WHA 52.19

101st Session                                       
Agenda item 9                                     
27 January 1998

Revised drug strategy

The Executive Board RECOMMENDS to the Fifty-first World Health Assembly the adoption of the following resolution: The Fifty-first World Health Assembly, Recalling resolutions WHA39.27, WHA41.16, WHA43.20, WHA45.27, WHA47.12, WHA47.13, WHA47.16, WHA47.17, and WHA49.14; Having considered the report of the Director-General on the revised drug strategy[1]; Noting the activities of WHO to further the implementation of the revised drug strategy, in particular through support to the development and implementation of national drug policies; the strategy to review and assess the effectiveness of the WHO Ethical Criteria for Medicinal Drug Promotion; the flow of market information; guidelines for drug donations; and model drug information; Recognizing with satisfaction the progress made, and approving WHO's comprehensive response to current and new challenges in the pharmaceutical sector; Commending the strong leadership shown by WHO in promoting the essential drugs concept and national drug policies, which are contributing to the rational use of resources in the pharmaceutical sector and to improved health care; Noting with satisfaction that a number of Member States have adopted guidelines for drug donations that were based on the interagency guidelines issued by WHO, but concerned that inappropriate drug donations, such as donations of expired, mislabelled, inessential products, continue to be common; Concerned about the situation in which one third of the world's population has no guaranteed access to essential drugs, in which new world trade agreements may have a negative impact on local manufacturing capacity and the access to and prices of pharmaceuticals in developing countries, and in which poor quality pharmaceutical raw materials and finished products continue to move in international trade; Concerned also that drugs continue to be irrationally used by prescribers, dispensers and the general public, and because unethical promotion in developed and developing countries and a lack of access to independent, scientifically validated drug information contribute to such abuses, <------------------------- p 2 ---------------------------> EB101.R24 1. URGES Member States: (1) to reaffirm their commitment to develop, implement and monitor national drug policies to ensure equitable access to essential drugs; (2) to ensure that public health rather than commercial interests have primacy in pharmaceutical and health policies and to review their options under the Agreement on Trade Related Aspects of Intellectual Property Rights to safeguard access to essential drugs; (3) to establish and enforce regulations that ensure good uniform quality assurance standards for all pharmaceutical materials and products manufactured in, imported to, exported from, or in transit through their countries; (4) to enact and enforce legislation or regulations in accordance with the principles of the WHO Ethical Criteria for Medicinal Drug Promotion, and to monitor drug promotion in collaboration with interested parties; (5) to develop or maintain national guidelines governing drug donations that are compatible with the interagency guidelines issued by WHO and to work with all interested parties to promote adherence to such guidelines; (6) to promote the rational use of drugs through the provision of independent, up-to-date and comparative drug information, and to integrate the rational use of drugs and information about commercial marketing strategies into training for health practitioners at all levels; (7) to promote and support consumer education on the rational use of drugs and its inclusion into school curricula; (8) to evaluate progress regularly, making use of indicators developed by WHO or other suitable mechanisms; (9) to continue their funding and material support for the revised drug strategy especially by the provision of extrabudgetary resources to WHO; 2. REQUESTS the Director-General: (1) to support Member States in their efforts to develop and implement policies and programmes that achieve the objectives of the revised drug strategy, including the development of tools, guidelines and methodologies for evaluation and monitoring; (2) to adopt a comprehensive strategy to implement the WHO Ethical Criteria for Medicinal Drug Promotion and to continue to review its effectiveness with all interested parties; (3) to extend the guidelines incorporated in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce to cover pharmaceutical starting materials; develop and disseminate uniform guidelines on the regulatory control, export, import and transit conditions of pharmaceutical products; and develop standards of practice for entities involved in international trade in pharmaceuticals and pharmaceutical raw materials; (4) to strengthen and expand the provision of independent information on market prices of raw materials of assured quality for production of essential drugs; <--------------------------- p 3 -------------------------> EB101.R24 (5) to continue the development and dissemination, also using electronic media such as the Internet, of independent information on pharmaceutical product safety and instances of counterfeit drugs or medicines, on drug selection and on rational prescribing; (6) to assist Member States to analyse the pharmaceutical and public health implications of agreements overseen by the World Trade Organization and to develop appropriate policies and regulatory measures; (7) to review and update the revised drug strategy to reflect current and continued challenges in the pharmaceutical sector and the principles articulated in the renewed health-for-all policy; (8) to report comprehensively to the Fifty-third World Health Assembly on progress achieved and problems encountered in the implementation and renewal of WHO's revised drug strategy, with recommendations for action. Sixteenth meeting, 27 January 1998 EB101/SR/16 = = =