PhRMA calls for Japan to relax appro rules

US drug trade body the Pharmaceutical Research and Manufacturers of America has proposed that the Japanese government should consider an  early evaluation system by easing the drug approval conditions if a new  compound has already been cleared in the USA and the European Union as  one of the measures to eliminate so-called "drug-lag." The appeal was  made by Ko Sekiguchi, chairman of the Japan executive committee of the  PhRMA, at a press meeting in Tokyo this month.

He continued by noting that there are five main factors causing the  drug-lag, including approval review which requires long-term, expensive  and slow-proceeding clinical trials, often with with difficult to  recruit patients, a National Health Insurance system that does not  promote incentives for R&D and leading to lost profits. He also  identified negative Japanese policies such as severe containment of  medical costs and a lack of preventive medicine activity, which Mr  Sekiguchi believes should be improved to encourage foreign-affiliated  pharmaceutical companies to invest in research in Japan.

He also said that the PhRMA agrees to the reform plan from the  Federation of Pharmaceutical Manufacturers Associations of Japan on the  NHI drug costing system (Marketletter January 5 & 12), saying that the  price of new medicines should be maintained during the patent-valid  period and expected that the Central Social Insurance Medical Council  (Chuikyo) would proceed to discuss the proposal with the aim of  introducing it.