Pharmaceutical and Health Case Association vs. Duque
Pharmaceutical and Health Case Association vs. Duque
Pharmaceutical and Health Case Association vs. Duque
Facts:
Petition for certiorari seeking to nullify the Revised Implementing Rules and
Regulations (RIRR) of E.O. 51 (Milk Code). Petitioner representing its
members that are manufacturers of breastmilk substitutes, claims that the
RIRR is not valid as it contains provisions that are not constitutional and go
beyond what it is supposed to implement. Milk Code was issued by President
Cory Aquino under the Freedom Constitution on Oct.1986. One of the
preambular clauses of the Milk Code states that the law seeks to give effect to
Art 11 of the Int’l Code of Marketing and Breastmilk Substitutes(ICBMS), a
code adopted by the World Health Assembly(WHA). From 1982-2006, The
WHA also adopted severe resolutions to the effect that breastfeeding should
be supported, hence, it should be ensured that nutrition and health claims are
not permitted for breastmilk substitutes. In 2006, the DOH issued the assailed
RIRR.
Issue:
Sub-Issue: W/N the pertinent int’l agreements entered into by the Phil are part
of the law of the land and may be implemented by DOH through the RIRR. If
yes, W/N the RIRR is in accord with int’l agreements
MAIN: W/N the DOH acted in excess of their jurisdiction, or with grave abuse
of discretion amounting to lack of excess of jurisdiction and in violation of the
Constitution by promulgating the RIRR.
Held:
No for WHA Resolutions. The Court ruled that DOH failed to establish that the
provisions pertinent WHA resolutions are customary international law that
may be deemed part of the law of the land. For an international rule to be
considered as customary law, it must be established that such rule is being
followed by states because they consider it as obligatory to comply with such
rules (opinion juris). The WHO resolutions, although signed by most of the
member states, were enforced or practiced by at least a majority of member
states. Unlike the ICBMS whereby legislature enacted most of the provisions
into the law via the Milk Code, the WHA Resolutions (specifically providing for
exclusive breastfeeding from 0-6 months, breastfeeding up to 24 Months and
absolutely prohibiting ads for breastmilk substitutes) have not been adopted
as domestic law nor are they followed in our country as well. The Filipinos
have the option of how to take care of their babies as they see fit. WHA
Resolutions may be classified as SOFT LAW – non-binding norms, principles
and practices that influence state behavior. Soft law is not part of int’l law.
However, the ICBMS had been transformed into domestic law through a
local legislation such as the Milk Code. The Milk Code is almost a verbatim
reproduction of ICBMS.
Main Sub-issue:
issue:
Yes. Some parts of the RIRR were not in consonance with the Milk Code such
as Sec. 4(f) ->advertising, promotions of formula are prohibited,
Sec. 11 -> prohibitions for advertising breastmilk substitutes intended for
infants and young children uo to 24 months
And Sec 46 -> sanctions for advertising .
These provisions are declared null and void. The DOH and respondents are
prohibited from implementing said provisions.
DECISION
AUSTRIA-MARTINEZ, J.:
The Court and all parties involved are in agreement that the best nourishment
for an infant is mother's milk. There is nothing greater than for a mother to
nurture her beloved child straight from her bosom. The ideal is, of course, for
each and every Filipino child to enjoy the unequaled benefits of breastmilk.
But how should this end be attained?
Executive Order No. 51 (Milk Code) was issued by President Corazon Aquino
on October 28, 1986 by virtue of the legislative powers granted to the
president under the Freedom Constitution. One of the preambular clauses of
the Milk Code states that the law seeks to give effect to Article 11 2 of the
International Code of Marketing of Breastmilk Substitutes (ICMBS), a code
adopted by the World Health Assembly (WHA) in 1981. From 1982 to 2006,
the WHA adopted several Resolutions to the effect that breastfeeding should
be supported, promoted and protected, hence, it should be ensured that
nutrition and health claims are not permitted for breastmilk substitutes.
