Does Nestlé's Monitoring Report Comply with The International Code?

A Legal Evaluation of The Nestlé Report "Nestlé Implementation of the WHO Code" by a Consultant for The International Baby Food Action Network (IBFAN) and The Geneva Infant Feeding Association (GIFA)

April 2000

Contents

• Summary of the Evaluation
• Introduction
• The Regime of Monitoring under the International Code
• The Concept of Self-monitoring under the International Code
• Nestlé's Self-monitoring
• Nestlé's Approach to Self-monitoring
• The Nestlé Instructions
• Responses from Governments to Nestlé
• The Essentials of a Self-monitoring Process
• Conclusions

1. Summary of the Evaluation

The International Code of Marketing of Breast-milk Substitutes provides for monitoring its application by WHO Member States (Article 11.2), and for self-monitoring by manufacturers and distributors of breast-milk substitutes and other products covered by the Code (Article 11.3).

Nestlé submitted a report entitled "Nestlé Implementation of the WHO Code (International Code of Marketing of Breast-milk Substitutes) ­ Official Response of Governments", to the Director-General of WHO in July 1999, alleging self-monitoring in accordance with Article 11.3 of the International Code. The criterion for self-monitoring under Article 11.3 of the Code is clearly laid down, namely any monitoring should be in accordance with the principles and aim of the Code. The criterion used by Nestlé in its alleged self-monitoring is what the governments endorse and accept as the interpretation of the International Code in their countries. Moreover, instead of investigating and inspecting the marketing practices of its own agents, marketing personnel, subsidiaries or any other entity working for Nestlé, the Company approached health ministries in 54 Member States of WHO and asked them to inform it of any violation of the International Code. The ministries of health were also asked to confirm, in writing, Nestlé's compliance with the Code. Nestlé then used these replies as written evidence of its compliance with the International Code.

As will be seen from the evaluation report, neither the criterion used by Nestlé for its alleged self-monitoring, nor its approach to self-monitoring is in conformity with Article 11.3 of the International Code.

Moreover, the replies from the ministries of health cannot be considered as written evidence of compliance with the International Code, because a large number of them is based on Nestlé's Instructions, which differ considerably from the International Code in many aspects. In addition, the wording of many of those replies does not support the claim made by Nestlé. At best, these replies could be considered as indicating monitoring by Member States of WHO under Article 11.2 of the Code.

Any self-monitoring by manufacturers and distributors of products covered by the International Code should meet three very important principles laid down by the World Health Assembly, namely transparency, independence and freedom from commercial influence.

The Nestlé Implementation Report does not constitute compliance with Article 11.3 of the International Code. At best, it is no more than an exercise in public relations.

2. Introduction

Nestlé submitted a report to the Director-General of the World Health Organization (WHO) in July 1999, entitled "Nestlé Implementation of the WHO Code (International Code of Marketing of Breast-milk Substitutes) ­ Official Response of Governments", (Nestlé Implementation Report). This Report has been widely distributed by Nestlé, it would appear, to officials of ministries of health of Member States of WHO, non-governmental organizations (NGOs), various health care institutions and professional bodies interested in the promotion of breast-feeding. It has also been widely publicised, including on the Internet.

The present document is the legal evaluation of the Nestlé Implementation Report by the International Baby Food Action Network (IBFAN), and the Geneva Infant Feeding Association (GIFA). This legal evaluation is carried out against the background of the International Code of Marketing of Breast-milk Substitutes (International Code), the preparatory work of the International Code and the relevant resolutions of the World Health Assembly (WHA) subsequent to the adoption of the International Code.

It is also intended to assess, how far, if at all, the Nestlé Implementation Report really complies with the International Code on self-monitoring by manufacturers and distributors of the products within the scope of the Code. Nestlé is one of these manufacturers and distributors.

3.The Regime of Monitoring under the International Code

Article 11 of the International Code envisages two types of monitoring the application of the Code, namely monitoring by Member States, and self-monitoring by manufacturers and distributors of products covered by the Code. So far as State-monitoring is concerned, it is provided for in Article 11.2 of the International Code, which reads as follows:

"Monitoring the application of this Code lies with governments acting individually, and collectively through the World Health Organization as provided in paragraphs 6 and 7 of this Article."

Paragraph 6 deals with annual reporting by the Member States of WHO on action taken to give effect to the Code at the national level. This reporting requirement is based on Article 62 of the WHO Constitution. Paragraph 7 deals with the reporting by the Director-General to the WHA, once every two years, on the status of implementation of the International Code.

Self-monitoring is dealt with in Article 11.3, which reads as follows:

"Independently of any other measures taken for implementation of this Code, manufacturers and distributors of products (1) within the scope of this Code should regard themselves as responsible for monitoring their marketing practices according to the principles and aim of this Code, and for taking steps to ensure that their conduct at every level conforms to them."

Let us now examine the Nestlé Implementation Report against the background of the provisions of the International Code and see what those provisions require Nestlé to do in the context of self-monitoring, and what Nestlé has in fact done in this context. Reference will also be made to the subsequent relevant resolutions of the WHA, when appropriate.

1. Art. 3 of the International Code defines those terms as follows: " '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 Code. A 'primary distributor' is a manufacturer's sales agent, representative, national distributor or broker." " 'Manufacturer' means a corporation or any other entity in the public or private sector engaged in the business or function (whether directly or through an agent or through an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code." back

4.The Concept of Self-monitoring under the International Code

It has to be stated, at the outset, that the title of the Nestlé Implementation Report is incorrect and can be misleading in that it uses the term "Implementation", which is not the responsibility of a manufacturer or distributor of breast-milk substitutes or any other product covered by the Code. Implementation of the International Code is solely the responsibility of Member States of WHO, by virtue of Article 11.1, which reads as follows:

"Governments should take action to give effect to the principles and aim of this Code, as appropriate to their social and legislative framework, including the adoption of national legislation, regulations or other suitable measures."

