CODEX-PANEL PORTRAIT Implementation of the WHO International Code of Marketing of Breast-milk Substitutes in Switzerland IMPRESSUM © 2012 Swiss Association for Foods for Special Dietary Uses, Berne Swiss Foundation for the Promotion of Breastfeeding, Berne Design: Nicole Eckert, Baden Text: Christine Aeschlimann, Berne; Beat Hodler, Berne 2 INHALT Purpose, Objectives and Methodology of the Codex Panel ..................................................................................................................... 4 The WHO International Code and the Swiss Producers’ Code .................................................................................................................. 5 The main provisions of the Swiss Producers’ Code ................................................................................................................................. 6 Monitoring in Switzerland ...................................................................................................................................................................... 7 Organizations and companies represented in the Codex Panel ............................................................................................................... 8 What has the Codex Panel achieved so far? ........................................................................................................................................... 9 Situation in Third World countries – basic consensus with the Federal Authorities ................................................................................. 10 Criticizing the Code and the Codex Panel – is it justified? ..................................................................................................................... 11 Sources ............................................................................................................................................................................................... 12 Contacts .............................................................................................................................................................................................. 13 3 PURPOSE, OBJECTIVES AND METHODOLOGY OF THE CODEX-PANEL The activities of the Codex Panel aim at fostering the relationship between mother and child and at supporting the mother in breastfeeding. The goal is to achieve a best possible ratio of breast-feed babies in Switzerland. By signing the Producers‘ Code of Marketing of Infant Formula («Verhaltenscodex der Hersteller über die Vermarktung von Säuglingsanfangsnahrungen», 1st edition 1982, 3rd revised edition 2010) the producers have committed themselves to exercising restraint in the marketing of infant formula and to encouraging mothers to breastfeed their babies during the first six months of life. In some aspects the rules of the Code of Marketing go beyond the legal requirements. In the Codex-Panel, which is equally composed, the representatives of the organizations affiliated to the Swiss Foundation for the Promotion of Breastfeeding and the Swiss manufacturers cooperate in view of achieving these aims. The Panel supervises the abidance by the Code. It monitors the advertising and the marketing practices of the manufacturers and verifies continuously their compliance with the basic principles of the Code. It develops recommendations regarding the interpretation of the Code. Any groups or individuals interested in the promotion of breastfeeding can inform the Codex Panel of violations of the Code as well as about any conduct that might possibly constitute a violation. The Panel presents the reported facts to the company concerned and asks it to make a statement in response. On the basis of the facts of the case, the Panel then tries to find a mutually acceptable solution. In this way overt and usually unintentional violations that occurred during advertising campaigns have been corrected by the companies concerned. The Panel can also make recommendations to the companies. With the revision of the Ordinance on Foodstuffs and Objects of Utility («Verordnung über Lebensmittel- und Gebrauchsgegenstände», LGV; SR 817.02) of March 7, 2008, restrictions on the promotion of Infant Formula have been introduced on a legal basis (see new article 11a LGV). The implementation of these rules falls within the competence of the Cantonal enforcement authorities. The Codex-Panel cooperates with the Federal Office of Public Health (BAG) and offers its assistance in all issues regarding the enforcement of article 11a LGV and the implementation of the International Code. 4 THE WHO INTERNATIONAL CODE AND THE SWISS PRODUCERS‘ CODE The International Code of WHO (1981) The Swiss solution In 1981, the World Health Organization (WHO) adopted the «International Code of Marketing of Breast-milk Substitutes». The International Code was the result of intense negotiations between governments, non-governmental organisations (NGO’s), professional associations and manufac-turers of infant formula. The International Code applies to the world as a whole. As a matter