Office of the State Council person in charge of health reform on the establishment of norms

 

Release of essential drugs procurement mechanism Quan

 
 
      
Ministry of Health

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   Recently, the State Council issued "to establish and regulate the government on primary health care institutions to do the basic mechanism of drug procurement guidance" (hereinafter referred to as "procurement mechanism"). In this connection, the reporter interviewed the State Council Leading Group Office is responsible for health reform people.

    Q: The implementation of the national essential drug system more than a year, why should the introduction of "procurement mechanism"?
    Establishment of a national essential drug system is to benefit people's livelihood system innovation designed to protect the masses of basic drugs. Start the implementation of this system since last year, has made significant progress and initial results, as of now, more than 50% of the government-run primary health care institutions to implement a basic drug system, and zero sales slip. However, there have been some new situations and new problems, outstanding performance in the procurement of essential drugs bidding irregularities, the problem is not artificially high drug prices reasonable solution effectively, some regions appeared off for some drugs, out of stock, etc., affect the essential drugs implementation of the system effectiveness and the level of benefit the masses. Medical reform by the State Council Leading Group of the instructions, the Office of the State Council jointly with relevant departments of the medical reform bidding and purchasing of essential drugs and the presence of key outstanding issues in-depth analysis, and actively learn from the successful experience of centralized procurement of drugs, carefully briefed on the aspects and international expert advice and recommendations, targeted measures proposed to form a "procurement mechanism" first draft. After soliciting departments, local views, repeatedly revised and improved to form a "procurement mechanism" manuscript, Office of the State Council plenary meeting health reform discussions, submitted to the State Leading Group Plenary medical reform considered by the State Council Office on November 19 Office formally issued the "procurement mechanism."
    "Procurement mechanism" is an important national essential drug system supporting documents, will effectively promote the country as soon as possible to establish a standard mechanism for centralized procurement of essential drugs at the provincial level and build a relatively complete supply of essential drugs with the primary security system to ensure a smooth system of essential drugs implementation.

    Q: The "procurement mechanism" introduced in the general considerations that? What are the innovative initiatives and highlights?
    "Procurement mechanism" the general idea is, the implementation of the provinces (autonomous regions and municipalities) as the unit of centralized purchasing, uniform distribution; adhere to the government leadership combined with the market mechanism play a dominant focus on bulk procurement, tendering and procurement combination of volume and price linked signed a contract to purchase the whole process at once, minimizing the procurement costs of essential drugs to achieve safe and effective, good quality, reasonable price and timely supply, promoting the production and supply of essential drugs, so that the people really benefit.
    "Procurement mechanism" for the obvious problems around, around the quality of essential drugs, price and supply of three core elements, a series of targeted and innovative measures, including: First, the main responsibility of a clear procurement by the provincial health administrative department of the main body responsible for the procurement agencies for the procurement of essential drugs procurement, and government-run primary care health facilities authority or trust agreement entered into with pharmaceutical suppliers signed purchase and sales contracts and is responsible for execution of the contract. Second, adhere to the volume and price-linked, through the preparation of procurement plans, specific purchases (temporarily unable to determine the number of commitments by way of a single source), the whole process of procurement to achieve a complete, signed a purchase and sales contracts, and strictly for payment. Give full play to the advantage of bulk purchases. Third, the quality first, price reasonable. Adhere to the quality first, take the "double envelope" tender, to ensure credibility, good quality, strong supply capacity of enterprises to compete. Meanwhile, the actual buying and selling prices of essential medicines to conduct a comprehensive market survey, in principle, concentrate on the actual purchase price shall not be higher than the market buying and selling prices to ensure that the purchase price is reasonable. Fourth, strict integrity of records and information disclosure system, for breach of contract, there quality standards, no such violations are treated on time delivery record, and made public, a strict system of market repaying overdue reform, the two any drugs during the year shall not participate in the national bidding. Through online procurement platform, to improve transparency of transactions, the purchase price of essential drugs, quantity and successful enterprises in time to the public, accept social supervision, from the system and mechanisms to create an open, fair and impartial procurement environment.

