基本药物流通价值链的经济学研究

【作者】 王强；

【导师】 陈文；

【作者基本信息】 复旦大学 ， 社会医学与卫生事业管理， 2010， 博士

【副题名】从新制度经济学视角分析基本药物流通价值链的制度选择

【摘要】 一、本文针对新医改和基本药物制度实施前后,基本药物制度和药品流通体制改革的政策研究与设计存在条块分割,缺乏从经济学理论层面的深度分析,忽略医生利益这些关键要素,导致政策模式和实施过程的现实障碍等学术与现实问题,结合第四次国家卫生服务专题调查,参考WHO与国家卫生部、药监局联合组织的《中国基本药物的可获得性及其使用的调查研究》相关内容,采用整群分层抽样调查对基层医疗机构与基本药物供应链有关的现况进行调查分析；采用典型案例深度调查分析基本药物流通价值链的政策作用节点及其作用机制；运用世界银行和哈佛大学的卫生改革与发展理论框架对基本药物供应链进行评估和价值链归因分析；运用新制度经济学关于合约、租值与交易费用的相关理论深入剖析价值链归因的经济学原理及其作用机制,力求以医生为关键利益主体,围绕医生租值回归分析基本药物流通价值链相关的采购、使用、销售、定价、补偿等方面的策略与方法,并对不同策略方法进行比较分析和评估,在此基础上提出策略优化与实施路径的政策建议。二、根据统计数据,以2004版基本药物目录为基数,各级医疗机构对于基本药物的使用较为广泛,特别是在社区/乡镇医院中使用比例达到90%以上。同时社区与乡镇基层医疗机构的基本药物采购配备比例也较高,达到80%左右或以上。虽然药店等企业采购配备基本药物的比例相对偏低,但由于医疗机构当前仍然是基本药物使用的主要渠道,故而基本药物的总体使用较为普遍。但是从药品品种占基本药物目录的比例来看,仍存在部分药品短缺情况,不管是城乡医疗机构采购使用、还是药店企业经营配备、乃至生产企业生产供应,都存在部分基本药物目录品种的缺失。若以最新基层版307个基本药物目录为基数,则一方面基层医疗机构基本药物配备使用占所有药品的比例明显下降,另一方面各基层医疗机构配备使用基本药物的完整性不足。基本药物供应链的主要问题表现为：(一)基本药物使用较为广泛,但供应链各环节均存在品种短缺。当前主要存在两种基本药物可及性问题,一是虽然基本药物为基层医疗机构普遍采用,但仍然存在选择使用大量非基本药物情况,患者的基本药物使用存在被替代的现实；二是在部分细分药品类别,部分质优价廉的基本药物无法有效获得。(二)基本药物并未起到降低费用负担的显著作用,未能有效缓解患者均次药品费用负担的增长势头,没有从根本上解决药品费用偏高问题。(三)基本药物合理使用仍未得到有效改善。医院级别越低,平均每处方用药品种越多,且越倾向于在处方中使用抗生素和针剂。不合理用药不仅意味着治疗效果难以达到预期目标,甚至引发新的药源性疾病,而且造成资源浪费和费用上涨。这些都将导致基本药物使用效率的下降。基本药物的上述问题是彼此关联的,现实问题首先体现为部分低价基本药物短缺；低价短缺导致基本药物整体价格水平的提高,再加上品种过多导致使用的内部离散度加大,共同造成基本药物经济性的丧失；现实中不合理用药的存在,也进一步增加了基本药物的费用负担,降低了药品的使用效率。三、在当前的医药流通体制改革过程中,与基本药物供应链相关的各利益环节存在多样化的改革探索和模式选择。(一)成交模式在以建立集中采购制度为主的基础上,衍生出公开／邀请招标、挂网限价竞价、委托采购、两阶段招标等模式,此外也仍然存在少量的分散采购模式。(二)配送渠道与集中采购相配套,存在厂商—配送商渠道、厂商—代理商—配送商渠道、采购方集中遴选渠道等模式。(三)日常采购支付在传统分散采购分散支付基础上,衍生出分散采购集中支付等新的模式探索。(四)基本药物零售作价几经变革,当前在顺加作价为主的基础上,存在差别差率作价、零差率作价和政府直接生产成本加成定价几种方式,但新制度正推进零差率作价,逐步成为基本药物主要的零售作价方式。(五)基本药物的使用决策规制主要包括处方规范与指南、处方结构控制和处方费用控制等手段。当前以后两者为现实可行的主要操作模式,临床应用指南和处方集等规范刚刚出台,正处于应用推广和磨合期。(六)基层医疗机构基本药物的筹资补偿模式在传统自收自支直接补偿的基础上,衍生出差额／全额收支分离补偿、医保总额预付补偿和商业分成间接补偿等多种模式。当然,各级财政补偿也是普遍并行的补偿模式,只是限于各地财政承受能力,往往无法与基本药物进行直接对口补偿。(七)基本药物目录制定环节,由于最新版基本药物目录已经发布,本文不再对该环节展开讨论,仅进行简略描述。四、在上述基本药物流通价值链的诸多利益环节和策略模式中,与基本药物供应链问题相关的主要有以下原因：(一)采购成本降低遭遇瓶颈。随着以集中招标为核心的医疗机构集中采购模式的普及与逐步推广,各地逐步形成了带有自身特点的定期集中采购模式,购、销、管、付各方也逐步在多次博弈中形成一定的利益均衡。采购成本逐步趋于稳定,进一步降价的难度加大。(二)基本药物处方缺乏有效制约机制。基本药物目录由于不存在强制性,对医生的处方行为不具有直接约束力。同时处方规范、结构控制和费用控制都未见严格可操作的奖惩机制和操作办法,因而处方约束并未带来直接的合理用药结果。(三)定价和补偿方式并未明显改善医疗机构收支结构。近年来,包括基层医疗机构在内的城市医疗机构药品收入和药品收支结余率、药品收支结余增长率之间存在严重的结构性矛盾,药品收入的增长没有带来收支结余的同比例增长。一方面,药品收入大幅增长,加重了患者的药品费用负担,抵消了纠风和降价等政策带来的好处；另一方面,药品收支结余大幅减少、药品收支结余率持续降低造成城市医院业务亏损加剧,使城市医院陷入资金补偿的困境。五、运用新制度经济学的合约、租值、交易费用等相关理论全面分析卫生服务过程中的供求价值转移、资源配置,以及基本药物的福利性定位及其供求关系。分析得出基本药物流通价值链问题的核心根源之一在于基本药物的福利性定位未能在公共筹资和支付上为满足居民基本需求提供足够保障；其二在于医生代理人通过药品对市场租值进行补偿的需求与基本药物的价值定位不一致；其三在于未能建立有效的基本药物市场均衡价格的发现机制。六、运用新制度经济学的租值、交易费用等相关理论,分别剖析基本药物流通价值链关键利益环节各种策略模式的经济学原理及其作用机制。在此基础上用系统分析方法对比筛选出理想条件下优化的策略模式和路径组合,主要包括：在较小的基本药物目录基础上,以医保预付提供利益驱动促进医生与医疗机构服务租值的回归;以零差率作价切断医疗机构与药品补偿的利益驱动并提供经济补偿的衡量尺度；以临床应用指南和处方集的大力推广应用和第三方评审提高医生扩大药品租值的市场成本；以坚决保障和大力促进处方外配竞争降低医生和医疗机构销售药品的市场租值；以医保支付方组织的省级集中采购和地市唯一品牌遴选、采购方渠道遴选和分散采购集中支付等市场化、社会化的采购策略组合,引导上游供应链的良性竞争,发现市场均衡价格并协调供应链的合理利益均衡。此外,还针对普遍存在的可支配医保及财政资金不足的现实约束,提出了补偿资金欠缺条件下的分步实施策略与路径选择。七、目前尚无法取得新基本药物制度实施效果的实证数据和资料,但可以推测,随着时间的推移和各地相关配套措施的陆续出台,基本药物的可及性将在相当程度上得到明显改善；基本药物使用效率的优化尚有待于《国家基本药物临床应用指南》和《国家基本药物处方集》的广泛应用及配套奖惩机制的实施；而最大的衍生问题是为实现对患者费用负担的有效降低,财政资金补偿压力骤增,以财政资金短期内全面替代药品补偿的可操作性较差；此外,仓促地实施全面限制基层医疗机构对非基本药物的配备使用,将带来新的可及性问题；与已有基本医疗保障制度衔接不到位,将造成基本医疗保障覆盖和服务能力的下降等。八、在优化策略和机制组合分析的基础上提出政策建议：(一)坚持政府主导与市场机制相结合的指导思路,围绕基本药物的福利性定位和医生合理租值形成与回归制定实施策略。明确政府以基本药物目录制定、临床用药、零售定价、筹资补偿和终端采购制度作为主要干预和规制目标范畴；以企业为主体的市场机制则在基本药物生产和流通供应链中上端发挥核心资源配置作用,在基本药物销售环节通过竞争促使资源有效配置。(二)在适度缩小基本药物目录(已实现)基础上,明确基层医疗机构首先将目录内基本药物作为必备的基础配置,然后根据居民基本医疗需求和市场竞争需要自主选择和动态调整非基本药物医保药品的配备供应。(三)以基本医疗保险为主,财政税收为辅筹集基本药物生产、流通和使用所需资金,逐步扩大医保筹资和补偿水平,同时将财政资金纳入医保统筹进行补偿与支付。在医保和财政资金充足地区,推行以医保为支付主体的、基于补偿项目科学监控、统计和测算的差额预付(管理成本预付、采购成本后付)制度；在医保和财政资金不足地区,推行基于补偿项目监控和审查的医保后付制度。积极稳妥提高医生诊疗服务项目的补偿标准和水平。(四)逐步取消基本药物生产成本加成定价或者参考生产成本加成定价,推行零差率为主的采购成本加成定价,即采购价销售。