【作者】 石磊；

【导师】 应松年；

【作者基本信息】 中国政法大学 ， 宪法学与行政法学， 2008， 博士

【摘要】 本文主要从公法学的角度,并结合经济学、行政学的基本理论,研究中国的药品政府管制,深入分析了药品政府管制的基本理念,管制机构,管制目标、范围与方式,运行机制四个问题。管制机构不仅回答了管制主体是什么,更进一步分析了管制主体应该如何设置。管制目标、范围与方式从静态方面回答了管制要解决的问题是什么,哪些属于政府管制的事项,如何管制。运行机制从动态方面回答了实现政府管制目标的运行和生成机制。管制机构,管制目标、范围与方式,运行机制三大部分组成了基本的管制体系。导论部分:首先从中国药品管制的一些典型案例入手,简要分析中国药品管制的现状与问题,引出研究药品政府管制在中国的现实意义。接着阐述了政府管制的形成和发展,以及对行政法学研究产生的影响。最后提出本文的逻辑思路和研究方法。第一章:药品政府管制的基本理论。政府管制可以从管制目的、管制主体、管制范围和管制方式四个方面来理解。药品政府管制,就是指为了矫正药品市场失灵,维护药品市场秩序,保障社会公众用药安全、有效,获得更多的医疗保健福利,政府管制机构依法对药品的研发、生产、经营、使用的全过程进行的行政管理与监督行为。药品政府管制产生的主要原因包括:缓解信息不对称、保护适度竞争、保障公共物品的有效供给和增进非市场性价值物品的有效供给。第二章:药品政府管制的历史变迁和现状分析。从美国的药品管制历史看,政府对药品的管制趋向是范围越来越大,管制强度越来越高。面向未来,随着科学和社会的发展,公共健康的概念,以及药品安全和效用的概念都在发生变化,人们对FDA保护公共健康的角色不断进行新的思考。中国经济社会尚处于成长发展阶段,中国的药品市场发展滞后,需要扶植以促进其成熟,在中国向市场经济转轨的今天,中国药品政府管制既面临市场失灵的普遍性问题,也面临行业落后、体制障碍等特殊性问题,这决定了药品管制机构的双重角色。第三章:药品政府管制的理念重塑。传统的政府管制模式应当在公共治理理论下进行基本理念的重新塑造。为实现“良好治理”,公共治理视野下的政府管制应当融入公益性、协作性、责任性、效能性的基本理念。第四章:药品政府管制机构。比较分析了美国、英国、日本、台湾地区的药品管制机构设置模式,总结出共同的经验和规律,包括设置相对独立的管制机构、组成人员的专业化和注重行业协会的作用等。在此基础上,深入分析中国药品管制机构设置的现状和存在的问题,并从组织机构、职权配置、人力资源和经费来源四个方面提出合理的改革思路。第五章:药品政府管制的目标、范围和方式。药品的特性以及药品行业的双重属性决定了药品政府管制目标的双重性,以社会性目标为主,兼顾经济性目标。中国药品政府管制的范围和强度总体呈扩张、强化趋势,但伴随着经济转轨条件下的放松管制。现代政府管制的方式处于不断创新之中,除了传统管制方式的改造外,药品政府管制需要引入新的、更为灵活的管制方式,如信息管制、标准管制和信用管制等。而这些新的管制方式,传统行政法学对其研究匮乏。第六章:药品政府管制的运行机制。政府对药品市场的管制是一个动态的、连续的过程,管制效果是管制的实质问题和最终归宿。这就要求不仅从实体法上规定药品政府管制合法性的权限和边界,还应通过一系列运行机制规范、约束、反馈、调整管制权的行使,保证政府管制的合理性。公众参与机制、激励性管制机制、管制影响评估机制和问责机制是实现“良好”的政府管制必需的运行机制。更多还原

【Abstract】 Combining with basic theories of economics and political science, this article focuses on the Chinese drug government regulation and analyzes four problems on drug government regulation mainly from the perspective of public law. The problems are fundamental principle, regulation agency, regulation objective, regulation scope and method, operating mechanism.The preamble: beginning with several typical cases of Chinese drug regulation, it briefly analyzes current status and problems of Chinese drug regulation and points out the practical significance of researching government regulation of drug in China. Then it clarifies the rise of government regulation and its influence on administrative law research. At last, the logical thoughts and the research methods of this article are mentioned.Chapter one: basic theories about drug government regulation.Government regulation can be understood by four aspects, i.e. objective, agency, scope and method. Government regulation of drug is the lawful administration and supervision taken by regulation agency on the whole course of drug research, production, management and use with an aim to rectify market failure , maintain the order of the drug market and ensure the safety of the public. The reasons for drug regulation include relieving the problem of asymmetric information, protecting moderate competition, ensuring the effective supply of public goods and increasing the effective supply of non-market value goods. Chapter two: Historical vicissitude and current status of drug government regulation. From the American history of drug regulation, we can see that the scope of government regulation of drug is becoming larger and larger while the intensity is getting higher and higher. With the development of science and society, the concepts of public health and drug safety and effect all change. The new thought of the role which FDA plays in protecting public health is put forward. China is still in transition to market economy and drug market needs further development. The Chinese drug government regulation is faced with both universal and special problems, i.e. market failure, backward industry and system barrier. Thus the drug regulation agency has to play double roles.Chapter three: the re-creation of the fundamental principle of drug government regulation. According to the theory of public governance, the fundamental principle of traditional government regulation should be reshaped. In order to realize "good governance", the fundamental principle of public, cooperation, responsibility and efficiency should be involved.Chapter four: the agency of drug government regulation. This chapter firstly compares the organization modes of drug regulation agencies in America, Britain, Japan and Taiwan district. Then common experience and regularity are found which include relatively independent regulation agency, professional members and industry association. On the basis of this, it thoroughly analyzes the current status and problems of the organization of drug regulation agency in China. Then it proposes a reasonable reform plan by four aspects of organization, authorities, human resource and financial source.Chapter five: the objective, scope and method of drug government regulation drug. The objective of drug regulation is mainly social and also economical, which depends on the character of drug industry. The scope of the Chinese drug government regulation tends to enlarge accompanying relaxation during the economy transition. Except for refinement of traditional regulation method, we need to introduce new and flexible methods such as information regulation, standard regulation and credit regulation. Chapter six: the operating mechanisms of drug government regulation. The regulation is dynamic and continuous and the effect is the essence. To ensure the rationality of drug regulation, the agency is not only regulated by the substantial laws but also restrained by certain operating mechanisms. It is necessary to establish the operating mechanisms of public participation, invigorative regulation, regulation effect evaluation and government accountability.更多还原