View full case

PHARMACEUTICAL v. HEALTH SECRETARY FRANCISCO T. DUQUE III

FACTS:

In the case of the subject petition for certiorari under Rule 65 of the Rules of Court, the controversy centers on the validity of Administrative Order (A.O.) No. 2006-0012 (Revised Implementing Rules and Regulations of Executive Order No. 51, otherwise known as the "Milk Code"). The petitioner, representing manufacturers of breastmilk substitutes, challenges the RIRR on the grounds that it contains unconstitutional provisions and exceeds the authority granted under the Milk Code. Respondents include the Health Secretary and other officials of the Department of Health (DOH), which issued the contested RIRR. Executive Order No. 51, issued by President Corazon Aquino in 1986, largely replicates the International Code of Marketing of Breastmilk Substitutes (ICMBS) adopted by the World Health Assembly (WHA) and aims to promote breastfeeding and regulate breastmilk substitutes. The petitioner claims that certain sections of the RIRR expand the scope of the Milk Code and impose stricter regulations, such as a total prohibition on advertising for breastmilk substitutes, which were not contemplated in the original legislation. On June 28, 2006, the petitioner sought to nullify the RIRR, filing a petition for certiorari and prohibition with a prayer for a temporary restraining order (TRO) or writ of preliminary injunction. The Supreme Court issued a TRO on August 15, 2006, preventing the implementation of the RIRR pending further proceedings. After exchanges of comments and replies, the case was set for oral arguments, during which the Court sought to address various pivotal issues, including the petitioner’s status as a real-party-in-interest and the constitutionality and conformity of the RIRR with both the Milk Code and relevant international agreements.

ISSUES:

  1. Whether or not petitioner is a real party-in-interest.

  2. Whether Administrative Order No. 2006-0012 (RIRR) issued by the Department of Health is constitutional.

    • 2.1. Whether the RIRR is in accord with the provisions of Executive Order No. 51 (Milk Code).

    • 2.2. Whether pertinent international agreements entered into by the Philippines are part of the law of the land and may be implemented by the DOH through the RIRR; and if in the affirmative, whether the RIRR is in accord with the international agreements.

    • 2.3. Whether Sections 4, 5(w), 22, 32, 47, and 52 of the RIRR violate the due process clause and are in restraint of trade.

    • 2.4. Whether Section 13 of the RIRR on Total Effect provides sufficient standards.

RULING:

  1. On petitioner's standing The Court ruled that the petitioner, an association representing its members who are manufacturers of breastmilk substitutes, has legal standing to file the suit on behalf of its members, as the issues raised directly affect their interests.

  2. On the constitutionality of the provisions of the RIRR

    • Pertinent International Agreements The Court ruled that the pertinent international agreements referenced by respondents did not automatically become part of the law of the land as they were not concurred in by the Senate. Consequently, these agreements do not have the force of law in this jurisdiction and cannot be directly implemented through the RIRR.

    • Compatibility with Executive Order No. 51 (Milk Code) The Court found several provisions of the RIRR to be inconsistent with the Milk Code:

      • Sections 4(f) and 11, which impose an absolute prohibition on advertising of breastmilk substitutes, were declared void for being ultra vires.

      • Section 46, which imposes administrative sanctions not provided for by the Milk Code, was also declared void as it exceeds the authority granted to DOH.

      • The rest of the provisions were upheld as they adhere to the standards set forth in the Milk Code.

    • Due Process and Restraint of Trade Except for Sections 4(f), 11, and 46, the remaining provisions of the RIRR were held to be reasonable regulations in furtherance of public health and welfare, therefore not constituting illegal restraint of trade or violation of the due process clause.

PRINCIPLES:

  1. Real Party-in-Interest An association has standing to file a suit on behalf of its members if their interests are directly affected by the action.

  2. Validity of Administrative Rules Administrative orders must strictly conform to the law they intend to implement and cannot exceed or alter the original scope of the law.

  3. International Agreements in Domestic Law International agreements become part of domestic law only through Senate concurrence; international recommendations are not self-executing and require legislation for domestic implementation.

  4. Police Powers and Public Welfare Regulatory measures aimed at protecting public health are legitimate exercises of police power, provided they do not exceed the legal mandate.

  5. Ultra Vires Doctrine Administrative agencies cannot exercise powers not granted to them by law; any action beyond their legal authority is void.