本文選題：新藥 + 價(jià)格水平�。� 參考：《上海交通大學(xué)》2014年博士論文

【摘要】：我國(guó)藥品價(jià)格，尤其是創(chuàng)新藥品（簡(jiǎn)稱“新藥”）價(jià)格，一直以來都是社會(huì)關(guān)注的焦點(diǎn)問題。一方面藥品價(jià)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(huì)詬病；另一方面，藥價(jià)虛高、新藥定價(jià)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(guó)內(nèi)藥品定價(jià)，尤其是新藥定價(jià)不合理現(xiàn)狀相聯(lián)系。可見，如何確立科學(xué)的新藥定價(jià)管理辦法或價(jià)格水平規(guī)制方法，將是政府價(jià)格管理部門和衛(wèi)生經(jīng)濟(jì)學(xué)界亟需研究的一項(xiàng)重要課題。 為了構(gòu)建相對(duì)合理的新藥定價(jià)管理機(jī)制，建立科學(xué)的新藥價(jià)格水平規(guī)制方法，本研究從政府規(guī)制視角提出了復(fù)合型價(jià)格水平規(guī)制（Compound Price-level Regulaion）模型（簡(jiǎn)稱CPR模型），并從四個(gè)環(huán)節(jié)去研究它。首先，探討CPR模型的研究基礎(chǔ)。由于新藥價(jià)格水平與研發(fā)支出之間有一定關(guān)聯(lián)性，本研究將首先探討價(jià)格水平規(guī)制下的研發(fā)支出均衡，構(gòu)建生產(chǎn)商與經(jīng)銷商的合作研發(fā)模型，從更為一般性角度探討價(jià)格規(guī)制情形下新藥生產(chǎn)商自主研發(fā)、經(jīng)銷商主導(dǎo)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(jìn)一步研究CPR模型奠定基礎(chǔ)。第二，，CPR模型設(shè)計(jì)。本研究不僅從新藥需方角度，考慮新藥的市場(chǎng)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(jié)合藥企（或新藥合作研發(fā)的供應(yīng)鏈）在價(jià)格水平規(guī)制下的研發(fā)支出決策，進(jìn)而推導(dǎo)出CPR模型。因?yàn)楣芾聿块T首先規(guī)制價(jià)格水平，處于主導(dǎo)者地位，藥企處于跟隨者地位，因此推導(dǎo)CPR模型存在兩個(gè)階段的博弈：第一階段，政府管理部門確立新藥價(jià)格水平策略；第二階段，藥企根據(jù)既定的價(jià)格水平而確定研發(fā)支出策略。同時(shí)，根據(jù)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(huì)福利最大化的CPR模型。第三，CPR模型的參數(shù)估計(jì)方法與數(shù)值模擬。介紹專家咨詢法、Gabor Granger法、最大似然估計(jì)等方法，可以對(duì)CPR模型的參數(shù)進(jìn)行估計(jì)；然后，根據(jù)CPR模型的限定條件對(duì)CPR模型合理賦值，利用軟件mathematic7.0求出CPR模型的均衡解，并進(jìn)行數(shù)值模擬。第四，CPR模型的配套機(jī)制設(shè)計(jì)。由于CPR模型涉及了“輸入變量”（單位可變成本）和“輸出變量”（價(jià)格水平），所以只有新藥批發(fā)價(jià)格水平范圍合理，以及新藥單位可變成本真實(shí)，CPR模型才能更為可靠。本研究針對(duì)有替代品新藥建立一次性招標(biāo)機(jī)制，針對(duì)無替代品新藥建立雙邊拍賣機(jī)制，理論表明這兩個(gè)機(jī)制都能達(dá)到縮小新藥批發(fā)價(jià)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(chǎn)”和“核查-罰金及更正”等三種懲罰機(jī)制，并建議利用“核查-罰金及更正”機(jī)制控制新藥企業(yè)的虛報(bào)成本行為。 通過新藥價(jià)格水平規(guī)制和CPR模型研究，可以得到如下結(jié)論： （一）CPR模型具有一般性、合理性、可操作性和可靠性特點(diǎn)，可以為新藥價(jià)格規(guī)制提供理論指導(dǎo)。 （二）小生產(chǎn)商與大經(jīng)銷商合作研發(fā)模型，不僅奠定了CPR模型的研究基礎(chǔ)，而且該合作研發(fā)模型能夠促進(jìn)系統(tǒng)利潤(rùn)增加，提高研發(fā)支出水平，這對(duì)指導(dǎo)中小制藥企業(yè)的生產(chǎn)和研發(fā)有重要啟示意義。 （三）應(yīng)用社會(huì)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(jià)格水平，保證合理研發(fā)支出水平，抑制“偽新藥”擾亂市場(chǎng)作用。而且，由于我國(guó)市場(chǎng)上多為創(chuàng)新程度較低、價(jià)格彈性較高的新藥，所以限定甚至調(diào)低當(dāng)前市場(chǎng)上新藥的價(jià)格，則會(huì)有助于研發(fā)支出水平的提高，促進(jìn)社會(huì)福利的增加。 （四）配套機(jī)制設(shè)計(jì)具有重要啟示。招標(biāo)機(jī)制設(shè)計(jì)能夠達(dá)到大大地縮小價(jià)格水平范圍的目的，而且這兩種機(jī)制都可以有效的防范或降低仿制藥、“偽新藥”的負(fù)面影響。此外，“核查-更正”機(jī)制能夠較好適用于CPR模型，“核查-罰金及更正”機(jī)制可以為控制仿制藥虛報(bào)成本提供借鑒，“核查-罰金及停止”機(jī)制可以為控制“偽新藥”虛報(bào)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(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2014
【分類號(hào)】：F426.72

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