On May 15, 2006, the DOH issued herein assailed RIRR which was to take
effect on July 7, 2006.
However, on June 28, 2006, petitioner, representing its members that are
manufacturers of breastmilk substitutes, filed the present Petition
for Certiorari and Prohibition with Prayer for the Issuance of a Temporary
Restraining Order (TRO) or Writ of Preliminary Injunction.
The main issue raised in the petition is whether respondents officers of the
DOH acted without or in excess of jurisdiction, or with grave abuse of
discretion amounting to lack or excess of jurisdiction, and in violation of the
provisions of the Constitution in promulgating the RIRR. 3
On August 15, 2006, the Court issued a Resolution granting a TRO enjoining
respondents from implementing the questioned RIRR.
After the Comment and Reply had been filed, the Court set the case for oral
arguments on June 19, 2007. The Court issued an Advisory (Guidance for
Oral Arguments) dated June 5, 2007, to wit:
2.1 Whether the RIRR is in accord with the provisions of Executive Order No.
51 (Milk Code);
2.3 Whether Sections 4, 5(w), 22, 32, 47, and 52 of the RIRR violate the due
process clause and are in restraint of trade; and
_____________
1 (1) United Nations Convention on the Rights of the Child; (2) the WHO and
Unicef "2002 Global Strategy on Infant and Young Child Feeding;" and (3)
various World Health Assembly (WHA) Resolutions.
With regard to the issue of whether petitioner may prosecute this case as the
real party-in-interest, the Court adopts the view enunciated in Executive
Secretary v. Court of Appeals,4 to wit:
xxxx
Petitioner assails the RIRR for allegedly going beyond the provisions of the
Milk Code, thereby amending and expanding the coverage of said law. The
defense of the DOH is that the RIRR implements not only the Milk Code but
also various international instruments 10 regarding infant and young child
nutrition. It is respondents' position that said international instruments are
deemed part of the law of the land and therefore the DOH may implement
them through the RIRR.
Under the 1987 Constitution, international law can become part of the sphere
of domestic law either by transformation or incorporation.11 The
transformation method requires that an international law be transformed into a
domestic law through a constitutional mechanism such as local legislation.
The incorporation method applies when, by mere constitutional declaration,
international law is deemed to have the force of domestic law. 12
The ICMBS and WHA Resolutions are not treaties as they have not been
concurred in by at least two-thirds of all members of the Senate as required
under Section 21, Article VII of the 1987 Constitution.
However, the ICMBS which was adopted by the WHA in 1981 had been
transformed into domestic law through local legislation, the Milk Code.
Consequently, it is the Milk Code that has the force and effect of law in this
jurisdiction and not the ICMBS per se.
The Milk Code is almost a verbatim reproduction of the ICMBS, but it is well to
emphasize at this point that the Code did not adopt the provision in
the ICMBS absolutely prohibiting advertising or other forms of promotion
to the general public of products within the scope of the ICMBS. Instead, the
Milk Code expressly provides that advertising, promotion, or other
marketing materials may be allowed if such materials are duly
authorized and approved by the Inter-Agency Committee (IAC).
embodies the incorporation method.14
Some legal scholars and judges look upon certain "general principles of law"
as a primary source of international law because they have the "character of
jus rationale" and are "valid through all kinds of human
societies." (Judge Tanaka in his dissenting opinion in the 1966 South West
Africa Case, 1966 I.C.J. 296). O'Connell holds that certain priniciples are part
of international law because they are "basic to legal systems generally"
and hence part of the jus gentium. These principles, he believes, are
established by a process of reasoning based on the common identity of all
legal systems. If there should be doubt or disagreement, one must look to
state practice and determine whether the municipal law principle provides a
just and acceptable solution. x x x 21 (Emphasis supplied)
xxxx
The initial factor for determining the existence of custom is the actual behavior
of states. This includes several elements: duration, consistency, and
generality of the practice of states.
xxxx
Duration therefore is not the most important element. More important is the
consistency and the generality of the practice. x x x
xxxx
Once the existence of state practice has been established, it becomes
necessary to determine why states behave the way they do. Do states behave
the way they do because they consider it obligatory to behave thus or do
they do it only as a matter of courtesy? Opinio juris, or the belief that a
certain form of behavior is obligatory, is what makes practice an
international rule. Without it, practice is not law.22 (Underscoring and
Emphasis supplied)
WHA Resolutions have not been embodied in any local legislation. Have they
attained the status of customary law and should they then be deemed
incorporated as part of the law of the land?