of principle, WHO does not issue different recommendations and regulations for developing countries and industrialized countries (in order to avoid so called «double standards»). However, the International Code mainly aims at regulating the situation in the developing countries where malnutrition and adverse sanitary conditions (lack of clean drinking water supplies) have particularly negative effects on the status of newborns. The International Code is a recommendation to the Member States requesting them to take appropriate measures to achieve the following objectives (article 1): • to provide safe and adequate nutrition for infants, • to protect and promote breastfeeding, • to ensure the proper use of breast-milk substitutes on the basis of adequate information and through appropriate marketing and distribution. In order to achieve these objectives, the International Code proposes a series of measures and restrictions concerning public advertising, relationships between producers and health professionals, labeling of products and product quality. A number of questions remained controversial after adoption or had to be readdressed, in response to lessons learned and to a changing environment. Recognising the need for clarification, the World Health Assembly adopted a series of resolutions between 1983 and 2001. These resolutions address the following issues: • the scope of the Code • the implementation and monitoring processes • the donation of infant formula to health care institutions • the duration of time during which breastfeeding should be protected (until 6 months). The UN-Resolution of October 19, 2010, on the «Millenium Development Goals» (Doc. A/RES/65/1) sets a target to reduce child mortality (goal 4) and to improve maternal health (goal 5). In this context the protection of breastfeeding plays an important role (see ciff. 74). WHO calls upon the Member States to take action to implement the principles and aims of the International Code «as appropriate to their social and legislative framework» and their overall development objectives, including national legislation, regulations or other suitable measures (article 11.1). Therefore it was necessary to reformulate the general and sometimes vague WHO recommendations in a way that takes the specific Swiss situation into account. For this purpose, as early as in January 1982, the Swiss producers signed a national Producers’ Code of Marketing of Breast-milk Substitutes. This Code followed the recommendations which the Swiss Association for Paediatrics (Schweizerische Gesellschaft für Pädiatrie, SGP) had issued at the time. In 1994 a revised version was adopted expressing the spirit of the various WHO resolutions as well as that of Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-up formulae. Several additional provisions were incorporated into this second version of the Code, such as: • the interdiction of giving free products to hospitals and clinics (a particular concern of WHO in 1994), • the producers’ obligation to extend the principles of the Code to downstream marketing levels, i.e. sensitizing retailers about the Code’s aims and principles. In 2008 article 11a was introduced in the Ordinance on Foodstuffs and Objects of Utility («Verordnung über Lebensmittel- und Gebrauchsgegenstände», LGV) taking on the provisions of Directive 2006/141/EC on restrictions to advertising (article 11 of the Directive). Further rules on the labeling of infant formulas (and of follow-up formulas) of the Directive were transposed in the Ordinance on Foods for Special Nurtrition Purposes («Verordnung des EDI über Speziallebensmittel», SR 817.022.104, articles 17a and 18a). The revised edition of the Producers‘ Code of Marketing agreed in 2010 reflects the new food law provisions and additionally contains several interpretations developed by the Codex-Panel over the years. 5 THE MAIN PROVISIONS OF THE SWISS PRODUCERS‘ CODE 1 Principles Communication to parents • Breast-milk is the natural food for an infant during the first months of life. Breastfeeding should be protected and promoted. • With respect to their quality, composition and nutritional value, infant formulae should be suitable for use: - as a complement to breast-milk when breast-milk becomes insufficient to satisfy the nutritional requirements of the infant (mixed feeding), - as a substitute for breast-milk only in cases when the mother does not breastfeed. • Health professionals – physicians, midwives, lactation consultants, mother-child advisors – should inform and advise mothers about the best nutrition for their infant. • Any communication to parents concerning the use of infant formula should contain a statement pointing out the need to consult a health professional and emphasizing the superiority of breast-milk (see above). • Any information should be worded so as not to discourage mothers from breastfeeding. • Advertising in magazines directed to the general public is prohibited. Permitted is only advertising in publications dedicated to the infant care and in scientific publications. The information should not imply