中国药品数据保护制度实施中的争议问题分析

Discussion and Countermeasures on THE Application of Drug Data Protection System in China

药品数据保护制度源自欧美国家并通过TRIPS协议成为全球共识,我国的国内法和TRIPS协议规定基本接轨。在药品数据保护制度的实施中,围绕着数据的真实性、数据是否享有专有权、需要提交数据的药品范围、数据保护与药物成本等问题产生了各种争议,影响了药品注册和审批工作的进程。基于中国医药行业的长远利益和知识产权保护的效果,提出在制定中国的药品数据保护制度时,还需要进一步加强制度的可操作性。

Proposition for drug data protection comes from the Occident. TRIPS Agreement establishes the basic rules for drug data protec- tion and domestic law is consistent with the provisions of TRIPS Agreement. In the drug registration approval process of China~ drug supervision department, the drug data protection has encountered some problems, including data authenticity, exclusive right of data, and scope of drugs re- quiring data submitted, data protection and drug costs. Based on long - term interests of pharmaceuticals industry and intellectual property protec- tion trends, there are a lot of difficulties in the drug data protection law enforcement in China to be overcome.