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8/3/2019 On Breastfeeding and Breastmilk Substitutes: the Legal Aspect
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On Breastfeeding and
Breastmilk Substitutes:
the Legal Aspect
N. M. Aguilar
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Expanded Breastfeeding Promotion
REPUBLIC ACT No. 10028, signed into law on
March 16, 2010 by then President Gloria Macapagal-Arroyo and known as “Expanded Breastfeeding
Promotion Act of 2009," expanded the promotion of
breastfeeding by amending Republic Act No. 7600,
otherwise known as “An Act to Provide Incentives to
all Government and Private Health Institutions with
Rooming-in and Breastfeeding Practices and for
Other Purposes.”
Declaration of Policy
The State adopts rooming-in as a national policy to
encourage, protect and support the practice of
breastfeeding. It shall create an environment where
basic physical, emotional, and psychological needs of
mothers and infants are fulfilled through the practice
of rooming-in and breastfeeding.
The State shall likewise protect working women
by providing safe and healthful working conditions,taking into account their maternal functions, and such
facilities and opportunities that will enhance their
welfare and enable them to realize their full potential
in the service of the nation. This is consistent with
international treaties and conventions to which the
Philippines is a signatory such as the Convention on
the Elimination of Discrimination Against Women
(CEDAW), which emphasizes provision of necessary
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supporting social services to enable parents to
combine family obligations with work
responsibilities; the Beijing Platform for Action and
Strategic Objective, which promotes harmonization
of work and family responsibilities for women and
men; and the Convention on the Rights of the Child,which recognizes a child's inherent right to life and
the State's obligations to ensure the child's survival
and development.
Breastfeeding has distinct advantages which
benefit the infant and the mother, including the
hospital and the country that adopt its practice. It is
the first preventive health measure that can be given
to the child at birth. It also enhances mother-infant
relationship. Furthermore, the practice of breastfeeding could save the country valuable foreign
exchange that may otherwise be used for milk
importation.
Breastmilk is the best food since it contains
essential nutrients completely suitable for the infant's
needs. It is also nature's first immunization, enabling
the infant to fight potential serious infection. It
contains growth factors that enhance the maturationof an infant's organ systems.
Towards this end, the State shall promote and
encourage breastfeeding and provide the specific
measures that would present opportunities for
mothers to continue expressing their milk and/or
breastfeeding their infant or young child. (Sec. 2, RA
7600 as amended by RA 10028)
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Definition of Terms
For purposes of the Act, the following definitions
are adopted:
a) Age of gestation - the length of time the fetus isinside the mother's womb.
b) Bottlefeeding - the method of feeding an infant
using a bottle with artificial nipples, the contents of
which can be any type of fluid.
c) Breastfeeding - the method of feeding an infant
directly from the human breast.
d) Breastmilk - the human milk from a mother.
e) Breastmilk substitute - any food being marketed
or otherwise represented as partial or total
replacement of breastmilk whether or not suitable forthat purpose.
f) Donor milk - the human milk from a non-
biological mother.
g) Expressed breastmilk - the human milk which
has been extracted from the breast by hand or by
breast pump. It can be fed to an infant using a
dropper, a nasogastric tube, a cup and spoon, or a
bottle.
h) Expressing milk - the act of extracting humanmilk from the breast by hand or by pump into a
container.
i) Formula feeding - the feeding of a newborn with
infant formula usually by bottle feeding. It is also
called artificial feeding.
j) Health institutions- are hospitals, health
infirmaries, health centers, lying-in centers, or
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puericulture centers with obstetrical and pediatric
services.
k) Health personnel- are professionals and
workers who manage and/or administer the entire
operations of health institutions and/or who are
involved in providing maternal and child healthservices.
l) Health workers - all persons who are engaged in
health and health-related work, and all persons
employed in all hospitals, sanitaria, health
infirmaries, health centers, rural health units,
barangay health stations, clinics and other health-
related establishments, whether government or
private, and shall include medical, allied health
professional, administrative and support personnel
employed regardless of their employment status.m) Infant - a child within zero (0) to twelve (12)
months of age.
