Senate

Gite of the ocretaey

FIFTEENTH CONGRESS OF THE —_)
REPUBLIC OF THE PHILIPPINES —_)
First Regular Session ) : 0 eG 14 pase

SENATE.
RECHIVED BY:
5.B.No, 2627

Introduced by Senator Loren Legarda

EXPLANATORY NOTE

One of the eight Millennium Development Goals that all United Nations member
states have agreed to achieve by the year 2015 is the reduction of child mortality rate. In
five years’ time, we are expected to diminish by two-thirds the rate of child deaths,
which are caused mostly by health hazards.

According to the World Health Organization (WHO), poor nutrition is associated
with over 50% of deaths in children under the age of five. Furthermore, the lack of
exclusive breastfeeding of infants during the first six months was found to have
contributed to more than a million child deaths each year, which can be réduced with
appropriate feeding.

Breastmilk is the ideal food for newborns and infants because it not only
provides them all the nutrients they need for healthy development, but also contains
antibodies that protect them from common childhood illnesses including diarrhea and
pneumonia. The WHO recommends that infants be restricted to breastfeeding for the
first six months of their life, after which, other foods should be given along with
continuous breastfeeding for up to two years and beyond.

Breastfeeding has also been proven to bring mothers several health benefits, such
as reduced risks of acquiring breast and ovarian cancer, faster restoration of pre-
pregnancy weight, and less probability of being obese.

Studies have also revealed that breastfeeding provides health benefits later in
life. Most adults who were breastfed as babies have lower blood pressure and lower
cholesterol, are less likely to become overweight and obese, and are less prone to type-2
diabetes.

In contrast, the use of infant formula can lead to some health hazards, primarily
because it lacks the antibodies found in breastmilk. Also, many families do not have
access to safe water, therefore, children are at greater risk of acquiring water-borne
diseases when powdered milk is mixed with unsafe water.

With the worldwide rate of less than 40% of infants under six months of age
being exclusively breastfed, a lot of parents are obviously still unaware of the necessity
of practicing breastfeeding. This is due to the lack of information on the multitude of
benefits that come with breastfeeding and on the consequences of using substitute
formula.


This bill aims to inform families, health workers, and those involved in the field
of infant and young child nutrition, on the advantages and superiority of breastfeeding,
maternal nutrition, and the proper use of infant formula, among others

A serious campaign on the promotion of breastfeeding should be implemented
so that everyone may well be aware that breastmilk not only satisfies the hunger of
infants and toddlers, but also ensures better health and improved development of both
mothers and their children.

In view of the foregoing, the passage of this bill is earnestly sought.

_—

—=——“Lo ARDA
Senator


weeyvaneune

GD Spewate
FIFTEENTH CONGRESS OF THE) , SAP ice of the Srvetary
REPUBLIC OF THE PHILIPPINES)

First Regular Session ) 0 O14 p43

REY

SENS do7
S. B. No. (2
RIVED BY: ©

Introduced by Senator Loren Legarda

AN ACT
PROTECTING, PROMOTING AND PRIORITIZING BREASTFEEDING
THROUGH CREATING A HOLISTIC FRAMEWORK FOR MOTHERS AS A
MEANS OF ENSURING THE HEALTH AND WELL-BEING OF INFANTS

Be it enacted by the Senate and House of Representatives of the Philippines in Congress
assembled: :

CHAPTER I
GENERAL PROVISIONS

SECTION 1. Short Title. This Act shall be known as the “Breastfeeding
Promotion Act of 2010.”

SEC. 2. Objectives. The objective of this Act is:

1. To contribute to the provision of safe and adequate nutrition for infants by
the protection, promotion and support of breast feeding and by ensuring the
proper use of breastmilk substitutes when these are necessary, on the basis of
adequate information and through appropriate marketing and distribution.

SEC. 3. Scope. This Act applies to the marketing and practices related thereto, of
the following products: breastmilk substitutes, including infant formula; and 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.

