基于《药品管理法》修订的药品违法与侵权行为条款修改建议

Legislative Proposals of the Drug Illegal Acts and Torts Based on the Revise of the Drug Administration Law of PRC

目的比较美欧药品违法行为与侵权行为的法律界定、法律责任,以期为构建我国药品责任法律制度提供参考和理论依据。方法采用文献研究和比较研究方法,探讨药品违法和侵权行为的在不同法律中设定的方式与联系,以及法律责任设定。结果药品违法与侵权行为分属行政规制与产品责任、民事侵权,目前,我国《药品管理法》关注药品质量约束机制和行政合规性,而《产品质量法》和《侵权责任法》缺乏有效衔接的侵权责任制度。同时,缺陷界定存在瑕疵,假劣药划分交叉混乱,赔偿责任设定未将行为人主观恶意程度和造成的损害后果作为特殊考量因素,致使司法实践和执法操作存在诸多适用难题。结论以药品管理法修订为契机,对药品违法与产品责任、侵权行为进行关联性条款设定,维护公众用药合法权益。

Objective To compare the definitions, legal liabilities of drug illegal acts and torts in US and Europe, so as to provide reference for building drug responsibility legal system in our country. Methods Using the method of literature study and comparative study, this paper discusses the drug illegal acts and torts in different laws. Results Illegal acts and torts refer to administrative regulation and product liability, at present, the Drug Administration Law in our country pays close attention to drug quality constraint mechanism and administrative compliance, but Product Quality Law and Tort Law are Lack of effective connect of liability system. At the same time, the definitions of defect and illegal acts are imperfect, and the compensation doesn＇t consider the badness degree of the illegal behavior and the damage consequence. So there are many problems in the judicial practice and law enforcement operations. Conclusion Our country should take steps to define drug illegal acts and torts clearly, revise the regulations to guide the management of drugs, to make sure of the safety of public health.