【作者】 叶露；

【导师】 胡善联；

【作者基本信息】 复旦大学 ， 社会医学与卫生事业管理， 2008， 博士

【摘要】 研究背景国家基本药物政策是国家公共卫生政策的重要组成部分,也是国家药物政策的核心内容之一。研究国家基本药物政策,为居民提供安全、可及、价廉的基本药物是控制药品费用、减轻疾病经济负担、保证基本药物公平可及的重要保障。设计国家的基本药物政策,提出对基本药物的生产、流通、定价和使用的政策建议和可行性方案,对于避免因病致贫、因病返贫有重要的现实意义,是建立国家基本卫生保健制度的重要组成部分。也为实现党中央提出“以人为本”的科学发展观和建设社会主义和谐社会的战略任务起着基础性作用。研究目的本课题的研究总目标是借鉴国际基本药物政策制定与推行的经验,从我国在执行基本药物政策20多年历程中药品生产流通使用各环节存在的症结、面临的问题出发,提出适合我国现阶段国情的,确保基本药物可及性的政策建议,为建立国家基本卫生保健制度提供理论、政策和实证依据。资料来源与研究方法本研究采用定性分析与定量分析相结合的研究方法,综合运用文献分析、定量分析和定性访谈等方法提出现阶段适合国情国家基本药物政策的思路,为相关政策的制订提供理论和实证依据。1、文献分析系统收集国家基本药物政策的方案与实践研究的国外文献,进行总结分析和比较,总结其经验,找出可借鉴之处;通过查阅文献来获得药品(特别是国家基本药物目录中的药品)在生产、流通和使用过程中存在的问题。2、定量分析(1)采用WHO/HAI最新研究方法调查上海市药品可获得性、药品价格、可负担程度,样本包括5家三级医疗机构、5家区级医疗机构、20家社区卫生服务中心和20家零售药店,分析医疗机构与零售药店药品价格的差别,并分析药品的可获得性以及消费者对选定疾病(高血压、糖尿病、成人呼吸系统感染、哮喘、抑郁症等)用药的经济可负担程度。(2)分析上海市药品费用控制政策的实施效果(3)在比较我国2004版国家基本药物目录与WHO基本药物的示范目录的基础上估测国家基本药物筹资水平。3、定性访谈(1)实地调查了山东、甘肃、广西三个省会及其地级市各一个,分别访谈物价、财政、医保、卫生、药监部门等领导,同时召开不同级别医院的医生、药剂师、药厂、零售药店、患者的座谈会。(2)采用美国哈佛大学“卫生系统诊断树”(health systems diagnostictree)作为分析工具。追溯我国基本药物实施过程中存在问题的根源统计分析软件基本药物可获得性实证研究采用WHO-HAI_NoMSG MSH 2005 workbookver4.02 Nov.xls。药品费用控制政策实施效果分析以及基本药物筹资水平估测均采用EXCEL2003进行统计分析。研究结论1、国家基本药物政策在构建社会主义和谐社会有着很重要的地位和作用。它既是追求健康公平是和谐社会内在要求,又是实现健康公平的途径,是实现卫生改革目标的重要导向2、基本药物供需链各环节都存在导致基本药物市场短缺的障碍。从政策层面上分析,基本药物生产、流通和使用不足可归因为筹资、支付、组织、规制和行为这五个控制阀门出现了问题,具体表现在药品降价过度、新药审批制度把关不严、公立医院运行机制存在缺陷、医疗保障制度不完善、医药流通体制不规范等方面,而药品降价政策则是这些政策及机制问题的突出表象。3、药品价格、可获得性及可负担性实证研究显示:1)上海市无论是医疗机构还是零售药店基本药物的可获得性都较低。公立医疗机构创新型品牌药可获得性的中位数是13.3%,最低价等效仿制药的可获得性的中位数是33.3%;零售药店创新型品牌药可获得性的中位数是10.0%,最低价等效仿制药的可获得性的中位数是15.0%。2)总体上等效仿制药可获得性高于创新品牌药,但是部分价格低廉的药品(如阿米替林)可获得性更低,仅为16.7%3)药品价格水平很高,尤其是创新型品牌药。其价格远远高于等效仿制药的价格。如,头孢曲松纳创新型品牌药在公立医疗机构售价的中位数是其最低价等效仿制药的10倍。零售药店的零售价格略低于公立医疗机构的零售价格。公立医疗机构等效仿制药零售价的中位价格比值比零售药店高出4%。4)常见慢性病的药品费用的可负担性较低,尤其是高血压、糖尿病等慢性病的药品费用可负担性更低。使用氨氯地平治疗高血压一个月,在公立医疗机构和零售药店购买氨氯地平创新型品牌药的费用都为2006年上海市最低工资8天的工资,购买氨氯地平等效仿制药的费用也都超过了2006年上海市最低工资4天的工资。4、药品费用控制政策实施效果分析显示:单纯对医疗机构进行药品费用控制,而没有任何激励机制或进行机制的转换,控制药品费用的目的是无法实现的。社区卫生服务中心实施收支两条线的运行政策,强调了各级政府对基本卫生服务的投入责任,在解决基层医疗机构补偿问题下,规范基层医疗机构的收入,达到降低医疗费用,减轻居民疾病负担的目的。这不失为确保基本药物可及性的办法之一5、基本药物费用筹资水平测算。按照WHO的312种基本药物目录范本计算,312种基本药物约占中国药品费用的24.2%,大约需要支出基本药物费用1002亿,折合人均药费77元。也就是说如果这些基本药物均由国家免费提供,国家需要支出1002亿元。6、保证基本药物可及性的政策建议政府发挥主导性的组织生产,配送作用。对基本药物目录内产品通过定点生产、统一价格、集中采购、统一配送等一系列政策。具体建议如下:(1)基本药物目录遴选1)基本药物遴选应遵循临床必需、安全有效、价格合理、质量可控、使用方便、中西药并重的原则2)为在制定基本药物目录过程中充分进行政策协调,保证目录的权威性和公正性,应成立由国务院牵头,国家发改委、卫生部及其国家食品药品监督管理局、劳动和社会保障部、国家中医药管理局、总后卫生部、财政部、商务部等部门有关领导和相关领域专家组成的国家基本药物领导小组。3)为便于遴选工作的开展,应成立以国家食品药品监督管理局和卫生部成员为主的基本药物领导小组办公室,具体负责组织协调工作;成立由权威临床医学、药学、流行病学、药物经济学和卫生管理等方面专家组成的专家咨询小组,主要负责对领导小组的工作提出专业咨询和建议,负责药品目录的分类和目录初稿的论证。4)基本药物遴选工作将包括社区疾病谱调查、社区用药品种收集与统计、备选药品分类整理、建立遴选专家库与专家评审、专家咨询小组论证和领导小组评审等程序。在对社区用药品种收集与统计基础上对被选的备选药品分类整理,建立遴选专家库与专家评审、专家咨询小组,对遴选专家的投票结果进行论证,并对补入复选名单的新增药品进行适当调整后,形成目录复稿,再经领导小组审定后发布。5)控制基本药物目录规模(西药300,中药200种),合理调整目录结构。(2)确保基本药物的供应。1)确保基本药物的生产对用量较大的常规药,组织集中采购;用量有限的常规药品则实行定点生产。政府必须制定一套选择企业定点生产的规则,包括准入条件、生产要求等,向符合定点生产条件的企业颁发基本药物生产许可证。生产的基本药品在保证质量的前提下,采用最简易的包装,并在包装盒上注名明基本药物。2)基本药物的采购由各省的卫生部门或医保部门集中采购。药品采购的原则可遵循WHO提出的原则。3)基本药物的配送。①实行统一配送。为了减少中间环节,确保基本药物的及时供应和保证质量,降低中间环节的成本,对基本药物政府可以实行统一配送的方式。根据当地经济发展水平和药品物流运转情况,在当地选择具有一定规模和物流能力的商业公司直接配送。政府确定配送价格,避免中间环节的过多加成。②贫困地区基本药物的配送。对于贫困和偏远地区更加需要政府的主导购买和配送来实现对基本药物的可及性。③必须对药品配送企业实行严格准入,以防无序竞争。要建立健全激励补偿机制,兼顾各方利益。药品销售终端的医疗机构和零售药店实行零差率销售;(3)确保基本药物的价格可承受性。1)合理定价。列入基本药物目录中药物必须全部纳入中央政府定价范围。为避免虚高定价,基本药物目录内的所有药品,必须经国家发改委的成本核定,派审计机构到生产企业确定成本,在合理生产成本基础上,加上适当利润,同时考虑药品的功效后制定价格。2)税收优惠。给生产、经销基本药物的企业税收优惠,或取消增值税,或给予退税等优惠政策,鼓励企业生产和经营。3)通过政府议价。根据组织集中采购时规模效应与企业进行议价,在确保药品质量的前提下尽可能降低进购成本。通过政府与企业议价,达到降低价格的目的。4)强制实施通用药品替代使用。(4)基本药物的筹资基本药物应该由政府免费提供。根据我国即将建立覆盖全民的基本医疗保健制度的改革目标下,不管是否有医疗保险,基本药物都应该实行免费提供。由政府将基本药物纳入基本卫生服务包中,患者凭处方在支付少量处方费后,在任何一家医疗机构或零售药店均可获得基本药物。对贫困人群、老人、儿童或其他弱势人群则免处方费。(5)促进基本药物的合理使用。完善医疗机构补偿机制,在规范财政补助方式和理顺医疗服务价格的前提下,切断医药间的直接经济利益联系,还要在行为规范上制定以循证医学为基础的临床诊疗规范和用药规范,规范医疗机构和医生的处方行为。7、相应的配套措施(1)创建有利于基本药物政策推行的多部门协调机制,建立多部门联动机制(2)加强国家基本药物政策的立法工作。(3)加强政府对基本药物的监管能力(4)整顿药品生产流通秩序,加快药品生产、流通领域的改革,积极促进药品生产流通的规模化和现代化。(5)构建零售药店和医院之间公平竞争的平台。(6)建立基本药物可及性评估体系更多还原

