Pharmaceutical and Health Care Assoc v. Duque III

8/10/2021 SUPREME COURT REPORTS ANNOTATED VOLUME 535 8/10/2021 SUPREME COURT REPORTS ANNOTATED VOLUME 535
interest if its members are affected by the action.

An organization has standing to assert the
concerns of its constituents. x x x x x x x We note
that, under its Articles of Incorporation, the respondent
was organized x x x to act as the representative of any
individual, company, entity or association on matters
related to the manpower recruitment industry, and to
VOL. 535, OCTOBER 9, 2007 265
perform other acts and activities necessary to
Pharmaceutical and Health Care Association of accomplish the purposes embodied
the Philippines vs. Duque III
* _______________
G.R. No. 173034. October 9, 2007.
* EN BANC.
PHARMACEUTICAL and HEALTH CARE
ASSOCIATION of the PHILIPPINES, petitioner,
vs. HEALTH SECRETARY FRANCISCO T. 266
DUQUE III; HEALTH UNDERSECRETARIES
DR. ETHELYN P. NIETO, DR. MARGARITA M.
GALON, ATTY. ALEXANDER A. PADILLA, &
DR. JADE F. DEL MUNDO; and ASSISTANT 266 SUPREME COURT REPORTS ANNOTATED
SECRETARIES DR. MARIO C. VILLAVERDE, Pharmaceutical and Health Care Association of the
DR. DAVID J. LOZADA, AND DR. NEMESIO T. Philippines vs. Duque III
GAKO, respondents.
therein. The respondent is, thus, the appropriate
Judicial Review; Locus Standi; Associations; An party to assert the rights of its members, because
organization has standing to assert the concerns of its it and its members are in every practical sense
constituents—it is but the medium through which its identical. x x x The respondent [association] is but
individual members seek to make more effective the the medium through which its individual
expression of their voices and the redress of their members seek to make more effective the
grievances.—With regard to the issue of whether expression of their voices and the redress of their
petitioner may prosecute this case as the real party-in- grievances (Emphasis supplied), which was reasserted
interest, the Court adopts the view enunciated in in Purok Bagong Silang Association, Inc. v. Yuipco, 489
Executive Secretary v. Court of Appeals, 429 SCRA 81 SCRA 382 (2006), where the Court ruled that an
(2004), to wit: The modern view is that an association association has the legal personality to represent its
has standing to complain of injuries to its members. This members because the results of the case will affect their
view fuses the legal identity of an association with that vital interests.
of its members. An association has standing to file
suit for its workers despite its lack of direct
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International Law; Treaties; Doctrine of

267
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 VOL. 535, OCTOBER 9, 2007 267
of the law of the land through transformation pursuant
to Article VII, Section 21 of the Constitution.—Under the Pharmaceutical and Health Care Association of the
1987 Constitution, international law can become part of Philippines vs. Duque III
the sphere of domestic law either by transformation or
incorporation. The transformation method requires that Milk Code; The Milk Code is almost a verbatim
an international law be transformed into a domestic law reproduction of the International Code of Marketing of
through a constitutional mechanism such as local Breastmilk Substitutes (ICMBS), but the Code did not
legislation. The incorporation method applies when, by adopt the provision in the International Code of
mere constitutional declaration, international law is Marketing of Breastmilk Substitutes (ICMBS) absolutely
deemed to have the force of domestic law. Treaties prohibiting advertising or other forms of promotion to the
become part of the law of the land through general public of products within the scope of the
transformation pursuant to Article VII, Section 21 of the International Code of Marketing of Breastmilk
Constitution which provides that “[n]o treaty or Substitutes (ICMBS).—The ICMBS and WHA
international agreement shall be valid and effective Resolutions are not treaties as they have not been
unless concurred in by at least two-thirds of all the concurred in by at least two-thirds of all members of the
members of the Senate.” Thus, treaties or conventional Senate as required under Section 21, Article VII of the
international law must go through a process prescribed 1987 Constitution. However, the ICMBS which was
by the Constitution for it to be transformed into adopted by the WHA in 1981 had been transformed into
municipal law that can be applied to domestic conflicts. domestic law through local legislation, the Milk Code.
Consequently, it is the Milk Code that has the force and
Same; Same; Same; Milk Code (E.O. No. 51); World effect of law in this jurisdiction and not the ICMBS per
Health Assembly (WHA); International Code of se. The Milk Code is almost a verbatim reproduction of
Marketing of Breastmilk Substitutes (ICMBS); the ICMBS, but it is well to emphasize at this point that
Advertisements; While the International Code of the Code did not adopt the provision in the ICMBS
Marketing of Breastmilk Substitutes (ICMBS) and World absolutely prohibiting advertising or other forms of
Health Assembly (WHA) Resolutions are not treaties as promotion to the general public of products within the
they have not been concurred in by at least two-thirds of scope of the ICMBS. Instead, the Milk Code expressly
all members of the Senate, the International Code of provides that advertising, promotion, or other
Marketing of Breastmilk Substitutes (ICMBS) which was marketing materials may be allowed if such
adopted by the World Health Assembly (WHA) in 1981 materials are duly authorized and approved by
had been transformed into domestic law through local the Inter-Agency Committee (IAC).
legislation, the

Same; Same; Same; Generally Accepted Principles of form part of the laws of the land even if they do not
Law; Section 2, Article II of the 1987 Constitution, derive from treaty obligations. The classical
whereby the Philippines adopts the generally accepted formulation in international law sees those
principles of international law as part of the law of the customary rules accepted as binding result from
land, embodies the incorporation method.—Section 2, the combination [of] two elements: the established,
Article II of the 1987 Constitution, to wit: “SECTION 2. widespread, and consistent practice on the part of
The Phil-ippines renounces war as an instrument of States; and a psychological element known as the
national policy, adopts the generally accepted opinion juris sive necessitates (opinion as to law or
principles of international law as part of the law necessity). Implicit in the latter element is a belief that
of the land and adheres to the policy of peace, equality, the practice in question is rendered obligatory by
justice, freedom, cooperation and amity with all nations the existence of a rule of law requiring it.
(Emphasis supplied),” embodies the incorporation (Emphasis supplied) “Generally accepted principles of
method. 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
Same; Same; Same; Same; Words and Phrases;
national policy, the principle of sovereign immunity, a
Generally accepted principles of international law, by
person’s right to life, liberty and due process, and pacta
virtue of the incorporation clause of the Constitution,
sunt servanda, among others. The concept of “generally
form part of the laws of the land even if they do not
accepted principles of law” has also been depicted in this
derive from treaty obligations; “Generally accepted
wise: Some legal scholars and judges look upon certain
principles of international law” refers to norms of general
“general principles of law” as a primary source of
or customary international law which are binding on all
international law because they have the “character of
states, i.e., renunciation of war as an instrument of
jus rationale” and are “valid through all kinds of
national policy, the principle of sovereign
human societies.” (Judge Tanaka in his dissenting
268
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
268 SUPREME COURT REPORTS ANNOTATED gentium. These principles, he believes, are established
by a process of reasoning based on the common identity
Pharmaceutical and Health Care Association of the of all legal systems. If there should be doubt or
Philippines vs. Duque III
disagreement, one must look to state practice and
determine whether the municipal law principle provides
immunity, a person’s right to life, liberty and due process, a just and acceptable solution. x x x (Emphasis supplied)
and pacta sunt servanda, among others.—In Mijares v.
Ranada, 455 SCRA 399 (2005) the Court held thus: Same; Same; Same; Same; Same; Customary
[G]enerally accepted principles of international law, by International Law; Custom or customary international
virtue of the incorporation clause of the Constitution, law means “a general and consistent practice of states

followed by them from a sense of legal obligation [opinio international rule. Without it, practice is not law.
juris],” which statement contains the two basic elements (Italics and Emphasis supplied) Clearly customary
of custom: the material factor, that is, how states behave, international law is deemed incorporated into our
and, the psychological or subjective factor, that is, why domestic system.
they behave the way they do; Customary international
law is deemed incorporated into our domestic system.— Same; Same; Same; Same; Milk Code (E.O. No. 51);
Fr. Joaquin G. Bernas defines customary World Health Assembly (WHA); While regulations, along
with conventions and agreements, duly adopted by the
269 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
VOL. 535, OCTOBER 9, 2007 269
force.—Regulations, along with conventions and
Pharmaceutical and Health Care Association of the agreements, duly adopted by the WHA bind member
Philippines vs. Duque III 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
international law as follows: Custom or customary
or agreements under Article 19 and regulations under
international law means “a general and consistent
Article 21 come into force. Article 23 of the WHO
practice of states followed by them from a sense of legal
Constitution reads: Article 23. The Health Assembly
obligation [opinio juris].” (Restatement) This
shall have authority to make recommendations to
statement contains the two basic elements of
Members with respect to any matter within the
custom: the material factor, that is, how states
competence of the Organization. (Emphasis supplied)
behave, and the psychological or subjective factor,
The absence of a provision in Article 23 of any
that is, why they behave the way they do. x x x x
mechanism by which the recommendation would come
The initial factor for determining the existence of custom
into force for member states is conspicuous.
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 270
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 270 SUPREME COURT REPORTS ANNOTATED
x Once the existence of state practice has been
Pharmaceutical and Health Care Association of the
established, it becomes necessary to determine why Philippines vs. Duque III
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? Same; Same; Same; Same; Same; Same;
Opinio juris, or the belief that a certain form of International Code of Marketing of Breastmilk
behavior is obligatory, is what makes practice an Substitutes (ICMBS); Unlike what has been done with

the International Code of Marketing of Breastmilk most notable is the UN Declaration of Human Rights,
Substitutes (ICMBS) whereby the legislature enacted which this Court has enforced in various cases,
most of the provisions into law which is the Milk Code, specifically, Government of Hongkong Special
the subsequent World Health Assembly (WHA) Administrative Region v. Olalia, 521 SCRA 470 (2007);
Resolutions, specifically providing for exclusive breast- Mejoff v. Director of Prisons, 90 Phil. 70, Mijares v.
feeding from 0-6 months, continued breastfeeding up to Rañada, 455 SCRA 397 (2005), and Shangri-la
24 months, and absolutely prohibiting advertisements International Hotel Management, Ltd. v. Developers
and promotions of breast-milk substitutes, have not been Group of Companies, Inc., 486 SCRA 405 (2006).
adopted as a domestic law.—The WHA Resolution
adopting the ICMBS and subsequent WHA Resolutions
271
urging member states to implement the ICMBS are
merely recommendatory and legally non-binding. Thus,
unlike what has been done with the ICMBS VOL. 535, OCTOBER 9, 2007 271
whereby the legislature enacted most of the
provisions into law which is the Milk Code, the Pharmaceutical and Health Care Association of the
subsequent WHA Resolutions, specifically Philippines vs. Duque III
providing for exclusive breastfeeding from 0-6
months, continued breastfeed-ing up to 24 months, Same; Same; Same; Same; Same; Same; Same;
and absolutely prohibiting advertisements and Administrative Law; The provisions of the World Health
promotions of breastmilk substitutes, have not Assembly (WHA) Resolutions cannot be considered as
been adopted as a domestic law. part of the law of the land that can be implemented by
executive agencies without the need of a law enacted by
Same; Same; Same; Same; Same; Same; Same; Soft the legislature.—Respondents failed to establish that the
Law; Words and Phrases; While “soft law” does not fall provisions of pertinent WHA Resolutions are customary
into any of the categories of international law set forth in international law that may be deemed part of the law of
Article 38, Chapter III of the 1946 Statute of the the land. Consequently, legislation is necessary to
International Court of Justice, it is, however, an transform the provisions of the WHA Resolutions into
expression of non-binding norms, principles, and domestic law. The provisions of the WHA
practices that influence state behavior.—It is propounded Resolutions cannot be considered as part of the
that WHA Resolutions may constitute “soft law” or non- law of the land that can be implemented by
binding norms, principles and practices that influence executive agencies without the need of a law
state behavior. “Soft law” does not fall into any of the enacted by the legislature.
categories of international law set forth in Article 38,
Chapter III of the 1946 Statute of the International Administrative Law; Milk Code; Health;
Court of Justice. It is, however, an expression of non- Breastfeeding; Breast-milk Substitutes; Advertisements;
binding norms, principles, and practices that influence National Health Policy (A.O. No. 2005-0014); The
state behavior. Certain declarations and resolutions of primacy of breastfeeding for children is emphasized as a
the UN General Assembly fall under this category. The national health policy but nowhere in A.O. No. 2005-

0014 is it declared that as part of such health policy, the Philippines vs. Duque III
advertisement or promotion of breastmilk substitutes
should be absolutely prohibited; The national policy of ment or promotion of breastmilk substitutes should be
protection, promotion and support of breast-feeding absolutely prohibited. The national policy of protection,
cannot automatically be equated with a total ban on promotion and support of breastfeeding cannot
advertising for breastmilk substitutes; In view of the automatically be equated with a total ban on advertising
enactment of the Milk Code which does not contain a for breastmilk substitutes. In view of the enactment of
total ban on the advertising and promotion of breastmilk the Milk Code which does not contain a total ban on the
substitutes, it follows that a total ban policy could be advertising and promotion of breastmilk substitutes, but
implemented only pursuant to a law amending the Milk instead, specifically creates an IAC which will regulate
Code passed by the constitutionally authorized branch of said advertising and promotion, it follows that a total
government, the legislature—only the provisions of the ban policy could be implemented only pursuant to a law
Milk Code, but not those of subsequent World Health amending the Milk Code passed by the constitutionally
Assembly (WHA) Resolutions, can be validly authorized branch of government, the legislature. Thus,
implemented by the Department of Health (DOH).— only the provisions of the Milk Code, but not those of
Respondents submit that the national policy on infant subsequent WHA Resolutions, can be validly
and young child feeding is embodied in A.O. No. 2005- implemented by the DOH through the subject RIRR.
0014, dated May 23, 2005. Basically, the Administrative
Order declared the following policy guidelines: (1) ideal
Same; Same; Same; Same; Same; The coverage of the
breastfeeding practices, such as early initiation of
Milk Code is not dependent on the age of the child but on
breastfeed-ing, exclusive breastfeeding for the first six
the kind of product being marketed to the public.—The
months, extended breast-feeding up to two years and
coverage of the Milk Code is not dependent on the age of
beyond; (2) appropriate complementary feeding, which is
the child but on the kind of product being marketed to
to start at age six months; (3) micronutrient
the public. The law treats infant formula, bottle-fed
supplementation; (4) universal salt iodization; (5) the
complementary food, and breastmilk substitute as
exercise of other feeding options; and (6) feeding in
separate and distinct product categories.
exceptionally difficult circumstances. Indeed, the
primacy of breastfeeding for children is emphasized as a
Same; Same; Same; Same; Same; Statutory
national health policy. However, nowhere in A.O. No.
Construction; The entirety of the Revised Implementing
2005-0014 is it declared that as part of such health
Rules and Regulations (RIRR), not merely truncated
policy, the advertise-
portions thereof, must be considered and construed
together—the particular words, clauses and phrases in
272
the Rule should not be studied as detached and isolated
expressions, but the whole and every part thereof must be
considered in fixing the meaning of any of its parts and
272 SUPREME COURT REPORTS ANNOTATED in order to produce a harmonious whole; The Revised
Implementing Rules and Regulations (RIRR), just like
Pharmaceutical and Health Care Association of the the Milk Code, also recognizes that in certain cases, the
use of breastmilk substitutes may be proper.—It is also like breastmilk substitutes and supplements, is a
incorrect for petitioner to say that the RIRR, unlike the relatively new area for regulation by the Department of
Milk Code, does not recognize that breastmilk Health (DOH).—Health is a legitimate subject matter for
substitutes may be a proper and possible substitute for regulation by the DOH (and certain other administrative
breastmilk. The entirety of the RIRR, not merely agencies) in exercise of police powers delegated to it. The
truncated portions thereof, must be considered and sheer span of jurisprudence on that matter precludes the
construed together. As held in De Luna v. Pascual, 495 need to further discuss it.However, health information,
SCRA 42 (2006), “[t]he particular words, clauses and particularly advertising materials on apparently non-
phrases in the Rule should not be studied as detached toxic products like breast-milk substitutes and
and isolated expressions, but the whole and every part supplements, is a relatively new area for regulation by
thereof must be considered in fixing the meaning of any the DOH.
of its parts and in order to produce a harmonious whole.”
Section 7 of the RIRR provides that “when medically Same; Same; Same; Same; Same; Same; The
indicated and only when Department of Health’s (DOH’s) power under the Milk
Code to control information regarding breastmilk vis-à-
273 vis breastmilk substitutes is not absolute as the power to
control does not encompass the power to absolutely
prohibit the advertising, marketing, and promotion of
breastmilk substitutes.—When it comes to information
VOL. 535, OCTOBER 9, 2007 273
regarding nutrition of infants and young children, the
Pharmaceutical and Health Care Association of the Milk Code specifically delegated to the Ministry of
Philippines vs. Duque III Health (hereinafter referred to as DOH) the power to
ensure that there is adequate, consistent and objective
information on breastfeeding and use of breastmilk
necessary, the use of breastmilk substitutes is
substitutes, supplements and related products; and the
proper if based on complete and updated information.”
power to control such information. These are expressly
Section 8 of the RIRR also states that information and
provided for in Sections 12 and 5(a), to wit: x x x
educational materials should include information on the
Further, DOH is authorized by the Milk Code to control
proper use of infant formula when the use thereof is
the content of any information on breastmilk vis-à-vis
needed. Hence, the RIRR, just like the Milk Code,
breastmilk substitutes, supplement and related
also recognizes that in certain cases, the use of
products, in the following manner: x x x The DOH is also
breastmilk substitutes may be proper.
authorized to control the purpose of the information and
to whom such information may be disseminated under
Same; Same; Same; Same; Same; Advertisements;
Sections 6 through 9 of the Milk Code to ensure that the
Police Power; Health is a legitimate subject matter for
information that
regulation by the Department of Health (DOH) (and
certain other administrative agencies) in exercise of police
274
powers delegated to it; Health information, particularly
advertising materials on apparently non-toxic products
274 SUPREME COURT REPORTS ANNOTATED government control over planning, provision, design, and
dissemination of information on infant feeding. Thus,
Pharmaceutical and Health Care Association of the Section 26(c) of the RIRR which requires containers and
Philippines vs. Duque III labels to state that the product offered is not a substitute
for breastmilk, is a reasonable means of enforcing
would reach pregnant women, mothers of infants, and Section 8(b) of the Milk Code and deterring
health professionals and workers in the health care circumvention of the protection and promotion of
system is restricted to scientific and factual matters and breastfeeding as embodied in Section 2 of the Milk Code.
shall not imply or create a belief that bottlefeeding is
equivalent or superior to breastfeeding. It bears Same; Same; Same; Same; Same; Same; The
emphasis, however, that the DOH’s power under the requirement under Section 26(f) of the Revised
Milk Code to control information regarding breastmilk Implementing Rules and Regulations (RIRR) for the
vis-à-vis breastmilk substitutes is not absolute as the label to contain the message regarding health hazards
power to control does not encompass the power to including the possibility of contamination with
absolutely prohibit the advertising, marketing, and pathogenic microorganisms is in accordance with Section
promotion of breastmilk substitutes. 5(b) of the Milk Code.—The label of a product contains
information about said product intended
Same; Same; Same; Same; Same; Same; Section
26(c) of the Revised Implementing Rules and Regulations 275
(RIRR) which requires containers and labels to state that

