Guiding opinions of the general office of the State Council on improving the centralized purchase of drugs in public hospitals

Source: People's governments of all provinces, autonomous regions and municipalities directly under the central government (GBF [2015] No 7) on February 28, 2015, all ministries and commissions under the State Council, and all directly affiliated institutions of the State Council: Improving the centralized purchase of drugs in public hospitals is an important content and key link of deepening the reform of the medical and health system It is of great significance to accelerate the reform of public hospitals, standardize the order of drug circulation, and establish and improve the drug supply security system based on the basic drug system With the consent of the State Council, the following guiding opinions are hereby put forward for improving the centralized drug procurement in public hospitals 1、 General idea We will fully implement the spirit of the 18th National Congress of the Communist Party of China and the second, third and fourth plenary sessions of the 18th Central Committee of the Communist Party of China, follow the general requirements that the market plays a decisive role in resource allocation and better play the role of the government, learn from the common practices of international drug procurement, fully absorb the experience of basic drug procurement, and stick to the centralized online drug procurement direction with the province (District, city) as the unit, and implement a platform Under linkage, open and transparent, classified procurement, measures such as recruitment of production enterprises, integration of recruitment and procurement, linking of quantity and price, double envelope system, and whole process monitoring are taken to strengthen the comprehensive supervision of the whole process of drug procurement and effectively guarantee the quality and supply of drugs Encourage local governments to explore and innovate in combination with the actual situation, and further improve the participation of hospitals in drug procurement The centralized purchase of drugs should help to eliminate the mechanism of supplementing medicine with drugs, accelerate the reform of public hospitals, especially county-level public hospitals; help to reduce the false high price of drugs, reduce the burden of people's drug use; help to prevent and curb corruption in the field of drug purchase and sale, resist commercial bribery; help to promote the integration and reorganization of drug production and distribution enterprises, fair competition, and promote the health of the pharmaceutical industry Healthy development 2、 Implement classified drug procurement (I) for basic drugs and non patent drugs with large clinical dosage, high procurement amount and produced 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 two envelope open bidding procurement, with the hospital as the main procurement body, purchasing drugs at the bid winning price Carry out purchasing with quantity The hospital shall formulate procurement plan and budget according to not less than 80% of the actual use of drugs in the previous year, and be specific to varieties, dosage forms and specifications In principle, there shall be no more than 3 dosage forms for each drug procurement, and no more than 2 specifications for each dosage form, taking into account the needs of adults and children The provincial drug purchasing agency shall, according to the summary of drug demand of the hospital, prepare a list of drugs to be purchased through public bidding, reasonably determine the quantity of drugs to be purchased by each bidding group, and publish it to the public Further improve the two envelope evaluation method The bidding drug manufacturer shall prepare both economic and technical bids and commercial bids at the same time The economic and technical bidding document mainly reviews the enterprise's GMP qualification certification, random inspection of drug quality, production scale, distribution capacity, sales volume, market reputation, electronic supervision capacity and other indicators, and will pass the GMP (2010) (revised in) certification, marketing in developed countries (regions) such as the European Union, the United States, Japan, etc., standardized dosage forms, specifications, packaging, etc as important indicators Only those enterprises that have passed the evaluation of economic and technical bids can enter the evaluation of commercial bids In the evaluation of commercial bids, the same bidding group selects the bid winner and the candidate bid winner from the lowest to the highest In order to avoid vicious competition, a comprehensive evaluation must be carried out for drugs with obviously low bidding price and possible quality and supply risks Give priority to purchasing generic drugs that reach international level In the pilot cities of public hospital reform, it is allowed to purchase drugs by itself on the provincial drug centralized purchase platform with the city as the unit The transaction price of the pilot cities shall not be higher than the provincial bid winning price If the transaction price of the pilot city is obviously 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 each province (District, city) （2） We will establish an open, transparent and multi-party price negotiation mechanism for some patented and exclusively produced drugs The results of the negotiation will be published on the national drug supply security comprehensive management information platform, and the hospital will purchase drugs according to the negotiation results （3） For non patent drugs, emergency (rescue) drugs, basic infusion drugs, drugs with small clinical dosage (the specific scope of the above drugs shall be determined by the provinces, districts and cities) and commonly used low-cost drugs in women and children's specialty, centralized hanging network shall be implemented and directly purchased by the hospital （4） Drugs that are clinically necessary, in small quantities and in short supply in the market shall be produced and purchased by the state through fixed-point bidding and price negotiation （5） Narcotic drugs, psychotropic drugs, free drugs for the prevention and treatment of infectious and parasitic diseases, vaccines under the national immunization plan, family planning drugs and herbal pieces shall be purchased in accordance with the current provisions of the state to ensure openness and transparency All drugs (excluding Chinese herbal pieces) used by the hospital shall be purchased through the provincial drug centralized procurement platform The provincial drug purchasing agency shall summarize the purchasing plan and budget reported by the hospital, reasonably prepare the drug purchasing catalogue of the hospital in its own administrative region according to the national basic drug catalogue, medical insurance drug reimbursement catalogue, basic drug clinical application guide and prescription set, etc., and classify the bidding drugs, negotiation drugs, direct drugs purchasing by the hospital and designated students Produce medicine, etc Encourage inter provincial cross regional, specialized hospitals and other joint procurement In principle, the procurement cycle is once a year For the drugs newly approved for marketing in the procurement cycle, local governments may, according to the needs of disease prevention and control, through the evaluation of pharmacoeconomics and evidence-based medicine, separately organize the centralized procurement with the province (District, city) as the unit 3、 To improve the way of drug payment settlement (1) to strengthen the management of drug purchase and sale contracts When signing a drug purchase contract, the hospital shall specify the type, dosage form, specification, price, quantity, distribution batch