n) Infant formula- the breastmilk substitute
formulated industrially in accordance with applicable
Codex Alimentarius standards, to satisfy the normal
nutritional requirements of infants up to six (6)
months of age, and adopted to their physiological
characteristics.
o) Lactation management - the general care of amother-infant nursing couple during the mother's
prenatal, immediate postpartum and postnatal
periods. It deals with educating and providing
knowledge and information to pregnant and lactating
mothers on the advantages of breastfeeding, the risks
associated with breastmilk substitutes and milk
products not suitable as breastmilk substitutes such
as, but not limited to, condensed milk and evaporated
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milk, the monitoring of breastfeeding mothers by
health workers and breastfeeding peer counselors for
service patients to ensure compliance with the
Department of Health, World Health Organization
(WHO) and the United Nations Children's Fund
(UNICEF) on the implementation of breastfeedingpolicies, the physiology of lactation, the
establishment and maintenance of lactation, the
proper care of the breasts and nipples, and such other
matters that would contribute to successful
breastfeeding.
p) Lactation stations - private, clean, sanitary, and
well-ventilated rooms or areas in the workplace or
public places where nursing mothers can wash up,
breastfeed or express their milk comfortably and
store this afterward.q) Low birth weight infant - a newborn weighing
less than two thousand five hundred (2,500) grams at
birth.
r) Nursing employee- any female worker,
regardless of employment status, who is
breastfeeding her infant and/or young child.
s) Mother's milk - the breastmilk from the
newborn's own mother.
t) Non-health facilities, establishment or institution - public places and working places, as
defined in subparagraphs (u) and (y), respectively.
u) Public place - enclosed or confined areas such
as schools, public transportation terminals, shopping
malls, and the like.
v) Rooming-in - the practice of placing the
newborn in the same room as the mother right after
delivery up to discharge to facilitate mother-infant
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bonding and to initiate breastfeeding. The infant may
either share the mother's bed or be placed in a crib
beside the mother.
w) Seriously ill mothers - are those who are: with
severe infections; in shock, in severe cardiac or
respiratory distress; or dying; or those with otherconditions that may be determined by the attending
physician as serious.
x) Wet-nursing - the feeding of a newborn from
another mother's breast when his/her own mother
cannot breastfeed.
y) Workplace - work premises, whether private
enterprises or government agencies, including their
subdivisions, instrumentalities and government-
owned and -controlled corporations.
z) Young child - a child from the age of twelve(12) months and one (1) day up to thirty-six (36)
moths. (Sec. 3, RA 7600 as amended )
Applicability
The provisions in this Chapter shall apply to all
private enterprises as well as government agencies,
including their subdivisions and instrumentalities,
and government-owned and -controlled corporations.
Upon application to, and determination by, the
Secretary of the Department of Labor and
Employment for the private sector, and the
Chairperson of the Civil Service Commission for the
public sector, all health and non-health facilities,
establishments and institutions may be exempted for
a renewable period of two (2) years from Section 6 of
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this Act where the establishment of lactation stations
is not feasible or necessary due to the peculiar
circumstances of the workplace or public place taking
into consideration, among others, number of women
employees, physical size of the establishment, and
the average number of women who visit.
