The Milk Code and Revised The Milk Code and Revised Implementing Rules and Implementing Rules and

RegulationsRegulations

Adapted from:Adapted from:Prof. Leticia Barbara B. Gutierrez, M.S.Prof. Leticia Barbara B. Gutierrez, M.S.Director IV Bureau of Food and DrugsDirector IV Bureau of Food and Drugs

““The Breastfeeding Highway… Begins at the Hospital”The Breastfeeding Highway… Begins at the Hospital” 17 December 2007 Manila Hotel 17 December 2007 Manila Hotel

Why promote breastfeedingWhy promote breastfeeding

BB est for babyest for baby

RR educes the incidence of allergies educes the incidence of allergies such as asthma and eczemasuch as asthma and eczema

E E conomical (least costly Poverty conomical (least costly Poverty Alleviation Strategy)Alleviation Strategy)

AA ntibodies – greater immunity to ntibodies – greater immunity to some infectious diseasessome infectious diseases

SS tool inoffensive – hardly ever tool inoffensive – hardly ever constipatedconstipated

TT emperature always idealemperature always ideal

FF resh milk - never goes off resh milk - never goes off

EE motionally bonding motionally bonding

EE cologically sound cologically sound

DD igested easily igested easily

II mmediately available mmediately available

NN utritionally optimal utritionally optimal

G G astroenteritis greatly astroenteritis greatly reducedreduced

E.O. 51E.O. 51

National Code of Marketing of National Code of Marketing of Breastmilk Substitutes, Breastmilk Breastmilk Substitutes, Breastmilk

Supplements,Supplements,

and Other Related Productsand Other Related Products

-Signed into law on 20 October 1986-Signed into law on 20 October 1986

Aim of the Code (Section 2)Aim of the Code (Section 2)

““to contribute to the provision of safe and to contribute to the provision of safe and adequate nutrition for infantsadequate nutrition for infants

-by the protection and promotion of -by the protection and promotion of breastfeeding; andbreastfeeding; and

-by ensuring the proper use of -by ensuring the proper use of breastmilk substitutes and breastmilk breastmilk substitutes and breastmilk supplements when these are necessary on supplements when these are necessary on the basis of adequate information and the basis of adequate information and through through appropriate marketing and appropriate marketing and distributiondistribution

Scope of the Code Scope of the Code (Section 3 of E.O. 51)(Section 3 of E.O. 51)

The Code applies to the The Code applies to the marketingmarketing, , and and practices related theretopractices related thereto, of , of the following products:the following products:

-breastmilk substitutes, including -breastmilk substitutes, including infant infant formula; formula;

-other milk products-other milk products

-foods and beverages, including -foods and beverages, including bottlefed complementary foods, when bottlefed complementary foods, when marketed or otherwise represented to be marketed or otherwise represented to be suitable, with or without modification, for use suitable, with or without modification, for use as partial or total replacement of breastmilk;as partial or total replacement of breastmilk;

-feeding bottles and teats-feeding bottles and teats

It also applies to their It also applies to their qualityquality and and availabilityavailability, , and to and to informationinformation concerning their use. concerning their use.

Scope of the Code Scope of the Code

Definition of termsDefinition of terms

““Health care systemHealth care system””-means governmental, non--means governmental, non-

governmental or private governmental or private institutions or organizations institutions or organizations engaged, directly or indirectly, in engaged, directly or indirectly, in health care for mothers, infants health care for mothers, infants and pregnant women; and and pregnant women; and nurseries or child care institutions. nurseries or child care institutions. It also includes health workers in It also includes health workers in private practice.private practice.

““Health WorkerHealth Worker””

means a person working in a means a person working in a component of such health care component of such health care system, whether professional or system, whether professional or non-professional, including non-professional, including volunteer workersvolunteer workers

Prohibitions / ViolationsProhibitions / ViolationsSec. 6 (b) Manufacturers and distributors Sec. 6 (b) Manufacturers and distributors shall not be permitted to give, directly or shall not be permitted to give, directly or indirectly, indirectly,

samples and supplies of products within the samples and supplies of products within the scope of this Codescope of this Code, or , or

gifts of any sort gifts of any sort

to any member of the general public, to any member of the general public, including members of their families, to including members of their families, to hospitals and other health institutions, as hospitals and other health institutions, as well as to personnel within the health care well as to personnel within the health care system, save as otherwise provided in this system, save as otherwise provided in this Code.Code.

