TRIPS协定下药品试验数据保护的例外与我国的立法选择  

Exceptions to Drug Test Data Protection under the TRIPS Agreement and China’s Legislative Choice

作　　者：张丽英[1,2,3,4] 段佳葆 

机构地区：[1]中国政法大学国际法学院 [2]中国法学会世界贸易组织法研究会 [3]中国国际经济法学会 [4]中国海事仲裁委员会 [5]不详

出　　处：《中国食品药品监管》2021年第1期35-41,共7页China Food & Drug Administration Magazine

基　　金：国家社科基金专项课题:“一带一路”国际合作框架机制设计(18VSJ050)。

摘　　要：关于药品试验数据以什么方式保护存在争议。《与贸易有关的知识产权协定》(TRIPS协定)第39条第3款规定了药品试验数据的反不正当竞争保护模式及其例外情形。我国采取的是与美国等发达国家相同的数据独占保护模式,高于TRIPS协定的保护标准。2018年,国家药品监督管理局公布的《药品试验数据保护实施办法(暂行)(征求意见稿)》进一步提高了数据保护的标准。然而,我国立法在数据保护的例外规定上却仍“照搬”TRIPS协定。这不仅会造成与数据独占保护模式的不契合,也会因缺乏合理的例外规定而无法很好地平衡公共利益和药品创新激励。因此,我国不应局限于TRIPS协定,而是应利用灵活条款,以数据独占保护模式为基础,考虑制定符合我国国情的例外规定。加之,目前全球正处于新型冠状病毒疫苗研制的关键时期,合理的例外规定可以在很好地实现公众健康的同时兼顾疫苗研发企业的利益,起到平衡二者的作用。本文拟通过对两种药品试验数据保护模式项下例外规定的比较研究,指出我国现行法律和《药品试验数据保护实施办法(暂行)(征求意见稿)》中有待完善的地方,并提出合理建议。There has been controversy over how to protect drug test data.Article 39 paragraph 3 of the TRIPS Agreement stipulates protection of drug test data against unfair commercial use and its exceptions.China adopts“data exclusivity”,the same data protection method adopted by the United States and other developed countries,which sets higher protection standards than the TRIPS Agreement.In 2018,the National Medical Products Administration of China issued the Drug Test Data Protection Implementation Measures(Provisional)(Draft for Public Comments),which would further improve data protection standards.However,China’s legislation is still copying TRIPS provisions in terms of data protection exceptions.This will not only result in inconsistency with data exclusivity,but also fail to keep balance between protecting public interest and stimulating drug innovation.Therefore,China should not be limited to TRIPS provisions,but should consider developing exception clauses suitable for our national conditions.In addition,coronavirus vaccine is now in the critical stage of R&D.Reasonable exceptions can maximize public health benefits while balancing the interests of vaccine R&D enterprises.Through a comparative study of the exceptions under the two methods of drug data protection,this paper points out areas that can be improved in China’s current laws and the Drug Test Data Protection Implementation Measures(Provisional)(Draft for Public Comments),and puts forward some suggestions.

关 键 词：药品试验数据 TRIPS协定 反不正当竞争保护 数据独占保护 保护例外 

分 类 号：R95[医药卫生—药学]