People\'s governments of provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions under The State Council:
Improving the centralized procurement of drugs in public hospitals is an important content and key link in deepening the reform of the medical and health system, which is of great significance for speeding up the reform of public hospitals, standardizing the order of drug circulation, and establishing and improving the drug supply guarantee system based on the basic drug system. With the consent of The State Council, the following guidelines are put forward to improve the centralized drug procurement of public hospitals.
First, the general idea
Comprehensively implement the spirit of the 18th CPC National Congress and the Second, Third and Fourth Plenary Sessions of the 18th CPC Central Committee, in accordance with the general requirements of the market playing a decisive role in resource allocation and giving better play to the role of the government, learn from the prevailing international drug procurement practices, fully absorb the experience of essential drug procurement, and adhere to the direction of centralized online drug procurement at the provincial (autonomous region and city) level. The implementation of a platform, up and down linkage, open and transparent, classified procurement, the adoption of manufacturing enterprises, recruitment and procurement integration, volume and price linkage, double envelope system, whole-process monitoring and other measures to strengthen the comprehensive supervision of the whole process of drug procurement, and effectively ensure the quality and supply of drugs. Local governments are encouraged to explore and innovate in light of actual conditions, and further improve the participation of hospitals in drug procurement.
Centralized drug procurement should be conducive to breaking the mechanism of supplementing medicine with drugs and speeding up the reform of public hospitals, especially county-level public hospitals. It is beneficial to reduce the virtual high price of drugs and reduce the burden of drugs for the people. It is conducive to preventing and curbing corruption in the field of drug purchase and sale, and resisting commercial bribery; It is conducive to promoting the integration and reorganization of drug production and circulation enterprises, fair competition, and promoting the healthy development of the pharmaceutical industry.
Second, implement classified drug procurement
(1) For essential drugs and generic drugs with large clinical dosage, high procurement amount, and production by multiple enterprises, give full play to the advantages of centralized batch procurement at the provincial level, and the provincial drug procurement agency adopts the double-envelope public bidding procurement, and the hospital, as the procurement body, purchases drugs at the winning price.
Implement the purchase with quantity. The hospital shall formulate the procurement plan and budget in accordance with no less than 80% of the actual use of drugs in the previous year, and it shall be specific to the varieties, dosage forms and specifications. In principle, the dosage forms of each drug purchase shall not exceed 3 kinds, and the corresponding specifications of each dosage form shall not exceed 2 kinds, taking into account the drug needs of adults and children. Provincial drug procurement agencies should, according to the summary of hospital drug demand, prepare a list of drugs purchased by public bidding, reasonably determine the quantity of drugs purchased by each bidding group, and announce it to the public.
Further improve the two-envelope evaluation method. A drug manufacturer submitting a bid shall simultaneously prepare an economic and technical bid and a commercial bid. The economic and technical tender mainly reviews the enterprise\'s drug production quality management practice (GMP) qualification certification, drug quality sampling inspection, production scale, distribution capacity, sales, market reputation, electronic supervision ability and other indicators, and will pass the "Drug production quality Management Practice (revised in 2010)" certification. In the European Union, the United States, Japan and other developed countries (regions) market sales, standardized dosage forms, specifications, packaging and other important indicators. Only enterprises that pass the evaluation of economic and technological tender can enter the evaluation of commercial tender. In the evaluation of commercial tender, the same bidding group selects the winning enterprise and the candidate winning enterprise according to the price from low to high. For drugs whose bidding price is obviously low and may have quality and supply risks, comprehensive evaluation must be carried out to avoid vicious competition. Priority is given to purchasing generic drugs that meet international standards.
In the pilot cities of public hospital reform, municipal units are allowed to purchase their own drugs on the provincial centralized procurement platform. The transaction price of the pilot city shall not be higher than the provincial bid price. If the transaction price of the pilot city is significantly lower than the provincial bid price, the provincial bid price shall be adjusted according to the transaction price of the pilot city, and the specific measures shall be formulated by the provinces (regions and municipalities).
(2) Establish an open, transparent and multi-party price negotiation mechanism for some patented drugs and exclusively produced drugs. The results of the negotiation are published on the national drug supply security integrated management information platform, and the hospital purchases drugs according to the results of the negotiation.
(3) For women and children specialized generic drugs, emergency (snatch) rescue drugs, basic infusion, small clinical dosage of drugs (the specific scope of the above drugs determined by the provinces and municipalities) and commonly used low-cost drugs, the implementation of centralized hanging network, directly purchased by the hospital.