It should be pointed out that "giving effect to" the principles and aim of the International Code, is the same as the "implementation" of the Code, which is a government responsibility and not that of Nestlé. Nestlé's responsibility is the monitoring of its own marketing practices, ­ according to the provisions of the International Code.

So far as the concept of self-monitoring is concerned, Article 11.3 of the Code imposes on a manufacturer and distributor of a product within the scope of the Code, such as Nestlé, the responsibility of monitoring its marketing practices and ensuring that its conduct, at every level, conforms to the principles and aim of the Code. Therefore, this responsibility consists of two elements, the first is the monitoring of marketing practices, and the second is ensuring that its conduct conforms to the aim and principles of the International Code.

What does "monitoring" mean? The term is not defined in the International Code. Therefore, it should be given its ordinary meaning. In accordance with the Vienna Convention on the Law of Treaties, 1969,

"A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose."(2)

While the International Code is not a treaty, the Vienna Convention can apply by analogy to the International Code. The ordinary meaning of "monitoring", according to The Concise Oxford Dictionary is to "maintain regular surveillance over."(3) Accordingly, Nestlé is required by the International Code to carry out regular surveys of its marketing practices. This suggests investigations and inspections of the various marketing practices carried out by Nestlé itself or on its behalf by its agents, marketing personnel, subsidiaries or any other entity acting in that capacity for it. What are to be surveyed are the marketing practices of those people and entities. The term "Marketing" is defined in Article 3 of the International Code as

"product promotion, distribution, selling, advertising, product public relations, and information services."

Therefore, Nestlé is responsible for monitoring all these activities. Furthermore, this responsibility implies going to where these activities are carried out, be it at sales outlets, shops, supermarkets, health care facilities, retailers premises and the Internet, in order to verify whether such activities are carried out in accordance with the principles and aim of the International Code.

Moreover, Nestlé is responsible for taking the necessary measures to ensure that its conduct, at every level, conforms to the principles and aim of the International Code. That is to say, Nestlé should make sure that all its agents, marketing personnel, subsidiaries and retailers respect the provisions of the Code in the exercise of their marketing activities. And if there is a violation of the Code at any level, this violation should be corrected by Nestlé. Furthermore, Nestlé is required by the International Code to inform its marketing personnel of their obligations under the Code according to Article 11.5, which reads:

"manufacturers and primary distributors of products within the scope of this Code should apprise each member of their marketing personnel of the Code and of their responsibilities under it."

The provision makes it clear that a manufacturer of breast-milk substitutes should make each member of its marketing personnel aware of their obligations under the International Code, when they promote, distribute, sell, advertise, do public relations and provide information services relating to breast-milk substitutes. There are a number of obligations imposed by the Code on those personnel. For example, the Code bans the giving of samples of products within its scope (Article 5.2). Furthermore, the Code does not allow the marketing personnel of manufacturers or distributors of such products, in their business capacity, to have direct or indirect contact with pregnant women or mothers of infants and young children (Article 5.5). It also bans the donations or low-price sales of supplies of those products, except under very strict conditions (Article 6.6). Therefore, any violation by any of Nestlé's marketing personnel of any of their obligations under the Code should be penalised by Nestlé. It would, therefore, appear that the Code envisages a link between informing marketing personnel of manufacturers and distributors of their responsibilities, surveying of their marketing practices and ensuring that they conform to the Code, at every level, for the purpose of self-monitoring under Article 11.3 of the Code.

Which are the criteria that should be applied by Nestlé in its monitoring process? The answer to this question is to be found in Article 11.3 of the International Code, which stipulates that manufacturers and distributors of products within the scope of the Code should carry out their monitoring responsibility "according to the principles and the aim of this Code". This should be done independently of any other measures taken for the implementation of the Code.

Let us now examine the Nestlé Implementation Report against the above concept of self-monitoring.

2.See Art. 31, para. 1, of the Convention; see also Art. 31, para. 1, of the Vienna Convention on the Law of Treaties between States and International Organizations or between International Organizations, 1986.back

3. See 9th ed.,1995, p. 879.back

4.On the history of the International Code, see Sami Shubber, The International Code of Marketing of Breast-milk Substitutes ­ An International Measure to Protect and Promote Breast-feeding 1998, pp. 3-45, published by Kluwer Law International.back

5.Nestlé's Self-monitoring

Under the heading "Criterion Used for self-Monitoring", the Nestlé Implementation Report states that

"in accordance with the International Code, the criterion used for self-monitoring in the current report is the International Code, as applied and defined by each country. In other words, the criterion is what the government endorses and accepts as the interpretation of the Code in that country... This is in accordance both with the International Code itself, as well as WHO's reinforcement of the sovereignty of governments and nature of WHO recommendations." (5)

Nestlé begins, accurately and correctly, with the statement that the criterion it used for self-monitoring was the International Code. But it goes on to qualify this criterion (i.e., the International Code) by the expression "as applied and defined by each country". Then it goes on "the criterion is what the government endorses and accepts as the interpretation of the Code in the country."

