药品侵权责任因果关系探讨

Discussion on Causation of Drug Tort Liability

目的合理分配举证责任,保护患者合法利益。方法依据《药品管理法》、《侵权责任法》等法律,运用医学药学知识和法理原则,通过案例分析,归纳出国内外重大药害事件或药品侵权责任中的因果关系举证责任分配。结果对原告而言,证明药品侵权责任因果关系是极为困难的,国内外重大药害事件或药品侵权责任中的因果关系往往是由国家机关确定的。结论利用国家机关对假劣药的查处结果,借助国内外药品不良反应信息等,可以降低原告对药品侵权责任因果关系的证明难度。

Objective To appropriately allocate burden of proof,so as to protect legal rights of patients.Methods Based on the laws such as Pharmaceutical Administration Law of PRC and Tort Liability Law and applying medical and pharmaceutical knowledge and principles,relative cases were analyzed and the allocation practice was summarized of the burden of proof for tort liability in major domestic and foreign drug phytotoxicity or drug tort events.Results It is extremely difficult for the plaintiff to prove the causation of drug tort liability because the causation is usually determined by the state authorities in drug tort liability cases or major domestic and foreign drug events.Conclusion The difficulty could be reduced by referencing the state investigation results on counterfeit drugs,and domestic and foreign information on adverse drug reactions.