Improving the centralized purchasing of medicines for public hospitals is an important part of the deepening of the reform of the pharmaceutical and healthcare system, and is of great significance for accelerating the reform of public hospitals, standardizing the order of the circulation of medicines, and establishing and improving the system of supplying and guaranteeing medicines on the basis of the basic drug system. With the consent of the State Council, is to improve the centralized procurement of drugs in public hospitals to put forward the following guidance.
One, 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 to play a decisive role in resource allocation and better play the role of the government, drawing on the common practice of international drug procurement, fully absorbing the experience of procurement of essential medicines, and adhering to the direction of the centralized procurement of medicines on-line on the basis of the provinces (autonomous regions and municipalities), and implementing the centralized procurement of medicines on one platform, up and down linkage, openness and transparency. A platform, upward and downward linkage, openness and transparency, categorized procurement, the adoption of measures such as recruiting manufacturers, recruiting and purchasing in one package, volume and price linkage, double-envelope system, and full-scale monitoring and control, etc., to strengthen the comprehensive supervision and control of the whole process of drug procurement, and to effectively safeguard the quality and supply of medicines. Encourage localities to explore and innovate in light of the actual situation, and further increase the participation of hospitals in drug procurement.
Centralized drug procurement should be conducive to the elimination of the mechanism of medicines, accelerate the reform of public hospitals, especially county-level public hospitals; conducive to reducing the inflated prices of medicines, alleviate the burden of people's medication; conducive to the prevention and curbing of corruption in the field of drug purchasing and marketing to resist commercial bribery; conducive to the promotion of the integration of drug production and distribution enterprises, fair competition, and promote the healthy development of the pharmaceutical industry.
Two, the implementation of drug classification procurement
(a) for clinical use, procurement of high amounts, multiple enterprises to produce essential medicines and generic drugs, to give full play to the advantages of the provincial centralized bulk purchasing, by the provincial drug purchasing agencies to take the two-envelope system of public bidding and procurement, hospitals, as the main body of the procurement, according to the winning price of the purchase of medicines.
Implementation of volume purchasing. Hospitals to formulate procurement plans and budgets in accordance with not less than 80% of the actual use of drugs in the previous year, and specific to the varieties, dosage forms and specifications, each drug purchased in principle no more than three types of dosage forms, each dosage form corresponding to the specifications of in principle no more than two, taking into account the needs of adults and children's medication. Provincial drug purchasing organizations should prepare a list of drugs to be purchased through public bidding based on the summary of hospital drug needs, reasonably determine the number of drugs to be purchased by each bidding group, and announce it to the public.
Further improving the double-envelope evaluation method. Bidding drug manufacturers must simultaneously prepare economic and technical bids and business bids. Economic and technical bids mainly on the enterprise's drug production quality management standard (GMP) qualification certification, drug quality sampling and testing, production scale, distribution capacity, sales, market reputation, electronic monitoring capabilities and other indicators for evaluation, and will be through the "Good Manufacturing Practice (Revised in 2010)" certification, in the European Union, the United States, Japan and other developed countries (regions), the listing and sales situation The standardized dosage forms, specifications, packaging, etc. are taken as important indicators. Enterprises that have passed the evaluation of economic and technical bids will be allowed to enter the evaluation of commercial bids. In the evaluation of business bids, the same bidding group selects the winning enterprise and the candidate winning enterprise according to the quotation from the lowest to the highest. For medicines whose bidding prices are obviously low and may have quality and supply risks, a comprehensive assessment must be conducted to avoid vicious competition. Priority will be given to the procurement of generic drugs that have reached international standards.
In the pilot cities of public hospital reform, the city is allowed to purchase on its own on the provincial centralized drug procurement platform. The transaction price in the pilot cities shall not be higher than the provincial bidding price. Pilot city transaction price is significantly lower than the provincial bidding price, the provincial bidding price should be adjusted according to the pilot city transaction price, the specific measures developed by the provinces (autonomous regions and municipalities).
(ii) for some patented drugs, exclusive production of drugs, the establishment of open and transparent, multi-party participation in the price negotiation mechanism. The results of the negotiations are published on the National Drug Supply Guarantee Comprehensive Management Information Platform, and hospitals purchase drugs according to the negotiation results.
(3) For generic medicines for women and children, emergency (rescue) medicines, basic infusion solutions, medicines with small clinical dosage (the specific scope of the above medicines will be determined by provinces, autonomous regions and municipalities) and commonly used low-priced medicines, centralized listing will be implemented, and hospitals will directly procure the medicines.
