【作者】 宁博；

【导师】 李士雪； 郝模；

【作者基本信息】 山东大学 ， 社会医学与卫生事业管理， 2014， 博士

【摘要】 研究背景基本药物制度是我国药品供应保障体系的核心,是新形势下我国药品管理领域推出的一项重大改革措施,其本质是在基层医疗服务运行体系改革的基础上,进行了一套完整的药品生产、流通、使用和监管的体制改革,其中药品流通体系的改革是变化最为突出的一环。从某种意义上来说基本药物流通政策的产生和发展,既与我国长期以来的药品政策实践有关,也与政策外环境的逻辑变化有关。在一些创新性的流通政策的驱动作用下,基本药物的价格得到很好的控制,基本药物覆盖的范围和销售规模不断扩大,为提高基本药物的可获得性和可负担性、满足最广大人民群众的基本医疗卫生需求做出重要贡献。从基本药物制度的带动作用来看,伴随着互联网和电子商务的兴起,基本药物流通的新型业态也得到了长足的发展,药品购销的规范性得到很大提升,相关流通企业的兼并重组步伐明显加快,药品行业集中度也随之提高,流通扁平化、少环节、可追踪、高效率的现代药品流通模式正逐步显现。但同时我们也要清楚的认识到,在有限的积极变化背后,还隐藏着许多激烈的利益冲突和矛盾,例如基本药物在市场供应和满足社会需求方面还存在很大的不足、配送不及时的问题比较突出、药品价格虚低引发恶性价格竞争、行业管理与规划与现行招标、定价规则存在一定矛盾等。这些问题的出现既受基本药物本身的经济属性所影响,也受原有的药品流通环境、政策环境的制约,因此要实现药品行业集中度的提升、提高药品生产和流通质量、促进药品流通行业的发展水平满足国民经济的发展需要还需要克服许多困难,这也预示着基本药物制度及相关管理措施短期内还需要经历剧烈的渠道重构和行业变革的考验,因此基本药物在流通的时效性、利益实现的均等性、产业整合的有效性方面还会受到较大的影响。上述背景说明,我国药品流通环节还存在很多先天的不足,在社会结构和各种利益关系深刻调整的时代背景下,国家药品政策的不完整性、行业外资本运作的盲目性、行业内业务模式创新的不确定性都有可能对流通环境和流通秩序的变化产生复杂的行业和社会影响,因此需要在不断的药品流通政策调整和市场竞争过程中得到完善。从更宏观的角度来看,政策调整不应仅仅局限于简单的行业升级改造,还要着眼于我国的医药卫生体制改革和社会主义市场经济建设,这对政府决策层面、学术研究层面还是企业运行层面来说,还必须要认真研究分析以基本药物为代表的整个医药流通市场的发展变化,深入了解基本药物制度背后所蕴含的客观发展规律,积极探索宏观调控与市场经济的有效资源配置方式,并在持续的改革过程中把握政策机遇,创造更集中、更开放、更有序的药品流通市场。研究目的本文着重从制度层面、机制层面和基本药物相关企业所开展的具体活动出发,将市场的外部性和政府规制的有效性结合起来,阐述了基本药物流通政策的主要内容,并将基本药物的流通政策与一般药品政策进行比较,了解新医改后我国药品政策主要的变化趋势,总结政策内容对药品生产流通行业、基层医疗机构和社会公众等方面的影响,具体来说本文的主要研究目的如下：(1)加强流通基础理论的研究,正确理解流通政策的定义、内容、分类、目标和功能,通过文献复习,全面了解我国药品流通环节的主要政策法规、行业发展现状、问题和发展趋势等内容。(2)总结中央和地方相关部门出台的关于基本药物流通环节的主要政策规定,通过对政策内容、变化趋势和功能等方面的分析,深入剖析基本药物流通政策产生和发展的规律与特征,全面展示基本药物流通政策的基本框架。(3)从基本药物的价格、招标采购、行业经营模式变化等方面总结基本药物对药品市场及药品流通环境产生的积极变化,同时指出基本药物流通政策出台后对产、供、销各环节所引发的消极的市场表现,并从理论层面分析导致市场消极表现的政策原因、体制原因等阻碍因素。(4)在较为全面掌握基本药物流通形势的基础上,围绕促进药品流通行业长期发展的“十二五”规划和基本药物政策运行过程中出现的问题,提出针对药品流通全行业升级和改善基本药物流通管理的建议,注重政策的可行性,强调社会管理方式的创新,从而为后续基本药物流通政策的调整提供有益的政策借鉴。资料来源与研究方法1、资料来源定性资料主要利用CNKI,万方、维普、EBSCO、PUBMED、MEDLINE等中英文数据库,以基本药物、流通、价格、招标、essential medicine等为主题词检索相关期刊和论文资料,搜集近年来国内外药品政策调整和药品流通体制改革相关文献；浏览中央各部委及地方行政管理网站,搜集医改、卫生、财政、物价、食品和药品监督、医保等政府部门出台的关于基本药物制度招标、配送、价格管理及综合医疗卫生体制改革等方面的政策文件。定量资料主要收集商务部、中国医药商业协会发布的年度药品流通统计分析报告,了解药品流通直报企业关于营业收入、市场分布、毛利润率、平均利润率、基本药物配送金额等数据；关注卫生、商务部门公布的行业动态信息,主要包括基本药物采购额、配送及时性、药品价格、遴选基本药物配送企业数量等信息；尽量收集工信部公布在资产总额排名前100位医药企业的公司年报或审计报告,分析政策变化对企业规模、资产、经营方式的影响。2、研究方法(1)规范研究规范研究是解决“应该是什么”的问题,即政策执行后所要实现的预期状态,包括政策目标和政策实现路径。规范研究具有价值性和伦理性的特征,它主要采用定性研究和思辨的方法来分析说明研究本身的优劣。本文紧密围绕中央、地方与基本药物相关的政策制度法规,通过对目标、决策、结果的描述和演绎推理,探索我国药品政策发展演变的规律,通过对药品改革过程中的价值冲突,客观反映事物的内在联系及经济现象的社会价值,从而有助于从价值判断的角度评判基本药物制度所引发的一系列社会现象的积极或者消极意义。(2)政策分析法政策研究是在经验研究、系统分析研究的基础上,以基本的社会问题为研究对象,对现实社会政策进行分析。本文较为全面汇总了中央和地方关于基本药物流通环节的各项政策文件、法律、法规,并对相关流通政策的发生、发展和变化进行梳理与归纳。同时,着重从政府行为和市场反应角度来分析政策目标、方案制订、政策的实施,并对可能的政策风险进行归纳概括,在此基础上依据市场经济的一般原理提出一组相互关联的政策改进建议。(3)比较分析法文章选取了部分基本药物制度实施过程中的创新性的流通政策,通过与原有药品管理政策进行比较,分析基本药物与非基本药物在流通属性的区别,找出政策变化的异同点,发现药品政策变化的趋势。(4)实证研究法利用基本药物价格、药品配送率、短缺药品构成等实证数据,对基本药物流通政策对我国药品政策环境、市场机构和供应链等方面的变化进行研究,并重点从价格、招标、产品准入、市场反应等方面分析了出现上述问题的原因。研究结果1、政策理论基本药物制度是新时期我国药品政策的核心,也是推动我国药品流通体制改革的一项重要制度。围绕基本药物制度实施的一系列改革措施对降低药品价格、促进产业集中提升、提高流通信息化水平、创新流通模式等方面已经产生了积极的影响。但同时有些措施也增加了基本药物流通的不确定性,对产供销链条乃至整个药品市场引发新的流通风险,因此需要对基本药物流通政策进行深入研究,并从机制层面展示并分析风险产生的原因,以利于下一阶段的政策调整。2、政策实践与基本药物制度密切相关的流通政策包括药品流通秩序(市场准入政策、流通行为政策、价格政策、调节和储备政策)和流通现代化(流通科学技术、流通基础设施)两个方面。新医改后我国出台了关于基本药物价格管理、招标采购、配送管理、药品电子监管等一系列措施,政策内容的主要变化是：首先在交易方式方面,真正意义上实现了药品零差率销售,初步实现了“医药分离”；采用“双信封”招标法,创新药品采购新机制；借助集中药品采购平台实现了统一交易、统一采购和统一配送,有效缩短流通时间、减少商流成本。在流通调控方面,普遍实行单一货源承诺的方式,减少了药品供应主体的数量,不断提高市场集中度；搜集药品供需信息,在生产企业和基层医疗机构间建立起有效供需的协调和精确的市场对接；建立价格参考机制和价格联动机制,提高价格决策透明度。在流通秩序方面,增加了产品市场准入的限制、不断优化产品种类、数量和剂型；增加了基本药物配送企业的遴选环节,强化对基本药物配送管理；对基本药物货款实行统一支付,加强购销合同的落实。