Developing the Japanese Generic Medicines Market: What Can We Learn from Europe?

Abstract

This paper originates from a ‘Generics Industry Forum’ that debated the development of the Japanese generic medicines retail market. Based on these discussions, the paper conducts a descriptive analysis of Japanese generic medicines policy and proposes recommendations for further developing the market by learning lessons from the European experience. The Japanese generic medicines market has benefited from measures that assure supply and quality of generic medicines, provide information about generic medicines, speed up registration of generic medicines on the reimbursement list, allow and reward generic substitution by pharmacists, increase patient co-payment, and reward physicians who adopt generic prescribing and/or who allow generic substitution. However, several factors hamper the development of this market, including extensions to the data exclusivity period and patent term of originator medicines, the requirement to launch the same generic medicine strengths as the originator medicine, mandatory reductions of reimbursement tariffs and weak incentives for physicians, pharmacists and patients to demand generic medicines. In order to sustain the development of the Japanese generic medicines market, a number of avenues were proposed that focused on speeding up market access of generic medicines, implementing a reference-pricing system and strengthening incentives for physicians, pharmacists and patients to demand generic medicines.