(4) For medicines that are clinically necessary, of small dosage, and in short supply in the market, they shall be designated for production by national bidding and purchased at bargained prices.
(v) For narcotic drugs, psychotropic drugs, free medicines for the prevention and treatment of infectious and parasitic diseases, vaccines of the National Immunization Program, family planning medicines and traditional Chinese medicine tablets, the procurement is conducted in accordance with the current regulations of the state to ensure openness and transparency.
All medicines used in hospitals (excluding traditional Chinese medicine tablets) should be procured through provincial centralized drug procurement platforms. Provincial drug procurement agencies should summarize the procurement plans and budgets reported by hospitals, based on the national essential drugs catalog, medical insurance drug reimbursement catalog, clinical application guidelines for essential drugs and prescription sets, etc., and reasonably prepare the procurement catalogs of drugs for hospitals in their administrative regions in accordance with the above principles, and categorize and list the drugs procured by bidding, procured by negotiation, procured by hospitals directly, and designated production of drugs. Joint procurement by inter-provincial and cross-regional organizations and specialized hospitals is encouraged. In principle, the procurement cycle is once a year. For newly approved drugs within the procurement cycle, each region can organize a separate centralized procurement by province (region, city) according to the needs of disease prevention and treatment, after pharmacoeconomic and evidence-based medical evaluation.
Three, improve the settlement of medicine
(A) to strengthen the management of drug purchase and sales contracts. Hospitals to sign drug purchase contracts should be clear procurement varieties, dosage forms, specifications, prices, quantities, distribution batch and time limit, settlement methods and settlement time. The purchasing quantity agreed upon in the contract shall be the entire purchasing quantity of a purchasing cycle declared in the purchasing plan.
(ii) standardize drug payment. Hospitals should be included in the budget management of drug revenues and expenditures, strictly in accordance with the contractual payment of goods, from delivery and acceptance to payment shall not exceed 30 days. Relying on and giving full play to the advantages of centralized payment and settlement of the provincial centralized drug purchasing platform, hospitals are encouraged to settle drug payments directly with drug manufacturers, and drug manufacturers and distribution companies to settle distribution costs.
Four, strengthen the management of drug distribution
(a) Drug manufacturers are the first responsible for ensuring the quality and supply of drugs. Drugs can be directly distributed by the winning manufacturer or commissioned by the distribution capacity of the drug business enterprises to distribute to designated hospitals. The drug manufacturing enterprises entrusted by the drug business enterprises should be filed on the provincial centralized drug procurement platform, and the filing status is open to the public. Provincial drug purchasing organizations should promptly publish a list of distribution enterprises for each hospital and accept social supervision.
(2) For the distribution of medicines in remote and inaccessible areas, health and family planning departments at all levels should strengthen the organization and coordination, in accordance with the principle of combining the near and far, urban and rural linkage, to improve the concentration of procurement and distribution, and to coordinate and do a good job in the management of the supply and distribution of medicines to hospitals and primary health care institutions. Encourage localities to explore the integration of distribution in counties and villages in light of the actual situation. Utilizing the advantages of the service network of the postal and other logistics industries, support their participation in the distribution of medicines in compliance with the provisions of the conditions.
(3) for the distribution of untimely impact on clinical use of drugs or refused to provide remote areas of the distribution services of the enterprise, the provincial drug procurement agencies should be corrected in a timely manner, and urged to rectify the deadline. For overdue rectification of the enterprise to cancel its bidding qualification, hospitals are therefore forced to use other enterprises to replace the drug, the cost overruns borne by the original winning enterprise, the specific measures developed by the provinces (autonomous regions and municipalities).
V. Standardize the construction of procurement platform
(a) Provincial drug procurement agencies are responsible for the use, management and maintenance of the provincial centralized drug procurement platform, the provincial (autonomous regions and municipalities) people's governments should give the necessary human, financial and material support to ensure that its work is normal operation.
(2) Establishing a mechanism for drug procurement data***sharing, unifying the standardized construction standards of provincial drug centralized procurement platforms, promoting the standardization of drug procurement codes, and realizing the interconnection and resource***sharing of information and data among the national drug supply guarantee comprehensive management information platform, provincial drug centralized procurement platforms, hospitals, health insurance agencies, and price authorities.
(3) provincial centralized drug procurement platform for hospitals at all levels and drug production and management enterprises to provide services to improve the bidding and procurement of drugs, distribution management, evaluation, statistical analysis, dynamic supervision and other capabilities, and timely collection and analysis of hospitals, drug procurement prices, quantities, payback time and drug production and management enterprises to deliver in place, bad records and other information, and regularly announced to the community. Encourage conditional places to carry out electronic transactions, take through the centralized drug procurement platform to sign electronic contracts, online payment and other ways to save transaction costs and improve transaction transparency.