Article 19. The Health Assembly shall have authority to adopt conventions or
agreements with respect to any matter within the competence of the
Organization. A two-thirds vote of the Health Assembly shall be required for
the adoption of such conventions or agreements, which shall come into
force for each Member when accepted by it in accordance with its
constitutional processes.
Article 21. The Health Assembly shall have authority to adopt regulations
concerning: (a) sanitary and quarantine requirements and other procedures
designed to prevent the international spread of disease; (b) nomenclatures
with respect to diseases, causes of death and public health practices; (c)
standards with respect to diagnostic procedures for international use; (d)
standards with respect to the safety, purity and potency of biological,
pharmaceutical and similar products moving in international commerce; (e)
advertising and labeling of biological, pharmaceutical and similar products
moving in international commerce.
The former Senior Legal Officer of WHO, Sami Shubber, stated that WHA
recommendations are generally not binding, but they "carry moral and political
weight, as they constitute the judgment on a health issue of the collective
membership of the highest international body in the field of health." 29 Even the
ICMBS itself was adopted as a mere recommendation, as WHA Resolution
No. 34.22 states:
In January 1981, the Executive Board of the World Health Organization at its
sixty-seventh session, considered the fourth draft of the code, endorsed it,
and unanimously recommended to the Thirty-fourth World Health Assembly
the text of a resolution by which it would adopt the code in the form of a
recommendation rather than a regulation. x x x (Emphasis supplied)
Art. 62. Each member shall report annually on the action taken with respect to
recommendations made to it by the Organization, and with respect to
conventions, agreements and regulations.
Apparently, the WHA Resolution adopting the ICMBS and subsequent WHA
Resolutions urging member states to implement the ICMBS are merely
recommendatory and legally non-binding. Thus, unlike what has been done
with the ICMBS whereby the legislature enacted most of the provisions
into law which is the Milk Code, the subsequent WHA
Resolutions,30 specifically providing for exclusive breastfeeding from 0-
6 months, continued breastfeeding up to 24 months, and absolutely
prohibiting advertisements and promotions of breastmilk substitutes,
have not been adopted as a domestic law.
"Soft law" does not fall into any of the categories of international law set forth
in Article 38, Chapter III of the 1946 Statute of the International Court of
Justice.32 It is, however, an expression of non-binding norms, principles, and
practices that influence state behavior. 33 Certain declarations and resolutions
of the UN General Assembly fall under this category. 34 The most notable is
the UN Declaration of Human Rights, which this Court has enforced in various
cases, specifically, Government of Hongkong Special Administrative Region
v. Olalia,35 Mejoff v. Director of Prisons,36 Mijares v. Rañada37 and Shangri-la
International Hotel Management, Ltd. v. Developers Group of Companies,
Inc..38
WHO has resorted to soft law. This was most evident at the time of the
Severe Acute Respiratory Syndrome (SARS) and Avian flu outbreaks.
Although the IHR Resolution does not create new international law
binding on WHO member states, it provides an excellent example of the
power of "soft law" in international relations. International lawyers
typically distinguish binding rules of international law-"hard law"-from
non-binding norms, principles, and practices that influence state
behavior-"soft law." WHO has during its existence generated many soft
law norms, creating a "soft law regime" in international governance for
public health.
The "soft law" SARS and IHR Resolutions represent significant steps in laying
the political groundwork for improved international cooperation on infectious
diseases. These resolutions clearly define WHO member states' normative
duty to cooperate fully with other countries and with WHO in connection with
infectious disease surveillance and response to outbreaks.
