The State Office issued a document emphasizing the supply and price stability of drugs in short supply and implementing the "1 + X" drug use mode

On October 11th, the general office of the State Council issued the opinions on Further Doing a good job in the work of ensuring supply and price stability of drugs in short supply The opinion points out that in recent years, the supply guarantee of short drugs in China has been strengthened continuously, and positive results have been achieved, but there are still some problems, such as the lack of timely and sensitive drug supply and price monitoring, the policy of drug purchase, use, reserve and price supervision, etc., the phenomenon of illegal market manipulation to raise prices is still prominent in some places, and some measures have been put forward to be implemented With the approval of the State Council, the following opinions are hereby put forward in order to further ensure the supply and price of drugs in short supply and better guarantee the basic drug demand of the masses The document will further do a good job in ensuring the supply and price of short drugs from six aspects: improving the sensitivity and timeliness of monitoring response, strengthening the use of basic drugs in medical institutions and the standardized management of drug use, improving the purchase of short drugs, strengthening the supervision and law enforcement of drug prices, improving the multi-level drug supply system and practically strengthening the organization and implementation It is particularly noteworthy that the document proposes that the distribution of drugs in short supply shall not be restricted by the distribution enterprises, and shall not be restricted by the "two ticket system" We need to promote the priority allocation and use of essential drugs, increase the proportion of the use of essential drugs, and gradually realize the proportion of the number of essential drugs allocated to primary medical and health institutions run by the government, secondary public hospitals, and tertiary public hospitals in principle not less than 90%, 80%, and 60% respectively We need to promote medical institutions at all levels to form a "1 + X" dominated by essential drugs ("1" is the national catalogue of essential drugs "X" is a non essential drug, which is determined by each region according to the actual situation) drug use mode, and the drug use structure is optimized and standardized People's governments of all provinces, autonomous regions and municipalities directly under the central government, ministries and commissions under the State Council, and organizations directly under the State Council: the Party Central Committee and the State Council attach great importance to the work of ensuring the supply of medicines in short supply In recent years, China's short supply of drugs has been continuously strengthened and achieved positive results, but it still faces problems such as the lack of timely and sensitive drug supply and price monitoring, the need to improve policies such as drug purchase, use, storage and price supervision, the phenomenon of illegal market manipulation to raise prices is still prominent in some places, and some measures have been introduced yet to be implemented With the approval of the State Council, the following opinions are hereby put forward in order to further ensure the supply and price of drugs in short supply and better guarantee the basic drug demand of the masses 1、 Improve the sensitivity and timeliness of monitoring response (1) strengthen collaborative monitoring Build a national multi-source information collection platform for short drugs, and the leading unit of the national short drugs supply guarantee work consultation linkage mechanism (hereinafter referred to as the national linkage mechanism) will establish a collaborative monitoring mechanism together with relevant departments such as industry and information technology, medical security, drug supervision and management, so as to realize the information connection and sharing in registration, production, procurement, price and other aspects of APIs and preparations , refine operable monitoring and early warning standards, conduct real-time dynamic monitoring and early warning and regularly form monitoring reports to strengthen collaborative response (in the charge of the national health and Health Commission, relevant departments and provincial people's governments, to be implemented by the end of December 2019 The first is the leading unit, the same below) (2) improve the hierarchical response The leading unit of the provincial linkage mechanism shall, within the prescribed time limit, organize to verify the clues of shortage or unreasonable price increase found in the monitoring and coordinate the response according to the situation If the provincial level can not coordinate to solve the problem, it shall report to the leading unit of the national linkage mechanism within the specified time limit After receiving reports or monitoring clues, the leading unit of the national linkage mechanism shall organize verification within the specified time limit and coordinate response according to the situation The leading unit of the national linkage mechanism shall timely refine and improve the requirements on the scope of responsibility, time limit and work process of the verification and response work of national and provincial organizations (the national health and Health Commission, relevant departments and provincial people's governments shall be responsible for it respectively, which shall be implemented