State Council: six aspects to do a good job in the shortage of drugs to ensure stable prices.


Release time:

2019-10-14

▍ Just now, the State Council issued a document to protect the shortage of drugs.
 
On October 11, the General Office of the State Council issued the "Opinions on Further Doing a Good Job in the Work of Guaranteing Supply and Stabilizing Prices of Shortage Drugs" (hereinafter referred to as the "Opinions").
 
Opinions show that in recent years, my country's shortage of drug supply guarantees have been continuously strengthened and positive results have been achieved, but drug supply and price monitoring are still not timely and sensitive, drug procurement, use, reserve, and price supervision policies need to be improved, and illegal market manipulation to raise prices The phenomenon is still prominent in some places, and some of the measures that have been introduced need to be implemented.
 
In order to further do a good job in ensuring the supply and price stability of drugs in shortage, and better protect the basic drug needs of the masses, with the consent of the State Council, the following opinions are put forward.
 
The document will improve the sensitivity and timeliness of monitoring and response, strengthen the allocation and use of essential drugs in medical institutions and the standardized management of drug use, improve the procurement of shortage drugs, increase drug price supervision and law enforcement, improve the multi-level drug supply system, and effectively strengthen the organization and implementation. To further do a good job in ensuring the supply and price of shortage drugs.
 
▍ Shortage of drugs is not limited to two-vote system, express delivery can also be delivered
 
Cyberlan found in the document that the State Council proposed further innovative measures to address the shortage of drug distribution.
 
The "opinion" shows that the distribution of drugs in shortage shall not be restricted to distribution enterprises and shall not be restricted by the "two-vote system. (The provincial people's governments are responsible, and the Ministry of Commerce, the State Administration of Taxation, and the National Medical Insurance Bureau participate) In areas that do not have the economy of distribution, in the absence of drug distribution companies participating in the competition, postal companies are encouraged to explore the distribution work. (The State Post Office is responsible, with the participation of the National Health Insurance Bureau).
 
Low distribution rate and difficult distribution have always been the pain points of shortage of drugs. This time the country has explored that postal enterprises should carry out distribution work. Perhaps ordinary logistics enterprises can also participate in the distribution of shortage drugs.
 
In addition, in the provisions on the purchase of shortage drugs, the document makes higher requirements for the medical insurance party:
 
Strict drug procurement compliance management. Relying on the provincial centralized drug procurement 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 promptly punishes the enterprise for failing to deliver and supply as agreed. Strengthen supervision and notification, and promote medical institutions to settle drug payments in a timely manner in accordance with the contract, and medical insurance funds to pay drug costs in a timely manner.
 
▍ Priority use of base drugs, rational drug use
 
It is worth noting that the "Opinions" clearly stated that through measures such as strengthening drug supervision and assessment, guiding and urging medical institutions to optimize drug catalogues and drug prescriptions, we will promote the priority use of essential drugs and increase the proportion of essential drug use.
 
In addition, it is necessary to adjust the national essential drug list in a timely manner, and gradually realize the government-run primary medical and health institutions and secondary publicHospitalIn principle, the proportion of essential drugs in tertiary public hospitals shall not be less than 90%, 80% and 60% respectively, and medical institutions at all levels shall be promoted to form a "1 + X" ("1" is the national essential drug list and "X" is a non-essential drug, which shall be determined by various localities according to the actual situation) drug use mode and optimize and standardize the drug use structure.
 
We will strengthen the management of the whole process of drug catalogue selection, procurement and use in medical institutions, promote the implementation of the requirements of "oral administration without intramuscular injection, intramuscular injection without infusion", and promote scientific and rational drug use.
 
As early as 2013, the former National Health and Family Planning Commission and other departments jointly formulated ten core information on rational drug use, including the principle that "if you can use it, you can use it less, you can use it less, you can use it more; if you can take it orally without intramuscular injection, you can inject it without infusion. In recent times, all parts of the country have called off outpatient infusion.
 
This time, the State Council once again issued a document emphasizing that, especially in the context of the continuous restriction of traditional Chinese medicine injections and the further escalation of the restriction order, a new round of regulatory requirements may be ushered in.
 
General Office of the State Council on Further Doing a Good Job in Shortage of Drugs
 
Opinions on the work of maintaining supply and price stability
 
State Council (2019)47.No.
 
