th a list of regulations that inhibit the ability of health care firms to do business in Japan and raise costs to the end-user and the health care system. Several of these issues also have been raised in the MOSS process.The United States continues to seek greater market access for U.S. medical devices and pharmaceutical products through the Enhanced Initiative on Deregulation and the Market-Oriented, Sector Selective (MOSS) Medical/Pharmaceutical talks. As Japan undertakes potentially extensive health care reforms, price reimbursement and regulatory issues remain the focus of bilateral consultations. The Administration conducted government consultations on Japanese deregulation of medical devices and pharmaceutical products in September and November 1997 and March 1998. The bilateral consultations addressed, in particular, specific Japanese government regulatory policies that continue to hinder the ability of U.S. firms to supply innovative and cost-effective medical devices and pharmaceutical products. The United States urged Japan's Ministry of Health and Welfare to ensure that the pricing system revision under consideration follow a consistent, transparent process and not be imposed disproportionately, or inappropriately, on new and innovative medical devices and pharmaceuticals. Of particular importance, the United States strongly opposes Japan's proposed implementation of a reference pricing system for pharmaceuticals. The United States believes that prices should be market-based. In March 1998, in response to priority U.S. Government deregulation requests, Japan announced its intention to undertake necessary measures to expand the acceptance of foreign clinical data and expedite approvals for new drug applications. These changes, while welcome, represent only incremental improvements. The United States will continue pressing for substantive deregulatory actions on these issues, as well as other U.S. deregulation priorities. The ...