All health and non-health facilities, establishments
or institutions which are exempted in complying with
the provisions of this Act but nevertheless opted to
comply are entitled to the benefits herein
stated: Provided, That they give their employees the
privilege of using the same. (Sec. 4, RA 7600 as
amended )
Facilities for Breastmilk Collection and Storage
The health institution adopting rooming-in and
breastfeeding shall provide equipment, facilities, and
supplies for breastmilk collection, storage and
utilization, the standards of which shall be defined by
the Department of Health. Health institutions are
likewise encouraged to set up milk banks for storage
of breastmilk donated by mothers and which have
undergone pasteurization. The stored breastmilk willprimarily be given to children in the neonatal
intensive care unit whose own mothers are seriously
ill. (Sec. 10, RA 7600 as amended )
Establishment of Lactation Stations
It is hereby mandated that all health and non-health
facilities, establishments or institutions shall establish
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lactation stations. The lactation stations shall be
adequately provided with the necessary equipment
and facilities, such as: lavatory for hand-washing,
unless there is an easily-accessible lavatory nearby;
refrigeration or appropriate cooling facilities for
storing expressed breastmilk; electrical outlets forbreast pumps; a small table; comfortable seats; and
other items, the standards of which shall be defined
by the Department of Health. The lactation station
shall not be located in the toilet.
In addition, all health and non-health facilities,
establishments or institutions shall take strict
measures to prevent any direct or indirect form of
promotion, marketing, and/or sales of infant formula
and/or breastmilk substitutes within the lactationstations, or in any event or circumstances which may
be conducive to the same.
Apart from the said minimum requirements, all
health and non-health facilities, establishments or
institutions may provide other suitable facilities or
services within the lactation station, all of which,
upon due substantiation, shall be considered eligible
for purposes of Section 14 of this Act. (Sec. 11 asadded by RA 10028 amending RA 7600)
Lactation Periods
Nursing employees shall granted break intervals in
addition to the regular time-off for meals to
breastfeed or express milk. These intervals, which
shall include the time it takes an employee to get to
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and from the workplace lactation station, shall be
counted as compensable hours worked. The
Department of Labor and Employment (DOLE) may
adjust the same: Provided, That such intervals shall
not be less than a total of forty (40) minutes for every
eight (8)-hour working period. (Sec. 12 as added by RA 10028 amending RA 7600)
Continuing Education, Re-education and Training
The Department of Health with the assistance of
other government agencies, professional and
nongovernmental organizations shall conduct
continuing information, education, re-education, and
training programs for physicians, nurses, midwives,
nutritionist-dietitians, community health workers andtraditional birth attendants (TBAs) and other health
worker on current and updated lactation management.
Information materials shall be given to all health
workers involved in maternal and infant care health
institutions. (Sec. 13 as added by RA 10028)
During the prenatal, perinatal and postnatal
consultations and/or confinements of the mothers orpregnant women in a health institution and the health
worker to immediately and continuously teach, train
and support the women on current and updated
lactation management and infant care, through
participatory strategies such as organization of
mothers' clubs and breastfeeding support groups and
to distribute written information materials on such
matters free of charge.
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importance, benefits, methods or techniques of
breastfeeding, and change of societal attitudes
towards breastfeeding. (Sec. 15, as added by RA
10028)
Breastfeeding Awareness Month
To raise awareness on the importance of and to
further promote breastfeeding, the month of August
in each and every year throughout the Philippines
shall be known as "Breastfeeding Awareness Month."
(Sec. 16 as added by RA 10028)
Public Education and Awareness Program
To ensure the meaningful observance of breastfeeding month as herein declared, a
comprehensive national public education and
awareness program shall be undertaken in order to
achieve the following objectives:
a) To protect, promote and support
breastfeeding in the Philippines as the
normal, natural and preferred method of
feeding infants and young children;
b) To guarantee the rightful place of
breastfeeding in society as a time honored
tradition and nurturing value as well as a
national health policy that must be enforced;
c) To provide information about the
benefits and superiority of breastfeeding and
the high risks and costs of bottlefeeding;
d) To generate awareness on, and full
enforcement of, national and international
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laws, codes, policies and programs on the
promotion and protection of safe and
adequate nutrition for infants and young
children by promoting and protecting
breastfeeding and regulating the marketing of
certain foods and feeding bottles, teats andpacifiers; and
e) To instill recognition and support and
ensure access to comprehensive, current and
culturally appropriate lactation care and
services for all women, children and
families, including support for breastfeeding
mothers in the work force.
