State Council on establishing and regulating the issuance of government-run 

 

Basic primary health care institutions guide drug procurement mechanism

 

Opinions

 

 
 
      
Ministry of Health

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SCS 〔2010〕 56

Provinces, autonomous regions and municipalities, 国务院各部委, agencies directly under:
"Establish and regulate the government-run primary care health institutions mechanisms for essential drugs procurement guidance" has been the State Council, is issued to you, please seriously with the practical implementation.
State Council
二○一 ○ 年 十一月 十九 日
 

 

 

 

    Establish and regulate the government primary health care institutions to do the basic mechanism of drug procurement guidance

 

    Establishment of a national essential drug system is to benefit people's livelihood system of innovation is the focus of recent medical and health system and difficult. Since the implementation of the system start, achieved remarkable progress and initial results, but there have been some new situations and new problems, the most prominent in the bidding and purchasing of essential drugs is not sufficiently standardized, effective and reasonable purchase price is not reduced, some areas are not part of the drug supply and distribution timely implementation of a basic drug system and the mass effect of the level of benefit. To ensure the smooth implementation of the basic drug system, is to establish and standardize the government-run primary care health institutions essential drugs procurement mechanism the following guidance:
    First, establish and standardize the basic general idea of the mechanism of drug procurement
     Of the basic drug system of government used to do primary health care, essential drugs and health institutions (including the addition of species provinces, autonomous regions, the same below) to implement the provinces (autonomous regions and municipalities) as the unit centralized purchasing, uniform distribution; adhere to government-led and market mechanism combination of play focus on bulk purchasing advantages, combined with the tender and procurement, purchase and sales contracts signed, once completed the whole process of procurement, to minimize procurement costs, and promote the production and supply of essential drugs. Through the establishment of the procurement of essential drugs and standardized mechanism to realize the essential drugs safe and effective, good quality, reasonable price and timely supply, and gradually establish a relatively comprehensive primary security system with basic medical supplies, so that the people really benefit.
Second, establish and standardize the basic mechanism of the main measures of drug procurement
(A) clearly related to the procurement of essential drugs the main responsibility. Government-run primary care health facilities with basic drugs under the control of government organizations and, through market competition procurement. Provincial health administration is the province (autonomous regions and municipalities) in charge of centralized procurement of essential drugs department, responsible for centralized procurement platform for the provincial structures to determine the status with independent legal and procurement of essential drugs procurement agencies to carry out procurement, and the centralized procurement of essential drugs the process of purchasing organizations and primary health care institutions to manage and supervise, coordinate and solve problems in procurement. Provinces (autonomous regions and municipalities) should make full use of existing drugs and drug concentration of centralized procurement platform for the procurement of essential drugs procurement agencies. City (prefecture) and the following no procurement platform, do not specify the procurement agencies.
      Centralized procurement of essential drugs for the Government to establish platform for online procurement system, non-profit, grassroots medical institutions, pharmaceutical production and business enterprises to provide drug procurement, distribution and settlement services. Provincial health administrative department of the use of essential drugs procurement agencies to carry out centralized procurement platform for the procurement of essential drugs, is responsible for platform use, management and maintenance. Primary health care purchasing organizations and health institutions and entered into license or commission agreement. Procurement agencies as the main responsibility for procurement, responsible for periodic summary of the province (autonomous regions and municipalities) of essential drugs procurement requirements, the preparation of essential drugs procurement plan, 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. Procurement agencies in the provision of services to businesses and not the fees charged by primary health care, procurement agencies the necessary funding for the work included in the government budget. Health, monitoring and other related departments to strengthen supervision of the procurement agencies.
Primary health care institutions in accordance with the Agreement periodically to the procurement of essential drugs in bodies demand timely payments according to agreement.
     (B) the preparation of essential drugs procurement plan reasonable. Regular summary of primary health care purchasing organizations and health institutions demand for essential drugs, basic drugs focus on the preparation of procurement plans, according to clinical need and procurement of basic essential drugs is virtually certain specific types, specifications, quality requirements, specifically the procurement quantity. To take into account the needs of adults and pediatric patients. Provinces (autonomous regions and municipalities), health administrative departments should strengthen guidance and coordination.
