Guidance on the procurement mechanism of essential drugs
The establishment of the national essential drugs system is a major institutional innovation benefiting people's livelihoods, and is the focus and difficulty of the reform of the medical and health system. Since the start of the implementation of the system, obvious progress has been made and initial results, but there are also some new situations, new problems, highlighted in the bidding and procurement of essential drugs is not standardized enough, the purchase price is not effectively and reasonably reduced, some areas of the supply of some medicines distribution is not timely, affecting the effect of the implementation of the system of essential medicines and the degree of benefit to the masses. In order to ensure the smooth implementation of the basic drug system, now on the establishment and standardization of government-run primary health care institutions of basic drugs procurement mechanism to put forward the following guidance:
The implementation of the basic drug system for the implementation of the basic drug system of the government-run primary health care institutions to use the basic drugs (including provinces, autonomous regions and municipalities of the additional varieties, hereinafter) the implementation of the provinces (autonomous regions and municipalities) as a unit of centralized procurement, unified distribution; adhere to the government-led and Combining government-led and market mechanisms, giving full play to the advantages of centralized bulk purchasing, combining bidding and purchasing, signing purchase and sales contracts, and completing the whole process of purchasing in one go, so as to minimize the cost of purchasing and promote the production and supply of essential drugs. Through the establishment and standardization of the procurement mechanism for essential medicines, the safety and effectiveness of essential medicines, their good quality, reasonable prices and timely supply will be realized, and a relatively complete supply and guarantee system for essential medicines at the grass-roots level will gradually be established, so that the public will truly benefit from them.
(I) to clarify the basic drugs procurement of the relevant responsibility of the main body. Government-organized primary health care institutions using basic drugs in the government organization and control, procurement through market competition. Provincial health administrative departments are the competent authorities for centralized purchasing of essential drugs in their provinces (autonomous regions and municipalities), responsible for building provincial centralized purchasing platforms, identifying purchasing agencies with independent legal persons and purchasing qualifications to carry out the procurement of essential drugs, and managing and supervising the purchasing agencies and primary healthcare institutions in the process of centralized purchasing of essential drugs, and coordinating the solution of problems arising from the purchasing process. Provinces (autonomous regions and municipalities) shall make full use of the existing centralized drug procurement platform and centralized drug procurement agencies to carry out the procurement of essential drugs. Municipalities (districts) and below do not set up procurement platforms and do not designate procurement organizations.
The centralized purchasing platform for essential drugs is a non-profit online purchasing system established by the government, which provides drug purchasing, distribution, and settlement services for grassroots medical and healthcare institutions, drug manufacturers and business enterprises. The purchasing organizations determined by the provincial health administrative departments utilize the centralized purchasing platform for basic drugs to carry out basic drug purchasing work, and are responsible for the use, management and maintenance of the platform. Primary healthcare institutions sign authorization or entrustment agreements with procurement agencies. As the main body responsible for procurement, the procurement agency is responsible for regularly summarizing the procurement demand for basic medicines in the province (district and city), preparing the procurement plan for basic medicines, implementing the procurement of basic medicines, and signing the purchase and sale contract with the medicine supply enterprises, and is responsible for the implementation of the contract. Purchasing organizations shall not charge enterprises and primary healthcare institutions in the process of providing services, and the necessary working expenses of the purchasing organizations are included in the government budget. Health, supervision and other relevant departments to effectively strengthen the supervision of procurement agencies.
Primary medical and health care institutions regularly submit to the purchasing agency their demand for basic medicines in accordance with the agreement, and make timely payments as agreed.
(ii) Rational preparation of basic drug procurement plan. Procurement agencies regularly summarize the basic drug needs of primary health care institutions, the preparation of basic drugs centralized procurement plan, in accordance with the clinical necessity and the grass-roots level of the actual determination of basic drug procurement of specific dosage forms, specifications, quality requirements, and a clear procurement of quantities. It is necessary to take into account the needs of adults and children for medication. Provinces (autonomous regions and municipalities) health administrative departments to strengthen guidance and coordination.
Temporarily unable to determine the number of provinces (autonomous regions and municipalities) can be procured through a single source of commitment, that is, for each type of basic drugs (specific to the dosage form and specifications) to choose only one enterprise procurement, so that the enterprise to obtain the supply area of the drug all market share, the supply area of all government-run primary health care institutions use of basic medicines (specific to the dosage form and specifications) only by the supply of a single enterprise. one enterprise to supply them.
(3) Strengthening market price surveys of essential medicines. Provinces (autonomous regions and municipalities) health administration and price supervisors and other relevant departments should conduct a comprehensive survey of the actual purchase and sale prices of essential medicines in the market in the past three years, including the retail prices of social retail pharmacies and the actual purchase prices of primary health care institutions before the implementation of the essential medicines system. The actual purchase and sale prices in the market should be used as an important basis for the procurement of basic drugs, and in principle, the centralized procurement price should not be higher than the actual purchase and sale prices in the market. The Ministry of Health and the National Development and Reform Commission to collect and summarize market price surveys around the establishment of basic drug price information base.