the product offered is not a substitute for breastmilk, is a
reasonable means of enforcing Section 8(b) of the Milk
VOL. 535, OCTOBER 9, 2007 275
Code and deterring circumvention of the protection and
promotion of breastfeeding as embodied in Section 2 of Pharmaceutical and Health Care Association of the
the Milk Code.—It may be argued that Section 8 of the Philippines vs. Duque III
Milk Code refers only to information given to health
workers regarding breastmilk substitutes, not to for the buyers thereof. The buyers of breastmilk
containers and labels thereof. However, such restrictive substitutes are mothers of infants, and Section 26 of the
application of Section 8(b) will result in the absurd RIRR merely adds a fair warning about the likelihood of
situation in which milk companies and distributors are pathogenic microorganisms being present in infant
forbidden to claim to health workers that their products formula and other related products when these are
are substitutes or equivalents of breastmilk, and yet be prepared and used inappropriately. Petitioner’s counsel
allowed to display on the containers and labels of their has admitted during the hearing on June 19, 2007 that
products the exact opposite message. That askewed formula milk is prone to contaminations and there is as
interpretation of the Milk Code is precisely what Section yet no technology that allows production of powdered
5(a) thereof seeks to avoid by mandating that all infant formula that eliminates all forms of
information regarding breast-milk vis-à-vis breastmilk contamination. Ineluctably, the requirement under
substitutes be consistent, at the same time giving the Section 26(f) of the RIRR for the label to contain the
message regarding health hazards including the Regulations (RIRR) are clearly violative of the Milk
possibility of contamination with pathogenic Code.—Sections 11 and 4(f) of the RIRR are clearly
microorganisms is in accordance with Section 5(b) of the violative of the Milk Code. However, although it is the
Milk Code. IAC
Same; Same; Same; Same; Same; Same; The 276

Department of Health (DOH) evidently arrogated to itself
not only the regulatory authority given to the Inter-
Agency Committee (IAC) but also imposed absolute
276 SUPREME COURT REPORTS ANNOTATED
prohibition on advertising, promotion, and marketing.—
Section 11 of the RIRR, to wit: “SECTION 11. Pharmaceutical and Health Care Association of the
Prohibition.—No advertising, promotions, sponsorships, Philippines vs. Duque III
or marketing materials and activities for breastmilk
substitutes intended for infants and young children up
which is authorized to promulgate rules and regulations
to twenty-four (24) months, shall be allowed, because
for the approval or rejection of advertising, promotional,
they tend to convey or give subliminal messages or
or other marketing materials under Section 12(a) of the
impressions that undermine breastmilk and
Milk Code, said provision must be related to Section 6
breastfeeding or otherwise exaggerate breastmilk
thereof which in turn provides that the rules and
substitutes and/or replacements, as well as related
regulations must be “pursuant to the applicable
products covered within the scope of this Code,”
standards provided for in this Code.” Said standards are
prohibits advertising, promotions, sponsorships or
set forth in Sections 5(b), 8(b), and 10 of the Code, which,
marketing materials and activities for breastmilk
at the risk of being repetitious, and for easy reference.
substitutes in line with the RIRR’s declaration of
principle under Section 4(f), to wit: SECTION 4.
Same; Same; Same; Same; Same; Same; The
Declaration of Principles.—x x x x (f) Advertising,
Department of Health (DOH) has the significant
promotions, or sponsorships of infant formula,
responsibility to translate into operational terms the
breastmilk substitutes and other related products are
standards set forth in Sections 5, 8, and 10 of the Milk
prohibited. The DOH, through its co-respondents,
Code, by which the Inter-Agency Committee (IAC) shall
evidently arrogated to itself not only the regulatory
screen advertising, promotional, or other marketing
authority given to the IAC but also imposed absolute
materials.—Section 12(b) of the Milk Code designates
prohibition on advertising, promotion, and marketing.
the DOH as the principal implementing agency for the
Yet, oddly enough, Section 12 of the RIRR reiterated the
enforcement of the provisions of the Code. In relation to
requirement of the Milk Code in Section 6 thereof for
such responsibility of the DOH, Section 5(a) of the Milk
prior approval by IAC of all advertising, marketing and
Code states that: SECTION 5. Information and
promotional materials prior to dissemination.
Education.—(a) The government shall ensure that
objective and consistent information is provided on
Same; Same; Same; Same; Same; Same; Sections 11
infant feeding, for use by families and those involved in
and 4(f) of the Revised Implementing Rules and
the field of infant nutrition. This responsibility shall
cover the planning, provision, design and dissemination marketing. Through that single provision, the DOH
of information, and the control thereof, on infant exercises control over the information content of
nutrition. (Emphasis supplied) Thus, the DOH has the advertising, promotional and marketing materials on
significant responsibility to translate into breastmilk vis-à-vis breastmilk substitutes, supplements
operational terms the standards set forth in and other related products. It also sets a viable standard
Sections 5, 8, and 10 of the Milk Code, by which against which the IAC may screen such materials before
the IAC shall screen advertising, promotional, or they are made public.
other marketing materials.
Same; Same; Same; Same; Same; Same; Correct
Same; Same; Same; Same; Same; Same; The “total information as to infant feeding and nutrition is infused
effect” standards set out in Section 13 of the Revised with public interest and welfare.—In Equi-Asia
Implementing Rules and Regulations (RIRR) bind the Placement, Inc. vs. Department of Foreign Affairs, 502
Inter-Agency Committee (IAC) in formulating its rules SCRA 295 (2006), the Court held: x x x [T]his Court had,
and regulations on advertising, promotion, and in the past, accepted as sufficient standards the
marketing.—It is pursuant to such responsibility that following: “public interest,” “justice and equity,” “public
the DOH correctly provided for Section 13 in the RIRR convenience and welfare,” and “simplicity, economy and
which reads as follows: SECTION 13. “Total Effect.”— welfare.” In this case, correct information as to infant
Promotion of products within the scope of this Code feeding and nutrition is infused with public interest and
must be objective and should not equate or make the welfare.
product appear to be as good or equal to breastmilk or
breastfeeding in the advertising concept. It must not in Same; Same; Same; Same; Same; Same; Section 22
any case undermine breast-milk or breastfeeding. The of the Revised Implementing Rules and Regulations
“total effect” should not directly or indirectly suggest (RIRR) does not prohibit the giving of information to
that buying their product would produce better indi- health professionals on scientific and factual matters—
what it prohibits is the involvement of the manufacturer
277 and distributor of the products covered by the Code in
activities for the promotion, education and production of
Information, Education and Communication (IEC)
materials regarding breastfeeding that are intended for
VOL. 535, OCTOBER 9, 2007 277
women and children.—Section 22 of the RIRR does not
Pharmaceutical and Health Care Association of the prohibit the giving of information to health
Philippines vs. Duque III professionals on scientific and factual matters.
What it prohibits is the involvement of the manufacturer
and distributor of the products covered by the Code in
viduals, or resulting in greater love, intelligence, ability,
activities for the promotion, education and production of
harmony or in any manner bring better health to the
Information, Education and Communication (IEC)
baby or other such exaggerated and unsubstantiated
materials regarding breastfeeding that are intended
claim. Such standards bind the IAC in formulating its
for women and children. Said provision cannot be
rules and regulations on advertising, promotion, and
construed to encompass even the dissemination of be given by milk companies or under what conditions
information to health professionals, as restricted health workers may accept the assistance, thus, Sections
by the Milk Code. 9 and 10 of the Revised Implementing Rules and
Regulations (RIRR) imposing limitations on the kind of
Same; Same; Same; Same; Same; It is the research done or extent of assistance given by milk
Department of Health (DOH) which is principally companies are completely in accord with the Milk Code.
responsible for the implementa- —Petitioner is also mistaken in arguing that Section 22
of the RIRR prohibits milk companies from giving
278 reasearch assistance and continuing education to health
professionals. Section 22 of the RIRR does not
pertain to research assistance to or the continuing
education of health professionals; rather, it deals
278 SUPREME COURT REPORTS ANNOTATED with breastfeeding promotion and education for
Pharmaceutical and Health Care Association of the women and children. Nothing in Section 22 of the
Philippines vs. Duque III RIRR prohibits milk companies from giving assistance
for research or continuing education to health
professionals; hence, petitioner’s argument against this
tion and enforcement of the provisions of said Code—it is
particular provision must be struck down. It is Sections
entirely up to the Department of Health (DOH) to decide
9 and 10 of the RIRR which govern research assistance.
which entities to call upon or allow to be part of
Said sections of the RIRR provide that research
policymaking bodies on breastfeeding.—Section 4(i) of
assistance for health workers and researchers
the RIRR provides that milk companies and their
may be allowed upon approval of an ethics
representatives should not form part of any
committee, and with certain disclosure
policymaking body or entity in relation to the
requirements imposed on the milk company and
advancement of breastfeeding. The Court finds nothing
on the recipient of the research award. The Milk
in said provisions which contravenes the Milk Code.
Code endows the DOH with the power to determine how
Note that under Section 12(b) of the Milk Code, it is the
such research or educational assistance may be given by
DOH which shall be principally responsible for the
milk companies or under what conditions health workers
implementation and enforcement of the provisions of
said Code. It is entirely up to the DOH to decide which
279
entities to call upon or allow to be part of policymaking
bodies on breastfeeding. Therefore, the RIRR’s
prohibition on milk companies’ participation in any
policymaking body in relation to the advancement of VOL. 535, OCTOBER 9, 2007 279
breastfeeding is in accord with the Milk Code.
Pharmaceutical and Health Care Association of the
Philippines vs. Duque III
Same; Same; Same; Same; Same; The Milk Code
endows the Department of Health (DOH) with the power
to determine how research or educational assistance may
may accept the assistance. Thus, Sections 9 and 10 of of Health (DOH) cannot provide for such fines in the
the RIRR imposing limitations on the kind of research Revised Implementing Rules and Regulations (RIRR).—
done or extent of assistance given by milk companies are In a more recent case, Perez v. LPG Refillers Association
completely in accord with the Milk Code. of the Philippines, Inc., 492 SCRA 638 (2006), the Court
upheld the Department of Energy (DOE) Circular No.
2000-06-10 implementing Batas Pambansa (B.P.) Blg.
Same; Same; Same; Same; Same; The law does not
33. The circular provided for fines for the commission of
proscribe the refusal of donations made by
prohibited acts. The Court found that nothing in the
manufacturers and distributors of breastmilk substitutes
circular contravened the law because the DOE was
—the Milk Code leaves it purely to the discretion of the
expressly authorized by B.P. Blg. 33 and R.A. No. 7638
Department of Health (DOH) whether to request or accept
to impose fines or penalties. In the
such donations.—As to the RIRR’s prohibition on
donations, said provisions are also consistent with the
280
Milk Code. Section 6(f) of the Milk Code provides that
donations may be made by manufacturers and
distributors of breastmilk substitutes upon the request or
with the approval of the DOH. The law does not 280 SUPREME COURT REPORTS ANNOTATED
proscribe the refusal of donations. The Milk Code leaves
it purely to the discretion of the DOH whether to request Pharmaceutical and Health Care Association of the
or accept such donations. The DOH then appropriately Philippines vs. Duque III
exercised its discretion through Section 51 of the RIRR
which sets forth its policy not to request or approve present case, neither the Milk Code nor the Revised
donations from manufacturers and distributors of Administrative Code grants the DOH the authority to fix
breastmilk substitutes. It was within the discretion of or impose administrative fines. Thus, without any
the DOH when it provided in Section 52 of the RIRR express grant of power to fix or impose such fines, the
that any donation from milk companies not covered by DOH cannot provide for those fines in the RIRR. In this
the Code should be coursed through the IAC which shall regard, the DOH again exceeded its authority by
determine whether such donation should be accepted or providing for such fines or sanctions in Section 46 of the
refused. As reasoned out by respondents, the DOH is not RIRR. Said provision is, therefore, null and void.
mandated by the Milk Code to accept donations. For that
matter, no person or entity can be forced to accept a Same; Same; Same; Non-Delegation of Powers; The
donation. There is, therefore, no real inconsistency express grant of rule-making power to an administrive
between the RIRR and the law because the Milk Code agency necessarily includes the power to amend, revise,
does not prohibit the DOH from refusing donations. alter, or repeal the same; It is a standard provision in
administrative rules that prior issuances of
Same; Same; Administrative Penalties; Since neither administrative agencies that are inconsistent therewith
the Milk Code nor the Revised Administrative Code are declared repealed or modified.—Section 57 of the
grants the Department of Health (DOH) the authority to RIRR does not provide for the repeal of laws but only
fix or impose administrative fines, then the Department orders, issuances and rules and regulations. Thus, said
provision is valid as it is within the DOH’s rule-making Pharmaceutical and Health Care Association of the
power. An administrative agency like respondent Philippines vs. Duque III
possesses quasi-legislative or rule-making power or the
power to make rules and regulations which results in nonetheless reserves to the government the power
delegated legislation that is within the confines of the to intervene whenever necessary to promote the
granting statute and the Constitution, and subject to the general welfare.” There can be no question that the
doctrine of non-delegability and separability of powers. unregulated use or proliferation of pesticides would be
Such express grant of rule-making power necessarily hazardous to our environment. Thus, in the aforecited
includes the power to amend, revise, alter, or repeal the case, the Court declared that “free enterprise does
same. This is to allow administrative agencies flexibility not call for removal of ‘protective regulations.’ ” x
in formulating and adjusting the details and manner by x x It must be clearly explained and proven by
which they are to implement the provisions of a law, in competent evidence just exactly how such
order to make it more responsive to the times. Hence, it protective regulation would result in the restraint
is a standard provision in administrative rules that prior of trade. [Emphasis and italics supplied]
issuances of administrative agencies that are
inconsistent therewith are declared repealed or Same; Same; Words and Phrases; Since all the
modified. regulatory provisions under the Milk Code apply equally
to both manufacturers and distributors, the Court sees no
Same; Same; Regulation of Trade; The framers of the harm in the Revised Implementing Rules and
constitution were well aware that trade must be subjected Regulations (RIRR) providing for just one term to
to some form of regulation for the public good—public encompass both entities—the definition of “milk
interest must be upheld over business interests.—The company” in the Revised Implementing Rules and
framers of the constitution were well aware that trade Regulations (RIRR) and the definitions of “distributor”
must be subjected to some form of regulation for the and “manufacturer” provided for under the Milk Code
public good. Public interest must be upheld over are practically the same.—The definition in the RIRR
business interests. In Pest Management Association of merely merged together under the term “milk company”
the Philippines v. Fertilizer and Pesticide Authority, 516 the entities defined separately under the Milk Code as
SCRA 360 (2007), it was held thus: x x x Furthermore, “distributor” and “manufacturer.” The RIRR also
as held in Association of Philippine Coconut Desiccators enumerated in Section 5(w) the products manufactured
v. Philippine Coconut Authority, despite the fact that or distributed by an entity that would qualify it as a
“our present Constitution enshrines free “milk company,” whereas in the Milk Code, what is used
enterprise as a policy, it is the phrase “products within the scope of this Code.”
Those are the only differences between the definitions
281 given in the Milk Code and the definition as restated in
the RIRR. Since all the regulatory provisions under the
Milk Code apply equally to both manufacturers and
distributors, the Court sees no harm in the RIRR
VOL. 535, OCTOBER 9, 2007 281
providing for just one term to encompass both entities.

