Health and Family Planning Commission of provinces, autonomous regions and municipalities directly under the Central Government, Health Bureau of Xinjiang Production and Construction Corps:
In order to implement the "Guiding Opinions of The General Office of the State Council on Improving the Centralized Procurement of Drugs in Public Hospitals" (State Council [2015] No. 7, hereinafter referred to as the "Opinions"), the relevant requirements are hereby notified as follows:
First, comprehensively establish a new mechanism for centralized drug procurement;
It is necessary to adhere to the direction of centralized drug procurement, implement a platform, top-down linkage, open and transparent, and classified procurement. Give full play to the role of the provincial leading group for centralized drug procurement, in light of local realities, pay close attention to the formulation of specific implementation measures, implement the division of responsibilities of departments, clarify the time schedule and technical roadmap, and timely report to The State Council medical reform Office to ensure that a new round of centralized drug procurement work is launched in 2015.
Provincial health and family planning administrative departments should take the initiative to strengthen communication and coordination with development and reform, finance, human resources and social security, commerce, food and drug supervision and other departments, and strive to do a good job in the quality and safety of drug procurement, price monitoring, distribution and use, medical insurance payment and other policies and measures, enhance and expand the effectiveness of centralized drug procurement.
2. Reasonably determine the scope of drug purchase;
The hospital shall formulate a procurement plan in accordance with no less than 80% of the actual use of drugs in the previous year, specific to the general name, dosage form and specification, the dosage form of each drug purchase shall not exceed 3 in principle, and the corresponding specification of each dosage form shall not exceed 2 in principle. The drug procurement budget is generally no more than 25-30% of the hospital\'s operating expenditure. Provincial drug procurement agencies should summarize and analyze hospital drug procurement plans and procurement budgets in a timely manner, reasonably determine the scope of drug procurement, implement volume procurement, give priority to the selection of drugs that meet clinical pathways, are included in major disease protection, major new drug development projects, and major public health projects, taking into account the drug needs of special groups such as women, the elderly and children. And make good connection with the reimbursement policy of medical insurance and new rural cooperative medical care.
Fully absorb the effective methods of standardizing dosage forms and specifications in the selection of national essential drugs, promote the standardization of drug dosage forms, specifications and packaging according to the national essential drugs list, medical insurance drug reimbursement list, clinical application guidelines and prescription sets of essential drugs, and follow the principles of commonly used clinical necessities, appropriate dosage forms and specifications, and convenient packaging and use. Efforts should be made to improve the concentration of drug procurement and use.
Third, detailed drug classification procurement measures;
To the province (region, city) as a unit, combined with the determined scope of drug procurement, to further refine all types of procurement of drugs. All drugs used in hospitals (excluding TCM decoction pieces) should be purchased online.
(1) Procurement of drugs through bidding. It can be sorted according to the percentage of the purchase amount of various drugs in the total amount of drug procurement in the previous year, and the essential drugs and generic drugs that have a cumulative proportion of not less than 80% and are produced by three or more enterprises are included in the scope of bidding procurement.
(2) Negotiation and purchase of drugs. It is necessary to adhere to government-led, multi-party participation, openness and transparency, pilot start, and implement national and provincial negotiations. In 2015, the state will start pilot negotiations on some patented drugs and exclusive production of drugs, and the program will be formulated separately. For drugs that cannot be included in the pilot negotiations for the time being, we will continue to explore ways and means of centralized procurement that are linked to volume and price in provinces (regions and municipalities) and have reasonable prices, and implement zero-margin sales. Encourage inter-provincial and inter-regional joint negotiations, combined with the national regional economic development strategy, to explore the formation of regional procurement prices that adapt to the medical insurance payment policy.
(3) Purchasing drugs directly from the Internet. Including women and children specialty generic drugs, emergency (grab) rescue drugs, basic infusion, commonly used low-cost drugs and drugs not included in the tender purchase. All localities may refer to the selection principles of women and children specialty generic drugs, emergency (rush) rescue drugs and demonstration drugs promulgated by industry associations and academic organizations entrusted by the National Health and Family Planning Commission, and reasonably determine the scope and specific dosage forms and specifications of relevant drugs in their region to meet the needs of prevention and control.
(4) Designated production of drugs by the State. To purchase directly online in accordance with the national unified purchase price, no longer negotiate the price.
(5) Narcotic drugs and psychotropic drugs of category I. The maximum ex-factory prices and the maximum retail prices will remain under management for the time being.
