药品不良反应救济的理论分析

Theoretical analysis on remedies for adverse drug reaction

药品不良反应属药品容许性危险,发生不良反应的药品不存在缺陷,药品企业不承担侵权责任。但受害人自担药品不良反应的损失有悖社会正义,对受害人予以救济是公平正义的要求。通过衡量各种冲突的利益,药品不良反应救济可以采用基金方式给予受害人补偿。有必要借鉴其他国家和地区的成功经验,构建我国科学规范的药品不良反应救济制度。

Adverse drug reactions（ADR） are admissible drug risks,but not the defects of a marketed drug.Drug enterprises shall not be liable for any tort liability caused.However,it is contrary to social justice that the victims alone bear the loss of adverse drug reactions.Therefore,it is the requirement of justice to remedy the victims in certain forms.Measuring the various conflicts of interests,compensation funds can be used to give relief to the victims of adverse drug reactions.It is necessary to draw on the experience of other countries and regions and to establish a scientific and standardized ADR relief system in China.