Balancing Infant Health and Commercial Freedom: Limits on Restricting Breast Milk Substitute Ads

The Supreme Court's 2007 decision in Pharmaceutical and Health Care Association of the Philippines v. Duque (G.R. No. 173034) settled an important question about how far government agencies may go in implementing laws that promote breastfeeding. The case involved a challenge by manufacturers of breast milk substitutes against the Department of Health's (DOH) Revised Implementing Rules and Regulations (RIRR) of the Milk Code. The Court ruled that while promoting breastfeeding is a valid national policy, the DOH overstepped its authority by imposing an absolute ban on advertising and other restrictions not found in the law it was supposed to implement.

The Milk Code and the 2006 RIRR

Executive Order No. 51, known as the Milk Code, was issued in 1986 to regulate the marketing of breast milk substitutes. It was based on the International Code of Marketing of Breastmilk Substitutes adopted by the World Health Assembly in 1981. Importantly, the Milk Code did not impose a total ban on advertising. Instead, it allowed advertising and promotion of these products if duly authorized and approved by an Inter-Agency Committee.

In May 2006, the DOH issued the RIRR, which went much further. Among other things, it prohibited all advertising and promotions of breast milk substitutes for infants and young children up to 24 months, expanded coverage to children up to three years old, absolutely prohibited health and nutrition claims, and barred donations and assistance from milk companies to health workers. The DOH justified these stricter rules by citing international instruments, including World Health Assembly (WHA) Resolutions that urged member states to implement exclusive breastfeeding and ban advertisements of substitutes.

The Issue: Did the DOH Exceed Its Authority?

The main question before the Court was whether the DOH acted with grave abuse of discretion in promulgating the RIRR. The petitioner argued that the RIRR went beyond the Milk Code and effectively amended it. The DOH countered that it was implementing not only the Milk Code but also international agreements that form part of Philippine law.

The Ruling: International Resolutions Are Not Law

The Court first addressed whether the WHA Resolutions invoked by the DOH are part of the law of the land. Under the 1987 Constitution, international law enters domestic law through two methods: transformation and incorporation. Treaties become domestic law through transformation, which requires Senate concurrence under Article VII, Section 21. The WHA Resolutions were not treaties, as they had not been concurred in by the Senate.

The Court explained that WHA Resolutions are mere recommendations under the WHO Constitution. They are "soft law"—non-binding norms that influence state behavior but do not have the force of law. The Court found no evidence that these resolutions had become customary international law, which would require proof that states follow them out of a sense of legal obligation. Since the WHA Resolutions had not been transformed into domestic law through legislation, the DOH could not implement them through the RIRR.

The Court also rejected the argument that the DOH could implement the resolutions under its general powers to define national health policy. While the national policy promotes and protects breastfeeding, the Court held that this "cannot automatically be equated with a total ban on advertising for breastmilk substitutes." A total ban could only be implemented through a law amending the Milk Code, passed by Congress.

The RIRR Exceeded the Milk Code

Having established that only the Milk Code could be implemented, the Court examined whether the RIRR was consistent with it. The Court found several provisions that went beyond the statute:

• Expanded coverage: The RIRR extended coverage to "young children" up to 36 months, while the Milk Code covers only infants aged 0-12 months.
• Absolute advertising ban: The Milk Code allows advertising subject to Inter-Agency Committee approval; the RIRR prohibited all advertising and promotions.
• Health claims: The RIRR absolutely prohibited all health and nutrition claims, which the Milk Code did not.
• Donations: The Milk Code allowed donations with the approval of the Ministry of Health; the RIRR strictly prohibited them.
• Labeling: The RIRR imposed additional labeling requirements not found in the Milk Code.

Because these provisions contradicted or went beyond the Milk Code, the Court ruled them invalid.

Practical Takeaways

• Agencies cannot expand the law. Administrative rules must implement, not amend, the statute they are based on. When an agency adds prohibitions or requirements not found in the law, courts will strike them down.
• International "soft law" is not automatically binding. WHA Resolutions and similar international recommendations do not become part of Philippine law unless transformed through legislation. Agencies cannot enforce them directly.
• Promoting breastfeeding remains valid policy. The decision did not question the importance of breastfeeding. It only limited how the government may pursue that goal—through legislation, not through administrative overreach.
• A total advertising ban requires a law. As of this ruling, the Milk Code's regulatory scheme—allowing advertising subject to Inter-Agency Committee approval—remained in effect.
• The legislature, not the executive, sets policy. If the government wants stricter rules on breast milk substitute marketing, it must amend the Milk Code through Congress.

This article is general information and not legal advice. For your specific situation, consult a lawyer or ask ASG Legal AI.