Case Summary (G.R. No. 173034)
Applicable Law
• 1987 Philippine Constitution (Article II, Section 15 – State shall protect and promote the right to health; Article II, Section 2 – incorporation of generally accepted principles of international law).
• Executive Order No. 51 (Milk Code, 1986) enacted under the Freedom Constitution and transformed the International Code of Marketing of Breast-milk Substitutes (ICMBS) into domestic law.
• Administrative Order No. 2005-0014 (National Policy on Infant and Young Child Feeding).
• Administrative Order No. 2006-0012 (Revised Implementing Rules and Regulations of the Milk Code, or RIRR).
Main Issues
- Whether PHAP has standing as real party-in-interest.
- Whether various RIRR provisions exceed DOH’s jurisdiction or constitute grave abuse of discretion.
- Whether international instruments invoked by DOH are part of Philippine law and properly implemented through the RIRR.
- Whether RIRR provisions conflict with the Milk Code, violate due process, or unreasonably restrain trade.
Petitioner's Standing
• Under the modern view, an association may litigate injuries to its members when its articles empower it to represent them.
• PHAP’s charter authorizes it to represent the pharmaceutical and health care industry before government agencies, making it the real party-in-interest.
Status of International Instruments
• Treaties (e.g., Convention on the Rights of the Child) require Senate concurrence (Art. VII, Sec. 21) and are not self-executing without transformation.
• The ICMBS was transformed into law via EO 51 (Milk Code).
• WHA resolutions, Global Strategy, and other non-treaty instruments are non-binding “soft law” or recommendations; they have not attained customary status with opinio juris.
• Consequently, only the Milk Code itself, not the ICMBS or subsequent WHO/UNICEF resolutions, furnishes DOH authority to regulate marketing of breast-milk substitutes.
Authority of DOH and National Health Policy
• Under the 1987 Administrative Code, DOH may define national health policy, promulgate implementing regulations, and propagate health information.
• A.O. 2005-0014 declares breastfeeding priorities but does not impose an absolute ban on advertising breast-milk substitutes.
• Without express legislative amendment, DOH cannot adopt new prohibitions that contradict the Milk Code.
Harmonization with the Milk Code
- Scope (RIRR Sections 2, 5(ff))
– Milk Code regulates products, not solely by child’s age; it covers breast-milk substitutes for infants and young children alike. - Recognition of Medical Indications (RIRR Sections 7, 8)
– RIRR affirms that substitutes are proper when medically indicated, aligning with Milk Code Sections 2 and 5(b). - Labeling and Health Claims (RIRR Sections 13, 15, 16, 26)
– Requirements such as “no substitute for breast-milk” statements and warnings against improper preparation implement Milk Code Sections 5(b), 8(b), and 10. - Information to Health Professionals (RIRR Section 22)
– Prohibits manufacturer involvement in public breastfeeding promotion but does not bar scientific and factual communication to health workers, consistent with Milk Code Sections 7(b) and 8(b). - Research and Continuing Education (RIRR Sections 9, 10, 32)
– Permits research support under DOH ethics guidelines, pursuant to Milk Code Section 8(e). - Donations (RIRR Sections 51, 52)
– DOH may refuse or subject donations to IAC approval, within the discretionary grant of Milk Code Section 6(f).
Ultra Vires Provisions
• Sections 4(f) and 11: impose an absolute ban on advertising, promotions, sponsorships, or marketing of breast-milk substitutes for children up to 24 months, usurping the IA
Case Syllabus (G.R. No. 173034)
Facts and Parties
- Petitioner: Pharmaceutical and Health Care Association of the Philippines, representing manufacturers and distributors of breastmilk substitutes
- Respondents: Secretary, Undersecretaries, and Assistant Secretaries of the Department of Health (DOH)
- Subject: Administrative Order No. 2006-0012 (RIRR) implementing Executive Order No. 51 (Milk Code) and relevant international agreements
- Underlying public policy: promotion, protection, and support of breastfeeding as the best nutrition for infants
Procedural History
- May 15, 2006: DOH issues the Revised Implementing Rules and Regulations of EO 51 (RIRR)
- June 28, 2006: Petitioner files certiorari under Rule 65 and seeks TRO/preliminary injunction
- August 15, 2006: Supreme Court grants TRO enjoining implementation of RIRR
- June 19, 2007: Oral arguments held; Advisory sets forth key issues
- Parties file memoranda; decision rendered October 9, 2007
Issues Presented
- Whether petitioner has standing as real party-in-interest
- Constitutionality of DOH’s RIRR under the separation of powers
- Whether RIRR faithfully implements EO 51 (Milk Code)
- Validity of incorporating international instruments through RIRR
- Alleged violations of the due process clause and unlawful restraint of trade
- Adequacy and clarity of standards in RIRR (e.g., “total effect” provision)
Petitioner’s Standing
- Association’s legal identity “fuses” with its individual members
- Amended Articles of Incorporation authorize representation of the pharmaceutical and health care industry
- Supreme Court precedents (Executive Secretary v. CA; Purok Bagong Silang Ass’n) support associative standing
- Petitioner may prosecute the case to vindicate members’ vital interests
International Instruments Invoked
- United Nations Convention on the Rights of the Child (CRC)
- International Code of Marketing of Breastmilk Substitutes (ICMBS) and WHO/UNICEF Global Strategy
- International Covenant on Economic, Social and Cultural Rights (ICESCR)
- Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW)
- Various World Health Assembly (WHA) Resolutions
Domestic Effect of International Law
- Transformation: treaties require Senate concurrence (Art VII, Sec 21 1987 Constitution)
- Incorporation: “generally accepted principles of international law” enter domestic law via Art II, Sec 2
- ICMBS is not a treaty but was transformed into local law by EO 51 (Milk Code)
- Other instruments (CRC, ICECSR, CEDAW) lack specific marketing provisions and require domestic legislation to be operative
WHA Resolutions and Soft Law
- WHO Constitution distinguishes binding regulations/conventions (Articles 19–22) from non-binding recommendations (Article 23)
- ICMBS adopted as a WHO recommendation under Art 23, not as binding regulation
- Subsequent WHA Resolutions urging implementation are recommendatory (“soft law”) and lack opinio juris and enforceability
- DOH cannot implement WHA Resolutions’ absolute bans absent legislative transformation
National Health Policy and DOH Authority
- Revised Administrative Code (EO 292) grants DOH power to define health policy, issue regulations, and propagate health information
- A.O. No. 2005-0014 declares national policy on infant and young child feeding (exclusive breastfeeding, complementary feeding, etc.)
- This policy does not itself enact an absolute ban on advertising breastmilk substitutes
- Milk C