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(1994) [French] [Spanish]
WHO ETHICAL CRITERIA FOR MEDICINAL DRUG PROMOTION
Background As far back as l967 the World Health Assembly expressed concern about improper pharmaceutical advertising. The 1968 Assembly unanimously agreed on Ethical and Scientific Criteria for Pharmaceutical Advertising. The emphasis in these criteria was that advertisements should provide scientifically based, balanced factual information without ambiguities. For prescription drugs, a minimum amount of information was recommended, which included generic name, dose, and contra- indications. Certain norms were recommended for non prescription drugs. The importance of "correct information" was stressed. Incorrect information could lead to improper use of drugs which then might not only be ineffective but harmful too. Sixteen years later, the WHO Nairobi Meeting on the Rational Use of Drugs endorsed a Revised Drug Strategy. This included a recommendation to update the l968 criteria on advertising and enlarge their scope to include all pharmaceutical promotion. Subsequently an international group of experts, with the widest possible participation of all interested parties, met and prepared draft Ethical Criteria for Medical Drug Promotion, which were adopted by the World Health Assembly in l988. Member States were urged to take account of these criteria in developing their own national measures, and to monitor and enforce the measures they developed. In l992 the World Health Assembly noted that "little information was available on any progress in controlling medical drug promotion using the concepts embodied in the ethical criteria". It requested the Council for International Organizations of Medical Sciences to convene a meeting of interested parties, in collaboration with WHO, to discuss the matter. This meeting reported on areas of progress and concern and made l9 recommendations for future action (see page ***),, which were endorsed in a resolution of this year's World Health Assembly. WHA Resolution on WHO Ethical Criteria The Assembly reaffirmed that: * the regulation of drugs must ensure not only the safety, efficacy and quality of drugs but also the accuracy of the information provided pursuant to their regulation; * patients, pharmacists and prescribers should have access to appropriate and understandable information about drugs and their side-effects; * the promotion of drugs must be accurate, fair and objective and presented in such a way as to conform to legal requirements and also to high ethical standards; * promotional claims should not be stronger than valid, up-to-date scientific evidence warrants, every effort being made to avoid ambiguity; * information for patients and prescribers which appears in leaflets of drugs in the manufacturing country should be supplied by the manufacturer to the countries to which the same drugs are exported. It requested the Director General: l) to implement the recommendations of the CIOMS/WHO consultation applicable to WHO, giving special attention to: * wide dissemination of the WHO Ethical Criteria to all Member States and other concerned parties; * measures to develop and disseminate materials on the WHO Ethical Criteria and methods to monitor their implementation; * monitoring the implementation of the WHO Ethical Criteria and collecting information on voluntary, self-regulatory national and international codes and guidelines that relate to the promotion of medicinal drugs, in consultation with all concerned parties; * carrying out studies or surveys of current promotional practices as necessary, and analysis of the effectiveness of the Ethical Criteria; * support to Member States, as appropriate, in strengthening drug regulatory capacity and mechanisms regarding the labelling and promotion of medicinal drugs; * dissemination of national experience in the promotion of medicinal drugs; * alert Member States to the importance of this role for universities and other educational institutions and assist them in educational programme development; * periodical review of the WHO Ethical Criteria in consultation with interested parties. (2) Report regularly, through the Executive Board, on progress made and problems encountered by WHO and Member States. The resolution called on all concerned parties to continue to collaborate in order to promote further and implement the principles embodied in the WHO Ethical Criteria by rapidly adopting, as appropriate, measures based on the CIOMS/WHO recommendations. Member States were urged to develop and implement national mechanisms, where relevant, to control drug promotion in accordance with the principles embodied in the WHO Ethical Criteria and as proposed in the WHO Certification Scheme. Copies of the complete text of the five resolutions summarised above and the Director-General's Report to the Assembly on the Revised Drug Strategy and on the WHO Ethical Criteria for Medicinal Drug Promotion (containing the report of the 1993 WHO/CIOMS Meeting on the WHO Ethical Criteria) are available from the WHO Action Programme on Essential Drugs.