The definition of “milk company” in the RIRR and the transaction. This is a separate category of speech which
definitions of “distributor” and “manufacturer” provided is not accorded the same level of protection as that given
for under the Milk Code are practically the same. The to other constitutionally guaranteed forms of expression
Court is not convinced that the definition of “milk but is nonetheless entitled to protection.
company” provided in the RIRR would bring about any
change in the treatment or regulation of “distributors” Same; Same; Same; Four-Part Analysis for
and “manufacturers” of breastmilk substitutes, as Evaluating Validity of Regulations of Commercial
defined under the Milk Code. Speech.—Central Hudson provides a four-part analysis
for evaluating the validity of regulations of commercial
PUNO, C.J., Concurring and Separate Opinion: speech. To begin with, the commercial speech must
“concern lawful activity and not be misleading” if it is to
Freedom of Expression; Commercial Speech; be protected under the First Amendment. Next, the
Breastmilk Substitutes; The advertising and promotion asserted governmental interest must be substantial. If
of breastmilk substitutes properly falls within the ambit both of these requirements are met, it must next be
of the term commercial speech—that is, determined whether the state regulation directly
advances the governmental interest asserted, and
282 whether it is not more extensive than is necessary to serve
that interest.
Same; Same; Same; The absolute ban on advertising

282 SUPREME COURT REPORTS ANNOTATED prescribed under Sections 4(f) and 11 of the Revised
Pharmaceutical and Health Care Association of the Implementing Rules and Regulations (RIRR) is unduly
Philippines vs. Duque III restrictive and is more than necessary to further the
avowed governmental interest of promoting the health of
infants and young children.—I proffer the humble view
speech that proposes an economic transaction—a
that the absolute ban on advertising prescribed under
separate category of speech which is not accorded the
Sections 4(f) and 11 of the RIRR is unduly restrictive and
same level of protection as that given to other
is more than necessary to further the avowed
constitutionally guaranteed forms of expression but is
governmental interest of promoting the health of infants
nonetheless entitled to protection.—I fully concur with
and young children. It ought to be self-evident, for
the well-written and comprehensive ponencia of my
instance, that the dvertisement of such products which
esteemed colleague, Ms. Justice Ma. Alicia Austria-
are strictly informative cuts too deep on free speech. The
Martinez. I write to elucidate another reason why the
laudable concern of the respondent for the promotion of
absolute ban on the advertising and promotion of
the health of infants and young children cannot justify
breastmilk substitutes found under Sections 4(f) and 11
the absolute, overarching ban.
of A.O. No. 2006-0012 (RIRR) should be struck down.
The advertising and promotion of breastmilk substitutes 283
properly falls within the ambit of the term commercial
speech—that is, speech that proproses an economic
VOL. 535, OCTOBER 9, 2007 283 Penalizing Violations Thereof, and for Other
Pharmaceutical and Health Care Association of Purposes (RIRR). Petitioner posits that the RIRR
the Philippines vs. Duque III is not valid as it contains provisions that are not
constitutional and go beyond the law it is supposed
to implement.
SPECIAL CIVIL ACTION in the Supreme Court.
Certiorari. 284
The facts are stated in the opinion of the Court.

Felicitas Aquino Arroyo, Ma. Pilar Martinez- 284 SUPREME COURT REPORTS
Caedo, Sandra Marie Olaso-Coronel and Grace ANNOTATED
Veronica C. Reyes for petitioner. Pharmaceutical and Health Care Association of
The Solicitor General for respondents. the Philippines vs. Duque III
Maria Shiela M. Bazar for Arugaan, Inc.
Bernas Law Offices for respondents-in- Named as respondents are the Health Secretary,
intervention and Theresia Hontiveros-Baraquel Under-secretaries, and Assistant Secretaries of the
and Loreta Ann P. Rosales. Department of Health (DOH). For purposes of
Maria Paz Luna for herself and herein petition, the DOH is deemed impleaded as a
movant/intervenors Pia Denise Ducay, et al. co-respondent since respondents issued the
Marvic M.V.F. Leonen for himself and questioned RIRR in their capacity as officials of
movant/inter-venors Karol Ruiz Austria, et al. said executive agency.
1
Executive Order No. 51 (Milk Code) was issued

AUSTRIA-MARTINEZ, J.:
by President Corazon Aquino on October 28, 1986
The Court and all parties involved are in by virtue of the legislative powers granted to the
agreement that the best nourishment for an infant president under the Freedom Constitution. One of
is mother’s milk. There is nothing greater than for the preambular clauses of the Milk Code 2 states
a mother to nurture her beloved child straight that the law seeks to give effect to Article 11 of the
from her bosom. The ideal is, of course, for each International Code of Marketing of Breastmilk
and every Filipino child to enjoy the unequaled Substitutes (ICMBS), a code adopted by the World
benefits of breastmilk. But how should this end be Health Assembly (WHA) in 1981. From 1982 to
attained? 2006, the WHA adopted several Resolutions to the
Before the Court is a petition for certiorari effect that breastfeeding should be sup-
under Rule 65 of the Rules of Court, seeking to
nullify Administrative Order (A.O.) No. 2006-0012 _______________
entitled, Revised Implementing Rules and
1 Section 11, Rule 3, 1997 Rules of Civil Procedure which
Regulations of Executive Order No. 51,
provides:
Otherwise Known as The “Milk Code,”
Relevant International Agreements,

Section 11. Misjoinder and non-joinder of parties.—Neither On May 15, 2006, the DOH issued herein
misjoinder nor non-joinder of parties is ground for dismissal of an assailed RIRR which was to take effect on July 7,
action. Parties may be dropped or added by order of the court 2006.
on motion of any party or on its own initiative at any stage of the However, on June 28, 2006, petitioner,
action and on such terms as are just. x x x (Emphasis supplied) representing its members that are manufacturers
of breastmilk substitutes, filed the present Petition
2 Article 11. Implementation and monitoring
for Certiorari and Prohibition with Prayer for the
11.1 Governments should take action to give effect to the principles Issuance of a Temporary Restraining Order (TRO)
and aim of this Code, as appropriate to their social and legislative or Writ of Preliminary Injunction.
framework, including the adoption of national legislation, regulations The main issue raised in the petition is whether
or other suitable measures. For this purpose, governments should respondents officers of the DOH acted without or
seek, when necessary, the cooperation of WHO, UNICEF and other in excess of jurisdiction, or with grave abuse of
agencies of the United Nations system. National policies and discretion amounting to lack or excess of
measures, including laws and regulations, which are adopted to give jurisdiction, and in violation of the provisions
3
of
effect to the principles and aim of this Code should be publicly stated, the Constitution in promulgating the RIRR.
and should apply on the same basis to all those involved in the On August 15, 2006, the Court issued a
manufacture and marketing of products within the scope of this Code. Resolution granting a TRO enjoining respondents
xxxx from implementing the questioned RIRR.
After the Comment and Reply had been filed,
285 the Court set the case for oral arguments on June
19, 2007. The Court issued an Advisory (Guidance
VOL. 535, OCTOBER 9, 2007 285 for Oral Arguments) dated June 5, 2007, to wit:
Pharmaceutical and Health Care Association of “The Court hereby sets the following issues:
1. Whether or not petitioner is a real party-in-
interest;
ported, promoted and protected, hence, it should be
ensured that nutrition and health claims are not 2. Whether Administrative Order No. 2006-0012 or
permitted for breastmilk substitutes. the Revised Implementing Rules and
In 1990, the Philippines ratified the Regulations (RIRR) issued by the Department of
International Convention on the Rights of the Health (DOH) is not constitutional;
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 3 Petition, Rollo, p. 12.
children, are informed of the advantages of
286
breastfeeding.

286 SUPREME COURT REPORTS “The modern view is that an association has standing to
ANNOTATED complain of injuries to its members. This view fuses the
Pharmaceutical and Health Care Association of legal identity of an association with that of its members.
the Philippines vs. Duque III An association has standing to file suit for its
workers despite its lack of direct interest if its
members are affected by the action. An
2.1. Whether the RIRR is in accord with the
organization has standing to assert the concerns
provisions of Executive Order No. 51 (Milk
of its constituents.
Code);
xxxx
2.2. Whether pertinent international agreements1 x x x We note that, under its Articles of Incorporation,
entered into by the Philippines are part of the the respondent was organized x x x to act as the
law of the land and may be implemented by the representative of any
DOH through the RIRR; If in the affirmative,
whether the RIRR is in accord with the
_______________
international agreements;
2.3. Whether Sections 4, 5(w), 22, 32, 47, and 52 of 4 G.R. No. 131719, May 25, 2004, 429 SCRA 81.
the RIRR violate the due process clause and are
in restraint of trade; and 287
2.4. Whether Section 13 of the RIRR on Total Effect

provides sufficient standards. VOL. 535, OCTOBER 9, 2007 287
Pharmaceutical and Health Care Association of
____________
1 (1) United Nations Convention on the Rights of the Child; (2)
the WHO and Unicef “2002 Global Strategy on Infant and individual, company, entity or association on matters
Young Child Feeding;” and (3) various World Health Assembly related to the manpower recruitment industry, and to
(WHA) Resolutions. perform other acts and activities necessary to
accomplish the purposes embodied therein. The
The parties filed their respective memoranda. respondent is, thus, the appropriate party to
The petition is partly imbued with merit. assert the rights of its members, because it and its
members are in every practical sense identical. x x
x The respondent [association] is but the medium
On the issue of petitioner’s standing
through which its individual members seek to
With regard to the issue of whether petitioner may make more effective the expression of their
5
voices
prosecute this case as the real party-in-interest, and the redress of their grievances.” (Emphasis
the Court adopts the view enunciated in Executive supplied)
4
Secretary v. Court of Appeals, to wit:
which was reasserted in 6 Purok Bagong Silang
Association, Inc. v. Yuipco, where the Court ruled
that an association has the legal personality to the Philippines vs. Duque III
represent its members because the7 results of the
case will affect their vital interests. on governmental action that would affect any of its
Herein petitioner’s Amended Articles of industry members, no matter how few or
Incorporation contains a similar provision just like numerous they are. Hence, petitioner, whose legal
in Executive Secretary, that the association is identity is deemed fused with its members, should
formed “to represent directly or through approved be considered as a real party-in-interest which
representatives the pharmaceutical and health stands to be benefited or injured by any judgment
care industry before the Philippine Government in the present action.
and any of its agencies, 8
the medical professions
and the general public.” Thus, as an organization,
petitioner definitely has an interest in fulfilling its On the constitutionality of the provisions of
avowed purpose of representing members who are the RIRR
part of the pharmaceutical and health care
9 First, the Court will determine if pertinent
industry. Petitioner is duly authorized to take the
international instruments adverted to by
appropriate course of action to bring to the
respondents are part of the law of the land.
attention of government agencies and the courts
Petitioner assails the RIRR for allegedly going
any grievance suffered by its members which are
beyond the provisions of the Milk Code, thereby
directly affected by the RIRR. Petitioner, which is
amending and expanding the coverage of said law.
mandated by its Amended Articles of Incorporation
The defense of the DOH is that the RIRR
to represent the entire industry, would be remiss
implements not only the Milk Code but also
in its duties if it fails to act 10
various international instruments regarding
infant and young child nutrition. It is respondents’
_______________ position that said international instruments are
5 Id., at pp. 96-97.
deemed part of the law of the land and therefore
6 G.R. No. 135092, May 4, 2006, 489 SCRA 382.
the DOH may implement them through the RIRR.
7 Id., at p. 396.
The Court notes that the following international
instruments invoked by respondents, namely: (1)
8 Annex “G,” Petitioner’s Memorandum dated July 19, 2007.
The United Nations Convention on the Rights of
9 Annexes “H,” “I,” and “J” of Petitioner’s Memorandum
the Child; (2) The International Covenant on
executed by Wyeth Philippines, Inc., Bristol Myers Squibb
Economic, Social and Cultural Rights; and (3) the
(Phils.), Inc., and Abbott Laboratories, Inc., respectively.
Convention on the Elimination of All Forms of
288 Discrimination Against Women, only provide in
general terms that steps must be taken by State
Parties to diminish infant and child mortality and
288 SUPREME COURT REPORTS inform society of the advantages of breastfeeding,
ANNOTATED
ensure the health and well-being of families,
_______________ Section 21 of the Constitution which provides that

“[n]o treaty or international agreement shall be
10 a) The UN Convention on the Rights of the Child (CRC); b)
valid and effective unless concurred in by at least
the International Code of Marketing Breastmilk Substitutes
two-thirds of all the members of the Senate.” Thus,
(ICMBS); c) the International Covenant on Economic, Social
treaties or conventional international law must go
and Cultural Rights (CSCR); d) the Convention on the
through a process prescribed by the Constitution
Elimination of All Forms of Discrimination Against Women
for it to be transformed into municipal
13
law that
(CEDAW); e) the Global Strategy for Infant and Young Child
can be applied to domestic conflicts.
Nutrition (Global Strategy); and f) various resolutions adopted
The ICMBS and WHA Resolutions are not
by the World Health Assembly.
treaties as they have not been concurred in by at
289 least two-thirds of all members of the Senate as
required under Section 21, Article VII of the 1987
Constitution.
VOL. 535, OCTOBER 9, 2007 289 However, the ICMBS which was adopted by the
Pharmaceutical and Health Care Association of WHA in 1981 had been transformed into domestic
the Philippines vs. Duque III law through local legislation, the Milk Code.
Consequently, it is the Milk Code
and ensure that women are provided with services
and nutrition in connection with pregnancy and _______________
lactation. Said instruments do not contain specific
11 Joaquin G. Bernas, S.J., Constitutional Structure and
provisions regarding the use or marketing of
Powers of Government (Notes and Cases) Part I (2005).
breastmilk substitutes.
12 Id.
The international instruments that do have
specific provisions regarding breastmilk 13 Joaquin G. Bernas, S.J., An Introduction to Public
substitutes are the ICMBS and various WHA International Law, 2002 Ed., p. 57.
Resolutions.
290
Under the 1987 Constitution, international law
can become part of the sphere of domestic law 11
either by transformation or incorporation. 290 SUPREME COURT REPORTS
The transformation method requires that an ANNOTATED
international law be transformed into a domestic Pharmaceutical and Health Care Association of
law through a constitutional mechanism such as the Philippines vs. Duque III
local legislation. The incorporation method applies
when, by mere constitutional declaration,
that has the force and effect of law in this
international 12law is deemed to have the force of
jurisdiction and not the ICMBS per se.
domestic law.
The Milk Code is almost a verbatim
Treaties become part of the law of the land
reproduction of the ICMBS, but it is well to
through transformation pursuant to Article VII,
emphasize at this point that the Code did not
adopt the provision in the ICMBS absolutely 25) also use the incorporation method.
prohibiting advertising or other forms of 15 G.R. No. 139325, April 12, 2005, 455 SCRA 397.
promotion to the general public of products
291
within the scope of the ICMBS. Instead, the
Milk Code expressly provides that
advertising, promotion, or other marketing VOL. 535, OCTOBER 9, 2007 291
materials may be allowed if such materials
are duly authorized and approved by the
Inter-Agency Committee (IAC).
On the other hand, Section 2, Article II of the
1987 Constitution, to wit: practice in question is rendered obligatory
16
by the
existence of a rule of law requiring it.” (Emphasis
“SECTION 2. The Philippines renounces war as an supplied)
instrument of national policy, adopts the generally
accepted principles of international law as part of “Generally accepted principles of international
the law of the land and adheres to the policy of peace, law” refers to norms of general or customary 17
equality, justice, freedom, cooperation and amity with all international law which are binding on all states,
nations. (Emphasis supplied) i.e., renunciation of war as an instrument of
14
national 18policy, the principle of sovereign
embodies the incorporation
15
method. immunity,19
a person’s right to life,20liberty and due
In Mijares v. Ranada, the Court held thus: process, and pacta sunt servanda, among others.
The concept of “generally accepted principles of
“[G]enerally accepted principles of international law, by law” has also been depicted in this wise:
virtue of the incorporation clause of the Constitution,
form part of the laws of the land even if they do not “Some legal scholars and judges look upon certain
derive from treaty obligations. The classical “general principles of law” as a primary source of
formulation in international law sees those international law because they have the “character of
customary rules accepted as binding result from jus rationale” and are “valid through all kinds of
the combination [of] two elements: the established, human societies.” (Judge Tanaka in his dissenting
widespread, and consistent practice on the part of opinion in the 1966 South West Africa Case, 1966 I.C.J.
States; and a psychological element known as the 296). O’Connell holds that certain priniciples are part of
opinion juris sive necessitates (opinion as to law or international law because they are “basic to legal
necessity). Implicit in the latter element is a belief that systems generally” and hence part of the jus
the 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
14 According to Fr. Bernas, the Austrian Constitution (Art. 9) determine whether the municipal law principle provides
and the Constitution of the Federal Republic of Germany (Art.
21
21
a just and acceptable solution. x x x” (Emphasis several elements: duration, consistency, and generality
supplied) of the practice of states.
The required duration can be either short or long. x x
Fr. Joaquin G. Bernas defines customary x
international law as follows: xxxx
Duration therefore is not the most important element.
“Custom or customary international law means “a
More important is the consistency and the generality of
general and consistent practice of states followed by them
the practice. x x x
from a sense of legal
xxxx
Once the existence of state practice has been
_______________ established, it becomes necessary to determine why
16 Id., at p. 421.
states behave the way they do. Do states behave the way
they do because they consider it obligatory to behave
17 Merlin M. Magallona, Fundamentals of Public
thus or do they do it only as a matter of courtesy?
International Law, 2005 Ed., p. 526.
Opinio juris, or the belief that a certain form of
18 Id., at p. 525.
behavior is obligatory, is what makes practice an
19 Government of Hong Kong Special Administrative Region 22
international rule. Without it, practice is not law.”
v. Olalia, G.R. No. 153675, April 19, 2007, 521 SCRA 470.
(Italics and Emphasis supplied)
20 Tañada v. Angara, 338 Phil. 546, 592; 272 SCRA 18
(1997). Clearly, customary international law23 is deemed
21 Louis Henkin, Richard C. Pugh, Oscar Schachter, Hans incorporated into our domestic system.
Smit, International Law, Cases and Materials, 2nd Ed., p. 96. WHA Resolutions have not been embodied in
any local legislation. Have they attained the status
292
of customary law and should they then be deemed
incorporated as part of the law of the land?
292 SUPREME COURT REPORTS The World Health Organization (WHO) is one of
ANNOTATED the international specialized agencies allied with 24
the United Nations (UN) by virtue of Article 57,
in relation to Article
_______________
obligation [opinio juris].” (Restatement) This
statement contains the two basic elements of 22 Supra note 13, at pp. 10-13.
custom: the material factor, that is, how states 23 Minucher v. Court of Appeals, 445 Phil. 250, 269; 397
behave, and the psychological or subjective factor, SCRA 244, 259-260 (2003).
that is, why they behave the way they do. 24 Article 57. The various specialized agencies, established by
xxxx intergovernmental agreement and having wide international
The initial factor for determining the existence of responsibilities, as defined in their basic instruments, in
custom is the actual behavior of states. This includes economic, social,
293 It may coordinate the activities of the specialized agencies

