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新藥價格水平規(guī)制理論研究

發(fā)布時間:2018-06-24 07:37

  本文選題:新藥 + 價格水平; 參考:《上海交通大學》2014年博士論文


【摘要】:我國藥品價格,尤其是創(chuàng)新藥品(簡稱“新藥”)價格,一直以來都是社會關注的焦點問題。一方面藥品價格不合理或存在“虛高”現(xiàn)象,成為“看病貴”主要推手,深受社會詬;另一方面,藥價虛高、新藥定價不合理,并沒有從源頭解決制藥企業(yè)研發(fā)能力提升的問題,反而低水平、淺層次的所謂研發(fā)創(chuàng)新屢見不鮮。而這兩種現(xiàn)象,又不得不同目前國內藥品定價,尤其是新藥定價不合理現(xiàn)狀相聯(lián)系?梢,如何確立科學的新藥定價管理辦法或價格水平規(guī)制方法,將是政府價格管理部門和衛(wèi)生經濟學界亟需研究的一項重要課題。 為了構建相對合理的新藥定價管理機制,建立科學的新藥價格水平規(guī)制方法,本研究從政府規(guī)制視角提出了復合型價格水平規(guī)制(Compound Price-level Regulaion)模型(簡稱CPR模型),并從四個環(huán)節(jié)去研究它。首先,探討CPR模型的研究基礎。由于新藥價格水平與研發(fā)支出之間有一定關聯(lián)性,本研究將首先探討價格水平規(guī)制下的研發(fā)支出均衡,構建生產商與經銷商的合作研發(fā)模型,從更為一般性角度探討價格規(guī)制情形下新藥生產商自主研發(fā)、經銷商主導合作研發(fā)以及完全合作研發(fā)三種情形下的研發(fā)支出均衡,從而為進一步研究CPR模型奠定基礎。第二,,CPR模型設計。本研究不僅從新藥需方角度,考慮新藥的市場需求和藥效,而且從新藥供方角度,考慮了新藥的單位可變成本,考慮新藥研發(fā)成功與否的不確定因素,并結合藥企(或新藥合作研發(fā)的供應鏈)在價格水平規(guī)制下的研發(fā)支出決策,進而推導出CPR模型。因為管理部門首先規(guī)制價格水平,處于主導者地位,藥企處于跟隨者地位,因此推導CPR模型存在兩個階段的博弈:第一階段,政府管理部門確立新藥價格水平策略;第二階段,藥企根據既定的價格水平而確定研發(fā)支出策略。同時,根據政府管理部門的選擇偏好或政策傾向不同,將分別探討患者效用最大化的CPR模型,以及社會福利最大化的CPR模型。第三,CPR模型的參數(shù)估計方法與數(shù)值模擬。介紹專家咨詢法、Gabor Granger法、最大似然估計等方法,可以對CPR模型的參數(shù)進行估計;然后,根據CPR模型的限定條件對CPR模型合理賦值,利用軟件mathematic7.0求出CPR模型的均衡解,并進行數(shù)值模擬。第四,CPR模型的配套機制設計。由于CPR模型涉及了“輸入變量”(單位可變成本)和“輸出變量”(價格水平),所以只有新藥批發(fā)價格水平范圍合理,以及新藥單位可變成本真實,CPR模型才能更為可靠。本研究針對有替代品新藥建立一次性招標機制,針對無替代品新藥建立雙邊拍賣機制,理論表明這兩個機制都能達到縮小新藥批發(fā)價格水平范圍的目的;本研究討論了“核查-更正”、“核查-罰金及停止生產”和“核查-罰金及更正”等三種懲罰機制,并建議利用“核查-罰金及更正”機制控制新藥企業(yè)的虛報成本行為。 通過新藥價格水平規(guī)制和CPR模型研究,可以得到如下結論: (一)CPR模型具有一般性、合理性、可操作性和可靠性特點,可以為新藥價格規(guī)制提供理論指導。 (二)小生產商與大經銷商合作研發(fā)模型,不僅奠定了CPR模型的研究基礎,而且該合作研發(fā)模型能夠促進系統(tǒng)利潤增加,提高研發(fā)支出水平,這對指導中小制藥企業(yè)的生產和研發(fā)有重要啟示意義。 (三)應用社會福利最大化CPR模型可以兼顧企業(yè)和患者利益,確定新藥合理價格水平,保證合理研發(fā)支出水平,抑制“偽新藥”擾亂市場作用。而且,由于我國市場上多為創(chuàng)新程度較低、價格彈性較高的新藥,所以限定甚至調低當前市場上新藥的價格,則會有助于研發(fā)支出水平的提高,促進社會福利的增加。 (四)配套機制設計具有重要啟示。招標機制設計能夠達到大大地縮小價格水平范圍的目的,而且這兩種機制都可以有效的防范或降低仿制藥、“偽新藥”的負面影響。此外,“核查-更正”機制能夠較好適用于CPR模型,“核查-罰金及更正”機制可以為控制仿制藥虛報成本提供借鑒,“核查-罰金及停止”機制可以為控制“偽新藥”虛報成本提供借鑒。
[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 .
【學位授予單位】:上海交通大學
【學位級別】:博士
【學位授予年份】:2014
【分類號】:F426.72

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