对医保和财政资金替代药品补偿有困难的地区,可采用基于省级招标中标价的零差率销售。(五)大力宣传推广和普及应用《基本药物临床应用指南》和《基本药物处方集》,以此作为医生临床诊疗和处方用药的专业依据。对各类规范和标准执行情况进行第三方检查评估,作为医生和医疗机构专业资质和执业资格评定的重要依据。(六)在条件成熟地区大力推广电子处方和处方信息网络共享(经患者授权),条件落后地区推行打印处方,重点建立有激励约束配套的医疗机构处方自由外配制度,大力发展医保定点零售药店,创造可行条件鼓励和吸引社会零售药店参与基本药物供应和销售竞争。(七)推行支付方组织、医疗机构为主体、卫生行政主管部门和财政部门担保的基本药物集中采购制度。包括：1、以省为单位组织严格面向生产厂商的基本药物集中采购,网上公开招标、竞价。在省级成交准入目录范围内组织以地市为单位的唯一品牌集中遴选。在实行医保预付制地区,折扣后价格为医保支付测算依据；在实行医保后付地区,折扣前价格为医保支付测算依据。2、以省为单位组织省级物流配送企业遴选,以地市为单位组织基层物流配送企业遴选。对有代理商参与投标的供应链环节为主要对象,尝试由税务等机构对从厂商到配送商的票据流进行抽查审计,严控非法促销费用的帐务处理空间。3、卫生行政部门主导,财政部门担保,以地市或县为单位组织医疗机构联合体完成基本药物成交合同的统一结算支付,及时结算并支付药品货款。对医疗机构资金确有困难的地区可探索财政担保,金融机构提供融资服务的第三方信用结算方式,确保基本药物供应方的合法权益和持续供应能力。(八)除上述从终端需求角度引导市场博弈与竞争外,原则上不直接干预企业对基本药物的生产组织和经营安排,必要时可配合使用税收等财政手段、信贷等货币手段间接调控基本药物的生产流通供应。(九)积极引进信息、金融、审计、评估等市场化专业中介服务,提供高效率、高质量的外部支撑与实施保障,降低政策执行过程的交易成本,改善政策干预效率和效果。(十)积极鼓励社会资本参与医疗卫生教育、医疗卫生服务提供和多元化竞争。扩大医疗服务供给,并逐步放开医疗服务市场价格,促进医疗服务市场竞争。更多还原

【Abstract】 I. By the initiation of health care reform and implementation of essential medicines policy, problems such as segmentation of essential medicines policies and reform of the pharmaceutical distribution system, lack of thorough analysis for the physician’s interest from the perspective of economic incentives become rising issues during the implementation process. This study used the methodology of stratified cluster sampling, investigated the status quo of the essential medicines provision in primary health facilities by referring to the Fourth National Health Services Survey and the "Survey of accessibility and utilization of Chinese essential medicines" conducted by WHO (World Health Organization), MOH (Ministry of Health) and FDA (Food and Drug Administration). The author also applied case study to analyze the policy influence on the pharmaceutical distribution value chain based on the health reform model developed by World Bank and Harvard University. Finally, the author focused on the key stakeholders of physicians by analyzing the value chain using the theory of contract, rent and transaction cost in new institutional economics, proposed strategies for purchasing, utilization, marketing, pricing and compensation in the essential medicines distribution value chain by alternatives comparison, analysis and assessment.II. According to statistics, utilization of essential medicines in primary health facilities was adequate based on the 2004 version of essential medicines list (above 2000 essential drugs). In community/township health care facilities, the purchasing rate of essential medicines reached 80%, and the utilization rate was beyond 90%. Although essential medicines were relatively less stored and sold in retail pharmacies, the total utilization rate of essential medicines were high because most of the drugs were sold in health facilities. However, there existed a shortage of some sorts of essential medicines throughout the distribution value chain in not only primary health facilities and retail pharmacies, but also in manufacturing. And if based on the latest version of essential medicines list involving 307 drugs, we could find that essential medicines were insufficient in primary health facilities. The problems in the essential medicines distribution chain contain:(1). Shortage of several sorts of essential medicines existed in the drug supply chain. There were two problems regarding accessibility of essential medicines. Firstly non-essential medicines were frequently used instead of essential medicines, although utilization of essential medicines in primary health facilities was relatively high. Secondly, for several diseases, the most cost-effective drugs could not be attained.(2). Using essential medicines did not significantly reduce health care expenditure and it could not slow down the increasing of drug cost.