertisement and the promotions of breastfeeding milk substitutes. xxxx ASSOCIATE JUSTICE SANTIAGO: Madam Solicitor General. what it does. What the AO 2006 is trying to prevent is any material that will undermine the practice of breastfeeding.xxxx What AO 2006-12.

xxxx ASSOCIATE JUSTICE SANTIAGO: x x x Don’t you think that the Department of Health overstepped its rule making authority when it totally banned advertising and promotion under Section 11 prescribed the total effect rule as well as the content of materials under Section 13 and 15 of the rules and regulations? SOLICITOR GENERAL DEVANADERA: Your Honor. that there is no absolute ban on advertising of breastmilk substitutes in the Revised Rules? . please. Your Honor. please. the InterAgency Committee is under the Department of Health. Madam Solicitor. xxxx ASSOCIATE JUSTICE NAZARIO: x x x Did I hear you correctly. Promotion and Marketing of Breastmilk Substitutes? SOLICITOR GENERAL DEVANADERA: Your Honor. it is provided that the InterAgency Committee. first we would like to stress that there is no total absolute ban. Your Honor. Second.and Regulations regarding the Advertising.

your Honor. 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. 535. 2007 329 Pharmaceutical and Health Care Association of the Philippines vs. Your Honor. xxxx 329 VOL. OCTOBER 9. which are—they should not undermine breastfeeding. because we have the Inter-Agency Committee that can evaluate some advertising and promotional materials. ASSOCIATE JUSTICE NAZARIO: But. Duque III .SOLICITOR GENERAL DEVANADERA: Yes. subject to the standards that we have stated earlier. Your Honor.

while it is titled Prohibition. or visual. Your Honor.— xxxx (b) Informational and educational materials. we take exceptions and standards have been set. however. particularly 12 and 13 and 15. whether written. because it is recognized that the Inter-Agency Committee has that power to evaluate promotional materials. promotional. One of which is that. the InterAgency Committee can allow if the advertising and promotions will not undermine breastmilk and breastfeed-ing. 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. it must be taken in relation with the other Sections. or other marketing materials under Section 12(a) of the Milk Code. and 10 of the Code. which. are quoted hereunder: SECTION 5. Your Honor. dealing with the feeding of infants and intended .x x x Section 11. 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. at the risk of being repetitious. audio. 8(b).63 Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code. Your Honor.” Said standards are set forth in Sections 5(b). and for easy reference. although it is the IAC which is authorized to promulgate rules and regulations for the approval or rejection of advertising. ASSOCIATE JUSTICE NAZARIO: So in short. Information and Education.

2007 hearing. shall include clear information on all the following points: (1) the benefits and superiority of breastfeeding. (2) maternal nutrition. and (5) where needed. 193-194. (4) the difficulty of reversing the decision not to breastfeed. 231. pp. the proper use of infant formula. (3) the negative effect on breast-feeding of introducing partial bottlefeeding. 237-240. the health hazards of unnecessary or improper use of infant formula and other breastmilk substitutes. Health Workers. and the preparation for and maintenance of breastfeeding. 330 330 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. When such materials contain information about the use of infant formula._______________ 63 TSN of June 19. Duque III to reach pregnant women and mothers of infants. Such materials shall not use any picture or text which may idealize the use of breastmilk substitutes. whether manufactured industrially or home-prepared. 198. in particular. xxxx SECTION 8.— xxxx . and. the health hazards of inappropriate foods of feeding methods. 295-300. they shall include the social and financial implications of its use.

Containers/Label. and which shall include the following points: (i) the words “Important Notice” or their equivalent. conspicuous and easily readable and understandable message in Pilipino or English printed on it.— (a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products. 535. (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. (ii) a statement of the superiority of breastfeeding. OCTOBER 9. and 331 VOL. 2007 331 . which message can not readily become separated from it. It shall also include the information specified in Section 5(b). and in such a way as not to discourage breastfeeding.(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. (b) Each container shall have a clear. or on a label. xxxx SECTION 10.

