Posted on: Tue 14-05-2019

The Overview of the International Code of Marketing of Breastmilk Substitutes and the National Regulations Presentation by Mrs Ummul-khairi A. Bobboi (NAFDAC) at the Annual Conference of the Association of Nigerian Nurses held at NAF Conference Center Abuja, on the 9^th May, 2019 

Outline of Presentation

1. Introduction
2. Who Key Facts on Child Nutrition
3. Overview of the International Code
4. Overview of the National Regulations made under NAFDAC Act
5. Analysis of the Regulations and some reviewed Regulations
6. How Companies reach mothers
7. Conclusion

Introduction

• Nigeria has one of the highest infant mortality rates in the world, with a corresponding low rate of exclusive breast feeding. Decline in breastfeeding, encouraged by aggressive marketing strategies by Infant food manufacturers is regarded as a major contributory factor to these unfavorable conditions.
• Fortunately, the major causes to the gory early child morbidity and mortality pictures are largely preventable: diarrhoeal disease, Acute Respiratory Infection (ARI), malaria, measles, malnutrition and recently HIV/AIDS.
• These morbidities result predominantly from inappropriate infant and young child feeding practices which are reflected in the persisting low exclusive and sustained breastfeeding rates in Nigeria with unsatisfactory complementary feeding practices. Nigerian Demographic health Survey, 2013 estimated exclusive breastfeeding rate at 17%, and this figure has not been exceeded thereafter.
• Breastfeeding has been scientifically proven to be a singular most important strategy for combating infant malnutrition, morbidity and mortality.
• The World Health Assembly (WHA), 1981 adopted the International Code of Marketing of Breastmilk Substitutes (BMS), as a weapon to protect Breastfeeding from the negative impact that aggressive advertising, free samples, milk nurses and other promotional techniques by Infant Food Manufacturers (IFM) were having on breastfeeding rates and duration. The Code was documented as WHA Resolution 34.22 of May, 1981.
• WHA member countries were urged to draw up their national Codes using the provisions of the International Code as a minimum. These national Codes are best to be backed by legislations containing adequate penal measures to ensure compliance.
• Nigeria, a member of WHA, was also a signatory to the Code in May 1981.
• Since the Code was adopted in 1981 more than ten other subsequent relevant WHA Resolutions have been added to it to sort out confusions and to address new threats to infant and young child health and survival. These new resolutions must be recognised as part of the original Code.

• The Code regulates the marketing of all BMS, which include:

• Any product marketed for baby feeding, whether suitable or not, during the first six months of life;
• Any product marketed for baby feeding after six months which replaces the breastmilk part of the diet;
• Any feeding bottle or teat (or pacifier).

• The Code regulates the marketing of all BMS, which include:

• Any product marketed for baby feeding, whether suitable or not, during the first six months of life;
• Any product marketed for baby feeding after six months which replaces the breastmilk part of the diet;
• Any feeding bottle or teat (or pacifier).

• The Code was designed to;

•  function internationally and nationally
• applies to both IFM and governments;
• is a baseline, so every government may strengthen its own to make it more effective in accordance with, e.g. environmental, cultural and other prevailing peculiar situations;
• IFM/Distributors must implement the Code even where a government has no measures for regulation;
• may be implemented through government regulation or law
• The Code does not try to stop infant formula and other products being available, or being sold, or used when necessary. But it does seek to stop activities designed to persuade people to use them, or to influence their choice, such as:
• Advertising, including posters in health facilities. 
• Giving free samples to mothers.
• Giving discount coupons to mothers.
• Giving free gifts to health workers and mothers.
• Giving free or low cost supplies of formula to health facilities.

KEY FACTS ACCORDING TO WHO

• Every infant and child has the right to good nutrition according to the "Convention on the Rights of the Child".
• Undernutrition is associated with 45% of child deaths.
• Globally in 2016, 155 million children under 5 were estimated to be stunted (too short for age), 52 million were estimated to be wasted (too thin for height), and 41 million were overweight or obese.
• About 40% of infants 0–6 months old are exclusively breastfed.
• Few children receive nutritionally adequate and safe complementary foods; in many countries less than a fourth of infants 6–23 months of age meet the criteria of dietary diversity and feeding frequency that are appropriate for their age.
• Over 820 000 children's lives could be saved every year among children under 5 years, if all children 0–23 months were optimally breastfed. Breastfeeding improves IQ, school attendance, and is associated with higher income in adult life. (1)
• Improving child development and reducing health costs through breastfeeding results in economic gains for individual families as well as at the national level.

