药品缺陷及其法律归责的探讨

On defects of drug and its law responsibility

目的准确定义药品缺陷并初步研究其法律归责。方法通过比较研究和系统思维,发现我国尚未对药品缺陷有科学的认识。结果与结论药品缺陷不等于药品不良反应,药品缺陷应该是药品不能提供对使用者所期待的治疗效果,存在可能危及人身安全的不合理危险,其法律归责可以考虑为无过错责任辅以国家救济的原则。

Object to define defects of drug accurately and to initially discuss its law responsibility. Method With comparative study and system thinking,we acquired few scientific recognition of drug＇s defects. Result ＆ Conclusion Defects of drug are not equal to negative drug reaction. The former one should be an unreasonable and potential risk which induces no expectant therapeutic efficacy to provide. And its law responsibility could be no-fault liability accompanied by state compensation.