PHAP V SECRETARY OF HEALTH
OCTOBER 9 2007 | AUSTRIA-MARTINEZ, J
FACTS
- Executive Order No. 51 (The Milk Code - TMC) was issued by Pres.
Aquino on Oct. 28, 1986 by virtue of the legislative powers granted to her
under the Freedom Constitution.
One of the preambular clauses of TMC the law seeks to give effect
to Article 11 of the International Code of Marketing of Breastmilk
Substituttes (ICMBS), a code adopted by the WHA (World Health
Assembly) in 1981.
- In 1990, the Philippine ratified the International Convention on the Rights
of the Child. Art. 24 of the instrument mandates that States should take
measure to diminish infant mortality and should ensure that all segments
of society are informed of the advantages of breastfeeding.
- From 1982 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.
- May 15, 2006 DOH issues the assailed RIRR (Revised Implementing
Rules and Regulations of E.O. 51 or A.O. No. 2006-0012) which was to
take effect on July 7, 2006. The RIRR imposes a ban on all
advertisements of breastmilk substitutes
- June 28, 2006 Petitioner filed the present Petition for Certiorari and
Prohibition with Prayer for the Issuance of a TRO or Writ of Preliminary
injunction.
- August 15, 2006 the Court issued a Resolution granting the TRO,
enjoining the respondents from implementing the assailed RIRR.
- Petitioner assails the RIRR for going beyond the provisions of TMC
thereby amending and expanding the coverage of the said law.
- DOH meanwhile contends that the RIRR implements not only TMC but
also various international instruments regarding infant and young child
nutrition. They posit that the said international instruments are deemed
part of the law of the land and therefore may be implemented by the DOH
in the RIRR.
ISSUE/S
1. Are the international instruments referred to by the respondents part of the
law of the land?
- The various international instruments invoked by respondents are:
(1) The UN Conventions on the Rights of the Child
(2) The International Convenant on Economic, Social, and Cultural Rights
(3) Convention on the Elimination of All Forms of Discrimination Against
Women
- These instruments only provide general terms of the steps that States
must take to prevent child mortality. Hence, they do not have anything
about the use and marketing of breastmilk substitutes
- The ICMBS and other WHA Resolutions however, are the international
instruments which have specific provisions on breastmilk substitutes
- Under the 1987 Constitution, international law can become part of
domestic law in 2 ways:
Transformation an international law is transformed into a domestic
law through a constitutional mechanism such as local legislation
Treaties become part of law of the land through this method,
pursuant to Art 7, Sec 21 wherein no treaty or international
agreement shall be valid.. unless concurred by at least 2/3 of
Senate
The ICMBS and WHA Resolutions are NOT treaties as they
havent been concurred in by the required 2/3 vote.
HOWEVER, the ICMBS has been transformed into domestic law
through local legislation that is TMC.
Therefore, it is not the ICMBS per se that has the force of
law but its TMC.
o While TMC is almost a verbatim reproduction of the
ICMBS, it did not adopt the latters provision on the
absolute prohibition on advertising of products within the
scope of the ICMBS. Instead the MC provides that
advertising promotion or other marketing materials may be
allowed if such materials are approved by a committee.
Incorporation by mere constitutional declaration, international law is
deemed to have the force of domestic law
This is found under Art 2, Sec 2 The Philippines adopts
generally accepted principles of international law as part of the law
of the land
In Mihares v. Ranada: International law becomes customary rules
accepted as binding as a result of two elements:
1.) Established, widespread, and consistent practice on part of the
state
2.) Opinion juris sive necessitates (opinion as to law or necessity.
Generally accepted principles of international law refer to norms of
general or customary international law which are binding on all
states, valid through all kinds of human societies, and basic to
legal systems generally
Fr. Bernas has a definition similar to the one above. Customary
international law has two factors:
1.) Material factor how states behave
The consistency and the generality of the practice
2.) Psychological or subjective factor why they behave the way
they do
 Once state practice has been established, now determine
why they behave they do. Is it ouor of courtesy or opinio
juris (the belief that a certain type of behavior is obligatory)
When a law satisfies the two factors it becomes part of customary
international law which is then incorporated into our domestic
system
2. Since the WHA Resolutions have not been embodied in any local
legislation, have they attained the status of customary law and hence part of
our law of the land?
- The World Health Organization (WHO) is one of the international
specialized agencies of the UN.
- According to the WHO Constitution, its the WHA which determines the
policies of the WHO, the former also has the power to adopt regulations
concerning advertising and labeling of pharmaceutical and similar
products and to make recommendations to members on any matter
within the Organizations competence
- Note that the legal effect of a regulation as opposed to recommendation is
quite different
Regulations which are duly adopted by the WHA are binding on
member states
On the other hand, recommendations of the WHA do not come into
force for its members unlike regulations. Rather, they carry moral and
political weight as they constitute the judgment on a health issue of the
collective membership of the highest body in the field of health.
- The WHA resolution adopting the ICMBS and the subsequent WHA
resolutions urging states to implement the ICMBS are merely
recommendatory and legally non-binding.
- Hence, unlike the ICMBS which has become TMC through legislative
enactment, the subsequent WHA Resolutions, which provide for exclusive
breastfeeding and prohibition on advertisements and promotions of
breastmilk have not been adopted as domestic law.
- WHA Resolutions have been viewed to constitute soft law or non-binding
norms, which influence state behavior. Soft law has been noted to be a
rapid means of norm creation, in order to reflect and respond to the
changing needs and demands of constituents (of the UN.)
- As previously discussed, for an international rule to be considered
customary law, it must be established that such rule is followed by states
because it is considered obligatory (opinio juris).
- In the case at bar, respondents have not presented any evidence to prove
that the WHA Resolutions are in fact enforced or practice by member W/n the provisions of the RIRR being in accordance with the Milk Code? Not all
states. Further, they failed to establish that provisions of pertinent WHA of them
Resolutions are customary international law that may be deemed part of
law of the land.
- Hence, legislation is necessary to transform the WHA resolutions into
domestic law. They cannot thus be implemented by executive agencies
without the need of a law to be enacted by legislature.
On other issues:
W/n the petitioner is the real party in interest? Yes.
- An association has standing to file suit for its workers despite its lack of
direct interest of its members are affected by the action. An organization
has standing to assert the concerns of its constituents. (Exec Sec vs CA)
- The Court has rules that an association has the legal personality to
represent its members because the results of the case will affect their vital
interests. (Purok Bagong Silang Association Inc. vs. Yuipco)
- In the petitioners Amended Articles of Incorporation, it states that the
association is formed to represent directly or through approved
representatives the pharmaceutical and health care industry before the
Philippine Government and any of its agencies, the medical professions
and the general public.
- Therefore, the petitioner, as an organization, has an interest in fulfilling its
avowed purpose of representing members who are part of the
pharmaceutical and health care industry. Petitioner is duly authorized to
bring to the attention of the government agencies and courts any
grievance suffered by its members which are directly affected by the
assailed RIRR.
- The petitioner, whose legal identity is deemed fused with its members,
should be considered as a legal party-in-interest which stands to be
benefited or injured by any judgment in the case.
W/n the DOH has the power to implement the WHA Resolutions under the
Revised Administrative Code even in the absence of a domestic law? Only the
provisions of the Milk Code. (as per the discussion above)
- Section 3, Chapter 1, Title IX of the RAC of 1987 provides that the DOH
shall define the national health policy and can issue orders and regulations
concerning the implementation of established health policies.
- A.O. No 2005 -0014 which provides the national policy on infant and young
child feeding, does not declare that as part of its policy, the advertisement
or promotion of breastmilk substitutes should be absolutely prohibited.
- Only the provisions of the Milk Code, but not those of the subsequent
WHA Resolutions, can be validly implemented by the DOH through the
subject RIRR.
- Assailed provisions: [1] extending the coverage to young children; [2]
imposing exclusive breastfeeding for infants from 0-6 months; [3] imposes
an absolute ban on advertising and promotion for breastmilk substitutes;
[4] requiring additional labeling requirements; [5] prohibits the
 dissemination of information on infant formula; [6] forbids milk
manufacturers and distributors to extend assistance in research and
continuing education Although the DOH has the power under the Milk
Code to control information regarding breastmilk vis--vis breastmilk
substitutes, this power is not absolute because it has no power to impose
an absolute prohibition in the marketing, promotion and advertising of
breastmilk substitutes. Several provisions of the Milk Code attest to the
fact that such power to control information is not absolute.
- Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code
because such provisions impose an absolute prohibition on advertising,
promotion and marketing of breastmilk substitutes, which is not provided
for in the Milk Code. Section 46 is violative of the Milk Code because the
DOH has exceeded its authority in imposing such fines or sanctions when
the Milk Code does not do so. Other assailed provisions are in
accordance with the Milk Code.
children; Section 32 giving of assistance, support and logistics or
training; Section 52 giving of donations
- In the instant case, petitioner failed to show how the aforementioned
sections hamper the trade of breastmilk substitutes. They also failed to
establish that these activities are essential and indispensable to their
trade.
Disposition: The Petition is Partially Granted. Only sections 4(f), 11 and 46
of A.O. 2006-0014 are declared null and void for being ultra vires. The TRO
is lifted insofar as the rest of the provisions of A.O. 2006-0012 is
concerned.