(4) Drugs that are clinically necessary, have a small dosage and are in short supply on the market shall be produced by the state through bidding and purchased at negotiated prices.
(5) Purchase of narcotic drugs, psychotropic drugs, free drugs for the prevention and treatment of infectious and parasitic diseases, vaccines for the national immunization program, family planning drugs and Chinese herbal decoction pieces in accordance with current state regulations to ensure openness and transparency.
All drugs used in hospitals (excluding TCM decoction pieces) should be purchased through the provincial centralized drug procurement platform. The provincial drug procurement agency shall summarize the procurement plan and budget reported by the hospital, and reasonably prepare the drug procurement list of the hospital in the administrative region in accordance with the above principles according to the national essential drugs list, medical insurance drug reimbursement list, clinical application guide of essential drugs and prescription set. List the procurement of drugs by bidding, negotiation, direct procurement of drugs by hospitals, designated production of drugs, etc. Encourage inter-provincial, cross-regional, specialized hospitals and other joint procurement. The procurement cycle principle is once a year. For newly approved drugs within the procurement cycle, all localities may, according to the needs of disease prevention and control, undergo pharmacoeconomics and evidence-based medicine evaluation, and separately organize centralized procurement at the provincial (autonomous region, municipality) level.
Third, improve the settlement method of drug payment
(1) Strengthen the management of drug purchase and sale contracts. When the hospital signs the drug purchase contract, it shall specify the purchase variety, dosage form, specification, price, quantity, distribution batch and time limit, settlement method and settlement time, etc. The purchase quantity stipulated in the contract shall be the total purchase quantity of a procurement cycle declared in the procurement plan.
(2) Standardize drug payment. The hospital shall incorporate the drug revenue and expenditure into the budget management, and make payment in strict accordance with the time agreed in the contract. The payment shall not exceed 30 days from the acceptance of the delivery to the payment. Relying on and giving full play to the advantages of centralized payment and settlement of provincial centralized drug procurement platforms, hospitals and drug manufacturers are encouraged to directly settle drug payments, and drug manufacturers and distribution enterprises settle distribution costs.
Fourth, strengthen drug distribution management
(1) Drug manufacturers shall be the first responsible persons for ensuring the quality and supply of drugs. The drug may be directly distributed by the winning bid manufacturer or entrusted to the drug distribution enterprise with distribution capacity to the designated hospital. The drug trading enterprises entrusted by the drug manufacturing enterprises shall be recorded on the provincial drug centralized procurement platform, and the record information shall be disclosed to the public. Provincial drug procurement agencies should publish the list of distribution enterprises of each hospital in a timely manner and accept social supervision.
(2) For drug distribution in remote and inconvenient areas, health and family planning departments at all levels should strengthen organization and coordination, improve the concentration of procurement and distribution in accordance with the principle of combining distance and urban and rural linkage, and coordinate the drug supply and distribution management of hospitals and grass-roots medical and health institutions. Encourage all localities to explore integrated county and rural distribution in light of actual conditions. Give full play to the service network advantages of postal services and other logistics industries to support their participation in drug distribution under prescribed conditions.
(3) For enterprises that do not affect clinical drugs in a timely manner or refuse to provide distribution services in remote areas, provincial drug procurement agencies should promptly correct and urge them to rectify within a time limit. In case the hospital is forced to use other enterprises to replace the drugs, the cost of overspending shall be borne by the original winning enterprise, and the specific measures shall be formulated by the provinces (regions and municipalities).
Fifth, standardize the construction of procurement platform
(1) The provincial drug procurement agency is responsible for the use, management and maintenance of the provincial drug centralized procurement platform, and the provincial (regional, municipal) people\'s government shall give the necessary human, financial and material support to ensure the normal operation of its work.
(2) Establish a drug procurement data sharing mechanism, unify the standardized construction standards of provincial centralized drug procurement platforms, promote the standardization of drug procurement codes, and realize information data interconnection and resource sharing of the national drug supply security comprehensive management information platform, provincial centralized drug procurement platform, hospitals, medical insurance agencies, and pricing authorities.
(3) The provincial centralized drug procurement platform should provide services for hospitals and drug production and management enterprises at all levels, improve the ability of drug bidding and procurement, distribution management, evaluation, statistical analysis, dynamic supervision, timely collection and analysis of hospital drug purchase prices, quantities, payment time and drug production and management enterprises distribution arrival rate, bad records, etc., and regularly announce to the public. Encourage the conditions of local electronic transactions, through the centralized drug procurement platform to sign electronic contracts, online payment and other ways to save transaction costs, improve the transparency of transactions.
