我国医药监管机构体系存在的问题与重构建议.PDFVIP

我国医药监管机构体系存在的问题与重构建议 ＊ 鄢 广 （西南政法大学行政法学院，重庆 401120） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2016）07-0872-05 DOI 10.6039/j.issn.1001-0408.2016.07.03 摘 要 目的：为重构我国的医药监管机构体系提供参考。方法：通过介绍英国、美国医药监管机构的设置模式，结合我国医药监 管机构的设置现状以及存在的问题，提出重构我国医药监管体系的设想。结果与结论：英国、美国遵循法治化、独立性、专业性原 则，分别设置了由卫生部门领导的各类型、各专业医药监管机构体系，集中承担药品器械监管、医疗机构监管、医保基金监管等职 能职责。而我国的医药监管职能则分散于食品药品监管部门、卫生计生部门、人力社保部门、物价部门等，存在法治化程度较低、 监管职能不明、缺乏独立性以及专业性不足等问题，不利于缓解“看病难、看病贵”与“药价虚高”现象。因此，有必要参照英国、美 国的经验，把握“大部制”改革契机，整合食品药品监管部门、卫生计生部门、人力社保部门等的医药监管职能，建立由国家卫生和 计划生育委员会领导的行政部门、行业监管机构与专业技术机构相结合的“大卫生”医药监管体系。 关键词 医药监管机构；职能整合；大部制；构建 Defects and Reconstruction Suggestion of Medical Regulatory System in China YAN Guang （School of Administrative Law ，Southwest University of Political Science Law ，Chongqing 401120，China ） ABSTRACT OBJECTIVE ：To provide reference for reconstructing medical regulatory system in China. METHODS ：Through in- troducing medical regulatory setting mode in Britain and USA ，combining the situation and problems of medical regulatory setting in China ，and the assumption was put forward for medical regulatory system construction. RESULTS CONCLUSIONS ：Adher- ing to the principle of legalization ，independence and speciality ，Britain and USA set up various types medical regulatory in each professional field led by health departments. These medical regulatory institutions are charged with drug instrument regulation ，medi- cal regulation monitoring ，medical insurance monitoring ，and other responsibilities. In China ，medical regulatory function scatters in Food Drug Administration ，Health and Family Planning Department ，Human Social Security Department ，Price Department ， etc.There are some problems which go against the relief of “difficulty and high cost of getting medical service”and “falsely high drug price”，such as low legalization ，unclear regulatory function ，poor independe