PHARMACLU1ICAL AND HLAL1H CARL

ASSOCIA1IONS OI 1HL PHILIPPINLS v. SLCRL1ARY IRANCISCO 1.

DUQUL III, et al.
G.R. No. J73034, 09 October 2007, Austria-Martinez, J. (Ln Banc)

v rier of tbe evactvevt of tbe Mit/ Coae rbicb aoe. vot covtaiv a totat bav ov tbe aarerti.ivg ava
rovotiov of brea.tvit/ .vb.titvte., bvt iv.teaa, .ecificatt, create. av .C rbicb ritt regvtate .aia
aarerti.ivg ava rovotiov, it fottor. tbat a totat bav otic, covta be ivtevevtea ovt, vr.vavt to a tar
avevaivg tbe Mit/ Coae a..ea b, tbe cov.titvtiovatt, avtboriea bravcb of gorervvevt, tbe tegi.tatvre.

Lxecutie Order ,L.O., No. 51 ,Milk Code, was issued by ormer President Corazon
Aquino to gie eect to Article 11 o the International Code o Marketing o Breastmilk
Substitutes ,ICMBS,. In line with the implementation or enorcement o this law, the DOl
issued the Reised Implementing Rules and Regulations ,RIRR, o L.O. 51. Part o the
prohibitions contained in the RIRR is the total ban on adertising and promotion o breast
milk substitutes.

Petitioner Pharmaceutical and lealth Care Association o the Philippines challenged
that said order and contends that the proisions o the RIRR are unconstitutional and go
beyond the law it is supposed to implement. It urther contends that respondent oicial o
the DOl acted in grae abuse o discretion in issuing the said RIRR.

Respondents, on the other hand, aer that the RIRR seeks not only to implement the
Milk Code but also arious international instruments which are deemed part o the law o
the land. Among these international instruments are the ICMBS and Resolutions issued by
the \orld lealth Agencies ,\lA,.

ISSUL:

\hether or not the RIRR issued by the DOl is constitutional

HLLD:

Petition PAR1IALL\ GRAN1LD.

Under the 198 Constitution, international law can become part o the sphere o
domestic law either by transormation or incorporation. 1he transormation method
requires that an international law be transormed into a domestic law through a
constitutional mechanism such as local legislation. 1he incorporation method applies when,
by mere constitutional declaration, international law is deemed to hae the orce o domestic
law.


1reaties become part o the law o the land through transormation pursuant to
Article VII, Section 21 o the Constitution which proides that no treaty or international
agreement shall be alid and eectie unless concurred in by at least two-thirds o all the
members o the Senate.` 1hus, treaties or conentional international law must go through a
process prescribed by the Constitution or it to be transormed into municipal law that can
be applied to domestic conlicts.

1he ICMBS and \lA Resolutions are not treaties as they hae not been concurred
in by at least two-thirds o all members o the Senate as required under Section 21, Article
VII o the 198 Constitution.

loweer, the ICMBS which was adopted by the \lA in 1981 had been
transormed into domestic law through local legislation, the Milk Code. Consequently, it is
the Milk Code that has the orce and eect o law in this jurisdiction and not the ICMBS er
.e.

1he Milk Code is almost a rerbativ reproduction o the ICMBS, but it is well to
emphasize at this point that the Code did not adopt the proision in the ICMBS absolutely
prohibiting adertising or other orms o promotion to the general public o products within
the scope o the ICMBS. Instead, the Milk Code expressly proides that adertising,
promotion, or other marketing materials may be allowed i such materials are duly
authorized and approed by the Inter-Agency Committee ,IAC,.

Apparently, the \lA Resolution adopting the ICMBS and subsequent \lA
Resolutions urging member states to implement the ICMBS are merely recommendatory and
legally non-binding. 1hus, unlike what has been done with the ICMBS whereby the
legislature enacted most o the proisions into law which is the Milk Code, the subsequent
\lA Resolutions, speciically proiding or exclusie breasteeding rom 0-6 months,
continued breasteeding up to 24 months, and absolutely prohibiting adertisements and
promotions o breastmilk substitutes, hae not been adopted as a domestic law.

As preiously discussed, or an international rule to be considered as customary law,
it must be established that such rule is being ollowed by states because they consider it
obligatory to comply with such rules ,oivio ;vri.,. Respondents hae not presented any
eidence to proe that the \lA Resolutions, although signed by most o the member
states, were in act enorced or practiced by at least a majority o the member states, neither
hae respondents proen that any compliance by member states with said \lA Resolutions
was obligatory in nature.

Respondents ailed to establish that the proisions o pertinent \lA Resolutions
are customary international law that may be deemed part o the law o the land.

Consequently, legislation is necessary to transorm the proisions o the \lA
Resolutions into domestic law. 1he proisions o the \lA Resolutions cannot be
considered as part o the law o the land that can be implemented by executie agencies
without the need o a law enacted by the legislature.

In iew o the enactment o the Milk Code which does not contain a total ban on the
adertising and promotion o breastmilk substitutes, but instead, speciically creates an IAC
which will regulate said adertising and promotion, it ollows that a total ban policy could be
implemented only pursuant to a law amending the Milk Code passed by the constitutionally
authorized branch o goernment, the legislature. Only the proisions o the Milk Code, but
not those o subsequent \lA Resolutions, can be alidly implemented by the DOl
through the subject RIRR.

Lxcept Sections 4,,, 11 and 46, the rest o the proisions o the RIRR are in
consonance with the objectie, purpose and intent o the Milk Code, constituting reasonable
regulation o an industry which aects public health and welare and, as such, the rest o the
RIRR do not constitute illegal restraint o trade nor are they iolatie o the due process
clause o the Constitution.