Can not determine the number of temporary purchases provinces (autonomous regions and municipalities) can be committed by way of single source procurement of essential drugs for each of the (specific to the dosage form and specifications) to select only a business purchase, so that the enterprises to obtain the drug supply in the region All market share within the region in the supply of primary health care of all government health institutions to do the basic use of drugs (specific to the dosage form and specifications) only by the supply of a business.
    (C) strengthening of basic drug market price survey. Provinces (autonomous regions and municipalities), health administration and other related departments in charge of prices of essential medicines to the actual purchase and sale price of nearly three years to conduct a comprehensive market survey of retail pharmacies, including retail prices of essential drugs and primary health care system and health institutions before the actual purchase price. Actual market buying and selling prices should be used as an important basis for the procurement of essential drugs, in principle, concentrate on the actual purchase price shall not be higher than the market buying and selling prices. Ministry of Health and National Development and Reform Commission to collect aggregate market price over the investigation, the establishment of essential medicines price information database.
Procurement agencies through centralized procurement to determine the purchase price (including shipping cost) is the primary health care institutions the actual sales price.
     (D) clearly the main supplier of essential medicines. In principle, the amount of large (the specific criteria by the provinces to determine) the production of essential medicines directly to corporate procurement, management commissioned by the manufacturers themselves or direct distribution and distribution enterprises; a small amount of essential drugs can concentrate on the procurement package to the pharmaceutical wholesale enterprises ( with distribution). They may also produce its pharmaceutical wholesale business sales business purchases. Either way, the main supplier of drugs must be responsible for the quality and supply.
     (E) Classification of purchasing different conditions. Distinguish between the different conditions of essential drugs, to take a different procurement methods:
- The exclusive production of essential drugs, taken with the production or wholesale business the way a separate negotiation procurement.
- A small grass-roots level but the amount required special medication, emergency medicine, the use of inviting tenders, quotations or purchase fixed the procurement of production.
- Common and inexpensive clinical (recommended daily average of 3 yuan using the cost of essential drugs, the specific standards by the provinces to determine), or the purchase price by the number of essential drugs has been basically stable, invitation to tender or Inquiry procurement purchases.
- Of basic drugs in the narcotic drugs, psychotropic drugs, free treatment of infectious and parasitic diseases medication, vaccine immunization program, family planning drugs and Chinese Herbal Medicine, based upon the existing provisions of State procurement.
- Other essential drugs should be a public bidding. In case of companies bidding in the tender price is higher than the market price of the actual purchasing, procurement agencies should be followed by a separate enterprise bargaining tender, the same can not be reached, that is declared in bid rejection.
- Way of the above have failed to procure essential drugs, the provincial health departments have agreed to, procurement organizations can look for alternative formulations, specifications re-purchase, or entrust qualified enterprises designated production, and timely report the Ministry of Health and the State Council deepen the health care system reform leading group office (hereinafter referred to as the Office of the State health care reform) for the record. Encouraged to explore the inter-provincial joint procurement of parts and other methods to further reduce the prices of essential drugs and ensure supply. 
     (F) adhere to quality first, price reasonable. To follow the quality of essential drugs procurement priority, the price reasonable. Encourage local use of the "double envelope" of the bidding system, which were prepared in the preparation of tender bids and commercial bids economic and technical, business investment also two bids. Mainly on economic and technical bids of production scale and distribution capabilities, sales, industry rankings, market reputation, and GMP (GSP) certification, history of drug quality random spot checks, electronic monitoring and other indicators of capacity assessment, to ensure the quality of essential drugs. Economic and technical tender evaluation only qualified companies to enter the commercial tender evaluation, business evaluation by the price of the lowest tender bid. You can also set up around the way qualifications of bidding enterprises screening; also essential medicines according to factors such as design quality and price score index system for comprehensive evaluation bidding companies. By the provincial health administrative department together with the main supply and procurement agencies in accordance with the actual situation, rational design of the province (autonomous regions and municipalities) to the specific tender approach.
     Procurement agencies to determine supply enterprises, the supply of pharmaceutical companies to supply samples to be sent to the provincial food and drug supervision department. Provincial food and drug supervision departments should strengthen the quality of the testing of basic medicines, if necessary, samples will be sampling the sample were compared with the record, the quality problems in accordance with the relevant provisions of the punishment, and in a timely manner to the public.
