新药价格水平规制理论研究

发布时间：2018-06-24 07:37

本文选题：新药 + 价格水平　；参考：《上海交通大学》2014年博士论文

【摘要】：我国药品价格，尤其是创新药品（简称“新药”）价格，一直以来都是社会关注的焦点问题。一方面药品价格不合理或存在“虚高”现象，成为“看病贵”主要推手，深受社会诟病；另一方面，药价虚高、新药定价不合理，并没有从源头解决制药企业研发能力提升的问题，反而低水平、浅层次的所谓研发创新屡见不鲜。而这两种现象，又不得不同目前国内药品定价，尤其是新药定价不合理现状相联系。可见，如何确立科学的新药定价管理办法或价格水平规制方法，将是政府价格管理部门和卫生经济学界亟需研究的一项重要课题。为了构建相对合理的新药定价管理机制，建立科学的新药价格水平规制方法，本研究从政府规制视角提出了复合型价格水平规制（Compound Price-level Regulaion）模型（简称CPR模型），并从四个环节去研究它。首先，探讨CPR模型的研究基础。由于新药价格水平与研发支出之间有一定关联性，本研究将首先探讨价格水平规制下的研发支出均衡，构建生产商与经销商的合作研发模型，从更为一般性角度探讨价格规制情形下新药生产商自主研发、经销商主导合作研发以及完全合作研发三种情形下的研发支出均衡，从而为进一步研究CPR模型奠定基础。第二，，CPR模型设计。本研究不仅从新药需方角度，考虑新药的市场需求和药效，而且从新药供方角度，考虑了新药的单位可变成本，考虑新药研发成功与否的不确定因素，并结合药企（或新药合作研发的供应链）在价格水平规制下的研发支出决策，进而推导出CPR模型。因为管理部门首先规制价格水平，处于主导者地位，药企处于跟随者地位，因此推导CPR模型存在两个阶段的博弈：第一阶段，政府管理部门确立新药价格水平策略；第二阶段，药企根据既定的价格水平而确定研发支出策略。同时，根据政府管理部门的选择偏好或政策倾向不同，将分别探讨患者效用最大化的CPR模型，以及社会福利最大化的CPR模型。第三，CPR模型的参数估计方法与数值模拟。介绍专家咨询法、Gabor Granger法、最大似然估计等方法，可以对CPR模型的参数进行估计；然后，根据CPR模型的限定条件对CPR模型合理赋值，利用软件mathematic7.0求出CPR模型的均衡解，并进行数值模拟。第四，CPR模型的配套机制设计。由于CPR模型涉及了“输入变量”（单位可变成本）和“输出变量”（价格水平），所以只有新药批发价格水平范围合理，以及新药单位可变成本真实，CPR模型才能更为可靠。本研究针对有替代品新药建立一次性招标机制，针对无替代品新药建立双边拍卖机制，理论表明这两个机制都能达到缩小新药批发价格水平范围的目的；本研究讨论了“核查-更正”、“核查-罚金及停止生产”和“核查-罚金及更正”等三种惩罚机制，并建议利用“核查-罚金及更正”机制控制新药企业的虚报成本行为。通过新药价格水平规制和CPR模型研究，可以得到如下结论：（一）CPR模型具有一般性、合理性、可操作性和可靠性特点，可以为新药价格规制提供理论指导。（二）小生产商与大经销商合作研发模型，不仅奠定了CPR模型的研究基础，而且该合作研发模型能够促进系统利润增加，提高研发支出水平，这对指导中小制药企业的生产和研发有重要启示意义。（三）应用社会福利最大化CPR模型可以兼顾企业和患者利益，确定新药合理价格水平，保证合理研发支出水平，抑制“伪新药”扰乱市场作用。而且，由于我国市场上多为创新程度较低、价格弹性较高的新药，所以限定甚至调低当前市场上新药的价格，则会有助于研发支出水平的提高，促进社会福利的增加。（四）配套机制设计具有重要启示。招标机制设计能够达到大大地缩小价格水平范围的目的，而且这两种机制都可以有效的防范或降低仿制药、“伪新药”的负面影响。此外，“核查-更正”机制能够较好适用于CPR模型，“核查-罚金及更正”机制可以为控制仿制药虚报成本提供借鉴，“核查-罚金及停止”机制可以为控制“伪新药”虚报成本提供借鉴。
[Abstract]:The price of Chinese medicines , especially innovative drugs ( " new drugs " ) , has always been the focus of social concern . On the one hand , the price of drugs is unreasonable or the phenomenon of " deficiency and high " has become the main driver of " watching the disease " and is deeply criticized by the society ;
On the other hand , the price of drugs is high , the pricing of new drugs is unreasonable , and it does not solve the problem of improving R & D capacity of pharmaceutical enterprises from the source , but the so - called R & D innovation at low level and shallow level is not uncommon . It can be seen that how to establish scientific new drug pricing management method or price level regulation method will be an important subject in government price management and health economics .

In order to build a relatively reasonable pricing management mechanism of new drugs and to establish a scientific and new drug price level regulation method , this paper puts forward the compound price - level Regulaion model ( CPR model ) from the perspective of government regulation .
In the second stage , the policy of R & D expenditure is determined according to the established price level . At the same time , according to the choice preference or policy orientation of the government management department , the CPR model with maximum utility maximization and the CPR model of maximum social welfare will be discussed .
Then , according to the defined conditions of the CPR model , the equilibrium solution of the CPR model is calculated and the equilibrium solution of the CPR model is obtained by software programming 7.0 , and the numerical simulation is carried out . The CPR model is reasonable in price level , and the CPR model can be more reliable . As the CPR model involves the establishment of a one - time bidding mechanism for the replacement of new drugs , and the establishment of a bilateral auction mechanism for the new drug - free drug , the theory shows that both mechanisms can achieve the aim of reducing the wholesale price level of the new drug .
This study discusses three kinds of punishment mechanisms , such as " Verification - Correction " , " Verification - Penalty and Stop Production " and " Verification - Penalty and Correction " , and suggests that the " verification - penalty and correction " mechanism should be used to control the fictitious cost behavior of new drug enterprises .

The following conclusions can be obtained through the new drug price level regulation and the CPR model research :

( 1 ) The CPR model has the characteristics of generality , rationality , operability and reliability , which can provide theoretical guidance for the regulation of the new drug price .

( 2 ) The cooperative R & D model of small producers and large dealers not only establishes the research foundation of the CPR model , but also can promote the increase of the system profit and improve the level of R & D expenditure , which has important implications for guiding the production and development of small pharmaceutical enterprises .

( 3 ) Applying social welfare maximization CPR model can take into account the interests of enterprises and patients , determine the reasonable price level of new drugs , guarantee reasonable R & D expenditure level , and restrain " pseudo - new drugs " from disturbing the market . Moreover , as the market of our country is a new drug with lower innovation and higher price elasticity , it will help to increase the level of R & D expenditure and promote the increase of social welfare .

( 4 ) The design of matching mechanism has important enlightenment . The design of bidding mechanism can reduce the price level greatly , and both mechanisms can effectively prevent or reduce the negative effects of generic drugs and " pseudo - new drugs " . In addition , the " verification - correction " mechanism can be applied to the CPR model , and the " verification - penalty and correction " mechanism can provide reference for the control of the cost of fake drugs .
【学位授予单位】：上海交通大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：F426.72

【参考文献】