SEC. 4. Definition of Terms. For the purposes of this Act, the following
definition of terms shall govern:

(a) “Advertising” means the business of conceptualizing, presenting or
making available to the public, through any ‘form of mass media, fact, data or
information about the attributes, features, quality or availability of products within the
scope of this Act.

(b)  “Breastmilk Substitute” means any food being marketed or otherwise
represented as a partial or total replacement for breastmilk, whether or not suitable for
that purpose.


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() “Complementary Food or Breastmilk Supplement” means any food
whether manufactured or locally prepared, suitable as a complement to breastmilk or to
infant formula, when either becomes insufficient to satisfy the nutritional requirements
of the infant. This can include products also commonly called as "weaning food".

(@) “Container” means any form of packaging of products for sale as a normal
retail unit, including wrappers :

(©) “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 Act. A “primary
distributor” is a manufacturer's sales agent, representative, national distributor or
broker.

(g) “DoH” refers to the Department of Health
(h) “Infant” means a person falling within the age bracket of 0-12 months.

(i) “RDA” refers to the Food and Drug Administration (FDA) created
pursuant to Republic Act No. 9711, formerly known as the Bureau of Food and Drugs
(BFAD).

() “Health care system” means governmental, non-governmental or private
institutions or organizations engaged, directly or indirectly, in health care for mothers,
infants and pregnant women; and nurseries or child care institutions. It also includes
health workers in private practice. For the purpose of this Act, the health care system
does not include pharmacies or other established sales outlets.

(k) “Health Worker” means a person working in a component of such health
care system, whether professional or non-professional, including volunteer workers. It
also includes health workers in private practice. Traditional and other birth attendants,
their assistants and other community volunteers involved in health and nutrition
promotion and education shall likewise be included.

() “Infant Formula” means a breastmilk substitute formulated industrially in
accordance with applicable Codex Alimentarius standards, to satisfy the normal
nutritional requirements of infants up to between four to six months of age, and
adapted to their physiological characteristics. Infant formula may also be prepared at
home in which case it is described as "home-prepared."

(m) “Label” means any tag, brand, mark, pictorial or other descriptive matter,
written, printed, stenciled, marked, embossed or impressed on, or attached to, a
container of any product within the scope of this Act.

(n) “Manufacturer” means a corporation or other entity in the public or
private sector engaged in the business or function (whether directly or through an agent
or an entity controlled by or under contract with, it) of manufacturing a product within
the scope of this Act.

(0) “Marketing” means product promotion, distribution, selling, advertising,
product public relations, and information services.

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(p) “Marketing firm” refers to any entity that does marketing or provides
marketing services.

(Q “Marketing personnel” means any person whose functions involve the
marketing of a product or products coming within the scope of this Act.

(©) “Milk company” shall refer to the ‘owner, manufacturer, distributor, of
breastmilk substitute or supplements, including their representatives who promote or
otherwise advance their commercial interests in marketing those products.

() “Other milk products, foods and beverages” refers to any provision or
drink marketed as a partial or total replacement of breastmilk.

() “Other related products” refers to all materials used to administer
breastmilk substitutes, such as, but not limited to, feeding bottles, teats and other
artificial feeding paraphernalia.

(u) “Products within the scope of this Act” shall pertain to breastmilk
substitutes, including infant formula, other milk products, food and beverages,
including bottle-fed complementary foods, as well as teats and other commodities
which intend to replace or substitute, in whole or in part, breastmilk and breastfeeding.

(v) “Promotions” means the practice of giving temporary additional value to
a product or service to achieve specific marketing objectives.

(w) “Sample” means single or small quantities of a product provided without
cost.

(x) “Secretary” shall mean the Secretary of Health.

(y) “Supplies” means quantities of a product provided for use over an
extended period, free or at a low price, for social purposes, including those provided to
families in need.