    Q: The price is high in the previous bidding and purchasing drugs has not solved the problem, the introduction of the "procurement mechanism" to ensure procurement of drugs at reasonable prices?
    Drug bidding a price higher concentration of such phenomena, the main reason is out of line tendering and procurement, provincial companies bidding to determine only the list of common secondary medical institutions bargaining. This "procurement mechanism" proposed specific measures are:
    The first volume and price linked to the preparation of procurement plans by the specific formulation of a clear procurement, specifications and quality requirements, specifically the number of purchases (or the introduction of a single source commitment); so, before the drug supply business in the tender can be more accurately calculate the number of suppliers and market share, easy to calculate costs and determine a reasonable offer.
    Second, strengthen the market price survey of essential drugs, requiring thorough investigation and control of essential drugs in recent years the retail price of retail pharmacies and essential drugs system of primary health care and health institutions before the actual purchase price, in principle, focus on the purchase price shall not exceed the actual purchase and sale market price. Thus, protection of the centralized purchasing price within reasonable limits.
    Third, the classification of the procurement approach taken to reasonably determine the targeted price. The existence of higher prices and artificially high prices of essential medicines for public tender, by means of two-envelope tender system, take advantage of market competition to form a reasonable purchase price. Meanwhile, after numerous exclusive species and the purchase price has been relatively stable and sufficient supply of essential drugs, the uniform pricing by exploring the way the government set prices reasonable. While the small amount of special medication, commonly used in emergency medicine and clinical use of low-cost drugs to invite tenders, quotations or purchase fixed production methods, reasonably determine the purchase price in order to ensure supply.
    Fourth, purchase and sales contracts signed after the end of bidding to ensure that the price of the basic purchase price, the maximum compression circulation, reduce the layers of the space increases.
    Fifth, the procurement of essential drugs strictly payment system, requiring acceptance from a delivery within 30 days after the payment, and the current drugs of payment, usually about 6 months or even longer, taking up a lot of liquidity of the enterprise, and new measures to implement uniform payments, will greatly reduce the cost of tying up working capital, further reducing the price of drugs.

    Q: In the lower drug prices at the same time, "procurement mechanism" to guarantee drug quality?
    Quality is priority "procurement mechanism" always adhere to the principle of centralized procurement of essential drugs is safe and effective in ensuring that, under the premise of good quality, reasonably determine the price of essential drugs.
    In the procurement chain, the implementation of the "double envelope" bidding system, not only on economic and technical bids GMP (GSP) certification, history of drug quality testing checks, electronic monitoring capacity of the index reflects the assessment of drug quality, but also production rating size, distribution capabilities, sales, industry rankings, market reputation and overall strength index, only the economic and technical tender evaluation qualified companies to enter the commercial tender evaluation, quality and reputation out of non-compliant enterprises.
    In the control session, the procurement of essential drugs for the whole process of quality control, delivery companies to send samples to the provincial drug supply food and drug supervision departments for the record, the provincial food and drug supervision departments should strengthen the quality of essential drugs testing, random sample, when necessary, samples were compared with the record to ensure the quality of essential drugs.
    In the penalties, the establishment of a "blacklist system", once the malicious drive down prices, supply of substandard quality drugs and other acts of the enterprise, removed from the national drug to market penalties bidding, through stringent monitoring measures to ensure drug quality and safety of a powerful .
    Meanwhile, the "procurement mechanism" is also proposed to gradually increase the quality standards of essential drugs, improve the information system of electronic monitoring of essential drugs, effective protection of both the centralized procurement of essential drugs in the current drug quality, but also long-term plan to establish a more scientific and reasonable evaluation and drug quality supervision system.