There is nothing in the provision to suggest that the International Code can be implemented as applied, defined, endorsed or accepted as the interpretation of the Code by any country. If we carry Nestlé's position to its logical conclusion, then it would be possible to argue that if in State A, where the International Code is not implemented in conformity with Article 11.1, there is a decree banning only the giving of free or subsidized supplies of breast-milk substitutes, Nestlé will use that decree as its criterion for monitoring its marketing practices. This is not what is envisaged under Article 11.3 of the Code, in conjunction with the relevant WHA resolutions.

Furthermore, Nestlé maintains that the criterion it has used is the International Code, as endorsed and accepted as the interpretation of the Code in a certain country. But this is a very strange argument, to say the least, because under Article 11.1 of the Code, Member States of WHO are called upon to implement the Code, not to interpret it, in national legislation, regulations or other suitable measures. Of course, a Member State may not be in a position to implement the Code in any of these ways, for some reason, such as lack of resources or expertise. But it would not be possible for that State, in its attempt to give effect to the Code, to take certain limited measures amounting to an interpretation of the Code, without implementing it in its entirety. Nestlé is willing to accept such measures as a criterion for self-monitoring. It must be pointed out that the WHA, when it adopted the Code, stressed that "the adoption and adherence to the International Code ... is a minimum requirement"(6), and it urged Member States

"to give full and unanimous support to the implementation ... of the provisions of the International Code in its entirety ..." (7)

Therefore, unless the International Code itself, as adopted by the WHA, and as clarified by subsequent relevant WHA resolutions, is used as the criterion for self-monitoring, any self-monitoring using a national instrument that does not give effect to the provisions of the Code, in their entirety, and those WHA resolutions, is flawed.

As such, it cannot constitute compliance with Article 11.3 of the International Code. It might be appropriate to conclude the discussion of this important criterion by invoking the position of the WHO and UNICEF Secretariats on Article 11.3, to the effect that

"the determination of whether manufacturers' and distributors' practices are or are not in conformity with the Code will be made on the basis of the Code itself, or national action taken to give effect to it."(8)

It might also be relevant to mention in this context that a national action giving effect to the International Code (implementation of the Code), in order to constitute full compliance with Article 11.1 of the Code, has to be: (a) either legislation, regulation or another measure of a legally binding nature; (b) it should contain the International Code in its entirety and as a minimum measure; and (c) include subsequent relevant resolutions of the WHA. Any national measure short of that would not be in line with the intent of Article 11.1 of the Code and the wish of the WHA, nor would it constitute the criterion for self-monitoring under Article 11.3.

Another issue raised in the Nestlé Implementation Report is the question of sovereignty and the legal nature of the recommendations of the WHA. It referred to the statement of the WHO Director-General to the effect that

"Member States are sovereign; they may ... implement WHO's recommendations to the letter; they may actually go beyond these recommendations; or they may simply ignore them altogether."(9)

Then the Report went on to refer to "WHO's reinforcement of the sovereignty of governments and nature of WHO recommendations", in an attempt to support its argument in relation to the criterion it used in its alleged self-monitoring. But this attempt fails, for the statement of the Director-General does not, by any stretch of the imagination "reinforce the sovereignty of governments", as alleged by Nestlé. Member States of WHO are sovereign States under international law and the statement of the Director-General does not add anything to that sovereignty. Moreover, the Director-General said nothing about reinforcing the sovereignty of Members of WHO, nor does she have the authority under international law to do so. The Director-General of WHO is "the chief technical and administrative officer of the Organization", according to the WHO Constitution (Article 31). Therefore, Nestlé's description of the statement of the Director-General could be misleading, as it attributes to it something of a legal nature which is not there.

As regards the nature of the WHO recommendations it is true that, per se, they are not binding from a legal point of view. However, it is indeed unfortunate that the Director-General believes that WHO recommendations may be ignored altogether by Member States. WHO recommendations on a public health issue, adopted by the WHA, express the collective judgement of the membership of the Organization, which is the highest health authority in the world. The WHA itself said so in 1981, when it adopted the International Code. It urged Member States to implement the International Code "as an expression of the collective will of the membership of the World Health Organization".(10) This position was reiterated by the Secretariats of both WHO and UNICEF later, when they said:

"Recommendations adopted by the Health Assembly for appropriate action by Member States in their territories express the judgement of the collective membership of the Organization on given public health issues ..."(11)

As such, recommendations of the WHA carry at least some moral and professional force and should have a persuasive authority. Furthermore, in certain situations, some recommendations of the WHA, not unlike those of the General Assembly of the United Nations, could have legal obligations for Member States (12) and cannot be ignored altogether by Member States.

Another issue raised in the Nestlé Implementation Report is that the Directive adopted by the European Communities (now the European Union) in 1991 (European Directive 91/321),

"... is the implementation of the International Code in Europe (see letter from government of Denmark, page 176)." (13)

This statement is misleading, for the European Directive 91/321, does not cover all the provisions of the International Code. To give but some examples of the differences between the Code and the Directive: The scope of the European Directive is narrower than that of the International Code, in that it applies to the composition and labelling of infant formulae, which is only one category of breast-milk substitutes(14). By contrast, the International Code applies to all breast-milk substitutes , as well as feeding bottles and teats, and covers more than the composition and labelling of those products(15). Furthermore, the European Directive allows the advertising of infant formulae in publications specializing in baby care and scientific publications(16); whereas the International Code bans advertising altogether, as well as any other form of promotion for products covered by it (17). Consequently, the European Directive cannot be considered as a proper implementation of the International Code as envisaged by its drafters and as expressed in Article 11.3 of the Code, and as urged by the WHA.