The Department of Health shall lead in the
implementation of the comprehensive national publiceducation and awareness program on breastfeeding
through a collaborative interagency and multi-
sectoral effort at all levels. (Sec. 17 as added by RA
10028)
Department of Health Certification
Any health and non-health facility, establishment
or institution satisfying the requirements of Sections6 and 7 herein relative to a proper lactation station
may apply with the local Department of Health office
for a 'working mother-baby friendly' certification.
The Department of Health shall promulgate
guidelines to determine eligibility for such
certification, which shall include an annual
Department of Health inspection to confirm the
continued compliance with its standards.
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society, specially parents and children, are informed
of the advantages of breastfeeding.
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.
On August 15, 2006, the Court issued a Resolution
granting a TRO enjoining respondents from
implementing the questioned RIRR.
On the issue of petitioner's standing
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, to wit:
The modern view is that an associationhas standing to complain of injuries to
its members. This view fuses the legal
identity of an association with that of its
members. 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
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of the land and therefore the DOH may implement
them through the RIRR.
The Court notes that the following international
instruments invoked by respondents, namely: (1) The
United Nations Convention on the Rights of theChild; (2) The International Covenant on Economic,
Social and Cultural Rights; and (3) the Convention
on the Elimination of All Forms of Discrimination
Against Women, only provide in general terms that
steps must be taken by State Parties to diminish
infant and child mortality and inform society of the
advantages of breastfeeding, ensure the health and
well-being of families, and ensure that women are
provided with services and nutrition in connection
with pregnancy and lactation. Said instruments donot contain specific provisions regarding the use or
marketing of breastmilk substitutes.
The international instruments that do have specific
provisions regarding breastmilk substitutes are the
ICMBS and various WHA Resolutions.
Under the 1987 Constitution, international law can
become part of the sphere of domestic law either bytransformation or incorporation. The
transformation method requires that an international
law be transformed into a domestic law through a
constitutional mechanism such as local legislation.
The incorporation method applies when, by mere
constitutional declaration, international law is
deemed to have the force of domestic law.
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recommendation rather than a
regulation. x x x (Emphasis supplied)
The legal value of WHA Resolutions as
recommendations is summarized in Article 62 of the
WHO Constitution, to wit:
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 urgingmember states to implement the ICMBS are merely
recommendatory and legally non-binding. Thus,
unlike what has been done with the ICMBS
whereby the legislature enacted most of the
provisions into law which is the Milk Code, the
subsequent WHA Resolutions, specifically
providing for exclusive breastfeeding from 0-6
months, continued breastfeeding up to 24 months,
and absolutely prohibiting advertisements andpromotions of breastmilk substitutes, have not
been adopted as a domestic law.
It is propounded that WHA Resolutions may
constitute “soft law” or non-binding norms,
principles and practices that influence state
behaviour. “Soft law” does not fall into any of the
categories of international law set forth in Article 38,
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Chapter III of the 1946 Statute of the International
Court of Justice. It is, however, an expression of non-
binding norms, principles, and practices that
influence state behaviour. Certain declarations and
resolutions of the UN General Assembly fall under
this category.The most notable is the UN Declarationof Human Rights, which this Court has enforced in
various cases, specifically, Government
of Hongkong Special Administrative Region v.
Olalia, Mejoff v. Director of
Prisons, Mijares v. Rañada[
and Shangri-la
International Hotel Management, Ltd. v. Developers
Group of Companies, Inc.
The World Intellectual Property Organization
(WIPO), a specialized agency attached to the UNwith the mandate to promote and protect intellectual
property worldwide, has resorted to soft law as a
rapid means of norm creation, in order “to reflect and
respond to the changing needs and demands of its
constituents.” Other international organizations
which have resorted to soft law include the
International Labor Organization and the Food and
Agriculture Organization (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
Syndrome (SARS) and Avian flu outbreaks.
