美国生物制品数据保护制度的立法演变与成因分析  

Analysis of the Legislative Evolution and Causes of Biologics Data Protection System in the United States

作　　者：姚雪芳[1] 丁锦希[1] 任宏业[1] 

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国药房》2017年第10期1302-1306,共5页China Pharmacy

基　　金：国家社会科学基金资助项目(No.13BFX120);国家食品药品监督管理总局委托研究项目;2015年华海药业研究生创新基金项目(No.1010030004)

摘　　要：目的:研究美国生物制品数据保护制度立法演变与成因,为我国生物制品数据保护制度设计提供参考。方法:从梳理美国生物制品数据保护特点出发,通过剖析美国生物制品数据保护制度的立法斗争,挖掘这一制度的形成过程和原因及对我国的启示。结果与结论:经过立法的探讨、演变与斗争后,美国于2010年颁布《生物制品价格竞争与创新法案》,确立了全球首个"强保护"标准的生物制品数据保护制度并确定12年的数据保护期;这一制度的立法基础是激励创新的战略需求,直接原因是美国建立了生物类似物简化申请途径,重要因素包括生物制品技术属性与专利保护特点。但我国现阶段暂不适合建立生物制品数据保护制度,未来在国情相匹配或者战略选择需要时,亦应按照由无到有、由弱到强的路径来实施该制度。同时,成熟的注册审批体系是建立数据保护制度的基础。OBJECTIVE：To study the legislative evolution and causes of biologics data protection system in the United States,and provide reference for designing biologics data protection system in China. METHODS：Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS CONCLUSIONS：After legislative discussion evolution and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world＇s first＂strong protection＂standard of biologics data protection system,and determined the 12-year data protection period. The legislative basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Currently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the basis of establishing data protection system.

关 键 词：生物制品数据保护 立法演变 制度成因 美国 

分 类 号：R951[医药卫生—药学]