(2) “Young child” means a person from the age of more than twelve (12)
months up to the age of three (3) years (36 months)

CHAPTER IT
INFORMATION AND EDUCATION

SEC. 5, The Department of Health shall ensure that objective and consistent
information is provided on infant and young child feeding for use by families and those
involved in the field of infant and young child nutrition. This responsibility shall cover
the planning, provision, design and dissemination of information, and the control
thereof, on infant and young child nutrition.

The Department of Health should take appropriate measures to encourage and
protect breastfeeding and promote the pringiples of this code, It should give
appropriate information, training and advice to health workers in regard to their
responsibilities, including the information specified in Section 6.

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SEC, 6. Standards. Informational and educational materials, whether written,
audio, or visual, dealing with the feeding of infants and intended to reach pregnant
women and mothers of infants, shall include clear information on all the following
points:

(a) __ the benefits and superiority of breastfeeding

(b) maternal nutrition, and the preparation for and maintenance of
breastfeeding ,

(©) the negative effect on breast feeding of introducing partial bottle-feeding

(d) the difficulty of reversing the decision not to breastfeed

(&) 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.

SEC. 7. Donations of informational or educational equipment or materials by
manufacturers or distributors should be made only upon written approval of the
appropriate government authority. Such equipment or materials may bear the donating
company’s name or logo, but should not refer to a proprietary product that is within the
scope of this Act, and should be distributed only through the health care system.

SEC. 8. Manufacturer, distributor or representatives of products covered by the
Code may be allowed to conduct or be involved in the promotion, education and
production of Information, Education and Communication (TEC) materials on
breastfeeding, infant and young child care and nutrition, as long as the programs and
materials used are reviewed and approved by the Secretary, Promotion of products
intended for infants 0-12 months as covered by this code will not be allowed in such
venues.

SEC. 9, Personnel employed in marketing products within the scope of this Code
shall not, as part of their job responsibilities, perform educational functions in relation
to pregnant women or mothers of infants and young, children. This should not be
understood as preventing such personnel from being used for other functions by the
health care systems at the request and with the written approval of the appropriate
authority of the government concerned.

CHAPTER III
RESEARCH

SEC. 10. Research, Ethics Committee, Purpose - The DOH shall ensure that
research conducted for public policy purposes, related to infant and young child
feeding, should, at all times, be free from any commercial influence/bias; accordingly,
the health worker or researcher involved in such must disclose any actual or potential
conflict of interest with the company/ person funding the research. In any event, such

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research and its funding shall be subjected to independent peer review. Towards
accomplishing these ends;

(a) Assistance for research and clinical trials given by manufacturers and
distributors are allowed only upon approval by an Ethics Committee and the DOH.
The same committee shall monitor said researches.

(b) The researches shall be conducted in accordance with an approved
protocol. Any changes in the protocol after it has been approved will be subject to a
new review and approval by the Ethics Committee

(0) Assistance for research may be’ allowed subject to the following
conditions:

1. Researches involving well or ill infants and children as subjects shall be
limited to physiological factors and therapeutic studies

2. These studies should in no case be harmful to the subject

3. Should be limited to those with potential benefits for the particular
subject.

(4) Recipients of research awards shall not allow themselves, their
organizations or their subjects, to be used directly or indirectly for any promotional
activity related to products within the scope of this Code. These may be by way of
display of posters and streamers patronizing the Company, their products and/or as
lecturers/speakers or testimonials in the promotion of the products that undermine
breastfeeding.

(&) Assistance for support of laboratory costs, reagents and other materials
shall be allowed only upon approval and review by the Ethics Committee regarding the
used based on submitted protocol.

SEC. 11. - Public Disclosure - For transparency purposes, a disclosure and/or
disclaimer of the sponsoring company should be done by the company itself, health
worker, researcher involved through verbal declaration during public presentation of
the research and in print upon publication.

