民法视野下药品不良反应救济制度研究

Judicial Relief for Adverse Drug Reaction in the View of Civil Law

我国民法中并无针对药品不良反应损害救济的相关规定,致使药品不良反应的救济存在法律适用困境。国外药品不良反应救济主要有严格责任、保险救济和基金救济三种模式。目前国内在确立药品不良反应民事责任之前,还不具备单独适用保险救济以及基金救济模式的条件,现行民法需要从药品的缺陷判断标准和判定时限进行改革,建立严格的无过错责任,并在立法改革的同时注重风险效益平衡以及风险分散作用。

There are no civil reliefs for adverse drug reactions with a lack of relevant legislative provisions in China.Foreign countries have seen the establishment of judicial relief for adverse drug reaction mainly comprising strict liability,insured liability and funding relief.Nevertheless,in China at present,before establishing civil liability for adverse drug reactions,no conditions are available for independently applying insurance benefits or funding relief.As a result,the existing civil law should be reformed by rationalizing the criteria for judging defective drugs and the time it takes,and establishing no-fault liability.Meanwhile,we should also lay emphasis on benefit risk balance and risk diversification,