Notice of the General Office of the State Council on printing and distributing the pilot program of centralized drug procurement and use organized by the state
General Office of the State Council on Printing and Distributing Drugs Organized by the State
Notice of centralized procurement and use of pilot programs
Guo Ban Fa [2019] No.2
People’s governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions and institutions directly under the State Council:
"The pilot program of centralized drug procurement and use organized by the state" (hereinafter referred to as the "program") has been approved by the State Council and is hereby issued to you, please implement it carefully.
All pilot cities should formulate implementation plans and supporting policies in accordance with the requirements of the "Program", strengthen organizational leadership, compact responsibilities at all levels, do a good job in publicity and guidance, and prevent risks to ensure the implementation of pilot tasks. Relevant provinces should closely follow the implementation of the pilot, actively create conditions, give support to pilot cities, and strengthen guidance, supervision and assessment.
All relevant departments and units should, in accordance with the requirements of division of labor, further decompose and refine the work involving their own departments and units, pay close attention to formulating specific measures, clarify the schedule, and promote implementation item by item. Involving multiple departments, the lead department should strengthen coordination and the relevant departments should cooperate closely. It is necessary to strengthen the overall concept, strengthen communication and cooperation, and achieve layout, supervision and results. The office of the pilot working group for centralized drug procurement and use organized by the state shall, jointly with relevant departments, do a good job in monitoring and analysis, regular notification, supervision and inspection, summary and evaluation, etc., and carry out key supervision in the pilot areas with slow progress and no obvious results, and report major issues to the State Council in a timely manner.
the General Office of the State Council
January 1, 2019
(This piece is publicly released)
The state organizes a pilot program for centralized drug procurement and use.
According to the deployment of the CPC Central Committee and the State Council, this plan is formulated in order to deepen the reform of the medical and health system, improve the drug price formation mechanism, and carry out the pilot project of centralized drug procurement and use organized by the state.
I. General requirements
(1) objectives and tasks.Eleven cities, including Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xi ‘an, were selected to select pilot varieties from generic drugs that passed the consistency evaluation of quality and efficacy (including the consistency evaluation according to the new registration classification of chemical drugs, hereinafter referred to as consistency evaluation), and the state organized the centralized procurement and use of drugs to realize the obvious reduction of drug prices and reduce the burden of patients’ drug expenses; Reduce the transaction cost of enterprises, purify the circulation environment and improve the industry ecology; Guide medical institutions to standardize drug use and support the reform of public hospitals; Explore and improve the centralized drug procurement mechanism and the market-oriented drug price formation mechanism.
(2) General idea.According to the general idea of national organization, alliance procurement and platform operation, that is, the state formulates basic policies, scope and requirements, organizes pilot areas to form alliances, and explores cross-regional alliance centralized procurement with quantity by taking public medical institutions in alliance areas as the main body of centralized procurement. On the basis of summarizing and evaluating the pilot work, we will gradually expand the coverage of centralized procurement and guide the society to form long-term stable expectations.
(3) Basic principles.First, adhere to the people-centered, ensure the demand for clinical drugs, effectively reduce the burden on patients, and ensure the quality and supply of drugs. Second, adhere to compliance with laws and regulations, strictly implement relevant policies and regulations, and ensure that special procurement procedures are standardized, open and transparent, and accept supervision from all parties throughout the process. Third, adhere to the combination of market mechanism and government role, not only respect the market-oriented drug price formation mechanism, but also give full play to the role of the government in building a platform, promoting docking, ensuring supply and strengthening supervision. Fourth, adhere to a smooth transition and proper convergence, and handle the relationship between the pilot work and the existing procurement policy.
Second, the scope and form of centralized procurement
(a) to participate in the enterprise.Any pharmaceutical manufacturer approved by the State Drug Administration and listed in Chinese mainland area within the scope of centralized procurement (the national general agent of imported drugs is regarded as a manufacturer) may participate.
(2) scope of drugs.Select pilot varieties from generic drugs corresponding to generic drugs that have passed the consistency evaluation.
(3) shortlisting criteria.Including quality shortlisting criteria and supply shortlisting criteria. The quality shortlisting criteria mainly consider the clinical efficacy, adverse reactions, batch stability, etc., and are based on the consistency evaluation in principle. The supply shortlisting criteria mainly consider the production capacity and supply stability of enterprises, and enterprises that can ensure the procurement volume in the pilot areas can be shortlisted. The specific indicators of shortlisting criteria shall be drawn up by the Joint Procurement Office.
