【作者】 熊平；

【导师】 周殿昆；

【作者基本信息】 西南财经大学 ， 产业经济学， 2007， 博士

【摘要】 近年来,由于我国药品注册审批中频繁发生商业贿赂和寻租事件,药品定价管理不科学,招标采购管理不严格,导致了药品流通秩序混乱,药价持续虚高。药价虚高直接损害了老百姓的切身利益,已经由管理问题和经济问题上升为社会问题和政治问题,激化了社会矛盾,成为了当前社会的一大隐患。政府为解决药品流通价格虚高问题,采取了降低药品价格、集中招标采购、改革药品定价体制、药品注册管理体制和进行双G认证(GMP、GSP)等措施。但是由于没有把握住药品流通有别于其它商品的特殊性,没有找准药价虚高背后的制度缺陷和根源,药价虚高问题依然未得到有效地解决。基于此,本文力图从系统分析药品注册审批、生产和流通体制缺陷入手,找出导致药价虚高的制度原因,针对性地提出修补这些制度缺陷的对策建议,供政府治理药价虚高问题决策时参考。论文揭示了药品流通有别于其它商品的特殊性,建立了研究药品流通价格虚高问题的四个假设。论文对我国药品流通体制演进的历史沿革、医疗体制、药品生产和营销体制、政府的药品监管体制、发达国家的药品流通管理模式和我国几种比较成功的药品流通模式,作了评述和对比研究。论文运用了系统论、SCP理论、交易费用理论、寻租理论、博弈论和规制理论等,通过构建药品生产企业、销售企业、医院、政府管理部门和患者等各种利益群体的一系列博弈模型,揭示了药品流通中各利益主体的相互关系,以及价格虚高问题的实质制度性根源,针对性地提出了治理药价虚高问题的路径。论文指出,药品价格虚高,表面看是价格问题,实质上是药品审批体制、生产和流通体制、医疗保障体制、政府管制体制等各个环节制度缺陷的综合作用,导致药品流通虚假差异化竞争造成的,必须系统地对前述各种体制进行综合配套改革,才能使问题得到根治。论文分3个层次,共6章:第一层次(绪论和第1~2章)为研究思路与立论基础部份,主要阐述论文的立题基础,药品流通问题的研究进展,论文的研究思路及相关的理论综述。同时对药品流通的特点,国内外药品流通模式的特点和流通体制改革的历史沿革作分析评述,找到论文研究的着眼点,为立论的展开奠定基础。第二层次(第3-4章)为主体研究部份,本部份在总结我国药品流通中存在的问题的基础上,提出了论文的研究假设,分析了医疗和药品营销系统资源的稀缺性,药品监管的制度缺陷、规制失效带来的机会主义行为,药品流通中的虚假差异化市场竞争和医患之间、医生与药品流通企业之间的信息不对称问题;通过建立经济学模型,用交易费用理论、寻租理论、渠道关系理论、市场绩效理论、系统论和博弈理论等对我国药品流通前端的注册审批、定价、招标问题,流通中的低效率问题进行了研究。揭示了药品流通中存在的深层次矛盾和药价虚高的根源;第三层次(第5-6章)为对策建议和论文总结。提出解决药品流通制度缺陷以及价格虚高问题的原则、步骤和方法,以及控制风险措施。总结本文的思路、研究逻辑、主要观点,以及今后需要改进的地方。论文提出了以下有创新性的观点:1、论文以系统论为指导,突破现有文献着眼于单个环节研究的局限性,系统全面地分析了我国药品流通及管理体制各环节上的弊端,并针对性地提出了推进药品流通体制改革的基本思路和具体措施。论文把药品流通体系分为前端和流通过程两大部份,把它看成是由前端部份的政府药品监管体系,药品流通过程,以及与之直接关联的医疗体系和患者组成的一个多环节系统。论文建立了医疗和药品流通资源的稀缺性假设,政府规制失效和机会主义行为假设,药品流通市场虚假差异化竞争假设,权力结构失衡条件下的博弈假设;构建了药品流通中权力结构失衡条件下的制药企业与医院、医生与患者的博弈模型;用交易费用理论、寻租理论、规制俘获理论、渠道权力结构理论、市场绩效理论和博弈论,分别对前端环节、流通过程部份和关联领域的制度缺陷作了深入分析和整体综合研究,从中找出了导致药价虚高的制度性根源,并系统地提出一套针对性的治理对策。2、论文用寻租理论和规制俘获理论,对药品流通前端环节——药品注册审批和定价中的制度缺陷和弊端作了分析。论文认为,政府药监机关官员设租,并诱导制药企业寻租,收取商业贿赂,被俘获导致了规制失效;制药企业寻租获取“新药批文”后,更换药品名称,虚增疗效,把寻租和商业贿赂发生的费用和其它不正当费用打入成本,倒逼药监机关认可其对药品的虚高定价,种下了市场药价虚高的祸根。论文认为,政府规制失效是药价虚高的根源。3、论文把我国药品流通渠道划分为处方药医院流通渠道和非处方药市场销售渠道,用渠道权力结构理论、博弈论,建立了药品流通中利益群体之间博弈模型,分析了医院和医药公司利用其控制处方药流通渠道的优势,向制药企业索取高回扣,制药企业只能屈从;医生利用其信息方面的绝对优势,开大处方、高价药,患者只能屈从等现行药品流通体制的弊端。论文认为,药品价格虚高的根源是政府对制药企业定价规制失效;药品流通过程的弊端也对药品价格虚高最终形成,起了助推作用,它使虚高药价成为事实,并迫使患者接受。从而论文全面系统地解释了造成药品价格虚高的体制和机制性原因,为找到解决药价虚高问题的路径和措施,奠定了基础。4、论文揭示了药品流通中,患者与医生之间信息严重不对称形成的委托代理关系。论述了由于医院处于寡头垄断地位,医生对病情和药品信息有完全的绝对控制权,有关政策法规缺失对患者权益的保护,患者维权成本高,导致患者对医院和医生滥用处方权和药品定价权的屈从,致使患者与医生之间形成畸形的委托代理关系。论文用经济学模型分析了作为代理人的医生,在医院监管失效条件下的道德风险,以及给患者造成的福利损失。论文指出,解决这个问题,既要提高医生的职业道德水平,又要大力治理商业贿赂,加强处方药用量及价格的监管。药价虚高及其背后的药品流通及管理体制涉及面广,且问题庞杂,受学识和篇幅限制,加之统计资料不全,本文未能建立计量模型对各具体环节作更深入地分析。药品流通体制改革的成本,有些是显形的,有些是隐性的,由于学识和资料有限,本文只讨论了改革的风险控制问题,而未对改革的成本作测算和分析。这些不足,有待以后继续研究予以弥补。更多还原

【Abstract】 Since the frequent occurrences of commercial bribe and rent seeking problem in the register, examination and approval processes of medicine, the unscientific management on medicine price-making and undemanding management on medicine bidding, the medicine circulation is in chaos, and medicine prices hike up. The rising prices of medicine not only hurt patients’benefits directly, but also sharpen social contradictions because it has been defined as social and political problem rather than management and economical problem. Government has adopted many measurements to solve the problem, such as price limitation, bidding centralization, reformations for price-making and register mechanisms and GMP & GSP certification. However, these measurements did not solve the problem effectively for failing to identify the particularity of medicine circulation and capture