US GOVT "CONCERN" OVER JAPANESE REG MOVES

The US Department of Commerce in late February officially notified Japan's Ministry of Health and Welfare of its concerns over the lack of prior consultation with regard to recent restrictive regulatory decisions. Concern was also expressed over the fact that industry representatives were only advised informally of the proposed changes, and without sufficient advance notice.

The proposed regulatory changes by the Health Insurance Bureau of the MHW were presented to industry representatives just prior to public announcement, and involved certain restrictions on vitamin therapy, on a number of oral drugs to be prescribed, and on the length of stay in specified hospitals.

The US government letter also pointed out that the Market-Oriented Sector- Selective agreement of 1986 requires both a transparent decision-making process and an opportunity for the affected industry to have full consultations with the MHW before implementation of proposed regulatory changes.