It might be pertinent here to comment on the letter of the Danish Government, which the Nestlé Implementation Report invokes. The letter refers to EC Directive 91/321 and goes on to say that the Danish Veterinary and Food Administration has implemented that Directive. It thus believes by doing so "the principles and aim of the International Code of marketing of Breast-milk Substitutes ... have been integrated into Danish law". This statement expresses the belief of the Danish authorities, which may not necessarily be in line with Article 11.1 of the International Code. As has been mentioned earlier, the EC Directive does not cover all the provisions of the International Code. Therefore, its implementation does not constitute proper implementation of the International Code. Furthermore, the Danish letter, it appears, was not intended to be a declaration of Nestlé's compliance with the Code. It would seem that the author of that letter was under the impression that

"... Nestlé would use the letter in connection with export of infant formulas to countries outside the EU in order to inform about the fact that Denmark had implemented the commission's Directives."(18)

It may be concluded that the criterion used by Nestlé for its alleged self-monitoring is not the one required by Article 11.3. Nestlé did not use the International Code and subsequent WHA relevant resolutions for the purpose of self-monitoring, nor did it use national measures which meet the conditions laid down in Article 11.1 and the resolutions of the WHA.

 

5.See the Nestlé Implementation Report, p.2.back

6. See Resolution WHA 34.22, last preambular paragraph.back

7. See ibid., operative para. 2 (1)., (emphasis added)back

8. See WHO/UNICEF Notes on the International Code of Marketing of Breast-milk Substitutes, 1982, p.11, para. 47, (emphasis added).back

9. See the statement of the WHO Director-General at the WHO Round Table, 19 November 1998, p.7, quoted in the Nestlé Implementation Report, p.2.back

10. See Resolution WHA34.22, operative paragraph 2 (1).back

11. See WHO/UNICEF Notes, loc. cit., p. 11, para. 45.back

12. On the legal effect of resolutions of WHA, see Shubber , loc. cit., pp. 194-202.back

13. See the Nestlé Implementation Report, p. 2.back

14. See Art. 1 of the Directive. The text of the European Directive is to be found in the Official Journal of the European Communities, L 175 (4.7.91), pp. 35-39.back

15. See Art. 2 of the International Code.back

16. See Art. 8.1 of the European Directive.back

17. See Art. 5 of the International Code.back

18. See Baby Milk Action, Briefing Paper (December 1999), p.11. back

6.Nestlé's Approach to Self-monitoring

According to the Nestlé Implementation Report, its approach to self-monitoring was as follows:

"1. Nestlé approached health ministries to ask the governments to inform Nestlé of any violations of the International Code as applied in their countries, which need to be corrected (See Exhibit 1 for a sample letter). The Nestlé Instructions (Exhibit 2 ...), where appropriate, were presented again to the government to assure that the government approved of our policies (or inform us if they did not), and the relevant government measures were referenced.

2. If the government was aware of any violations, or if they did not agree with a Nestlé policy in implementing the Code, it was asked to inform Nestlé, and the Company proceeded to take corrective action.

3. When the point had been reached where the government was in a position to confirm Nestlé's Code compliance, it was asked to do so in writing." (19)

Nestlé's approach to self-monitoring calls for the following comments:

(a) Self-monitoring, from a linguistic point of view, means monitoring by oneself, and not by someone else. In this respect, Nestlé has not, itself, carried out its obligations under Article 11.3 of the International Code, namely surveying, investigating, and inspecting its marketing personnel, contractors, places of distribution of its products, and facilities of the health care systems, etc., in order to ensure that its marketing practices conform to the provisions of the International Code. To ask ministries of health to tell Nestlé of any violations of the International Code is tantamount to asking them to monitor Nestlé's marketing practices, but is not self-monitoring by Nestlé. If so, then this exercise does not amount to self-monitoring. It is "passing the buck", which is not what is intended under Article 11.3 of the International Code. In fact, Nestlé itself admits , fortuitously, that its alleged self-monitoring was State monitoring, in accordance with Article 11.2 of the International Code. The Nestlé Implementation Report states:

"A second strength of the current process [self-monitoring] is that it fostered communication between the Company [Nestlé] and each government on the International Code, and the government exercised the role given to it by Article 11.2 of the International Code, as being responsible for monitoring."(20)

(b) Article 11.3 of the Code clearly states that manufacturers and distributors of products covered by it "should regard themselves as responsible for monitoring their marketing practices" (emphasis added). The Code does not say that Nestlé should go and ask ministries of health of WHO Member States to tell Nestlé if the Company, or any of its agents or personnel, are violating the International Code. Moreover, there is nothing under the Code permitting Nestlé to ask ministries of health if they agree with the Company's policy on implementation of the Code, and then to consider that as self-monitoring under Article 11.3. The drafters of the Code intended that entities like Nestlé should check, investigate and ensure that they, their agents, personnel, contractors, and so on, are complying with the provisions of the Code insofar as their marketing practices are concerned. And if they discover any violation of the Code, then they should correct it, rather than ask ministries of health to tell them of violations of the Code. At the 1998 WHA, the Director of Family and Reproductive Health stated that

"manufacturers and distributors of foods intended for infants and young children had ... a responsibility to monitor their marketing practices in ... [accordance with] the principles and aim of the Code and ... [relevant] resolutions of the World Health Assembly." (21)