     (Vii) fully listen to the views of primary health care institutions. To play a primary health care managers and health workers and health institutions in the procurement of essential drugs in the active role. In the procurement planning, bid evaluation, negotiations and other important aspects, there must be a substantial proportion of primary care managers and medical personnel and health institutions are represented in particular by the provincial health administrative department together with the procurement agencies in accordance with actual conditions.
(Viii) entered into a purchase and sales contracts of essential drugs. Representatives of procurement agencies and health institutions and availability of primary health care companies signed a purchase and sales contracts, clear varieties, types, specifications, quantity, price, delivery time and location, time of payment, performance methods, such as breach of contract, and is responsible for the implementation of the contract. If the purchase amount of the contract can not meet the needs of clinical medicine, primary health care institutions can apply, by the procurement agencies signed an additional contract with the supplier firms, in principle, rejected the supplier firms. The Ministry of Health in conjunction with relevant departments to formulate and implement a standard contract text.
    (I) procurement of essential drugs strictly payment system. Country to establish a sound payment system for the procurement of essential drugs, and clearly in the purchase and sale contract payment process and time. Supply enterprises in accordance with contract requirements to drug distribution to primary health care institutions, the primary medical and health institutions and issue a receipt for the delivery and acceptance, procurement agencies, according to sign a single payment, in principle, to the payment from the acceptance of delivery shall not exceed 30 Day (number of days in the contract.) Failure to make the payment, the procurement agencies to pay liquidated damages to the company. Procurement agencies to set up a special account, to develop specific processes and methods of payment for primary care health institutions of the purchase price of essential drugs for unified payment. Can be set up around a certain working capital procurement of essential drugs to ensure the timely and full payment of the purchase price of essential medicines.
(J) to establish a strict system of credit records and lay off the market. The procurement process to provide false documents, or malicious intent to raise prices lower prices, refusing to sign a contract bid, the supply of substandard quality of drugs, failure to timely delivery supply contract to the procurement agencies, health institutions and primary health care individuals or a disguised bribe bribery, should be recorded shall be punished according to the following: a violation stern warning and a deadline for correction or rectification; fails to do or secondary violations by the provincial health administrative department and the illegal enterprise The list of legal and illegal violations to the public, all provinces (autonomous regions and municipalities) within two years shall not allow the enterprise and its legal representatives in the province (autonomous regions and municipalities) of any drugs bidding. Violation of relevant laws and regulations, to be punished according to law.
      Health and other relevant departments involved in these illegal activities in the procurement agencies, health agencies and related personnel shall be punished according to relevant regulations, and to disclose their bad record, accept social supervision.
(Xi) improve the monitoring of essential drugs and supply of electronic information systems. State Food and Drug Administration to improve the national unity of the basic drug information bar (electronic monitoring code) and the Drug electronic monitoring platform for all varieties of basic drugs of electronic monitoring. April 1, 2011, the provinces (autonomous regions and municipalities) shall not purchase drugs without electronic monitoring into the network and use basic drug information does not identify the bar code unified enterprise supply essential drugs. 
     Encourage the provinces (autonomous regions and municipalities), the centralized procurement of essential drugs to further expand the capabilities of the platform, open up the health administrative departments, essential drugs and primary production and wholesale enterprises of information between the medical and health institutions channels, and establish a basic drug from the factory to use the entire process of real-time the supply of updated information systems, dynamic monitoring and analysis of drug production, distribution, inventory and usage. Place to encourage qualified to carry out electronic transactions, reduce the transaction costs and improve the transparency of transactions.
     (Xii) regulate the quality standards of essential drugs and packaging specifications. State Food and Drug Administration to gradually increase the quality standards of essential drugs. The Ministry of Health primary health care to gradually standardize the basic drugs and health institutions to use formulations and specifications, according to the actual needs of primary drug to determine the standard formulation of essential drugs, standard specifications and standard packaging. Norms at the national essential drugs are not introduced formulations and specifications before the provinces (autonomous regions and municipalities), each of the procurement of essential drugs in principle, more than three kinds of formulations, dosage forms corresponding to the specifications of each principle, more than 2 species.
     (Xiii) the establishment of essential drugs procurement information disclosure system. The provincial health administrative departments must take the initiative in the procurement end of the 3 days of primary health care to the public health sector purchase prices of essential drugs, procurement quantity and successful business, accept social supervision, while the Ministry of Health reported to the State Council for record and copy medical reform office. Encourage the news media and other sectors of the community supervision of essential drugs procurement process, the establishment of prizes reporting system, create an open, fair and impartial procurement environment.