This duty is neither binding nor enforceable, but, in the wake of the
SARS epidemic, the duty is powerful politically for two reasons. First, the
SARS outbreak has taught the lesson that participating in, and enhancing,
international cooperation on infectious 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 consistent state
practice on infectious disease surveillance and outbreak response, perhaps
crystallizing eventually into customary international law on infectious disease
prevention and control.41
Second, the Court will determine whether the 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.
Respondents submit that the national policy on infant and young child feeding
is embodied in A.O. No. 2005-0014, dated May 23, 2005. Basically, the
Administrative Order declared the following policy guidelines: (1) ideal
breastfeeding practices, such as early initiation of breastfeeding, exclusive
breastfeeding for the first six months, extended breastfeeding up to two years
and beyond; (2) appropriate complementary feeding, which is to start at age
six months; (3) micronutrient supplementation; (4) universal salt iodization; (5)
the exercise of other feeding options; and (6) feeding in exceptionally difficult
circumstances. Indeed, the primacy of breastfeeding for children is
emphasized as a national health policy. However, nowhere in A.O. No.
2005-0014 is it declared that as part of such health policy, the
advertisement or promotion of breastmilk substitutes should be
absolutely prohibited.
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.
Third, the Court will now determine whether the provisions of the RIRR are in
accordance with those of the Milk Code.
In support of its claim that the RIRR is inconsistent with the Milk Code,
petitioner alleges the following:
1. The Milk Code limits its coverage to children 0-12 months old, but the RIRR
extended its coverage to "young children" or those from ages two years old
and beyond:
2. The Milk Code recognizes that infant formula may be a proper and possible
substitute for breastmilk in certain instances; but the RIRR provides "exclusive
breastfeeding for infants from 0-6 months" and declares that "there is no
substitute nor replacement for breastmilk":
3. The Milk Code only regulates and does not impose unreasonable
requirements for advertising and promotion; RIRR imposes an absolute ban
on such activities for breastmilk substitutes intended for infants from 0-24
months old or beyond, and forbids the use of health and nutritional claims.
Section 13 of the RIRR, which provides for a "total effect" in the promotion of
products within the scope of the Code, is vague:
4. The RIRR imposes additional labeling requirements not found in the Milk
Code:
(iii) a statement that the product shall be (e) Instructions for appropriate prepara-
used only on the advice of a health tion, and a warning against the health
worker as to the need for its use and the hazards of inappropriate preparation; and
proper methods of use; and
(iv) instructions for appropriate (f) The health hazards of unnecessary or
preparation, and a warning against the improper use of infant formula and other
health hazards of inappropriate related products including information
preparation. that powdered infant formula may contain
pathogenic microorganisms and must be
prepared and used appropriately.
7. The Milk Code regulates the giving of donations; RIRR absolutely prohibits
it.
8. The RIRR provides for administrative sanctions not imposed by the Milk
Code.
a) 1st violation – Warning;
1. Petitioner is mistaken in its claim that the Milk Code's coverage is limited
only to children 0-12 months old. Section 3 of the Milk Code states:
SECTION 3. Scope of the Code – The Code applies to the marketing, and
practices related thereto, of the following products: breastmilk substitutes,
including infant formula; other milk products, foods and beverages, including
bottle-fed complementary foods, when marketed or otherwise represented to
be suitable, with or without modification, for use as a partial or total
replacement of breastmilk; feeding bottles and teats. It also applies to their
quality and availability, and to information concerning their use.
Clearly, the coverage of the Milk Code is not dependent on the age of the
child but on the kind of product being marketed to the public. The law treats
infant formula, bottle-fed complementary food, and breastmilk substitute as
separate and distinct product categories.