CHAPTER IV
ADVERTISING, PROMOTION AND SPONSORSHIPS

SEC. 12. Responsibilities of the Secretary - ‘The Secretary shall review all
advertising, promotion or other marketing materials, whether written, audio, visual,
audio-visual and electronics, including but not limited to mail, email, text messages,
telephone calls and web site advertising for products as defined under section 9 and 10
of this code.

The Secretary shall develop, update substantive and procedural guidelines for
reviewing advertising, promotional and marketing materials, including its screening

when deemed appropriate. All such materials must have been approved and consented

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to in writing by the Secretary before the Company's first public or commercial
exhibition.

SEC. 13. Prior Written Consent and Approval of the Secretary - No advertising,
promotion or other marketing materials as defined in sections 14 and 15, whether
written, audio, visual, audio-visual, and electronic shall be printed, published,
distributed, exhibited and broadcasted or in any manner released to the public without
the prior review and approval by the Secretary. No blanket or general approval shall be
allowed. Such written approval must be specific in product and time bound.

SEC. 14. Advertising.

(a) Advertising for infant formula and other products within the scope of this
code intended for infants 0-6 months shall not be allowed.

(b) Advertising for infant formula and other products within the scope of this
code intended for infants 6-12 months shall be allowed upon review and approval of the
Secretary.

(Advertising of breastmilk supplement for a young child 12 months and
older shall be allowed.

SEC. 15. Promotions.
(a) The General Public and Mothers

1. Promotion for products within the scope of this code intended for infants
0-12 months shall not be allowed.

2. Promotions of breastmilk supplement for a young child 12 months and
older shall be allowed as long as it does not undermine superiority of
breastfeeding.

(b) Healthcare System and Health Workers

1. Promotion of products within the scope of this code intended for infants
0-12 months shall be allowed upon the review and approval of the
Secretary.

2, Promotion of products for a young child 12 months and older shall be
allowed as long as it does not undermine superiority of breastfeeding.

SEC 16. Contents 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 or superiority of breastfeeding or which idealize the use of
breastmilk substitutes and milk supplements. In this connection, no pictures of babies
and children together with their mothers, fathers, siblings, grandparents, other relatives
or caregivers (or yayas) shall be used in any advertisements for infant formula and
breastmilk supplements.


(b) The term “humanized”, “Maternalized”, “close to mother’s milk” or
similar words describing breastmilk substitutes or-milk supplements

(c) __ Pictures or texts that idealize the use of infant and milk formula.
SEC. 17. Health and Nutritional Claims.

(a) Health and nutritional claims for products within the scope of the Act are
allowed as long as it is based on scientific and factual information upon review and
approval by the Secretary.

(b) False or misleading information or claims of products within the scope of
the Code are prohibited.

(©) 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.

SEC. 18. Information to Healthcare Workers. - Information provided by
manufacturers and distributors to health professionals regarding, products within the
scope of this Code shall be restricted to scientific and factual information, and such
information shall not imply or create a belief that bottle-feeding is equivalent or
superior to breastfeeding. It shall also include the information specified in Section 6 ().

SEC. 19. Promotions in Healthcare System. -

(a) No facility of the health care system shall be used for the purpose of
promoting products intended for infant 0-12 months within the scope of this Act. This Act
does not however preclude the dissemination of scientific and factual information to
health professionals as provided in Section 18.

(b) Facilities of the health care system shall not be used for the display of
products, posters and materials intended for infants 0-12 months within the scope of this
Code as provided by a manufacturer or distributor.

() Manufacturers, distributors and marketing firms or the representatives are
prohibited from using the health workers in‘ the dissemination, distribution and
promotion of products intended for infants 0-12 months within the scope of this Act.

(d) The use by the health care system of "professional service" representatives,
"mothercraft nurses" or similar personnel, provided or paid for by manufacturers or
distributors, shall not be permitted. .

SEC. 20. Classes, Seminars for Women, - Manufacturers, distributors and
representatives of milk companies shall not be allowed to hold activities, classes and
seminars for pregnant women and mother of infants related to the promotion of
products intended for infants 0-12 months as covered by this Act.