“The Code”

The World Health Assembly (WHA) in 1981 adopted the International Code of Marketing of Breast Milk Substitutes (BMS), as a weapon to protect Breastfeeding from the negative impact that aggressive marketing and  promotional techniques by Infant Food Manufacturers (IFM) were having on breastfeeding rates and duration. The Code was documented as WHA Resolution 34.22 of May, 1981.

What is the International Code of Marketing of Breast Milk Substitute

The Code is a set of recommendations to regulate the marketing of breast-milk substitutes, feeding bottles and teats.

The Code was formulated in response to the realization that poor infant feeding practices were negatively affecting the growth, health and development of children, and were a major cause of mortality in infants

and young children. Poor infant feeding practices therefore were a serious obstacle to social and economic development.

Since the Code was adopted in 1981 more than ten other subsequent relevant WHA Resolutions have been added to it to sort out confusions and address new threats to infant and young child health and survival. These new resolutions must be recognised as part of the original Code.

Articles of the Code

The International Code has eleven articles;

1. Aim of the Code:             The aim of this Code is to contribute to the provision of safe and adequate nutrition for infants, by:
   • protection and promotion of breast-feeding through ensuring appropriate marketing and distribution.
   • Ensuring the proper use of BMS, when these are necessary,
   •  Ensuring that the use of BMS is based on adequate information.
2. Scope of the Code: The Code applies to the marketing, and practices related thereto, of the following products: breast-milk substitutes, including
   • infant formula;
   • 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 breast milk; feeding bottles and teats. It also applies to their quality and availability, and to information concerning their us

3. Definitions
4. Information and Education
5. General Public and Mothers
6. Health care Systems
7. Health Workers
8. Persons employed by manufacturers and distributors of infant food products
9. Labelling
10. Quality
11. Implementation and Monitoring

Summary of the Code

The provisions Code can be summarized as follows:

• No advertising of any of these products to the public.
• No free samples to mothers.
• No promotion of products in health care facilities, including the distribution of free or low-cost supplies.
• No company sales representatives to advise mothers.
• No gifts or personal samples to health workers.
• No words or pictures idealizing artificial feeding, or pictures of infants on labels of infant milk containers.
• Information to health workers should be scientific and factual.
• All information on artificial infant feeding, including that on labels, should explain the benefits of breastfeeding and the costs and hazards associated with artificial feeding.
• Unsuitable products, such as sweetened condensed milk should not be promoted for babies.
• Manufacturers and distributors should comply with the Code’s provisions even if countries have not adopted laws or other measures. 

Highlights of the National Regulations on BMS 2005

The document has 22 Regulations:

1. Registration of Designated Product
2. Application for registration
3. Invalidation of certificate of registration
4. Information and educational materials on infant feeding
5. Restrictions regarding information, educational materials and equipments
6. Restrictions on healthcare facility
7. Donation to be approved by the Agency
8. Questions as regards the use of products
9. Prohibition of the advertisement or promotion of Designated Products
10. Manufacturers to disclose their contributions
11. Prohibition of promotion by manufacturers and distributors.
12. Prohibition of persons employed by manufacturers and distributors
13. Composition of Designated Products
14. Prohibition of the sale of unwholesome product
15. What labels and marks on Designated Products shall include, etc
16. Self monitoring by manufacturers and distributors, etc
17. Offences
18. Offences by bodies corporate, etc
19. Forfeiture after conviction
20. Forfeiture of Designated Products seized
21. Interpretation
22. Citation

• Nigeria’s Code instruments still in existence, are:

1. Code of Ethics and Professional Standards for Marketing of Breastmilk Substitutes;
2. Decree No. 41 of 30^th December, 1990- Marketing (Breastmilk Substitutes) Decree 1990 (now  an Act);
3. Decree (now an Act) No. 22 of 23^rd March, 1999- Marketing (Breastmilk Substitutes) (Amendment) Decree 1999 which is currently being reviewed.
4. NAFDAC-Marketing of Infant and Young Children Food and other Designated Products (Registration, Sales, etc.) Regulations 2005 – which has been reviewed and waiting for final approval by Honourable Minster of Health.

Who Should implement the CODE

Monitoring the implementation of the Code is the joint responsibility of all stakeholders involved in Infant and Young Child Feeding.

