Breastmilk Substitute Act (BMS Act)

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BMS Act 2013 Monitoring, Enforcement and Awareness

Background:

The contribution of breastfeeding to survival, health, and development in children as well as mother’s health and human capital development is well known (Victora et al. 2016). Poor breastfeeding practices increase the risk of mortality and morbidity. Suboptimal breastfeeding practices have been linked to 8, 000,000 death among children worldwide (Black et al.2013).Breastfeeding practices are influenced by socioeconomic, cultural and individual factors, as well as by the presence or absence of public policies that support and promote breastfeeding and marketing strategies of breast-milk substitutes (BMS). Among these factors, the promotion of manufactured BMS (including infant formula, follow up formula, baby food, commercially manufactured complementary foods) results in suboptimal breastfeeding practices. Promotion of BMS negatively affects the choice and ability of mothers to optimally breastfeed their children (Rollims et al.2016). The International Code of Marketing of Breast-milk substitute code was adopted by the World Health Assembly (WHA) in 1981 in response to a rise in mortality due to the promotion of BMS (WHO 1981). Since then the WHA has endorsed a number of subsequent relevant resolutions to clarify aspects of the Code. Collectively, the International Code and Subsequent WHA resolutions are referred to as the code. The Code outlines the responsibilities of governments, health care systems and workers as well as those of the companies that market or manufacture BMS products (WHO 41 1981). A further challenge is the monitoring and enforcement of the Code, which are both necessary to detect and report violations and ensure mechanisms to effectively intervene to comply with national Code related measures. In this regard, only 32 countries reported to WHO that they have monitoring mechanism in place and of those, few are fully functional.

In Bangladesh, breastfeeding practices are deteriorating, especially exclusive breastfeeding particularly among the working women. A recent study among Bangladeshi women shows that social norms appeared to support breastfeeding but not as internationally recommend. Infant formula, solid food or local beverages are commonly introduced soon after birth (Swigart TM; et al. 2017). In this regard, following the innocent declaration, Government of the People’s Republic of Bangladesh passed an ordinance on marketing of breast milk substitutes in 1984, Ordinance no. XXXIII. It was amended in 1990 to make compulsory registration of every brand of infant formula before marketing. The 1984 ordinance was considered as weak. In the inauguration ceremony of WBW 2010, the honorable Prime Minister Seikh Hasina declared to take necessary steps for improvement of Breast Milk Substitute ordinance 1984. Government of Bangladesh along with BBF (Bangladesh Breastfeeding Foundation), Civil Societies and UN organizations in Bangladesh developed a new law following the International Code. The new law was entitled as “Breast-milk Substitutes, Infant Foods, Commercially Manufactured Complementary Foods and the Accessories Thereof (Regulation of Marketing), act 2013 and was gazetted on the 22^thSeptember, 2013 to control unethical promotion of BMS. In order to implement the Act country wide, it was necessary to disseminate among the people, health professionals and Civil Society.

Introduction:

Breastfeeding is the birth right of a child which can ensure adequate food and nutritional security, optimal health outcome, develop a bright and productive future generation for sustainable development of a country. Baby formula or breast-milk substitute is an widespread alternative option for child feeding which partially or totally replaces breastfeeding resulted adverse health outcomes for children who are formula feed compared with those who breastfeed. Bangladesh government

General objective:

The main objective of BMS Act monitoring, enforcement and awareness build up among the general people is to create the optimum breastfeeding rate and reduce the promotion of BMS. So that people can get rid of the hazards of BMS products and accessories as well as Bangladesh, our country can get a healthier nation.

Specific objectives:

1. To increase awareness among stakeholders and general population on BMS Act 2013 and its rules 2017.

2. To reduce or stop the violation of BMS Act 2013.

3. To restrict marketing of the BMS product.

4. To support IPHN in monitoring and taking actions on BMS Act violation.

5. To create a system of monitoring of BMS Act compliance.

BMS Act -2013 violation commonly found in Govt. ,private hospitals, clinic, Private chambers ; market etc:

Places of visit	Target groups
Markets and shops	Pharmacy, Grocery, Super shop, Fruit shop, bakery & confectionaries, Cosmetics shop, retailers and other shops
Govt. Sadar hospital, UHC,MCWC,MCH/Private Hospital/Clinic	Doctors, staff nurses, medical officers, EPI staff, Ayas, ward boys and other health staff
Media	Billboards, Televisions, Radio, local and national newspapers ,Facebook, twitter, You tube, websites
Doctor’s chamber	Doctors, other staff, mothers

Outcome:

A. Market Monitoring for violation detection:

Market (Pharmacies/Departmental stores/Confectionaries/Groceries) visit is a regular activity for monitoring the BMS Act 2013. In the fiscal year 2017-18 respective both male and female divisional officers of BBF visited the markets one day in every week.