    Q: How to achieve timely delivery of essential medicines to every primary care health institutions, continue to file, not out of stock, "procurement mechanism" What are the considerations?
    Relative to large medical institutions, primary care health facilities scattered, small amount of drugs, distribution, profit margins, in the drug supply chain in a weak position, especially those located in remote, small-scale grass-roots health care institutions can not effectively protect the drug supply . "Procurement mechanism" proposed by the companies to determine their own essential drugs supply and distribution enterprises entrusted with the operation or direct delivery by the supplier of pharmaceutical companies be responsible for the quality and supply. Transferring part of the drug distribution to the market, give full play to market the role of resource allocation and division of labor to achieve the distribution of medicines in a timely manner, it is "procurement mechanism" of an innovation. This design does not mean that the government let go of whatever part of delivery, on the contrary, the Government will be mainly through the supervision and service to ensure timely delivery of essential medicines in place for easy accessibility.
    In regulation, the clear responsibility of the main drug distribution, by contract constraints. Procurement agencies in the purchase and sale and supply companies signed a contract to supply a clear way in the contract, time, place and requirements, clear delivery and distribution business is primarily responsible. Distribution or supply business is self-distribution of pharmaceutical enterprises entrusted by the supplier firms to choose. Once the supply of essential drugs and other issues not in time, be liable for default by the supplier firms. The move, to resolve the current drug distribution areas of corporate responsibility in the production and distribution division of the knot disease is difficult to provide a legal basis.
    In services, the establishment of non-profit online centralized procurement platform for the primary care health institutions, pharmaceutical production and business enterprises to provide drug procurement, distribution and settlement services. Primary health care institutions on the platform of orders placed, delivery within the specified time enterprise, primary health care institutions confirmed online procurement agencies to pay on time. Meanwhile, relevant departments using a centralized procurement platform for the supply of the drug transactions and the implementation of dynamic monitoring of drug procurement, use and return funds usage, when it fails to timely availability, rapid coordination of treatment, to avoid breaking for essential drugs, out of stock situation.
    Through the new design of the system, primary care health institutions only need to post online orders, delivery will be required pharmaceutical companies to the door in time to ensure the easy availability of essential drugs. Meanwhile, the "procurement mechanism" also encourage all centralized procurement of essential drugs to further expand the platform functionality to centralized purchasing, based on the introduction of the concept of modern logistics in the pharmaceutical supply system, the establishment of essential medicines from the factory to use the entire process of real-time updates system, further improve the efficiency of distribution.

    Q: "procurement mechanism" after the implementation of pharmaceutical production and operation of enterprises will have what impact?
    Establish a standard mechanism for centralized procurement of essential drugs, essential drugs both to protect the quality, price and supply, but also to promote the production of essential medicines. Only manufacturers are willing to production, distribution companies are willing to distribution of essential drugs to a fundamental guarantee quality and supply. At present, the production and circulation of drugs there are many small, scattered, chaotic problem, as many as 5,257 drug manufacturers, drug wholesalers 13000, there have been industry overcapacity and structural oversupply conditions. In the long run, centralized procurement mechanism to regulate pharmaceuticals production and circulation order, and establish healthy competition, and guide enterprises optimize drug production and structure, integration of resources has a positive significance.
    At present, the new procurement mechanism for the protection of pharmaceutical production and management companies a reasonable profit, there are many positive measures. "Procurement mechanism" make clear the number of procurement and supply area, bulk purchases, increased sales of the enterprise, effectively reducing the cost of advertising and marketing will help enterprises reduce costs, improve efficiency and effectiveness. Through a unified payment system, the procurement agencies to pay for a unified drug money, and shorten the payment cycle to 30 days, enterprises do not again a reminder of each primary health care institutions, distribution costs, capital mobility increased. Particular emphasis is the centralized procurement of essential drugs is not simply to lower prices, but the protection of enterprises on the basis of a reasonable profit, compression circulation unreasonable costs, in order to achieve reasonable prices.
    Meanwhile, the new procurement mechanism is the existing pattern of interests profound adjustment, drug production enterprises also need to focus on new mechanisms to actively adapt, adjust and expand the new development. Under the new procurement services to pharmaceutical enterprises will gradually shift the focus to the distribution function up. At present, some enterprises have begun to transition or expand services, and actively improve the service network below the county level, for the characteristics of primary health care institutions to provide distribution services, on a drug inventory management and other integrated services.

