美国对药品不良反应引发药害事件的赔偿及其启示  

Enlightenment of U.S.Injury Compensation System for Incident Caused by ADRs

作　　者：何达[1] 储藏[1] 陈盛新[1] 

机构地区：[1]第二军医大学药学院药事管理学教研室,上海200433

出　　处：《中国药事》2009年第10期1024-1026,共3页Chinese Pharmaceutical Affairs

摘　　要：目的分析美国对药品不良反应引发的药害事件的赔偿制度,探讨其对我国相关法律调整的启示。方法收集有关美国药品不良反应引发药害事件的法律法规、案例及文献,采用描述性和比较分析的方法研究其对患者的赔偿及救济制度。结果与结论努力维护消费者的合法权利应该成为立法的核心思想:①对药害事件有过错的责任方,设立惩罚性损害赔偿制度;②严格界定药品不良反应免责标准,因为大部分药品不良反应实为设计缺陷或制造缺陷;③建立严重药物不良反应损害的社会保险或救助的法规和机制。Objective To analyze U.S.injury compensation system for incident caused by ADRs,compare it with the existing legal loopholes in China,and discuss the enlightenment for the legal system in China.Methods U.S.injury compensation system for incident caused by ADRs,the case study of literature and legal laws and regulations were collected.The descriptive method was used in this study.Results and Conclusions This study found the U.S.injury compensation system for incident caused by ADRs takes the life and health rights of consumer as the ultimate goal, compared with which China should（1）perfect its relevant laws in order to give patients legal status for compensation. （2）establish compensation system for punitive damages, redefine the legal standard between drug quality defects and adverse drug reactions. （3） pharmaceutical enterprises, medical institutions and individual patients should act in accordance with the division of their functions and duties to form a complete set of system.

关 键 词：伤害补偿制度 不良反应 事件 

分 类 号：R951.712[医药卫生—药学]