Section 4(h) of the Milk Code defines infant formula as "a breastmilk
substitute x x x to satisfy the normal nutritional requirements of infants up to
between four to six months of age, and adapted to their physiological
characteristics"; while under Section 4(b), bottle-fed complementary food
refers to "any food, whether manufactured or locally prepared, suitable as a
complement to breastmilk or infant formula, when either becomes insufficient
to satisfy the nutritional requirements of the infant." An infant under Section
4(e) is a person falling within the age bracket 0-12 months. It is the
nourishment of this group of infants or children aged 0-12 months that is
sought to be promoted and protected by the Milk Code.
Evidently, as long as what is being marketed falls within the scope of the Milk
Code as provided in Section 3, then it can be subject to regulation pursuant to
said law, even if the product is to be used by children aged over 12 months.
There is, therefore, nothing objectionable with Sections 2 42 and 5(ff)43 of the
RIRR.
2. It is also incorrect for petitioner to say that the RIRR, unlike the Milk Code,
does not recognize that breastmilk substitutes may be a proper and possible
substitute for breastmilk.
The entirety of the RIRR, not merely truncated portions thereof, must be
considered and construed together. As held in De Luna v. Pascual,44 "[t]he
particular words, clauses and phrases in 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 in order to produce
a harmonious whole."
Section 7 of the RIRR provides that "when medically indicated and only when
necessary, the use of breastmilk substitutes is proper if based on
complete and updated information." Section 8 of the RIRR also states that
information and educational materials should include information on the
proper use of infant formula when the use thereof is needed.
Hence, the RIRR, just like the Milk Code, also recognizes that in certain
cases, the use of breastmilk substitutes may be proper.
Health is a legitimate subject matter for regulation by the DOH (and certain
other administrative agencies) in exercise of police powers delegated to it.
The sheer span of jurisprudence on that matter precludes the need to further
discuss it..48 However, health information, particularly advertising materials on
apparently non-toxic products like breastmilk substitutes and supplements, is
a relatively new area for regulation by the DOH. 49
Seventy years later, the 1987 Administrative Code tasked respondent DOH to
carry out the state policy pronounced under Section 15, Article II of the 1987
Constitution, which is "to protect and promote the right to health of the people
and instill health consciousness among them."52 To that end, it was granted
under Section 3 of the Administrative Code the power to "(6) propagate health
information and educate the population on important health, medical and
environmental matters which have health implications." 53
xxxx
(1) To promulgate such rules and regulations as are necessary 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 necessary for or
incidental to the attainment of the purposes and objectives of this Code.
SECTION 5. Information and Education –
SECTION 5. x x x
xxxx
SECTION 10. Containers/Label –
xxxx
(d) The term "humanized," "maternalized" or similar terms shall not be used.
(Emphasis supplied)
The DOH is also authorized to control the purpose of the information and to
whom such information may be disseminated under Sections 6 through 9 of
the Milk Code54 to ensure that the information that would reach pregnant
women, mothers of infants, and health professionals and workers in the health
care system is restricted to scientific and factual matters and shall not imply
or create a belief that bottlefeeding is equivalent or superior to breastfeeding.
It bears emphasis, however, that the DOH's power under the Milk Code
to control information regarding breastmilk vis-a-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.
The following are the provisions of the Milk Code that unequivocally indicate
that the control over information given to the DOH is not absolute and that
absolute prohibition is not contemplated by the Code:
SECTION 2. Aim of the Code – The aim of the Code is to contribute to the
provision of safe and adequate nutrition for 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 of adequate information and through appropriate marketing and
distribution.
b) Section 3 which specifically states that the Code applies to the marketing of
and practices related to breastmilk substitutes, including infant formula, and to
information concerning their use;
c) Section 5(a) which provides that the government shall ensure that objective
and consistent information is provided on infant feeding;
d) Section 5(b) which provides that written, audio or visual informational and
educational materials shall not use any picture or text which may idealize the
use of breastmilk substitutes and should include information on the health
hazards of unnecessary or improper use of said product;
e) Section 6(a) in relation to Section 12(a) which creates and empowers the
IAC to review and examine advertising, promotion, and other marketing
materials;
f) Section 8(b) which states that milk companies may provide information to
health professionals but such information should be restricted to factual and
scientific matters and shall not imply or create a belief that bottlefeeding is
equivalent or superior to breastfeeding; and
g) Section 10 which provides that containers or labels should not contain
information that would discourage breastfeeding and idealize the use of infant
formula.
