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    国际重大药害案例及其影响研究

    摘要

    基于对药害相关概念、药害类型、药害发生率的简要分析,本报告认为与药物不良反应(ADR)相同,药害可分为A型和B型两个主要类型,4个附加类型。报告从6个方面系统阐述了药品责任的特殊性与药品责任的立法问题,并对有重大影响的11个药害案例进行重点分析。世界各国对于药害救济机制均可概括为两种基本模式,即赔偿和补偿。补偿则是通过向药品企业收取款项以及自愿捐助等途径建立一笔基金,在药害发生时直接由该基金为受害人提供救济。药害救济赔偿主要通过法律诉讼的方式解决,由于药害事件的赔偿金额巨大,保险行业在药害事件的救济赔偿中发挥重要作用。

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    关键词: 案例国际药害

    Abstract

    Based on general analysis of the concepts,event style,and the event being happened possibility regarding to the Drug-Induced Injury Event,the author considers that the Drug-Induced Injury Event can be divided into two main types (A and B),and four additional types,which were the same as that of Adverse Drug Reaction (ADR). The author discussed systemically the particularity and legislative problem of the drug responsibility in six different aspects,and emphatically analyzed the eleven cases of the Drug-Induced Injury Events which have significant influence in our country. Around the world the Remedies of the Drug-Induced Injury Event can be summarized as two basic modes,i.e.,reparation and compensation. Compensation mode means that the victims are to be compensated with remedies indemnity when the drug-induced injury event occurs,from a fund established or payments received from drug companies,or that contributed by volunteers. Compensation mode for Remedies of the Drug-Induced Injury Event is being resolved primarily by legal proceedings. Due to huge amount of indemnity,the Insurance industry plays an important role in the Compensation for Remedies of the Drug-Induced Injury Event.

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