中国药品数据保护制度实施中的争议问题分析

摘要

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's 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.