by which the IAC shall screen advertising. (Emphasis supplied) Thus. Section 5(a) of the Milk Code states that: SECTION 5. or other marketing materials. intelligence. “Total Effect. and 10 of the Milk Code. It is pursuant to such responsibility that the DOH correctly provided for Section 13 in the RIRR which reads as follows: “SECTION 13. It must not in any case undermine breastmilk or breastfeeding.— (a) The government shall ensure that objective and consistent information is provided on infant feeding. on infant nutrition. provision. 8. and the control thereof. Section 12(b) of the Milk Code designates the DOH as the principal implementing agency for the enforcement of the provisions of the Code. the DOH has the significant responsibility to translate into operational terms the standards set forth in Sections 5. The “total effect” should not directly or indirectly suggest that buying their product would produce better individuals. ability. Duque III (iv) instructions for appropriate preparation. This responsibility shall cover the planning. or resulting in greater love.Pharmaceutical and Health Care Association of the Philippines vs. design and dissemination of information. harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim. and a warning against the health hazards of inappropriate preparation.”—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.” . In relation to such responsibility of the DOH. for use by families and those involved in the field of infant nutrition. promotional. Information and Education.

in the past. in relation to Section 8(b)67 of the same Code. promotional and marketing materials on breastmilk vis-à-vis breastmilk substi- 332 332 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Section 7(b)66 of the Milk Code. .64 the Court held: “x x x *T+his Court had.” and “simplicity. vs. 4. supplements and other related products. economy and welfare. In Equi-Asia Placement. correct information as to infant feeding and nutrition is infused with public interest and welfare. Inc. the Court also finds that there is no inconsistency between the provisions of the Milk Code and the RIRR. Department of Foreign Affairs. Through that single provision.Such standards bind the IAC in formulating its rules and regulations on advertising. allows dissemination of information to health professionals but such information is restricted to scientific and factual matters.” “justice and equity. Duque III tutes. the DOH exercises control over the information content of advertising. promotion.” “public convenience and welfare. It also sets a viable standard against which the IAC may screen such materials before they are made public. accepted as sufficient standards the following: “public interest.”65 In this case. With regard to activities for dissemination of information to health professionals. and marketing.

. at p. 67 SECTION 8.Contrary to petitioner’s claim. 66 SECTION 7. preclude the dissemination of information to health professionals as provided in Section 8(b). 2006. This Code does not.— xxxx (b) No facility of the health care system shall be used for the purpose of promoting infant formula or other products within the scope of this Code. Health Workers. 152214. Section 22 of the RIRR does not prohibit the giving of information to health profes- _______________ 64 G. 314.R. 502 SCRA 295. September 19. 333 . however. Health Care System. 65 Id.— xxxx (b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters and such information shall not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding. It shall also include the information specified in Section 5(b). No.

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. 535. 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 breast-feeding. Duque III sionals on scientific and factual matters. OCTOBER 9. Note that under Section 12(b) of the Milk Code. it is the DOH which shall be principally _______________ 68 SECTION 8. The Court finds nothing in said provisions which contravenes the Milk Code.VOL. Said provision cannot be construed to encompass even the dissemination of information to health professionals. 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. 2007 333 Pharmaceutical and Health Care Association of the Philippines vs.— xxxx . Health Workers. 5. What it prohibits is the involvement of the manufacturer and distributor of the products covered by the Code in activities for the promotion. Next. Education and Communication (IEC) materials regarding breastfeeding that are intended for women and children. as restricted by the Milk Code. education and production of Information. while Sections 22 and 32 of the RIRR absolutely forbid the same.

in accordance with the rules and regulations promulgated by the Ministry of Health. Duque III responsible for the implementation and enforcement of the provisions of said Code. of health professionals. Section 2270 of the RIRR does not pertain to research assistance to or the continuing education of health professionals. 69 SECTION 4.(e) Manufacturers and distributors of products within the scope of this Code may assist in the research. scholarships and continuing education. 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. and their representatives. Therefore. rather. should not form part of any policymaking body or entity in relation to the advancement of breastfeeding. 334 334 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. it deals . 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.—The following are the underlying principles from which the revised rules and regulations are premised upon: xxxx (i) Milk companies. Declaration of Principles. It is entirely up to the DOH to decide which entities to call upon or allow to be part of policymaking bodies on breastfeeding.

