Regulatory Reform in Japan: Proposed Changes

In late September 2001, the Japanese health authority released an early draft of its new medical industry reform plan. Though it seems unlikely that the plan will be ready by the April 2002 target date, the draft document gives insight into changes likely to come to Japan’s medical industry in the coming years.

The Medical Vision for the 21st Century includes plans for the following. First, the government hopes to promote electronic medical records and other IT solutions in the medical area. Japan was a relatively late adapter to the IT revolution, and is behind the U.S. and other Western countries with regard to electronic patient records and the like. The government would like to promote the use of electronic clinical records and the sharing of such records between medical institutions. This would include an electronic certification system that certifies the right for an individual to access patient information. The government would also like to promote electronic processing of insurance reimbursement forms, moving towards online, paperless transactions. U.S. firms with equipment that fulfills these functions may see a surge in interest from Japan. However, such firms are well advised to keep in mind the significant and difficult localization work required for such a product to be successful in Japan.

Easing regulations on medical advertisements is also part of the draft plan. In the first issue of PBI Asian Medical eNewsletter, we reported on the strict regulations with regard to medical device and pharmaceutical advertising in Japan. Though huge changes should not be expected, the government has indicated that it will discuss regulations on advertisements with the expectation of making them more permissive. In addition, the number of items that medical institutions are allowed to advertise is expected to increase.