我国药品安全行政问责制的实施困境与完善建议  

Dilemma and Suggestions on Administrative Accountability System of Drug Safety in China

作　　者：彭悦[1] 宋跃晋[1] 

机构地区：[1]广东药学院医药经济学院,广州510006

出　　处：《中国药事》2015年第10期999-1005,共7页Chinese Pharmaceutical Affairs

基　　金：广东省哲学社会科学"十二五"规划学科共建项目<医疗纠纷的实证分析-依医疗损害赔偿案件的判决为依据>(编号GD12XFX07)(阶段性成果)

摘　　要：目的:探讨中美药品安全行政问责的实施机制,为完善该制度、预防药品安全事件发生、提高药品监管水平提供建议。方法:分析我国药品安全行政问责的实施机制,以及在行政问责体制发展较为健全的美国其药品安全行政问责制的主、客体与实施机制,通过对比,从中发现国内该机制运行中的主要实施困境与形成原因。结果:国内的药品安全行政问责机制存在问责程序不规范、问责对象职责不明确及问责范围狭窄等问题,其主要归因于相关法律体系欠缺、政务信息不透明及问责文化缺失。结论:针对我国药品安全行政问责制的主要问题,应从健全行政问责法律体系、完善绩效评估制度、加大政务信息公开力度等3个方面来完善我国的药品安全行政问责制。Objective： To discuss the administrative accountability system of drug safety in China and US, and to provide suggestions to improve the ability of drug administration. Methods：Through the comparative analysis of the drug safety administration accountability mechanisms in China and US, the domestic dififculties in operation of the mechanism and reasons were analyzed. Results：There were some problems existing in current system, such as irregular procedure, unclear responsibility and narrow scope of accountability. These problems could be attributed to the lack of relevant legal system, non-transparent government information, and a lack of accountability culture.Conclusion： In order to improve the drug safety administration accountability system, relevant authorities should improve the legal system of administrative accountability and performance evaluation, and increase the intensity of government information publicity.

关 键 词：行政问责 药品安全 实施困境 经验借鉴 

分 类 号：R95[医药卫生—药学]