or create a belief that bottle feeding is equivalent or superior to breastfeeding (article 11a para. 1 of LGV). • In the retail trade advertising with the aim to stimulate the sale of infant formula is not permitted. Equally not permitted are specific displays, cent-off coupons, tie-in sales, special promotional activities (reduced price campaigns), teasers or package deals (article 11a para. 2 of LGV). • The distribution of free or reduced-price products, samples or any other promotional gifts directly or indirectly via the health care system is prohibited (article 11a para. 3 of LGV). Scope of the Code The Code refers to the promotion and marketing of infant formula as defined in article 17 para. 1 of the Ordinance on Foods for Special Nutrition Purposes2 and Directive 2006/141/EC (today Regulation (EU) No. 609/2013 on «food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control»). Advertising for and labeling of infant formula • The labeling is regulated by the general provisions of the Ordinance on Labeling and Promotion of Foodstuffs («Verordnung des EDI über die Kennzeichnung und Anpreisung von Lebensmitteln», LKV, SR 817.022.21) and article 17a of the Ordinance on Foods for Special Nutrition Purposes. • Advertising texts and labels should: - point out the superiority of breastfeeding over the use of the product as a substitute or complement to breast-milk, - objectively and comprehensively communicate the appropriate preparation and use of the formula and contain a warning about the health hazards of inappropriate preparation (on the package). • The packaging should carry the following IMPORTANT NOTICE (or equivalent) in an easily visible manner: Breastfeeding is ideal for your child. Please consult a health professional if your child requires a complementary food or if you do not breastfeed. • The display of pictures of infants on formula containers and wordings which idealize the product are prohibited (article 17a para. 8 of the Ordinance on Foods for Special Nutrition Purposes). Communication to physicians, health professionals, clinics and hospitals • Any information provided to health professionals has to be factual and objective and should not create the impression that bottle feeding of formula is equivalent or superior to breastfeeding. • Health professionals shall decide independently and according to the indication on the use of infant formula in the hospital, thus ensuring that the mother is in no way restrained from breastfeeding. • The manufacturers respect the free and autonomous decision of the health professionals in the establishment of the feeding plan for the infant and in the advice given to the mother. • Direct or indirect financial or material inducements are not permitted. • Any delivery of infant formula to hospitals, clinics and other health institutions – whether for the internal use or for dispensing to the mother leaving the establishment – has to be invoiced. 6 MONITORING IN SWITZERLAND The International Code requires in its article 11 that governments monitor the application of the Code and cooperate for this purpose with manufacturers and distributors as well as with nongovernmental organisations, professional groups and consumer organizations (Article 11.2 and 11.4). Manufacturers are urged to implement the Code‘s requirements within their respective companies (Article 11.5). In the Swiss context the implementation of this aim had to be achieved within the framework of existing legislation. This meant taking into account health policies, the federal structures (legislative authority lies with the Confederation, but implementation with the Cantons) and the principles of commercial law (freedom of trade and of economic pursuit). Based on these insights, the Swiss UNICEF Working Group for the Promotion of Breastfeeding (today the Swiss Foundation for the Promotion of Breastfeeding) and the section Infant Nutrition of the Swiss Association for Foods for Special Dietary Uses initiated the formation of a Codex Panel in 1995. The open dialogue within a body representing both sides in equal numbers made it possible to achieve a consensus on all essential matters of the Code, to discuss questionable marketing practices openly and to implement corrections speedily whenever necessary. This cooperation has re- sulted in a «spirit of shared purpose» that also guides the Panel in matters that are not formally within the scope of the Code (such as follow-up formula and complementary foods) and places the wellbeing of the child and the mother first and foremost. The implementation of the legally binding rules on advertising and promotion of infant formula introduced in article 11a LGV now falls in the competence of the Cantonal enforcement authorities. Nevertheless it is considered expedient that the primary concerned and interested parties, who have expert knowledge of the market, continue to monitor the activities of the manufacturers and to discuss presumed infringements in a board composed of an equal number of representatives. It is of paramount importance that the organisations involved in the surveillance have an all-embracing view over all aspects of the marketing activities and by that are in a position to apply a systematic monitoring. The Panel remains available to the Cantonal authorities as a board of specialists. We would like to see the public more deeply involved in the Panel’s activities and the opportunity to report violations to the Panel used more actively. 