SEC. 21. Inducements. - Financial or material inducements to promote products
within the scope of this Act shall not be given by milk companies to nor shall this be
accepted by the general public, mothers, pregnant women, health workers, hospital and

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other health institution, as well as to personnel within the health care system including
members of their families except as provided for in section 6 and 20.

SEC. 22, Samples and Supplies. - Samples.and supplies of products within the
scope of this code intended for infants 0-12 months or equipment/utensils for the
preparation or use of these products from manufacturers, distributors and
representatives shall not be allowed. to be given to any member of the general public,
mothers, pregnant women, health workers, hospitals and other health institutions, as
well as personnel within the healthcare system, including members of their families
except as provided for in sections 6 and 26.

Samples and supplies of products within the scope of this code intended for
infants 0-12 months cannot be given by health workers to the general public, mothers
and pregnant women including members of their families.

SEC. 23. Gifts of Any Sort. - Gift of any sort with or without company
name/logo, product or brand = name to.—-promote products or
equipment/utensils/articles for the preparation or use of these products within the
scope of this Act intended for infants 0-12 months, from manufacturers, distributors and
representatives shall not be allowed to be given to any member of the general public,
mothers, pregnant women, health workers, hospitals and other health institutions, as
well as personne] within the healthcare system, including, members of their families.

SEC. 24. Point of Sale. - There shall be no point of sale advertising, giving of
samples or any promotion devices to induce sales directly to the consumers at the retail
level, such as special displays, discount coupons, premiums, rebates, special sales,
bonus and tie-in sales, loss-leaders, prizes or gifts for the products intended for infants
0-12 months within the scope of this Act. This provision shall not restrict the
establishment of pricing policies and practices intended to provide products at lower
prices on a long-term basis.

CHAPTER V
CONTINUING EDUCATION, TRAINING

SEC. 25. Continuing Education and Training. - Manufacturers and distributors
of products within the scope of this Act may assist in the research, scholarships and
continuing education of health professionals, in accordance with the rules and
regulations promulgated by the Department of Health.

CHAPTER VI
DONATION

SEC. 26, Donations. - Nothing herein contained shall prevent donations from
manufacturers and distributors of products within the scope of this Act upon the
approval of the Secretary.

(a) Government and non-profit organizations accredited by the Department
of Social Work and Development that care for infants and children, and lack access to
wet nurses and lactating mothers ~=may receive donations from
manufacturers/ distributors of products.


(bt) In cases of_disasters/emergencies, donations —_ from
manufacturers/distributors/ organizations and other of products within the scope of
the code may be received/ distributed to the affected population under the supervision
of government agencies or non-profit organizations. The organizations concerned shall
submit a written report within thirty (30) days from receipt of donations including
name of organization, donations received, distribution list and other permanent details.
Receiving institutions shall not participate in any promotional activities of
manufacturer/ distributors of products within the scope of the Code.

(©) Donations should only be the last resort when other means such as human
milk banking and wet nursing have failed after reasonable effort.

(d) Equipment and materials, in addition to those referred to in Section 7,
donated to health care system may bear a company’s name or logo, but should not refer
to any proprietary product within the scope of this Act.

(c) Babies with inborn error of metabolism.

CHAPTER VII
CONTAINERS/LABELS

SEC. 27. Containers/Labels.

(a) Containers and/or labels shall be designed to provide the necessary
information about the appropriate use of the products, and in such a way as not to
discourage breastfeeding.

(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:

1. The words “Important Notice" or their equivalent
2. Astatement of the superiority of breastfeeding

3. 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

4. Instructions for appropriate preparation, and a warning against the health
hazards of inappropriate preparation.

(©) Neither the container nor the label shall have pictures or texts which may
idealize the use of infant formula. They may, however, have graphics for easy
identification of the product and for illustrating methods of preparation.

(d) The term "humanized," "maternalized" or similar terms shall not be used.