the origin of systematical flaw. This essay will try to identify the systematical cause of medicine price -rising by systematically analyzing the flaws in register, examination and approval, production and circulation processes of medicine, and to raise policy suggestions for government’s reference.This essay reveals the particularity of medicine circulation as well as some premises in accordance with economical assumptions; reviews the history of medicine circulation mechanism, medical system, marketing and production systems of medicine and government supervision system in China; and compares the differences between the management modes of medicine ciculation in developed countries and some successful modes in China.By using system theory, SCP theory, transaction cost theory, rent seeking theory, game theory and regulation theory and creating game theoretical models with the different interest parties such as producer, seller, hospital, government and patient, the essay reveals the relationships of interest parties in medicine circulation and the origin of price-hiking problem and raises the way of solving this problem. The essay also indicats that the hiking price of medicine is not a pricing problem as it seems to be. The problem is actually induced by the synthetical action of system flaws including approval, production & circulation of medicine, health care and government regulation. It must be thoroughly solved by comprehensive reformation of foregoing systems with a systematical view.This essay is divided into 3 parts, totally 5 chapters: part 1 (introduction and Chapter I and II) is the basic part to illustrate research train and make a point. it will mainly elaborate the base of the point, introduce the progress of research on medicine circulation problem, reveal the author’s train of thought, and summarize the theories used in the essay. Meanwhile, it will review the particularities of medicine circulation, the characteristics of medicine circulation models both nationally and abroad and the reformation history of circulation mechanism in China to establish the foundation of basic points.The second part (Chapter III and IV) is the main body of research. it will raise 3 economical assumptions on the summarization of the problems in China’s medicine circulation. By establishing economical models and using transaction theory, rent seeking theory, channel relationship theory, market performance theory system theory and game theory, this part will analyze the register, approval, pricing and biding problems before medicine circulation and the low efficiency in the circulation, reveal the further contradiction in medicine circulation and the origin of hiking price.The third part (Chapter V and VI) is for conclusion and suggestions. This part offers the principles, methods, measures and theoretical base for solving the hiking price problem in medicine circulation, and raises policy suggestions for reformation and risk control.This essay has the following innovative views:1. Guided by system theory, this essay breaks the limitation of the existing single-link researches, analyzes systematically and comprehensively the flaws of all links in China’s medicine circulation and management mechanism and raises the basic points and concrete measures about how to push the reformation in medicine circulation system systematically and ultimately. The essay divides the medicine