3、政策效应从经济角度来看,基本药物价格得到降低,基层医疗机构对药品收入的依赖程度下降；基本药物销售金额稳步增加,尤其是独家基本药物、中成药所占比例明显增加；药品采购联动趋势增强、价格的透明度不断提升；此外现代药品交易方式开始普及,电子商务发展速度和交易规模不断提高。从行业发展角度来看,优势企业规模不断扩大,企业间并购现象开始增多；生产企业在流通产业链的地位上升,区域性药品龙头企业的社会功用不断增强；第三方药品物流企业获得较大发展空间,配送企业物流设施条件和物流管理能力明显提高；药品物流园区建设数量增多,流通资源整合力度不断加大。从社会角度来看,基本药物的流通层次减少,流通行业扁平化发展趋势增加；药品电子监管的实施力度不断增强,有效保证了药品流通秩序的稳定；药品产供销一体化设计水平提高,促进了基本药物流通方式适应生产结构和消费结构的变化。4、政策缺陷在价格管理环节存在部分药品定价过低,引发企业恶性价格竞争；药品价格信息采集工作力度不足,难以反映真实的生产成本；部分地区存在加价销售和二次议价的行为,扰乱正常市场秩序。在招标环节存在招标采购规则违背市场规律,降低药品可选择性和采购主体地位；招标规则差异较大,造成新型市场分割现象的出现。购销合同执行环节存在基本药物配送效率不高,部分地区配送秩序混乱；部分药品生产企业信息化改造滞后,不利于监管效率的提高。结论与建议基本药物的流通政策对我国药品交易方式、行业秩序、信息化改造、流通基础设施建设等方面都带来了积极的社会影响,符合我国药品流通体制改革的发展要求,也会对整个宏观医疗卫生体制改革和社会主义市场经济建设产生全局式的影响。但由于政策实施时间较短及体制障碍,新的药品政策的实施对我国医药及相关领域的影响短期内还会产生一定的抑制作用,一些改革的阻力和负性社会效应还客观存在,因此未来相当长时间内仍然要加大改革力度,尤其是要促进商品流通体制改革、医疗卫生体制改革和行政管理体制改革的联动,加强政策的协调性,从而缓解发展改革中的各种利益矛盾。更多还原

【Abstract】 BackgroundThe essential medicine policy is a great reform of the medical system which is in the core position of the drug supply security system in our country. In essence, it carries out a complete reform of regulatory including the drug production, distribution and the rational use, and the circulation system reform makes the maximal changes in all of them. Below policy drive, prices of essential medicines have spiked, the enlargement of essential medicine policy expands the market size, as well as the availability of drugs. Otherwise, the driving role of the reform promotes the development of electronic commerce with will benefit business order and it will encourage the reorganization of enterprises to an advanced stage of business model.We have also carefully noted that there are still serious conflicts such as the short supply of goods, slow delivery and price disorder et al. these problems are mainly due to the economic value of policy itself and the original environment of circulation systems. These results suggest there are still many trials in the near future which mean that it will affect the effectiveness, balanced and availability of essential medicines. As is stated above, the inherent inferior of policy environment is common and the policy reforms are more vulnerable to the incomplete, blind and uncertainty changes. Therefore we have to make further study on the market condition and the developments according to objective law due to the essential medicine policy and to make a further open and orderly environment by active exploration on macro-modulation in the socialist market economy.ObjectiveThe article presents the changes and features of essential medicine policy from the layers of system, mechanism and practice which combines with market externality and regulation of the public sectors. Based on this, it concludes the actual influences on domestic drug production, management enterprises, grassroots medical institutions and the society. And the specific purpose includes:(1) To strengthen the research on the basic theory on circulation policies including the definition, content, classification, functions and so on. Meanwhile, to have a complete understanding on the current development, management policy, problems and variation tendency of pharmaceutical distribution through literature review.(2) To summarize the policies and regulations associated with drug distribution from the central and local governments. And to display the whole system by policy analysis on contents, functions and characteristic which aims to make a deep analysis on essential medicine policy.