TRIPS框架下药品试验数据保护的适用范围与我国的立法选择

Application scope of drug test data protection under TRIPS and the legislative choice of China

WTO框架下的TRIPS协议对其成员国提出了实施药品试验数据保护的基本要求。基于相关条款的模糊性和灵活性,各个国家在本国的立法实践上存在很大的区别,其中药品试验数据保护的适用范围的差异最大。本文首先对TRIPS的相关条款进行梳理,从法理的角度探讨药品试验数据保护适用范围的理论依据;通过构建试验数据保护范围的评价指标体系,选取14个保护范围明确的国家进行比较,分析药品试验数据保护适用范围应该遵循的规律和原则;结合我国药品试验数据保护的发展现状及应该解决的实际问题,提出我国药品试验数据保护适用范围的界定的合理化建议。

There is a basic requirement on the protection of drug test data of TRIPS under the WTO frame.Because of the flexibility and ambiguity of relevant provisions,big differences exist in the domestic legislation practice of different countries,especially the diversity of application scope. First of all,this paper analyzed the related terms of the TRIPS and explored the theoretical basis of the application scope from the perspective of legal theory.Furthermore,by constructing the evaluation indexes system,the application scopes of drug data protection of 14 countries with clear definition are compared and researched,then the rules and principles which we must follow to define the scope of drug data protection are put forward. At last,this paper threw out the proper advices on the definition of the application scope of drug data protection in China with the consideration of the development and problems of the current drug data protection in our country.