on breastfeeding and breastmilk substitutes: the legal aspect

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



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



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)



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



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



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



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



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



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



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.



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



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.



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



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.



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,



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



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,



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



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



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



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



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



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



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



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.



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)



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



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.



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



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.



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

on breastfeeding and breastmilk substitutes: the legal aspect

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