Policy interpretation of the notice on carrying out the centralized purchase and use of the second batch of drugs organized by the state

In order to thoroughly implement the decision-making and deployment of the Party Central Committee and the State Council, maintain the efforts of centralized procurement and use reform, continue to expand the effectiveness of the reform, continue to explore and establish a standardized and normalized centralized procurement and use system of drugs, with the consent of the State Council, the state health insurance bureau and other five departments have formulated the notice on carrying out the second batch of centralized procurement and use of drugs organized by the state (hereinafter referred to as the "notice"), now the "notice" is read as follows 1、 Background: the pilot program of centralized purchase and use of drugs (hereinafter referred to as the "4 + 7" pilot program) and the expansion of drugs have made steady progress, the burden of the masses has been significantly reduced, the level of drug quality has been improved, and positive results have been achieved In order to further benefit more patients and form the stable expectation of the society and industry for the reform, the executive meeting of the State Council requested to continue to promote the centralized procurement of drugs and expand the scope of centralized procurement and use of drugs On the basis of summarizing the "4 + 7" pilot and expansion policies and practices, the State Medical Insurance Bureau, the State Health Commission, the State Drug Administration and other departments have formed the second batch of national drug centralized procurement and use ideas 2、 Main contents of the document (1) insist on centralized procurement with quantity In the second batch of national organizations, centralized procurement and use of drugs are still focused on volume procurement Specifically, the procurement alliance is composed of all provinces and Xinjiang production and Construction Corps All public medical institutions and military medical institutions in the alliance area participate in the alliance Medical institutions and retail pharmacies designated by medical insurance designated by social organizations and medical insurance designated by public organizations can participate in the alliance voluntarily After the volume is summarized according to the demand, the procurement with volume will be implemented （2） Adhere to drug quality standards and ensure supply Continue to insist on the selection of drug varieties from generic drugs corresponding to generic drugs that pass the consistency evaluation of quality and efficacy (including the approval of listing according to the new registration classification of chemical drugs), focus on the selection of more competitive varieties, and consider the clinical efficacy, adverse reactions, batch stability and other factors of drugs The enterprises participating in the centralized purchase must clarify the source and supply guarantee of API The winning enterprise shall guarantee the quality and supply within the purchase agreement period （3） Adhere to and improve the selection rules of centralized procurement The second batch of countries organized the centralized purchase and use of drugs, on the basis of absorbing the pilot experience, further improved the purchase rules, kept the market moderately competitive, and allowed certain differences in the prices of different selected enterprises of the same drug At the same time, different centralized purchase agreement periods are set according to the number of selected enterprises When the number of selected enterprises is large, the agreement period is relatively long and the market expectation is stable （4） Adhere to the working mechanism of national organization, alliance procurement and platform operation The national unified organization, the provinces and Xinjiang production and Construction Corps form a Procurement Alliance, and entrust the joint procurement office as the centralized procurement platform to organize the implementation Shanghai Pharmaceutical centralized bidding procurement management office is responsible for the daily work of the joint procurement office and the specific implementation （5） Adhere to and improve supporting policies and measures We will continue to adhere to the policy requirements and safeguard measures of "4 + 7" pilot and expansion, ensure the quality, supply, purchase and use of selected drugs and timely collection of funds, implement the prepayment of medical insurance funds, encourage direct settlement between medical insurance and enterprises, and implement measures such as surplus retention of medical institutions, open up all links of centralized procurement, and ensure that the market mechanism plays its full role The circular requires all localities and departments to improve their political positions, improve the leadership system, strengthen the implementation of responsibilities, establish a working mechanism, carefully organize the implementation, strengthen the publicity and guidance of reform, and strengthen risk prevention The people's governments of all provinces, autonomous regions and municipalities directly under the central government, Xinjiang production and Construction Corps, and relevant units of the Army: since the pilot implementation of centralized drug procurement and use organized by the state, positive results have been achieved, which have played a positive role in reducing the prices of virtual high drugs, reducing the burden of the masses, and promoting the continuous deepening of the reform of the medical and health system In order to thoroughly implement the decision-making and deployment of the Party Central Committee and the State Council, maintain the efforts of centralized procurement and use reform, continue to expand the effectiveness of reform, continue to explore and establish a standardized and normalized centralized procurement and use system of drugs, according to the notice of the general office of the State Council on printing and distributing the pilot program of centralized procurement and use of drugs organized by the state (GBF [2019] No.2) and the With the approval of the State Council, the spirit of the implementation opinions of nine departments including the National Health Insurance Bureau on the pilot project of centralized drug purchase and use by national organizations to expand the regional scope (medical insurance Fa [2019] No 56) is as follows: 1 Form an alliance to summarize the demand for centralized drug purchase and use The second batch of national organizations for centralized purchase and use of drugs will no longer select