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State Council: Six aspects of the shortage of drugs to ensure the stability of the price work

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Just now, the State Council issued a document on six aspects to ensure that the shortage of drugs is guaranteed.


▍ just now, the State Council issued a document to ensure shortage of medicine


On October 11, the General Office of the State Council issued the "Opinions on Further Improving the Supply of Stabilized Drugs for Shortage of Drugs" (hereinafter referred to as "Opinions").


The opinion shows that in recent years, China's shortage of supply of medicines has been continuously strengthened and achieved positive results, but it still faces insufficient and timely monitoring of drug supply and price. The policies of drug procurement, use, reserve and price supervision need to be improved, and illegally manipulate the market to raise prices. The phenomenon is still prominent in some places, and some of the measures that have already been introduced need to be implemented.


In order to further improve the supply of shortages of drugs and stabilize the price, and better protect the basic needs of the people, the State Council agreed to make the following comments.


The document improves the sensitivity and timeliness of monitoring and response, strengthens the management of basic drug use and drug use in medical institutions, improves the procurement of short-term drugs, strengthens the supervision and enforcement of drug prices, improves the multi-level supply system for drugs, and strengthens organizational implementation. In one aspect, we will further improve the supply of shortages of medicines.


▍ shortage medicine is not limited to two-vote system, express delivery can also be sent


In the document, Cypress Blue found that in order to solve the shortage of drug distribution problems, the State Council proposed further innovative measures.


The "Opinions" show that the shortage of drugs must not be restricted to the distribution enterprises, and is not subject to the "two-vote system". (The provincial people's governments are responsible for the participation of the Ministry of Commerce, the State Administration of Taxation, and the National Medical Insurance Bureau.) Areas that do not have the economics of distribution, and encourage the exploration of postal enterprises to carry out distribution work without the participation of drug distribution enterprises. (The State Post Bureau is responsible for the participation of the National Medical Insurance Bureau).


The low distribution rate and the difficulty of distribution have always been the pain point of the shortage of drugs. The country is exploring the distribution work by postal enterprises, and perhaps the general logistics enterprises can also participate in the shortage of medicines.


In addition, in the provisions for the procurement of shortage medicines, the documents have made higher requirements for medical insurance:


Strict drug purchase performance management. The provincial medical security department relies on the provincial centralized drug procurement platform to regularly monitor the drug delivery rate, the quantity of purchases, the settlement of payment, etc., strictly manage the purchase and sale of drugs, and punish the enterprises in accordance with the contractual provisions for distribution and supply. . Intensify supervision and notification, and promote medical institutions to timely settle drug loans and medical insurance funds to pay for drugs in a timely manner.


▍Priority use of base medicine, rational use of medicine


It is worth noting that the "Opinions" clarify that by strengthening drug use supervision and assessment, guiding and urging medical institutions to optimize drug use lists and drug formula sets, etc., it will promote the priority use of essential drugs and increase the proportion of essential drugs.


In addition, it is necessary to adjust the national essential medicines list in a timely manner, and gradually realize that the proportion of basic drug-equipped products in government-run primary health care institutions, second-level public hospitals, and tertiary public hospitals is not less than 90%, 80%, and 60%, respectively. Promote the establishment of a “1+X” (“1” for the National Essential Drugs List and “X” for non-essential drugs, which are determined by local authorities) to optimize and standardize the drug structure.


Strengthen the management of the whole process of drug catalogue selection, procurement, and use in medical institutions, and promote the implementation of the requirements of “can be taken orally without intramuscular injection, and can be injected without intramuscular injection” to promote scientific and rational use of drugs.


As early as 2013, the former National Health and Family Planning Commission and other departments jointly formulated the top ten core information for rational use of drugs, including the use of drugs to follow the "can not be used, can be used less, can not be used less; can not be intramuscular injection, can be intramuscular injection Do not infuse and other principles. Recently, all over the country have called for outpatient infusion.


The State Council once again issued a document stressing that, in particular, in the context of continuous restrictions on Chinese medicine injections and further escalation of restrictions, a new round of regulatory requirements will be ushered in.


