论我国药物临床试验侵权责任归责原则的类型化确立  

Study on the Classification Establishment of Imputation Principle of Tort Liability of Clinical Drug Trial

作　　者：黄鹏 HUANG Peng(School of Clinical Medicine,Shanghai University of Medicine and Health Sciences,Shanghai 201318,China)

机构地区：[1]上海健康医学院临床医学院,上海201318

出　　处：《医学与哲学》2021年第11期71-75,79,共6页Medicine and Philosophy

基　　金：2020年上海市卫生健康委员会基金项目(20204Y0379)。

摘　　要：目前,我国立法尚未规定药物临床试验侵权责任归责原则,在司法实践中受试者权益无法得到有效保护。在借鉴域外典型国家先法经验的基础上,结合我国实际情况,确立药物临床试验侵权责任的归责原则。我国应依据客观标准调整治疗性临床试验与非治疗性临床试验的内涵,对非治疗性临床试验适用无过错责任原则,对治疗性临床试验适用过错推定责任原则,并通过立法在临床试验侵权责任下对归责原则予以规定,同时建立临床试验强制保险制度作为诉讼途径的补充。对药物侵权责任归责原则进行类型化确立符合我国实际情况,能够有效保护受试者权益。At present,the imputation principle of tort liability of clinical drug trial has not been stipulated in the legislation of China,and the application of imputation principle is confused in judicial practice,which makes the rights and interests of subjects unable to be effectively protected.In accordance with situations in China,this paper establishes the imputation principle for tort liability in clinical drug trial by borrowing typical legislation experience in foreign countries.China should adjust the connotation of therapeutic clinical trials and non-therapeutic clinical trials according to objective standards,apply the principle of no-fault liability to non-therapeutic clinical trials,and apply the principle of presumption of fault liability to therapeutic clinical trials,and stipulate the application of imputation principle under tort liability of clinical drug trial through legislation.At the same time,the compulsory insurance system of clinical trial should be established as a supplement to the litigation.The classification establishment of the imputation principle of tort liability of clinical drug trial is consistent with the actual situation in China and can effectively protect the rights and interests of subjects.

关 键 词：药物临床试验 侵权责任 归责原则 

分 类 号：R-05[医药卫生]