Sec.6 (d) Manufacturers and Sec.6 (d) Manufacturers and distributors distributors shall not distribute to shall not distribute to pregnant women or mothers of pregnant women or mothers of infants any gifts or articles or utensilsinfants any gifts or articles or utensils which may promote the use of which may promote the use of breastmilk substitutes or bottle breastmilk substitutes or bottle feeding, nor shall any other groups, feeding, nor shall any other groups, institutions or individuals distribute institutions or individuals distribute such gifts, utensils or products to the such gifts, utensils or products to the general public and mothers.general public and mothers.

Sec.7 (b) No facility of the health care Sec.7 (b) No facility of the health care system shall be used for the purpose system shall be used for the purpose of of promoting infant formula or other promoting infant formula or other products within the scope of this products within the scope of this CodeCode..

Sec.7 (c) Facilities of the health care Sec.7 (c) Facilities of the health care system shall not be used for the system shall not be used for the display of products within the scope of display of products within the scope of this Codethis Code, or , or for placards or posters for placards or posters concerning such products.concerning such products.

Sec.7 (d) The use by the health care Sec.7 (d) The use by the health care system of “professional service” system of “professional service” representatives, “mothercraft representatives, “mothercraft nurses” or similar personnel, nurses” or similar personnel, provided or paid for by provided or paid for by manufacturers or distributors shall manufacturers or distributors shall not be permittednot be permitted..

Sec.7 (e) In health education classes Sec.7 (e) In health education classes for mothers and the general public, for mothers and the general public, health workers and community health workers and community workers shall workers shall emphasize the hazards emphasize the hazards and risks of the improper use of and risks of the improper use of breastmilk substitutesbreastmilk substitutes particularly particularly infant formula. Feeding with infant infant formula. Feeding with infant formula shall be demonstrated only formula shall be demonstrated only to mothers who may not be able to to mothers who may not be able to breastfeed breastfeed for medical or other for medical or other legitimate reasonslegitimate reasons..

Sec.8 (c) Sec.8 (c) No financial or material No financial or material inducementsinducements to promote products to promote products within the scope of this Code shall be within the scope of this Code shall be offered by manufacturers or offered by manufacturers or distributors to health workers or distributors to health workers or members of their families, nor shall members of their families, nor shall these be accepted by the health these be accepted by the health workers or members of their families, workers or members of their families, xxx.xxx.

Sec.8 (d) Sec.8 (d) SamplesSamples of infant formula or of infant formula or other products within the scope of other products within the scope of this Code, or of this Code, or of equipment or utensils equipment or utensils for their preparation or use, shall not for their preparation or use, shall not be provided to health workersbe provided to health workers except except when necessary for the purpose of when necessary for the purpose of professional evaluation or research in professional evaluation or research in accordance with the rules and accordance with the rules and regulations promulgated by the DOH.regulations promulgated by the DOH.

A.O. 2006-0012A.O. 2006-0012

Revised Implementing Rules Revised Implementing Rules and Regulations of E.O. 51and Regulations of E.O. 51

INTRODUCTIONINTRODUCTION

-the A.O. was challenged before the Supreme -the A.O. was challenged before the Supreme Court in a petition for certiorari under Rule 65 Court in a petition for certiorari under Rule 65 of the Rules of Court.of the Rules of Court.

-the petition sought the nullification of the -the petition sought the nullification of the entire Administrative Order 2006-0012.entire Administrative Order 2006-0012.

-SC decided the case on 9 October 2007-SC decided the case on 9 October 2007

-out of 59 Sections, only three sections of the -out of 59 Sections, only three sections of the RIRR were declared null and void; all other RIRR were declared null and void; all other provisions were sustained. provisions were sustained.

