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

发布时间：2018-05-12 08:03

本文选题：TRIPS + 药品　；参考：《中国新药杂志》2015年20期

【摘要】：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。
[Abstract]:The TRIPS protocol under the framework of WTO puts forward the basic requirements for the implementation of drug test data protection for its member countries. Based on the fuzziness and flexibility of the relevant provisions, there are great differences in the legislative practice of each country, among which the application range of drug test data protection is the largest. This paper firstly combs the relevant provisions of TRIPS, discusses the theoretical basis of the scope of application of drug test data protection from the perspective of legal theory, and constructs the evaluation index system of the scope of test data protection. Select 14 countries with clear scope of protection to compare, analyze the rules and principles that should be followed in the scope of application of drug test data protection, combine with the current situation of the development of drug test data protection in China and the practical problems that should be solved. This paper puts forward some reasonable suggestions on the definition of the scope of application of drug test data protection in China.
【作者单位】：沈阳药科大学工商管理学院;
【基金】：国家社会科学基金项目(13CFX086) 四川医事卫生法治研究中心青年基金项目(YF13-Q01)
【分类号】：R95

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