—The DOH shall ensure that research conducted for public policy purposes. the health worker or researcher involved in such must disclose any actual or potential conflict of interest with the com-pany/person funding the research. such research and its findings shall be subjected to independent peer review. hence. x x x. relating to infant and young child feeding should. Nothing in Section 22 of the RIRR prohibits milk companies from giving assistance for research or continuing education to health professionals. Said sections of the RIRR provide that _______________ 70 SECTION 22.with breastfeeding promotion and education for women and children. In any event. a disclosure and/or disclaimer of the sponsoring company should be done by the company itself. at all times. education and production of Information. Education and Communication (IEC) materials on breastfeeding. health worker. No manufacturer. researcher involved through verbal declaration during the public presentation of the research and in print upon publication. 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. Purpose. Research. 535.—For transparency purposes. petitioner’s argument against this particular provision must be struck down. be free form any commercial influence/bias. distributor. 2007 335 . 72 SECTION 10. It is Sections 971 and 1072 of the RIRR which govern research assistance. 335 VOL. Ethics Committee. or representatives of products covered by the Code shall be allowed to conduct or be involved in any activity on breastfeeding promotion. accordingly. 71 SECTION 9. OCTOBER 9. Public Disclosure.

protect and support breastfeeding and appropriate infant and young child feeding. of health professionals in accordance with the rules and regulations promulgated by the Ministry of Health. 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. No assistance. Petitioner complains that Section 3273 of the RIRR prohibits milk companies from giving assistance. scholarships and the continuing education. The Milk Code leaves it purely to the discretion of the DOH whether to request or accept such donations. now DOH.—It is the primary responsibility of the health workers to promote. Thus. support. and with certain disclosure requirements imposed on the milk company and on the recipient of the research award. . support. Duque III research assistance for health workers and researchers may be allowed upon approval of an ethics committee. The law does not proscribe the refusal of donations.Pharmaceutical and Health Care Association of the Philippines vs. which provides that manufacturers and distributors of breastmilk substitutes may assist in researches. logistics or training to health workers. 74 Supra note 68. 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. said provisions are also consistent with the Milk Code. Part of this responsibility is to continuously update their knowledge and skills on breastfeeding. 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. This provision is within the prerogative given to the DOH under Section 8(e)74 of the Milk Code. logistics or training from milk companies shall be permitted. Primary Responsibility of Health Workers. The DOH then appropriately exercised _______________ 73 SECTION 32. As to the RIRR’s prohibition on donations. 6.

no real inconsistency between the RIRR and the law because the Milk Code does not prohibit the DOH from refusing donations. With regard to Section 46 of the RIRR providing for administrative sanctions that are not found in the Milk Code. Phil-ippine Air Lines. Thus. the Court upholds petitioner’s objection thereto. The glaring difference in said case and the present case before the Court is that. 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. 76 is misplaced. 776) the power to impose fines and civil penalties. Inc. remit. .336 336 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. the DOH is not mandated by the Milk Code to accept donations. the Court upheld the CAB’s Resolution imposing administrative fines. Duque III its discretion through Section 5175 of the RIRR which sets forth its policy not to request or approve donations from manufacturers and distributors of breastmilk substitutes. the Civil Aeronautics Administration (CAA) was expressly granted by the law (R. No. Respondent’s reliance on Civil Aeronautics Board v. As reasoned out by respondents. therefore. For that matter. 7. no person or entity can be forced to accept a donation. in the Civil Aeronautics Board. increase or compromise such fine and civil penalties. There is. 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.A. mitigate.

June 26. OCTOBER 9. 7638 to impose fines or penalties. 2007 337 Pharmaceutical and Health Care Association of the Philippines vs. Blg. LPG Refillers Association of the Philippines. 2006. 33 and R. Perez v.77 the Court upheld the Department of _______________ 75 SECTION 51. defined and covered under the Milk Code and these implementing rules and regulations.P. materials. No. 77 G. 142.—Donations of products. 33. 2000-06-10 implementing Batas Pambansa (B. Donations Within the Scope of This Code. 492 SCRA 638. 535.A. 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. 159149. No. 63 SCRA 524 (1975).) Blg.In a more recent case.. . 337 VOL.R. 76 159-A Phil. shall be strictly prohibited. Inc. Duque III Energy (DOE) Circular No.

