日本药品上市许可持有人制度下的临床试验保险设置研究对中国的启示

The enlightenment of Japan's drug clinical trial insurance system under the marketing authorization holder system to China

研究日本临床试验保险的相关法律要求与现有的保险产品情况,为我国临床试验保险法律制度及保险产品设计提供参考。以日本临床试验的申办者为研究对象,通过文献对比研究,梳理日本法律得出日本对临床试验保险的法律要求、申办者应负的法律责任、现有的临床试验保险产品的相关经验。日本法律要求临床试验申办者必须为受试者准备临床试验保险。申办者除存在过错时需承担赔偿责任外,无过错时亦应承担道义上的补偿责任,并有专门的行业指导原则做规范。日本的临床保险产品严格依照法律,设计了涵盖赔偿责任和补偿责任的组合式保险产品。

The aim of this article was to study Japan＇s laws and regulations about clinical trial insurance,and provide reference for designing China＇s clinical trial insurance system. Japan＇s legal requirements on clinical trial insurance,sponsor＇s legal liabilities and status of current insurance products were summarized by sorting out Japan＇s laws and regulations. It was found that insurance are required in Japan,sponsors have the liability of compensation or indemnity when subjects have hurts no matter whether they have faults or not in regard of laws and industry guidelines. Japan＇s insurance products contain both compensation or indemnity to adapt to the situation.