Pharmaceutical v Duque

FACTS:
 Petition for certiorari seeking to nullify the Revised Implementing Rules and Regulations
(RIRR) of E.O. 51 (Milk Code).
 Petitioner Pharmaceutical and Health Care association of the Philippines claims that the RIRR
is not valid as it contains provisions that are not constitutional and go beyond what it is
supposed to implement.
 The Milk Code was issued by President Aquino
 One of the preambular clauses of the Milk Code states that the law seeks to give effect to Art
11 of the International Code of Marketing and Breastmilk Substitutes (ICMBS), a code adopted
by the World Health Assembly (WHA).
 The WHA also adopted several resolutions stating that breastfeeding should be supported, it
should be ensured that nutrition and health claims are not permitted for breast milk
substitutes.
 The DOH issued the assailed RIRR, which is to take effect some time in 2006.

ISSUE:
Sub-Issue: Whether or Not the pertinent international agreements entered into by the Phil are part of
the law of the land and may be implemented by DOH through the RIRR. If yes, W/N the RIRR is in accord
with int’l agreements

RULING:
 Yes for ICMBS. Under 1987 Constitution, international law can become domestic law by
transformation (thru constitutional mechanism such as local legislation) or incorporation
(mere constitutional declaration)
 In transformation, there is a need for the concurrence of at least 2/3 of all members of the
Senate for treaties to form part of the law of the land.
 The ICBMS and WHA resolutions were not treaties as they have not been concurred by 2/3 of all
members of the Senate as required under Sec, 21, Art 8.
 ICBMS had been transformed into domestic law through a local legislation such as the Milk
Code. The Milk Code is almost a verbatim reproduction of ICMBS.

 No for WHA Resolutions. The Court ruled that DOH failed to establish that the provisions
pertinent WHA resolutions are customary int’l law that may be deemed part of the law of the
land. For an int’l rule to be considered as customary law, it must be established that such rule
is being followed by states because they consider it as obligatory to comply with such rules
(opinion juris). The WHO resolutions, although signed by most of the member states, were
enforced or practiced by at least a majority of member states. Unlike the ICMBS whereby
legislature enacted most of the provisions into the law via the Milk Code, the WHA Resolutions
(specifically providing for exclusive breastfeeding from 0-6 months, breastfeeding up to 24
Months and absolutely prohibiting ads for breastmilk substitutes) have not been adopted as
domestic law nor are they followed in our country as well. The Filipinos have the option of how
to take care of their babies as they see fit.
 WHA Resolutions may be classified as SOFT LAW – non-binding norms, principles and practices
that influence state behavior. Soft law is not part of international law.
 Consequently, legislation is necessary to transform the provisions of the WHA Resolutions into
domestic law. 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