(b) Any license. the DOH cannot provide for those fines in the RIRR.00) nor more than Thirty Thousand Pesos (P30. shall be penalized. or the partners and/or the persons directly responsible therefor. neither the Milk Code nor the Revised Administrative Code grants the DOH the authority to fix or impose administrative fines.000. or of the rules and regulations issued pursuant to this Code. upon conviction. Sanctions. 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. the chairman of the Board of Directors. Thus.— (a) Any person who violates the provisions of this Code or the rules and regulations issued pursuant to this Code shall. without any express grant of power to fix or impose such fines. Should the offense be committed by a juridical person. therefore. upon recommendation of the Ministry of Health. may.In the present case. The DOH is not left without any means to enforce its rules and regulations. be suspended or revoked in the event of repeated violations of this Code. 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. (Emphasis supplied) 338 338 SUPREME COURT REPORTS ANNOTATED . distributor. to wit: “SECTION 13.00) or both. permit or authority issued by any government agency to any health worker.” 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. In this regard. Said provision is. general manager. or for the pursuit of their business. manufacturer. the president. or marketing firm or personnel for the practice of their profession or occupation. the DOH again exceeded its authority by providing for such fines or sanctions in Section 46 of the RIRR.000. null and void.

and rules and regulations or parts thereof inconsistent with these revised rules and implementing regulations are hereby repealed or modified accordingly.—All orders. Thus. In fine. and subject to the doctrine of non-delegability and separability of powers. null and void. Section 57 reads: “SECTION 57. said provision is valid as it is within the DOH’s rule-making power. revise. Hence. issuances. Repealing Clause. alter. issuances and rules and regulations. only Sections 4(f). 11 and 46 are ultra vires.Pharmaceutical and Health Care Association of the Philippines vs. therefore. _______________ . The rest of the provisions of the RIRR are in consonance with the Milk Code. Petitioner’s claim that Section 57 of the RIRR repeals existing laws that are contrary to the RIRR is frivolous. Duque III 8. it is a standard provision in administrative rules that prior issu-ances of administrative agencies that are inconsistent therewith are declared repealed or modified.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.78 Such express grant of rule-making power necessarily includes the power to amend. or repeal the same. 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. beyond the authority of the DOH to promulgate and in contravention of the Milk Code and.” Section 57 of the RIRR does not provide for the repeal of laws but only orders.

130584. Inc.85 22. 2007 339 Pharmaceutical and Health Care Association of the Philippines vs.83 5(w). National Telecommunications Commission. v. 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. 145. 155-156.84 11. 493 SCRA 86. 456 Phil. v. Court of Appeals. and is offensive to the due process clause of the Constitution. June 27. No. 686 (2003). Duque III Lastly. pp. 97. OCTOBER 9. at p. 156.R. 535. 686-687.82 4(i). 2006. 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. G.87 _______________ . 408 SCRA 678. 79 Yazaki Torres Manufacturing. Inc.86 32. 80 Supra note 78.”81 (Emphasis supplied) Petitioner refers to Sections 4(f). 339 VOL.78 Smart Communications.

82 SECTION 4. 86 Supra note 70. including their representatives who promote or otherwise advance their commercial interests in marketing those products. or by any other description of such nature. Declaration of Principles.81 Petitioner’s Memorandum. Declaration of Principles. follow-up milk. as well as related products covered within the scope of this Code. or sponsorships of infant formula. manufacturer. 85 SECTION 11.—x x x (i) Milk companies. or marketing materials and activities for breastmilk substitutes intended for infants and young children up to twenty-four (24) months. because they tend to convey or give subliminal messages or impressions that undermine breastmilk and breastfeeding or otherwise exaggerate breastmilk substitutes and/or replacements. distributor. sponsorships.—No advertising.—The following are the underlying principles from which the revised rules and regulations are premised upon: xxxx (f) Advertising. 84 SECTION 5. Prohibition. promotions. of infant formula. and their representatives. x x x x (w) “Milk Company” shall refer to the owner. 83 SECTION 4. x x x. 87 Supra note 73. breastmilk substitute or replacement. promotions. should not form part of any policymaking body or entity in relation to the advancement of breastfeeding. shall be allowed. breastmilk substitutes and other related products are prohibited. . milk formula. milk supplement.

