药物Ⅰ期临床试验保障制度中的补偿责任——日本相关法规及内容对我国的启示

Compensation responsibility in the drug phase I clinical trial safeguard system:enlightenment from Japan’s relevant regulations and contents to China

通过对文献以及日本相关法律制度的梳理,发现日本在补偿责任的界定以及强制性上都有法律明确规定,具体的补偿内容完备,覆盖面广。我国药物临床试验补偿责任的规定在法律框架、补偿责任保险、补偿制度方面都存在不足。借鉴日本的补偿制度,我国需要进一步确立临床试验补偿责任的法律地位,完善补偿责任的内容设计,构建我国健康受试者的损害救济制度。

Based on the analysis of literature and the relevant Japanese legal system,it was found that regulations on the definition of compensation liability and mandatory are clear in Japan.And the specific compensation content is complete and a wide range was covered.The provisions on the compensation responsibility for drug clinical trials in China are insufficient in legal framework,compensation liability insurance,and compensation system.Drawing on the compensation system of Japan,the legal status of compensation for clinical trials should be established,the content design of compensation responsibility should be improved,and a damage relief system should be constructed for healthy subjects in China.