【作者】 刘素坤；

【导师】 王俊豪；

【作者基本信息】 东北财经大学 ， 规制经济学， 2013， 博士

【摘要】 制药产业是典型的依靠技术创新驱动的高技术产业。制药强国的新药研发强度基本上在15%以上,全球100强的制药企业也几乎都是研发型企业,这些企业仅依靠少数的“重磅炸弹”级药物就能够获得垄断性的市场份额和高额的利润。然而中国制药产业的发展现状却非如此,甚至是违背了制药产业发展的特征：一方面,制药产业技术创新投入较低,不仅远远低于国际制药产业技术创新投入强度,还低于国内高技术产业技术创新投入平均水平；另一方面,制药产业技术创新产出数量可观,国家食品药品监督管理局每年都会批准几百、几千种“新药”,而实际上这些新药的创新程度并不高。目前,中国的实际国情需要制药企业不断的进行技术创新。中国在构建创新型国家,以及制药产业发展政策都积极引导企业进行技术创新；中国社会保障制度的不断完善,人口增加,社会老龄化等因素增加了药品市场需求；除此之外,随着社会经济发展,社会对新药的需求,也促使企业进行技术创新。因此,研究制药企业技术创新问题具有很强的实践意义和价值：有助于发现中国医药产业技术创新能力的不足之处,通过对中国医药产业技术创新现状的研究,挖掘其中存在的问题,了解制药产业技术创新的不足是提出解决问题的措施和建议的前提；有利于推动中国制药产业的发展,实现由制药大国向制药强国的转变。企业的内部因素和企业外部因素共同决定了企业的技术创新活动,本文主要研究技术创新的企业外部因素中最直接影响企业技术创新的新药规制和专利保护作为本文的研究对象。本文主要研究以新药研发为目的的技术创新活动,研究新药规制和专利保护两个方面对制药产业技术创新的激励作用,以及提出基于这两个方面的激励制药产业技术创新的政策措施。本文主要研究内容如下：一、研究中国制药产业技术创新的现状及问题。本部分内容在分析制药产业技术创新的特征的基础上,利用产业数据,从国内外角度和横向纵向维度,分析中国制药产业的技术创新投入(研究经费和研发人员)和产出(专利和新药)的现状,以及存在的问题。研究结果表明,中国制药产业技术创新投入严重不足,与之不匹配的是SFDA批准的新药数量较大。二、研究中国新药规制对制药产业技术创新激励作用。本部分内容首先研究了中国新药规制的历史演变过程及现状,为后续分析提供制度背景。然后,分析政府新药规制对企业技术创新投资决策的影响.。最后,在理论分析的基础上,利用2005-2011年省级面板数据,验证新药规制对制药产业技术创新的激励效果。计量结果表明,在中国比较宽松的新药规制情况下,新药规制与对制药产业技术创新投入呈负相关关系。因此,为了提高中国制药产业技术创新程度,促进企业加大技术创新投入力度,政府应提高药品注册审批的标准,设计科学的、合理的药品定价制度。三、研究药品专利制度对制药产业技术创新的激励作用。本部分内容首先研究了中国专利制度历史演变的过程,同时,分析中国药品专利制度的改革历史。然后,在借鉴前人的最优专利模型的基础上分析药品最优专利设计对技术创新的影响。再次,本文构建了含有立法强度与执法强度的药品专利保护强度测算新指标体系,并测算了中国1995-2011年药品专利保护强度以及2002—2011年各省的药品专利保护强度。最后,在此基础上,本部分通过数据检验中国药品专利保护对制药企业技术创新投入激励效果,计量结果显示：中国药品专利保护对技术创新投入的非线性关系显著,但是不存在门槛效应,即加强药品专利保护仍然是激励企业技术创新投入的有效手段。四、优化中国制药产业技术创新激励机制。本部分主要从新药规制和专利制度角度出发,研究优化激励中国制药产业技术创新的政策建议。本部分以原创药品生命周期为依据,分析制药企业研发预期收益,得出影响企业研发收益的主要因素是药品专利有效保护期限、新药的价格、新药销售产量等。本部分以增加企业研发收益为目的,结合药品研发上市过程中的政府规制政策和前几章的分析结论,提出从药品专利制度、药品的注册审批和药品定价制度以及新药规制和专利制度之间协调的角度激励企业增加技术创新投入的政策建议。相比已有研究成果,本文可能的创新之处主要表现为以下三个方面：(1)为研究中国制药产业技术创新活动提供新的研究视角。本文研究新药规制(药品注册管理、药品定价)以及药品专利保护对制药企业技术创新投入的影响,克服了以往只是片面研究其中一方面因素对制药产业技术创新的影响的不足。(2)构建了药品专利保护强度新指标体系。在前人研究基础上,结合中国经济发展转型期特征,修正国外只注重专利立法强度的评价指标体系,构建了既涵盖立法强度又包括执法强度指标的药品专利保护强度新指标体系。(3)提出优化中国制药产业技术激励机制的政策建议。本文以药品研发为主线,分析药品研发过程中的政府规制和药品专利以及他们对企业研发收益的影响。此基础上,提出减少无谓时间损失、优化定价策略、加强政府规制等角度出发构建了激励制药企业技术创新的政策体系。更多还原

