nt could clearly identify only 21 percent of the market as being held by foreign firms, although this figure almost certainly undercounts the foreign share since sales of U.S. products by Japanese distributors are particularly difficult to track.The Administration continues to pursue improved medical and pharmaceutical product market access in the context of the Market-Oriented Sector-Selective (MOSS) Medical Equipment and Pharmaceutical talks. One issue of regular discussion is the reimbursement process and schedule under Japan's national health insurance system for U.S. medical equipment and pharmaceutical products. Reimbursement prices in Japan often do not adequately, or in a timely fashion, compensate firms for the costs inherent in developing and marketing new, innovative equipment and pharmaceutical products in Japan. The United States is monitoring this issue through consultations with industry and through the MOSS.At the February 1997 MOSS meeting, Japan announced a possible reduction of the "R zone" for medical devices from the current 15 percent. If implemented, this action will make it even more difficult for U.S. firms to sell their products in Japan at reasonable prices. At present, the U.S. Government is working to resolve this issue. In addition, the U.S. Government is concerned with a variety of other obstacles facing U.S. pharmaceutical and medical equipment manufacturers when they seek to market their products in Japan. These range from a slow and sometimes non-transparent approval process to regulations that prevent certain products from being sold in hard gelatin capsules in Japan. In addition, the U.S. Government advocates greater industry access to policy-making councils from which they are presently excluded.The U.S. medical products industries continue to support Japan's deregulation initiatives. For the third year in a row, these industries, and the U.S. Government, provided the Government of Japan wi...