(4) The form of centralized procurement.According to the number of short-listed production enterprises of each drug, the corresponding centralized procurement method is adopted: if there are three or more short-listed production enterprises, the bidding procurement method is adopted; If there are two short-listed production enterprises, they shall adopt the way of bargaining purchase; If there is only one short-listed production enterprise, it shall be negotiated and purchased.
Third, specific measures
(1) Purchase with quantity, and exchange price with quantity.On the basis of the purchase quantity submitted by public medical institutions in the pilot area, the total purchase quantity is estimated according to 60%-70% of the total annual drug consumption of all public medical institutions in the pilot area, and the centralized purchase price of drugs is formed. The public medical institutions in the pilot cities or their representatives sign a purchase and sale contract with the production enterprises according to the above purchase price. For the remaining amount, public medical institutions can still purchase other net-hanging varieties with appropriate prices for centralized procurement of drugs at the provincial level.
(two) the combination of recruitment and adoption, to ensure the use.Public medical institutions in the pilot areas should give priority to the use of centralized procurement products determined by different forms such as bidding, bargaining and negotiation, so as to ensure that the contract dosage is completed within one year.
(3) Ensure quality and supply.It is necessary to strictly implement the quality shortlisting standards and supply shortlisting standards, effectively prevent low-priced bids regardless of quality, and strengthen the whole chain quality supervision of the production, circulation and use of selected drugs. On this premise, establish a system of investigation, evaluation, assessment and monitoring of the product quality and supply capacity of the shortlisted enterprises. The production enterprises independently select the operating enterprises with distribution ability and good credibility to distribute the centralized procurement products, and establish the emergency reserve, inventory and shutdown reporting system of the production enterprises according to the purchase and sale contracts. In case of non-delivery according to the contract and failure to guarantee the quality and supply, compensation, punishment, withdrawal, alternative and emergency safeguard measures should be taken accordingly to ensure the quality and supply of drugs.
(four) to ensure the payment, reduce transaction costs.As the first person responsible for drug payment settlement, medical institutions should settle accounts with enterprises in a timely manner according to the provisions of the contract, so as to reduce the transaction costs of enterprises. Strictly investigate the problem that medical institutions do not settle drug payments on time. On the basis of the total budget, the medical insurance fund shall be paid to the medical institution in advance at not less than 30% of the purchase amount. Conditional cities can pilot direct settlement of medical insurance.
Fourth, policy convergence, three medical linkage
(a) to explore the coordination of medical insurance payment standards and purchase prices in pilot cities.For centrally purchased drugs, within the scope of the medical insurance catalogue, the centralized purchase price is taken as the medical insurance payment standard. In principle, the medical insurance fund will settle the original research drugs, reference preparations and generic drugs that have passed the consistency evaluation under the same general name according to the same payment standard. If the price of drugs used by patients is higher than the payment standard, the part that exceeds the payment standard shall be paid by the patients themselves. If the price of drugs used by patients is quite different from the centralized purchase price of selected drugs, the payment standard can be adjusted gradually, and it will be adjusted in place within 2-3 years, and supporting policies and measures will be formulated; Patients who use drugs with a price lower than the payment standard shall be paid at the actual price. On the basis of ensuring quality and supply, guide medical institutions and patients to form reasonable medication habits.
(2) Promote the reform of medical institutions through mechanism transformation.Through the pilot, we will gradually squeeze out the water content of drug prices, improve the structure of drug use, reduce the proportion of drugs in medical institutions, and make room for the reform of public hospitals. It is necessary to deepen the reform of medical insurance payment methods, establish an incentive and risk sharing mechanism of "balance retention and reasonable cost overruns sharing" between medical insurance agencies and medical institutions, promote medical institutions to use selected drugs with appropriate prices, and reduce the operating costs of public medical institutions. If the balance of medical service income and expenditure of public medical institutions is formed, it can be used as a whole for personnel salary expenditure in accordance with the requirements of "two permits" (allowing medical and health institutions to break through the current wage control level of public institutions, allowing medical service income to deduct costs and withdraw various funds according to regulations).
