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Executive Summary

WORLD HEALTH ASSN. EXPERT CMTES. ON ETHICAL DRUG PROMOTION and natl. drug registration and regulation will be formed during 1987 as part of the WHO's Action Program on the Rational Use of Drugs adopted by the World Health Assembly meeting May 5-16 in Geneva, Switzerland. Under the plan adopted by the Assembly, WHO will draw up a list of possible committee members which will be submitted for approval by WHO's executive committee at a meeting scheduled for January, 1987. Once the composition is set, the committees will hold at least two meetings during 1987 leading to the preparation of a report on the issues to be presented at the next World Health Assembly in May, 1988. Proposals for members to serve on the committees will be made to WHO by organizations that have an interest in the group's Essential Drugs Program. Among these are industry groups such as the U.S. Pharmaceutical Mfrs. Assn. and its internatl. affiliate, the Internatl. Federation of Pharmaceutical Mfrs. Assns. (IFPMA), consumer groups such as Health Action Internal., and medical/disease specific groups such as the internatl. affiliates of the American Lung Assn. and the Natl. Cancer Society. Member nations of WHO may also submit candidates for the committees. The committees will be the forum for further debate on whether WHO should support revisions to an existing 1968 resolution on pharmaceutical advertising, and whether WHO should support national regulation policies to key the use of pharmaceuticals in both developed and developing countries to a "medical needs" criteria. Health Action Internatl. has been actively seeking WHO support for both policies. At its recently concluded meeting in Geneva, the World Health Assembly adopted without modification the report of the Nairobi Conference on the Rational Use of Drugs prepared by WHO Director Hafdan Mahler. The report, including a "revised drug strategy," is a broadly worded document calling for cooperation between the pharmaceutical industry, consumer organizations and national drug regulation authorities in establishing drug policies. The report promotes increased distribution of information on pharmaceuticals, encourages research into products for serious diseases and supports efforts to establish national drug policies in developing countries with assistance from WHO ("The Pink Sheet" April 7, p. 12). The official U.S. delegation included FDA Com. Young, who was in charge of presenting the U.S. position on the drug issues and Surgeon General C. Everett Koop, MD. They were assisted by a group of advisors that included Project HOPE Director William Walsh, MD, and representatives of the State Dept. PMA President Mossinghoff and VP-Internatl. Jay Kingham attended the meeting in association with officials of the Geneva-based IFPMA. At a May 26 press conference, IFPMA President P. W. Cunliffe stated his association's view of its responsibilities. Cunliffe said industry has a responsibility to provide safe and effective existing medicines, to distribute fair and accurate information about its products, and to continue research into new medicines to treat diseases where there is inadequate existing therapy. "No proposal aimed at improving the use of essential drugs now should be allowed to put at risk the research that will provide better medicines in the future." Cunliffe added that "as far as the revised drug strategy is concerned, we do not accept any interpretation of it which asserts that a dramatic reduction in the number of permitted drugs offers a practical way to progress. This would severely curtail the aspirations of people. It would deny optimum treatment to those who can afford it and do nothing to raise the standard of treatment of the least privileged." Of the goals listed in the revised drug strategy, Cunliffe said that those projects "which would offer the greatest benefit in the shortest time are: firstly, to work to facilitate the establishment of national drug policies; secondly, help for developing countries to overcome the problems of lack of hard currency, and; thirdly, extension of the WHO Certification Scheme."

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