【Abstract】 Pharmaceutical industry is an typical innovation-oriented high technique industry.R&D intensity is generally more than15%in developed pharmaceutical countries, and the leading pharmaceutical firms are almost R&D-oriented firms.Depend on technical innovation and intellectual property rights protection system, R&D-oriented pharmaceutical firms take up most market share and earn monopoly profit even by limited "blockbuster medicine".However, this was not the case of development in China pharmaceutical industry.To some extent, even against some base rules of the pharmaceutical industry:on the one hand, the investment of technology innovation is low, not only far lower than the average level of R&D in the international pharmaceutical industry, but also lower than the average level in domestic high technology industry technology innovation input; on the other hand, the State Food and Drug Administration approves hundreds of "new drug" every year, many of them are low-tech drug.At present, the actual national conditions need the pharmaceutical firms engage in technical innovation in China. On one hand the Chinese government is constructing innovation-oriented country. So the as well as the pharmaceutical industry development policies actively guide enterprise to carry out technical innovation. On the other hand, the improvement of the social security system, population increase, the social aging increases the drug market demand; In addition, along with the social economic development, social demand for new drugs, has also encouraged companies to carry out technological innovation. Research on the pharmaceutical enterprise technology innovation has a strong practical significance and value:on the one hand, this study will help to find the deficiency of China pharmaceutical industry technology innovation ability, so puts forward the measures and Suggestions to solve the problem;on the other hand, this study will is also beneficial to promote the development of China pharmaceutical industry.The internal and external factors of firms decide the enterprise’s technology innovation activities. Because new drug regulation and patent protection most directly impact on the benefits of firms technology innovation, this paper selected the two external factors of technology innovation protection as the research object.This paper mainly research on the new drugs research and development for the purpose of technical innovation activities, and research on incentive effect of the two aspects of research new drug regulation and patent protection of pharmaceutical industry technical innovation, and put forward policy measures which based on the two aspects of new drug regulation and patent protection to encourage pharmaceutical industry technical innovation.The main research contents of this paper including:1. Analyze the problems and the basic situation of China pharmaceutical industry technical innovation.This part of the paper analyzes the characteristics of technological innovation in the pharmaceutical industry, and use the industry data, from two dimensions which are not only the home and abroad dimension but also the horizontal and longitudinal dimension analyzes China pharmaceutical industry technical innovation investment (research funding and research and development personnel) and output (patent and the current situation of new drugs), as well as the existing problems. The research results show that China’s pharmaceutical industry technical innovation investment is serious insufficient, which does not match up to the quantity and large scale of new drugs.2. Study the innovation incentive of China drug regulation on pharmaceutical industry technology.Firstly, this part studies the historical evolution process and situation of China drug regulation, which provided institutional background for subsequent analysis. Then, this part analyzes the government new drug regulation effects on investment decisions of enterprise technical innovation. On the basis of theoretical analysis, and use the provincial panel data from2005to2011, this part verifies incentive effect of the new regulation on the pharmaceutical industry technical innovation. The results show that under the condition of China, if relaxing the drug regulation, new drug regulation is negatively related to pharmaceutical industry technical innovation investment. Therefore, in order to improve the technical innovation level of China pharmaceutical industry and promote the firms to enhance investment in technological innovation, the government should raise the standards of drug registration for examination, approval, design scientific and reasonable drug price system.3. Research the innovation incentive of China’s drug patent system on pharmaceutical industry technology.Firstly, this part studies historical evolution process of China’s patent system, analyzes the history of the China’s drug patent system reform. Secondly, on the basis of the optimal patent model, this paper analyzes optimal drug patent design influence on technical innovation. Thirdly, this article innovatively build a new index system of drug patent protection which contains legislation index and law enforcement index, and calculate the strength of the China drug patent protection in1995-2011and provincial drug patent protection strength in2002-2011.Finally, this paper uses the method of measurement test the innovation incentive of China’s drug patent system on pharmaceutical industry technology. The research results show that the relationship between the China’s drug patent protection and technical innovation investment is non-linear, but there is no threshold effect. Namely strengthening drug patent protection is still the effective means to encourage enterprise technical innovation input.4. Improve the technical innovation incentive mechanism of China pharmaceutical industry.This part mainly research the technical innovation incentive mechanism of China pharmaceutical industry from the angle of new drug regulation and patent system.This part analyzes the cost and forecast that earnings of research and development of pharmaceutical enterprise forecast earnings, based on original drug lifecycle, we get the conclusion that the main factors that are influencing the enterprise research and development gains is the drug patent protection period, sales of drugs price, the new production, etc. In order to increase the enterprise research and development of earnings, combined with the listed drug research and development in the process of government regulation policy and the analysis of previous chapters, this part put forward some policy recommendations to encourage companies to increase technical innovation investment from the drug patent system, drug registration and drug pricing system, and the coordination between new drugs regulation and patent system. Based on the existing research results, the possible innovations of this article are as follows:First, the study provides a new perspective for the research on China pharmaceutical industry technical innovation activities. Based on new drug research and development process for the analysis of the main line, this paper studies the drug registration management, drug pricing and drug patent protection on the influence of the pharmaceutical enterprise technical innovation investment, overcome the previous studies just unilateral one impact on the pharmaceutical industry technical innovation.Second, this article innovatively builds a new index system of drug patent protection strength. On the basis of predecessors’ research, this article innovatively builds a new index system of drug patent protection which contains legislation index and law enforcement index. This make patent protection more objectively quantitative evaluation of drug patent system, not only provides a scientific objective basis for drug patent system economics, empirical research, but also in order to strengthen drug patent protection indicates the operational direction.Third, the study put forward a new perspective for improving incentive mechanism on China pharmaceutical industry technical innovation activities. Based on drug research and development as the main line, this paper analyzes the impact of government regulation and drug patent system on enterprise research and development benefit. And based on the above analysis, this paper puts forward some policy recommendations to optimize the technical innovation incentive mechanism of China pharmaceutical industry.更多还原