circulation system into two parts, namely preceding stage and circulation process, and regards the circulation mechanism as a multi-link system comprised of government medicine supervision system of preceding stage, the sales and logistic channel of circulation process, and the related health care system and patients. By utilizing corresponding theories and methods, this essay analyzes the system flaws in preceding stage, circulation process and related parts, finds the systematic origin of hiking price and raises the pertinency measurements. The essay considers the hiking price of medicine is caused by system flaws in preceding stage, circulation process and related parts, and only systematical and synthetical measures can solve the problem.2. The essay raises the concept of“Medicine pricing paradox theory”, the theory is defined as: when the supply of the medicine is over the demand, as well as the price is hiking, the higher price medicine with same quality will have better sales channels. With the supply and demand theory, SCP VS, the system theory and the government regulation failure theory, the essay analyzes the distortion of pricing mechanism and damage of circulation order caused by the hospital’s monopoly under the irregulative situation. The essay also proposes that in order to solve the price hiking problem in circulation, it’s necessary to reform the current medicine circulation mechanism in hospital and conduct the separation of the hospital and the pharmacy to force the doctors to prescribe reasonably; it’s necessary to improve the transparency of the medicine market, credit level and transaction speed to avoid possible bribery; it’s necessary to build up strict supervisory mechanism to smooth the registration, pricing and bidding processes of new medicine,. Meanwhile, it should build up reasonable financial rebating mechanism and relatively reform the medical system.3. The essay reveals the causes of price hiking both in interest mechanism and system. It divides the medicine circulation channels into prescriptive medicine circulation and OTC circulation, analyzes the two channels respectively and establishes the game models with the transaction cost theory, rent seeking theory, game theory and government regulation theory The essay points out that the government is maker of the confusion of medicine circulation, the doctor is both the victim and the gainer of the noneffective regulation, while the patient is the victim. So the essay proposes the policy suggestions to reform current unreasonable systems of medicine bidding, registration and pricing.4. The essay reveals the agency relationship between the doctor and the patient caused by the information asymmetry and analyzes the reasons: the doctor fully control the illness conditions and medicine informations under the monopoly of the hospital. the patient have to obey the doctor’s authority of prescription and pricing due to the lack of related protection. The essay applies the economic model to analyze that the doctor made the patient suffer loss under the situation that the hospital is absent of supervisory, and gives the solution of improving the doctor’s moral standard; and controlling bribery to enhance the supervision on pricing and quantity of the medicine.Due to my limited research ability and knowledge, there are still many aspects need to be improved for those problems in medicine circulation.更多还原