| 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.â– 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. â– 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.â– 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...
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