(3). Irrational drug use continued to be a significant issue. Antibiotic and injection were more widely used in lower-level hospital. Irrational drug use could bring about drug-induced diseases and increase drug expenditure. Both of them lead to inefficient use of essential medicines.The above problems were interrelated. We first observed shortage of some sorts of essential medicines in the distribution systems, which lead to higher pharmaceutical expenditure. Non-essential medicines could substitute essential medicines, which also related with high drug cost. Additionally, irrational drug use could further worsen the cost burden and reduce efficiency of drug utilization.III. In the recent reform of pharmaceutical distribution system, alternatives regarding each interest link throughout the essential medicines supply chain include:(1). The current purchasing model was based on centralized bidding system. Related schemes include centralized competitive bidding, competitive bidding with price limit, entrust purchasing, centralized and single-brand selection competitive bidding. In addition, dispersed purchasing model was also employed in few places.(2). The drug distribution mode was coordinated with manufactory centralized purchasing. The alternatives were manufactory combined with distribution merchants, manufactory with agents combined with distribution merchants and centralized selection by manufactory.(3). Purchasing methods included the decentralized procurement and payment as well as the decentralized procurement and centralized payment.(4). The pricing for essential medicines also had various alternatives. In the past, we used cost plus method. Recently, discriminated cost plus, zero-markup rate and public production cost plus method were applied. The zero-markup pricing would become the major pricing method under the new policy.(5). Several mechanisms including prescription guidelines, monitoring of the prescription combination and control of prescription cost were adopted to regulate the physician’s or pharmacists’behaviors in terms of prescribing essential medicines. The latter two mechanisms were more feasible and dominated, the former one were currently underway. (6). The traditional compensation model was actually compensated by their own revenue and expenditure. Now there were more compensation models for primary health facilities. Separation between revenue and expenditure, insurance capitation and public-private partnership were applied. Public compensation was the widely-used model. However, constrained by the financial condition, some local government could not cover compensation for essential medicines.(7). A new essential medicines list has been published recently, I will briefly introduce it in the following section.Ⅳ. In the above alternatives, the following factors may cause the problems existed in the essential medicines supply chain.(1). The purchasing cost could hardly be lowered. In the centralized competitive bidding model, the stakeholders such as purchasing parties, distribution parties, regulation parties reached their equibrilium. It would be more difficult to break the equibrilium and bring the cost down.(2). Lack of regulation on essential medicines prescription. First, the essential medicines list was not mandatory, which had little influence on physician’s prescribing behaviors. Second, prescription guidelines, monitoring and cost control were not applied with economic incentives, which resulted in no direct effect on rational drug use.