through consultation with and recommendations to such
agencies and through recommendations to the General
VOL. 535, OCTOBER 9, 2007 293
Assembly and to the Members of the United Nations.
Pharmaceutical and Health Care Association of 26 Article 18. The functions of the Health Assembly shall be:
the Philippines vs. Duque III (a) to determine the policies of the Organization x x x.
(Emphasis supplied)
25
63 of the UN Charter. Under the 1946 WHO 27 Article 21. The Health Assembly shall have authority to
Constitution, it is the26
WHA which determines the adopt regulations concerning: x x x
policies of the WHO, and has the power to adopt (e) advertising and labeling of biological,
regulations concerning “advertising and labeling of pharmaceutical and similar products moving in
biological, pharmaceutical and similar
27
products international commerce. (Emphasis supplied)
moving in international commerce,” and to “make 28 Article 23. The Health Assembly shall have authority to
recommendations to members with respect to any make recommendations to Members with respect to any
matter within
28
the competence of the matter within the competence of the Organization. (Emphasis
Organization.” The legal effect of its regulations, supplied)
as opposed to recommendations, is quite different.
294
Regulations, along with conventions and
agreements, duly adopted by the WHA bind
member states thus: 294 SUPREME COURT REPORTS
ANNOTATED
Article 19. The Health Assembly shall have authority to
adopt conventions or agreements with respect to any Pharmaceutical and Health Care Association of
matter within the Philippines vs. Duque III
_______________
the competence of the Organization. A two-thirds vote of
the Health Assembly shall be required for the adoption
cultural, educational, health, and related fields, shall be of such conventions or agreements, which shall
brought into relationship with the United Nations in come into force for each Member when accepted
accordance with the provisions of Article 63. by it in accordance with its constitutional
Such agencies thus brought into relationship with the United processes.
Nations are hereinafter referred to as specialized agencies. Article 20. Each Member undertakes that it will,
25Article 63. The Economic and Social Council may enter into within eighteen months after the adoption by the Health
agreements with any of the agencies referred to in Article 57, Assembly of a convention or agreement, take action
defining the terms on which the agency concerned shall be relative to the acceptance of such convention or
brought into relationship with the United Nations. Such agreement. Each Member shall notify the Director-
agreements shall be subject to approval by the General General of the action taken, and if it does not accept
Assembly. such convention or agreement within the time limit, it
will furnish a statement of the reasons for non-
acceptance. In case of acceptance, each Member agrees Pharmaceutical and Health Care Association of
to make an annual report to the Director-General in the Philippines vs. Duque III
accordance with Chapter XIV.
Article 21. The Health Assembly shall have
The absence of a provision in Article 23 of any
authority to adopt regulations concerning: (a)
mechanism by which the recommendation would
sanitary and quarantine requirements and other
come into force for member states is conspicuous.
procedures designed to prevent the international spread
The former Senior Legal Officer of WHO, Sami
of disease; (b) nomenclatures with respect to diseases,
Shubber, stated that WHA recommendations are
causes of death and public health practices; (c)
generally not binding, but they “carry moral and
standards with respect to diagnostic procedures for
political weight, as they constitute the judgment
international use; (d) standards with respect to the
on a health issue of the collective membership of
safety, purity and potency of biological, pharmaceutical
the highest international body in the field of
and similar products moving in international commerce; 29
health.” Even the ICMBS itself was adopted as a
(e) advertising and labeling of biological,
mere recommendation, as WHA Resolution No.
pharmaceutical and similar products moving in
34.22 states:
international commerce.
Article 22. Regulations adopted pursuant to “The Thirty-Fourth World Health Assembly x x x adopts,
Article 21 shall come into force for all Members in the sense of Article 23 of the Constitution, the
after due notice has been given of their adoption by International Code of Marketing of Breastmilk
the Health Assembly except for such Members as Substitutes annexed to the present resolution.”
may notify the Director-General of rejection or (Emphasis supplied)
reservations within the period stated in the notice.
(Emphasis supplied) The Introduction to the ICMBS also reads as
follows:
On the other hand, under Article 23,
recommendations of the WHA do not come “In January 1981, the Executive Board of the World
into force for members, in the same way that Health Organization at its sixty-seventh session,
conventions or agreements under Article 19 and considered the fourth draft of the code, endorsed it, and
regulations under Article 21 come into force. unanimously recommended to the Thirty-fourth World
Article 23 of the WHO Constitution reads: Health Assembly the text of a resolution by which it
would adopt the code in the form of a
Article 23. The Health Assembly shall have authority to recommendation rather than a regulation. x x x”
make recommendations to Members with respect to (Emphasis supplied)
any matter within the competence of the Organization.
(Emphasis supplied) The legal value of WHA Resolutions as
recommendations is summarized in Article 62 of
295 the WHO Constitution, to wit:
VOL. 535, OCTOBER 9, 2007 295

“Art. 62. Each member shall report annually on the requirement.”

action taken with respect to recommendations made to it (b) In Resolution No. 39.28 (May 16, 1986), the WHA
by the Organization, and with respect to conventions, requested the WHO Director General to direct the
agreements and regulations.” attention of member states to the fact that any food or
drink given before complementary feeding is
Apparently, the WHA Resolution adopting the
nutritionally required may interfere with the initiation
ICMBS and subsequent WHA Resolutions urging
or maintenance of breastfeeding and therefore should
member states to implement the ICMBS are
neither be promoted nor encouraged for us by infants
merely recommendatory and legally
during this period.
(c) In Resolution No. 43.3 (May 14, 1990), the WHA urged
_______________
member states to protect and promote breastfeeding as
29 See David Fidler, Developments Involving SARS, an essential component of nutrition policies so as to
International Law, and Infectious Disease Control at the Fifty- enable infants to be exclusively breastfed during the
Sixth Meeting of the World Health Assembly, June 2003, ASIL. first four to six months of life.
(d) In Resolution No. 45.34 (May 14, 1992), the WHA
296 urged member states to implement the targets of the
Innocenti Declaration specifically, to give effect to the
296 SUPREME COURT REPORTS ICMBS.
ANNOTATED (e) In Resolution No. 46.7 (May 10, 1993), the WHA urged
Pharmaceutical and Health Care Association of member states to strive to eliminate under-nutrition,
the Philippines vs. Duque III malnutrition and nutritional deficiency among children.
(f) In Resolution No. 47.5 (May 9, 1994), the WHA urged
non-binding. Thus, unlike what has been done member states to ensure that there are no donations of
with the ICMBS whereby the legislature supplies of breastmilk substitutes and other products
enacted most of the provisions into law covered by the ICMBS in any part of the health care
which is the30Milk Code, the subsequent WHA system.
Resolutions, specifically providing for (g) In Resolution No. 49.15 (May 25, 1996), the WHA
exclusive breastfeeding from 0-6 months, urged member states to ensure that complementary
continued foods are not marketed for or used in ways that
undermine exclusive and sustained breastfeeding.
_______________
297
30 In Resolution No. 34.22 (May 21, 1981), the WHA, acting
under Article 23 of the WHO Constitution, adopted the ICBMS. VOL. 535, OCTOBER 9, 2007 297
(a) In Resolution No. 35.26 (May 1982), the WHA urged Pharmaceutical and Health Care Association of
member states to implement the ICBMS as a “minimum the Philippines vs. Duque III

breastfeeding up to 24 months, and (j) In Resolution No. 58.32 (May 25, 2005), the WHA
absolutely prohibiting advertisements and urged member states to continue to protect and promote
promotions of breastmilk substitutes, have exclusive breastfeeding for six months.
not been adopted as a domestic law. (k) In Resolution No. 59.21 (May 27, 2006), the WHA
It is propounded that WHA Resolutions may reiterated its support for the Gobal strategy for Infant
constitute “soft law” or non-binding norms, and Young Child Feeding.
principles31 and practices that influence state
behavior. 31 David Fidler, supra note 29.
“Soft law” does not fall into any of the categories 32 Article 38. 1. The Court, whose function is to decide in
of international law set forth in Article 38, Chapter accordance with international law such disputes as are
III of the 321946 Statute of the International Court submitted to it,
of Justice. It is, however,
298
_______________
298 SUPREME COURT REPORTS
(h) In Resolution No. 54.2 (May 2002), the WHA, noting
ANNOTATED
that “despite the fact that the International Code of
Marketing of Breastmilk Substitutes and relevant
subsequent World Health Assembly resolutions state
that there should be no advertising or other forms of
promotion of products within its scope, new modern an expression of non-binding norms, principles, 33
communication methods including electronic means, are and practices that influence state behavior.
currently increasingly being used to promote such Certain declarations and resolutions of the 34
UN
products; and conscious of the need for the Codex
General Assembly fall under this category. The
most notable is the UN Declaration of Human
Alimentarius Commission to take the International
Rights, which this Court has enforced in various
Code and subsequent relevant Health Assembly
cases, specifically, Government of 35Hongkong
resolutions into consideration in dealing with health
Special Administrative Region v. Olalia, Mejoff v.
claims in the development of food standards and 36 37
Director of Prisons, Mijares v. Rañada and
guidelines x x x,” urged member states to develop new
Shangri-La International Hotel Management, Ltd.
approaches to protect, promote and support exclusive 38
v. Developers Group of Companies, Inc.
breastfeeding for six months as a global public health
The World Intellectual Property Organization
recommendation.
(WIPO), a specialized agency attached to the UN
(i) In Resolution No. 55.25 (May 15, 2002), the WHA
with the mandate to promote and protect
requested the Codex Alimentarius Commission to
intellectual property worldwide, has resorted to
ensure that labelling of processed foods for infants and
soft law as a rapid means of norm creation, in
young children be consistent with the WHO policy under
order “to reflect and respond to the changing
39
needs
the ICBMS.
and demands of its constituents.” Other

international organizations which have resorted to Labor Organization and the Food and Agriculture
soft law include the International Organization 40 (in the form of the Codex
Alimentarius).
_______________ WHO has resorted to soft law. This was most
evident at the time of the Severe Acute Respiratory
shall apply: a) international conventions, whether general or Syndrome (SARS) and Avian flu outbreaks.
particular, establishing rules expressly recognized by the
contesting states; b) international custom, as evidence of a “Although the IHR Resolution does not create new
general practice accepted as law; c) the general principles of law international law binding on WHO member states,
recognized by civilized nations; d) subject to the provisions of it provides an excellent example of the power of
Article 59, judicial decisions and the teachings of the most “soft law” in international relations. International
highly qualified publicists of the various na-tions, as subsidiary lawyers typically distinguish binding rules of
means for the determination of rules of law. international law—”hard law”—from non-binding
33 Supra note 29. norms, principles, and practices that influence
34 Louis Henkin, et al., International Law, Cases and state behavior—”soft law.” WHO has during its
Materials, 2nd Ed., supra note 21, at pp. 114-136. existence generated many soft law norms, creating
35 Supra note 19.
a “soft law regime” in international governance for
public health.
36 90 Phil. 70 (1951).
The “soft law” SARS and IHR Resolutions represent
37 Supra note 15.
significant steps in laying the political groundwork for
38 G.R. No. 159938, March 31, 2006, 486 SCRA 405.
improved international cooperation on infectious
39 Edward Kwakwa, Some Comments on Rulemaking at the
diseases. These resolutions clearly define WHO member
World Intellectual Property Organization,
states’ normative duty to cooperate fully with other
www.law.duke.edu/shell/cite; September 13, 2007, 12:33, citing
countries and with WHO in connection with infectious
the 1999 WIPO Resolution Concerning Provisions on the
disease surveillance and response to outbreaks.
Protection of Well-Known Marks, 2000 WIPO Recommendation
This duty is neither binding nor enforceable,
Concerning Trademark Licenses, and 2001 WIPO
but, in the wake of the SARS epidemic, the duty is
Recommendation Concerning Provisions on the Protection of
powerful politically for two reasons. First, the SARS
Marks and other Industrial Property Rights in Signs on the
outbreak has taught the lesson that participating in, and
Internet.
enhancing, international cooperation on infectious
299 disease controls is in a country’s self-interest x x x if this
warning is heeded, the “soft law” in the SARS and IHR
Resolution could inform the development of general and
VOL. 535, OCTOBER 9, 2007 299 consistent state practice on infectious disease
Pharmaceutical and Health Care Association of surveillance and outbreak response, perhaps
the Philippines vs. Duque III crystallizing eventually into customary international law
41
on infectious disease prevention and control.”

In the Philippines, the executive department compliance by member states with said WHA
implemented certain measures recommended by Resolutions was obligatory in nature.
WHO to address the outbreaks of SARS and Avian Respondents failed to establish that the
flu by issuing Executive Order (E.O.) No. 201 on provisions of pertinent WHA Resolutions are
April 26, 2003 and E.O. No. 280 on Febru- 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
40 Id. into domestic law. The provisions of the WHA
41 Supra note 29. Resolutions cannot be considered as part of
the law of the land that can be implemented
300
by executive agencies without the need of a
law enacted by the legislature.
300 SUPREME COURT REPORTS Second, the Court will determine whether the
ANNOTATED DOH may implement the provisions of the WHA
Resolutions by virtue of its powers and functions
under the Revised Administrative Code even in the
absence of a domestic law.
Section 3, Chapter 1, Title IX of the Revised
ary 2, 2004, delegating to various departments Administrative Code of 1987 provides that the
broad powers to close down schools/establishments, DOH shall define the national health policy
conduct health surveillance and monitoring, and and implement a national health plan within the
ban importation of poultry and agricultural framework of the government’s general poli-
products.
It must be emphasized that even under such an 301
international emergency, the duty of a state to
implement the IHR Resolution was still considered
VOL. 535, OCTOBER 9, 2007 301
not binding or enforceable, although said
resolutions had great political influence. Pharmaceutical and Health Care Association of
As previously discussed, for an international the Philippines vs. Duque III
rule to be considered as customary law, it must be
established that such rule is being followed by cies and plans, and issue orders and
states because they consider it obligatory to regulations concerning the implementation
comply with such rules (opinio juris). Respondents of established health policies.
have not presented any evidence to prove that the It is crucial to ascertain whether the absolute
WHA Resolutions, although signed by most of the prohibition on advertising and other forms of
member states, were in fact enforced or practiced promotion of breastmilk substitutes provided in
by at least a majority of the member states; some WHA Resolutions has been adopted as part
neither have respondents proven that any of the national health policy.
Respondents submit that the national policy on 302 SUPREME COURT REPORTS
infant and young child feeding is embodied in A.O. ANNOTATED
No. 2005-0014, dated May 23, 2005. Basically, the Pharmaceutical and Health Care Association of
Administrative Order declared the following policy the Philippines vs. Duque III
guidelines: (1) ideal breastfeeding practices, such
as early initiation of breastfeeding, exclusive
Third, the Court will now determine whether the
breastfeeding for the first six months, extended
provisions of the RIRR are in accordance with
breastfeeding up to two years and beyond; (2)
those of the Milk Code.
appropriate complementary feeding, which is to
In support of its claim that the RIRR is
start at age six months; (3) micronutrient
inconsistent with the Milk Code, petitioner alleges
supplementation; (4) universal salt iodization; (5)
the following:
the exercise of other feeding options; and (6)
feeding in exceptionally difficult circumstances. 1. The Milk Code limits its coverage to
Indeed, the primacy of breastfeeding for children is children 0-12 months old, but the RIRR
emphasized as a national health policy. However, extended its coverage to “young children”
nowhere in A.O. No. 2005-0014 is it declared or those from ages two years old and
that as part of such health policy, the beyond:
advertisement or promotion of breastmilk
substitutes should be absolutely prohibited. MILK CODE RIRR
The national policy of protection, promotion and
support of breastfeeding cannot automatically be
equated with a total ban on advertising for
breastmilk substitutes.
In view of the enactment of the Milk Code which
does not contain a total ban on the advertising and
promotion of breastmilk substitutes, but instead,
specifically creates an IAC which will regulate said
advertising and promotion, it follows that a total
ban policy could be implemented only pursuant to
a law amending the Milk Code passed by the
constitutionally authorized branch of government,
the legislature.
Thus, only the provisions of the Milk Code, but
not those of subsequent WHA Resolutions, can
be validly implemented by the DOH through the
subject RIRR.
302