     (Xiv) the establishment of essential drugs guide price dynamic adjustment mechanism. Pricing authorities to strengthen basic research and market the drug costs of buying and selling price monitoring, to further improve the pricing of essential drugs, the dynamic adjustment of the price level of essential medicines guide, guiding rationally determine the concentration of the purchase price around. And after numerous varieties of exclusive focus on the purchase price has been basically stable and sufficient supply of essential drugs, to seek the implementation of national uniform pricing. Provinces (autonomous regions, municipalities) charge of prices of essential medicines to strengthen the price supervision and inspection of the implementation, investigate and punish violations of various prices.
     (Xv) To promote rational use of primary medical staff. All localities and departments should establish and standardize the use of the basic mechanisms of drug procurement opportunities, guide and regulate the drug conduct grass-roots medical staff. Strengthen grass-roots training and assessment of medical personnel as soon as possible to promote clinical guidelines and essential drug formulary in general use at the grassroots level to encourage the use of information systems around the primary health care institutions and medical personnel to monitor drug use behaviors. Strengthen publicity and guide changes in drug use habits of the people, promoting choice and rational clinical use of essential drugs. 
    Third, establish and regulate the work of the basic requirements of drug procurement mechanism
     (A) carrying out work. To establish and standardize the procurement of essential drugs involved in multi-stakeholder mechanism to adjust, will encounter many difficulties and obstacles, all localities and departments to effectively raise awareness, strengthen confidence, well-organized and implemented. To strengthen the propaganda and training, to fight drug production and distribution sector, primary health care institutions and the community understanding and support. Close follow-up study to new situations and new problems and properly handle the centralized procurement of essential drugs due to the conflicts, continue to improve policies and measures. Provinces (autonomous regions and municipalities), the leading group of medical reform in accordance with the spirit of this advice, and quickly adopt the province (district, city) government-run primary care health institutions specific methods of procurement of essential drugs, in principle, this guidance should be issued in 30 working days of introduction, and send a copy to the Office of the State Council and Ministry of Health medical reform record. The provinces (autonomous regions and municipalities) approval of the leading group of medical reform, sub-provincial cities with independent planning and procurement of essential drugs capital cities can be organized and implemented separately. All localities should try before the end of December 2010 in accordance with the provisions of the procurement practices of the views of a procurement cycle to complete the procurement of essential drugs.
     (B) the implementation of all responsibility. Provinces (autonomous regions and municipalities) people's government of the province (autonomous regions and municipalities) overall responsibility for procurement of essential drugs. Procurement agencies directly responsible for the procurement of essential drugs, carried out in strict accordance with relevant provisions of the procurement, protection of the quality and supply of essential drugs, rational to reduce the purchase price. Health administrative departments should strengthen the primary health care purchasing organizations as well as the supervision and guidance of health institutions to carry out regular assessments to ensure the smooth implementation of the procurement of essential drugs. Development and reform (medical reform office, the price), finance, social security, commercial, industrial and information technology, monitoring and other relevant departments must perform their duties in close coordination, increase support and strengthen the whole process of sourcing and procurement of the main supervision.
     (C) to encourage active exploration. All localities and departments should further explore the basic drugs reduce the purchase price, security of supply and quality of effective measures to ensure primary health care institutions according to the actual purchase price of sale of essential drugs. Encouraged through the development of modern logistics and other means to further reduce the cost of drug distribution, drug distribution to achieve openness, transparency, and guide merger and reorganization of pharmaceutical enterprises, speed up structural adjustment, regulate production and distribution of essential medicines order to promote the healthy production and circulation of drugs development. Unified market around the country to adhere to and maintain a fair competitive environment, oppose all forms of local protectionism.
      (D) strengthen the examination and evaluation. Office of the State health care reform with the relevant departments to procurement of essential drugs to health care reform as a core indicator of job evaluation, procurement of essential drugs throughout the assessment, and linked with the capital subsidy. To select some provinces (autonomous regions and municipalities) to focus on contact guidance, sum up and promote best practices. Provinces (autonomous regions and municipalities), the leading group of medical reform at the end of December 2010 should be implemented before the situation of the views of the Office of the State Council for health care reform. (Source: State Council)