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深化我国药品监管体制改革研究

Deepening Our Reform of the Drug Regulatory System

【作者】 刘伟

【导师】 霍海燕;

【作者基本信息】 郑州大学 , 公共管理, 2012, 硕士

【摘要】 随着经济社会发展和人民生活水平提高,人民群众对健康的需求越来越高。对于国家而言,医药经济的发展具有重要意义。然而,目前现状不能让有关各方满意。显然,政府的药品管理是关键因素。在众多政府药品管理政策和行为中,药品管理体制发挥着基础性作用。因此,提高药品管理水平,首要的是完善药品管理体制。通过对1998年以来三次药品监管体制改革的深入分析,可以看出虽然取得许多成效,但是国家对药品管理职能定位仍然不是十分准确,药品管理体制改革受到诸多方面影响。政府药品管理应主要包括药品经济管理、安全管理和可及性管理三个方面,要正确处理三方面之间的关系。从对目前现状来看,我国药品安全仍处于矛盾凸显期和风险高发期,医药产业发展亟待政策支持,药品价格虚高引发公众不满。造成目前这种现状的原因,从体制上来讲,主要是药品经济管理职能薄弱和“以药养医”机制,导致医药企业低水平重复和产业发展水平不高,药品职能过于分散,机构设置不尽合理。国外药品监管的具体方法、手段和措施等技术层面的内容,我国可以借鉴和模仿,但对于国外药品监管体制,我国可以借鉴的很少。深化我国药品监管体制改革,必须结合国情,遵循我国行政管理体制改革的指导思想、基本原则,建议实现药品监管职能的集中统一,把药品安全监管、行业管理、价格和广告监管等职能集中统一赋予当前食品药品监管部门;独立设置食品药品监管部门;加快推进医药分开;加快推进食品监管体制改革。

【Abstract】 Along with the economic and social development and the people’s living standards improve, people’s requirement of health more and more high. In terms of nations, medicine economic development to have the important meaning. However, the present situation can’t let all the parties concerned satisfied. Obviously, the government’s drug management is the key factor. In numerous government drug management policy and behavior, the drug management system plays an essential role. Therefore, improve the drug management level, the first is to perfect the drug management system.Based on1998three times since the drug administration system reform of analysis, we can see that although obtained many achievements, but the country to drug management function orientation is still not very accurate, the drug management system reform is affected by many effect. The drug management should be mainly include drug economic management, security management and accessibility management three aspects, to correctly handle the relationship between the three aspects. From now on the current situation, our drug safety is still in the time of obvious contradiction and risk almost two decades, medicine industry development to be policy support, drug prices empty tall trigger public discontent. At present, the cause for the current situation, from system speaking, a major drug economic management function is weak and " drug-maintaining-medicine " mechanism, leading medical enterprise repeat at low level and the industrial development level is not high, drug function too scattered, institutional setup is not rational.Supervision of foreign drugs specific methods and means and measures of the content of the technical level, our country can learn and imitate, but for foreign drug supervision system, our country can use less. Deepening our reform of the drug regulatory system, must according to its actual conditions, follow our administrative management system reform of guiding ideology, basic principles, suggested the drug regulatory function realization centralized and unified, the drug safety supervision, industry management, price and advertising supervision function centralized and unified gave the current food and drug supervision department; Set up independently the food and drug administration department; Speed up the policy of separating pharmacies from medical institutions; Speed up the food monitoring and management system reform.

【关键词】 药品监管体制安全发展
【Key words】 drugregulatorysystemsafetydevelop
  • 【网络出版投稿人】 郑州大学
  • 【网络出版年期】2012年 09期
  • 【分类号】F203;F426.72
  • 【被引频次】24
  • 【下载频次】877
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