MILK CODE RIRR VOL. 535, OCTOBER 9, 2007 303

WHEREAS, in order Section 2. Purpose.— Pharmaceutical and Health Care Association of
to ensure that safe and These Revised Rules and the Philippines vs. Duque III
adequate nutrition for Regulations are hereby
infants is provided, promulgated to ensure the feeding for infants from 0-6 months” and
there is a need to provision of safe and declares that “there is no substitute nor
protect and promote adequate nutrition for replacement for breastmilk:”
breastfeeding and to infants and young
inform the public children by the promotion,
MILK CODE RIRR
about the proper use of protection and support of
breastmilk substitutes breastfeeding and by WHEREAS, in order to ensure Section 4.
and supplements and ensuring the proper use of that safe and adequate Declaration of
related products breastmilk substitutes, nutrition for infants is
Principles.—The
through adequate, breastmilk supplements provided, there is a need to following are the
consistent and and related products protect underlying
objective information when these are medically
and promote breastfeeding and principles from

and appropriate indicated and only when to inform the public about which the revised
regulation of the necessary, on the basis of the proper use of breastmilk
rules and
marketing and adequate information and substitutes and supplements regulations are
distribution of the said through appropriate and related products through premised upon:
substitutes, marketing and adequate, consistent and a. Exclusive
supplements and distribution. objective information and breastfeeding is

related products; appropriate regulation of the for infants from 0
SECTION 4(e). Section 5(ff). “Young marketing and distribution of to six (6) months.
the said substitutes, b. There is no
“Infant” means a Child” means a person

person falling within from the age of more than supplements and related substitute or
the age bracket of 0-12 twelve (12) months up to products; replacement for
months. the age of three (3) years breastmilk.
(36 months).
3. The Milk Code only regulates and does not
2. The Milk Code recognizes that infant impose unreasonable requirements for
formula may be a proper and possible advertising and promotion; RIRR imposes
substitute for breastmilk in certain an absolute ban on such activities for
instances; but the RIRR provides “exclusive breastmilk substitutes intended for infants
breast- from 0-24 months old or beyond, and
forbids the use of health and nutritional
303 claims. Section 13 of the RIRR, which
provides for a “total effect” in the

promotion of products within the scope of materials and activities for

the Code, is vague: breastmilk substitutes
intended for infants and
MILK CODE RIRR young
children up to twenty- four
SECTION 6. The General Section 4.
(24) months, shall be allowed,
Public and Mothers.—(a) Declaration of
because they tend to convey
No advertising, promotion or Principles.—The
or give subliminal messages
other marketing materials, following are the
or impressions that
whether written, audio or underlying
undermine breastmilk and
visual, for products within principles from
breast-
the scope of this Code shall which the revised
feeding or otherwise
be printed, published, distrib rules and
exaggerate breastmilk
regulations are
substitutes
premised upon: x x
and/or replacements, as well
xx
as related products covered
within the scope of this Code.
304
Section 13. “Total
Effect.”—Promotion of
304 SUPREME COURT REPORTS products
ANNOTATED within the
scope of this Code
Pharmaceutical and Health Care Association of must be objective and should
not equate or make the

product appear to be as good
or
uted, exhibited and f. Advertising, promotions, or
to breastmilk or
equal
broadcast unless sponsor-ships breastfeeding in the
such materials are
of infant formula, breastmilk advertising

duly authorized substitutes and
concept. It must not in any

and approved by
other related products are case undermine breastmilk

an inter-agency prohibited. or breast-feeding. The “total
committee created effect” should not directly or

herein pursuant to indirectly suggest that buying
the applicable their product would produce
standards provided better individuals, or
for in this Code. resulting in greater love,
Section 11. Prohibition.— intelligence, ability, harmony
No advertising, promotions, or in any manner bring better
sponsorships, or marketing
health to the baby or other

such exaggerated and a. Texts,

unsubstantiated claim. pictures,
illustrations or
305 information
which
discourage or
VOL. 535, OCTOBER 9, 2007 305 tend to
Pharmaceutical and Health Care Association of undermine the
the Philippines vs. Duque III benefits or
superiority of
breastfeeding
Section 15.
or which
Content of idealize the use
Materials.— of breastmilk
The following substitutes and
shall not be milk
included in supplements.
advertising, In this
promotional connection, no
and marketing pictures of
materials: babies and
children
together with
their mothers,
fathers,
siblings,
grandparents,
other relatives
or caregivers
(or yayas) shall
be used in any
advertisements
for infant
formula and
breastmilk
supplements;

b. The term Section 16.

“humanized,” All health and
“maternalized,” nutrition
“close to claims for
mother’s milk” products
or similar within the
words in scope of the
describing Code are
breastmilk absolutely
substitutes or prohibited. For
milk this purpose,
supplements; any phrase or
words that
c. Pictures or
connotes to
texts that
increase
idealize the use
emotional,
of infant and
intellectual
milk formula.
abilities of the
infant and
young child
and other like
phrases shall
not be allowed.
306

ANNOTATED
4. The RIRR imposes additional labeling

requirements not found in the Milk Code:
MILK CODE RIRR

SECTION 10. Section 26. Content.
Containers/ Label.— —Each container/label
(a) Containers and/or
shall contain such
MILK CODE RIRR MILK CODE RIRR

labels shall be designed message, in both pathogenic
to provide the necessary Filipino and English microorganisms and
information about the languages, and which must be prepared and
appropriate use of the message cannot be used appropriately.
products, and in such a readily separated
way as not to discourage therefrom, relative the 307
breastfeeding. following points:
(b) Each container shall (a) The words or phrase
have a clear, conspicuous “Im-portant Notice” or VOL. 535, OCTOBER 9, 2007 307
and easily readable and “Government Warning” Pharmaceutical and Health Care Association of
understandable message or their equivalent; the Philippines vs. Duque III
in Pilipino or English (b) A statement of the
printed on it, or on a superiority of
label, which message can breastfeeding; 5. The Milk Code allows dissemination of
not readily become (c) A statement that information on infant formula to health
separated from it, and there is no substitute for professionals; the RIRR totally prohibits
which shall include the breastmilk; such activity:
follow-ing points: (d) A statement that
(i) the words “Important the product shall be MILK CODE RIRR
Notice” or their used only on the advice SECTION 7. Health Section 22. No
equivalent; of a health worker as to Care System.— manufacturer, distributor,
(ii) a statement of the the need for its use and
(b) No facility of the or representatives of

superiority of the proper methods of health care system products covered by the
breastfeeding; use; shall be used for the Code shall be allowed to
(iii) a statement that the (e) Instructions for purpose of promoting conduct or be involved in
product shall be used appropria te infant formula or any activity on
only onthe advice of a preparation, and a other products breastfeeding promotion,
health worker as to the warning against the within the scope of education and production of
need for its use and the health hazards of this Code. This Code Information, Education and
proper methods of use; inappropriate does not, however, Communication (IEC)
and preparation; and preclude the materials on breastfeeding,
(iv) instructions for (f) The health hazards dissemination of holding of or participating
appropriate preparation, of unnecessary or information to health as speakers in classes or
and a warning against improper use of infant professionals as seminars for women and
the health hazards of formula and other provided in Section children activities and to
inappropriate related products 8(b). avoid the use of these
preparation. including information
SECTION 8. Health venues to market their

that powdered infant
Workers.— brands or company names.
formula may contain



(b) Information SECTION 16. All health Health Principles.—
provided by and nutrition claims for Workers.— The following are the
manufacturers and products within the scope of (e) underlying principles from
distributors to health the Code are absolutely Manufacturers which the revised rules and
professionals prohibited. For this and distributors regulations are prem-ised upon:
regarding products purpose, any phrase or of products i. Milk companies, and their
within the scope of words that connotes to within the scope representatives, should not form
this Code shall be increase emotional, of this Code may part of any policymaking body
restricted to scientific intellectual abilities of the assist in the or entity in relation to the
and factual matters infant and young child and research, advancement of breasfeeding.
and such information other like phrases shall not scholarships and SECTION 22. No manufact
shall not imply or be allowed. continuing urer, distributor, or
create a belief that education, of representatives of products
bottle-feeding is health covered by the Code shall be
equivalent or professionals, in allowed to conduct or be
superior to accordance with involved in any activity on
breastfeeding. It the rules and breastfeeding promotion,
shall also include the regulations education and production of
information specified promulgated by Information, Education and
in Section 5(b). the Ministry of Communication (IEC) materials
Health. on breast-feeding, holding of or
6. The Milk Code permits milk manufacturers participating as speakers in
and distributors to extend assistance in classes or seminars for women
research and continuing education of and children activities and to
health professionals; RIRR absolutely avoid the use of these venues to
forbids the same. market their brands or company
names.
308
SECTION 32. Primary
Responsibility of Health
Work-ers.—It is the primary
308 SUPREME COURT REPORTS responsibility of the health
ANNOTATED workers to promote, protect and
Pharmaceutical and Health Care Association of support breastfeeding and
the Philippines vs. Duque III appropriate infant and young
child feeding. Part of this
responsibility is to continuously
MILK CODE RIRR update their knowledge and
SECTION 8. Section 4. Declaration of skills on breastfeeding. No


assistance, support, logistics or SECTION 6. The Section 51. Donations
training from milk companies General Public Within the Scope
and Mothers.—
of This Code.—Donations
309 (f) Nothing herein
of products, materials,
contained shall
defined and covered under

prevent donations the Milk Code and these
VOL. 535, OCTOBER 9, 2007 309 from manufacturers implementing rules and
Pharmaceutical and Health Care Association of and distributors of regulations, shall be strictly
the Philippines vs. Duque III products within the prohibited.
scope of this Code
Section 52. Other

upon request by or Donations By Milk
shall be permitted.
with the approval of Companies
the Ministry of Not Covered
by this
7. The Milk Code regulates the giving of Health. Code.—Donations of
donations; RIRR absolutely prohibits it. products,
equipments, and the like,
MILK CODE RIRR not otherw ise falling within
the scope of this Code or
these Rules, given by milk
companies and their agents,
representatives, whether in
kind or in cash, may only be
coursed through the Inter
Agency Committee (IAC),
which shall determine
whether such donation be
accepted or otherwise.
8. The RIRR provides for administrative

sanctions not imposed by the Milk Code.
MILK CODE RIRR

MILK CODE RIRR Pesos,

depending on
Section 46.
the gravity and
Administrative
extent of the
Sanctions.—
violation,
The following
including the
administrative
recall of the
sanctions shall
offending
be imposed upon
product;
any person,
c) 3rd violation
juridical or
—Adminis-
natural, found to
trative Fine of
have violated
a minimum of
the
Sixty
Thousand
310 (P60,000.00) to
One Hundred
Fifty Thousand
(P150,000.00)
ANNOTATED
Pesos,
Pharmaceutical and Health Care Association of depending on
the Philippines vs. Duque III the gravity and
extent of the
provisions of violation, and
the Code and in addition
its thereto, the
implementing recall of the
Rules and offending
Regulations: product, and

a) 1st violation suspension of

—Warning; the Certificate
b) 2nd
of Product
violation— Registration
Adminis- (CPR);
trative fine of a d) 4th violation
minimum of —Admin-
Ten Thousand istrative Fine
(P10,000.00) to of a minimum
Fifty Thousand of Two
(P50,000.00) Hundred

Thousand cancellation

(P200,000.00) of the CPR,
to Five revocation of
Hundred the License
(P500,000.00) to Operate
Thousand (LTO) of the
Pesos, company
depending on concerned,
the gravity and including the
extent of the black-listing
violation; and of the
in addition company to
thereto, the be furnished
recall of the the
product, Department
revocation of of Budget
the CPR, and
suspension of Management
the License to (DBM) and
Operate (LTO) the
for one year; Department
e) 5th and of Trade and
succeeding Industry
repeated (DTI);
violations— f) An
Adminis- additional
trative Fine of penalty of
One Million Two
(P1,000,000.00) Thousand
Pesos, the Five
recall of the Hundred
offending (P2,500.00)
product, Pesos per
day shall be
311 made for
every day
the violation
VOL. 535, OCTOBER 9, 2007 311 continues
Pharmaceutical and Health Care Association of after having
the Philippines vs. Duque III received the

order from The RIRR provides for repeal of existing

the IAC or
9.
laws to the contrary.
other such
appropriate The Court shall resolve the merits of the
body, allegations of petitioner seriatim.
notifying 1. Petitioner is mistaken in its claim that the
and Milk Code’s coverage is limited only to children 0-
penalizing 12 months old. Section 3 of the Milk Code states:
the company
for the 312
infraction.
For purposes
of 312 SUPREME COURT REPORTS
determining ANNOTATED
whether or Pharmaceutical and Health Care Association of
not there is the Philippines vs. Duque III
“re-peated”
violation,
“SECTION 3. Scope of the Code.—The Code applies to
each product
the marketing, and practices related thereto, of the
violation
following products: breastmilk substitutes, including
belonging or
owned by a infant formula; other milk products, foods and
company, beverages, including bottle-fed complementary foods,
including when marketed or otherwise represented to be suitable,
those of their with or without modification, for use as a partial or total
subsidiaries, replacement of breastmilk; feeding bottles and teats. It
are deemed also applies to their quality and availability, and to
to be information concerning their use.”
violations of
the Clearly, the coverage of the Milk Code is not
concerned dependent on the age of the child but on the kind
milk of product being marketed to the public. The law
company and treats infant formula, bottle-fed complementary
shall not be food, and breastmilk substitute as separate and
based on the distinct product categories.
specific Section 4(h) of the Milk Code defines infant
violating formula as “a breastmilk substitute x x x to satisfy
product the normal nutritional requirements of infants up
alone. to between four to six months of age, and
adapted to their physiological characteristics”;
42
while under Section 4(b), bottle-fed complementary therefore,
43
nothing objectionable with Sections 2
food refers to “any food, whether manufactured or and 5(ff) of the RIRR.
locally prepared, suitable as a complement to 2. It is also incorrect for petitioner to say that
breastmilk or infant formula, when either becomes the RIRR, unlike the Milk Code, does not recognize
insufficient to satisfy the nutritional requirements that breastmilk substitutes may be a proper and
of the infant.” An infant under Section 4(e) is a possible substitute for breastmilk.
person falling within the age bracket 0-12 months. The entirety of the RIRR, not merely truncated
It is the nourishment of this group of infants or portions thereof, must be considered and construed
44
children aged 0-12 months that is sought to be together. As held in De Luna v. Pascual, “[t]he
promoted and protected by the Milk Code. particular words, clauses and phrases in the Rule
But there is another target group. Breastmilk should not be studied as detached and isolated
substitute is defined under Section 4(a) as “any expressions, but the whole and every part thereof
food being marketed or otherwise presented as a must be considered in fixing the meaning of any of
partial or total replacement for breastmilk, its parts and in order to produce a harmonious
whether or not suitable for that purpose.” This whole.”
section conspicuously lacks reference to any Section 7 of the RIRR provides that “when
particular age-group of children. Hence, the medically indicated and only when necessary, the
provision of the Milk Code cannot be use of breastmilk substitutes is proper if
considered exclusive for children aged 0-12 based on complete and updated infor-mation.”
months. In other words, breastmilk substitutes Section 8 of the RIRR also states that information
may also be intended for young children more than
12 months of age. Therefore, by regulating _______________
breastmilk substitutes, the Milk
42 Section 2. Purpose.—These Revised Rules and Regulations
313 are hereby promulgated to ensure the provision of safe and
adequate nutrition for infants and young children by the
VOL. 535, OCTOBER 9, 2007 313 promotion, protection and support of breastfeeding and by
ensuring the proper use of breastmilk substitutes, breastmilk
supplements and related products when these are medically
indicated and only when necessary, on the basis of adequate
information and through appropriate marketing and
Code also intends to protect and promote the distribution. (Italics supplied)
nourishment of children more than 12 months old. 43 Section 5(ff). “Young Child” means a person from the age
Evidently, as long as what is being marketed of more than twelve (12) months up to the age of three (3) years
falls within the scope of the Milk Code as provided (36 months). (Italics supplied)
in Section 3, then it can be subject to regulation 44 G.R. No. 144218, July 14, 2006, 495 SCRA 42, 55.
pursuant to said law, even if the product is to be
used by children aged over 12 months. There is, 314
42
314 SUPREME COURT REPORTS 48 Jacobson v. Massachusetts, 197 US 11 (1905); Beltran v.