They covered almost 234 markets during July to December, 2018 in the city corporations.

They observed there the different promotional activities of BMS companies where in majority (70%) found the display of BMS product in all divisions, which is under the clause 4(1) of BMS Act 2013.

Violation found (Both Health Facilities and Market & Pharmacy) are shown below:

Most of the following violations are “Display of BMS Product” which is under clause 4(1). Other violations are also detected. Very few of them are shown below:

bmsact3 — BMS product displaying in Janani Pharmacy at Shishu Hospital Gate Khulna

bmsact4 — BMS product displaying in Mojid store at Chowrasta Bazar, Barishal

bmsact5 — An Agreement between shop owner and BMS Company found in Notun Bazar Area, Barishal Sadar, Barishal

On November 23, 2018 at A.K.M Gias Uddin Milky Auditorium Youth Club of Bangladesh organized ?Nutri Career Fest 2018? with the financial support of Marks Active School, a product of Abul Khair Group, where the high-ranking nutritionists and who works with the nutrition sector of renowned hospitals and non-government organizations of Bangladesh participated in the program which is a Violation of clause 4 sub-clause (2) section (b) sub-section (ii) under BMS Act 2013.

B. Enforcement of BMS Act:

1. BBF made writ petition against six BMS companies on May, 2018 to stop the promotion of BMS products. They are Abul Khair Consumers, Baby Nutrition Care Ltd, GSK, JES International, Nestle Bangladesh Ltd, Vitalic Dairy and Food Industries.

2. According to the decision of National Advisory Committee meeting (06/08/2018), no breast-milk substitutes, infant foods, commercially manufactured complementary foods or any accessories will be imported, locally produced, marketed, sold or distributed without registration. Institute of Public Health Nutrition (IPHN) has the jurisdiction to register these products.

3. Letters with evidence of the violation were sent at several times to Director of IPHN to take necessary actions against BMS Act violations.

Mobile court arranged at Khulna at 17 Octobor,2019

Mobile court ongoing about BMS act-2013 — Mobile court on BMS act 2013 ,Khulna sadar at 17 Oct 2019.

C. Awareness of BMS Act:

one (01) TOT and one hundred one (101) orientation program on BMS Act 2013 (total 102 program) were successfully completed in the fiscal year 2017-18.

BANGLADESH BMS ACT (2013) and its rules-2017: A 20 point summary

Subject	Point
1. Aim	To contribute to the provision of safe and adequate nutrition for infants by the protection and promotion of breastfeeding and the proper use of breastmilk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution.
2. Title	This Act may be called the Breast-milk Substitutes, infant Foods, Commercially Manufactured Complementary Foods and the Accessories thereof (Regulation of Marketing) Act, 2013
3. Definitions	· Breast milk substitute(for 0-6 month old baby). · Infant formula (for 6-1 years old baby). · Infant foods (for 1 -5 years old children). · Label –No cartoon, no mother & babies picture have in the lebel of BMS product. · Commercially manufactured complementary foods (for 6-5 years old children) · Person-Seller, distributor, marketer, company, importer etc. · Health worker · Health facilities
4. Restrictions Of –	· Advertisement · Promotion technique such as :-display in shop · No person can use any health care Centre to sell, distribute. · No person can use any medicine selling Centre for selling, distribute. · Involve conflict of interest by health personalities · To contact any mother · Donation of BMS product in emergency.
5. Advertising	No advertising of BMS products to the public. No nutrition or health claims on products.
6. Free Samples, Gift, discount coupon,	No free samples to mothers ,their families or health care workers
7. Health care facilities	No promotions of products, i.e. no product displays, posters, calendars or distribution of promotional materials. NO use of mother craft nurse or similar company paid personnel.
8. Pharmacy	No person (defined in definition sector) can use any medicine selling Centre for selling, distribute.
9. Shop	As promotion technique no person can display in shop or specific self with
10. Supplies	No free or low-cost supplies of breastmilk substitutes to any part of the health care system
11. Prescription	For any special circumstances of an infant or children such as -adoption, critical health condition of baby/mother, death of mother etc. Condition only registered doctors can prescribed for BMS product to baby with proper mentioning the explanation of prescribing.
12. Information	Information & educational information must explain the benefits of breastfeeding, the health hazard associated with bottle feeding and the cost of using infant formula. Product information must be factual and scientific. Governments to avoid of conflicts of interest so materials under infant and young child programmers should not be sponsored by companies.
13. Labels	Product labels must clearly state the superiority of breastfeeding, the need for the advice of a health care worker and a warning about health hazards. No pictures of infants, mother of an infant, children, cartoon, and other picture related to mother and child, or text idealizing the use of infant formula. Labels must contain warning that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately.
14. Registration to IPHN	For BMS product and accessories import, locally produce, selling, distribution; the company, importer, producer, marketer, seller all need to have registration from IPHN.
15. BMS product Quality need to asses before registration to IPHN	Radiation free Certificate , certificate of BSTI, Codex alimentations commission certificate etc.
16. Renew Registration certificate	Companies, importer, distributor, marketer, seller all must maintain and renew their registration certificate as required.
17. Mode of paying the Compensation to the family of the victimized child	In case of violation, the Court may issue an order for a BMS company to compensate the family of a victimized child as penalty for violating the BMS Act.
18. Implementation	· The National Advisory Committee( the committee) shall consists of members from the Ministry of Health and Family Welfare, nominated officers ,the Department of Health ,a child specialist or nutritionist, a non-governmental organization(NGO) representative, and the director of the Institute of Public Health Nutrition . · The Functions of the committee will be advice and provide recommendations to the Government on the enforcement and monitoring of the BMS Act. The Committee will meet at least once every three months.
19. Criminal code	The offence is punishable through the act of criminal code.
20. Mobile court	The offence can be punishable by Mobile court.

