日本药品数据保护制度评价及对我国的启示——基于对日本创新药物再审查政策绩效的实证研究

Evaluation of Japanese data protection system from the perspective of economics——the empirical analysis based on the performance of reexamination Policy on Japanese innovative drugs

日本药品数据保护制度以对药品注册过程中所提交的数据信息实施知识产权保护为手段,通过授予原研厂商一定期限的市场独占权,有效保护了原研厂商的利益并鼓励其研发积极性。文章通过建立绩效评价指标体系,对日本药品数据保护制度实施绩效进行评价,研究结果表明,日本药品数据保护制度对创新药物研发起到了良好的正向激励效应。同时日本政府通过将药品数据保护制度与药品上市后监测制度捆绑实施,并配套以医疗保险制度和药品定价机制,较大程度地遏制了药品数据保护制度的负面效应,其经验值得我国借鉴。

Japaneae data protection system,which is supposed to protect the submitted data during the process of drug registration as an intellectual property（IP）protection,has effectively ensured the benefits and encouraged the initiatives of drug research companies by granting those companies a certain period of market exclusivity.With an establishment of the performance evaluation system,this paper will scientifically assess the Japanese data protection system on an economic level.The result has demonstrated that Japanese data protection system has a positively favorable effect on the RD of innovative drugs.Meanwhile,Japanese government has successfully linked the data protection system to the post-marketing surveillance system combined with a set of the medical insurance and the drug pricing mechanism,which has to a great extent contained the side effects of the data protection system.This advanced experience should be drawn upon by China.