ANNOTATED Secretary of Health, G.R. No. 133640, November 25, 2005, 476
Pharmaceutical and Health Care Association of SCRA 168, 196; St. Lukes’s Medical Center Employees
the Philippines vs. Duque III Association-AFW v. National Labor Relations Commission, G.R.
No. 162053, March 7, 2007, 517 SCRA 677; Tablarin v.
and educational materials should include Gutierrez, G.R. No. L-78164, July 31, 1987, 152 SCRA 730, 741;
information on the proper use of infant formula Pollution Adjudication Board v. Court of Appeals, G.R. No.
when the use thereof is needed. 93891, March 11, 1991, 195 SCRA 112, 123-124; Rivera v.
Hence, the RIRR, just like the Milk Code, Campbell, 34 Phil. 348, 353-354 (1916); Lorenzo v. Director of
also recognizes that in certain cases, the use Health, 50 Phil. 595, 597 (1927).
of breastmilk substitutes may be proper. 49 As early as People v. Pomar, 46 Phil. 440, 445 (1924), we
3. The Court
45
shall 46 ascertain the merits of already noted that “advancing civilization is bringing
allegations 3 and 4 together as they are within the
interlinked with each other.
315
To resolve the question of whether the labeling
requirements and advertising regulations under
the RIRR are valid, it is important to deal first VOL. 535, OCTOBER 9, 2007 315
with the nature, purpose, and depth of the
regulatory powers of the DOH, as defined in
47 the Philippines vs. Duque III
general under the 1987 Administrative Code, and
as delegated in particular under the Milk Code.
Health is a legitimate subject matter for As early as the 1917 Revised
50
Administrative Code
regulation by the DOH (and certain other of the Philippine Islands, health information was
administrative agencies) in exercise of police already within the ambit of 51the regulatory powers
powers delegated to it. The sheer span of of the predecessor of DOH. Section 938 thereof
jurisprudence on that matter precludes the need to charged it with the duty to protect the health of
48
further discuss it. However, health information, the people, and vested it with such powers as “(g)
particularly advertising materials on apparently the dissemination of hygienic information among
non-toxic products like breastmilk substitutes and the people and especially the inculcation of
supplements, is a relatively new area for knowledge as to the proper care of infants and
regulation by the DOH.
49
the methods of preventing and combating
dangerous communicable diseases.”
Seventy years later, the 1987 Administrative
_______________
Code tasked respondent DOH to carry out the
45 See pp. 19-21. state policy pronounced under Section 15, Article
46 See p. 21. II of the 1987 Constitution, which is “to protect
47 Executive Order No. 292, made effective on November 23, and promote the right to health of the people52and
1989 by Proclamation No. 495. instill health consciousness among them.” To
that end, it was granted under Section 3 of the power to control such information. These are
Administrative Code the power to “(6) propagate expressly provided for in Sections 12 and 5(a), to
health information and educate the population wit:
on important health, medical and environmental
matters which have health implications.”
53
SECTION 12. Implementation and Monitoring—
When it comes to information regarding xxxx
nutrition of infants and young children, however, (b) The Ministry of Health shall be principally
the Milk Code specifically delegated to the responsible for the implementation and enforcement of
Ministry of Health (hereinafter referred to as the provisions of this Code. For this purpose, the
DOH) the power to ensure that there is adequate, Ministry of Health shall have the following powers and
consistent and objective information on functions:
breastfeeding and use of breast-milk substitutes, (1) To promulgate such rules and regulations as are necessary
supplements and related products; and the or proper for the implementation of this Code and the
accomplishment of its purposes and objectives.
_______________ xxxx
(4) To exercise such other powers and functions as may be
scope of police power of the state today things which
necessary for or incidental to the attainment of the purposes
were not thought of as being with in such power
and objectives of this Code.
yesterday. The development of civilization, the rapidly
increasing population, the growth of public opinion, with [an SECTION 5. Information and Education—
increasing] desire on the part of the masses and of the (a) The government shall ensure that objective and
government to look after and care for the interests of the consistent information is provided on infant feeding, for
individuals of the state, have brought within the police power of use by families and those involved in the field of infant
the state many questions for regulation which formerly were nutrition. This responsibility shall cover the planning,
not so considered.” provision, design and dissemination of information, and
50 Act No. 2711, approved on March 10, 1917. the control thereof, on infant nutrition. (Emphasis
51 Known then as Public Health Service. supplied)
52 Section 1, Chapter I, Title IX, Executive Order No. 292.
53 Id., at Section 3. Further, DOH is authorized by the Milk Code to
control the content of any information on
316 breastmilk vis-à-vis breastmilk substitutes,
supplement and related products, in the following
manner:
ANNOTATED “SECTION 5. x x x
Pharmaceutical and Health Care Association of (b) Informational and educational materials, whether
the Philippines vs. Duque III written, audio, or visual, dealing with the feeding of
infants and intended to reach pregnant women and
mothers of infants, shall include clear information on all
the following points: (1) the benefits and superiority of use of the products, and in such a way as not to
breastfeeding; (2) maternal nutrition, and the discourage breastfeeding.
preparation for and maintenance of breastfeeding; (3) xxxx
the negative effect on breast-feeding of introducing (d) The term “humanized,” “maternalized” or similar
partial bottlefeeding; (4) the difficulty of reversing the terms shall not be used. (Emphasis supplied)
decision not to breastfeed; and (5) where needed, the
proper use of infant formula, whether manufactured The DOH is also authorized to control the purpose
industrially or of the information and to whom such information
may be disseminated
54
under Sections 6 through 9 of
317 the Milk Code to ensure
VOL. 535, OCTOBER 9, 2007 317 _______________
Pharmaceutical and Health Care Association of 54 SECTION 6. The General Public and Mothers.—
(a) No advertising, promotion or other marketing materials,
whether written, audio or visual, for products within the
home-prepared. When such materials contain
scope of this Code shall be printed, published,
information about the use of infant formula, they
distributed, exhibited and broadcast unless such
shall include the social and financial implications
materials are duly authorized and approved by an inter-
of its use; the health hazards of inappropriate
agency committee created herein pursuant to the
foods or feeding methods; and, in particular, the
applicable standards provided for in this Code.
health hazards of unnecessary or improper use of
infant formula and other breastmilk substitutes. (b) Manufacturers and distributors shall not be permitted
Such materials shall not use any picture or text to give, directly or indirectly, samples and supplies of
which may idealize the use of breastmilk products within the scope of this Code or gifts of any
substitutes. sort to
SECTION 8. Health Workers.—
318
xxxx
(b) Information provided by manufacturers and
distributors to health professionals regarding products 318 SUPREME COURT REPORTS
within the scope of this Code shall be restricted to ANNOTATED
scientific and factual matters, and such
information shall not imply or create a belief that the Philippines vs. Duque III
bot-tlefeeding is equivalent or superior to
breastfeeding. It shall also include the
information specified in Section 5(b).
that the information that would reach pregnant
SECTION 10. Containers/Label.—
women, mothers of infants, and health
(a) Containers and/or labels shall be designed to
professionals and workers in
provide the necessary information about the appropriate
_______________ No facility of the health care system shall be used for

(b) the purpose of promoting infant formula or other
any member of the general public, including members of
products within the scope of this Code. This Code does
their families, to hospitals and other health institutions,
not, however,
as well as to personnel within the health care system,
save as otherwise provided in this Code. 319
(c) There shall be no point-of-sale advertising, giving of
samples or any other promotion devices to induce sales
VOL. 535, OCTOBER 9, 2007 319
directly to the consumers at the retail level, such as
special displays, discount coupons, premiums, special Pharmaceutical and Health Care Association of
sales, bonus and tie-in sales for the products within the the Philippines vs. Duque III
scope of this Code. This provision shall not restrict the
establishment of pricing policies and practices intended the health care system is restricted to scientific
to provide products at lower prices on a long-term basis. and factual matters and shall not imply or create
(d) Manufactures and distributors shall not distribute to a belief that bottlefeed-ing is equivalent or
pregnant women or mothers of infants any gifts or superior to breastfeeding.
articles or utensils which may promote the use of
breastmilk substitutes or bottlefeeding, nor shall any _______________
other groups, institutions or individuals distribute such
gifts, utensils or products to the general public and preclude the dissemination of information to health
mothers. professionals as provided in Section 8(b).
(e) Marketing personnel shall be prohibited from (c) Facilities of the health care system shall not be used for
advertising or promoting in any other manner the the display of products within the scope of this Code, or
products covered by this Code, either directly or for placards or posters concerning such products.
indirectly, to pregnant women or with mother of infants, (d) The use by the health care system of “professional
except as otherwise provided by this Code. service” representatives, “mothercraft nurses” or similar
(f) Nothing herein contained shall prevent donations from personnel, provided or paid for by manufacturers or
manufacturers and distributors or products within the distributors, shall not be permitted.
scope of this Code upon request by or with the approval (e) In health education classes for mothers and the general
of the Ministry of Health. public, health workers and community workers shall
emphasize the hazards and risks of the improper use of
SECTION 7. Health Care System.— breast-milk substitutes particularly infant formula.
Feeding with infant formula shall be demonstrated only
(a) The Ministry of Health shall take appropriate measures
to mothers who may not be able to breastfeed for
to encourage and promote breastfeeding. It shall provide
medical or other legitimate reasons.
objective and consistent information, training and
advice to health workers on infant nutrition, and on SECTION 8. Health Workers.—
their obligations under this Code.

(a) Health workers shall encourage and promote breast- over information given to the DOH is not absolute
feeding and shall make themselves familiar with and that absolute prohibition is not contemplated
objectives and consistent information on maternal and by the Code:
infant nutrition, and with their responsibilities under a) Section 2 which requires adequate
this Code. information and appropriate marketing and
(b) Information provided by manufacturers and distributors distribution of breastmilk substitutes, to wit:
to health professionals regarding products within the
“SECTION 2. Aim of the Code.—The aim of the Code is
scope of this Code shall be restricted to scientific and
to contribute to the provision of safe and adequate
factual matters and such information shall not imply or
nutrition for infants by the protection and promotion of
create a belief that bottlefeeding is equivalent or
breastfeeding and by ensuring the proper use of
superior to breastfeeding. It shall also include the
breastmilk substitutes and breastmilk supplements
information specified in Section 5(b).
when these are necessary, on the basis of adequate
(c) No financial or material inducements to promote
information and through appropriate marketing and
products within the scope of this Code shall be offered
distribution.”
by manufacturers or distributors to health workers or
members of their families, nor shall these be accepted
by the health workers or members of their families, _______________
except as otherwise provided in Section 8(e).

preparation or use, shall not be provided to health
(d) Samples of infant formula or other products within the workers except when necessary for the purpose of
scope of this Code, or of equipment or utensils for their professional evaluation or research in accordance with
the rules and regulations promulgated by the Ministry
320
of Health. No health workers shall give samples of
infant formula to pregnant women and mothers of
320 SUPREME COURT REPORTS infants or members of their families.
ANNOTATED (e) Manufacturers and distributors of products within the
Pharmaceutical and Health Care Association of scope of this Code may assist in the research,
the Philippines vs. Duque III scholarships and continuing education, of health
professionals, in accordance with the rules and
regulations promulgated by the Ministry of Health.
It bears emphasis, however, that the DOH’s power
under the Milk Code to control information SECTION 9. Persons employed by Manufacturers and
regarding breastmilk vis-à-vis breastmilk Distributors.—Personnel employed in marketing products
substitutes is not absolute as the power to control
within the scope of this Code shall not, as part of their job
does not encompass the power to absolutely
responsibilities, perform educational functions in relation to
prohibit the advertising, marketing, and promotion
pregnant women or mothers of infants.
of breastmilk substitutes.
The following are the provisions of the Milk 321
Code that unequivocally indicate that the control
VOL. 535, OCTOBER 9, 2007 321 It is in this context that the Court now examines
Pharmaceutical and Health Care Association of the assailed provisions of the RIRR regarding
the Philippines vs. Duque III labeling and advertising.
55 56
Sections 13 on “total effect” and 26 of Rule
VII of the RIRR contain some labeling
b) Section 3 which specifically states that the
requirements, specifically: a) that there be a
Code applies to the marketing of and
statement that there is no substitute to
practices related to breastmilk substitutes,
breastmilk; and b) that there be a statement that
including infant formula, and to
powdered infant formula may contain pathogenic
information concerning their use;
microorganisms and must be
c) Section 5(a) which provides that the
government shall ensure that objective and
_______________
consistent information is provided on
infant feeding; 55 See p. 20.
d) Section 5(b) which provides that written, 56 See p. 21.
audio or visual informational and
322
educational materials shall not use any
picture or text which may idealize the use
of breastmilk substitutes and should 322 SUPREME COURT REPORTS
include information on the health hazards ANNOTATED
of unnecessary or improper use of said
product; the Philippines vs. Duque III
e) Section 6(a) in relation to Section 12(a)
which creates and empowers the IAC to 57
prepared and used appropriately. Section 16 of
review and examine advertising,
the RIRR prohibits all health and nutrition claims
promotion, and other marketing materials;
for products within the scope of the Milk Code,
f) Section 8(b) which states that milk such as claims of increased emotional and
companies may provide information to intellectual abilities of the infant and young child.
health professionals but such information These requirements and limitations are
should be restricted to factual and scientific consistent with the provisions of Section 8 of the
matters and shall not imply or create a Milk Code, to wit:
belief that bottlefeeding is equivalent or
superior to breastfeeding; and “SECTION 8. Health workers—
g) Section 10 which provides that containers xxxx
or labels should not contain information (b) Information provided by manufacturers and
that would discourage breast-feeding and distributors to health professionals regarding products
idealize the use of infant formula. within the scope of this Code shall be restricted to
scientific and factual matters, and such information

shall not imply or create a belief that bottlefeed-ing is milk substitutes, not to containers and labels
equivalent or superior to breastfeeding. It shall also 58
thereof. However, such restrictive application of
include the information specified in Section 5.” Section 8(b) will result in the absurd situation in
(Emphasis supplied) which milk companies and distributors are
59 forbidden to claim to health workers that their
and Section 10(d) which bars the use on products are substitutes or equivalents of
containers and labels of the terms “humanized,” breastmilk, and yet be allowed to display on the
“maternalized,” or similar terms. containers and labels of their products the exact
These provisions of the Milk Code expressly opposite message. That askewed interpretation of
forbid information that would imply or create a the Milk Code is precisely what Section 5(a)
belief that there is any milk product equivalent to thereof seeks to avoid by mandating that all
breastmilk or which is humanized or maternalized, information regarding breast-milk vis-à-vis
as such information would be inconsistent with the breastmilk substitutes be consistent, at the same
superiority of breastfeeding. time giving the government control over planning,
It may be argued that Section 8 of the Milk provision, design, and dissemination of information
Code refers only to information given to health on infant feeding.
workers regarding breast- Thus, Section 26(c) of the RIRR which requires
containers and labels to state that the product
_______________ offered is not a substitute for breastmilk, is a
reasonable means of enforcing Section 8(b) of the
57 SECTION 16. All health and nutrition claims for products
Milk Code and deterring circumvention of the
within the scope of the Code are absolutely prohibited. For this
protection and promotion
60
of breastfeeding as
purpose, any phrase or words that connotes to increase
embodied in Section
61
2 of the Milk Code.
emotional, intellectual abilities of the infant and young child
Section 26(f) of the RIRR is an equally
and other like phrases shall not be allowed.
reasonable labeling requirement. It implements
58 See p. 30.
Section 5(b) of the Milk Code which reads:
59 SECTION 10. Containers/Label.—
xxxx _______________
(d) The term “humanized,” “maternalized” or similar terms shall not
60 SECTION 2. Aim of the Code.—The aim of the Code is to
be used.
contribute to the provision of safe and adequate nutrition for
323 infants by the protection and promotion of breastfeeding and by
ensuring the proper use of breastmilk substitutes and
breastmilk supplements when these are necessary, on the basis
VOL. 535, OCTOBER 9, 2007 323
of adequate information and through appropriate marketing
Pharmaceutical and Health Care Association of and distribution.
the Philippines vs. Duque III 61 SECTION 26. Content.—Each container/label shall contain
such message, in both Filipino and English languages, and