【Abstract】 BackgroundNational essential medicine policy is one of the key components of national pharmaceutical policy and national public health policy at large.Research on essential medicine policy,along with practical institutional design concerning the systematic provision of safe,accessible,and affordable medicines will lead great support to national decision in containing pharmaceutical expenditure and reducing the economic burden of illness.In addition to proposing a systematic solution with regard to the manufacture,distribution, and use of essential medicines,this study has significant implications for national efforts to prevent people from being impoverished by the financial burden of diseases,to establish the national essential health care system,as well as to implement the scientific development and the building of harmonious socialist society.ObjectivesThe objective of the research is to design a framework of national essential medicines policy in line with current situation,and provide useful evidences for the establishment of national essential health care system.MethodsThe research follows the roadmap from the review of international experiences to domestic investigation on the issues of industrial organization covering the manufacture,distribution, and use of essential medicine.Both quantitative and qualitative methods are used.Empirical study on medicine prices,availability and affordability in Shanghai by using the WHO/HAI methodology.Medicine prices,availability,affordability and price components were measured in the public sector(public hospital clinics) and retail pharmacies.A total of 41 medicines were included in the survey.Prices and availability were measured in public hospitals and retail pharmacies in four randomly selected districts.In each of the four areas, five public hospitals and five private pharmacies were selected for survey.Five tertiary hospitals were also selected for survey in Shanghai municipal. The affordability of standard treatments was calculated in pre-selected conditions which identified in the WHO/HAI manual by comparing the total cost of medicines prescribed at a standard dose,to the daily wage of the lowest paid worker(25 Yuan,RMB).The treatment costs were calculated by using the price data collected at the facilities.The financing of national essential medicine was also measured based on the comparison between China Essential drug list and WHO model drug list.Statistic analysis software used are WHO-HAI_NoMSG MSH 2005 workbook ver 4.02 Nov.xls & Excel 2003 for medicines availability study and national essential medicine expenditure measurement,respectively.Conclusion1.Equitable access to essential medicines is the fundamental right to health,It is not only an intrinsic demand of a harmonious society in pursuit of equity,but a crucial process in achieving the goals of current health care reform.2.The major obstacles in the way of access to essential medicines may come from any point of the supply and demand chain.Among all factors,profit is the uppermost problem. Cheap essential medicines are being driven away from the market by distorted registration, regulation and pricing mechanism.Price-ceiling strategy in order for controlling pharmaceutical expenditure objectively results in the shortage of essential medicines.3.The finding of the empirical study on medicine prices,availability and affordability in Shanghai:1) Low availability of medicines for both public sector and retail pharmacies in Shanghai...In public facilities,the median availability was 13.3%for IBs and 33.3%for LPGs.In private pharmacies,the median availability was 10.0%and 15.0%for IBs and LPGs,respectively.2) The availability of low price medicines was higher than innovator brand medicine in the surveyed facilities,but for some medicines such as Amitilin,the availability is 16.7%much lower than any other medicines.3) The prices