Pharmaceutical and Health Care Association of the Philippines v Duque III
Facts:
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 Intl 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.
Issue:
Sub-Issue: W/N the pertinent intl 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 intl agreements
MAIN: W/N the DOH acted w/o or in excess of their jurisdiction, or with grave abuse of discretion amounting to lack of excess of jurisdiction
and in violation of the Constitution by promulgating the RIRR.
Held:
Sub-issue:
Yes for ICBMS. Under 1987 Consti, intl law can become domestic law by transformation (thru constitutional mechanism such as local
legislation) or incorporation (mere constitutional declaration i.e treaties) 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. However, the 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 ICBMS.
No for WHA Resolutions. The Court ruled that DOH failed to establish that the provisions pertinent WHA resolutions are customary intl law that
may be deemed part of the law of the land. For an intl 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 ICBMS 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 intl law.
Main issue:
Yes. Some parts of the RIRR were not in consonance with the Milk Code such as Sec. 4(f) ->advertising, promotions of formula are prohibited,
Sec 11 -> prohibitions for advertising breastmilk substitutes intended for infants and young children uo to 24 months
And Sec 46 -> sanctions for advertising .
These provisions are declared null and void. The DOH and respondents are prohibited from implementing said provisions.
PHARMACEUTICAL AND HEALTH CARE vs DUQUE III
Posted on March 6, 2009 by raquel
PHARMACEUTICAL AND HEALTH CARE ASSOCIATION OF THE PHILIPPINESvs. HEALTH SECRETARY FRANCISCO T. DUQUE III
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. 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 respondents officers of the DOH acted without or in excess of jurisdiction, or with grave abuse of discretion amounting
to lack or excess of jurisdiction, and in violation of the provisions of the Constitution in promulgating the RIRR
RULING:
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, UNRC, ICESR, CEDAW, 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 (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.
Pharmaceutical and Health Care Association of the Philippines vs. Duque III
(Austria-Martinez, October 9, 2007)
Nature: Special Civil Action in the Supreme Court. Certiorari
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
Ratio:

1. Are the international instruments referred to by the respondents part of the law of the land?
Facts:
- The various international instruments invoked by respondents are:
- 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) The UN Conventions on the Rights of the Child

(1) One of the preambular clauses of TMC the law seeks to give effect to Article 11 of the International Code of Marketing of (2) The International Convenant on Economic, Social, and Cultural Rights
Breastmilk Substituttes (ICMBS), a code adopted by the WHA (World Health Assembly) in 1981.
(3) Convention on the Elimination of All Forms of Discrimination Against Women
- 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 - These instruments only provide general terms of the steps that States must take to prevent child mortality. Hence, they do not
breastfeeding. have anything about the use and marketing of breastmilk substitutes

- 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.
- The ICMBS and other WHA Resolutions however, are the international instruments which have specific provisions on breastmilk
- May 15, 2006 DOH issues the assailed RIRR (Revised Implementing Rules and Regulations of E.O. 51 or A.O. No. 2006-0012) substitutes
which was to take effect on July 7, 2006. The RIRR imposes a ban on all advertisements of breastmilk substitutes
- Under the 1987 Constitution, international law can become part of domestic law in 2 ways:
- 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. (1) Transformation an international law is transformed into a domestic law through a constitutional mechanism such as local
legislation
- August 15, 2006 the Court issued a Resolution granting the TRO, enjoining the respondents from implementing the assailed
RIRR. 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
- Petitioner assails the RIRR for going beyond the provisions of TMC thereby amending and expanding the coverage of the said
law. The ICMBS and WHA Resolutions are NOT treaties as they havent been concurred in by the required 2/3 vote.

- DOH meanwhile contends that the RIRR implements not only TMC but also various international instruments regarding infant and HOWEVER, the ICMBS has been transformed into domestic law through local legislation that is TMC.
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. 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
Issue: W/n the RIRR is unconstitutional? be allowed if such materials are approved by a committee.

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 (2) Incorporation by mere constitutional declaration, international law is deemed to have the force of domestic law
of the land and may thus be implemented through an RIRR, if so, is the RIRR in accord with such international agreements?
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

Note: I focused on the parts on international law. The other matters (in case maam asks) are at the bottom of the digest. 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

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 2.) Opinion juris sive necessitates (opinion as to law or necessity.
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.
 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
(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.
- 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 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.
- 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.
W/n the provisions of the RIRR being in accordance with the Milk Code? Not all of them
- 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.

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 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.