药品缺陷侵权法律问题与对策研究——以权利救济为视角  

Research on Legal Problems and Countermeasures of Drug Defect Infringement-From the Perspective of Right Relief

作　　者：李俊 张进 羊海燕 LI Jun;ZHANG Jin;YANG Haiyan(Law School,Southwest Medical University,Luzhou 646000,China;School of International Law,China University of Political Science and Law,Beijing 100091,China)

机构地区：[1]西南医科大学法学院,四川泸州646000 [2]中国政法大学国际法学院,北京100091

出　　处：《中国现代应用药学》2022年第14期1889-1894,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：四川省社会科学研究“十四五”规划2021年度课题基地重大项目(SC21EZD058);四川医事卫生法治研究中心课题项目(YF22-Q07)。

摘　　要：目的 解决药品缺陷侵权的权利救济问题,保障用药患者的合法权利。方法 梳理药品缺陷侵权的立法现状与权利救济现状,分析中国药品缺陷侵权权利救济存在的问题,并针对问题提出相应的解决措施。结果 药品缺陷侵权的相关立法不完善,权利救济案件数量少且成功率低,权利救济现实情况堪忧。药品缺陷概念缺失与认定标准不明确、侵权归责原则不明、举证责任分配不合理、救济途径单一以及药品缺陷认定困难是药品缺陷侵权在权利救济方面存在的现实问题。结论 药品缺陷侵权的权利救济问题不容忽视,必须通过明确药品缺陷概念与认定标准、完善药品缺陷的归责原则立法、拓宽救济途径、完善药品鉴定制度以及建立、健全多元救济体系等措施,对药品缺陷侵权问题加以规制,从而提高药品服务的质量,保证用药安全。OBJECTIVE To solve the problem of right relief of drug defect infringement and to protect the legitimate rights of patients. METHODS The legislative status and right relief status of drug defect infringement were reviewed, the existing problems in the right relief of drug defect infringement in China were analyzed, and the corresponding solutions were put forward. RESULTS The relevant legislation of drug defect infringement was imperfect, the number of rights relief cases was small and the success rate was low, and the reality of rights relief was worrying. The lack of the concept of drug defects and the unclear identification standards, the unclear principle of tort liability, the unreasonable distribution of burden of proof, the single relief way and the difficulty in identifying drug defects were the practical problems in the right relief of drug defect infringement. CONCLUSION The right remedy of drug defect infringement can not be ignored. It is necessary to regulate the problem of drug defect infringement by clarifying the concept and identification standard of drug defect, improving the legislation of imputation principle of drug defect, broadening the relief way, improving the drug identification system and establishing and perfecting the multiple relief system, so as to improve the quality of drug services and ensure the safety of medication.

关 键 词：药品缺陷 权利救济 法律制度 

分 类 号：R951[医药卫生—药学]