【industry news】 the general office of the State Council issued the opinions on

Copyfrom： Release time：2019-10-17 The editor：

[industry news] the general office of the State Council issued the opinions on further ensuring the supply and price stability of drugs in short supply.

     Recently, the general office of the State Council issued the opinions on further ensuring the supply and price of drugs in short supply (hereinafter referred to as the opinions).

     The opinion points out that 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, and the policy of drug purchase, use, storage and price supervision needs to be improved.

      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 opinions put forward the following corresponding policies and measures.

     In terms of supply assurance, first, strengthen collaborative monitoring. Build a national multi-source information collection platform for drugs in short supply, establish a collaborative monitoring mechanism, realize the information connection and sharing of APIs and preparations in registration, production, procurement, price and other aspects, and improve the sensitivity and timeliness of monitoring response. Second, to manage the list of drugs in short supply. We will implement the management system for the list of drugs in short supply, formulate the key monitoring list and the list of drugs in short supply for clinical use at the national and provincial levels, and dynamically adjust them. The third is to implement the stop production report of drugs in short supply. Where the holder of a drug listing license stops producing a drug in short supply, he shall report to the drug regulatory department in accordance with the provisions. 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 linkage mechanism at the same level, and the health department shall timely study and determine the risk of drug shortage. Fourth, implement the policies of direct online and independent recording and purchasing. For the varieties in the list of drugs in short supply, enterprises are allowed to quote independently on the provincial drug centralized purchase platform, directly link to the Internet, and medical institutions are allowed to purchase independently; for the drugs in the list of drugs in short supply and the list of key monitoring, medical institutions can search for drug manufacturers offline, and record independently on the provincial drug centralized purchase platform. Fifth, establish and improve the normal reserve mechanism of drugs in short supply. Optimize the central and local medicine reserve structure, give full play to the provincial medicine reserve function, select a batch of drugs that are clinically necessary, whose dosage is uncertain and prone to shortage to be included in the reserve, and clarify the procedures for transferring the drugs in short reserve.

     In terms of price stabilization, first, strengthen the monitoring and early warning of abnormal drug prices. Regularly monitor the change of purchase price. In case of abnormal price fluctuation, timely understand the situation and prompt early warning. Second, we will strengthen the regulation of drug prices. We will improve the mechanism for the investigation of drug price and cost, and establish a credit evaluation system for price and bidding procurement. For the drugs with abnormal price increase or frequency and large price difference among regions, the measures such as cost investigation and suspension of network hanging shall be comprehensively used to restrict them. The third is to strengthen the law enforcement of illegal acts. We will establish a mechanism for coordinated and coordinated work among departments, carry out joint rectification by multiple departments, and publish the results of rectification to the public in a timely manner. If a crime is constituted, the criminal responsibility shall be investigated according to law, and the relevant responsible persons shall be disposed resolutely, so as to form an effective deterrent.

      The opinion emphasizes that regular reports shall be made, supervision and accountability shall be strengthened, and timely interviews shall be conducted and rectification shall be supervised to ensure the effectiveness of relevant measures. We should strengthen publicity and guidance, regularly report the work of supply and price stabilization of drugs in short supply, and take the initiative to respond to social concerns.