(e) Neither the container nor the label of milk products intended for infants 0-
12 months within the scope of this Act shall have pictures of babies and children
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together with their mothers, fathers, siblings, grandparents, other relatives or caregivers
(or yayas) or such other pictures and graphics of similar import.

SEC, 28, Infant Feeding Warning. - Food products within the scope of this Act
marketed for infant feeding, which do not meet ali the requirements of an infant
formula but which can be modified to do so, shall carry on the label a warning that the
unmodified product should not be the sole source of nourishment of an infant

SEC. 29. Authority of the FDA. - The labels of food products within the scope of
this Act shall, in addition to the requirements in the preceding paragraphs, conform
with the rules and regulations of the Food and Drugs Administration.

CHAPTER VII
QUALITY

SEC. 30. Quality. -

(@) The quality of products is an essential element for the protection of the
health of infants, and therefore shall be of high recogni zed standard.

(b) Food products within the scope of this Act shall when sold or otherwise
distributed, meet applicable standards recommended by the Codex Alimentarius
Commission and also the Codex Code of Hygienic Practice for Foods for Infants and
Children.

(To prevent quality deterioration. adulteration or contamination of food
products within the scope of this Act, distribution outlets, including the smallest sari-
saristore, shall not be allowed to open cans and boxes for the purpose of retailing
them by the cup, bag or in any other form.

CHAPTER IX
IMPLEMENTATION AND MONITORING

SEC. 31. Powers and Functions of the Secretary.~

(a) For purposes of Section 8 of this Act, the Secretary shall have the
following, powers and functions:

1. To review and examine all advertising, promotion or other marketing
materials, whether written, audio or visual, on products within the
scope of this Act; :

2. To approve or disapprove, delete objectionable portions from and
prohibit the printing, publication. distribution, exhibition and
broadcast of, all advertising promotion or other marketing materials,
whether written, audio or visual, on products within the scope of this
Act;

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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

4, To promulgate such rules and regulations as are necessary or proper
for the implementation of Section 8 of this Act.

(b) The Department of Health shall be principally responsible for the
implementation and enforcement of the provisions of this Act. For this purpose, the
Department of Health shall have the following powers and function:

1. To promulgate such rules and regulations as are necessary or proper
for the implementation of this Act and the accomplishment of its
purposes and objectives.

2. To call the assistance of government agencies and the private sector to
ensure the implementation and enforcement of, and strict compliance
with, the provisions of this Act and the rules and regulations
promulgated in accordance herewith.

3, To cause the prosecution of the violators of this Act and other
pertinent laws on products covered by this Act.

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
Act.

CHAPTER XI
SANCTIONS

SEC. 32. Sanctions. -

(a) Any person who violates the pravisions of this Act or the rules and
regulations issued pursuant to this Act shall, upon conviction, be punished by
penalty of Two Hundred Fifty Thousand Pesos (P250,000.00). 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 therefore,
shall be penalized.

(©) 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 professional or occupation, or for the pursuit of their business, may,
upon recommendation of the Department of Health, be suspended or revoked in the
event of repeated violations of this Act, or of the rules and regulations issued pursuant
to this Act.

CHAPTER XIII
FINAL PROVISIONS

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SEC. 33. Implementing Rules and Regulations. - The Department shall issue the
implementing rules and regulations for this Act within one hundred twenty days (120)
days from its effectivity.

SEC. 34. Separability Clause. - If for any reason, any part or provision this Act
be declared invalid or unconstitutional, such invalidity or unconstitutionality shall not
affect the other provisions which shall remain in full force and effect.

SEC. 35. Repealing Clause. ~ Executive Order No. 51, promulgated on October
20, 1986 is hereby repealed. All orders, issuances, and rules and regulations or parts
thereof inconsistent with this Act are hereby repealed and modified accordingly.

SEC. 36. Effectivity. - This Act shall take effect fifteen (15) days after its
publication in any newspaper of general circulation.

Approved,

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