It is in this context that the Court now examines the assailed provisions of the
RIRR regarding labeling and advertising.
Sections 1355 on "total effect" and 2656 of Rule VII of the RIRR contain some
labeling requirements, specifically: a) that there be a statement that there is
no substitute to breastmilk; and b) that there be a statement that powdered
infant formula may contain pathogenic microorganisms and must be prepared
and used appropriately. Section 1657 of the RIRR prohibits all health and
nutrition claims for products within the scope of the Milk Code, such as claims
of increased emotional and intellectual abilities of the infant and young child.
xxxx
and Section 10(d)59 which bars the use on containers and labels of the terms
"humanized," "maternalized," or similar terms.
These provisions of the Milk Code expressly forbid information that would
imply or create a belief that there is any milk product equivalent to breastmilk
or which is humanized or maternalized, as such information would be
inconsistent with the superiority of breastfeeding.
It may be argued that Section 8 of the Milk Code refers only to information
given to health workers regarding breastmilk substitutes, not to containers and
labels thereof. However, such restrictive application of Section 8(b) will result
in the absurd situation in which milk companies and distributors are forbidden
to claim to health workers that their products are substitutes or equivalents of
breastmilk, and yet be allowed to display on the containers and labels of their
products the exact opposite message. That askewed interpretation of the Milk
Code is precisely what Section 5(a) thereof seeks to avoid by mandating that
all information regarding breastmilk vis-a-vis breastmilk substitutes
be consistent, at the same time giving the government control over planning,
provision, design, and dissemination of information on infant feeding.
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 Milk Code and deterring circumvention
of the protection and promotion of breastfeeding as embodied in Section 2 60 of
the Milk Code.
SECTION 5. x x x
xxxx
Petitioner’s counsel has admitted during the hearing on June 19, 2007 that
formula milk is prone to contaminations and there is as yet no technology that
allows production of powdered infant formula that eliminates all forms of
contamination.62
Ineluctably, the requirement under Section 26(f) 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.
the Milk Code invested regulatory authority over advertising, promotional and
marketing materials to an IAC, thus:
(3) To prescribe the internal and operational procedure for the exercise of its
powers and functions as well as the performance of its duties and
responsibilities; and
xxxx
The DOH, through its co-respondents, evidently arrogated to itself not only the
regulatory authority given to the IAC but also imposed absolute prohibition on
advertising, promotion, and marketing.
Yet, oddly enough, Section 12 of the RIRR reiterated the requirement of the
Milk Code in Section 6 thereof for prior approval by IAC of all advertising,
marketing and promotional materials prior to dissemination.
Even respondents, through the OSG, acknowledged the authority of IAC, and
repeatedly insisted, during the oral arguments on June 19, 2007, that the
prohibition under Section 11 is not actually operational, viz:
xxxx
We have to read Section 11 together with the other Sections because the
other Section, Section 12, provides for the inter agency committee that is
empowered to process and evaluate all the advertising and promotion
materials.
xxxx
What AO 2006-12, what it does, it does not prohibit the sale and manufacture,
it simply regulates the advertisement and the promotions of breastfeeding milk
substitutes.
xxxx
Now, the prohibition on advertising, Your Honor, must be taken together with
the provision on the Inter-Agency Committee that processes and evaluates
because there may be some information dissemination that are straight
forward information dissemination. What the AO 2006 is trying to prevent is
any material that will undermine the practice of breastfeeding, Your Honor.
xxxx
Madam Solicitor General, under the Milk Code, which body has authority or
power to promulgate Rules and Regulations regarding the Advertising,
Promotion and Marketing of Breastmilk Substitutes?
xxxx
x x x Don't you think that the Department of Health overstepped its rule
making authority when it totally banned advertising and promotion under
Section 11 prescribed the total effect rule as well as the content of materials
under Section 13 and 15 of the rules and regulations?
