论我国药物临床试验侵权责任存在的问题及完善

Problems and Improvement of Tort Liabilities for Drug Clinical Trials in China

我国关于药物临床试验侵权责任的立法相对滞后,既没有针对药物临床试验的专门立法,也没有在《民法典》中予以规定,导致在司法实践中处理该类纠纷时,适用法律不一,选择原则各异。为了更好地规范这类行为,可以在借鉴他国立法经验的基础上,根据我国实际制定专门的《人体医学试验法》,完善《民法典》侵权责任编。通过在司法实践过程中适用“盖然性因果关系”、以“法定行为标准”判断过错、严格免责事由等措施来保护试药者的合法权益。

There is a lag in the legislation on tort liabilities for drug clinical trials in China,and it is shown that there is neither any special legislation on drug clinical trials nor any provision concerning it in The Civil Code of the People’s Republic of China.Consequently,various legal provisions and principles are applied in the judicial practice concerning the disputes of tort liabilities for drug clinical trials.To regulate the drug clinical trials in a better way,it is sensible to formulate The Act of Human Medical Test and modify provisions in“the Section of Tort Liabilities”in The Civil Code of the People’s Republic of China by making reference to corresponding legislation abroad and based on actual circumstances in China.Thereafter,the principle of probable causality,the legal act standard in deciding fault and being strict with the subject matter of exemption should be applied in judicial practice,aiming to protect the legitimate rights and interests of the subjects of the clinical trials.