我国药品产业政府规制研究
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摘要
药品产业在世界各国都被实施严格的政府规制,发达国家通过对药品产业进行社会性规制,不仅确保了产品安全和有效,切实保障了公众用药健康和生命权益,改善了药品市场信息高度不对称状态,同时形成了鼓励和促进药品产业创新激励机制的制度性安排。通过政府有形之手和市场机制无形之手的合力作用,发达国家药品市场不仅走出了假药泛滥和产业危机的境地,而且成为世界型制药企业并占据了世界医药市场的重要版图。相比于发达国家,我国政府对药品产业规制时间短、经验欠缺、理论缺乏指导,在促使我国药品市场繁荣兴旺的同时也埋下了严重的隐患,如药品市场结构不合理导致药品产业处于较低的发展阶段,产业结构升级和优化难以实施;创新能力差导致我国制药企业无法参与附加值较高的国际制剂市场;规模不经济导致我国药品市场处于较低的利润率或亏损边缘。这是因为传统药品产业规制研究多是沿着单一的社会性规制思路,这与发达国家政府规制的模式具有一定关系。然而在转型期的我国,现阶段药品产业政府规制的研究如果还停留在单一的社会性规制的路径上,很可能无法达到我国制定的产业发展目标。因此本文对药品产业政府规制研究采用了双重规制的思路,即对产业实施社会性规制同时必须强化经济性规制,加强对药品产业的进入规制和价格规制,促进药品产业资源配置效率向帕累托最优效率的趋近。
本文以我国药品产业政府规制为核心展开论述。采用规范分析、比较分析等方法,遵循从理论到实践、从一般到特殊、从静态到动态的研究思路,对我国药品产业政府规制进行了系统、全面地分析研究。研究框架结构分为八个部分,第一章是导论,主要是介绍了论文的研究背景、研究意义、研究对象和方法,研究思路和研究框架,以及论文的拟创新之处。第二章首先对政府规制研究进行了文献综述,主要包括对国内外政府规制领域相关研究成果和药品产业政府规制相关研究的综述,同时对已有文献作了评价。在第三章建立了药品产业政府规制的理论研究框架。厘清了药品产业的概念、特征和属性,在此基础上展开对药品产业政府规制的需求和供给分析,通过分析研究探寻政府规制的客观必要性和可行性,以及药品产业政府规制的特征和规制内容,并从成本收益角度考察了药品产业政府规制的绩效。第四章是药品产业政府规制的背景考察:基于SCP的分析。运用产业经济学的结构—行为—绩效(SCP)范式分析了我国药品产业的现状,进而为研究药品产业的政府规制奠定了背景基础。第五章是发达国家与我国药品产业政府规制比较,对发达国家与我国药品产业的进入规制、价格规制、信息规制和质量规制进行了比较分析。通过比较不仅明晰了我国药品产业政府规制存在的主要问题,同时也为我国规制改革给予了启示。第六章是在前文基础上论述我国药品产业政府规制的动态变迁与存在问题,研究了我国药品产业政府规制的历史沿革,分析了我国药品产业规制存在问题和成因。第七章提出我国药品产业政府规制改革的思路建议和解决对策,针对我国药品产业规制存在的问题提出了相应对策,并且对我国药品产业政府规制的配套性改革进行了研究。第八章是本文的研究结论及研究展望,总结了本文主要结论,并对以后的研究方向进行了展望。
Pharmaceutical industries in the countries around the world have been implementing strict government regulation. Most developed countries have implemented social regulation on pharmaceutical industries, not only to ensure the product safe and effective, protect the interests of public health and life, but also improve market information on the non-pharmaceutical symmetric state, and encourage and facilitate the innovation incentives of the pharmaceutical industry. Through the visible hand of government and the invisible hand of market mechanism, the developed countries not only get out of the counterfeit drugs flooding the market, but also become the world-based pharmaceutical company, and have accounted for an important map of the world pharmaceutical market. Compared with developed countries, the time of Chinese government on the pharmaceutical industry regulation is short and lack of experience. As the prosperity of China's pharmaceutical market, there also are some serious hidden dangers, such as the irrational structure of the pharmaceutical market, which make it difficult to upgrade and optimize the industrial structure. The low innovation capability of pharmaceutical companies makes it unable to participate in international preparations market. The diseconomies scale of China's pharmaceutical lead to lower profitability and losses. This is because the traditional view of pharmaceutical industry regulation is mostly along a single idea of social regulation, which is work well in developed countries. However, in the transition period our country, government regulation of pharmaceutical industry is not only social regulation, it may not be able to achieve our goal on industrial development. Therefore, this article explores the dual regulatory system of government regulation, not only strengthen the social regulation, but also strengthen the economic regulation. The economic regutlaiton includes the access regulation and price regulation, and promote the pharmaceutical industry to the Pareto efficiency of resource allocation.
