公共健康危机视域下药品试验数据专有权保护研究  

Research on the Exclusive Right Protection of Drug Test Data from the Perspective of Public Health Crisis

作　　者：刘娜 LIU Na(School of Law,Xi'an University of Finance and Economics,Xi'an 710061)

机构地区：[1]西安财经大学法学院,西安710061

出　　处：《中国发明与专利》2021年第10期60-66,共7页China Invention & Patent

摘　　要：目前,药品试验数据专有权保护作为国际保护新趋势,是超出TRIPs协议标准的更高标准的TRIPsPlus保护,然而,其高标准保护要求也对药品试验数据保护带来了一些挑战。通过对公共健康保护与药品试验数据的关联问题进行分析,探讨了公共健康危机视域下药品试验数据专有权保护面临的药品试验数据法律属性模糊、药品试验数据保护范围规定不完善、药品试验数据强制许可配套措施缺位、缺少平衡药企私益与公益的制度设计等挑战,并对美国和欧盟的药品试验数据专有权保护进行分析借鉴,由此提出药品试验数据专有权保护的制度设计。At present, as a new trend of international protection, the exclusive right of drug test data protection is TRIPs-Plus protection that exceeds the TRIPs protocol standard. However, its high standard protection requirements also bring some challenges to drug test data protection. Through the analysis of the relationship between public health protection and drug test data, it discusses the fuzzy legal attributes of drug test data, imperfect regulations on the protection scope of drug test data, and drug test under the perspective of public health crisis. The lack of supporting measures for compulsory licensing of drug test data, the lack of a system design that balances the private interests of drug companies and the public welfare, etc., and analyzes and draws on the protection of the exclusive rights of drug test data in the United States and the European Union, and proposes a system for the protection of exclusive rights of drug test data.

关 键 词：药品试验数据 专有权保护 公共健康危机 

分 类 号：D923.4[政治法律—民商法学]