(3). The pricing and compensation model did not adjust the distorted structure of revenue and expenditure in health facilities. Recently, the structure of pharmaceutical revenue and balance was unreasonable among health facilities including primary health care institution. On the one hand, the increase of pharmaceutical expenditure induced financial burden for patients, and offset the impact of price regulation. On the other hand, the decrease of balance through pharmaceutical sales exacerbated the financial situation in urban hospitals.(4). By far the empirical data regarding the effect of the essential medicines policy were unavailable, but we can predict that the accessibility to essential medicines would be significantly improved to a considerable extent over time after perfection of the specific strategies. Nevertheless, utilization of essential medicines would only be increased after implementation of the National Essential Drug Guideline and the National Essential Drug Formulary. Yet the primary derivative question is whether it could reduce patients’financial burden. Currently, local governments confronted the rising pressure to compensate primary health facilities for not selling medicines. Even in affluent cities like Shanghai where public funding could afford the compensation, they still had to figure out the feasible mechanisms for financial compensation.(5). Economic analysis based on rental and transaction cost theory was conducted to analyze the provision, demand and resource allocation of medical services. Essential medicines were defined as quasi-public goods. The author found that the causes to the problems within essential medicines distribution value chain were:1. as quasi-public goods, essential medicines were not guaranteed by public financing.2. Contradiction between physicians’financial incentive for rental compensation and public feature of essential medicines.3. Market equilibrium price for essential medicines had not been identified and determined.(6).The author systematically compared and combined different kinds of alternatives using theories such as rental and transaction cost in the new institutional economics in order to find out the best strategy under ideal conditions. The recommended solutions were:based on the latest essential medicines list, using capitation as a key insurance solution to encourage health facilities seeking the right financial incentive; applying zero-markup method to disconnect the interest between health care facilities and pharmaceutical industry; promoting clinical guidelines and formulary and conducting the third party accreditation to induce cost for physicians seeking pharmaceutical rental compensation; facilitating patients to buy medicines outside the health institution so as to reduce the rental profits for medical facilities; applying centralized competitive bidding at provincial level and single-brand selection at county/prefecture level that organized by the department of health insurance and applying decentralized purchasing with centralized payment to guide healthy competition among upstream supply chain and find out the equilibrium price. Furthermore, considering the inadequate public financing, substitute financing strategies should be applied gradually.(7). Based on the optimal solution, the author proposed policy recommendations as follows:a. Given the government-led and market-supplemented guidelines, government should target on formulation of essential medicines list, regulation of clinical prescription, monitoring retail pricing, public financing and regulation of purchasing mechanism. And pharmaceutical companies in the market should play a critical role in recourse allocation throughout the manufacturing and provision chain of essential medicines. And they should also compete in the selling market of essential medicines.b. Based on the current essential medicines list, primary health facilities must ensure that all the essential medicines in the list should be stored and utilized. And the list could then be gradually