我国药物临床试验侵权归责原则适用的困境与完善路径  

The Dilemmas and Ways to Improve the Application of the Principle of Tort Liability for Drug Clinical Trials in China

作　　者：尹珊 郑新月 羊海燕 Yin Shan;Zheng Xinyue;Yang Haiyan(Southwest Medical University,Luzhou 646000,China)

机构地区：[1]西南医科大学,四川泸州646000

出　　处：《锦州医科大学学报(社会科学版)》2025年第2期26-31,共6页Journal of Jinzhou Medical University(Social Science Edition)

基　　金：四川省哲学社会科学重点研究基地资助项目“健康医疗数据共享的法治保障研究”(编号:SC23E049);四川医事卫生法治研究中心—中国卫生法学会2024年联合立项项目“多主体利益视角下个人健康医疗数据权利配置研究”(编号:YF24-Q06)的研究成果。

摘　　要：我国法律目前在药物临床试验侵权责任的具体归责原则方面并无明确规定,这严重影响着对受试者权益的保护。鉴于此,笔者从伦理学和法经济学视角出发,尝试确立药物临床试验侵权归责应遵循的核心理念与操作原则。通过对比分析多元归责原则,明确其法律逻辑,建议根据临床试验的治疗性与非治疗性特性,构建差异化的侵权归责原则体系。同时,强化《中华人民共和国民法典》中人格权编与侵权责任编的协调联动,形成对受试者权益的全面、规范保护,倡导构建申办者、研究者与受试者之间的多主体利益平衡机制,以此弥补现有的立法空白及责任原则在药物临床试验中的局限性。China’s Civil Code does not cover the specific liability principle of drug clinical trial tort liability,which affects the definition of infringement and the protection of subjects'rights and interests.In view of this,from the perspective of ethics and law and economics,the author establishes the core concepts and operating principles that should be followed for the tort liability of drug clinical trials.Through comparative analysis of the multiple imputation principle,the legal logic is established,and it is suggested to build a differentiated imputation principle system according to the therapeutic and non-therapeutic characteristics of clinical trials.At the same time,strengthen the coordination and linkage of personality rights and tort liability in the Civil Code,form a comprehensive and standardized protection of subjects’rights and interests,and advocate the construction of a multi-subject interest balance mechanism between sponsors,researchers and subjects.In order to make up for the existing legislative gap and the limitation of the liability principle in drug clinical trials.

关 键 词：药物临床试验 侵权归责原则 受试者权益保护 利益平衡 

分 类 号：R-052[医药卫生]