7 ORGANISATIONS AND COMPANIES REPRESENTED IN THE CODEX-PANEL Swiss Foundation for the Promotion of Breastfeeding (since 2000) Swiss Association for Foods for Special Dietary Uses (Association Diet) 6 seats, represented are among others the following organisations: - Swiss Committee for UNICEF (UNICEF Switzerland) - Swiss Society of Paediatrics (Schweizerische Gesellschaft für Pädiatrie – SGP) - Swiss Association of Health Visitors (Schweizerischer Verband der Mütterberaterinnen – SVM) - Association of Swiss Lactation Consultants IBCLC (Berufsverband Schweizerischer Stillberaterinnen – BSS) - La Leche League Switzerland (LLL CH) - Swiss Federation of Midwives (Schweizerischer Hebammenverband – SHV) 6 seats, the following companies are represented: - Nestlé Suisse SA - Milupa SA - Hero AG - Hipp GmbH & Co. Vertrieb KG - Holle baby food GmbH - Bimbosan AG Co-signatory of the Code but not represented in the Panel (production in Switzerland without marketing): Hochdorf Nutrifood AF / Hochdorf Nutritec AG The chairmanship of the Codex Panel alternates from meeting to meeting; the Secretary’s duties lie with the Association Diet. For the present composition of the Panel see: www.stiftungstillen.ch Codex-Panel Codex-Panel 8 WHAT HAS THE CODEX PANEL ACHIEVED SO FAR? The equal representation of members of the Swiss Foundation for the Promotion of Breastfeeding (replacing the former Swiss UNICEF Working Group for the Promotion of Breastfeeding since July 2000) and of Swiss manufacturers within the Panel ensures that the restriction on promotion stipulated by the food law regulations in force and the complementary provisions of the Code can be monitored area-wide and violations responded to quickly. The Panel also receives suggestions from the general public. Since the Codex Panel was established in 1995, regular meetings have been held, usually at 6 months intervals. Numerous individual cases have been examined and general criteria for the assessment of advertising and product information have been elaborated. A summary of the Panel’s decisions can be obtained by the Association Diet and by the Swiss Foundation for the Promotion of Breastfeeding. Some examples of the cases examined are: IMPORTANT NOTICE on the superiority of breast-milk and of breastfeeding The Panel considers it as very important that the IMPORTANT NOTICE does not remain an empty phrase. The IMPORTANT NOTICE should guide the product information as well as the communication to mothers and health professionals. The breastfeeding mother should not be led to doubt what she is doing. The Panel has scrutinized a large number of statements and has succeeded in convincing the manufacturers to avoid ambiguous phrases such as «if you do not have enough milk, use the product …» or «After four months, your child needs a change». The phrase «This product resembles breast-milk» was also ruled out. Feeding schedules As a result of a Panel initiative, today the manufacturers list breastmilk as the first choice among infant feeding tables and schedules. Samples Already on the basis of the Code of 1994 the Panel had defined clear rules regarding the distribution of samples: Under no circumstances samples were to be distributed without specific request and simply for advertising purposes. Additionally the Panel had intervened with pharmacies and drugstores that samples should only be given to mothers in the context of a consultation and that samples should not be laid out for free self-service. In 2008 in accordance with the EU-Directive the prohibition to give free samples was introduced into Swiss legislation3. Portion packages of infant formula must be sold at a price which corresponds at least to the price per kilogram of the respective product on the market. Advertising for follow-up formula and complementary food The Code applies to infant formula only. However, the basic principle of protecting and promoting breastfeeding and appropriate conduct should also be reflected in advertisements for baby foods intended for children after the age of 6 months. As a result of the Panel’s initiative in this matter, the manufacturers have agreed to refrain from any disparaging statements about breast-milk and breastfeeding in their advertising and marketing of such products. Age indication The Panel has monitored adherence to the age indication «after 4 to 6 months» – today «after 6 months» – for all follow-up formula. Discussions were held with suppliers of products which do not fall under the scope of the Code but may influence breastfeeding practices in the first 6 months, e.g. fruit and vegetable beverages or infant teas. The same goes for retail companies in particular with regard of the promotional activities by