The General Office of the State Council is about furthering the shortage of drugs


Advice on guaranteeing stable price work


State Office issued [2019] 47


The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions of the State Council, and their respective agencies:


The Party Central Committee and the State Council attach great importance to the shortage of supply of medicines. In recent years, China's shortage of supply of medicines has been continuously strengthened and achieved positive results. However, it still faces insufficient and timely monitoring of drug supply and price. The policies of drug procurement, use, reserve and price supervision need to be improved, and illegal market manipulation raises prices. The localities are still outstanding, and some of the measures that have already been introduced need to be implemented. In order to further improve the supply of shortages of drugs and stabilize the price, and better protect the basic needs of the people, with the consent of the State Council, the following opinions are proposed.


First, improve the sensitivity and timeliness of monitoring response


(1) Strengthen collaborative monitoring. To build a multi-source information collection platform for the shortage of drugs in the country, and the leading unit of the National Shortage Drug Supply and Support Consultation Mechanism (hereinafter referred to as the National Linkage Mechanism) will establish a coordinated monitoring mechanism with relevant departments such as industry and informatization, medical insurance, and drug supervision and management. Realize the sharing of information on the registration, production, procurement, and price of APIs and preparations, refine operational monitoring and early warning standards, dynamically monitor and monitor real-time, and form monitoring reports on a regular basis to strengthen synergies. (The National Health and Health Commission, relevant departments, and provincial governments are responsible for implementation before the end of December 2019. The first place is the lead unit, the same below)


(2) Improve the graded response. The lead agency of the provincial linkage mechanism shall organize and verify the shortage of monitoring or unreasonable price increase clues within the prescribed time limit and coordinate the response according to the situation. If the provincial level cannot be resolved in a coordinated manner, it shall report to the lead unit of the national linkage mechanism within the prescribed time limit. After receiving the report or monitoring the discovery clues, the lead unit of the national linkage mechanism shall organize the verification within the specified time limit and coordinate the response according to the situation. The lead unit of the national linkage mechanism shall timely refine and improve the requirements, time limits and work processes of the verification and response work of the national and provincial organizations. (The National Health and Health Commission, relevant departments, and provincial governments are responsible for implementation. They will be implemented before the end of December 2019. They will be responsible for the respective units according to their respective responsibilities, the same below)


(3) Implementing classified disposal. For some short-term drugs with poor substitution, insufficient production power and unstable market supply, we will strengthen the construction of centralized production bases for small-sized medicines (short-term medicines), improve and implement centralized procurement policies, and strengthen reserves to ensure supply. (Ministry of Industry and Information Technology, National Medical Insurance Bureau, etc.) To determine the shortage of drugs that are not produced by enterprises or cannot be resumed in a short period of time, the lead unit of the National Linkage Mechanism will promptly consult relevant departments and localities to promote the recovery of production. Accelerate drug registration and approval, organize temporary import procurement and other means to ensure supply. (The National Health and Health Commission, the Ministry of Industry and Information Technology, the Ministry of Ecology and Environment, the General Administration of Customs, the State Food and Drug Administration, etc.) are responsible for the shortage of pharmaceutical raw materials or preparations for drug production or preparations that require production suspension and remediation due to environmental factors such as excessive discharges. Production transition period. (Responsible for the Ministry of Ecology


(4) Do a good job in managing the shortage of drugs. The state implements a shortage of drug list management system, and the specific measures are formulated by the National Health and Health Committee and the State Food and Drug Administration. The lead units of the national and provincial linkage mechanism will, in conjunction with the member units, formulate a list of key national and provincial clinically essential shortages of drugs and a list of shortages of drugs, and adjust them dynamically. Focus on the monitoring and dynamic tracking of the drugs in the list, and timely release the list of drugs that have sufficient market supply and can form effective competition. For the drugs in the short-term drug list, all relevant departments and localities shall respond promptly according to their duties. (The National Health and Health Commission, relevant departments, and provincial governments are responsible for implementation, before the end of December 2019)