the recall of the offending product.88 and 5289 as the provisions that suppress the trade of milk and. and in addition thereto. including the recall of the offending product.000.00) to Fifty Thousand (P50.000. b) 2nd violation—Administrative fine of a minimum of Ten Thousand (P10.00) Pesos.000. and in addition thereto. _______________ 88 SECTION 46.000.000.000.00) Thousand Pesos. thus. depending on the gravity and extent of the violation. (c) 3rd violation—Administrative Fine of a minimum of Sixty Thousand (P60. depending on the gravity and extent of the violation.00) Pesos. the recall of the product. depending on the gravity and extent of the violation.—The following administrative sanctions shall be imposed upon any person. and suspension of the Certificate of Product Registration (CPR). Administrative Sanctions. found to have violated the provisions of the Code and its implementing Rules and Regulations: a) 1st violation—Warning. Duque III 46.00) to Five Hundred (P500.00) to One Hundred Fifty Thousand (P150. revocation of the CPR. violate the due process clause of the Constitution. (d) 4th violation—Administrative Fine of a minimum of Two Hundred Thousand (P200. . juridical or natural. suspension of the License to Operate (LTO) for one year.340 340 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs.

despite the fact that “our present Constitution enshrines free enterprise as a policy. including the blacklisting of the company to be furnished the Department of Budget and Management (DBM) and the Department of Trade and Industry (DTI). it nonetheless reserves to the government the power to intervene whenever necessary to promote the general welfare. 2007 341 Pharmaceutical and Health Care Association of the Philippines vs.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. are deemed to be violations of the concerned milk company and shall not be based on the specific violating product alone. the recall of the offending product.” There can be no question that the unregulated use or proliferation of pesticides would . Other Donations By Milk Companies Not Covered by this Code. (f) An additional penalty of Two Thou-sand Five Hundred (P2. notifying and penalizing the company for the infraction. Fertilizer and Pesticide Authority. not otherwise falling within the scope of this Code or these 341 VOL. as held in Association of Philippine Coconut Desiccators v. For purposes of determining whether or not there is “re-peated” violation.00) Pesos. 89 SECTION 52. each product violation belonging or owned by a company.000. including those of their subsidiaries.500. Duque III The framers of the constitution were well aware that trade must be subjected to some form of regulation for the public good. and the like. 535.—Donations of products. revocation of the License to Operate (LTO) of the company concerned.(e) 5th and succeeding repeated—Administrative Fine of One Million (P1. cancellation of the CPR.000.90 In Pest Management Association of the Philippines v. Philippine Coconut Authority. OCTOBER 9. equipments. Public interest must be upheld over business interests.91 it was held thus: “x x x Furthermore.

be hazardous to our environment. petitioner failed to show that the proscription of milk manufacturers’ participation in any policymaking body (Section 4[i]). 85 (2003). February 21. Land Transportation Franchising and Regulatory Board. 413 SCRA 75. may only be coursed through the Inter Agency Committee (IAC). which shall determine whether such donation be accepted or otherwise. whether in kind or in cash. in the aforecited case. 156041. 342 342 SUPREME COURT REPORTS ANNOTATED .” [Emphasis and italics supplied] In this case. 90 Eastern Assurance & Surety Corporation v. Petitioner has not established that the proscribed activities are indispensable to the trade of breastmilk substitutes. 91 G. support and logistics or training (Section 32). and the giving of donations (Section 52) would unreasonably hamper the trade of breastmilk substitutes. given by milk companies and their agents. the giving of assistance. 516 SCRA 360. 399. 2007. classes and seminars for women and children (Section 22). 459 Phil. 395. the Court declared that “free enterprise does not call for removal of ‘protective regulations.R. Thus. _______________ Rules. No.’ ” 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. representatives. Petitioner failed to demonstrate that the aforementioned provisions of the RIRR are unreasonable and oppressive for being in restraint of trade.