The people's governments of all provinces, autonomous regions and municipalities directly under the Central Government, all ministries and commissions of the State Council and all institutions 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, my country's shortage of drug supply guarantees have been continuously strengthened and positive results have been achieved. However, drug supply and price monitoring are still not timely and sensitive, and drug procurement, use, storage, and price supervision policies need to be improved. The phenomenon of illegal manipulation of the market to raise prices is in some places. It is still more prominent, and some of the measures that have been introduced need to be implemented. In order to further do a good job in ensuring the supply and price stability of drugs in shortage, and better protect the basic drug needs of the masses, with the consent of the State Council, the following opinions are hereby put forward.
 
1. improve the sensitivity and timeliness of monitoring response
 
Collaborative monitoring (I) be strengthened. Build a national multi-source information collection platform for shortage of drugs, and the lead unit of the national shortage of drug supply guarantee work consultation linkage mechanism (hereinafter referred to as the national linkage mechanism) will establish a collaborative monitoring mechanism with relevant departments such as industry and information technology, medical security, drug supervision and management, etc. Realize the information connection and sharing of API and preparation in registration, production, procurement, price, etc., and refine the operable monitoring and early warning standards, real-time dynamic monitoring and early warning and regular formation of monitoring reports to strengthen collaborative response. (The National Health Commission, relevant departments and provincial people's governments are responsible for the implementation before the end of December 2019. The first one is the lead unit, the same below)
 
(II) improve the grading response. The leading unit of the provincial linkage mechanism shall organize the verification of the shortage or unreasonable price increase clues found in the monitoring within the prescribed time limit and coordinate the response according to the situation. If the provincial level cannot coordinate the solution, it shall report to the leading unit of the national linkage mechanism within the prescribed time limit. After receiving the report or monitoring clues, the lead unit of the national linkage mechanism shall organize the verification within the prescribed time limit and coordinate the response according to the situation. The leading unit of the national linkage mechanism shall promptly refine and improve the requirements of the scope of responsibilities, time limit, and work process of the verification and response work of national and provincial organizations. (The National Health Commission, relevant departments and provincial people's governments are respectively responsible for the implementation before the end of December 2019. They are respectively responsible for the relevant units to take the lead according to their responsibilities, the same below)
 
(III) implement classified disposal. For some shortage drugs with poor substitution, insufficient production power of enterprises and unstable market supply, we should strengthen the construction of centralized production bases for small varieties of drugs (shortage drugs), improve and implement the centralized procurement policy, and strengthen reserves to ensure supply. (The Ministry of Industry and Information Technology, the National Medical Insurance Administration, etc. are respectively responsible) For the shortage of drugs that are determined to be unproduced by enterprises or cannot resume production in a short period of time, the lead unit of the national linkage mechanism will promptly consult relevant departments and localities to promote the resumption of production by enterprises. Speed up drug registration approval, organize temporary import procurement, etc. to ensure supply. (The National 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.) shall be responsible for the shortage of pharmaceutical raw materials or preparation production lines that need to be stopped for rectification due to environmental factors such as excessive emissions. Production transition period. (Ministry of Ecology and Environment)
 
(IV) do a good job in the shortage of drug list management. The state implements a shortage of drug list management system, and the specific measures are formulated by the National Health Commission in conjunction with the State Food and Drug Administration and other departments. The leading units of the national and provincial linkage mechanisms, together with the member units, respectively, formulate and dynamically adjust the national and provincial key monitoring lists of clinically essential drugs and the list of drugs in short supply. Focus on monitoring and dynamic tracking of the drugs in the list, and timely call out the list of drugs that are adequately supplied in the market and can form effective competition. For the drugs in the shortage list, the relevant departments and localities shall respond in a timely manner according to their responsibilities. (The National Health Commission, relevant departments and provincial people's governments are respectively responsible for the implementation before the end of December 2019)
 