before the end of December 2019 Take the lead respectively for relevant units according to their responsibilities, the same below) (III) implement classified disposal For some short drugs with poor substitutability, insufficient production power and unstable market supply, we should strengthen the construction of centralized production base for small drugs (short drugs), improve and implement centralized procurement policies and strengthen reserves to ensure the supply (the Ministry of industry and information technology, the state health insurance bureau, etc are respectively responsible for) for determining that there is no enterprise to produce or that production cannot be resumed in a short period of time, the leading unit of the national linkage mechanism shall promptly consult with relevant departments and local governments, and take measures to promote the enterprise to resume production, accelerate the approval of drug registration, organize temporary import procurement, etc to ensure the supply (the national health and Health Commission, the Ministry of industry and information technology, the Ministry of ecological environment, the General Administration of customs, the State Food and drug administration, etc.) shall provide a reasonable production transition period for the production line of pharmaceutical raw materials or preparations that need to be stopped for rectification due to environmental factors such as excessive emissions (the Ministry of ecology and environment is responsible for) (4) to manage the list of drugs in short supply The State shall implement the management system for the list of drugs in short supply, and the specific measures shall be formulated by the state health and Health Commission in conjunction with the State Food and Drug Administration and other departments The leading units of the national and provincial linkage mechanisms shall, together with each member unit, formulate the national and provincial key monitoring lists and short drug lists of clinically necessary and vulnerable drugs and dynamically adjust them The drugs in the list shall be monitored and tracked dynamically, and the drugs with sufficient market supply and effective competition shall be timely transferred out of the list For the drugs in the list of drugs in short supply, all relevant departments and local governments shall timely respond according to their responsibilities (the national health and Health Commission, relevant departments and provincial people's governments shall be responsible for it respectively, which shall be implemented before the end of December 2019) (V) implementation of the report on the suspension of production of drugs in short supply The leading unit of the provincial linkage mechanism shall evaluate the drugs in the list of drugs in short supply at the provincial level, and report to the leading unit of the national linkage mechanism in a timely manner according to the regulations if it is necessary to make a stop production report The leading unit of the national linkage mechanism, together with the relevant departments, shall comprehensively demonstrate the drugs reported at the provincial level and the drugs in the national list of short drugs, and issue an announcement to the society and make dynamic adjustment for the short drugs that really need to be shut down If the holder of the drug listing license stops producing the drugs in short supply, he shall report to the drug regulatory department of the State Council or the people's government at the provincial level in accordance with the provisions, and upon receiving the report, the drug regulatory department shall timely notify the leading unit of the linkage mechanism at the same level in accordance with the provisions The above specific provisions and time limit requirements shall be formulated by the leading unit of the national linkage mechanism and the State Food and drug administration respectively according to their responsibilities The medical security department shall timely report the impact of the suspension of production on the market supply situation to the leading unit of the same level linkage mechanism according to the previous platform procurement information The health department should study and judge the risk of drug shortage in time according to the previous clinical use information of medical institutions (the national health and Health Commission, the state health insurance bureau and the State Food and drug administration are responsible respectively, with the participation of the Ministry of industry and information technology, etc., and implemented by the end of December 2019) II Strengthen the use of basic drugs in medical institutions and the management of drug use specifications (VI) promote the priority use of basic drugs and rational use of drugs By strengthening the supervision and assessment of drug use, guiding and urging medical institutions to optimize the drug use catalogue and drug prescription set, we will promote the priority of the allocation and use of essential drugs, increase the proportion of the use of essential drugs, and timely adjust the national essential drugs catalogue, so as to gradually realize the proportion of the number of essential drugs in primary medical and health institutions run by the government, secondary public hospitals and tertiary public hospitals At least 90%, 80% and 60% respectively, to promote medical institutions at all levels to form a "1 + X" (1 is the national catalogue of basic drugs, "X" is non basic drugs, determined by each region according to the actual