The purchasing price (including distribution costs) determined by the purchasing agency through centralized purchasing is the actual selling price for primary health care institutions.
(d) clear basic drug supply main body. In principle, the amount of large (specific criteria determined by the provinces, autonomous regions and municipalities) of basic drugs directly to the production enterprises to purchase, the production enterprises commissioned by their own business enterprises for distribution or direct distribution; small amount of basic drugs can be centralized and packaged to the drug wholesale enterprises procurement (including distribution). They can also be purchased from wholesale enterprises that sell drugs on behalf of the manufacturing enterprises. Regardless of which approach is taken, the main body of supply is responsible for the quality and supply of drugs together.
(E) differentiation of the situation of categorized procurement. Differentiation of different situations of essential drugs, to take different procurement methods:
-- exclusive production of essential drugs, to take with the production or wholesale enterprises for the purchase of separate bargaining.
-- For special medicines and first-aid medicines that are necessary for the grassroots but in small quantities, procurement is carried out by inviting tenders, requesting quotations, or fixed-point production.
-- For essential drugs that are commonly used in clinical practice and have low prices (recommended to be those with an average daily use cost of less than RMB 3 yuan, with the specific standards to be determined by the provinces, autonomous regions and municipalities on their own), or whose prices have been basically stabilized after repeated purchases, the method of procurement is by invitation to bidding or request for quotations.
-- Narcotic drugs, psychotropic drugs, medicines for free treatment of infectious and parasitic diseases, vaccines for immunization planning, family planning medicines, and traditional Chinese medicine tablets among the basic medicines will still be procured in accordance with the existing national regulations.
--All other essential drugs shall be procured through public bidding. If the bidding price is higher than the actual market price, the purchasing organization shall bargain with the bidding enterprises individually, and if no agreement can be reached, the bidding shall be declared invalid.
--The above ways are not able to purchase the basic drugs, agreed by the provincial health administrative department, the purchasing agency can look for alternative dosage forms, specifications re-procurement, or commissioned by a qualified enterprise designated for production, and promptly reported to the Ministry of Health and the State Council to deepen the reform of the medical and health system, the leading group of the Office of the State Council Medical Reform (hereinafter referred to as the Office of the State Council for the record). hereinafter referred to as the State Council Office of Medical Reform) for the record. Encourage localities to explore inter-provincial joint purchasing and other ways to further reduce the price of essential drugs and ensure supply.
(6) Adhere to the priority of quality and reasonable price. The procurement of essential medicines should follow the principle of quality first and price reasonable. Encourage localities to adopt a "double envelope" bidding system, that is, in the preparation of bids, respectively, the preparation of economic and technical bids and business bids, enterprises at the same time to vote for two bids. Economic and technical bids mainly on the enterprise production scale, distribution capacity, sales, industry rankings, market reputation, as well as GMP (GSP) qualification certification, the history of drug quality testing and sampling, electronic monitoring capabilities and other indicators for evaluation, to ensure the quality of essential medicines. Only enterprises that have passed the evaluation of economic and technical bids can enter the evaluation of business bids, and the evaluation of business bids will be awarded to the one with the lowest price. Each region can also set up qualification conditions to screen the bidding enterprises; it can also design a scoring index system based on the quality and price of essential drugs and other elements, and conduct comprehensive scoring of the bidding enterprises. By the provincial health administrative departments in conjunction with the procurement agency based on the main body of supply and the actual situation, the rational design of the province (district, city) specific bidding methods.
After the procurement agency to determine the supply enterprise, the supply enterprise to supply samples of drugs to be sent to the provincial food and drug regulatory departments for the record. Provincial food and drug regulatory authorities to strengthen the quality of essential drugs sampling, if necessary, the sampling samples and record samples for comparison, the quality of the problems in accordance with the relevant provisions of the punishment, and promptly announced to the community.
(VII) fully listen to the views of primary health care institutions. To play the primary health care institutions managers and medical workers in the procurement of basic drugs play an active role. In the procurement plan development, bid evaluation, negotiation and other important links, there should be a considerable proportion of primary health care institution managers and medical staff representatives to participate in the specific provincial health administrative departments in conjunction with the purchasing agency in accordance with the actual situation to determine.
(viii) Signing of basic drug purchase and sales contracts. Purchasing organizations on behalf of primary health care institutions and supply enterprises to sign purchase and sales contracts, clear varieties, dosage forms, specifications, quantities, prices, delivery time and place, payment time, performance mode, liability for breach of contract, etc., and is responsible for the implementation of the contract. If the contracted purchase quantity cannot meet the needs of clinical use of drugs, primary health care institutions can apply for additional contracts to be signed between the purchasing agency and the supplier enterprises, and the supplier enterprises shall not refuse in principle. The Ministry of Health in conjunction with the relevant departments to develop and implement a standard contract text.