(3) To point out the favorable changes of the drug market and management model related to policy of pricing, bidding and so on. It has also collected some passive behaviors from the perspective of production, supply and sale, which aims to reflect the deficiencies and system barriers. (4) To give suggestions concentrated on the upgrading of circulation and administration of essential medicines based on the comprehensive study of the system. Thus it would provide useful recommendations for further policy adjustments.Data and methods1dataThe qualitative data mainly comes from literatures and dissertations of CNKI, EBSCO, PubMed, Medline et al by using the key word of essential medicine, circulation, price and so on which aims to collect the information of policy adjustments in and out of china. And the public documents related to bidding, logistics management and pricing et al are achieved by visiting the website of governments departments.Some quantitative data, such as the amount of sales, shipping amount, market distribution et al, comes from the annual statistical report of ministry of commerce, pharmaceutical commercial association in china. And some others such as purchases, timeliness rate, number of enterprises, property are obtained from the government notice.2Methods(1)Normative studyThe normative study mainly focuses on the goals and approaches of policy with characteristc of value and ethical. Some methods of qualitative research are employed in the study which to demonstrate the pros and cons. In the artical, it studys the circulation system related to essential medicine policy by describing and reasoning which reflects the inherent value conflictand relationship between economic phenomenons. All tthose are conductive to elaborate the positive and negative significance from the perspective of true value. (2) Policy analysisPolicy ananlysis takes the social problems as the object of the study and set comprehensive study on the actual policies. In this article, it summarizes all the policies of ciuculation system related to the essential medicine policy and discusses the target, process and results from the angle of government action and market response. Thus it proposed a set of related policy recommendatons.3Comparative analysesIt selects some innovative policies related to the essential medicine policy and makes comparative study with the traditional regulations which can help to distinguish the differences in properties od circulation. It can slso find out the differences and the trends of policies.4Enpirical approachUseing the data of price, delivery data, componeats of shortages et al, the paper emphatically studies the effects of drug policies, market response and changes of supply chains. Meanwhile, it analyzes the existent reason from the angle of price, bidding, market access and so on.Results1policy theoryPresently, the essential medicine policy is the core of drug policy in china which also constitutes the important part of the medicine circulation system reform. Some innovative measures have been implemented and have achieved positive impact. But some measures also bring uncertainty in the aspect of circulation of essential medicine and some even trigger new market risks. Therefore, intensive study should be made which aims to analysis the cause of problems and to provide further policy adjustments in the future.2PracticesThe circulation order and modernization of drugs are closely connected with essential medicine policy. During the period