On the 23 May 1980, the Thirty-Third World Health Assembly (WHA) supported the proposal that there should be an International Code of Marketing of infant formula and other products that are used as breast-milk substitutes.1 The WHA had previously expressed concern about declining breastfeeding rates and had recommended to Member States that they give priority to preventing malnutrition in infants and young children by supporting and promoting breast feeding, taking legislative and social action to facilitate breast feeding and by regulating the inappropriate promotion of infant foods that could be used to replace breast milk. The WHO and UNICEF responded to these earlier concerns by convening a meeting in Geneva in October 1979 that was attended by a wide range of representatives including government officials, organisations of the United Nations system, non-governmental organisations and the infant-food industry. It was from that discussion that the concept of an International Code of Marketing of Breast-Milk Substitutes emerged, and this was subsequently presented to the WHA in May 1980. WHO and UNICEF were requested to take forward the preparation of the code and were specifically asked to involve all concerned parties and to reach a conclusion as soon as possible.

On 21 May 1981, the Thirty-Fourth WHA adopted the fourth draft of the International Code of Marketing of Breast-Milk Substitutes as a minimum requirement to protect and promote appropriate feeding for infants and young children.2 It was decided that the code should be adopted as a recommendation rather than a regulation and that the implementation of the code should be closely monitored according to existing WHO constitutional procedures, with future assemblies assessing the situation in the light of reports from member states, and taking measures, it judged necessary for its effective application.

The code is underpinned by 11 articles with article 1 setting out the aim of the code which is to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breast feeding and by ensuring the proper use of breast-milk substitutes; in particular, the aim emphasises the need for milk substitutes to be based on adequate information and to be provided through appropriate marketing and distribution.3 Articles 2 and 3 cover the scope and definitions used in the code. Subsequent articles relate to government responsibility to 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; there are recommendations for manufacturers and distributors of breast milk substitutes with specific reference to advertising and labeling and advice and information for healthcare systems and healthcare workers that focus on the encouragement of breast feeding and promotion of the principles of the code. Article 10 provides recommendations on quality and standards for milk substitutes, and article 11 sets out arrangements for monitoring the implementation of the code.

The introduction to the code clearly states that governments, organisations of the United Nations system, non-governmental organisations, experts in various related disciplines, consumer groups and industry need to cooperate in activities aimed at improving maternal, infant and young child health and nutrition. At that time, it was anticipated that the code would provide the framework for this to be achieved. However, the evidence from the last three decades indicates that the aspiration of collective cooperation has not been fulfilled. There has been an unrelenting series of disputes, predominantly relating to alleged violations of the code, which have provoked high profile acrimonious exchanges, boycotts and legal proceedings. An internet search of the milk substitute code is dominated by claims of violation being raised by non-governmental organisations (predominantly Baby Milk Action) against milk formula companies (predominantly Nestle). Most striking is the absence of a website commissioned by an official independent governance body which provides comprehensive and validated data on claims of violation and their outcomes.

The arrangements for implementation and monitoring of the code are set out in article 11 and state that individual governments should take action to give effect to the principles and aim of the code and, if appropriate, consider the adoption of national legislation, regulations or other suitable measures. Governments are also advised that they can seek the cooperation of the WHO, UNICEF and other agencies of the United Nations system. In accordance with article 62 of the constitution of the WHO, member states need to communicate annually to the director-general on action taken to give effect to the principles and aim of this code and the director-general reports every 2 years to the WHA on the status of the implementation of the code.

Article 11 emphasises that manufacturers and distributors of products within the scope of the code should, independently of any other measures taken for implementation of this code, regard themselves as responsible for monitoring their marketing practices according to the principles and aim of the code and for taking steps to ensure that their conduct at every level conforms to them. The code also states that non-governmental organisations, professional groups, institutions and individuals should have the responsibility of drawing the attention of manufacturers or distributors to activities which are incompatible with the principles and aim of the code, so that appropriate action can be taken. The appropriate governmental authority should also be informed.