Your Honor, please, first we would like to stress that there is no total absolute
ban. Second, the Inter-Agency Committee is under the Department of Health,
Your Honor.
xxxx
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?
It's not an absolute ban, Your Honor, because we have the Inter-Agency
Committee that can evaluate some advertising and promotional materials,
subject to the standards that we have stated earlier, which are- they should
not undermine breastfeeding, Your Honor.
xxxx
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 Inter-Agency Committee can allow if the advertising and promotions
will not undermine breastmilk and breastfeeding, Your Honor. 63
Sections 11 and 4(f) of the RIRR are clearly violative of the Milk Code.
xxxx
xxxx
xxxx
xxxx
SECTION 10. Containers/Label –
(b) Each container shall have a clear, conspicuous and easily readable and
understandable message in Pilipino or English printed on it, or on a label,
which message can not readily become separated from it, and which shall
include the following points:
(iii) a statement that the product shall be used only on the advice of a health
worker as to the need for its use and the proper methods of use; and
(iv) instructions for appropriate preparation, and a warning against the health
hazards of inappropriate preparation.
Section 12(b) of the Milk Code designates the DOH as the principal
implementing agency for the enforcement of the provisions of the Code. In
relation to such responsibility of the DOH, Section 5(a) of the Milk Code states
that:
SECTION 13. "Total Effect" - Promotion of products within the scope of this
Code must be objective and should not equate or make the product appear to
be as good or equal to breastmilk or breastfeeding in the advertising concept.
It must not in any case undermine breastmilk or breastfeeding. The "total
effect" should not directly or indirectly suggest that buying their product would
produce better individuals, or resulting in greater love, intelligence, ability,
harmony or in any manner bring better health to the baby or other such
exaggerated and unsubstantiated claim.
Such standards bind the IAC in formulating its rules and regulations on
advertising, promotion, and marketing. Through that single provision, the DOH
exercises control over the information content of advertising, promotional and
marketing materials on breastmilk vis-a-vis breastmilk substitutes,
supplements and other related products. It also sets a viable standard against
which the IAC may screen such materials before they are made public.
5. Next, petitioner alleges that Section 8(e) 68 of the Milk Code permits milk
manufacturers and distributors to extend assistance in research and in the
continuing education of health professionals, while Sections 22 and 32 of the
RIRR absolutely forbid the same. Petitioner also assails Section 4(i) 69 of the
RIRR prohibiting milk manufacturers' and distributors' participation in any
policymaking body in relation to the advancement of breastfeeding.
Section 4(i) of the RIRR provides that milk companies and their
representatives should not form part of any policymaking body or entity in
relation to the advancement of breastfeeding. The Court finds nothing in said
provisions which contravenes the Milk Code. Note that under Section 12(b) of
the Milk Code, it is the DOH which shall be principally responsible for the
implementation and enforcement of the provisions of said Code. It is entirely
up to the DOH to decide which 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 breastfeeding is in accord with the Milk Code.
It is Sections 971 and 1072 of the RIRR which govern research assistance. Said
sections of the RIRR provide that research assistance for health workers
and researchers may be allowed upon approval of an ethics committee,
and with certain disclosure requirements imposed on the milk company
and on the recipient of the research award.
The Milk Code endows the DOH with the power to determine how such
research or educational assistance may be given by milk companies or under
what conditions health workers may accept 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 companies are completely in accord with
the Milk Code.
Petitioner complains that Section 3273 of the RIRR prohibits milk companies
from giving assistance, support, logistics or training to health workers. This
provision is within the prerogative given to the DOH under Section 8(e) 74 of
the Milk Code, which provides that manufacturers and distributors of
breastmilk substitutes may assist in researches, scholarships and the
continuing education, of health professionals in accordance with the rules and
regulations promulgated by the Ministry of Health, now DOH.