x x x. breastmilk substitute or replacement. manufacturer. distributor of infant formula.” to wit: “SECTION 5. 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. follow-up milk. (w) “Milk Company” shall refer to the owner. Said section provides for the definition of the term “milk company. milk formula. On the other hand. . including their representatives who promote or otherwise advance their commercial interests in marketing those products”.” whereas in the Milk Code. milk supplement. or by any other description of such nature.” Those are the only differences between the definitions given in the Milk Code and the definition as re-stated in the RIRR.Pharmaceutical and Health Care Association of the Philippines vs. 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. Duque III Petitioner also failed to convince the Court that Section 5(w) of the RIRR is unreasonable and oppressive.” Notably. representative. national distributor or broker. A “primary distributor” is a manufacturer’s sales agent. Section 4 of the Milk Code provides: (d) “Distributor” means a person.” The RIRR also enumerated in Section 5(w) the products manufactured or distributed by an entity that would qualify it as a “milk company. xxxx (j) “Manufacturer” means a corporation or other entity in the public or private sector engaged in the business or function (whether directly or indirectly or through an agent or and entity controlled by or under contract with it) of manufacturing a products within the scope of this Code. what is used is the phrase “products within the scope of this Code.

Sections 4(f). 535. 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. 11 and 46 of Administrative Order No. the petition is PARTIALLY GRANTED. 11 and 46. the Court sees no harm in the RIRR providing for just one term to 343 VOL. the rest of the RIRR do not constitute illegal restraint of trade nor are they violative of the due process clause of the Constitution. purpose and intent of the Milk Code. 2006 are declared NULL and VOID for being ultra vires. Except Sections 4(f). OCTOBER 9.Since all the regulatory provisions under the Milk Code apply equally to both manufacturers and distributors. 2006-0012 dated May 12. 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. WHEREFORE. Duque III encompass both entities. the rest of the provisions of the RIRR are in consonance with the objective. The Department of Health and respondents are PROHIBITED from implementing said provisions. 2007 343 Pharmaceutical and Health Care Association of the Philippines vs. as defined under the Milk Code. . constituting reasonable regulation of an industry which affects public health and welfare and. as such.

On Official Leave. Ms.. Quisumbing. JJ. I write to elucidate another reason why the absolute ban on the advertising . Chico-Nazario. Velasco. Justice Ma. Sandoval-Gutierrez. Garcia. C. Jr. 344 344 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Corona. Ynares-Santiago and Azcuna. JJ.The Temporary Restraining Order issued on August 15. Puno (C. Duque III CONCURRING AND SEPARATE OPINION PUNO. Alicia Austria-Martinez. and Reyes. SO ORDERED. Carpio. Tinga. 2006-0012 is concerned.).. concur. Carpio-Morales.. Nachura. 2006 is LIFTED insofar as the rest of the provisions of Administrative Order No. J.J.: I fully concur with the well-written and comprehensive po-nencia of my esteemed colleague.J. No Part.

2006-0012 (RIRR) should be struck down. Supreme Court struck down a law prohibiting the advertising of prices for priscription drugs. The advertising and promotion of breastmilk substitutes properly falls within the ambit of the term commercial speech—that is.O.S. 1817. 48 L. 535. This view started to melt down in the 1970s. Ct.1 It fastened itself to the view that the broad powers of government to regulate commerce reasonably includes the power to regulate speech concerning articles of commerce.S.and promotion of breastmilk substitutes found under Sections 4(f) and 11 of A. 762. In Virginia Pharmacy Board v. 2d 346 (1976). 2 422 U. the United States Supreme Court took the view that commercial speech is not protected by the First Amendment. OCTOBER 9. It ruled that consumers have a strong _______________ 1 The First Amendment as applied to the States thgrough the Fourteenth Amendment. Virginia Citizens Consumer Council. No. It held that price information was important to consumers. 2007 . Ed. 96 S. protects commercial speech from unwarranted governmental regulation. and that the First Amendment protects the “right to receive information” as well as the right to speak. speech that proproses an economic transaction. 345 VOL. 1825. This is a separate category of speech which is not accorded the same level of protection as that given to other constitutionally guaranteed forms of expression but is nonetheless entitled to protection.2 the U. A look at the development of jurisprudence on the subject would show us that initially and for many years. 748.

