政府规制影响评估制度的法经济学思考——以医疗器械规制评估为例  

A Thought on RIA: Taking the Regulation Impact Assessment for Medical Devices as an Example

作　　者：蒋海洪[1] 

机构地区：[1]上海理工大学食品药品监管法规研究所,上海200093

出　　处：《广东商学院学报》2013年第2期78-86,共9页Journal of Guangdong University of Business Studies

基　　金：2011年度上海市教委科研创新一般项目(11YS294);2013年度上海市教委科研创新重点项目(13ZS147)

摘　　要：规制影响评估制度是判断政府规制必要性和合理性的有效工具,我国虽有试点但尚未正式建立。在评估政府规制影响时,应注意规制供求分析、规制成本收益分析、规制资源配置分析等三个经济学维度的运用。制度供求均衡理论、效率最大化、法律的经济分析方法等相关理论对规制影响评估制度的构建有诸多启发。从医疗器械规制的评估分析来看,建立规制影响评估制度应该注重规制必要性和合理性的评估,合理评估规制的成本与收益,慎重确定规制影响评估的评估方法,谨慎确立规制影响评估的评估机构等。The system of regulation impact assessment（RIA） is an effective approach to judge the necessity and reasonableness of regulations,but it has not been officially built in China.Supply and demand analysis,cost and benefit analysis,and resource allocation analysis constitute the three dimensions of economics in the assessment of government regulations.It is useful to refer to some law-economics theories such as the balance between supply and demand,efficiency maximization,the economic analysis of law,and the hypothesis of limited reasoning.The paper takes medical device regulations as an example and puts forward some suggestions for the eventual establishment of RIA,which include focusing on assessing the necessity and reasonableness of regulations,assessing the cost and benefit of regulations,cautiously determining the method of RIA,and cautiously establishing the assessment institution,etc.

关 键 词：政府规制 规制影响评估制度 医疗器械规制 法经济学 成本收益分析 

分 类 号：D922.1[政治法律—宪法学与行政法学] D90-05[政治法律—法学]