of new medical reform, it has issued a number of reform measures and the variations mainly come to these aspects:Firstly, from the standpoint of transaction, a zero sales rate policy for essential medicine is made which promotes the separation of medicine and drugs. Two envelop bidding method takes the place of comprehensive evaluation method which brings innovation mechanism for drug bidding. And with the help of online trading platform for pharmaceuticals, the trade cost has been cut down as the integration of transaction, purchasing and delivery.Secondly, from the standpoint of regulation, the number of supplier decreases as the implement of single source commitment which also improves concentration consequently. The coordination mechanism of supply and demand is founded as the establishment of the market docking. And it intends to improve transparency of price as a result of the mechanism of reference price and linkage price.Thirdly, form the standpoint of order, restrictive measures increase the difficulty of market access for medicines and promote the optimization of types and specifications. What’s more it makes selection for distribution enterprises with enforcing management and to ensure the implement of the contract.3EffectsJudging from the economic are, the price of essential medicine falls and it incurs less reliant for drug income for primary health institutions. And the amount of sales increased especially for exclusive drugs and Chinese patent drug. As linkage of bidding, the transparency of price is high. In addition, automated system for transactions has become popular which greatly promote the e-commerce development.Judging from the development of industry, the scale of outstanding enterprises gradually escalates expands by merging the small ones. And the status of the manufactory enterprises comes to a high position and plays a great role in some certain areas. Meanwhile, the logistic facilities have upgraded and the business growth promotes the third party logistics companies and the logistic park which favors the integration of the industry.4Deficiencies(1) Some essential medicines are artificially low priced which is liable to cut-throat competition; the collection of price is inefficient which cannot demonstrate the exact cost; in some areas, the essential medicine has clapped an extra price and it indeed disturbs the order of market.(2) Some regulations for bidding are against the laws of market and leading a low selectivity for drugs which cannot ensure the principal position for entities. Whereas, there are large differences of regulations in different provinces and it will consequently lead to market segmentation.(3) The delivery for essential medicine is in low speed with disorder circulation. The transformation progresses at a slow pace in some enterprises which will go against the supervision.Conclusion and suggestionThe policies related to essential medicine bring positive changes in transaction, industry order, and information construction et al. All those comply with the development of pharmaceutical circulation system and will promote profound changes in medical reform and the construction of socialist market economy.As lacks of time and system barrier, the new policies are likely to cause the inhibition in the short-term. Therefore, we have to deepen reform especially to adjust the coordination of circulation system, the medical system and the management system which aims to mediate the conflicts.更多还原