In addition. Next. and whether it is not more extensive than is necessary to serve that interest. both the Interna- _______________ . In this landmark decision. In applying the First Amendment. We now apply this four-part test to the case at bar. First. Duque III First Amendment interest in the free flow of information about goods and services available in the marketplace and that any state regulation must support a substantial interest. it must next be determined whether the state regulation directly advances the governmental interest asserted.345 Pharmaceutical and Health Care Association of the Philippines vs. which reaches all promotional advertising regardless of the impact of the touted service on overall energy use. the U. it is not claimed that the advertisement at issue is an unlawful activity or is inaccurate. Public Service Commission 3 is the watershed case that established the primary test for evaluating the constitutionality of commercial speech regulations. Central Hudson provides a four-part analysis for evaluating the validity of regulations of commercial speech. the asserted governmental interest must be substantial.S.S. is more extensive than necessary to further the state’s interest in energy conservation. Central Hudson Gas & Electric v. Court rejected the highly paternalistic view that the government has complete power to suppress or regulate commercial speech. To begin with. the commercial speech must “concern lawful activity and not be misleading” if it is to be protected under the First Amendment. If both of these requirements are met. the U. it ruled that there must be a showing that a more limited restriction on the content of promotional advertising would not adequately serve the interest of the State. Supreme Court held that the regulation issued by the Public Service Commission of the State of New York. In fact.

Duque III tional Code and the Milk Code recognize and concede that there are instances when breastmilk substitutes may be necessary.3 447 U. To be sure. breastfeeding is the tested and proven method of providing optimal nutrition to infants and young children. 557 (1980). The rationale of the absolute ban is to prevent mothers from succumbing to suggestive and misleading marketing and propaganda which may be contained in advertisements of breastmilk substitutes. prescinding from these predicates.S. we now come to the critical inquiry: whether the complete suppression of the advertisement and promotion of breast-milk substitutes is no more than . Third. This interest is expressed as a national policy in no less than the fundamental law of our land and is also embodied in various international agreements where we are a party. the interest of the state in preserving and promoting the health of its citizens is inextricably linked to its own existence. there is an undeniable causal relationship between the interest of government and the advertising ban. Fourth and finally. there is no doubt that the governmental interest in providing safe and adequate nutrition to infants and young children is substantial. 346 346 SUPREME COURT REPORTS ANNOTATED Pharmaceutical and Health Care Association of the Philippines vs. Unquestionably. Second.

299 SCRA 199 [1998]) The promotion of public health is a fundamental obligation of the State—the health of the people is a primordial governmental concern. for instance. the Legislature deemed it necessary to phase out commercial blood banks—this action may seriously affect the owners and operators.—When the law speaks in clear and categorical language. 2006 declared null and void. but only for application. that the dvertisement of such products which are strictly informative cuts too deep on free speech. 2006-0012 dated May 12. I proffer the humble view that the absolute ban on advertising prescribed under Sections 4(f) and 11 of the RIRR is unduly restrictive and is more than necessary to further the avowed governmental interest of promoting the health of infants and young children. Court of Appeals. 347 VOL. OCTOBER 9. 535. overarching ban. (Republic vs. 11 and 46 of Administrative Order No. In serving the interest of the public.necessary to further the interest of the state in the protection and promotion of the right to health of infants and young children. Sections 4(f). It ought to be self-evident. The laudable concern of the respondent for the promotion of the health of infants and young children cannot justify the absolute. Opinions of the Secretary of Justice are unavailing to supplant or rectify any mistake or omission in the law. Lorenzo Petition partially granted. and to give meaning to the purpose of the law. of commercial blood . as well as the employees. there is no reason for interpretation or construction. Notes. 2007 347 AFI International Trading Corporation (Zamboanga Buying Station) vs.

banks but their interests must give way to serve a higher end for the interest of the public. 476 SCRA 168 [2005]) ——o0o—— [Pharmaceutical and Health Care Association of the Philippines vs. Duque III. 535 SCRA 265(2007)] . Secretary of Health. (Beltran vs.