large distributors of non-branded products. The Panel holds a constructive dialogue with these companies. Implementing billing of formula deliveries to hospitals and clinics The interdiction of distributing infant formula free of charge to hospitals and clinics can only be implemented if these institutions are sensitized to the issue. To this end, the Panel supports the activities of the Swiss Foundation for the Promotion of Breastfeeding in connection with the «Baby-Friendly Hospital Initiative». The Code requests that the health personnel must not be influenced in any way in the decisions about the eventual use of infant formula. For this reason the Panel has defined to what extent and up to what value donations or gifts of useful items (e.g. thermometers) may be given to hospitals and clinics. The display of a company logo without explicit product advertisement is not prohibited. Defining acceptable advertising media Only infant care journals, scientific publications and publications for health professionals are allowed to carry advertisements for infant formula. Advertising in general publications is not permitted. The Panel defines a list of journals in each category. 9 SITUATION IN DEVELOPING COUNTRIES – BASIC CONSENSUS WITH THE FEDERAL AUTHORITIES In view of the deliberations in the WHO, the manufacturers and the competent federal authorities – Swiss Federal Office of Public Health (SFOPH), Swiss Agency for Development and Cooperation (SDC) and the Political Directorate of the Federal Department of Foreign Affairs (DFA) – have agreed upon a basic consensus on the issue of infant and child nutrition in developing countries4: Nobody contests • that in Third World countries too many children die of diseases that can be prevented and treated, • that the most important of these diseases is diarrhea, often combined with malnutrition, • that extended breastfeeding (> 1 year) together with oral rehydration therapy (ORT) are the two main pillars in the fight against diarrhea in young children, • that breastfeeding is one of the cheapest and healthiest practices for the well-being of mother and child, • that breastfeeding is a significant factor in the fight against population growth in poor countries, • that after the age of 4 to 6 months, all children need complementary food that meets their nutritional requirements. For these reasons, all forces have to be pooled in order • to encourage mothers to breastfeed their children, • to warn against a careless abandonment of breastfeeding. This applies in particular to the growing number of mothers who have to live in poor economic and sanitary circumstances, • to avoid having infant formula marketing and early introduction of complementary food negatively affect mothers’ readiness to breast feed and result in premature abandonment of breastfeeding, this applies in particular to mothers living in poor countries, • to inform mothers about the correct use of children’s food, • to find sustainable ways to reconcile the opposing interests of food manufacturers and health promoters. (unofficial translation) 10 CRITISING THE CODE AND THE CODEX PANEL – IS IT JUSTIFIED? Activist groups are of the opinion that the International Code is not insufficiently respected and implemented. Their criticisms mainly concern the situation with respect to several developing countries. However, they also think that the Swiss Code does not sufficiently respect the International Code. The following aspects are controversial: Scope of the Code The International Code applies to «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.» (article 2) This provision has caused a considerable number of controversial discussions on international level. Activist groups deduce from this provision that advertising not only of infant formula, but also of follow-up formula, is not permitted. The scope of the Swiss Code is limited to infant formula and restricts – in accordance with the EU-Directive – advertising for this group of foods only. The Codex Panel is of the opinion that advertising of follow-up formula which are clearly only recommended for the time after 6 months is not liable to prevent a mother from breastfeeding at an early stage in the infant’s life. However, the Panel places great emphasis on the intention that the basic principles of the Code should also be respected in the advertising and marketing of follow-up formula. The manufacturers have agreed to take on this commitment. Implementing a general ban on advertising In the interpretation of the International Baby Food Action Network (IBFAN) and of other organisations, the International Code contains a general ban on advertising. The Panel is of the opinion that a general ban on advertising is incompatible with Swiss legislation currently in force and esteems that a general ban does not constitute an appropriate means to achieve the objectives of the Code, that is to protect breastfeeding and to guarantee optimum nutrition of the infant. Advertising and product information are not intrinsically bad and undesirable. The main point is that advertising should not