(c) In its sample letter (the letter to the Ministry of Health of Malaysia), Nestlé is asking the Ministry to judge the Company's marketing practices on infant formula products by the Malaysian Code of Ethics for Infant Formula Products. The latter Code cannot be considered as a proper implementation of the International Code, as required by Article 11.1 of the Code. Firstly, the Malaysian instrument is a "Code of Ethics", which is non-binding; therefore, it cannot be considered as a proper legal instrument for the purpose of the implementation envisaged in Article 11.1 of the International Code. Secondly, the scope of the Malaysian Code of Ethics is limited to infant formula which, as said above, is only one category of breast-milk substitutes. As such, it cannot constitute a criterion for measuring Nestlé's responsibility for self-monitoring under Article 11.3. In the Nestlé letter to the Malaysian Ministry of Health, Nestlé appears to be asking for its responsibility under the International Code to be assessed by a much weaker instrument, namely the Malaysian Code of Ethics. The letter says:

"Nestlé has taken very seriously its responsibility to market our Infant Formula products in accordance with the International Code, which is implemented in Malaysia through the Malaysian Code of Ethics for Infant Formula Products."(22)

If the latter Code is only a partial implementation of the International Code, in a non-binding instrument, how could it be the criterion for measuring Nestlé's compliance with the International Code? The Malaysian Code of Ethics was first formulated in 1979 and was revised in 1983, 1985 and 1995(23). As its name suggests, it is a code of ethical practices for the infant formula industry and for medical and health professionals/personnel. The penalties provided in the Code of Ethics do not appear to constitute penalties in the proper sense of the word. The strongest penalty in it is a written warning to the parent company, in case of violation ( 24). As said earlier, its scope is limited to one category of breast-milk substitute. Furthermore, it does not cover some of the provisions of the International Code, e.g., Article 6.6. of the International Code on supplies and Article 9.2 (d) on pictures or texts on labels. And it contains no reference at all to its being an implementation of the International Code.

(d) The contents of the letter of the Malaysian Ministry of Health to Nestlé may not necessarily confirm Nestlé's alleged compliance with Article 11.3 of the International Code. The letter starts by thanking Nestlé for its co-operation with the Ministry

"... in upholding the Code of Ethics for Infant Formula Products. It is hoped that your Industry will further improve in your actions towards promoting, protecting and supporting breast feeding and continue to abide by the Code."(25)

Strictly speaking, the letter does not say expressly that Nestlé was complying with the Code of Ethics. It expresses the hope that "Nestlé will continue to abide by the Code". While this phrase could be interpreted in favour of Nestlé's alleged self-monitoring, it is vague and general; therefore, it provides little support for Nestlé's thesis. Even if one were to accept this statement as compliance, it would seem to be compliance with a national instrument which cannot be regarded as a proper implementation of the International Code as envisaged by the drafters of the International Code. As regards "upholding the Code of Ethics", the letter might have been intended to refer to the support provided by Nestlé in the preparation of the Code of Ethics. The Malaysian Minister of Health acknowledged receipt of strong support and cooperation from the infant formula industry during the preparation of the revised edition of the Code of Ethics in question.(26)

(e) In its approach to its alleged self-monitoring, Nestlé asked that when "the government was in a position to confirm Nestlé's Code compliance, it was asked to do so in writing." Here, again, there is an indication that Nestlé expects the government concerned to monitor Nestlé's marketing practices, and then when the government completes this process, it should state in writing: we confirm that Nestlé is in compliance with the International Code. This approach cannot be considered as relevant to the self-monitoring envisaged under the International Code because, in fact, it amounts to third-party monitoring.

19 See the Nestlé Implementation Report, p.3.back

20 Ibid., p, 8, under the heading "Conclusions and Ways to Strengthen the Current Approach".back

21 See Fifty-first World Health Assembly, WHO Doc. A51/A/SR/4, 15 May 1998, p. 11.back

22 See the Nestlé Implementation Report, p. 4.back

23 For the text of the Malaysian Code of Ethics, see Ellen Sokol, The Code Handbook ­ A Guide to Implementing the International Code of Marketing of Breast-milk Substitutes, (1997), pp. 221-239.back

24 See ibid., p. 238, under "(d) Penalty", para. (i).back

25 See the Nestlé Implementation Report. p. 104.back

26 See Foreword to the Code of Ethics by Y.B. Encik Chua Jui Meng, Minister of Health, Malaysia, note 23 above, p. 224.back

7.The Nestlé Instructions

Nestlé presented its Instructions for the Implementation of the International Code (Nestlé Instructions), to 54 governments of WHO Member States. Eight of these governments, namely, Guyana, Saint Vincent and the Grenadines, Antigua and Barbuda, South Africa (the provinces of Mpumalanga and Northern Cape), Madagascar, Comores, Cyprus and Romania have referred, expressly or implicitly, to the Nestlé Instructions and seem to base their replies on them when replying to Nestlé's request for confirmation that it is complying with the International Code. It would, therefore, be fair and reasonable to make the following comments on those Instructions:

Nature of the document

The Nestlé Instructions is a complex document, and any person who is not well conversant with the International Code, WHA subsequent relevant resolutions and other circumstances surrounding the adoption of the Code, may not appreciate the significant differences between the Instructions and the Code. The Instructions use clever language, a deliberate choice of words, and also vague language, which departs from the language and intent of the International Code in many ways. Yet the difference between the Code and the Instructions may not be appreciated by the uninitiated. It is well known that when Nestlé requested WHO to review its Instructions in 1982, it took a multi-disciplinary team of the WHO Secretariat some weeks to do so. Therefore, it would not be fair and reasonable to expect senior officials of ministries of health, who are often very busy, to review and appreciate the differences between the Code and the Instructions.