which message cannot be readily separated therefrom, relative microorganisms being present in infant formula
the follow-ing points: and other related products when these are
xxxx prepared and used inappropriately.
(f) The health hazards of unnecessary or improper use of Petitioner’s counsel has admitted during the
infant formula and other related products including information hearing on June 19, 2007 that formula milk is
that prone to contaminations and there is as yet no
technology that allows production of powdered
324
infant formula62 that eliminates all forms of
contamination.
324 SUPREME COURT REPORTS Ineluctably, the requirement under Section 26(f)
ANNOTATED of the RIRR for the label to contain the message
regarding health hazards including the possibility
of contamination with pathogenic microorganisms
is in accordance with Section 5(b) of the Milk Code.
“SECTION 5. x x x
_______________
xxxx
(b) Informational and educational materials, whether powdered infant formula may contain pathogenic
written, audio, or visual, dealing with the feeding of microorganisms and must be prepared and used appropriately.
infants and intended to reach pregnant women and 62 TSN of the hearing of June 19, 2007, pp. 114-120.
mothers of infants, shall include clear information on all
the following points: x x x (5) where needed, the proper 325
use of infant formula, whether manufactured
industrially or home-prepared. When such materials
VOL. 535, OCTOBER 9, 2007 325
contain information about the use of infant formula,
they shall include the social and financial implications of Pharmaceutical and Health Care Association of
its use; the health hazards of inappropriate foods the Philippines vs. Duque III
or feeding methods; and, in particular, the health
hazards of unnecessary or improper use of infant The authority of DOH to control information
formula and other breastmilk substitutes. Such regarding breastmilk vis-à-vis breastmilk
materials shall not use any picture or text which may substitutes and supplements and related products
idealize the use of breastmilk substitutes. (Emphasis cannot be questioned. It is its intervention into the
supplied) area of advertising, promotion, and marketing that
is being assailed by petitioner.
The label of a product contains information about In furtherance of Section 6(a) of the Milk Code,
said product intended for the buyers thereof. The to wit:
buyers of breast-milk substitutes are mothers of
infants, and Section 26 of the RIRR merely adds a SECTION 6. The General Public and Mothers.—
fair warning about the likelihood of pathogenic
(a) No advertising, promotion or other marketing marketing materials, whether written, audio or
materials, whether written, audio or visual, for products visual, on products within the scope of this Code;
within the scope of this Code shall be printed, published,
distributed, exhibited and broadcast unless such 326
materials are duly authorized and approved by an inter-
agency committee created herein pursuant to the
applicable standards provided for in this Code.
ANNOTATED
the Milk Code invested regulatory authority over Pharmaceutical and Health Care Association of
advertising, promotional and marketing materials the Philippines vs. Duque III
to an IAC, thus:
(3) To prescribe the internal and operational
SECTION 12. Implementation and Monitoring.—
procedure for the exercise of its powers and
(a) For purposes of Section 6(a) of this Code, an inter-
functions as well as the performance of its duties
agency committee composed of the following members is
and responsibilities; and
hereby created:
(4) To promulgate such rules and regulations
Minister of Health Chairman as are necessary or proper for the
.......................................................... implementation of Section 6(a) of this Code.
Minister of Trade and Industry Member x x x (Emphasis supplied)
.......................................
Minister of Justice Member However, Section 11 of the RIRR, to wit:
..........................................................
“SECTION 11. Prohibition.—No advertising,
Minister of Social Services and Development Member
promotions, sponsorships, or marketing materials and
..................
activities for breastmilk substitutes intended for infants
and young children up to twenty-four (24) months, shall
The members may designate their duly authorized
be allowed, because they tend to convey or give
representative to every meeting of the Committee.
subliminal messages or impressions that undermine
The Committee shall have the following powers and
breastmilk and breastfeeding or otherwise exaggerate
functions:
breastmilk substitutes and/or replacements, as well as
(1) To review and examine all advertising, related products covered within the scope of this Code.”
promotion or other marketing materials, whether
written, audio or visual, on products within the prohibits advertising, promotions, sponsorships or
scope of this Code; marketing materials and activities for breastmilk
substitutes in line with the RIRR’s declaration of
(2) To approve or disapprove, delete objectionable
principle under Section 4(f), to wit:
portions from and prohibit the printing,
publication, distribution, exhibition and “SECTION 4. Declaration of Principles.—
broadcast of, all advertising promotion or other xxxx

(f) Advertising, promotions, or sponsorships of infant 24 months shall be allowed because this is the standard they
formula, breastmilk substitutes and other related tend to convey or give subliminal messages or impression
products are prohibited.” undermine that breastmilk or breastfeeding x x x.
We have to read Section 11 together with the other Sections
The DOH, through its co-respondents, evidently because the other Section, Section 12, provides for the inter
arrogated to itself not only the regulatory agency committee that is empowered to process and evaluate
authority given to the IAC but also imposed all the advertising and promotion materials.
absolute prohibition on advertising, promotion, xxxx
and marketing. What AO 2006-12, what it does, it does not prohibit the sale
Yet, oddly enough, Section 12 of the RIRR and manufacture, it simply regulates the advertisement and
reiterated the requirement of the Milk Code in the promotions of breastfeeding milk substitutes.
Section 6 thereof for prior approval by IAC of all xxxx
advertising, marketing and promotional materials Now, the prohibition on advertising, Your Honor, must be
prior to dissemination. taken together with the provision on the InterAgency
Even respondents, through the OSG, Committee that processes and evaluates because there may be
acknowledged the authority of IAC, and repeatedly some information dissemination that are straight forward
insisted, during the oral argu- information dissemination. What the AO 2006 is trying to
prevent is any material that will undermine the practice of
327
breastfeeding, Your Honor.
xxxx
VOL. 535, OCTOBER 9, 2007 327
ASSOCIATE JUSTICE SANTIAGO:
the Philippines vs. Duque III Madam Solicitor General, under the Milk Code, which body
has authority or power to promulgate Rules
ments on June 19, 2007, that the prohibition under
Section 11 is not actually operational, viz.: 328
SOLICITOR GENERAL DEVANADERA:

xxxx ANNOTATED
x x x Now, the crux of the matter that is being questioned by Pharmaceutical and Health Care Association of
Petitioner is whether or not there is an absolute prohibition on the Philippines vs. Duque III
advertising making AO 2006-12 unconstitutional. We
maintained that what AO 2006-12 provides is not an absolute and Regulations regarding the Advertising, Promotion and
prohibition because Section 11 while it states and it is entitled Marketing of Breastmilk Substitutes?
prohibition it states that no advertising, promotion,
sponsorship or marketing materials and activities for breast SOLICITOR GENERAL DEVANADERA:
milk substitutes intended for infants and young children up to

Your Honor, please, it is provided that the InterAgency xxxx

Committee, Your Honor.
xxxx 329
ASSOCIATE JUSTICE SANTIAGO:

VOL. 535, OCTOBER 9, 2007 329
x x x Don’t you think that the Department of Health Pharmaceutical and Health Care Association of
overstepped its rule making authority when it totally banned the Philippines vs. Duque III
advertising and promotion under Section 11 prescribed the
total effect rule as well as the content of materials under x x x Section 11, while it is titled Prohibition, it must be taken
Section 13 and 15 of the rules and regulations? in relation with the other Sections, particularly 12 and 13 and
15, Your Honor, because it is recognized that the Inter-Agency
Committee has that power to evaluate promotional materials,
Your Honor, please, first we would like to stress that there is Your Honor.
no total absolute ban. Second, the InterAgency Committee is
ASSOCIATE JUSTICE NAZARIO:
under the Department of Health, Your Honor.
xxxx So in short, will you please clarify there’s no absolute ban on
advertisement regarding milk substitute regarding infants two
(2) years below?
x x x Did I hear you correctly, Madam Solicitor, that there is no
absolute ban on advertising of breastmilk substitutes in the
Revised Rules?
We can proudly say that the general rule is that there is a
prohibition, however, we take exceptions and standards have
been set. One of which is that, the InterAgency Committee can
Yes, your Honor. allow if the advertising and promotions will not undermine
63
breastmilk and breastfeed-ing, Your Honor.

Sections 11 and 4(f) of the RIRR are clearly
But, would you nevertheless agree that there is an absolute violative of the Milk Code.
ban on advertising of breastmilk substitutes intended for However, although it is the IAC which is
children two (2) years old and younger? authorized to promulgate rules and regulations for
the approval or rejection of advertising,
promotional, or other marketing materials under
It’s not an absolute ban, Your Honor, because we have the Section 12(a) of the Milk Code, said provision must
Inter-Agency Committee that can evaluate some advertising be related to Section 6 thereof which in turn
and promotional materials, subject to the standards that we provides that the rules and regulations must be
have stated earlier, which are—they should not undermine “pursuant to the applicable standards provided for
breastfeeding, Your Honor. in this Code.” Said standards are set forth in
Sections 5(b), 8(b), and 10 of the Code, which, at text which may idealize the use of breastmilk
the risk of being repetitious, and for easy substitutes.
reference, are quoted hereunder: xxxx
SECTION 8. Health Workers.—
SECTION 5. Information and Education.— xxxx
xxxx (b) Information provided by manufacturers and
(b) Informational and educational materials, whether distributors to health professionals regarding products
written, audio, or visual, dealing with the feeding of within the scope of this Code shall be restricted to
infants and intended scientific and factual matters and such information shall
not imply or create a belief that bottle feeding is
_______________ equivalent or superior to breastfeeding. It shall also
include the information specified in Section 5(b).
63 TSN of June 19, 2007 hearing, pp. 193-194, 198, 231, 237-
xxxx
240, 295-300.
SECTION 10. Containers/Label.—
330 (a) Containers and/or labels shall be designed to
provide the necessary information about the appropriate
use of the products, and in such a way as not to
330 SUPREME COURT REPORTS discourage breastfeeding.
ANNOTATED (b) Each container shall have a clear, conspicuous and
Pharmaceutical and Health Care Association of easily readable and understandable message in Pilipino
the Philippines vs. Duque III or English printed on it, or on a label, which message
can not readily become separated from it, and which
to reach pregnant women and mothers of infants, shall shall include the following points:
include clear information on all the following points: (1)
(i ) the words “Important Notice” or their
the benefits and superiority of breastfeeding; (2)
equivalent;
maternal nutrition, and the preparation for and
maintenance of breastfeeding; (3) the negative effect on (ii) a statement of the superiority of breastfeeding;
breast-feeding of introducing partial bottlefeeding; (4) (iii) a statement that the product shall be used only
the difficulty of reversing the decision not to breastfeed; on the advice of a health worker as to the need
and (5) where needed, the proper use of infant formula, for its use and the proper methods of use; and
whether manufactured industrially or home-prepared.
When such materials contain information about the use 331
of infant formula, they shall include the social and
financial implications of its use; the health hazards of VOL. 535, OCTOBER 9, 2007 331
inappropriate foods of feeding methods; and, in
particular, the health hazards of unnecessary or
improper use of infant formula and other breastmilk
substitutes. Such materials shall not use any picture or

instructions for appropriate preparation, and a bring better health to the baby or other such
(iv) warning against the health hazards of exaggerated and unsubstantiated claim.”
inappropriate preparation.
Such standards bind the IAC in formulating its
Section 12(b) of the Milk Code designates the DOH rules and regulations on advertising, promotion,
as the principal implementing agency for the and marketing. Through that single provision, the
enforcement of the provisions of the Code. In DOH exercises control over the information
relation to such responsibility of the DOH, Section content of advertising, promotional and marketing
5(a) of the Milk Code states that: materials on breastmilk vis-à-vis breastmilk
substi-
SECTION 5. Information and Education.—
(a) The government shall ensure that objective and 332
consistent information is provided on infant feeding, for
use by families and those involved in the field of infant 332 SUPREME COURT REPORTS
nutrition. This responsibility shall cover the planning, ANNOTATED
provision, design and dissemination of information, and
the control thereof, on infant nutrition. (Emphasis
supplied)
Thus, the DOH has the significant tutes, supplements and other related products. It
responsibility to translate into operational also sets a viable standard against which the IAC
terms the standards set forth in Sections 5, 8, may screen such materials before they are made
and 10 of the Milk Code, by which the IAC public.
shall screen advertising, promotional, or In Equi-Asia64Placement, Inc. vs. Department of
other marketing materials. Foreign Affairs, the Court held:
It is pursuant to such responsibility that the
DOH correctly provided for Section 13 in the RIRR “x x x [T]his Court had, in the past, accepted as
which reads as follows: sufficient standards the following: “public interest,”
“justice and equity,” “public convenience
65
and welfare,”
“SECTION 13. “Total Effect.”—Promotion of products and “simplicity, economy and welfare.”
within the scope of this Code must be objective and
should not equate or make the product appear to be as In this case, correct information as to infant
good or equal to breastmilk or breastfeeding in the feeding and nutrition is infused with public
advertising concept. It must not in any case undermine interest and welfare.
breastmilk or breastfeeding. The “total effect” should not 4. With regard to activities for dissemination of
directly or indirectly suggest that buying their product information to health professionals, the Court also
would produce better individuals, or resulting in greater finds that there is no inconsistency between the
love, intelligence, ability, harmony or in any manner provisions
66
of the Milk Code and the RIRR. Section 67
7(b) of the Milk Code, in relation to Section 8(b)
of the same Code, allows dissemination of
information to health professionals but such Education and Communication (IEC) materials
information is restricted to scientific and regarding breastfeeding that are intended for
factual matters. women and children. Said provision cannot be
Contrary to petitioner’s claim, Section 22 of the construed to encompass even the dissemination
RIRR does not prohibit the giving of of information to health professionals, as
information to health profes- restricted by the Milk Code. 68
5. Next, petitioner alleges that Section 8(e) of
_______________ the Milk Code permits milk manufacturers and
distributors to extend assistance in research and in
64 G.R. No. 152214, September 19, 2006, 502 SCRA 295. the continuing education of health professionals,
65 Id., at p. 314. while Sections 22 and 32 of the RIRR absolutely
66 SECTION 7. Health Care System.— forbid
69
the same. Petitioner also assails Section
xxxx 4(i) of the RIRR prohibiting milk manufacturers’
(b) No facility of the health care system shall be used for the and distributors’ participation in any policymaking
purpose of promoting infant formula or other products within body in relation to the advancement of
the scope of this Code. This Code does not, however, preclude breastfeeding.
the dissemination of information to health professionals as Section 4(i) of the RIRR provides that milk
provided in Section 8(b). companies and their representatives should not
67 SECTION 8. Health Workers.— form part of any policymaking body or entity in
xxxx relation to the advancement of breast-feeding. The
(b) Information provided by manufacturers and distributors Court finds nothing in said provisions which
to health professionals regarding products within the scope of contravenes the Milk Code. Note that under
this Code shall be restricted to scientific and factual matters Section 12(b) of the Milk Code, it is the DOH
and such information shall not imply or create a belief that which shall be principally
bottlefeeding is equivalent or superior to breastfeeding. It shall
also include the information specified in Section 5(b). _______________
333 68 SECTION 8. Health Workers.—

xxxx
(e) Manufacturers and distributors of products within the
VOL. 535, OCTOBER 9, 2007 333
scope of this Code may assist in the research, scholarships and
Pharmaceutical and Health Care Association of continuing education, of health professionals, in accordance
the Philippines vs. Duque III with the rules and regulations promulgated by the Ministry of
Health.
sionals on scientific and factual matters. 69 SECTION 4. Declaration of Principles.—The following are
What it prohibits is the involvement of the the underlying principles from which the revised rules and
manufacturer and distributor of the products regulations are premised upon:
covered by the Code in activities for the promotion, xxxx
education and production of Information,
(i) Milk companies, and their representatives, should not _______________

form part of any policymaking body or entity in relation to the
70 SECTION 22. No manufacturer, distributor, or
advancement of breastfeeding.
representatives of products covered by the Code shall be
334 allowed to conduct or be involved in any activity on
breastfeeding promotion, education and production of
Information, Education and Communication (IEC) materials on
breastfeeding, holding of or participating as speakers in classes
ANNOTATED
or seminars for women and children activities and to avoid the
Pharmaceutical and Health Care Association of use of these venues to market their brands or company names.
the Philippines vs. Duque III 71 SECTION 9. Research, Ethics Committee, Purpose.—The
DOH shall ensure that research conducted for public policy
responsible for the implementation and purposes, relating to infant and young child feeding should, at
enforcement of the provisions of said Code. It is all times, be free form any commercial influence/bias;
entirely up to the DOH to decide which entities to accordingly, the health worker or researcher involved in such
call upon or allow to be part of policymaking bodies must disclose any actual or potential conflict of interest with
on breastfeeding. Therefore, the RIRR’s prohibition the com-pany/person funding the research. In any event, such
on milk companies’ participation in any research and its findings shall be subjected to independent peer
policymaking body in relation to the advancement review. x x x.
of breastfeeding is in accord with the Milk Code. 72 SECTION 10. Public Disclosure.—For transparency
Petitioner is also mistaken in arguing that purposes, a disclosure and/or disclaimer of the sponsoring
Section 22 of the RIRR prohibits milk companies company should be done by the company itself, health worker,
from giving reasearch assistance and continuing 70
researcher involved through verbal declaration during the
education to health professionals. Section 22 of public presentation of the research and in print upon
the RIRR does not pertain to research publication.
assistance to or the continuing education of
health professionals; rather, it deals with 335
breastfeeding promotion and education for