    Q: "procurement mechanism" proposed by procurement agencies is the responsibility of centralized procurement of essential drugs subject, this design is based on what kind of consideration? Procurement agencies and primary health care institutions What is the relationship?
    "Procurement mechanism" proposed procurement agencies as the main responsibility for the procurement of essential medicines. Procurement agency on behalf of primary health care institutions and is responsible for execution of the contract procurement of drugs will help realize the amount of price-linked, variable decentralized procurement is centralized purchasing, centralized payment payments become decentralized, the maximum compression of intermediate links, to improve procurement efficiency and reduce procurement costs; is conducive to primary care health institutions to eliminate the drug from the fundamental mechanism of subsidizing hospitals; clear rights and responsibilities of procurement agencies, is conducive to responsible departments of drug supervision and management of the procurement chain.
    "Procurement mechanism" to define the conditions and nature of procurement agencies, which determined by the provincial health administrative department, and have independent legal and procurement qualifications. Procurement of essential drugs in order to ensure the public welfare, but also provides the procurement process in the delivery of services to enterprises and primary care not to charge any fees and health institutions, funding for the necessary work required to be included in the government budget.
    As the main responsibility by the procurement agencies to carry out the procurement of essential drugs, basic medical needs of purchasing organizations and health agencies. "Procurement mechanism" to further clarify the provinces (autonomous regions and municipalities) health administrative department of essential drugs in the region, centralized purchasing department is responsible for centralized procurement platform for the provincial structures, and centralized procurement of essential drugs in primary health care purchasing organizations and health institutions management and supervision, coordinate and solve problems in procurement, to ensure the smooth development of the procurement.
    Primary health care purchasing organizations and health institutions and signed authorization or trust agreement, the procurement agencies in the region periodically summarize essential drugs procurement requirements, the preparation of pharmaceutical procurement plans, the implementation of the procurement of essential drugs and medical supplies companies with signed purchase and sales contracts, responsible for the execution of the contract payments, etc. . At the same time, primary health care institutions should follow the requirements of the agreement, the procurement agencies regularly to the treatment needs of basic medicines, and timely payment.

    Q: "procurement mechanism" proposed initiatives to be effectively implemented?
    New procurement system policies, and operating requirements of high end "procurement mechanism" of the country, all relevant departments to implement specific requirements for the work proposed. First, a clear schedule, requiring provinces (autonomous regions and municipalities) and Xinjiang Production and Construction Corps, the leading group of medical reform in accordance with "procurement mechanism" of the spirit, and quickly adopt the province (district, city) government-run primary care health institutions specific procurement of essential drugs approach, in principle, the introduction of 30 working days. As soon as possible under the new procurement practices to complete a procurement cycle, procurement of essential drugs. Second, strengthen training and guidance, the Office of the State Council will implement the health reform "procurement mechanism" to make special arrangements, and conduct intensive training, the preparation of the centralized procurement of essential drugs operation manual, guidance and help throughout the work as soon as possible to ensure the system does not distort, does not deformation. Third, establish an incentive mechanism, the Office of the State Council will, together with relevant departments of health reform on the progress and effectiveness of procurement around the pooled analysis, and procurement of essential drugs as one of the core indicators of health reform assessment, procurement of essential drugs throughout the assessment, and with capital subsidy linked.
    Previously, Anhui Province has been in accordance with the "procurement mechanism" to carry out the requirements of a procurement of essential drugs, basic realization of the basic drug procurement target for the country played an exemplary role. (Source: National Development and Reform Commission website)