Scope of the International Code

The Nestlé Instructions contain a glaring misrepresentation of the International Code when they reproduce Article 2 of the Code (Scope of the Code). Nestlé's text inserts the following under Article 2 of the Code:

"N.B. The scope is clarified in Annex 3 (p.33) of the Code:

During the first four to six months of life, breast milk alone is usually adequate to sustain the normal infant's nutritional requirements. Breast milk may be replaced (substituted for) during this period by bona fide breast-milk substitutes, including infant formula. Any other food, such as cow's milk, fruit juices, cereals, vegetables, or any other fluid, solid or semi-solid food intended for infants and given after this initial period, can no longer be considered as a replacement for breast milk (or as its bona fide substitute)." (27)

The quoted passage is taken from the statement of the representative of the Executive Board of WHO before the WHA, Dr. Mork, in 1981. Neither the text of the International Code adopted by the WHA on 21 May 1981, nor the text subsequently published by the WHO Secretariat, contain such an N.B. Furthermore, the insertion of the N.B. is misleading, in that it may give the impression that Annex 3 constitutes part of the International Code, as adopted by the WHA which, of course, is not the case. The statement of the representative of the Executive Board is not the same as the pronouncement of the WHA. The latter is responsible for determining the policies of the WHO, according to the Organization's Constitution , (28) whereas statements of members of the Executive Board represent their personal views. Members of the Executive Board are individuals who are technically qualified in the field of health, according to the WHO Constitution (29). Incidentally, Nestlé also took the liberty of underlining two terms in Article 3 of the Code, when the text of the provision was reproduced in its Instructions, without any basis under the Code. The term "primary distributor", in the definition of "distributor" , and the term "sales outlets", in the definition of "health care system", were underlined by Nestlé.(30) While the underlining does not affect the substance of the definitions, it adds something which is not in the Code. A reproduction of a WHO text should be entirely faithful to the original.

Differences between the Nestlé Instructions and the International Code

There are serious and significant differences between the Nestlé Instructions and the International Code. While this evaluation of the Nestlé Implementation Report is not intended to be a review of the Nestlé Instructions, it would be appropriate to give some examples of these differences between the Code and the Instructions:

(a) Article 2 of the International Code applies to breast-milk substitutes, including infant formula, as well as other milk products, foods and beverages, which would fall under the heading of breast-milk substitutes when marketed or otherwise represented as a partial or total replacement of breast-milk. The Nestlé Instructions apply to infant formula only. This considerably narrows the scope of the Instructions.

(b) Article 4.2 (e) of the International Code bans the " use of any pictures or text which may idealize the use of breast-milk substitutes" on informational and educational materials. By contrast, Nestlé Instructions allow the use of "baby pictures ... to enhance the educational value of information." This constitutes a breach of Article 4.2 (e), which is intended to prevent the use of educational and informational materials for the promotion of breast-milk substitutes and other products covered by the Code; and the use of such pictures is a form of promotion.

(c) Article 5.1 of the International Code bans the advertising and any other form of promotion to the general public of products covered by the Code. Nestlé Instructions speak of "information relating to infant formula must not be communicated directly to mothers or the general public."

There is a significant difference between advertising and any other form of promotion and "information". Moreover, the ban under the International Code applies to direct and indirect advertising and promotion, whereas the Nestlé Instructions apply to communication of information "directly" only, to mothers and the general public. Thus, the ban under the Instructions is narrower than under the Code.

(d) Article 6.4 of the International Code bans the use of "professional service representatives", "mothercraft nurses" and similar personnel in the health care system, provided or paid for by manufacturers or distributors of products covered by the Code. By contrast, the Nestlé Instructions say

" company personnel must not be used by the health care system for advising mothers or similar duties."

The wording used by the Instructions could be misleading, for "mothercraft nurses" may not necessarily be Nestlé company personnel. They could be paid for by Nestlé without being Nestlé staff members. Furthermore, while the Code does not allow the use of such personnel for any purposes, the Nestlé Instructions limit the ban to "advising mothers or similar duties". The latter is narrower than the Code and the clever and careful language the Instructions use may mislead many a person, who is not familiar with the Code, and thus allow promotional activities under the provision.

(e) Article 6.6 of the International Code allows the donations of supplies of breast-milk substitutes and other products covered by it, and the low-price sales of these products to "institutions or organizations", under certain specific conditions. In addition, the WHA adopted a resolution in 1994 banning the giving of such supplies to "any part of the health care system".(31)The Nestlé Instructions ban free or low-price infant formula supplies "to maternity wards and hospitals". The term "maternity wards and hospitals" covers a very narrow range of medical institutions, whereas the term "any part of the health care system" applies to a much wider range. For Article 3 of the International Code defines "health care system" as

"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."

Moreover, while Article 6.6 allows the donation or low-price sale of supplies of breast-milk substitutes only for use or distribution "for infants who have to be fed on breast-milk substitutes", the Nestlé Instructions used a language which is different from the Code's. They use the following language:

"Free or low-price infant formula supplies may not be donated to maternity wards and hospitals for use by healthy newborn babies."

The Code's language was chosen by the drafters of the Code in order to limit the recipients of such supplies and thus prevent the use of supplies as a form of promotion of breast-milk substitutes. The Nestlé Instructions introduce a different wording, which is open to abuse.

Elsewhere in the Instructions, one finds devious language used under Annex 5, heading "Clinical Validation Policy", which distorts the intent of Article 6.6, and thus misleads. Under the latter heading, Nestlé refers to its commitments under the International Code and goes on to say:

"since breast-feeding is to be encouraged for all babies, only those babies who have to be fed on a breast-milk substitute may participate in trials ­ these may, however, include babies whose mothers, after consultation with a doctor, have chosen not to breast-feed, or chosen to discontinue breast-feeding, or chosen to complement breast-feeding." [Emphasis added.]