adapted to the actual demand in the market.c. Finance essential medicines provision, distribution, utilization through health insurance complemented by public funding, gradually increase the level of insurance financing and compensation, and include public funding into the regulation of health insurance. In the areas with affluent insurance and public funding, capitation method combined with scientific measurement and calculation should be applied; whereas in areas with insufficient funding, propayment system with monitoring and censoring should be applied. Meanwhile, compensation of medical services for physicians should be steadily improved.d. Production cost plus pricing and cost plus pricing reference to production cost should gradually be cancelled. Zero-markup pricing, which equals to purchasing price, should be implemented. In the areas where insurance and government could not afford pharmaceutical compensation, alternatives such as bid price through competitive bidding at province level could be used.e. Essential Medicines Clinical Guideline and Essential Medicines Formulary should be promoted in health facilities and referred as professional prescription for physicians, and should be assessed by a third party as a crucial qualification test for health facilities and physicians.f. Electronic prescription and formulary information network (authorized by the patients) could be promoted in areas with necessary infrastructure. Otherwise computer-based printed prescription should be used. More importantly, retail industry certified by department of health insurance should be given the incentive to compete with health facilities to provide essential medicines.g. The centralized purchasing system of essential medicines composed of purchasing parties, health facilities, health care administration and department of finance should adopt the following strategies:a) Centralized competitive bidding through transparent on-line competition among manufacturing companies should be organized at the provincial level. Within each province, single-brand selection should be applied at the county level. Under the prepayment insurance system, health insurance payment should be calculated based on the discount price. Under the propayment insurance system, payment should be according to the price before discounting.b) Each province should organize selection of logistic companies. Grass roots logistic companies should be selected at the county level. For the provision chain in which agent companies participated, tax department should examine the bills so as to control illegal promoting behaviors.c) Each county should purchase the pharmaceutical cost using public financing for the health care institution unity under the guidance of health administration at a timely manner. For areas where public could not afford the expenditure, financial institutions could be integrated to provide financing services and third-party trust for the sustainability of the essential medicines provision.h. Except for the regulation on the terminal demand, government should not intervene the organization and production of essential medicines manufactories in principle. Financial and monetary methodologies could be used to indirectly affect the production and distribution of essential medicines if necessary.i. Introduce agent services such as information, finance, auditing and assessment to provide support for efficient and high quality policy implementation so as to reduce the transaction cost and improve the outcome.j. Moreover, we should promote diversified competition by encouraging participation of private parties into health care education, health services, expanding provision of medical services, and gradually permitting price competition in health care market.更多还原