of innovative brands were considerably higher than that of their generic equivalents in both public sector and retail pharmacies.In the public sector,the median price of innovator brand ceftriaxone injection was almost 10 times higher than that of the lowest price generic found in the facilities surveyed.The median price of some medicines was lower in retail pharmacies than that in the public sector.4) Low affordability was observed for some common ailments,in particular noncommunicable diseases such as hypertension,diabetes,etc.For example,one month’s hypertension treatment using innovator brand amlodipine costs the lowest paid unskilled government worker 8 days’ wages,and treatment with the cheapest generic costs more than 4 days wages,when purchased from either the public or private sector.4.The results of analysis the effect on drug expenditures control policies in ShanghaiControl drug expenditures of hospitals without economic incentives and operation mechanizing transformation,the purpose of the policy cannot be achieved.The policy on separating revenues and expenditures of community health center is one of good way to ensure accessibility of essential medicines,because it emphasizes that the government at different level has financing responsibility on basic health care.In order to alleviating people’ disease of economics burden,the government formulates the policy to regulate the health center’ revenue by the subsidies of community health center.5.Measurement of essential medicines cost.The measurement base on the 312 types drugs in the WHO essential model list.The total drug costs will be 100.2 billion.Yuan.6.Feasible protocols of policy designTo promote access to essential medicines,government needs to take a set of joint measures, such as designated production,centralized procurement,distribution and storage,etc...(1)Selection of essential medicines1) The selection process should comply with following principles:clinically necessary,safe and effective,reasonable price,quality guaranteed,easy to use,and pay equal attention to both traditional Chinese medicines and the chemical medicines.2) A National Essential Medicine Leading Group led by the State Council should be established to coordinate cross-sector issues.The Group should at least include members from National Development and Reform Commission,Ministry of Health and its,State Food and Drug Administration,Ministry of Labor and Social Security,State Administration of Traditional Chinese Medicine,General Logistics Health Department in Military,Ministry of Finance,and Ministry of Commerce. 3) An office should be set up to carry out concrete work.Members should come from Ministry of Health and its State Food and Drug Administration.A Consulting Group consisted of well-knowned experts of clinical medicine,pharmacy,epidemiology, pharmacoeconomics and health management should be established to provide professional consultation and suggestion to the Leading Group,and identify prevalent diseases,set priorities and revise draft list.4) Selection procedure of essential medicines is as follows:Firstly,to investigate disease incidence and common medicines in community healthcare center to identify priorities; secondly,to evaluate similar medicines circulating in the market;to conduct experts consulting conference to enhance evidence and make final list.5) Restrict the size of Essential Medicine List,adjust list structure,keep list rational and updated.300 kinds of chemical medicines and 200 kinds of traditional Chinese medicines are probably optimal.