Pharma V Duque

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PHARMACEUTICAL AND HEALTH CARE ASSOCIATION OF THE PHILIPPINESvs.

HEALTH SECRETARY FRANCISCO T. DUQUE III


Petition for certiorari seeking to nullify the Revised Implementing Rules and Regulations (RIRR)
of E.O. 51 (Milk Code). Petitioner claims that the RIRR is not valid as it contains provisions that
are not constitutional and go beyond what it is supposed to implement. Milk Code was issued by
President Cory Aquino under the Freedom Constitution on Oct.1986.  One of the preambular
clauses of the Milk Code states that the law seeks to give effect to Art 11 of the Int’l Code of
Marketing and Breastmilk Substitutes(ICBMS), a code adopted by the World Health
Assembly(WHA). From 1982-2006, The WHA also adopted severe resolutions to the effect that
breastfeeding should be supported, hence, it should be ensured that nutrition and health claims
are not permitted for breastmilk substitutes. In 2006, the DOH issued the assailed RIRR.

FACTS: On October 28, 1986, Executive Order No. 51 (Milk Code) was issued by
President Corazon Aquino by virtue of the legislative powers granted to the president
under the Freedom Constitution. The Milk Code states that the law seeks to give effect
to Article 112 of the International Code of Marketing of Breastmilk Substitutes (ICMBS),
a code adopted by the World Health Assembly (WHA) in 1981. From 1982 to 2006, the
WHA adopted several Resolutions to the effect that breastfeeding should be supported,
promoted and protected, hence, it should be ensured that nutrition and health claims
are not permitted for breastmilk substitutes. the Philippines ratified the International
Convention on the Rights of the Child in which Article 24 of said instrument provides
that State Parties should take appropriate measures to diminish infant and child
mortality, and ensure that all segments of society, specially parents and children, are
informed of the advantages of breastfeeding. the DOH issued RIRR which was to take
effect on July 7, 2006. a petition for certiorari under Rule 65 of the Rules of Court,
seeking to nullify Revised Implementing Rules and Regulations of The “Milk Code,”
assailing that the RIRR was going beyond the provisions of the Milk Code, thereby
amending and expanding the coverage of said law.

Issue:
Whether or not the Revised implementing Rules and Regulations (RIRR) issued by the
DOH is not Constitutional.

Held:
The Supreme Court PARTIALLY GRANTED the petition. Sections 4(f), 11 and 46 of
Administrative Order No. 2006-0012 dated May 12, 2006 are declared NULL and VOID
for being ultra vires. The Department of Health and respondents are PROHIBITED from
implementing said provisions. The international instruments pointed out by the
respondents, United Nations Conventions on the Rights of the Child, the International
Covenant on Economic, Social and Cultural Rights, the Convention on the Elimination
of All Forms of Discrimination against Women, are deemed part of the law of the land
and therefore the DOH may implement them through the RIRR. Customary international
law is deemed incorporated into our domestic system. Custom or customary
international law means “a general and consistent practice of states followed by them
from a sense of legal obligation (opinio juris). 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. “Generally accepted principles of international law” refers to norms of
general or customary international law which are binding on all states. The Milk Code is
a verbatim reproduction of the International Code of Marketing for Breastmilk
Substitution(ICMBS), but it did not prohibit advertising or other forms of promotion to the
general public of products. 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). In this regard, the WHA
Resolutions adopting the ICMBS are merely recommendatory and legally non-binding.
This may constitute “soft law” or non-binding norms, principles and practices that
influence state behavior. Respondents have not presented any evidence to prove that
the WHA Resolutions, although signed by most of the member states, were in fact
enforced or practiced by at least a majority of the member states and obligatory in
nature. 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. On the other hand, the petitioners also failed to explain and
prove by competent evidence just exactly how such protective regulation would result in
the restraint of trade. Since all the regulatory provisions under the Milk Code apply
equally to both manufacturers and distributors, the Court sees no harm in the RIRR.
Except Sections 4(f), 11 and 46, the rest of the provisions of the RIRR are in
consonance with the objective, purpose and intent of the Milk Code.

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