4. Adhere to the double-envelope bidding system;
Drug procurement by bidding must be directed to the production enterprises, which shall bid directly and submit economic and technical tenders and commercial tenders at the same time. It is necessary to strengthen the awareness of drug quality and safety and risk assessment, and reasonably control the number of enterprises that pass the evaluation of economic and technical tenders. Enterprises that have passed the evaluation of economic and technical tender are no longer sorted, and the winning enterprises and candidate winning enterprises are selected from the lowest to the highest according to the quotation of the commercial tender.
It is necessary to integrate recruitment and procurement, purchase with quantity, and link quantity and price. From the perspective of favorable competition, meeting demand and ensuring supply, different drug situations are distinguished, drug characteristics and quality requirements of public hospitals are combined, and according to the technical requirements of generic drug quality consistency evaluation, bidding groups are scientifically set, and the number of winning companies in each group is not more than 2. It is necessary to optimize the combination and merging of similar drugs with indications and functional efficacy through the standardization of dosage forms and specifications, reduce the number of negotiated product regulations, and promote fair competition.
If the bid price is obviously low, comprehensive evaluation should be strengthened to monitor the quality of drugs and the actual supply guarantee. For only 1 or 2 companies bidding specifications, special bargaining can be organized. It is necessary to disclose the bargaining rules, and the prices of the same varieties of bargaining products should refer to the bidding prices, so as to avoid and reduce the influence of human factors as far as possible, so as to be open, transparent, fair and just.
In order to maintain a fair competitive environment and form a national unified market, the opening time of bidding for drug procurement across the country is uniformly concentrated in mid-to-late November each year. Realize the linkage of bidding and procurement policies, facilitate the rational bidding of production enterprises, organize and arrange production in advance, and avoid the fluctuation of drug prices due to the asynchronous opening of bids. It is necessary to optimize the process, simplify the application procedure, and improve the service quality and efficiency.
5. Improve the management of hospital drug payment;
The time from the acceptance of the drug delivery to the payment shall not exceed 30 days. Strengthen policy guidance, encourage hospitals to choose opening banks through public bidding, open bank accounts through mutual benefit, and the bank provides corresponding drug working capital services, speed up hospital payment time, and reduce enterprise financing costs and drug production and circulation costs. To correct and prevent the phenomenon and behavior of the hospital in the form of acceptance bill to delay the payment time. Drug expenditures should be included in budget management and annual assessment, and regularly announced to the public. Gradually achieve the overall proportion of drugs (excluding traditional Chinese medicine decoction pieces) to less than 30%.
6. Improve drug supply and distribution management;
The distribution of drugs in public hospitals should take into account the grass-roots supply, especially to the vast rural areas. Encourage integrated distribution between counties and villages, and focus on ensuring drug supply in remote and inaccessible areas. It is necessary to implement the requirements that drug manufacturers are the main responsibility for supply and distribution, strengthen assessment supervision and rectification, and establish and improve the mechanism of drug distribution interview, withdrawal, punishment and restriction. Enterprises with low distribution rate, refusal to undertake grassroots drug distribution, and repeated offenses shall be disqualified from winning the bid, hanging the network, and disqualified from supplying. It is necessary to study and refine the supporting measures that hospitals are forced to use other enterprises to replace drugs, and the cost of overspending is borne by the original bidding enterprise.
Further strengthen the monitoring and early warning of drug shortage, select a number of hospitals and grass-roots medical and health institutions according to the region as monitoring points for drug shortage, timely grasp and analyze the causes of shortage, straighten out the link between supply and demand, explore a variety of ways to ensure the needs of patients at the grass-roots level of drug use.
7. Accelerate the standardization of the procurement platform;
The centralized drug procurement platform should adhere to the government\'s leadership and maintain the non-profit nature of public welfare. It is necessary to ensure the human, financial and material resources required for the standardized construction of the platform, and ensure the docking and connectivity with the national drug supply security comprehensive management information platform by the end of 2015, and the safe transmission of data and information.
Provincial drug procurement agencies should enhance service awareness, comprehensively promote information disclosure, regularly publish hospital drug purchase prices, quantities, payment time and drug production and management enterprises delivery rate, bad records, etc., and timely do a good job of online transaction data summary and monitoring and analysis, reasonable use of differential price comparison rules, calculate the average price of various drugs in the market. Collect information about drug purchase prices at different stages and drug prices in neighboring countries and regions to provide support for various drug purchases.
It is necessary to use modern information technology such as the Internet and big data to continuously expand and upgrade the service and supervision functions of the procurement platform, improve the intelligence level of the platform, adapt to the new characteristics and new requirements of signing electronic contracts, online payment and settlement, and online electronic transactions, and create conditions for promoting the direct settlement of drug payments between hospitals and drug manufacturers, and the settlement of distribution costs between production enterprises and distribution enterprises.