situation) drug use mode, optimize and standardize the drug use structure We will strengthen the whole process management of drug catalog selection, purchase and use in medical institutions, promote the implementation of the requirements of "no intramuscular injection for oral administration, no infusion for intramuscular injection", and promote scientific and rational drug use (in the charge of the State Health Commission and the State Administration of traditional Chinese Medicine) (VII) optimize the management and use of medicines in short supply in medical institutions We will improve the national, provincial, municipal and county-level monitoring network and information reporting system for drugs in short supply, guide and promote public medical institutions to formulate and improve regulations on the management of drugs in short supply, and specify the requirements for analysis, evaluation and information reporting of drugs in short supply in medical institutions (in the charge of the national health and Health Commission and the State Administration of traditional Chinese medicine, to be implemented by the end of December 2019) guide and promote medical institutions to reasonably set up warning lines for the inventory of emergency (emergency) drugs and other specific drugs To dynamically update the guidelines for alternative use of clinically available drugs, support relevant industry organizations to recommend alternative varieties of clinically available drugs and dynamically update them, and guide medical institutions to standardize the use of drugs Support and encourage County Central hospitals to increase the reserve of medicines that are easy to be short of (in the charge of the national health and Health Commission and the State Administration of traditional Chinese Medicine) encourage the places where conditions permit to explore and adopt effective ways to open the varieties of drugs sold by relevant medical institutions and social pharmacies to the public, and unblock the channels for the public to purchase drugs (the people's governments at the provincial level shall be responsible for) 3 Improve the procurement of drugs in short supply (8) implement the policy of direct online procurement For the varieties listed in the national and provincial drug shortage list, enterprises are allowed to quote independently on the provincial drug centralized procurement platform, directly hang the network, and medical institutions are allowed to purchase independently Supervision and guidance should not only improve price monitoring and management, but also avoid unreasonable administrative intervention The provincial medical security department shall strengthen the supervision of the direct online price, timely collect and analyze the information related to the actual purchase price of the direct online, and regularly publish it on the provincial drug centralized purchase platform (the state health insurance bureau is responsible for) (IX) allowing medical institutions to record and purchase independently For the drugs in the key monitoring list and the list of drugs in short supply, if there is no enterprise on the provincial drug centralized purchase platform or they are not listed in the provincial centralized purchase directory, the medical institutions can put forward the purchase demand, search for the drug manufacturers offline, negotiate with the drug suppliers directly, negotiate and determine the purchase price according to the principle of fairness, and then select the drugs at the provincial level The centralized procurement platform shall record independently and be open and transparent The medical security and health departments shall, according to their duties, strengthen the supervision of the purchase and use of the drugs for record If the drugs purchased directly through the Internet or independently on record belong to the scope of the medical insurance catalog, the medical security department shall timely pay according to the regulations (the state health insurance bureau and the state health and health commission are respectively responsible for) (x) strict administration of drug procurement and performance Relying on the provincial drug centralized purchase platform, the provincial medical security department regularly monitors the drug distribution rate, purchase quantity, payment settlement, etc., strictly manages the drug purchase and sale contract, and punishes the enterprises for failing to distribute and supply according to the contract in time We will strengthen supervision and notification, and promote medical institutions to settle drug payments in accordance with contracts and medical insurance funds to pay drug fees in a timely manner (the state health insurance bureau and the state health and Health Commission shall be responsible for them respectively) the distribution of drugs in short supply shall not be limited to the distribution enterprises, and shall not be subject to the "two ticket system" (each provincial people's government is responsible, and the Ministry of Commerce, the State Administration of Taxation, and the state health insurance bureau participate) in regions without distribution economy, in the absence of drug distribution enterprises to participate in the competition, the postal enterprises are encouraged to explore the distribution work (in the charge of the State Post Office, with the participation of the state health insurance bureau) IV increase the supervision and law enforcement of drug prices (XI) strengthen the monitoring and early warning of abnormal drug prices According to