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.
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