In this paper, we use the government regulation of China's pharmaceutical industry as key discussion and use methods of normative analysis, comparative analysis, and general to specific iedas, static to dynamic ideas, systematic and comprehensive analysis. This paper can bee is divided into eight parts. The first chapter is the introduction. In ths part we introduce the research background, research significance, research object and methods, research ideas and research framework, as well as papers innovations. Chapter II is the literature review of government regulation. In this part, firstly, we have conducted literature review of domestic and foreign government regulation; secondly, we have conducted literature review of domestic and foreign government regulation on pharmaceutical industry; thirdly, we give some comments on the related literature. Chapter III is the theoretical research framework of government regulation on pharmaceutical industry. In the part, we firstly clarify the concept, characteristics and attributes of the pharmaceutical industry; secondly, we have explore the demand and supply of government regulation on pharmaceutical industry; thirdly, we analyze the objective and content of government regulation on pharmaceutical industry; at last, we explore the cost-benefit performance of government regulation on pharmaceutical industry. Chapter IV is background of government regulation whcich based on the analysis of SCP. In the part, we use of the structure - conduct - performance (SCP) paradigm to analyze the status of China's pharmaceutical industry, and has laid a background to government regulation. Chapter V is the comparison between China's government regulation on pharmaceutical industry and developed countries's government regulation on pharmaceutical industry, which includes the entry regulation, price regulation, information regulation and quality regulation. Chapter VI is the dynamics history of China's pharmaceutical industry and the problems of China's government regulation on pharmaceutical industry. Chapter VII is the countermeasure of China's government regulation on pharmaceutical industry, and includes the social regulation, economic regulation and the supporting reform. Chapter VIII is the conclusions of this research and research prospects, summarizes the main conclusions of this article, and future research directions.
本文以我国药品产业政府规制为核心展开论述。采用规范分析、比较分析等方法,遵循从理论到实践、从一般到特殊、从静态到动态的研究思路,对我国药品产业政府规制进行了系统、全面地分析研究。研究框架结构分为八个部分,第一章是导论,主要是介绍了论文的研究背景、研究意义、研究对象和方法,研究思路和研究框架,以及论文的拟创新之处。第二章首先对政府规制研究进行了文献综述,主要包括对国内外政府规制领域相关研究成果和药品产业政府规制相关研究的综述,同时对已有文献作了评价。在第三章建立了药品产业政府规制的理论研究框架。厘清了药品产业的概念、特征和属性,在此基础上展开对药品产业政府规制的需求和供给分析,通过分析研究探寻政府规制的客观必要性和可行性,以及药品产业政府规制的特征和规制内容,并从成本收益角度考察了药品产业政府规制的绩效。第四章是药品产业政府规制的背景考察:基于SCP的分析。运用产业经济学的结构—行为—绩效(SCP)范式分析了我国药品产业的现状,进而为研究药品产业的政府规制奠定了背景基础。第五章是发达国家与我国药品产业政府规制比较,对发达国家与我国药品产业的进入规制、价格规制、信息规制和质量规制进行了比较分析。通过比较不仅明晰了我国药品产业政府规制存在的主要问题,同时也为我国规制改革给予了启示。第六章是在前文基础上论述我国药品产业政府规制的动态变迁与存在问题,研究了我国药品产业政府规制的历史沿革,分析了我国药品产业规制存在问题和成因。第七章提出我国药品产业政府规制改革的思路建议和解决对策,针对我国药品产业规制存在的问题提出了相应对策,并且对我国药品产业政府规制的配套性改革进行了研究。第八章是本文的研究结论及研究展望,总结了本文主要结论,并对以后的研究方向进行了展望。
Pharmaceutical industries in the countries around the world have been implementing strict government regulation. Most developed countries have implemented social regulation on pharmaceutical industries, not only to ensure the product safe and effective, protect the interests of public health and life, but also improve market information on the non-pharmaceutical symmetric state, and encourage and facilitate the innovation incentives of the pharmaceutical industry. Through the visible hand of government and the invisible hand of market mechanism, the developed countries not only get out of the counterfeit drugs flooding the market, but also become the world-based pharmaceutical