women and children. Nothing in Section 22 of VOL. 535, OCTOBER 9, 2007 335
the RIRR prohibits milk companies from giving
assistance for research or continuing education to
health professionals; hence, petitioner’s argument
against this particular provision must be struck
down. research assistance for health workers and
71 72
It is Sections 9 and 10 of the RIRR which researchers may be allowed upon approval of
govern research assistance. Said sections of the an ethics committee, and with certain
RIRR provide that disclosure requirements imposed on the milk
company and on the recipient of the research
award.
The Milk Code endows the DOH with the power breastfeeding. No assistance, support, logistics or training from
to determine how such research or educational milk companies shall be permitted.
assistance may be given by milk companies or 74 Supra note 68.
under what conditions health workers may accept
336
the assistance. Thus, Sections 9 and 10 of the
RIRR imposing limitations on the kind of research
done or extent of assistance given by milk 336 SUPREME COURT REPORTS
companies are completely in accord with the Milk ANNOTATED
Code. 73 Pharmaceutical and Health Care Association of
Petitioner complains that Section 32 of the
RIRR prohibits milk companies from giving
assistance, support, logistics or training to health 75
workers. This provision is within the74 prerogative its discretion through Section 51 of the RIRR
given to the DOH under Section 8(e) of the Milk which sets forth its policy not to request or approve
Code, which provides that manufacturers and donations from manufacturers and distributors of
distributors of breastmilk substitutes may assist in breastmilk substitutes.
researches, scholarships and the continuing It was within the discretion of the DOH when it
education, of health professionals in accordance provided in Section 52 of the RIRR that any
with the rules and regulations promulgated by the donation from milk companies not covered by the
Ministry of Health, now DOH. Code should be coursed through the IAC which
6. As to the RIRR’s prohibition on donations, shall determine whether such donation should be
said provisions are also consistent with the Milk accepted or refused. As reasoned out by
Code. Section 6(f) of the Milk Code provides that respondents, the DOH is not mandated by the Milk
donations may be made by manufacturers and Code to accept donations. For that matter, no
distributors of breastmilk substitutes upon the person or entity can be forced to accept a donation.
request or with the approval of the DOH. The There is, therefore, no real inconsistency between
law does not proscribe the refusal of donations. the RIRR and the law because the Milk Code does
The Milk Code leaves it purely to the discretion of not prohibit the DOH from refusing donations.
the DOH whether to request or accept such 7. With regard to Section 46 of the RIRR
donations. The DOH then appropriately exercised providing for administrative sanctions that are not
found in the Milk Code, the Court upholds
petitioner’s objection thereto.
_______________
Respondent’s reliance on Civil76 Aeronautics
73 SECTION 32. Primary Responsibility of Health Workers.— Board v. Phil-ippine Air Lines, Inc. is misplaced.
It is the primary responsibility of the health workers to The glaring difference in said case and the present
promote, protect and support breastfeeding and appropriate case before the Court is that, in the Civil
infant and young child feeding. Part of this responsibility is to Aeronautics Board, the Civil Aeronautics
continuously update their knowledge and skills on Administration (CAA) was expressly granted by
the law (R.A. No. 776) the power to impose fines
and civil penalties, while the Civil Aeronautics those fines in the RIRR. In this regard, the DOH
Board (CAB) was granted by the same law the again exceeded its authority by providing for such
power to review on appeal the order or decision of fines or sanctions in Section 46 of the RIRR. Said
the CAA and to determine whether to impose, provision is, therefore, null and void.
remit, mitigate, increase or compromise such fine The DOH is not left without any means to
and civil penalties. Thus, the Court upheld the enforce its rules and regulations. Section 12(b) (3)
CAB’s Resolution imposing administrative fines. of the Milk Code authorizes the DOH to “cause the
In a more recent case, Perez v. LPG
77
Refillers prosecution of the violators of this Code and other
Association of the Philippines, Inc., the Court pertinent laws on products covered by this Code.”
upheld the Department of Section 13 of the Milk Code provides for the
penalties to be imposed on violators of the
_______________ provision of the Milk Code or the rules and
regulations issued pursuant to it, to wit:
75 SECTION 51. Donations Within the Scope of This Code.—
Donations of products, materials, defined and covered under the “SECTION 13. Sanctions.—
Milk Code and these implementing rules and regulations, shall
(a) Any person who violates the provisions of this
be strictly prohibited.
Code or the rules and regulations issued
76 159-A Phil. 142; 63 SCRA 524 (1975).
pursuant to this Code shall, upon conviction,
77 G.R. No. 159149, June 26, 2006, 492 SCRA 638.
be punished by a penalty of two (2) months to
337 one (1) year imprisonment or a fine of not less
than One Thousand Pesos (P1,000.00) nor more
than Thirty Thousand Pesos (P30,000.00) or
VOL. 535, OCTOBER 9, 2007 337 both. Should the offense be committed by a
Pharmaceutical and Health Care Association of juridical person, the chairman of the Board of
the Philippines vs. Duque III Directors, the president, general manager, or the
partners and/or the persons directly responsible
Energy (DOE) Circular No. 2000-06-10 therefor, shall be penalized.
implementing Batas Pambansa (B.P.) Blg. 33. The (b) Any license, permit or authority issued by any
circular provided for fines for the commission of government agency to any health worker,
prohibited acts. The Court found that nothing in distributor, manufacturer, or marketing firm or
the circular contravened the law because the DOE personnel for the practice of their profession or
was expressly authorized by B.P. Blg. 33 and R.A. occupation, or for the pursuit of their business,
No. 7638 to impose fines or penalties. may, upon recommendation of the Ministry of
In the present case, neither the Milk Code nor Health, be suspended or revoked in the event of
the Revised Administrative Code grants the DOH repeated violations of this Code, or of the rules
the authority to fix or impose administrative fines. and regulations issued pursuant to this Code.
Thus, without any express grant of power to fix or (Emphasis supplied)
impose such fines, the DOH cannot provide for
338 are inconsistent therewith are declared repealed or

modified.
In fine, only Sections 4(f), 11 and 46 are ultra
vires, beyond the authority of the DOH to
ANNOTATED
promulgate and in contravention of the Milk Code
Pharmaceutical and Health Care Association of and, therefore, null and void. The rest of the
the Philippines vs. Duque III provisions of the RIRR are in consonance with the
Milk Code.
8. Petitioner’s claim that Section 57 of the RIRR
repeals existing laws that are contrary to the RIRR _______________
is frivolous.
Section 57 reads: 78 Smart Communications, Inc. v. National
Telecommunications Commission, 456 Phil. 145, 155-156; 408
“SECTION 57. Repealing Clause.—All orders, issuances, SCRA 678, 686 (2003).
and rules and regulations or parts thereof inconsistent 79 Yazaki Torres Manufacturing, Inc. v. Court of Appeals,
with these revised rules and implementing regulations G.R. No. 130584, June 27, 2006, 493 SCRA 86, 97.
are hereby repealed or modified accordingly.” 80 Supra note 78, at p. 156; pp. 686-687.
Section 57 of the RIRR does not provide for the 339

repeal of laws but only orders, issuances and rules
and regulations. Thus, said provision is valid as it
is within the DOH’s rule-making power. VOL. 535, OCTOBER 9, 2007 339
An administrative agency like respondent Pharmaceutical and Health Care Association of
possesses quasi-legislative or rule-making power or the Philippines vs. Duque III
the power to make rules and regulations which
results in delegated legislation that is within the Lastly, petitioner makes a “catch-all” allegation
confines of the granting statute and the that:
Constitution, and subject to the doctrine 78of non-
delegability and separability of powers. Such “x x x [T]he questioned RIRR sought to be implemented
express grant of rule-making power necessarily by the Respondents is unnecessary and oppressive,
includes the power79
to amend, revise, alter, or and is offensive to the due process clause of the
repeal the same. This is to allow administrative Constitution, insofar as the same is in restraint of
agencies flexibility in formulating and adjusting trade and because a provision therein is inadequate to
the details and manner by which80 they are to provide the public with a comprehensible basis to
implement the provisions of a law, in order to determine81 whether or not they have committed a
make it more responsive to the times. Hence, it is a violation.” (Emphasis supplied)
standard provision in administrative rules that 82 83 84 85
prior issu-ances of administrative agencies that Petitioner

86 87
refers to Sections 4(f), 4(i), 5(w), 11,
22, 32,
88 89
_______________ 46, and 52 as the provisions that suppress the
trade of milk and, thus, violate the due process
81 Petitioner’s Memorandum.
clause of the Constitution.
82 SECTION 4. Declaration of Principles.—The following are
the underlying principles from which the revised rules and
_______________
regulations are premised upon:
xxxx 88 SECTION 46. Administrative Sanctions.—The following
(f) Advertising, promotions, or sponsorships of infant administrative sanctions shall be imposed upon any person,
formula, breastmilk substitutes and other related products are juridical or natural, found to have violated the provisions of the
prohibited. Code and its implementing Rules and Regulations:
83 SECTION 4. Declaration of Principles.—x x x (i) Milk
companies, and their representatives, should not form part of a) 1st violation—Warning;
any policymaking body or entity in relation to the advancement b) 2nd violation—Administrative fine of a minimum of Ten
of breastfeeding. Thousand (P10,000.00) to Fifty Thousand (P50,000.00)
84 SECTION 5. x x x x (w) “Milk Company” shall refer to the Pesos, depending on the gravity and extent of the
owner, manufacturer, distributor, of infant formula, follow-up violation, including the recall of the offending product;
milk, milk formula, milk supplement, breastmilk substitute or (c) 3rd violation—Administrative Fine of a minimum of
replacement, or by any other description of such nature, Sixty Thousand (P60,000.00) to One Hundred Fifty
including their representatives who promote or otherwise Thousand (P150,000.00) Pesos, depending on the
advance their commercial interests in marketing those gravity and extent of the violation, and in addition
products; x x x. thereto, the recall of the offending product, and
85 SECTION 11. Prohibition.—No advertising, promotions, suspension of the Certificate of Product Registration
sponsorships, or marketing materials and activities for (CPR);
breastmilk substitutes intended for infants and young children (d) 4th violation—Administrative Fine of a minimum of
up to twenty-four (24) months, shall be allowed, because they Two Hundred Thousand (P200,000.00) to Five Hundred
tend to convey or give subliminal messages or impressions that (P500,000.00) Thousand Pesos, depending on the
undermine breastmilk and breastfeeding or otherwise gravity and extent of the violation; and in addition
exaggerate breastmilk substitutes and/or replacements, as well thereto, the recall of the product, revocation of the CPR,
as related products covered within the scope of this Code. suspension of the License to Operate (LTO) for one year;
86 Supra note 70.
(e) 5th and succeeding repeated—Administrative Fine of
87 Supra note 73.
One Million (P1,000,000.00) Pesos, the recall of the
340 offending product, cancellation of the CPR, revocation of

the License to Operate (LTO) of the company concerned,
including the blacklisting of the company to be
340 SUPREME COURT REPORTS furnished the Department of Budget and Management
ANNOTATED (DBM) and the Department of Trade and Industry
Pharmaceutical and Health Care Association of (DTI);
88 89
(f) An additional penalty of Two Thou-sand Five Hundred unregulated use or proliferation of pesticides would be
(P2,500.00) Pesos per day shall be made for every day hazardous to our environment. Thus, in the aforecited
the violation continues after having received the order case, the Court declared that “free enterprise does
from the IAC or other such appropriate body, notifying not call for removal of ‘protective regulations.’ ” x
and penalizing the company for the infraction. For x x It must be clearly explained and proven by
purposes of determining whether or not there is “re- competent evidence just exactly how such
peated” violation, each product violation belonging or protective regulation would result in the restraint
owned by a company, including those of their of trade.” [Emphasis and italics supplied]
subsidiaries, are deemed to be violations of the
concerned milk company and shall not be based on the In this case, petitioner failed to show that the
specific violating product alone. proscription of milk manufacturers’ participation
in any policymaking body (Section 4[i]), classes and
89 SECTION 52. Other Donations By Milk Companies Not seminars for women and children (Section 22); the
Covered by this Code.—Donations of products, equipments, and giving of assistance, support and logistics or
the like, not otherwise falling within the scope of this Code or training (Section 32); and the giving of donations
these (Section 52) would unreasonably hamper the trade
of breastmilk substitutes. Petitioner has not
341 established that the proscribed activities are
indispensable to the trade of breastmilk
VOL. 535, OCTOBER 9, 2007 341 substitutes. Petitioner failed to demonstrate that
the aforementioned provisions of the RIRR are
Pharmaceutical and Health Care Association of unreasonable and oppressive for being in restraint
the Philippines vs. Duque III of trade.
The framers of the constitution were well aware _______________

that trade must be subjected to some form of
regulation for the public good. Public interest
90
must Rules, given by milk companies and their agents,
be upheld over business interests. In Pest representatives, whether in kind or in cash, may only be
Management Association of the 91Philippines v. coursed through the Inter Agency Committee (IAC), which shall
Fertilizer and Pesticide Authority, it was held determine whether such donation be accepted or otherwise.
thus: 90 Eastern Assurance & Surety Corporation v. Land
Transportation Franchising and Regulatory Board, 459 Phil.
“x x x Furthermore, as held in Association of Philippine
395, 399; 413 SCRA 75, 85 (2003).
Coconut Desiccators v. Philippine Coconut Authority, 91 G.R. No. 156041, February 21, 2007, 516 SCRA 360.
despite the fact that “our present Constitution
enshrines free enterprise as a policy, it 342
nonetheless reserves to the government the power
to intervene whenever necessary to promote the
general welfare.” There can be no question that the
ANNOTATED
Pharmaceutical and Health Care Association of manufactured or distributed by an entity that

the Philippines vs. Duque III would qualify it as a “milk company,” whereas in
the Milk Code, what is used is the phrase
“products within the scope of this Code.” Those are
Petitioner also failed to convince the Court that
the only differences between the definitions given
Section 5(w) of the RIRR is unreasonable and
in the Milk Code and the definition as re-stated in
oppressive. Said section provides for the definition
the RIRR.
of the term “milk company,” to wit:
Since all the regulatory provisions under the
“SECTION 5. x x x. (w) “Milk Company” shall refer to Milk Code apply equally to both manufacturers
the owner, manufacturer, distributor of infant formula, and distributors, the Court sees no harm in the
follow-up milk, milk formula, milk supplement, RIRR providing for just one term to
breastmilk substitute or replacement, or by any other 343
description of such nature, including their
representatives who promote or otherwise advance their
commercial interests in marketing those products”; VOL. 535, OCTOBER 9, 2007 343
On the other hand, Section 4 of the Milk Code
provides:
(d) “Distributor” means a person, corporation or any encompass both entities. The definition of “milk
other entity in the public or private sector engaged in company” in the RIRR and the definitions of
the business (whether directly or indirectly) of “distributor” and “manufacturer” provided for
marketing at the wholesale or retail level a product under the Milk Code are practically the same.
within the scope of this Code. A “primary distributor” is The Court is not convinced that the definition of
a manufacturer’s sales agent, representative, national “milk company” provided in the RIRR would bring
distributor or broker. about any change in the treatment or regulation of
xxxx “distributors” and “manufacturers” of breastmilk
(j) “Manufacturer” means a corporation or other substitutes, as defined under the Milk Code.
entity in the public or private sector engaged in the Except Sections 4(f), 11 and 46, the rest of the
business or function (whether directly or indirectly or provisions of the RIRR are in consonance with the
through an agent or and entity controlled by or under objective, purpose and intent of the Milk Code,
contract with it) of manufacturing a products within the constituting reasonable regulation of an industry
scope of this Code.” which affects public health and welfare and, as
such, the rest of the RIRR do not constitute illegal
Notably, the definition in the RIRR merely merged restraint of trade nor are they violative of the due
together under the term “milk company” the process clause of the Constitution.
entities defined separately under the Milk Code as WHEREFORE, the petition is PARTIALLY
“distributor” and “manufacturer.” The RIRR also GRANTED. Sections 4(f), 11 and 46 of
enumerated in Section 5(w) the products Administrative Order No. 2006-0012 dated May
8/10/2021 SUPREME COURT REPORTS ANNOTATED VOLUME 535
12, 2006 are declared NULL and VOID for being

ultra vires. The Department of Health and
respondents are PROHIBITED from implementing
said provisions.
The Temporary Restraining Order issued on
August 15, 2006 is LIFTED insofar as the rest of
the provisions of Administrative Order No. 2006-
0012 is concerned.
SO ORDERED.
Puno (C.J.), Quisumbing, Sandoval-

Gutierrez, Carpio, Corona, Carpio-Morales, Tinga,
Chico-Nazario, Garcia, Velasco, Jr. and Reyes, JJ.,
concur.
Ynares-Santiago and Azcuna, JJ., On
Official Leave.
Nachura, J., No Part.
344

ANNOTATED
CONCURRING AND SEPARATE OPINION
PUNO, C.J.:
I fully concur with the well-written and

comprehensive po-nencia of my esteemed
colleague, Ms. Justice Ma. Alicia Austria-Martinez.
I write to elucidate another reason why the
absolute ban on the advertising and promotion of
breastmilk substitutes found under Sections 4(f)
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interest if its members are affected by the action.

International Law; Treaties; Doctrine of

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(RIRR) which requires containers and labels to state that

Same; Same; Same; Same; Same; Same; The 276

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Same; Same; Same; The absolute ban on advertising

The facts are stated in the opinion of the Court.

Executive Order No. 51 (Milk Code) was issued

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2.4. Whether Section 13 of the RIRR on Total Effect

_______________ Section 21 of the Constitution which provides that

293 It may coordinate the activities of the specialized agencies

VOL. 535, OCTOBER 9, 2007 295

“Art. 62. Each member shall report annually on the requirement.”

which is the30Milk Code, the subsequent WHA system.

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MILK CODE RIRR VOL. 535, OCTOBER 9, 2007 303

and promote breastfeeding and principles from

supplements and distribution. objective information and breastfeeding is

“Infant” means a Child” means a person

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promotion of products within the scope of materials and activities for

the Philippines vs. Duque III

of infant formula, breastmilk advertising

concept. It must not in any

other related products are case undermine breastmilk

committee created effect” should not directly or

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such exaggerated and a. Texts,

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b. The term Section 16.

306 SUPREME COURT REPORTS

4. The RIRR imposes additional labeling

MILK CODE RIRR

MILK CODE RIRR MILK CODE RIRR

(b) No facility of the or representatives of

SECTION 8. Health venues to market their

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MILK CODE RIRR MILK CODE RIRR

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MILK CODE RIRR MILK CODE RIRR

defined and covered under

scope of this Code

Section 52. Other

8. The RIRR provides for administrative

MILK CODE RIRR

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MILK CODE RIRR Pesos,

a) 1st violation suspension of

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Thousand cancellation

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order from The RIRR provides for repeal of existing

314 SUPREME COURT REPORTS 48 Jacobson v. Massachusetts, 197 US 11 (1905); Beltran v.

VOL. 535, OCTOBER 9, 2007 317 _______________