(3) Compacting the responsibility of medical institutions to ensure the dosage.Encourage the use of drugs selected in centralized procurement, and incorporate the use of selected drugs into the performance appraisal of medical institutions and medical personnel. All relevant departments and medical institutions shall not affect the rational use and supply guarantee of selected drugs on the grounds of cost control, drug proportion, and drug specifications and quantity requirements of medical institutions. Medical institutions that fail to purchase and use drugs according to regulations shall be punished in the indicators of total medical insurance, bonus funds for the reform of public hospitals, grade evaluation of medical institutions, designated medical insurance qualifications, and target responsibility assessment of medical institutions’ responsible persons. Medical personnel who do not use drugs in accordance with the regulations shall be dealt with severely in accordance with the corresponding provisions of the Prescription Management Measures and the Hospital Prescription Review Management Specification (Trial). It is necessary to further improve the guidelines for clinical application of drugs, strengthen the monitoring of drug use in medical institutions, strictly review and comment prescriptions, strengthen the publicity and training of Yamatonokusushi, organize comprehensive clinical evaluation of drugs, promote scientific and rational drug use, and ensure the safety of patients.
(four) clear departmental responsibilities, do a good job of policy convergence.In order to ensure that the national organization of centralized drug procurement and use pilots can achieve the purpose of reducing drug prices and promoting reform, the competent departments of medical insurance, medical care and medicine should perform their respective duties and coordinate with each other. The National Medical Insurance Bureau undertakes the responsibility of formulating the pilot scheme, relevant policies and supervising the implementation, and guides local medical insurance departments to do a good job in medical insurance payment, settlement and total budget management; Health departments at all levels are responsible for guiding and supervising the use of selected drugs in medical institutions, monitoring and early warning information on drug shortage, and guiding the reform of public hospitals; National Medical Products Administration is responsible for identifying the varieties that have passed the consistency evaluation and the relevant qualifications of pharmaceutical production enterprises, and the provincial drug supervision departments should strengthen the supervision and inspection of the quality of the selected drugs, and urge the production enterprises to implement the measures of stopping production.
V. Organizational form
(a) the establishment of a pilot working group and office.The general office of the State Council, the National Medical Insurance Bureau, the National Health and Wellness Commission, and National Medical Products Administration form a national pilot working group for centralized drug procurement and use (hereinafter referred to as the pilot working group) to lead the pilot work, study major issues, and deploy and implement key tasks. The office of the pilot working group is located in the National Medical Insurance Bureau, and is attended by personnel selected by the National Medical Insurance Bureau, the National Health and Wellness Commission, National Medical Products Administration and the Joint Procurement Office. It is specifically responsible for organizing the pilot, coordinating relevant work between departments and between departments and localities, and strengthening publicity and guidance and policy interpretation.
(2) Establish a joint procurement office.Under the leadership of the pilot working group and its office, a joint procurement office was established to carry out centralized procurement on behalf of the alliance area. The joint procurement office is composed of one representative from each pilot city, and the director candidate is determined by the pilot area. As the deputy director, the representatives of each pilot area are responsible for implementing centralized procurement on behalf of public medical institutions in the pilot area, organizing and supervising the implementation of centralized procurement results. Shanghai Pharmaceutical Centralized Bidding and Purchasing Affairs Management Office undertakes the daily work of the joint purchasing office and is responsible for the specific implementation. The joint procurement office consists of a supervision group, an expert group and a centralized procurement group.
1. Monitoring Group. Responsible for the supervision of centralized drug procurement, timely acceptance and handling of relevant reports and complaints.
2. Expert group. Organize experts in several fields (including experts recommended by national academic organizations, experts from Hong Kong Hospital Authority and relevant experts recommended by pilot areas) to set up expert groups to provide technical advice on relevant policies, clinical use and procurement operations.
3. Centralized purchasing team. Responsible for the specific implementation of centralized procurement, the joint procurement office will train the members of the centralized procurement team, and sign a commitment letter of honesty and confidentiality and a statement of interest avoidance.
VI. Organization of work
The Joint Procurement Office summarizes the drug consumption information of public medical institutions in the pilot areas, further improves the implementation plan, drafts and issues centralized procurement announcements, carries out specific work on centralized drug procurement, announces procurement results, urges the pilot areas to implement the results of centralized procurement, and strengthens supervision and inspection. In the pilot area, the network was completed on the provincial procurement platform according to the centralized procurement price, and the centralized procurement subject signed a quantity purchase and sale contract with the enterprise according to the centralized procurement price and implemented the procurement. The centralized procurement results were implemented in early 2019, with a period of one year. The office of the pilot working group shall guide and supervise the whole process of centralized procurement and use. In case of major problems in the joint procurement office and the pilot area, report to the office of the pilot working group in a timely manner.