Definitions	BMS Act article :- (2(g),(h), (i),(j),(l),(m) (n))	Applies to breastmilk substitutes or any food being marketed or otherwise represented as a partial or total replacement for breastmilk. These include products such as: g) “breast-milk substitutes” means any infant food ,for a child up to the age of six months, prepared, marketed or otherwise presented as a partial or total preplacement of breast-milk . (h) “ Infant foods” means any food, for a child above the age of six months , prepared , marketed or otherwise presented as a partial or total replacement of breast-milk; (i)“Label” means any displaying written, articulated, stamped, printed, drawn or designed form, which is affixed to or otherwise pated on or glued any receptacle; (j) “Commercially manufactured complementary foods” means any food, by whatever name called, for requirement of a child from six months to five years of age manufactures commercially with appropriate nutrients; (k) “Advertisement “shall include an announcement or also a presentation in written or printed form or through light or sound, of any notice, circular, envelop, label or nay other similar documents through print and electronic media, email or internet. (l) “Person” shall include any company, society, organization, or group of people, and also include ,incorporated or not ,any importer ,producer ,marketing agency , seller or distributor of any breast-milk substitutes ,infant foods ,commercially manufactured complementary foods and any accessories thereto ; (m) “Health workers” means for carrying out the purpose of this Act, a person engaged to provide health care services to an infant mother of an infant or a pregnant mother. (n) “ Health care Centre” means a public or private institution or organization or private practitioners clinic or child day care Centre which is engaged in providing health care ,directly or indirectly ,to infants, mothers of infants or pregnant women; and shall also include a nursery or any other child care institution .
Advertising	BMS act -2013; Article 4(2(a))	To distribute to any people ,particularly any person or student or their family member who is engaged in or related to health care ,nutrition, or education ,any leaflet ,hand bill or similar instrument wherein there is an advertisement of any breast-milk substitutes ,infant foods ,commercially manufactured complementary foods or any accessories thereof .
Free Samples, Gift, discount coupon,	BMS act -2013; Article 4(2(b (i))	To offer or propose to offer any person any gift ,discount coupon ,price reduction or any other material free of cost ;
Pharmacy	BMS act -2013; Article 4(1) & 4(2(iv))	4(1) For the purpose of import ,local production ,marketing ,sale or distribution ; no person shall print ,exhibit ,circulate or publish any advertisement of any breast-milk substitutes ,infant foods ,commercially manufactured complementary foods and accessories thereof or engage himself in any such work. (2) Within the scope of sub-section (1), among others the following things particularly shall not be done, (iv)to use any health care Centre or any medicine selling Centre;
Shop	BMS act -2013 Article 4(1)	4(1) For the purpose of import ,local production ,marketing ,sale or distribution ; no person shall print ,exhibit ,circulate or publish any advertisement of any breast-milk substitutes ,infant foods ,commercially manufactured complementary foods and accessories thereof or engage himself in any such work.
Label	BMS act -2013 Article 6(1(a),(c)); 6(2(a, b ,c, d ))	6(1(a)- an statement captioned as “ There is no substitutes of or equivalent to breast-milk” ,just below the name of the commodity , with such size of letters that are equal to the name of the commodity; (c) as the case may be a warning message captioned as- “Breast-milk substitutes ,infant foods not the real source of nutrition “ or “commercially manufactured complementary foods are not real source of nutrition”; (2) A receptacle or label attached to the receptacle as mentioned in sub-section(1)- (a) shall not contain any picture of a baby or another or both or any other similar picture thereof; (b) shall not contain any graphics or cartoon pictures for easy identification of a breast-milk substitutes ,infant foods, and commercially manufactured complementary foods; (c) shall not print any word suitable for or usable by a child or any other similar word; (d) Shall not print or contain any other prescribed descriptions.