(V) implementation of drug shortage shutdown report. The leading unit of the provincial linkage mechanism evaluates the drugs in the list of drugs in shortage at the provincial level, and if it considers that a shutdown report is necessary, it shall promptly report to the leading unit of the national linkage mechanism in accordance with the provisions. The leading unit of the national linkage mechanism, together with relevant departments, comprehensively demonstrates the drugs reported at the provincial level and the drugs in the national shortage drug list, and shall issue an announcement to the public and dynamically adjust the shortage of drugs that really need to be reported to stop production. If the drug marketing license holder stops producing drugs in shortage, he shall report to the drug regulatory department of the State Council or the provincial people's government in accordance with the regulations, and the drug regulatory department shall promptly notify the lead unit of the linkage mechanism at the same level after receiving the report. 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 according to their respective responsibilities. The medical security department shall report the impact of the shutdown on the market supply situation to the lead unit of the linkage mechanism at the same level in a timely manner based on the previous platform procurement information. The health department shall timely study and judge the risk of shortage of discontinued drugs according to the past clinical use information of medical institutions. (The National Health Commission, the National Medical Insurance Administration, and the National Food and Drug Administration are respectively responsible, with the participation of the Ministry of Industry and Information Technology, etc., to be implemented before the end of December 2019)
 
2. Strengthening the Use of Essential Medicines and the Standardized Management of Medication in Medical Institutions
 
(VI) promote the priority allocation and rational use of essential drugs. Through measures such as strengthening drug supervision and assessment, guiding and urging medical institutions to optimize drug catalogues and drug prescription sets, we will promote the priority allocation and use of essential drugs, increase the proportion of essential drug use, and timely adjust the national essential drug catalogue, so as to gradually realize that the proportion of essential drugs provided by government-run primary medical and health institutions, secondary public hospitals and tertiary public hospitals shall not be less than 90%, 80% and 60% respectively in principle, promote medical institutions at all levels to form a "1 X" ("1" is the national essential drug list, "X" is a non-essential drug, and is determined by localities based on actual conditions) medication patterns, and optimize and standardize the medication structure. We will strengthen the management of the whole process of drug catalogue selection, procurement and use in medical institutions, promote the implementation of the requirements of "oral administration without intramuscular injection, intramuscular injection without infusion", and promote scientific and rational drug use. (National Health Commission, NationalMedicineBureau is responsible for)
 
(VII) optimize the management and use of shortage drugs in medical institutions. We will improve the national, provincial, municipal and county-level drug shortage monitoring network and direct information reporting system, guide and promote public medical institutions to formulate and improve regulations on drug shortage management, and refine and clarify the requirements for drug shortage analysis and evaluation and information reporting in medical institutions. (The National Health Commission and the State Administration of Traditional Chinese Medicine are responsible for the implementation before the end of December 2019) To guide and promote medical institutions to reasonably set up emergency (rush) rescue drugs and other specific drug inventory warning lines. Dynamically update the guidelines for the alternative use of drugs in clinical shortage, support relevant industry organizations to recommend alternative varieties of drugs in clinical shortage and update them dynamically, and guide medical institutions to standardize the alternative use of drugs. Support and encourage county central hospitals to increase the reserve of drugs that are easily in short supply. (The National Health Commission and the State Administration of Traditional Chinese Medicine are responsible) Encourage qualified places to explore effective ways to disclose relevant medical institutions and society to the publicPharmacyIn the sale of drug varieties, smooth the masses to buy drugs channels. (The provincial people's government is responsible for)
 
3. Improving the Procurement of Drugs in Shortage
 
(VIII) implement the direct net procurement policy. For varieties in the national and provincial shortage list of drugs, allowingEnterpriseIn the provincial drug centralized procurement platform independent quotation, direct network, medical institutions independent procurement. Supervision and guidance of local both to improve price monitoring and management, but also to avoid unreasonable administrative intervention. Provincial medical security departments should strengthen the supervision of direct online prices, timely collect and analyze information related to the actual purchase prices of direct online, and regularly publish them on the provincial centralized drug procurement platform. (National Health Insurance Agency)
 
(IX) allow medical institutions to record their own procurement. For the drugs in the key monitoring list of clinically necessary drugs and the list of drugs in short supply, if there are no enterprises on the provincial centralized drug procurement platform or are not listed in the provincial centralized drug procurement catalogue, medical institutions can put forward procurement requirements, search for drug manufacturers offline, directly negotiate with drug supply enterprises, determine the procurement price through negotiation according to the principle of fairness, and independently file on the provincial centralized drug procurement platform to be open and transparent. The medical security and health departments shall, in accordance with their duties, strengthen the supervision of the procurement and use of drugs for record procurement. If the drugs purchased directly on the Internet and independently on record belong to the scope of the medical insurance catalogue, the medical security department shall pay in time according to the regulations. (The National Health Insurance Bureau and the National Health Commission are responsible respectively)
 
