TPP生物制品数据保护条款与中国政策定位研究

Data protection provisions for biologics in TPP and policy orientation in China

本文从《跨太平洋伙伴关系协议》(TPP)生物制品数据保护条款出发,在剖析条款要点与制度效应基础上,根据产业发展水平探究我国生物制品数据保护政策定位问题。研究发现,现阶段我国创新投入水平和居民支付能力与生物制品数据保护制度并不匹配,实施该制度的负效应将大正效应。建议我国在完善产业配套制度、促进产业转型升级的同时,审时度势,谨慎分析利弊,并设计相应谈判策略预案。

This paper proceeds from the data protection provisions of Trans-Pacific Partnership Agreement （TPP）. The essential principles and the underlying policy influence of the provisions and the policy orientation of data protection provisions for biologics in China were discussed. Research results indicated that the R＆D investment and healthcare affordability in China failed to match the establishment of biologics data protection system. The system will be more detrimental than beneficial if established without careful consideration. Therefore, China should improve the industry supporting system, promote industry transformation and upgrading, and then analyze advantages and disadvantages. Meanwhile, the negotiation plan of data protection for biologics must be designed in advance.