(2) Provision of essential medicines1) ProductionRegular medicines with a great amount of usage should be procured by a central institution; Regular medicines with a few amount of usage and some special medicines should be produced in a pharmaceutical company designated by government.Besides,government should set up a series of rules to regulate those medicine suppliers,including admission standards and good manufacture practices,then,award licenses to them.Use the simplest package and clear label as long as quality has been guaranteed.2) ProcurementEssential medicines should be procured in a centralized way at provincial level by the health department or insurance agencies.Large quantities may encourage competition and lead to more competitive drug prices.The basic principles of procurement can follow the WHO suggestions.3) DistributionDistribution systems must ensure timely delivery of appropriate quantities to central or provincial stores and adequate supply to health facilities where the products are needed.■Distribute essential medicines by a united agency to reduce sales cost,and make sure that those medicines are delivered in time and with good quality at the lowest cost. ■Government’s sectors should pay more efforts in purchasing and delivering essential medicines,to improve the availability in poor and remote areas.They can do it by themselves,or devolve to private companies via tender competition.■Prospective suppliers should be pre-qualified to avoid illegal competition.Reasonable incentive and compensative mechanism should be set up to balance interests of different stakeholders.Hospitals and pharmacies are forbidden to get profit from essential medicines.(3) Affordable pricesThe key for the access to essential medicines is affordable price.1) Reasonable pricing mechanismEssential medicines should be priced by the central government.Their production costs should be calculated by the Development and Reform Commission,and audited by authorized organizations.Based on accurate cost survey,terminal price is allowed to involve proper profit to compensate producers.2) Tax preferential policyTax preferential policy could grant to producers and distribution companies to encourage them to provide essential medicines.3) Government price negotiation makes favorable prices.As the largest buyer,government can negotiate with manufacturers through centralized procurement,in order to achieve economies of scale on the basis of good quality.4) Use generic medicines to substitute patent ones.(4) Financing of essential medicinesEssential medicine should be provided free by the government.The basic healthcare system reform is in pursuit of universal access to essential medicines.Government counts the essential medicines into the basic healthcare service package.With prescription,patients can have access to any kind of essential medicines from health care facilities and retail drug stores after paying for prescription fee.However,it’s free for those poor,old,children and social vulnerable population.(5) Rational use of essential medicinesTo encourage the rational use of medicine,government should on the one hand cut off the direct economic linkage with drug prescription and dispensation,with the assistance of innovative reimbursement model and full publicity of medical service price;and on the other hand,regulate the prescription behavior of healthcare facilities and physicians by using diagnosis and treatment guidelines as well as enhanced supervision upon behavior.Besides the system measure,government should supervise and monitor the extent of rational use situation,which should be feed back to physicians and used to establish related diagnosis and treatment guidelines.(7) Policy recommendation1) To establish the multi-sector cooperation mechanism will benefit the promotion of essential medicine policy2) To strengthen the legislation of national essential medicine policy3) To strengthen the government ability of essential medicine monitoring4) Regulate the order of medicine production and circulation system,the faster the reform, the larger the scale and promoting modernization5) To build a platform for fair competition between the hospitals and the retail pharmacies.6) To set up evaluation system towards the access to essential medicines更多还原