8. Standardize the management of drug use in hospitals;
Provincial (autonomous regions, municipalities) drug administration departments should fulfill their responsibilities, continue to promote public hospitals to prioritize the use of essential drugs, and achieve a certain proportion of use. Establish a prescription review and doctor interview system, focus on tracking and monitoring auxiliary drugs and drugs that are used too often in hospitals, clarify the prescribing authority of doctors, and proactively communicate with patients when prescriptions involve expensive drugs, regulate the dosage, and strive to reduce the burden of drug costs for patients with acute and long-term drug use. Comprehensively improve the overall number and professional quality of pharmacists, give full play to the role of pharmacists in drug guidance, encourage pharmacists in retail pharmacies to regularly train in secondary or above medical institutions, and actively explore pharmacists\' online pharmaceutical services.
Accelerate the construction of a comprehensive evaluation system for clinical drugs (consumables) focusing on essential drugs. Select some tertiary and secondary hospitals and primary medical and health institutions with strong comprehensive strength such as medical treatment, teaching and scientific research in the province as a unit to evaluate the safety, effectiveness, rationality, compliance and economy of drugs (consumables), provide clinical technical support for regulating drug procurement and equipment use, and promote the standardization of drug dosage forms, specifications and packaging.
9. Strengthen drug procurement guidance in pilot cities of public hospital reform
To adhere to the three medical linkage, highlight the comprehensive reform, combined with the local actual research and development of public hospital reform pilot cities to the city as a unit of their own procurement of specific methods, with comprehensive reform, promote each other, and the specific methods will be reported to The State Council medical reform office for the record. Hospitals in pilot cities should purchase drugs and conduct online transactions on the provincial centralized drug procurement platform. For packaged drugs purchased in bulk, the cost should be reasonably digested and the sales rate should be zero. 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. Vigorously develop modern pharmaceutical logistics, and explore the form and path of realizing outpatient pharmaceutical services by social retail pharmacies and medical insurance designated pharmacies. It is necessary to strengthen drug policy research, promote centralized drug procurement in coordination with other reform policies, and maximize the benefits of drug procurement.
10. Strengthen comprehensive supervision;
Comprehensive supervision of the whole process of drug procurement should be strengthened. We will seriously investigate and punish the behaviors of drug production and trading enterprises such as fraud, bidding and bidding, and price gouging, and strictly implement the integrity record and market liquidation system. All forms of local protection are prohibited. Seriously investigate and punish hospital violations of procurement contracts, off-line procurement and other violations. For the purchase price formed through bidding, negotiation, fixed-point production, etc., the hospital shall not organize other bargaining; For the price of drugs purchased directly from hospitals, it is necessary to strengthen market monitoring and tracking, and maintain the market environment and order of fair competition. Standardize and purify the circulation channels of drugs in the hospital, and regularly publish the list of drug trading enterprises that set up settlement accounts in the hospital to the public, and accept social supervision. We will resolutely curb corruption in the field of drug purchase and sale and resist commercial bribery. Strengthen the construction of the clean government system of provincial drug procurement agencies, enhance the awareness of integrity and self-discipline, and prevent and eliminate various risks of clean government.
11. Increase publicity and training;
Improving the centralized procurement of drugs in public hospitals must 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.
It is necessary to make full use of traditional media such as radio, newspapers and television and new media such as wechat and Weibo to let all sectors of society understand the necessity, difficulty and complexity of eliminating medicine to supplement medicine and reversing the profit-oriented behavior of public hospitals, and use the "four advantages" to test the effectiveness of centralized drug procurement in public hospitals. It is necessary to widely publicize the direction, significance, measures and effectiveness of the "Opinions", further unify thinking, build consensus, and give full play to the role of medical personnel as the main force of medical reform, mobilize all positive factors, strengthen confidence, overcome difficulties, and build a new mechanism for drug procurement.
Improving the centralized procurement of drugs in public hospitals is a major adjustment of the existing interest pattern, with strong professionalism and policy, and high social attention. Health and family planning administrative departments at all levels should enhance their sense of responsibility and sense of urgency, unify their thinking and understanding to the "Opinions", fully understand the spirit and essence of the "Opinions", promote the linkage of the three doctors, and create a new situation of deepening medical reform.
National Health and Family Planning Commission
June 11, 2015
Source: National Health and Family Planning Commission, People\'s Republic of China