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Executive Summary

WHO RATIONAL DRUG USE CMTES. SHOULD INCLUDE MD/PATIENT GROUP representatives to reflect consumer views if WHO chooses to establish such expert panels at the World Health Assembly meeting in May, Pharmaceutical Mfrs. Assn. Senior VP-Internatl. Jay Kingham asserted at a Jan. 27 press briefing. "From our perspective, we will be emphasizing that the types of consumer groups that are represented in these discussions are patient groups and practicing physicians, the real users of drugs, rather than the types of groups that are encompassed in the Internatl. Organization of Consumer Unions (IOCU)," Kingham said. PMA has "already made the point that such groups were conspicuously absent from Nairobi [at WHO's Rational Drug Use Conference, Nov. 25-29]," Kingham said. "What we have in mind, in terms of patient groups, are organized heart assns., cancer societies, diabetes foundations, the type of groups which have interntl. affiliations." He noted that at its meeting last week, WHO's executive board gave consumerists, through the IOCU, a nongovernmental organization status, a consultative status similar to that of industry. The establishment of expert cmtes. to study six subject areas is expected to be the principal recommendation of WHO Director General Hafdan Mahler when he makes his report on the Nairobi conference to the World Health Assembly conference, which begins May 5 in Geneva, Switzerland. The two-week meeting of WHO's decisionmaking body will focus on the rational use of drugs during its May 13-14 sessions. According to Kingham, Mahler's report will not be available until late March. PMA indicated that the six subject areas are: (1) draft guidelines for natl. drug policies; (2) guidelines for minimal regulatory requirements for registration and labeling of drugs; (3) consideration of the WHO certification scheme for drugs moving in internatl. commerce; (4) an examination of drug information, including data sheets and model formularies; (5) a review of training on pharmacology and drug use, particularly by health care workers in developing countries at the paraprofessional level; and (6) the development of ethical norms for the advertising and promotion of pharmaceuticals. Noting that the last area was of "most concern to the pharmaceutical industry," Kingham added that "several of these subject areas are open to wide interpretation as to exactly what they will encompass." PMA will closely monitor both the composition of these expert panels and the role of the WHO staff in interpreting the parameters for the discussions, he said. According to PMA, Mahler's report to the World Health Assembly will emphasize WHO's role as an advisory body and not, as consumer activists contend, an internatl. regulatory body. "On the down side," Kingham cautioned, "there does remain the possibility that some govt., or group of govts. such as the Scandinavians, will attempt to introduce a resolution that goes beyond what Dr. Mahler is representing from Nairobi. We could not rule out, even though Nairobi did not come out this way, that some aberrant govt. or group of govts. would recommend a resolution calling for a marketing code for pharmaceuticals."

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