Pharmaceutical and Health Care Association of the Philippines vs. DOH
Pharmaceutical and
Health Care Association of the Philippines vs. Duque III
(Austria-Martinez,
October 9, 2007)
Petitioner:
Pharmaceutical and Healthcare Association of the Philippines
Respondents: DOH Sec.
Francisco Duque III, DOH Undersecretaries Dr. Ethelyn Nieto, Dr. Margarita
Galon, Atty. Alexander Padilla and Dr. Jade Del Mundo; and Asst. Secretaries
Dr. Mario Villaverde, Dr. David Lozada and Dr. Nemesio Gako
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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.
(1) 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.
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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.
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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.
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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
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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.
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August 15, 2006 – the Court issued a
Resolution granting the TRO, enjoining the respondents from implementing the
assailed RIRR.
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Petitioner assails the RIRR for going beyond
the provisions of TMC thereby amending and expanding the coverage of the said law.
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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.
Sub-issue(s): W/n the RIRR
is in accord with TMC? W/n pertinent international agreements entered into by
the Philippines are part of the law of the land and may thus be implemented
through an RIRR, if so, is the RIRR in accord with such international
agreements?
Held: No. However
what may be implemented is the RIRR based on the Milk Code which in turn is
based on the ICMBS as this is deemed part of the law of the land. The other WHA
Resolutions however cannot be imposed as they are not deemed part of the law of
the land.
Ratio:
1.
Are the international instruments referred to
by the respondents part of the law of the land?
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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
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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
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The ICMBS and other WHA Resolutions however,
are the international instruments which have specific provisions on breastmilk
substitutes
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Under the 1987 Constitution, international law
can become part of domestic law in 2 ways:
(1)
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 haven’t 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 it’s TMC.
o
While TMC is almost a verbatim reproduction of
the ICMBS, it did not adopt the latter’s 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.
(2)
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
1.
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?
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The World Health Organization (WHO) is one of
the international specialized agencies of the UN.
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According to the WHO Constitution, it’s 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 Organization’s competence”
-
Note that the legal effect of a regulation as
opposed to recommendation is quite different
(1)
Regulations which are duly adopted by the WHA
are binding on member states
(2)
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.
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The WHA resolution adopting the ICMBS and the
subsequent WHA resolutions urging states to implement the ICMBS are merely
recommendatory and legally non-binding.
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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.
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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.)
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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).
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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 states. Further, they failed to establish that provisions
of pertinent WHA 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.
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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)
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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)
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In the petitioner’s 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.”
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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.
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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)
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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.
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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.
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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.
W/n
the provisions of the RIRR being in accordance with the Milk Code? Not all of
them
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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-à-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.
W/n
Section 13 of the RIRR providing a sufficient standard? Yes.
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Questioned provision, in addition to Section
26 of Rule VII provide labeling requirements for breastmilk substitutes à found to be in
consonance with the Milk Code
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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?
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Section in question only repeals orders,
issuances and rules and regulations, not laws.
The provision is valid as it is within the DOH’s rule-making power.
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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)?
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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.
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Section 4 – proscription of milk
manufacturers’ participation in any policymaking body; Section 22 – classes and
seminars for women and children; Section 32 – giving of assistance, support and
logistics or training; Section 52 – giving of donations
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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.
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