some regions to carry out the pilot project The procurement alliance is composed of all provinces and Xinjiang production and Construction Corps All public medical institutions and military medical institutions in the alliance region will participate in the experiment Designated social medical institutions and designated retail pharmacies of medical insurance can participate in the experiment voluntarily Medical institutions participating in the procurement of the alliance and designated retail pharmacies of medical insurance shall accurately submit the procurement volume and other information of relevant drugs in recent two years according to the requirements, and the provincial medical insurance department shall summarize the procurement demand of the province According to the number of selected enterprises, the joint procurement office determines the agreed procurement volume based on 50% - 80% of the total procurement demand, and implements the procurement with volume After the result of centralized procurement of the alliance, it will be implemented synchronously in the whole country 2、 To define the scope of centralized procurement and use of drug varieties, the State shall organize the centralized procurement and use of drug varieties to be selected from generic drugs corresponding to generic drugs through the consistency evaluation of quality and efficacy (including approval for listing according to the new registration classification of chemical drugs) We will expand the scope of drugs purchased and used centrally by state organizations, and focus on the selection of more competitive varieties Considering the clinical efficacy, adverse reactions, batch stability and other factors of drugs, the specific selection indicators shall be prepared by the joint procurement office Responsibility for the supply of compaction capacity: relevant enterprises shall explain the source of API and supply guarantee measures, calculate the capacity according to the production and supply capacity of API and preparation, and report to the joint procurement office truthfully in advance The winning enterprises shall ensure to meet the agreed purchase volume demand of the selected drugs in the selected area within the purchase agreement period, and promise the Countermeasures after supply interruption due to uncontrollable factors 3、 We should improve the centralized purchase rules, explore and improve the market-oriented drug price formation mechanism, adopt the competitive purchase mode, and maintain moderate competitiveness In order to ensure the quality, safety and stable supply of the selected drugs, it is allowed to select multiple companies In principle, when there are a large number of declared companies, the number of selected companies can be relatively large Under the premise of ensuring that the burden of the masses is reduced after centralized purchase, it is allowed that the prices of different selected enterprises of the same drug are different According to the number of selected enterprises, different centralized purchase agreement periods are set In principle, when the number of selected enterprises is large, the agreement period is relatively long and the market expectation is stable 4、 Adhere to the working mechanism of national organization, alliance procurement and platform operation, and organize all provinces and Xinjiang production and Construction Corps to form a Procurement Alliance, and entrust the joint procurement office as the centralized procurement platform to organize the implementation The joint procurement office shall formulate specific procurement rules according to the basic requirements determined by the national organization drug centralized procurement and use pilot working group office, carry out centralized procurement operations on behalf of the alliance region, organize and urge the implementation of centralized procurement results Shanghai Pharmaceutical centralized bidding procurement management office is responsible for the daily work of the joint procurement office and the specific implementation 5、 Adhere to the policy and measures of purchasing with quantity, adhere to the policy requirements and guarantee measures of the national organization of drug centralized purchase and use pilot and pilot expansion of regional scope, and ensure the quality, supply, purchase and use of selected drugs and timely payment collection Strengthen the supervision and inspection of the quality of the selected drugs We will strengthen guidance and supervision over the use of selected drugs in medical institutions, and monitor and warn of drug shortages According to the notice of the general office of the State Council on printing and distributing the pilot program of centralized drug purchase and use organized by the state (GBF [2019] No 2), the medical insurance fund shall prepay the medical institutions in advance, and the medical institutions shall timely collect the payment Encourage direct settlement between medical insurance and enterprises We will implement measures to retain the surplus of medical institutions, and encourage medical institutions and medical personnel to participate in the reform of centralized procurement and use 6、 To strengthen the organization and guarantee, all relevant departments should improve their political positions, strengthen the organization and leadership, establish the spirit of reform, perform their duties, coordinate and coordinate, and continue to promote reform In accordance with the guidance requirements of the office of the pilot working group on centralized drug procurement and use organized by the state and the coordination arrangement of the joint procurement office, we should thoroughly implement various policies, scientifically set implementation plans and conscientiously complete various tasks In combination with the promotion of centralized procurement and use of drugs organized by the state, we will continue to explore and improve relevant policies of centralized procurement of drugs organized by the state and at the provincial level, and drive the continuous deepening of medical reform We should strengthen the publicity and guidance of reform and do a good job in the publicity and training of medical personnel We should enhance the awareness of the rule of law and build consensus on reform Formulate all plans in advance, strengthen communication and coordination, and ensure the smooth implementation of centralized drug purchase and use organized by the state State Medical Insurance Bureau, State Health Commission, State Drug Administration, Ministry of industry and information technology, logistics support department of Central Military Commission, January 13, 2020