基于定性比较分析的政府新药政策研究

发布时间：2019-06-12 19:05

【摘要】：我国医药市场总量居于全球第三位，但新药创制能力远远落后于欧美制药强国甚至印度。想要增强我国的药物创新能力，仅仅依靠制药企业是远远不够的。由于医药市场存在着市场失灵现象，就需要政府制定政策适度干预和辅助新药研制活动。具体来说，政府应该在新药研发的各个环节建立科学有效的新药政策，为新药从研发、注册审批到最终上市整个过程提供激励与保障，从而营造利于药物创新活动的政策软环境。本文首先分析医药市场的特征来论证政府制定政策辅助药物创新的必要性，在厘清药物创新活动各阶段特点的基础上，总结出能够对药物创新产生激励和保障效果的政府新药政策包括政府投入政策、注册审批政策、定价政策与专利保护政策并提出本文假设。之后，按照特定标准选定30个国家作为样本，确定关键影响因素并进行赋值，运用定性比较分析方法（QCA），分析制药强国的药物创新能力与其所采用的新药政策及组合类型的逻辑关系。根据软件运行的结果，对各类新药政策的特点与激励效果进行分析和评价，以此得出与我国国情和医药产业发展规律相适应的政府新药政策类型并就相关政策的改进方向提出建议。本文得出的具体结论包括：第一，严格的注册审批与强力度的专利保护是增强药物创新能力的必要条件。第二，新药投入政策的类型、定价政策类型与一国药物创新能力无正相关关系。我国进行新药投入和定价政策类型的选择上应遵循由政府主导逐步过渡到企业主导的模式，，最终由企业担当药物创新活动的主体。因此，最终确定政府主导新药投入的投入政策、与国际标准一致的注册审批政策、企业自主定价的定价政策和强力度的专利保护政策是我国为鼓励药物创新而应当实行的政府新药政策类型。
[Abstract]:China's medical market is in the third place in the world, but the new drug creation ability is far behind the European and American pharmaceutical powers and even India. It is not enough to rely on pharmaceutical enterprises to enhance our drug innovation ability. Due to the market failure in the medical market, it is necessary for the government to develop the policy of moderate intervention and the development of the new drug. In particular, the government should set up a scientific and effective new drug policy in all aspects of the R & D of new drugs, and provide incentives and guarantees for new drugs from R & D, registration and approval to the whole process of the final listing, so as to create a policy soft environment conducive to drug innovation activities. This paper first analyzes the characteristics of the medical market to demonstrate the necessity of the government to develop the policy-assisted drug innovation. On the basis of clarifying the characteristics of the various stages of the drug innovation activity, the government's new drug policy, including the government's input and administration, is summarized. Policy, registration and approval policy, pricing policy and patent protection policy and making this paper false After that,30 countries are selected as the sample according to the specific criteria, the key influencing factors are determined and assigned, and the qualitative comparative analysis method (QCA) is used to analyze the drug innovation ability of the pharmaceutical power and the new drug policy and the combination type of the combination type. Based on the results of the software operation, the characteristics and the incentive effect of various new drug policies are analyzed and evaluated, so as to obtain the new type of new drug policy which is compatible with the national conditions and the development law of the pharmaceutical industry, and put forward the construction of the improvement of the related policies. The conclusion of this paper is that the patent protection of the first, the strict registration and approval and the strong strength is the necessary to enhance the innovation ability of the drug Conditions. Second, the type of new drug investment policy, the type of pricing policy and the non-positive phase of a country's drug innovation ability The choice of the type of new drug input and pricing policy in China should follow the mode of gradual transition from the government to the enterprise-led mode, and finally the enterprise will act as the drug innovation activity. Therefore, the government's investment policy of leading the new drug investment, the registration and approval policy in line with the international standard, the pricing policy of the self-pricing of the enterprise and the patent protection policy of the strong strength are the government new drug administration that our country should implement to encourage drug innovation
【学位授予单位】：哈尔滨工业大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72

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