The emphasised expressions convey a notion which is drastically different from the notion of "infants who have to be fed on breast-milk substitutes", as intended by the drafters of the Code. As the chief drafter of the Code, Sir Robert Jennings, former Judge and President of the International Court of Justice, has said in a paper for the WHO on the intent of Article 6.6 in relation to the phrase "infants who have to be fed on breast-milk substitutes":

"This means infants who, for clinical reasons cannot be breast-fed and for whom, therefore, there is no option other than the use of substitutes. 'Have to' is a phrase indicating an absence of any choice in the matter. Of course the wrongful use of substitutes for infants who do not 'have to be' thus fed, will change them into infants that do. But this is precisely what the Code seeks to prevent. This is apparent from the whole intent and purpose of the Code, and if any doubt on this point can be imagined, it must be dispelled by a reading of the Code as a whole, including its preamble."(32)

In the absence of compulsion, a mother choosing to use a breast-milk substitute in feeding her infant for any reason, would not turn the infant into one that "has to be fed on breast-milk substitutes".

(f) Article 7.3 of the International Code bans the provision of financial or material inducement to promote products covered by the Code to health workers or members of their families. By contrast, the Nestlé Instructions allow the giving of "low-cost items of professional utility, or culturally appropriate gifts" to health workers, and give a long list of those items.(33) These items include "inexpensive" materials, "material intended for health workers (including those attending congresses and conferences), which either have educational purposes or render a genuine service", weight charts, wall charts, calculators, weighing scales and stethoscopes. The giving of such materials and tools cannot be in line with Article 7.3 of the Code, as this practice is promotional in nature.

Relevant WHA resolutions

The Nestlé Instructions allege that they take into account the relevant WHA resolutions which were adopted after the adoption of the International Code.(34) But in practice, these resolutions are not, in fact, taken into account by Nestlé. A clear example is the donation of low-price sales of supplies of breast-milk substitutes, which are not allowed to "maternity wards and hospitals", according to the Nestlé Instructions, whereas the relevant WHA resolution bans the same supplies to "any part of the health care system"(35). These resolutions of the WHA clarify the intent of some of the provisions of the Code and, as such, are relevant to the process of implementation and monitoring of the Code.

27 See the Nestlé Implementation Report, p. 25.back

28 See Art. 18 (a) of the WHO Constitution.back

29 See ibid., Art. 24.back

30 See the Nestlé Implementation Report, p.35.back

31 See Resolution WHA47.5, operative paragraph 2 (2). back

32 This passage is cited in Shubber , loc.cit., p. 136, (emphasis added).back

33 See the Nestlé Implementation Report, Annex 4, p. 41.back

34 In the Introduction to the Updated Nestlé Instructions, July 1996, under the heading "Purpose", it is stated that "this July 1996 version updates Nestlé's policy ... and also takes into account subsequent related World Health Assembly resolutions where appropriate." Ibid., p. 23. In the WHA resolutions the expression "subsequent relevant Health Assembly resolutions" is used. See WHA43.3, operative paragraph 2 (1) c.back

35 See above, p. 16.back

8. The Responses from Governments to Nestlé

Nestlé relies heavily on the responses it has received from 54 governments of WHO Member States, as

"written evidence ... indicating satisfaction with Nestlé's implementation of the International Code in their country ..." (36)

It is not the purpose of this evaluation of the Nestlé Implementation Report to discredit, or cast doubt on, the authenticity of the letters in question.(37) However, it would be fair and reasonable to make the following comments:

(a) The responses under consideration do not constitute "written evidence" from 54 governments indicating satisfaction with Nestlé's implementation of the International Code.

First, as has been mentioned earlier,(38) the implementation of the International Code is not the responsibility of Nestlé, it is the responsibility of governments of WHO Member States under Article 11.1 of the Code. Moreover, these responses are not relevant to the alleged self-monitoring by Nestlé, because they could, at best, be considered as evidence of State monitoring under Article 11.2 of the Code. Nestlé, itself, admits as much.(39)

(b) One does not know whether the governments were told for what purpose their responses would be used, and whether or not they were told by Nestlé that their responses would be published. At least in one case, the author of the letter from the Danish Ministry of Food, Agriculture and Fisheries, Danish Veterinary Administration, Dr. Bente Koch, said that she was "very surprised" that her letter was used in this way.(40) Certainly, Nestlé's sample letter does not contain any indication about the possible publication of the responses from governments. And yet, the sample letter attaches "a draft letter which the [government] could use" for its reply.(41) This draft letter has not been included in the Nestlé Implementation Report. It would be legitimate to ask: Had the people in the ministries of health been told that Nestlé was going to publish their letters in a document, widely distributed all over the world, and as "written evidence" from them of Nestle's compliance with the International Code, would they have written such letters?

(c) Eight of the 54 responses under consideration are based on Nestlé's Instructions, as has been demonstrated earlier, which differ significantly from the provisions of the International Code, while two responses (those from Burundi and Rwanda) are based on Nestlé's annual reports. Therefore, they cannot constitute the criterion required for self-monitoring under Article 11.3 of International Code. Furthermore, some of those responses do not support the thesis of self-monitoring claimed by Nestlé. The letter from Oman merely thanks Nestlé for attending a meeting in the Omani Ministry of Health in 1998. Another letter says that Nestlé is not complying with the International Code, as the Nestlé Implementation Report admits.(42) The letter from the Dominican Republic refers to the need to examine the labelling of infant formula. And the letter from Egypt is sent by a national society which does not appear to have any link with the Ministry of Health of Egypt.