(5) Implementing a report on the suspension of production of a shortage of drugs. The lead unit of the provincial linkage mechanism shall evaluate the drugs in the list of provincial-level shortage drugs, and if it is deemed necessary to report the suspension of production, it shall promptly report to the lead unit of the national linkage mechanism as required. The lead unit of the national linkage mechanism will jointly demonstrate with the relevant departments the drugs reported in the provincial level and the drugs in the national shortage of drugs, and the shortage of drugs that need to be reported for production stoppage should be announced to the public and adjusted dynamically. If the holder of the drug marketing license stops producing the shortage of drugs, it shall report it to the drug regulatory department of the State Council or the provincial people's government in accordance with the regulations. After receiving the report, the drug supervision and administration department shall promptly notify the lead unit of the same-level linkage mechanism as required. The above specific regulations and time limits are required to be formulated by the national linkage mechanism and the State Food and Drug Administration according to their respective responsibilities. The medical security department shall, in accordance with the procurement information of the previous platform, report to the lead unit of the same level linkage mechanism in a timely manner the impact of the suspension of production on the market supply situation. The health and health department should promptly study the risk of drug shortages based on the medical use information of the medical institutions. (The National Health and Health Commission, the National Medical Insurance Bureau, and the State Food and Drug Administration are responsible respectively, and the Ministry of Industry and Information Technology participates in the implementation before December 2019)


Second, strengthen the management of essential drugs in medical institutions and the management of drug use


(6) Promote the priority use and rational use of essential drugs. By strengthening drug supervision and assessment, guiding and urging medical institutions to optimize drug use lists and drug formulas, etc., promote the priority use of essential drugs, increase the proportion of essential drugs, and timely adjust the national essential drug list to gradually realize the government's primary health care. In principle, the proportion of basic drug-equipped products in institutions, second-level public hospitals, and tertiary public hospitals is not less than 90%, 80%, and 60%, respectively, and promotes the establishment of “1+X” based on essential drugs. ("1" is the national essential drug list, "X" is a non-essential drug, and is determined by the local authorities according to the actual situation) to optimize and standardize the drug structure. Strengthen the management of the whole process of drug catalogue selection, procurement, and use in medical institutions, and promote the implementation of the requirements of “can be taken orally without intramuscular injection, and can be injected without intramuscular injection” to promote scientific and rational use of drugs. (Responsible by the National Health and Health Commission and the State Administration of Traditional Chinese Medicine)


(7) Optimizing the management and use of drugs in medical institutions. We will improve the national, provincial, municipal, and county-level shortage drug monitoring networks and information direct reporting systems, and guide the promotion of public medical institutions to formulate and improve the shortage of drug management regulations, and clarify the requirements for analysis and evaluation of information on shortages of medical institutions and information reporting. (The National Health and Health Commission and the State Administration of Traditional Chinese Medicine are responsible for implementation before the end of December 2019) to guide medical institutions to properly set up special drug inventory warning lines such as emergency (rush) and rescue drugs. Dynamically update the guidelines for the replacement of clinically-supplemented drugs, support related industry organizations to recommend alternative varieties for clinically replaceable shortages of drugs and update them dynamically, and guide medical institutions to regulate the use of drugs instead. Support the county central hospitals to increase the reserve of shortages of drugs needed. (The National Health and Health Commission and the State Administration of Traditional Chinese Medicine are responsible for encouraging them to explore effective ways to disclose the types of drugs sold by relevant medical institutions and social pharmacies to the public, and to open channels for drug purchases. (Responsible by provincial governments)


Third, improve the shortage of drug procurement work


(8) Implementing the direct network procurement policy. For the varieties in the list of national and provincial shortage medicines, enterprises are allowed to make their own quotations on the provincial drug centralized procurement platform, directly hang the net, and the medical institutions purchase independently. Supervision and guidance should not only improve price monitoring and management, but also avoid unreasonable administrative intervention. The provincial medical security department should strengthen the supervision of the price of direct net connection, collect and analyze the relevant information of the actual purchase price of the direct net, and publish it regularly on the provincial drug centralized procurement platform. (Responsible by the National Health Insurance Bureau)