Six, strengthen the comprehensive supervision and management
(a) to strengthen the rational use of medication training and assessment of medical personnel, play the role of pharmacist's guidance on medication, standardize the behavior of doctors' prescriptions, and effectively reduce the irrational use of medication. The establishment of prescription review and physician interview system, focusing on the tracking and monitoring of auxiliary drugs, hospital overuse of drugs. To establish and improve the comprehensive evaluation system of clinical medication focusing on basic drugs, and to promote the standardization of drug dosage forms, specifications and packaging.
(2) Selecting a number of hospitals and primary medical and healthcare institutions as monitoring points for drug shortages on a provincial (regional and municipal) basis, collecting and analyzing information on the supply and demand of drugs in a timely manner, and strengthening the monitoring of and early warning for drug shortages.
(3) The centralized procurement of medicines will be an important assessment of hospitals and their responsible persons, and will be included in the target management and evaluation of hospital accreditation. For hospitals that violate offline procurement and delay payment, depending on the severity of the case, they will be notified and criticized, rectified within a certain period of time, ordered to pay liquidated damages, and downgraded and other treatments. Involved in commercial bribery and other corrupt behavior, according to the law, serious investigation and punishment.
(D) to strengthen the supervision and inspection of the implementation of drug prices, strengthen the drug cost survey and market price monitoring of purchases and sales, standardize price behavior, and protect the legitimate rights and interests of patients. In accordance with the law, seriously investigate and deal with price violations and monopoly behavior, as well as forgery or false invoices, dependence on the business, "walking papers" and other illegal acts. Strengthening the quality tracking of key medicines and the whole process of quality supervision, and cracking down on the production and sale of counterfeit and shoddy medicines.
(E) Strictly implement the integrity record and market clearance system. Provinces (autonomous regions and municipalities) should establish and improve the inspection and supervision system, establish the integrity record of drug production and operation enterprises and timely publicize it to the society. For enterprises included in the list of bad records, hospitals are not allowed to purchase their medicines within two years. Strengthening of hospitals, drug production and management enterprises to fulfill the "medical and health care institutions, pharmaceutical products integrity of the purchase and sale contract" supervision.
(F) comprehensively promote information disclosure, to ensure that all aspects of drug procurement in the sunshine operation. The establishment of a reward reporting system, consciously accept the National People's Congress, the Chinese People's Political Consultative Conference and the community supervision. Adhere to the national unified market, maintain a level playing field, and oppose all forms of local protection.
VII, effectively strengthen the organization and leadership
(a) the implementation of the responsibility of all parties. The people's governments of all provinces (autonomous regions and municipalities) should strengthen organizational leadership and supervision and evaluation, and promptly study and solve major problems in the centralized procurement of medicines. Health planning, development and reform, human resources and social security, finance, business, industry and information technology, industry and commerce, food and drug supervision, insurance supervision and other relevant departments should play their respective roles and work closely together to form a synergy. Medical insurance agencies and commercial insurance institutions should settle medical expenses with medical institutions in a timely manner and in full according to the regulations.
(2) Carefully organized and implemented. Provinces (autonomous regions and municipalities) should, in accordance with the spirit of this opinion, urgently study and formulate the implementation plan of centralized procurement of drugs for local public hospitals, and comprehensively 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. Localities can explore various forms of cross-regional joint procurement in accordance with the "four favorable" principles specified in the general idea of this opinion. The centralized procurement of medicines for military hospitals will be studied and formulated by the competent military health authorities.
(3) Strengthen the prevention of integrity risks. Strengthen the supervision of provincial drug procurement organizations, improve the internal constraints and external supervision mechanism of provincial drug procurement organizations, adhere to the system of power management and management, strengthen the education of clean practice, and constantly improve the business capacity and clean consciousness. It has established a monitoring mechanism for the operation of power, realized mutual constraints and coordination of power, and implemented a system of regular rotation of personnel in important positions.
(D) do a good job of public opinion propaganda and guidance. The centralized procurement of drugs involves the adjustment of the interests of many parties, all regions, all relevant departments should adhere to the correct orientation, strengthen the policy interpretation and public opinion guidance, fully publicize the centralized procurement of drugs policy direction, meaning, measures and results, and properly respond to social concerns and create a good social atmosphere.
General Office of the State Council
February 9, 2015