It was within the discretion of the DOH when it provided in Section 52 of the
RIRR that any donation from milk companies not covered by the Code should
be coursed through the IAC which shall determine whether such donation
should be accepted or refused. As reasoned out by respondents, the DOH is
not mandated by the Milk Code to accept donations. For that matter, no
person or entity can be forced to accept a donation. There is, therefore, no
real inconsistency between the RIRR and the law because the Milk Code
does not prohibit the DOH from refusing donations.
In the present case, neither the Milk Code nor the Revised Administrative
Code grants the DOH the authority to fix or impose administrative fines. Thus,
without any express grant of power to fix or impose such fines, the DOH
cannot provide for those fines in the RIRR. In this regard, the DOH again
exceeded its authority by providing for such fines or sanctions in Section 46 of
the RIRR. Said provision is, therefore, null and void.
The DOH is not left without any means to enforce its rules and regulations.
Section 12(b) (3) of the Milk Code authorizes the DOH to "cause the
prosecution of the violators of this Code and other pertinent laws on products
covered by this Code." 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:
SECTION 13. Sanctions –
(a) Any person who violates the provisions of this Code or the rules and
regulations issued pursuant to this Code shall, upon conviction, be
punished by a penalty of two (2) months to 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 both. Should the offense be committed by a
juridical person, the chairman of the Board of Directors, the president, general
manager, or the partners and/or the persons directly responsible therefor,
shall be penalized.
(b) Any license, permit or authority issued by any government agency to any
health worker, distributor, manufacturer, or marketing firm or personnel for the
practice of their profession or occupation, or for the pursuit of their business,
may, upon recommendation of the Ministry of Health, be suspended or
revoked in the event of repeated violations of this Code, or of the rules and
regulations issued pursuant to this Code. (Emphasis supplied)
Section 57 reads:
Section 57 of the RIRR does not provide for the 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.
In fine, only Sections 4(f), 11 and 46 are ultra vires, beyond the authority of
the DOH to promulgate and in contravention of the Milk Code and, therefore,
null and void. The rest of the provisions of the RIRR are in consonance with
the Milk Code.
The framers of the constitution were well aware that trade must be subjected
to some form of regulation for the public good. Public interest must be upheld
over business interests.90 In Pest Management Association of the Philippines
v. Fertilizer and Pesticide Authority,91 it was held thus:
Petitioner also failed to convince the Court that Section 5(w) of the RIRR is
unreasonable and oppressive. Said section provides for the definition of the
term "milk company," to wit:
(d) "Distributor" means a person, corporation or any other entity in the public
or private sector engaged in the business (whether directly or indirectly) of
marketing at the wholesale or retail level a product within the scope of this
Code. A "primary distributor" is a manufacturer's sales agent, representative,
national distributor or broker.
xxxx
Notably, the definition in the RIRR merely merged together under the term
"milk company" the entities defined separately under the Milk Code as
"distributor" and "manufacturer." The RIRR also enumerated in Section 5(w)
the products manufactured or distributed by an entity that 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 the only differences
between the definitions given in the Milk Code and the definition as re-stated
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 providing
for just one term to encompass both entities. The definition of "milk company"
in the RIRR and the definitions of "distributor" and "manufacturer" provided for
under the Milk Code are practically the same.
The Court is not convinced that the definition of "milk company" provided in
the RIRR would bring about any change in the treatment or regulation of
"distributors" and "manufacturers" of breastmilk substitutes, as defined under
the Milk Code.
Except Sections 4(f), 11 and 46, the rest of the provisions of the RIRR are in
consonance with the objective, purpose and intent of the Milk Code,
constituting reasonable regulation of an industry which affects public health
and welfare and, as such, the rest of the RIRR do not constitute illegal
restraint of trade nor are they violative of the due process clause of the
Constitution.
SO ORDERED.