(IX) strict payment system for the procurement of essential drugs. Each region to establish a comprehensive payment system for the procurement of essential drugs, and in the purchase and sale contracts to specify the payment procedures and time. Supply enterprises in accordance with the contract requirements will be distributed to the primary health care institutions, primary health care institutions for delivery and acceptance of delivery and issued a receipt, the purchasing agency according to the receipt of payment, in principle, from the delivery and acceptance of payment shall not exceed 30 days (the specific number of days to be agreed in the contract). If payment is not made on time, the procuring organization shall pay liquidated damages to the enterprise. Procurement agencies shall set up special accounts, develop specific payment processes and methods, and make uniform payments for basic drug deliveries to all primary healthcare institutions. Each region can set up a certain amount of basic drug procurement working capital, to ensure that the basic drug payment in full and timely payment.
(J) the establishment of strict integrity records and market clearance system. The procurement process to provide false documents, deliberately raise prices or maliciously low prices, refused to sign a contract after winning the bid, the supply of substandard quality of drugs, not in accordance with the provisions of the contract for timely delivery of supplies, to the purchasing agency, the primary health care institutions and individuals to bribery or bribery in disguise, are recorded and punished in accordance with the following provisions: a violation of a stern warning, and a limited period of time to rectify or rectify; late correction Or second violation, by the provincial health administrative department will violate the list of enterprises and legal representatives and violations of the law to the public, all provinces (autonomous regions and municipalities) within two years shall not be allowed to allow the enterprise and its legal representatives to participate in the province (autonomous regions and municipalities) of any drug bidding and procurement. Violation of relevant laws and regulations, to be punished according to law.
Health and other relevant departments to participate in the above violations of the procurement agencies, health care institutions and related personnel in accordance with the relevant provisions to be severely punished, and publicize their bad records, accept social supervision.
(xi) Improve the information system for the electronic supervision and supply of essential drugs. The State Food and Drug Administration to improve the national unified basic drug information bar code (electronic regulatory code) and drug electronic monitoring platform, the basic drugs for all varieties of electronic monitoring. 2011 April 1 onwards, the provinces (autonomous regions and municipalities) shall not be purchased into the drug electronic monitoring network and did not use the basic drug information bar code uniform identification of the supply of basic drugs of the enterprise.
All provinces (autonomous regions and municipalities) are encouraged to further expand the functions of the centralized purchasing platform for essential medicines, to open up the information channels between the health administrative departments, essential medicines manufacturers and wholesalers, and primary medical and healthcare institutions, and to set up a real-time supply information system for the whole process of real-time updating of the essential medicines from the factory to the use of them, and to dynamically supervise and analyze the situation of the production, circulation, stockpiling and use of the medicines. Places with the conditions are encouraged to carry out electronic transactions, saving transaction costs and improving transaction transparency.
(xii) standardize the quality standards and packaging specifications of essential drugs. The State Food and Drug Administration to gradually improve the quality standards of basic drugs. The Ministry of Health shall gradually standardize the dosage forms and specifications of basic medicines used in primary health care institutions, and determine the standard dosage forms, standard specifications and standard packaging of basic medicines according to the actual needs of grass-roots medicine. Before the state has issued standardized dosage forms and specifications for basic drugs, each province (autonomous region and city) will purchase no more than three dosage forms of each basic drug in principle, and no more than two specifications corresponding to each dosage form in principle.
(xiii) Establishment of a system for publicizing information on the procurement of essential medicines. Provincial health administrative departments must take the initiative within three days of the end of the procurement to the community to announce the primary health care institutions of basic drugs procurement prices, procurement of quantities and winning enterprises, to accept social supervision, and at the same time reported to the Ministry of Health for the record and copied to the State Council Office of Health Care Reform. Encourage the news media and other sectors of society to monitor the basic drug procurement process, the establishment of a reward reporting system to create an open, fair and just procurement environment.
(xiv) the establishment of basic drugs guide price dynamic adjustment mechanism. Price authorities to strengthen the cost of basic drugs and market price monitoring of purchases and sales, and further improve the pricing of basic drugs, dynamic adjustment of the level of basic drug guide price, to guide the local centralized purchasing price is reasonable. Exclusive varieties and the centralized purchasing price has been basically stable and adequate supply of basic drugs, to explore the implementation of national unified pricing. Provinces (autonomous regions and municipalities) price authorities should strengthen the supervision and inspection of the implementation of the price of basic drugs, and investigate and deal with all kinds of price violations in accordance with the law.
(xv) Promote the rational use of drugs by grass-roots medical personnel. All regions and departments concerned should take advantage of the opportunity to establish and standardize the procurement mechanism of basic drugs to guide and regulate the behavior of grass-roots medical personnel in the use of drugs. Strengthen the training and assessment of grass-roots medical personnel, as soon as possible to promote the clinical application of basic drugs guide and prescription set in the grass-roots level of universal use, and encourage the use of information systems around the grass-roots level of medical and health institutions and medical personnel of the use of medication behavior to regulate. Increase publicity efforts to guide the public to change their medication habits, and promote the clinical preference and rational use of basic drugs.