PUBLIC INTERNATIONAL LAW CASE DIGEST

15. PHARMACEUTICAL vs. DUQUE

G.R. No. 173034 [535 SCRA 265] 09 October 2007

Pharmaceutical and Health Care Association of the Philippines vs. Duque III, 535
Ponente: Austria-Martinez, J.

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 Int’l 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 #1:

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, Whether or not
the RIRR is in accord with international agreements.

RULING:

Yes for ICBMS.

Under 1987 Constitution, an international law can become a 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.

ISSUE #2:

Whether or not the DOH acted without 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.

RULING:

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 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 int’l law.

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15. PHARMACEUTICAL vs. DUQUE
G.R. No. 173034 [535 SCRA 265] 09 October 2007

PRINCIPLES:

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; Under the 1987 Constitution, international law
can become part of the sphere of domestic law either by transformation or incorporation;
Treaties become part of the law of the land through transformation pursuant to Article VII,
Section 21 of the Constitution.—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. The incorporation method
applies when, by mere constitutional declaration, international law is deemed to have the
force of domestic law. Treaties become part of the law of the land through transformation
pursuant to Article VII, Section 21 of the Constitution which provides that “[n]o treaty or
international agreement shall be valid and effective unless concurred in by at least two-thirds
of all the members of the Senate.” Thus, treaties or conventional international law must go
through a process prescribed by the Constitution for it to be transformed into municipal law
that can be applied to domestic conflicts.

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; MILK CODE (E.O. NO. 51); World Health
Assembly (WHA); International Code of Marketing of Breastmilk Substitutes (ICMBS);
Advertisements; While the International Code of Marketing of Breastmilk Substitutes (ICMBS)
and World Health Assembly (WHA) Resolutions are not treaties as they have not been
concurred in by at least two-thirds of all members of the Senate, the International Code of
Marketing of Breastmilk Substitutes (ICMBS) which was adopted by the World Health
Assembly (WHA) in 1981 had been transformed into domestic law through local legislation,
the Milk Code; The Milk Code is almost a verbatim reproduction of the International Code of
Marketing of Breastmilk Substitutes (ICMBS), but the Code did not adopt the provision in the
International Code of Marketing of Breastmilk Substitutes (ICMBS) absolutely prohibiting
advertising or other forms of promotion to the general public of products within the scope of
the International Code of Marketing of Breastmilk Substitutes (ICMBS).—The ICMBS and WHA
Resolutions are not treaties as they have not been concurred in by at least two-thirds of all
members of the Senate as required under Section 21, Article VII of the 1987 Constitution.
However, the ICMBS which was adopted by the WHA in 1981 had been transformed into
domestic law through local legislation, the Milk Code. Consequently, it is the Milk Code that
has the force and effect of law in this jurisdiction and not the ICMBS per se. The Milk Code is
almost a verbatim reproduction of the ICMBS, but it is well to emphasize at this point that the
Code did not adopt the provision in the ICMBS absolutely prohibiting advertising or other
forms of promotion to the general public of products within the scope of the ICMBS. 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).

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
Section 2, Article II of the 1987 Constitution, whereby the Philippines adopts the generally
accepted principles of international law as part of the law of the land, embodies the
incorporation method.—Section 2, Article II of the 1987 Constitution, to wit: “SECTION 2. The
Phil-ippines renounces war as an instrument of national policy, adopts the generally accepted
principles of international law as part of the law of the land and adheres to the policy of peace,
equality, justice, freedom, cooperation and amity with all nations (Emphasis supplied),”
embodies the incorporation method.

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
Generally accepted principles of international law, by virtue of the incorporation clause of the
Constitution, form part of the laws of the land even if they do not derive from treaty
obligations; “Generally accepted principles of international law” refers to norms of general or
customary international law which are binding on all states, i.e., renunciation of war as an
instrument of national policy, the principle of sovereign immunity, a person’s right to life,
liberty and due process, and pacta sunt servanda, among others.—In Mijares v. Ranada, 455
SCRA 399 (2005) the Court held thus: [G]enerally accepted principles of international law, by
virtue of the incorporation clause of the Constitution, form part of the laws of the land even
if they do not derive from treaty obligations. The classical formulation in international law
sees those customary rules accepted as binding result from the combination [of] two
elements: the established, widespread, and consistent practice on the part of States; and a
psychological element known as the opinion juris sive necessitates (opinion as to law or
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G.R. No. 173034 [535 SCRA 265] 09 October 2007

necessity). Implicit in the latter element is a belief that the practice in question is rendered
obligatory by the existence of a rule of law requiring it. (Emphasis supplied) “Generally
accepted principles of international law” refers to norms of general or customary international
law which are binding on all states, i.e., renunciation of war as an instrument of national
policy, the principle of sovereign immunity, a person’s right to life, liberty and due process,
and pacta sunt servanda, among others. The concept of “generally accepted principles of law”
has also been depicted in this wise: Some legal scholars and judges look upon certain “general
principles of law” as a primary source of international law because they have the “character
of jus rationale” and are “valid through all kinds of human societies.” (Judge Tanaka in his
dissenting opinion in the 1966 South West Africa Case, 1966 I.C.J. 296). O’Connell holds that
certain priniciples are part of international law because they are “basic to legal systems
generally” and hence part of the jus gentium. These principles, he believes, are established
by a process of reasoning based on the common identity of all legal systems. If there should
be doubt or disagreement, one must look to state practice and determine whether the
municipal law principle provides a just and acceptable solution. x x x (Emphasis supplied)