(9) Allow medical institutions to make their own records for purchase. For the drug list in the clinically necessary shortage of drugs and the drugs in the shortage of drugs list, if there is no enterprise network on the provincial drug centralized procurement platform or is not included in the centralized procurement catalogue of the province, the medical institution may propose procurement requirements and search for drugs offline. Production enterprises, and directly negotiate with the drug supply enterprises, negotiate the purchase price in accordance with the principle of fairness, and independently file the provincial drug centralized procurement platform to be open and transparent. The medical security and health departments should strengthen the supervision of the procurement and use of drugs for filing and purchasing according to their respective duties. Directly linked to the network procurement and self-registered drugs are covered by the medical insurance catalogue, and the medical security department must pay in time according to regulations. (The National Medical Insurance Bureau and the National Health and Health Commission are responsible respectively)


(10) Strict management of pharmaceutical procurement performance. The provincial medical security department relies on the provincial centralized drug procurement platform to regularly monitor the drug delivery rate, the quantity of purchases, the settlement of payment, etc., strictly manage the purchase and sale of drugs, and punish the enterprises in accordance with the contractual provisions for distribution and supply. . Intensify supervision and notification, and promote medical institutions to timely settle drug loans and medical insurance funds to pay for drugs in a timely manner. (The National Medical Insurance Bureau and the National Health and Health Commission are responsible for each). The shortage of drug distribution must not limit the distribution enterprises, and is not subject to the "two-vote system" restriction. (The provincial people's governments are responsible for the participation of the Ministry of Commerce, the State Administration of Taxation, and the National Medical Insurance Bureau.) Areas that do not have the economics of distribution, and encourage the exploration of postal enterprises to carry out distribution work without the participation of drug distribution enterprises. (The State Post Bureau is responsible for the participation of the National Health Insurance Bureau)


Fourth, increase drug price supervision and enforcement


(11) Strengthen monitoring and early warning of abnormal drug prices. The provincial medical security department regularly monitors the changes in drug purchase prices based on the provincial centralized drug procurement platform. When the price fluctuates abnormally, it promptly understands the situation and prompts early warning, and reports the lead unit of the provincial linkage mechanism. The State Medical Insurance Bureau collated and promptly prompts relevant departments and localities to provide early warning key monitoring information, early warning of abnormal price fluctuations, provide price investigation clues and basic data to market supervision departments, and report to the national linkage mechanism lead unit. (Responsible by the National Health Insurance Bureau)


(12) Strengthening the normalization of drug prices. Comprehensive use of monitoring and early warning, cost investigation, correspondence and consultation, information disclosure, suspension of network, etc. for drugs that have a price increase or frequency anomaly, large regional price differences, serious mismatched distribution, or multiple early warnings. Measures are firmly bound. To improve the working mechanism of drug price and cost investigation, the national and provincial medical security departments may implement or entrust the implementation of cost investigation according to the needs of the work. (Responsible for the National Medical Insurance Bureau) Based on the centralized bidding and procurement work of drugs, establish a credit evaluation system for price and bidding procurement, conduct credit evaluation on the price and supply behavior of drug supply entities, and implement corresponding incentive and disciplinary measures. (The National Health Insurance Bureau is responsible for the participation of relevant departments)


(13) Increase the enforcement of illegal activities such as the monopoly of bulk drugs. Establish a coordinated work mechanism for market supervision, public security, taxation, drug supervision and management, and carry out multi-departmental rectification, and the results of remediation will be announced to the public in a timely manner. The most stringent standards are used to investigate and deal with the monopoly of raw materials and preparations in the field of drugs, and the price is illegal. The company insists on investigating and handling the criminal responsibility; it constitutes a criminal responsibility for criminality, and resolutely disposes of relevant responsible persons to form an effective shock. (The General Administration of Market Supervision is responsible for the participation of the National Development and Reform Commission, the Ministry of Public Security, the State Administration of Taxation, and the State Food and Drug Administration. It has made progress and continued to advance by the end of December 2019.)


(14) Classification properly handles the problem of excessive price increases for some drugs. If the price increase is unreasonable and illegal, the punishment shall be imposed according to the law;