日本药品数据保护制度评价及对我国启示.docVIP

日本药品数据保护制度评价及对我国启示摘 要 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。 关键词 日本 创新药物 数据保护制度 中图分类号：R951 文献标识码：C 文章编号：1006-1533(2011)12-0615-06 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 DING Jin-xi，LUO Xi-wei，WANG Ying-wei （Pharmaceutical Intellectual Property Research Institute，China Pharmaceutical University，Nanjing，211198） ASTRACT 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 R D 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. KEY WORDS Japan；innovative drugs；drug data protection policy 创新药物研发不仅与人类健康密切相关，并已成为全球生物医药高新产业发展的核心源动力。制约创新药物研发的瓶颈在于其巨额的前期投资和漫长的投资回报周期，尤其是临床试验阶段，通常70%的研发投入和2/3的研发周期都用于药品临床试验[1]。然而，由于不符合专利审查的三性要求，药品临床试验数据难以得到有效的知识产权保护，其核心技术易被仿制，从而产生技术溢出效应，即“搭便车”现象[2]。因此，如何对创新药物研发过程中的数据信息进行有效保护，已成为各国政府重点关注的问题。 2001年11月，中国正式加入WTO，并在《中国加入WTO工作组报告》第284段承诺履行TRIPS协议相关规定。2002年8月，我