• Relevant Sections of the Codes have specified the persons/groups that shall be involved in monitoring and these include:
  • Regulatory Body (NAFDAC);
  • Health Care System/Health Institutions
  • Health Professional Bodies;
  • Health Workers
  • Mothers and Caregivers;
  • Relevant NGOs;
  • Child Care Facilities
  • Manufacturers and Distributors of Breast milk Substitutes and their marketing personnel
  • Media and Advertising Agencies

ANALYSIS OF THE NATIONAL REGULATIONS

Twenty two (22) Regulations are listed in this subsidiary Legislation

REGULATIONS 1 &  2:

To give effect to the International Code and Subsequent Relevant WHA Resolutions by making the registration of Designated Products mandatory. The process and various requirement for registration are listed.

REGULATION 3

It list grounds for the invalidation of certificate of registration which includes promotion and advertisement of designated Products.

REGULATION 4

 In line with Article 4 of the Code,  it vests the Agency with the powers to control the;

• production,
• provision,
• planning,
•  design and
•  designation of information and educational materials on infant and young child feeding.

Sub Regulation 2 of Regulation 4 lists the Information to be listed in the Information and Educational materials

REGULATION 5

• It is consistent with Article 7 (2) of the code requiring that information provided by manufacturers and distributors to health professional regarding products within the scope should be scientific and factual.
• It incorporates provisions of section 3 (1) (a) of Act No 41 of 1990 by prescribing the use of the 3 indigenous languages in addition to English for information and Educational materials.

It indicates health hazards.

• Donations of educational and information materials or equipment with the approval of NAFDAC – This has been reviewed in line with a new Resolution by the World Health Assembly to read  - “The Agency shall control the planning, design, production, provision and dissemination of Information , Educational and Communication(IEC) materials on Infant and Young Child Foods and feeding designed to be used by families and those involved in the field of infant and young child’s health and nutrition”.

REGULATION 6

• It captures Article 6 and prohibits the promotion of designated products in health care facilities, display of such products, placards or  posters or for the distribution of materials concerning the items provided by manufacturer or distributor.
• The head of a health care facility is under obligation to present to NAFDAC in writing, a full disclosure of any contribution by a distributor  - This has been reviewed in line with a new Resolution by the World Health Assembly.
• To read - Donation of Breastmilk Substitutes and related products, equipment, information and educational materials to a health care facility by manufacturers or distributors of the Products is hereby prohibited;
• The head of a health care facility should prohibit acceptance into the Health care facility of gifts in the form of samples designated products or supplies of the same or gift of any article which may idealize or promote the use of designated product.

REGULATION 7

• A substantial compliance with Article 6 (6) and (7) as modified by WHA  47:5 (1994). Donation, low price sales or supplies of designated product to be made to social welfare institutions subject to the written approval of NAFDAC.
• To ensure that required breastmilk substitutes in emergency responses are purchased and distributed according to strict criteria.
• The supply or donation: The manufacturer shall ensure that Breastmilk Substitutes and related products donated for emergency or procured by government for humanitarian programmes do not display company’s brand name and logo.
• to be used or distributed for infants for whom it has been prescribed
• to be continued for as long as the infant needs them
• it is the duty of Health workers to encourage and protect breast feeding.
• it is mandatory for health workers to make a disclosure to their employers in writing of any contribution made by a distributor or manufacturer on behalf of the health worker, for fellowship, study tour, research grant, attendance at professional conference or for other similar purposes. This has been reviewed in line with a new Resolution by the World Health Assembly to read –
• It is an offence for the manufacturers or distributors of the Products to compromise or seek to compromise the healthcare system including a health care facility, health worker, the regulator or their staff with inducements contrary to the provisions of these Regulations;
• Manufacturers and distributors of Breastmilk Substitutes and related products shall not sponsor meetings of health professionals and scientific meetings;

REGULATION 8

• Request for answers to technical questions by health professionals to distributors or manufacturers regarding the use of a product should be in writing and should not include general promotional literature unless it answers directly to the questions asked.

REGULATION 9

• Absolute prohibition of the advertisement or promotion of designated products. It captures Article 5.