company, and have accounted for an important map of the world pharmaceutical market. Compared with developed countries, the time of Chinese government on the pharmaceutical industry regulation is short and lack of experience. As the prosperity of China's pharmaceutical market, there also are some serious hidden dangers, such as the irrational structure of the pharmaceutical market, which make it difficult to upgrade and optimize the industrial structure. The low innovation capability of pharmaceutical companies makes it unable to participate in international preparations market. The diseconomies scale of China's pharmaceutical lead to lower profitability and losses. This is because the traditional view of pharmaceutical industry regulation is mostly along a single idea of social regulation, which is work well in developed countries. However, in the transition period our country, government regulation of pharmaceutical industry is not only social regulation, it may not be able to achieve our goal on industrial development. Therefore, this article explores the dual regulatory system of government regulation, not only strengthen the social regulation, but also strengthen the economic regulation. The economic regutlaiton includes the access regulation and price regulation, and promote the pharmaceutical industry to the Pareto efficiency of resource allocation.
In this paper, we use the government regulation of China's pharmaceutical industry as key discussion and use methods of normative analysis, comparative analysis, and general to specific iedas, static to dynamic ideas, systematic and comprehensive analysis. This paper can bee is divided into eight parts. The first chapter is the introduction. In ths part we introduce the research background, research significance, research object and methods, research ideas and research framework, as well as papers innovations. Chapter II is the literature review of government regulation. In this part, firstly, we have conducted literature review of domestic and foreign government regulation; secondly, we have conducted literature review of domestic and foreign government regulation on pharmaceutical industry; thirdly, we give some comments on the related literature. Chapter III is the theoretical research framework of government regulation on pharmaceutical industry. In the part, we firstly clarify the concept, characteristics and attributes of the pharmaceutical industry; secondly, we have explore the demand and supply of government regulation on pharmaceutical industry; thirdly, we analyze the objective and content of government regulation on pharmaceutical industry; at last, we explore the cost-benefit performance of government regulation on pharmaceutical industry. Chapter IV is background of government regulation whcich based on the analysis of SCP. In the part, we use of the structure - conduct - performance (SCP) paradigm to analyze the status of China's pharmaceutical industry, and has laid a background to government regulation. Chapter V is the comparison between China's government regulation on pharmaceutical industry and developed countries's government regulation on pharmaceutical industry, which includes the entry regulation, price regulation, information regulation and quality regulation. Chapter VI is the dynamics history of China's pharmaceutical industry and the problems of China's government regulation on pharmaceutical industry. Chapter VII is the countermeasure of China's government regulation on pharmaceutical industry, and includes the social regulation, economic regulation and the supporting reform. Chapter VIII is the conclusions of this research and research prospects, summarizes the main conclusions of this article, and future research directions.
引文
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