Nullified ProvisionsNullified Provisions

Section 4 (f) and Section 11 Section 4 (f) and Section 11 - on the absolute prohibition on the - on the absolute prohibition on the

advertising, promotions, or advertising, promotions, or sponsorships or marketing of infant sponsorships or marketing of infant formula, breastmilk substitutes and formula, breastmilk substitutes and other related productsother related products

Section 46Section 46- on the Administrative Sanctions- on the Administrative Sanctions

Highlights of the Revised Highlights of the Revised Implementing Rules and Implementing Rules and

Regulations of Regulations of

Executive Order No. 51 Executive Order No. 51

(Administrative Order 2006-0012)(Administrative Order 2006-0012)

Declaration of Principles (Sec. 4)Declaration of Principles (Sec. 4)

(a)(a) Exclusive breastfeeding is for Exclusive breastfeeding is for infants from zero (0) to six (6) infants from zero (0) to six (6) months;months;

(b)(b) There is no substitute nor There is no substitute nor replacement for breastmilkreplacement for breastmilk

(c)(c) Appropriate and safe Appropriate and safe complementary feeding should start complementary feeding should start from six months onwards in from six months onwards in addition to breastfeeding. addition to breastfeeding.

d)d) Breastfeeding is still appropriate for Breastfeeding is still appropriate for young children up to (twenty-four young children up to (twenty-four months) two years of age months) two years of age and and beyondbeyond;;

e)e) Other related products such as, but Other related products such as, but not exclusive of, teats, feeding bottles, not exclusive of, teats, feeding bottles, and artificial feeding paraphernalia and artificial feeding paraphernalia are prohibitedare prohibited in health facilities. in health facilities.

Other Prohibited ActsOther Prohibited Acts

Sec. 21. Gifts of any sort from milk Sec. 21. Gifts of any sort from milk companies/manufacturers, distributors, companies/manufacturers, distributors, and representatives of products within and representatives of products within the scope of this Code, the scope of this Code, with or without with or without company name or logo or brand namecompany name or logo or brand name shall not be given to any member of the shall not be given to any member of the general public, to hospitals and other general public, to hospitals and other health facilities, including their health facilities, including their personnel and members of their personnel and members of their families.families.

Sec. 32. It is the primary Sec. 32. It is the primary responsibility of the health responsibility of the health workers to promote, protect and workers to promote, protect and support breastfeeding and support breastfeeding and appropriate infant and young child appropriate infant and young child feeding.feeding.

No assistance, support, logistics or No assistance, support, logistics or training from milk companies shall training from milk companies shall be permittedbe permitted..

Sec. 35. “xxx. No health care facility Sec. 35. “xxx. No health care facility should be used for promotions of should be used for promotions of products within the scope of this products within the scope of this Code nor as venues that undermine Code nor as venues that undermine breastfeeding.breastfeeding.

Sec. 51. Donations of products, Sec. 51. Donations of products, materials, defined and covered under materials, defined and covered under the Milk Code and these the Milk Code and these implementing rules and regulations, implementing rules and regulations, shall be strictly prohibited.shall be strictly prohibited.

Sec. 52. Donations of products, Sec. 52. Donations of products, equipment, and the like, equipment, and the like, not not otherwise falling within the scope of otherwise falling within the scope of this Code or these Rulesthis Code or these Rules, given by , given by milk companies and their agents, milk companies and their agents, representatives, representatives, whether in kind or in whether in kind or in cashcash, may only be coursed through , may only be coursed through the Inter-Agency Committee (IAC), the Inter-Agency Committee (IAC), which shall determine whether such which shall determine whether such donation be accepted or otherwise.donation be accepted or otherwise.

Implementation & MonitoringImplementation & Monitoring

The DOH as the lead agency The DOH as the lead agency

BFAD Hotline BFAD Hotline

807-07-16807-07-16

SanctionsSanctions

2 months to 1 year imprisonment or a 2 months to 1 year imprisonment or a fine of not less that 1,000.00 nor more fine of not less that 1,000.00 nor more than 30,000.00than 30,000.00

Suspension or Revocation of license, Suspension or Revocation of license, permit or authority issued by any permit or authority issued by any government agency to any health government agency to any health worker, distributor, manufacturer, or worker, distributor, manufacturer, or marketing firm or personnel for the marketing firm or personnel for the practice of their profession or occupationpractice of their profession or occupation

Salamat poSalamat po !! !!