Unfortunately, the evidence indicates that this rather complex multi-agency monitoring framework has failed to deliver effective corporate governance. It is probably not surprising that each of the components of this self-regulatory structure continue to manifest aspects of self-interest, and this is likely to continue in the absence of an “ombudsman” or independent body with the authority to arbitrate and ensure that actions taken by respective parties are in keeping with the spirit of the code.

The UK regulations on infant formulae and follow-on formulae were most recently revised in November 2007,4 following the publication of the European Commission Directive 2006/141/EC,5 which closely reflects the principles of the International Code for Marketing of Breast Milk. The responsibility for implementation and monitoring of these regulations in the UK rests with the Food Standards Agency (FSA), which is an independent government department. However, investigations of alleged violations of the code by milk substitute companies, particularly where there are concerns over advertising and labeling, are generally the responsibility of local authority regulatory officers. Issues relating to breaches of the code by healthcare systems or healthcare workers may be addressed by health authorities or professional bodies. It is not possible to determine if this fragmented approach to investigation and data collection is able to provide a complete picture of national performance as FSA have not yet published comprehensive information on code compliance.

In the absence of effective governance and validated information from an official national organisation, a number of self-appointed monitoring groups have opportunistically elected to fill this vacuum, the most influential in the UK being Baby Milk Action.6 The code does encourage non-governmental organisations to draw the attention of manufacturers or distributors to activities which are incompatible with the principles and aim of the code so that appropriate action can be taken. It also states that the appropriate governmental authority should also be informed. However, it is clear that it is difficult for these organisations to access all relevant information and to provide an independent and fully informed view. Moreover, from the way that they are constituted and the methods that they have adopted, it is unlikely that they will be able to embrace the confidence of all relevant parties.

Within the UK, there is a need for a more transparent governance structure that has clearly defined responsibilities for ensuring that there are reliable and sustainable systems in place that will underpin the effective delivery of the code. The remit of such a national governing body could be to oversee the process for responding to claims of violation to ensure that standards are being met for the investigation of claims of violation and to make available in the public domain, a register of all claims of violation with the outcome and action taken. For this to be achieved, a priority for the group would be to review all relevant code monitoring processes and to take measures to ensure that reliable and sustainable systems are in place. Robust data will be required to provide assurance to relevant parties and to determine more clearly the extent of the issue and to advice on appropriate actions. This group could also have broader governance responsibilities relating to the implementation of the code. It is essential that the membership of the governance body has the confidence of all interested parties, and the members will require a range of skills and expertise to assure governments, industry, non-governmental organisations, professional groups, institutions and individuals that they are informed, transparent and independent.

In addition to strengthening the governance arrangements at national level, it is also important that there are reliable systems in place that will demonstrate effective international accountability. Although international monitoring systems have been developed,7 the current arrangements dictate that it is the responsibility of individual Member States to decide what actions, if any, are taken in response to a claim of violation of the code, and there is a risk that there may be global inconsistency in approach and outcome. A not uncommon scenario is that a non-governmental organisation from one country claims that a violation took place in another country, and the milk formula company which is allegedly responsible is based in another country. Violation claims that cross national and continental boundaries need to be addressed within a framework of international governance that is transparent, consistent and sustainable.

In 1981, the International Code of Marketing of Breast Milk Substitutes was viewed as a seminal policy, and few would disagree with that opinion today. The controversy that has bedevilled the code for 30 years is almost entirely limited to matters of interpretation and compliance. However, because these issues have been so protracted it has led to an atmosphere of mistrust that has now become embedded between key agencies. Moreover, there has been considerable debate on how healthcare workers, including paediatricians, should relate to milk formula companies.8 It is, therefore, timely to reflect on the vision of those who initiated the code and to embrace the original spirit of the code which is that participation and cooperation are essential if activities aimed at the improvement of maternal, infant and child nutrition are to be successful. To enable this to happen, it is proposed that measures are taken to replace current hostilities with effective national and international governance.