EXECUTIVE BOARD 122nd Session Provisional agenda item 8.1
EB122/27 10 December 2007
Reports of advisory bodies Expert committees and study groups1 Report by the Secretariat
THE SELECTION AND USE OF ESSENTIAL MEDICINES Report of the WHO Expert Committee, 2007 (including the 15th Model List of Essential Medicines) Geneva, 19–23 March 20072 Main recommendations 1. The Expert Committee reviewed a number of proposals for additions and deletions to the WHO Model List of Essential Medicines, and made several recommendations for changes to the Model List, to be published as the 15th Model List of Essential Medicines. These changes included recommendations on medicines for malaria, HIV and leishmaniasis as well as on several medicines for children. 2. Following the adoption of resolution EB120.R13 on better medicines for children, the Expert Committee recommended that the Executive Board should be requested to consider the establishment of a subcommittee on the selection and use of essential medicines for children, whose terms of reference would include the drawing up of a WHO model list of essential medicines for children. At its 121st session in May 2007, the Executive Board in resolution EB121.R2 decided to establish as from June 2007 a temporary subcommittee of the Expert Committee on the Selection and Use of Essential Medicines. 3. The Expert Committee recognized that there was a need to make decisions about amending the Model List in between formal meetings; in response, it recommended that all the options should be considered, including virtual meetings.
1 The Regulations for Expert Advisory Panels and Committees provide that the Director-General shall submit to the Executive Board a report on meetings of expert committees containing observations on the implications of the expert committee reports and recommendations on the follow-up action to be taken. 2
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Significance for public health policies 4. Many Member States have national lists of essential medicines adapted from the WHO Model List of Essential Medicines, and hence changes in the Model List, particularly those concerning inclusion of medicines suitable for children, can have an important impact on the selection of essential medicines at a national level. 5. Recognition of the need to update the list comprehensively in order to include medicines appropriate for children has the potential to improve health outcomes significantly in relation to the Millennium Development Goals.
Implications for the Organization’s programmes 6. The Committee’s updating of the Model List provides important guidance for other WHO and United Nations programmes, including the WHO/United Nations prequalification programme and for procurement agencies. 7. The updated Model List will be used by countries as a template for updating national lists as appropriate. The areas particularly concerned by the fifteenth revision of the Model List are medicines for malaria and HIV, as well as those for children. 8. The transparent process in which applications and expert assessments may be posted on WHO’s electronic information service (MedNet), can be used by countries as part of their own process for updating national lists.
EVALUATION OF CERTAIN FOOD ADDITIVES Sixty-eighth report of the Joint FAO/WHO Expert Committee on Food Additives1 Geneva, 19–28 June 2007 Main recommendations 9. The Committee made recommendations on the safety of several food additives and contaminants in food. In addition, specifications were prepared or reviewed for a number of food additives. The report also contains several general recommendations, covering subjects that include the safety assessment of flavouring agents and the development of guidelines for the safety assessment of enzymes produced by genetically modified organisms. 10. The Committee evaluated several food additives, some of them for specifications only. Acceptable daily intakes were established and other advice on safety was provided in respect of 12 food additives; this included advice on the suitability of using specific food additives in infant formulas.
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11. The Committee also performed assessments on certain food contaminants, mycotoxins, with a detailed exposure assessment for aflatoxins and a risk assessment of ochratoxin A, for which the Committee retained the previously established tolerable intake. 12. Summaries of the toxicological and related information upon which the safety assessments of the compounds were made, and of the identity and purity of food additives and flavouring agents will be published, respectively, by WHO in its Food Additives Series, and by FAO in its compendium of food additive specifications.
Significance for public health policies 13. The Committee’s work identifies and, if possible, quantifies the public health significance of additives, flavouring agents and contaminants in food through scientific risk assessment by international consensus decision. It is a complex process that includes assembling and analysing all relevant data; interpreting studies of general toxicity, carcinogenicity, genotoxicity, reproductive toxicity and teratogenicity; extrapolating to human beings the effects observed in laboratory animals; and characterizing hazards to human beings on the basis of available toxicological and epidemiological data. 14. Although all Member States face the problem of assessing potential risks from chemicals in food, only a few national or regional scientific institutions can assess the relevant toxicological and related data. Member States therefore need to be provided with valid information on both the general aspects of risk assessment and the evaluations of specific food additives and flavouring agents covered in the Committee’s report. The Committee’s complex work in reaching an international consensus in the evaluation of these compounds means that no other organization has comparable influence on public health decisions related to food safety. 15. The Committee’s recommendations are used by the Codex Alimentarius Commission for setting international food standards. Such standards are established only for substances that have been evaluated by the Committee and that have been allocated an acceptable daily intake, tolerable intake or other relevant safety statement, thus ensuring that food commodities in international trade meet strict safety standards. 16. The scientific advice provided by the Committee directly serves Member States in setting up their national food safety programmes.
Implications for the Organization’s programmes 17. The evaluation of chemicals in food by the Committee is a continuing activity, and four meetings (two on food additives and contaminants, and two on residues of veterinary drugs in food) are scheduled for the period 2008–2009. 18. WHO is a partner in the Joint FAO/WHO Food Standards Programme, which administers the Codex Alimentarius Commission. The Committee’s work is very important for the Commission. 19. Regional offices and WHO Representatives also make use of the Committee’s evaluations when advising Member States on food safety regulatory programmes.
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