Although the IHR Resolution does
not create new international law
binding on WHO member states, it
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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 forimproved 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 norenforceable, 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,
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of products within the scope of the Code, is
vague:
MILK CODE RIRR
SECTION
6. The GeneralPublic and
Mothers. –
(a) No
advertising,
promotion or
other marketing
materials,
whether written,
audio or visual,
for productswithin the scope
of this Codeshall
be printed,
published,
distributed,
exhibited and
broadcast unless
such materials
are dulyauthorized and
approved by an
inter-agency
committee create
d herein pursuant
to the applicable
standards
Section 4. Declaration of
Principles – The following arethe underlying principles from
which the revised rules and
regulations are premised upon:
x x x x
f. Advertising, promotions, or
sponsor-ships of infant
formula, breastmilk substitutes
and other related products areprohibited.
Section 11. Prohibition – No
advertising, promotions,
sponsorships, or marketing
materials and
activities for breastmilk substitute
s intendedfor infants and young
children up to twenty-four (24)months, shall be allowed, because
they tend to convey or give
subliminal messages or
impressions that
undermine breastmilk and
breastfeeding or otherwise
exaggerate breastmilksubstitutes
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provided for in
this Code.
and/or replacements, as well as
related products covered within
the scope of this Code.
Section 13. “Total Effect” -
Promotion of products within thescope 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 productwould 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.
Section 15. Content of Materials. - The following shall
not be included in advertising,
promotional and marketing
materials:
a. Texts, pictures, illustrations
or information which discourage
or tend to undermine the benefits
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Thousand (P10,000.00)
to Fifty Thousand
(P50,000.00) Pesos,
depending on the
gravity and extent of
the violation, includingthe recall of the
offending product;
c) 3rd
violation –
Administrative Fine of
a minimum of Sixty
Thousand (P60,000.00)
to One Hundred Fifty
Thousand
(P150,000.00) Pesos,
depending on thegravity and extent of
the violation, and in
addition thereto, the
recall of the offending
product, and suspension
of the Certificate of
Product Registration
(CPR);
d) 4
th
violation –Administrative Fine of
a minimum of Two
Hundred Thousand
(P200,000.00) to Five
Hundred (P500,000.00)
Thousand Pesos,
depending on the
gravity and extent of
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the violation; and in
addition thereto, the
recall of the product,
revocation of the CPR,
suspension of the
License to Operate(LTO) for one year;
e) 5th
and succeeding
repeated violations –
Administrative Fine of
One Million
(P1,000,000.00) Pesos,
the recall of the
offending
product, cancellation
of the CPR, revocationof the License to
Operate (LTO) of the
company concerned,
including the
blacklisting of the
company to be
furnished the
Department of Budget
and Management(DBM) and the
Department of Trade
and Industry (DTI);
f) An additional penalty of
Two Thou-sand Five
Hundred (P2,500.00)
Pesos per day shall be
made for every day the
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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 andbeverages, 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 satisfythe 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
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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.
But there is another target group.
Breastmilk substitute is defined under Section 4(a)
as “any food being marketed or otherwise presented
as a partial or total replacement for breastmilk,
whether or not suitable for that purpose.” This
section conspicuously lacks reference to any
particular age-group of children. Hence, the
provision of the Milk Code cannot be
considered exclusive for children aged 0-12
months. In other words, breastmilk substitutes mayalso be intended for young children more than 12
months of age. Therefore, by regulating breastmilk
substitutes, the Milk Code also intends to protect and
promote the nourishment of children more than 12
months old.
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 regulationpursuant 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 and 5(ff) of the RIRR.
2. It is also incorrect for petitioner to say that the
RIRR, unlike the Milk Code, does not recognize
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Administrative Code, and as delegated in particular
under the Milk Code.
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. 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.
As early as the 1917 Revised Administrative Code
of the Philippine Islands, health information was
already within the ambit of the regulatory powers of the predecessor of DOH. Section 938 thereof charged
it with the duty to protect the health of the people,
and vested it with such powers as “(g) the
dissemination of hygienic information among the
people and especially the inculcation of knowledge
as to the proper care of infants and the methods of
preventing and combating dangerous communicable
diseases.”