and time limit, settlement method and settlement time, etc The purchase quantity agreed in the contract shall be the total purchase quantity of a purchase cycle declared by the purchase plan （2） To standardize the payment of drug payment The hospital shall include the revenue and expenditure of drugs into the budget management, and pay the payment strictly in accordance with the time stipulated in the contract The payment shall not exceed 30 days from the time of qualified delivery and acceptance to the time of payment Relying on and giving full play to the advantages of centralized payment and settlement of provincial drug procurement platform, hospitals and drug manufacturers are encouraged to directly settle drug payment, and drug manufacturers and distribution enterprises are encouraged to settle distribution expenses 4、 Strengthening the management of drug distribution (1) drug manufacturers are the first responsible person for ensuring the quality and supply of drugs Drugs may be distributed directly by the winning manufacturer or entrusted to the drug distributor with distribution capacity to the designated hospital The pharmaceutical trading enterprises entrusted by the pharmaceutical production enterprises shall be put on record on the provincial pharmaceutical centralized purchase platform, and the record shall be made public to the public Provincial drug purchasing agencies shall timely publish the list of distribution enterprises of each hospital and accept social supervision （2） For drug distribution in remote and inconvenient traffic areas, health and family planning departments at all levels should strengthen organization and coordination, improve the concentration of procurement and distribution, and coordinate the management of drug supply and distribution between hospitals and grass-roots medical and health institutions in accordance with the principle of the combination of far and near and the linkage between urban and rural areas Encourage all localities to explore the county and Village Integrated Distribution in combination with the actual situation Give full play to the advantages of service network of logistics industry such as post, and support them to participate in drug distribution under the conditions that meet the regulations （3） For the enterprises that do not affect clinical medication or refuse to provide delivery service in remote areas due to the delay of delivery, the provincial drug purchasing agency shall correct them in time and urge them to rectify within a time limit If a hospital is forced to use drugs from other enterprises to replace an enterprise that has not changed within the time limit due to the disqualification of its winning bid, the overspending expenses shall be borne by the original winning enterprise, and the specific measures shall be formulated by each province (District, city) 5、 To standardize the construction of procurement platform (I) the provincial drug procurement agency is responsible for the use, management and maintenance of the provincial drug centralized procurement platform, and the provincial (District, city) people's Government shall provide necessary human, financial and material support to ensure its normal operation （2） Establish a drug purchase data sharing mechanism, unify the standardized construction standards of provincial drug centralized purchase platforms, promote the standardization of drug purchase codes, and realize the interconnection and resource sharing of information and data such as the national drug supply security comprehensive management information platform, provincial drug centralized purchase platform, hospitals, medical insurance agencies, price authorities （3） The provincial drug centralized procurement platform shall provide services for hospitals and drug production and marketing enterprises at all levels, improve the ability of drug bidding and procurement, distribution management, evaluation, statistical analysis, dynamic supervision, timely collect and analyze the price, quantity, payment collection time, delivery rate and bad records of drug production and marketing enterprises in hospitals, and regularly publicize them to the public 。 We will encourage places where conditions permit to carry out electronic transactions, and adopt various ways such as signing electronic contracts through centralized drug purchase platforms and online payment, so as to save transaction costs and improve transaction transparency 6、 Strengthen the comprehensive supervision and management (1) strengthen the training and assessment of rational drug use of medical personnel, give play to the role of pharmacists in drug use guidance, standardize doctors' prescription behavior, and effectively reduce unreasonable drug use A prescription review and doctor interview system shall be established, focusing on tracking and monitoring the auxiliary drugs and the drugs that are used abnormally in hospitals We will establish and improve a comprehensive evaluation system for clinical use of essential drugs, and promote the standardization of drug dosage forms, specifications and packaging （2） Taking the province (District, city) as the unit, select a number of hospitals and grass-roots medical and health institutions as the monitoring points of drug shortage, collect and analyze the information of drug supply and demand in time, and strengthen the monitoring and early warning of drug shortage （3） The centralized purchase of drugs is taken as an important assessment content of the hospital and its responsible person, and included in the objective management and hospital evaluation According to the seriousness of the case, the hospital that purchases and delays the payment for goods under the network in violation of regulations shall be criticized in a notice, rectified within a time limit, ordered to pay liquidated damages, and reduced in grade Those involved in corruption such as commercial bribery shall be investigated and dealt with seriously according to law （4） We will 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, standardize price behavior, and protect the legitimate rights and interests of patients In accordance with the law, we will seriously investigate and deal with price violations and monopolistic acts, as well as counterfeiting or falsely issuing invoices, affiliated operations, and "walk away" and other illegal acts We will strengthen quality tracking of key drugs and quality supervision throughout the process, and crack down on the manufacture and sale of counterfeit and substandard drugs （5） Strictly implement the integrity record and market clearing system All provinces (districts and cities) shall establish and improve the inspection and supervision system, establish the good faith records of pharmaceutical production and trading enterprises and timely publish them to the public For enterprises listed in the list of bad records, the hospital shall not purchase their drugs within two years We will strengthen supervision over the implementation of the clean purchase and sale contract for pharmaceutical products of medical and health institutions by hospitals and pharmaceutical production and marketing enterprises （6） We will comprehensively promote information disclosure and ensure that all aspects of drug procurement operate in the sun We will establish a reward reporting system and consciously accept the supervision of the people's Congress, the CPPCC and all sectors of society Adhere to the national unified market, maintain a fair competition environment, and oppose all forms of local protection 7、 Practically strengthen organizational leadership (1) implement the responsibilities of all parties People's governments of all provinces (districts and cities) should strengthen organizational leadership, supervision and evaluation, and study and solve drug collection in time