我国药品领域引入惩罚性赔偿制度初探

Initiation of Punitive Compensation System in Drug Field in China

目的:在药品领域引入惩罚性赔偿制度以弥补我国对药品损害事件法律责任的立法不足,规制医药企业违法行为,提高药品领域的监管效率。方法:通过对国内、外相关法律条文的查阅了解国外惩罚性赔偿制度的定义、功能等,分析了我国引入惩罚性赔偿制度的必要性并提出在我国建立惩罚性赔偿制度的适用条件。结果与结论:我国药品领域亟需引入惩罚性赔偿制度,且应建立具有本国特色的制度。建议在我国《药品管理法》中引入相关内容,并明确我国药品领域引入惩罚性赔偿的适用条件以及如何确定惩罚性赔偿的数额等。

OBJECTIVE： To initiate punitive compensation system in drug field to make up the insufficiency in the legis-lation of legal liability of drug injury events, regulate unlawful act of pharmaceutical enterprises and enhance supervision efficiency in drug field. METHODS： The definition and function, etc. of the punitive compensation system were studied by reviewing the pertinent legal clauses both at home and abroad, furthermore, the necessity of initiating the punitive compensation system in China was analyzed and the application conditions of the punitive compensation system was put forward. RESULTS ＆ CONCLUSIONS： It is urgent to initiate the punitive compensation system in drug field and establish a punitive system with Chinese characteristics. It is advisable to initiate the related contents in Pharmaceutical Administration Law of the People＇ s Republic of China and define the application conditions of the punitive compensation system as well as the way to establish the amount of compensation, etc.