Pharmaceutical and Health Care Association of the Philippines, petitioner

Health Secretary Francisco T. Duque III; Health Undersecretaries Dr. Ethelyn P. Nieto, Dr.
Margarita M. Galon, Atty. Alexander A. Padilla, & Dr. Jade F. Del Mundo; and Assistant
Sectretaries Dr. Mario C. Villaverde, Dr. David J. Lozada, and Dr. Nemesio T. Gako,
Respondents

FACTS:
Petition for Certiorari and Prohibition with Prayer for the Issuance of a Temporary
Restraining Order.

Petitioner represented the manufacturers of breastmilk substitutes who are seeking

to nullify Administrative Order No. 2006-0012 entitled “Revised Implementing Rules
and Regulations of Executive Order No. 51”, otherwise known as the “Milk Code”,
Relevant International Agreements, Penalizing Violations Thereof, and for other Purposes
(RIRR) issued by herein respondents.

Petitioner avers that the alleged RIRR goes beyond the provisions of the “Milk
Code” thereby amending and expanding the coverage of the said law.

Respondents contends that the RIRR implements not only the “Milk Code” but also
various international instruments that have specific provisions regarding breastmilk
substitutes, particularly the (1) International Code of Marketing Breastmilk Substitute
(ICMBS) and (2) various World Health Assembly (WHA) Resolutions.

BACKGROUND OF LAW:
E.O. No. 51 (MILK CODE) – issued by President Aquino October 28, 1986
- the law seeks to give effect to Art. 11 of ICMBS, which encourage that
breastmilk should be supported, promoted and protected and should be ensured that
nutrition and health claims are not permitted for breastmilk substitute.

ISSUES:
1) Whether or not the pertinent agreements entered into by the Philippines are
part of the law of the land and may be implemented by the DOH through the
RIRR
2) Whether or Not the RIRR is in accord with the provisions of E.O. 51 (Milk Code)

RULING:
1) The Court held that ICMBS was properly transformed into domestic law through
legislation entitled the “Milk Code”.

The 1987 Constitution states that 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, Sec. 21 of the 1987 Constitution, which states that:
“No treaty or international agreement shall be valid and effective unless concurred
in by at least two-thirds of all the members of the Senate”.

The ICMBS and WHA Resolutions are not treaties. However, ICMBS which was
adopted by the WHA had been transformed into domestic law through local legislation, the
Milk Code. Hence, it is the Milk Code that has the force and effect of law in this
jurisdiction and not the ICMBS.

While WHA Resolutions, the Court held that it cannot be considered part of the law
of the land that can be implemented by executive agencies without the need of a law
enacted by the legislature.
 Mijares vs Ranada provides that the generally accepted principles of international,
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 the States; and a psychological element known as the opinion juris sive
necessitates (opinion as to law or 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.

The WHA Resolutions which adopted the ICMBS does not fall under the purview of
an international law. Opinio juris or the belief that a certain form of behaviour is
obligatory, is what makes practice an international rule. Without it, practice is not law. It is
important that the existence of state practice has been established whether they consider it
obligatory or as a matter of courtesy. Further, WHA Resolutions have not been embodied in
any local legislation and only constitute as “Soft law” or non-binding norms, principles and
practices that influence state behavior.

The respondents failed to present the necessary evidence to prove that the WHA
Resolutions were in fact enforced or practiced by at least a majority of the member states;
neither have respondents proven that any compliance by member states with the said WHA
Resolutions was obligatory in nature.

2) The Court ruled that the rest of the provisions of the RIRR as being in consonance
with the Milk Code.

Although the Milk Code is an almost a verbatim production of the ICMBS, it did not
adopt the provisions 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) which is a clear indication of an exception. This was contrary to the total
prohibition issued under Sec. 4(f) and Sec. 11 of the RIRR thereby clearly violative of the said
code.

HENCE, the Court PARTIALLY GRANTED the petition. Sections 4(f), 11 and 46 of
the Administrative Order No. 2006-0012 are declared NULL and VOID for being ultra
vires. The Department of Health and respondents are PROHIBITED from
implementation said provisions.

FROM GOOGLE FORM

 Petition for Certiorari and Prohibition with Prayer for the Issuance of a Temporary
Restraining Order.
 Petitioner represents the manufacturers of breastmilk substitutes
 Seeking to nullify Administrative Order No. 2006-0012 or RIRR of Executive
Order No. 51”, otherwise known as the “Milk Code” which was issued by herein
respondents.
 Petitioner avers that the alleged RIRR goes beyond the provisions of the “Milk Code”
thereby amending and expanding the coverage of the said law.
 Respondents contends that the RIRR implements not only the “Milk Code” but also
various international instruments that have specific provisions regarding breastmilk
substitutes, particularly the (1) International Code of Marketing Breastmilk
Substitute (ICMBS) and (2) various World Health Assembly (WHA) Resolutions.
ISSUE:
1. Whether or not the ICMBS and WHA Resolutions are part of the law of the land and
may be implemented by the DOH through the RIRR
2. Whether or Not the RIRR is in accord with the provisions of E.O. 51 (Milk Code)
RULING:
1. (YES) The Court held that ICMBS was properly transformed into domestic law
through legislation entitled E.O. No. 51 or the “Milk Code”.
 The 1987 Constitution states that international law can become part of the sphere of
domestic law either by transformation or incorporation.
a. transformation method requires that an international law be transformed into a
domestic law through a constitutional mechanism such as local legislation.
a. incorporation method applies when, by mere constitutional declaration,
international law is deemed to have the force of domestic law.
Hence, it is the Milk Code that has the force and effect of law in this jurisdiction and not
the ICMBS.
(NO) While WHA Resolutions, the Court held that it cannot be considered part of the
law of the land that can be implemented by executive agencies without the need of a law
enacted by the legislature for failure to comply with the incorporation clause.
Mijares vs Ranada provides that the 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. Provided that it comply with the two elements:
(1) the established, widespread, and consistent practice on the part of the States; and (2) a
psychological element known as the opinion juris sive necessitates (opinion as to law or
necessity) or the belief that the practice in question is rendered obligatory by the existence of
a rule of law requiring it.
Further, the respondents failed to present the necessary evidence to prove that the WHA
Resolutions were in fact enforced or practised by at least a majority of the member states;
neither have respondents proven that any compliance by member states with the said WHA
Resolutions was obligatory in nature.
In fact it has been declared that WHA Resolutions only constitute “soft law” or non-binding
norms, principles and practices that influence state behavior.
2) (YES) The Court ruled that the rest of the provisions of the RIRR as being in
consonance with the Milk Code.
Although the Milk Code is an almost a verbatim production of the ICMBS, it did not
adopt the provisions 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) which is a clear indication of an exception. This was contrary to the total
prohibition issued under Sec. 4(f) and Sec. 11 of the RIRR thereby clearly violative of the said
code.
HENCE, the Court PARTIALLY GRANTED the petition. Sections 4(f), 11 and 46 of the
Administrative Order No. 2006-0012 are declared NULL and VOID for being ultra vires.
The Department of Health and respondents are PROHIBITED from implementation said
provisions