Provisions relating to import, local production, sale etc., of breastmilk substitutes, infant foods, etc.	BMS act -2013 Article (5)	No person shall, without registration under this Act, import, produce locally, market, sell or distribute any breast-milk substitutes, infant foods, Commercially manufactured complementary foods or any accessories thereof.
Registration:- Certificate need for registration of the BMS product for quality control	BMS act -2013 Bylaw -2017 Article 10(2(a, b, c, d)	(a) A Safety certificate issued by appropriate authority from its country of origin that the breastmilk Substitute, Infant Food ,Commercially Manufactured Complementary Food or the Accessories thereof is free from radioactivity; (b) A certificate issued by the Bangladesh Atomic Energy Commission that the Breastmilk Substitute ,Infant Food ,Commercially Manufactured Complementary Food or the Accessories thereof is free from radioactivity; (c) A copy of the Certificate issued by the Bangladesh Standards and testing Institute(BSTI); (d) A copy of the Certificate issued by the Codex Alimentations Commission;
Penalty	BMS act -2013 Article 12(1)&(2)	(1) If anyone contravenes any provision of this Act, Such contravention shall constitute of an offence, and for that, he shall be punished with imprisonment which, May extent to maximum 3(three) years or with fine which may extent to maximum 5, 00000 (five lacs) or with both. (2) If a child becomes ill or dies from the use of any breast-milk substitutes ,infant foods , commercially manufactured complementary foods or of any accessories thereof , it shall constitute a punishable offence under this act , and for that ,the company that has produced such breast-milk substitutes ,infant foods, complementary infant foods manufactured commercially or the accessories thereof shall be punished 10(ten) years of imprisonment or with fine which may extent to maximum 50,00000 (fifty lacs) or with both and the fine so imposed shall be given in the prescribed manner as a compensation to the family of the victim.
Mode of paying the Compensation to the family of the victimized child	BMS act by law-2017 Article (12(1))	If any penalty is imposed against the accused person by the court under sub-section (2) of section 12 of the Act, the court may issue an order to deposit such penalty as compensation in the bank account of father, mother or legal guardian of that victimized child under such sub-section.
Criminal code	BMS act -2013 Article (17)	Application of the criminal code: For lodging a complaint, conducting an investigation, holding a trial and disposing an appeal in respect of an offence under this Act, the provisions of the Criminal Code shall be applicable.
Mobile court	BMS act -2013 Article (18)	Application of Act 59 of 2009 : Notwithstanding anything contained contrary in this Act, offence punishable under this Act may be triable in accordance with the provisions of the Mobile Court Act,2009(Act NO.59 of 2009)
Challenge for implementing the BMS act -2013 & its Rules-2017 in Bangladesh	The Control of Essential Commodities Act, 1956 (East Pakistan Act) 2(xviii)	Definitions 2. In this Act, unless there is anything repugnant in the subject or context,- (xviii) infant and patient foods and allied articles;
Challenge for implementing the BMS act -2013 & its Rules-2017 in Bangladesh ; The contradictory law “ The essential commodity control order,1981 Article :-(22(1),(2(i )) & The schedule (5)	The Essential commodity control order,1981 (22(1),(2(i)) Page: 374 The Essential commodity control order,1981 Page 377 The Schedule (5)	(22) Licence . – (1) No person other than a producer or Importer shall engage in any undertaking involving purchase ,sale or storage for sale of any scheduled article unless he is a dealer and holds a licence issued in this behalf by the Deputy commissioner . (2) The licence fee for the following scheduled articles shall be as follows:- Particulars of articles Licence fee (taka) Renewal fee. (i) Milk food 25 25 Milk food (all types of milk food for infants, bulk or packet, all types of non-fat dried milk including condensed milk, all sorts of patient food. I.e. Horlicks, Ovaltine, Malted Milk).