试论我国临床试验中侵权责任制度的确立与完善

Study on the Establishment and Improvement of Tort Liability Systemin Clinical Trials in China

近年来,我国经济社会的高速发展和愈发清晰的老龄化趋势使得医疗、医药行业快速扩张,而临床试验作为药品研发和上市的必经阶段,其试验规模和试验种类也随之迅速增长。但是,临床试验具有高度的风险性和损害结果的不可逆性,极易侵害受试者的身体健康和生命安全,在实践中也出现了诊疗行为与临床试验行为混淆、责任承担主体不清等一系列问题。因此,我们有必要结合国情完善我国临床试验中侵权责任归责的路径,即以法律的形式确立临床试验侵权责任的独立性与归责原则。同时,规定受试者主张的与争议事项有关的证据属于申办者或研究者掌握管理的,应当由申办者或研究者提供。在此基础上,还建议建立配套保险机制,以期让受试者及时获得应有的赔偿。

In recent years,the rapid development of China’s economy and society,as well as the increasingly clear trend of aging,have spurred the rapid expansion of the medical and pharmaceutical industries.Clinical trials,as a necessary stage for drug research and marketing,have also seen a rapid increase in their scale and types of trials.However,clinical trials have a high degree of risk and irreversibility of damage results,which can easily harm the physical health and life safety of subjects.In practice,there have also been a series of problems such as confusion between diagnosis and treatment behavior and clinical trial behavior,and unclear responsibility bearers.However,there is currently no provision for infringement liability in clinical trials in Chinese law,which is not only detrimental to protecting the legitimate rights and interests of subjects,but also to the standardized development of clinical trials in China.Therefore,it is necessary for China to improve the path of liability for infringement in clinical trials based on its own national conditions,that is,to establish the independence and principles of liability for infringement in clinical trials in the form of law:to apply the principle of presumption of fault to non therapeutic clinical trials;The principle of fault liability is applicable to therapeutic clinical trials.Meanwhile,if the evidence related to the disputed matter claimed by the subjects belongs to the control and management of the applicant or researcher,it should be provided by the applicant or researcher.On this basis,it is also recommended to establish a supporting insurance mechanism in order to enable subjects to receive the appropriate compensation in a timely manner.