6. Strengthen comprehensive oversight and management
(1) Strengthen the training and assessment of medical personnel on rational drug use, give full play to the role of pharmacists in drug use guidance, regulate doctors\' prescribing behavior, and effectively reduce irrational drug use. Establish a prescription review and doctor interview system, focusing on tracking and monitoring auxiliary drugs and drugs used in hospitals. Establish and improve a comprehensive evaluation system for clinical drugs, focusing on essential drugs, and promote the standardization of drug dosage forms, specifications, and packaging.
(2) Select a number of hospitals and grass-roots medical and health institutions as monitoring points for drugs in shortage, collect and analyze drug supply and demand information in a timely manner, and strengthen monitoring and early warning of drugs in shortage.
(3) The centralized drug procurement as an important assessment content of the hospital and its responsible person, into the target management and hospital review and evaluation work. Hospitals that purchase offline in violation of regulations and delay payment for goods will be given notice of criticism, rectification within a time limit, ordered to pay liquidated damages, and reduced grades according to the seriousness of the circumstances. Those involving commercial bribery and other corrupt acts shall be severely investigated and dealt with according to law.
(4) Strengthen the supervision and inspection of the implementation of drug prices, strengthen the investigation of drug costs and the monitoring of market purchase and sale prices, regulate price behaviors, and protect the legitimate rights and interests of patients. In accordance with the law, we will seriously investigate and punish illegal pricing and monopoly activities, as well as illegal activities such as forging or falsifying invoices, affiliated business operations, and "selling tickets". We will strengthen quality tracking and whole-process quality supervision of key drugs, and crack down on the production and sale of counterfeit and shoddy drugs.
(5) Strictly implement the integrity record and market liquidation system. All provinces (autonomous regions and municipalities) shall establish a sound inspection and supervision system, establish a record of the integrity of drug production and management enterprises, and promptly publish it to the public. For enterprises listed in the list of bad records, the hospital shall not purchase their drugs within two years. Strengthen the supervision of hospitals and pharmaceutical production and marketing enterprises to fulfill the "Clean Purchase and sale Contracts for Pharmaceutical Products in Medical and health Institutions".
(6) Comprehensively promote the disclosure of information to ensure that all aspects of drug procurement operate in the sunshine. We will establish a reward reporting system and consciously accept the supervision of the People\'s Congress, the CPPCC and all sectors of society. We should uphold a unified national market, maintain a level playing field, and oppose all forms of local protection.
7. Effectively strengthen organizational leadership
1. Fulfilling the responsibilities of all parties. The people\'s governments of all provinces (autonomous regions and municipalities) shall strengthen organizational leadership, supervision and evaluation, and promptly study and solve major problems in the centralized drug procurement. Health and family planning, development and reform, human resources and social security, finance, commerce, industry and information technology, industry and commerce, food and drug supervision, insurance supervision and other relevant departments should each perform their respective duties and closely cooperate to form a synergy. Medical insurance agencies and commercial insurance institutions shall settle medical expenses with medical institutions in a timely and full manner in accordance with regulations.
2. Careful organization and implementation. All provinces (autonomous regions and municipalities) shall, in accordance with the spirit of these opinions, promptly study and formulate implementation plans for centralized drug procurement in local public hospitals, and fully launch a new round of drug procurement in 2015. Provincial drug procurement agencies should effectively do a good job in the organization and management of local drug centralized procurement and specific implementation. Local governments may explore various forms of cross-regional joint procurement in accordance with the actual situation and the "four favorable" principles clearly defined in the general ideas of these Opinions. Measures for centralized drug procurement in military hospitals shall be formulated by the competent military health department.
3. Strengthening prevention of risks to clean government. Strengthen the supervision of provincial drug procurement agencies, improve the internal restriction and external supervision mechanism of provincial drug procurement agencies, adhere to the system to manage power, management and personnel, strengthen the education of clean employment, and constantly improve the professional ability and integrity awareness. Establish a monitoring mechanism for power operation, realize mutual restriction and coordination of power, and implement a regular rotation system for personnel in important positions.
4. Do a good job in public publicity and guidance. Centralized drug procurement involves multi-interest adjustment, all regions and relevant departments should adhere to the correct orientation, strengthen policy interpretation and public opinion guidance, fully publicize the policy direction, significance, measures and effectiveness of centralized drug procurement, properly respond to social concerns, and create a good social atmosphere.
General Office of the State Council, 9 February 2015
Source: China Government Network