REGULATION 10

• Manufacturers or distributors shall, subject to the approval of NAFDAC, disclose to the institution to which a recipient health worker is affiliated to any contribution made to or on his behalf for fellowship, study tour, research grant, attendance at professional conference, or the like and similar disclosure shall be made by the recipient to his employers. This has been reviewed in line with a new Resolution by the World Health Assembly to read -
• It is an offence for the manufacturers or distributors of the Products to compromise or seek to compromise the healthcare system including a health care facility, health worker, the regulator or their staff with inducements contrary to the provisions of these Regulations;

REGULATION 11

• The promotion of designated products by a distributor or manufacturer within a Health care facility is prohibited.
• Captures article 8 by prohibiting the use of sales volume to calculate bonuses – by manufacturer, distributor or retailer as a system of incentive for the marketing personnel.
• No set quotas and special display of designated products is allowed as well.

REGULATIONS 13 & 14

• The Regulations captures Article 10 of the code by prohibiting the sale of unwholesome designated products while adopting standards prescribed by NAFDAC and when such standards don’t exist to adhere to Codex Alimentarius Commissions directive.

REGULATION 15

• In line with Article 9 of the Code and same as section 3 of the Act No 41 of 1990 prescribes the labelling requirements.

REGULATION 16

• Manufacturers and distributor under obligation to monitor their practices according to the provisions of the Regulations and to ensure that their conduct at every level conforms with the Regulations.

REGULATIONS 17, 18, AND 19

• It prescribes offences for individual violators body corporate violators and their  key officials involved in the commission of any offence.
• Individual - term of imprisonment not exceeding 2 years or a fine of N50,000.00 or both.
• Body Corporate – fine not exceeding N100,000.00. Forfeiture of the offending items on conviction to the Federal Government of Nigeria.-  this has been reviewed in line with a new Resolution by the World Health Assembly to read –
• A person who contravenes any provision of these Regulations is guilty of an offence and liable on conviction with the following Penalties;
• Warning letters for first offenders.
• Seizure of offending articles for destruction.
• Hold or detention of product to allow possible corrective action.
• Administrative fines.
• Closure of business premises.

• Invalidation of Marketing License.
• Confiscation of assets.
• Prosecution of recalcitrant offenders, leading to fines running between no less than N150,000 – N2,000,000 and jail term not exceeding 6 months, as appropriate.
•  Where an offence under these Regulations is committed by a body corporate or firm or other association of individuals, every:
• director, manager, head, secretary or other similar officer of the company;

• partner or officer of the company;
• trustee of an Incorporated Trustee Organization concerned; or
• person concerned in the management of the affairs of the association
• shall be guilty of that offence and liable to be proceeded against and punished for the offence in the same manner as if he had himself committed the offence unless it is proved that the act or omission constituting the offence took place without his knowledge, consent or connivance.
•  Where a director, a staff, a partner or a trustee of a body corporate in the course of duty commits an offence under these Regulations, the body corporate shall be guilty of that offence and liable to be proceeded against and punished for the offence as if the offence had been committed by the body corporate.

REGULATION 20

• Any designated product seized by the Agency shall be forfeited to the Federal Government of Nigeria and shall be dealt with in such manner as the Honourable Minister may from time to time determine.

REGULATION 21

Some of the key words or terms defined are

“Designated product” means –

1. Infant formula; or
2. Follow-up formula; or
3. Any product marketed otherwise represented or commonly used for feeding of infants; or
4. Product to be fed by use of a feeding bottle; or
5. Beverages, milk, cereals, and other food intended for use by infant and young children whether industrially made or occurring naturally; or
6. Feeding bottles, teats, and pacifiers; or
7. Products stated to promote breast feeding; and
8. Such other products as may be specified by the Agency.

Prohibited promotional practice” includes

1. Special displays of designated products
2. Discount coupons
3. The selling of designated products at a reduced price, unless such reduction in price is intended to be permanent;
4. The distribution of gifts or items of little or no cost bearing the name or logo of a manufacturer or distributor;
5. The use of printed materials including books, pamphlets or posters bearing the name, logo, graphic or other representation of a proprietary product or the name or logo of a manufacturer or distributor.

b. “Promote” includes advertising, giving of samples or gifts of designated products, or materials or information or decorations related thereto.

c. “Promotion” means any method of introducing, familiarizing or encouraging a person to purchase a designated product. “advertisement” includes advertising in publication by  television, internet, radio, film, video or telephone, Traditional communication media, by display or signs, bills boards, notices or goods, by exhibition of pictures or models and in any other manner.

Understanding Marketing How do Companies get to Mothers & Babies?

Conclusion

It is instructive to note that the new regulations are not a replacement of the 1990 Act. It fills the loopholes in the 1990 Act and brings it more in conformity with the Code and the subsequent relevant Resolutions of the World Health Assembly.

Thank you for listening.

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