(d) The wording of the above responses does not lend itself to establishing the process of State-monitoring, in general, let alone self-monitoring. Expressions like "to the best of my knowledge", "not aware of violations", "will inform you of any violations", "I have not noticed any of their products being sold here", and "the Health Authority understands", to give but a few examples, cannot by any standard of proof establish that Nestlé has been complying with the International Code. If the responses in question were really intended as proof of Nestlé's compliance with the International Code, one would have seen wording like "we have carried out an inspection and investigation of the market, retailers' premises and the health care system facilities, and have found that Nestlé is in full compliance with the International Code, or the national legal instrument giving effect to it."

36 See the Nestlé Implementation Report, p. 5.back

37 For a thorough and detailed analysis of the Government Responses to Nestlé, see IBFAN's Briefing Paper, Don't judge a book by its cover ­ The truth behind Nestlé's book, Appendix, January 2000.back

38 See above p. 3.back

39 See above pp.10-11.back

40 See above note 18, p.11back

41 . See the Nestlé Implementation Report, Exhibit 1, p. 4.back

42 See ibid, p. 5.back

9. The Essentials of a Self-monitoring Process

If Article 11.3 of the International Code on self-monitoring by manufacturers and distributors of products covered by the Code is to be implemented properly, then the following essential elements must be present in order to be in line with the principles and aim of the Code.

(a) These were laid down in a 1996 resolution by the WHA, where the Assembly urged Member States

"to ensure that monitoring the application of the International Code and subsequent relevant resolutions is carried out in a transparent, independent manner, free from commercial influence." (43)

While this resolution is addressed to Member States of WHO, in relation to State-monitoring under Article 11.2 of the International Code, the principles contained in the resolution are perfectly suitable for self-monitoring by the industry under Article 11.3. These principles are

1. Transparency;

2. Independence; and

3. Freedom from commercial influence.

(b) Any self-monitoring exercise by any manufacturer or distributor of breast-milk substitutes, or any other product covered by the International Code, should be transparent. That is to say, the process should be evident to anybody interested in the protection and promotion of breast-feeding. The transparency of the monitoring process enhances its credibility.

(c) The process of self-monitoring should be free from any pressure or influence, be it financial, administrative, political or any other influence. Only when monitors are free from any influence or pressure can their assessment of the marketing practices of Nestlé, or any other manufacturer or distributor of breast-milk substitutes or other products covered by the International Code, be impartial and objective. It may be relevant here to say that Nestlé had established a body called the Nestlé Infant Formula Commission (NIFAC) in 1982, headed by the late Senator Edmund Muskie and comprising a number of persons of high integrity and standing, for the purpose of examining complaints against Nestlé for non-compliance with the International Code. NIFAC was disestablished in 1991. However, a legitimate criticism against NIFAC is that it lacked the necessary independence, because of its full dependence on Nestlé for its financing and the appointment of its members.

(d) Any self-monitoring process by manufacturers or distributors of products within the scope of the Code should be free from any commercial influence. That is to say, the monitoring should not be subject to pressure or influence from any commercial side, be it the company itself or any of its subsidiaries or marketing personnel. This principle leads one to ask: If the personnel of a company producing breast-milk substitutes are monitoring the marketing practices of their own company, would this process meet the above principle? It would be doubtful if such personnel could be immune from the influence of their company (their employer). There is also a possible conflict of interest between the company and strict compliance with the International Code. The monitors are employed by the company and are therefore likely to give preference to the commercial interest of their employer over the promotion and protection of breast-feeding. Therefore, self-monitoring by manufacturers and distributors of products covered by the International Code under Article 11.3 could be unsatisfactory or inadequate. This shortcoming was noted by the participants at a meeting held under the auspices of WHO at The Hague in 1991, who declared that

"self-monitoring by the infant-food industry has in some cases been found to be inadequate or unsatisfactory."(44)

(e) Any self-monitoring by the industry under Article 11.3, should be entrusted to an independent panel composed of persons representing various disciplines relevant to the International Code, such as doctors, nurses, nutritionists, economists, lawyers, and administrators. Members of the panel should be conversant with the Code, the work of WHO, UNICEF, the United Nations system, and NGOs. They should be persons of high integrity and should possess the three principles contained in the resolution of WHA mentioned above, namely transparency, independence and freedom from commercial influence in the exercise of their monitoring function. And the criterion for monitoring must be the International Code, or national measures properly implementing the Code. It might be interesting to point out that, following the decision of the General Synod of the Church of England in 1994 to suspend its support for the Nestlé boycott (45), a group was established in the U.K. This group was called the Interagency Group on Breast-feeding Monitoring (IGBM), and was composed of NGOs, academic institutions and Churches. The purpose of the IGBM was to carry out independent research into violations of the International Code, by manufacturers and distributors of products covered by the Code, in four countries, namely, Poland, Bangladesh, Thailand and South Africa. The IGBM might represent a model for the panel suggested above, because in carrying out its research it maintained "complete independence from both the companies and IBFAN".(46) Incidentally, the IGBM has found many violations of the International Code in all the countries where the monitoring took place, and Nestlé is one of the offending companies.(47) IBFAN has also monitored the application of the Code in several countries, and has also found that Nestlé has been violating the Code.(48)

43 See Resolution WHA49.15, operative paragraph 3 (3).back

44 See Review and Evaluation of National Action Taken to Give Effect to the International Code of Marketin