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
CUSTOMARY INTERNATIONAL LAW; Custom or customary international law means “a general
and consistent practice of states followed by them from a sense of legal obligation [opinio
juris],” which statement contains the two basic elements of custom: the material factor, that
is, how states behave, and, the psychological or subjective factor, that is, why they behave
the way they do; Customary international law is deemed incorporated into our domestic
system.—Fr. Joaquin G. Bernas defines customary international law as follows: Custom or
customary international law means “a general and consistent practice of states followed by
them from a sense of legal obligation [opinio juris].” (Restatement) This statement contains
the two basic elements of custom: the material factor, that is, how states behave, and the
psychological or subjective factor, that is, why they behave the way they do. x x x x The initial
factor for determining the existence of custom is the actual behavior of states. This includes
several elements: duration, consistency, and generality of the practice of states. The required
duration can be either short or long. x x x x x x x Duration therefore is not the most important
element. More important is the consistency and the generality of the practice. x x x x x x x
Once the existence of state practice has been established, it becomes necessary to determine
why states behave the way they do. Do states behave the way they do because they consider
it obligatory to behave thus or do they do it only as a matter of courtesy? Opinio juris, or the
belief that a certain form of behavior is obligatory, is what makes practice an international
rule. Without it, practice is not law. (Italics and Emphasis supplied) Clearly customary
international law is deemed incorporated into our domestic system.

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
MILK CODE (E.O. NO. 51); World Health Assembly (WHA); While regulations, along with
conventions and agreements, duly adopted by the World Health Assembly (WHA) bind
member states, recommendations of the World Health Assembly (WHA) do not come into
force for members, in the same way that conventions or agreements and regulations come
into force.—Regulations, along with conventions and agreements, duly adopted by the WHA
bind member states thus: x x x On the other hand, under Article 23, recommendations of the
WHA do not come into force for members, in the same way that conventions or agreements
under Article 19 and regulations under Article 21 come into force. Article 23 of the WHO
Constitution reads: Article 23. The Health Assembly shall have authority to make
recommendations to Members with respect to any matter within the competence of the
Organization. (Emphasis supplied) The absence of a provision in Article 23 of any mechanism
by which the recommendation would come into force for member states is conspicuous.

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
MILK CODE (E.O. NO. 51); INTERNATIONAL CODE OF MARKETING OF BREASTMILK
SUBSTITUTES (ICMBS); Unlike what has been done with the International Code of Marketing
of Breastmilk Substitutes (ICMBS) whereby the legislature enacted most of the provisions into
law which is the Milk Code, the subsequent World Health Assembly (WHA) Resolutions,
specifically providing for exclusive breast-feeding from 0-6 months, continued breastfeeding
up to 24 months, and absolutely prohibiting advertisements and promotions of breast-milk
substitutes, have not been adopted as a domestic law.—The WHA Resolution adopting the
ICMBS and subsequent WHA Resolutions urging member states to implement the ICMBS are
merely recommendatory and legally non-binding. Thus, unlike what has been done with the
ICMBS whereby the legislature enacted most of the provisions into law which is the Milk Code,
the subsequent WHA Resolutions, specifically providing for exclusive breastfeeding from 0-6
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G.R. No. 173034 [535 SCRA 265] 09 October 2007

months, continued breastfeed-ing up to 24 months, and absolutely prohibiting advertisements

and promotions of breastmilk substitutes, have not been adopted as a domestic law.

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
MILK CODE (E.O. NO. 51); While “soft law” does not fall into any of the categories of
international law set forth in Article 38, Chapter III of the 1946 Statute of the International
Court of Justice, it is, however, an expression of non-binding norms, principles, and practices
that influence state behavior.—It is propounded that WHA Resolutions may constitute “soft
law” or non-binding norms, principles and practices that influence state behavior. “Soft law”
does not fall into any of the categories of international law set forth in Article 38, Chapter III
of the 1946 Statute of the International Court of Justice. It is, however, an expression of non-
binding norms, principles, and practices that influence state behavior. Certain declarations
and resolutions of the UN General Assembly fall under this category. The most notable is the
UN Declaration of Human Rights, which this Court has enforced in various cases, specifically,
Government of Hongkong Special Administrative Region v. Olalia, 521 SCRA 470 (2007);
Mejoff v. Director of Prisons, 90 Phil. 70, Mijares v. Rañada, 455 SCRA 397 (2005), and
Shangri-la International Hotel Management, Ltd. v. Developers Group of Companies, Inc.,
486 SCRA 405 (2006).

INTERNATIONAL LAW; TREATIES; DOCTRINE OF INCORPORATION AND DOCTRINE OF

TRANSFORMATION; WORDS AND PHRASES; GENERALLY ACCEPTED PRINCIPLES OF LAW;
MILK CODE (E.O. NO. 51); ADMINISTRATIVE LAW; The provisions of the World Health
Assembly (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.—
Respondents failed to establish that the provisions of pertinent WHA Resolutions are
customary international law that may be deemed part of the law of the land. 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.

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