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.” To that end, it was
granted under Section 3 of the Administrative Code
the power to “(6) propagate health information
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and mothers of infants, shall
include clear information on all
the following points: (1) the
benefits and superiority of
breastfeeding; (2) maternal
nutrition, and the preparation forand maintenance of breastfeeding;
(3) the negative effect on
breastfeeding of introducing
partial bottlefeeding; (4) the
difficulty of reversing the decision
not to breastfeed; and (5) where
needed, the proper use of infant
formula, whether manufactured
industrially or home-
prepared. When such materials contain information about the
use of infant formula, they shall
include the social and financial
implications of its use; the health
hazards of inappropriate foods or
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 text which may
idealize the use
of breastmilk substitutes.
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SECTION 8. Health
Workers –
x x x x
(b) Information provided by
manufacturers and distributors tohealth professionals regarding
products 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 bottlefeeding is equivalent
or superior to breastfeeding. It
shall also include the
information specified in Section5(b) .
SECTION
10. Containers/Label –
(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 asnot to discourage breastfeeding.x x x x
(d) The term “humanized,”
“maternalized” or similar terms
shall not be used. (Emphasis
supplied)
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In this case, correct information as to infant
feeding and nutrition is infused with public interest
and welfare.
4. With regard to activities for dissemination of
information to health professionals, the Court alsofinds that there is no inconsistency between the
provisions of the Milk Code and the RIRR. Section
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 information is restricted to scientific and
factual matters.
Contrary to petitioner's claim, Section 22 of the
RIRR does not prohibit the giving of information tohealth 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 activities for the promotion, education
and production of Information, Education and
Communication (IEC) materials regarding
breastfeeding that are intended for women and
children. Said provision cannot be construed to
encompass even the dissemination of information to health professionals, as
restricted by the Milk Code.
5. Next, petitioner alleges that Section 8(e) 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
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argument against this particular provision must be
struck down.
It is Sections 9 and 10 of the RIRR which govern
research assistance. Said sections of the RIRR
provide that research assistance for health workersand 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 RIRRimposing 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 32 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) of the Milk Code,which providesthat 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.
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Respondent's reliance on Civil Aeronautics Board
v. Philippine Air Lines, Inc. is misplaced. The
glaring difference in said case and the present case
before the Court is that, in the Civil Aeronautics
Board , the Civil Aeronautics Administration (CAA)
was expressly granted by the law (R.A. No. 776)the power to impose fines and civil penalties, while
the Civil Aeronautics Board (CAB) was granted by
the same law the power to review on appeal the order
or decision of the CAA and to determine whether to
impose, remit, mitigate, increase or compromise such
fine and civil penalties. Thus, the Court upheld the
CAB's Resolution imposing administrative fines.
In a more recent case, Perez v.
LPG Refillers Association of the Philippines, Inc., theCourt upheld the Department of Energy (DOE)
Circular No. 2000-06-10 implementing Batas
Pambansa (B.P.) Blg. 33. The circular provided for
fines for the commission of prohibited acts. The
Court found that nothing in the circular contravened
the law because the DOE was expressly authorized
by B.P. Blg. 33 and R.A. No. 7638 to impose fines
or penalties.
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
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SECTION 5 x x x. (w) “Milk
Company” shall refer to the owner,
manufacturer, distributor of infant
formula, follow-up milk, milk formula,
milk supplement, breastmilk substitute or
replacement, or by any other descriptionof such nature, including their
representatives who promote or
otherwise advance their commercial
interests in marketing those products;
On the other hand, Section 4 of the Milk Code
provides:
(d) “Distributor” means a person,
corporation or any other entity in thepublic 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.
x x x x(j) “Manufacturer” means a
corporation or other entity in the public
or private sector engaged in the business
or function (whether directly or
indirectly or through an agent or and
entity controlled by or under contract
with it) of manufacturing a products
within the scope of this Code.
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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 productsmanufactured 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 RIRRproviding 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
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