W/n Section 13 of the RIRR providing a sufficient standard? Yes.

- Questioned provision, in addition to Section 26 of Rule VII provide labeling
requirements for breastmilk substitutes found to be in consonance with
the Milk Code
- The provisions in question provide reasonable means of enforcing related
provisions in the Milk Code.

W/n Section 57 of the RIRR repeals existing laws?

- Section in question only repeals orders, issuances and rules and
regulations, not laws. The provision is valid as it is within the DOHs rule-
making power.
- An administrative agency has quasi-legislative or rule-making power.
However, such power is limited to making rules and regulation subjected to
the boundaries set by the granting statute and the Constitution. The power
is also subject to the doctrine of non-delegability and separability of
powers. The power, which includes amending, revising, altering or
repealing, is granted to allow for flexibility in the implementation of the
laws.

W/n On Section 4, 5(w), 11, 22, 32, 47 and 52 violates the due process clause
of the Constitution (Article III Section 1)?
- Despite the fact that the present Constitution enshrines free enterprise as
a policy, it nonetheless reserves to the government the power to intervene
whenever necessary to promote the general welfare free enterprise
does not call for the removal of protective regulations. It must be clearly
explained and proven by competent evidence just exactly how such
protective regulation would result in the restraint of trade.
- Section 4 proscription of milk manufacturers participation in any
policymaking body; Section 22 classes and seminars for women and