后TRIPs时代美国药品试验数据保护的路径演变及应对策略

The Path Evolution and Countermeasures of Drug Test Data Protection in the United States in the Post-TRIPs Era

美国简化新药申请(ANDA)的问世直接催生了药品试验数据专有权保护制度的出台,从国内立法到TRIPs协议、FTA以及TPP,美国的药品试验数据保护制度一直处于不断强化的演变之路,作为美国主要的贸易合作伙伴,应警惕药品试验数据的强保护对于药品可及性及公共健康安全的不利影响,制定符合我国的药品试验数据保护制度。

The abbreviated new drug applications(ANDA)directly led to the advent of drug test data exclusive rights protection system,from the domestic legislation to the TRIPs agreement,FTA and TPP,America's drug test data protection system has been constantly strengthened the evolution.As America's main trading partners,we should be alert to the test data of strong protection for drug accessibility and the negative impact of the public health,to develop pharmaceutical test data protection system in our country.