Regulatory Influences on the Decision to Introduce Pharmaceutical Products in Japan
1 September 1998
By Dr. Richard Rapp and Dr. Richard Rozek with Gakushuin University Professor of Economics Tshuruhiko Nambu
The Japanese regulatory system for pharmaceuticals includes both approval of products for commercial sales and determination of reimbursement prices. The time required to repeat tests in Japan prior to submitting an application for approval and the threat of frequent price reductions discourages firms from introducing innovative medicines in Japan.
Dr. Rapp and Dr. Rozek interviewed and obtained survey responses from U.S., European and Japanese firms operating in Japan. Based on these data, they concluded that if the government reduced existing regulatory pressures, it could encourage development and launch of new products to the benefit of consumers in Japan.
This article was published in the Journal of World Intellectual Property, Vol. 1, No.5, pp.763-799. Reprints are available from the author upon request.
