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Executive Summary

U.S.-JAPAN PHARMACEUTICAL TRADE TALKS FOCUS ON PRODUCT APPROVAL TIME and five other issues of interest to the drug and device industry, according to a Commerce Dept. spokesman. The all-day negotiations, which took place Aug. 20 in Hawaii, included discussions on establishment of a time clock like FDA's 180-day regulatory limit for new drug review. Currently, Japan's Ministry of Health & Welfare does not operate under time strictures, although the country has reportedly offered to establish an informal target limit of 365 days. The U.S. delegation is seeking faster approval times particularly for drug and diagnostic test kits designed for in-home use. Mfrs. of such kits reportedly have found it extremely difficult to obtain marketing approval in Japan. The U.S. delegation was headed by the Treasury Asst. Secty. for Internatl. Affairs David Mulford, PhD. The Japanese delegation was led by the Ministry of Health & Welfare's Vice Minister Hitoshi Yoshimura. P Another major topic of trade negotiations for the pharmaceutical industry continues to be the transfer of product approvals from Japanese licensees. Formerly, pharmaceuticals developed by foreign mfrs. had to be licensed to a Japanese firm in order to obtain approval. However, because the Ministry of Health & Welfare issues approvals in a company's name, if a U.S. mfr. now wishes to terminate an earlier marketing agreement with a Japanese firm in order to sell the product there itself, the U.S. mfr. must acquire the Japanese firm's consent. lf the Japanese firm chooses not to transfer the license back to the U.S. mfr., the U.S. firm's only alternative is to'go through the entire regulatory review process in order to obtain marketing approval for the drug under its own name. P The U.S. delegation is also seeking "transparency" in the Japanese govt.'s drug price-setting procedure. Drug prices are set by the govt. in Japan, and U.S. firms would like to participate in the price-setting process. Two other topics discussed in Hawaii are vitamin and health food regulation and the export and re-export of blood products. U.S. industry would like Japan to regulate vitamins and health foods as foods or food supplements, as FDA does. Currently, the Japanese govt. regulates some products as foods and some as drugs.

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