discourage a mother from breastfeeding. At the same time, the mother should not be denied access to necessary information enabling her to choose an appropriate complementary food at a time of her choice. The Panel supports breastfeeding-friendly advertising that allows the mother to make her own decision responsibly. As early as 1981, during the negotiations about the International Code, the Swiss Delegation to the 34th World Health Assembly stated the following: The Code explicitly respects an objective need for breast-milk substitutes, the Code does not seek to prevent the sale and use of such products where use is indicated. The Code intends to prevent all practices – particularly marketing practices – that undermine the basic principle of active protection and promotion of breastfeeding and seeks to ensure the proper use of such products when these are necessary. (unofficial translation) The Panel aims to establish monitoring processes that guarantee the observance of the legal requirements, define binding provisions and guidelines for the implementation of the Code and that are capable of assessing new developments and innovative marketing practices without delay (e.g. via the internet). In this context prohibitions are not as important as the interpretation on whether an advertising slogan and marketing practice hampers the promotion of breastfeeding. Only specific examples can help the Panel to define what is permitted and what is not. Monitoring the implementation of the Code Article 11 of the International Code regulates the implementation and monitoring and requests governments to «take action to give effect to the principles and aim of this Code, as appropriate to their social and legislative framework». For this purpose governments should collaborate with «nongovernmental organisations, professional groups, and consumer organizations» (article 11.2). Manufacturers are urged «to 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» (article 11.3). The Codex Panel thinks that voluntary self-regulation based on constructive dialogue between all parties concerned and going beyond the exigencies of article 11a LGV is a better strategy to achieve the aim of the WHO Code than government action (see Monitoring in Switzerland, page 7). Implementing decisions and recommendations The International Code obliges manufacturers to ensure their own monitoring, that is to monitor the implementation of the Code’s provisions within their own companies. Since all important manufacturers are represented on the Panel internal monitoring is guaranteed and the companies themselves report their members’ 11 violations to the Panel. Additionally the Cantonal authorities now enforce the restrictions on advertising and promotion based on article 11a LGV in the framework of their inspection activities. Transparency of Panel activities Activist groups reproach the Panel for exercising its duties in closed session. Through the Panel’s contact with retailers, in particular with large distributors, the basic principles of the Code can be implemented at the retail level. The same applies to pharmacies and drugstores which have been requested to comply with the restrictions on advertising in their retail outlets. The Panel has repeatedly informed the public about its activities and achievements, in particular during the International Breastfeeding Weeks (40th week of the year). Furthermore, advertising and marketing practices of manufacturers can be reported to the Panel at any time. Each input will be carefully examined and the reporter will receive a response after the investigation has been completed. SOURCES 1 Extract from: Producers‘ Code of Marketing of breastmilk substitutes, revised edition 2010; Codex-Panel summary of decisions, status May 2011. 2. Infant Formulae means foodstuffs intended for particular nutritional use by infants in good health (children up to 12 months) during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding. 3. LGV article 11a: The distribution of free or price reduced products, samples or any other promotional gifts to the public or pregnant women, mothers and members of their families is prohibited, be it directly or indirectly via the healthcare system. (unofficial translation) 4. «Grundkonsens für eine gemeinsame Haltung zu Fragen der Säuglings- und Kleinkinderernährung»; signed by: Association Diet, section Infant Nutrition, Beat Hodler; DFA, Swiss Agency for Development and Cooperation, Ambassador W. Fust; DHA, Swiss Federal Office of Public Health, Prof. T. Zeltner; DFA, Political Management, Ambassador J.-M. Boulgaris; February 1997 12 CONTACTS Swiss Association for Foods for Special Dietary Uses (Association Diet) Swiss Foundation for the Promotion of Breastfeeding Elfenstrasse 19, PO Box 1009, 3000 Berne 6 Tel. +41 (0) 31 352 11 88 / Fax. +41 (0) 31 352 11 85 [email protected] Schwarztorstrasse 87, 3007 Berne Tel. +41 (0) 31 381 49 66 / Fax. +41 (0) 31 381 46 67 [email protected] www.stiftungstillen.ch Vereinigung Schweizer Hersteller von Kindernährmitteln
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