摘要
目的:根据现行的法律法规,明确侵权责任认定的归责原则在我国药物临床试验中的适用。方法:采用文献研究,法律研究和案例分析方法,分别探析了过错责任原则、无过错责任原则和公平责任原则在我国药物临床试验所致侵权责任认定中是否适用以及暂无适用的归责原则是否有必要规定适用。结论:在现行的法律法规之下,药物临床试验致人损害的侵权责任认定仅适用过错责任原则(但不包括过错推定原则)。法律没有必要规定或者扩大解释以期在药物临床试验的侵权责任认定中适用无过错责任原则,但有必要规定在满足公平责任原则的适用条件时,在药物临床试验的侵权责任认定中适用公平责任原则。
Objective： To explicit the application of principal of tortious liability attribution in clinical trial in accordance with the current laws and regulations. Method： With the methodology of literature research, legal study and case study, the paper analyzed whether principle of fault liability, principle of liability without fault and principle of equitable liability could be respectively applied to the confirmation of tort liability in clinical trial, and whether it was necessary to establish a principle if no one can be applied now. Conclusion： In accordance with the current laws and regulations, the confirmation of tort liability in clinical trial applies the principle of fault liability （but not include presumed-default liability）. While it is not necessary to expand the principle of liability without default to be applied under the present laws and regulations, it is necessary to apply the principle of equitable liability where the acts of tort meet the requirements of that principle.
出处
《中药与临床》
2014年第1期34-36,45,共4页
Pharmacy and Clinics of Chinese Materia Medica
关键词
药物临床试验
侵权责任
归责原则
Clinical trial
tort liability
doctrine of liability fixation