(X) strict drug procurement compliance management. Relying on the provincial centralized drug procurement 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 promptly punishes the enterprise for failing to deliver and supply as agreed. Strengthen supervision and notification, and promote medical institutions to settle drug payments in a timely manner in accordance with the contract, and medical insurance funds to pay drug costs in a timely manner. (The National Health Insurance Bureau and the National Health Commission are respectively responsible for) The distribution of drugs in shortage shall not be restricted to distribution enterprises and shall not be restricted by the "two-vote system. (The provincial people's governments are responsible, and the Ministry of Commerce, the State Administration of Taxation, and the National Medical Insurance Bureau participate) In areas that do not have the economy of distribution, in the absence of drug distribution companies participating in the competition, postal companies are encouraged to explore the distribution work. (The State Post Office is responsible for the participation of the National Health Insurance Bureau)
 
4. strengthen drug price supervision and law enforcement
 
(11) Strengthen the monitoring and early warning of abnormal drug prices. Relying on the provincial centralized drug procurement platform, the provincial medical security department regularly monitors the changes in drug procurement prices, and promptly understands the situation and prompts early warnings for abnormal price fluctuations, and reports to the provincial linkage mechanism lead unit. The National Health Insurance Bureau collates and promptly prompts relevant departments and localities with information on key monitoring varieties, warns of abnormal drug price fluctuations, provides market supervision and other departments with price investigation clues and basic data, and reports to the lead unit of the national linkage mechanism. (National Health Insurance Agency)
 
(12) Strengthen the normal supervision of drug prices. For drugs with abnormal price increases or frequency, large price differences between regions, serious poor distribution or repeated early warning, etc., the comprehensive use of monitoring and early warning, cost investigation, letter interviews, information disclosure, suspension of the network and other measures, resolutely restrict. To improve the working mechanism of drug price cost investigation, the national and provincial medical security departments can implement or entrust the implementation of cost investigation according to the needs of the work. (The National Medical Insurance Bureau is responsible for) relying on the centralized bidding and procurement of drugs, establishing a price and bidding and procurement credit evaluation system, carrying out credit evaluation on the price and supply behavior of drug suppliers, and implementing corresponding incentive and disciplinary measures. (National Health Insurance Bureau is responsible for, the relevant departments involved)
 
(13) Strengthen the law enforcement of illegal acts such as the monopoly of raw materials. Establish a coordinated work mechanism for market supervision, public security, taxation, drug supervision and management departments, carry out multi-departmental joint rectification, and announce the rectification results to the public in a timely manner. Investigate and deal with monopolies and price violations in the field of raw materials and preparations with the strictest standards in accordance with the law, and insist on heavy and quick investigation and punishment; those who constitute crimes shall be investigated for criminal responsibility in accordance with the law, and the relevant responsible persons shall be resolutely dealt with to form an effective deterrent. (The State Administration of Market Supervision is responsible, with 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. Phased progress has been made and continued to advance before the end of December 2019)
 
(14) Classify and properly handle the problem of excessive drug price increases. If the price increase is unreasonable and illegal, penalties shall be imposed in accordance with the law; if the price increase is unreasonable but does not constitute a violation of the law, the interview urges the enterprise to take the initiative to correct, and if necessary, take measures such as public exposure, suspension of the Internet, and punishment for breach of trust. (The General Administration of Market Supervision and the State Health Insurance Administration are respectively responsible, with the participation of relevant departments) Strive to urge a group of enterprises to take the initiative to correct improper price behavior by the end of December 2019, suspend the online procurement qualification of a group of drugs with abnormal price increases, punish a group of enterprises suspected of price violations, fraudulent insurance or serious dishonesty, and expose a number of typical cases of abnormal price increases and monopoly, so as to curb the excessive rise in drug prices. (The General Administration of Market Supervision and the National Health Insurance Bureau are respectively responsible, with the participation of all relevant departments)
 
5. Improve the Multi-level Supply System of Shortage Drugs
 
(15) Establish and improve the normal reserve mechanism of shortage drugs. Optimize the central and local pharmaceutical reserve structure, increase the shortage of drug reserves. Give full play to the provincial pharmaceutical reserve function, screening a number of clinically necessary, uncertain dosage and prone to shortage of drugs into the reserve. (The Ministry of Industry and Information Technology and the provincial people's governments are respectively responsible, with the participation of the Ministry of Finance, etc., to be implemented by the end of June 2020) Clarify the procedures for the transfer of drugs in short supply to facilitate the procurement and use of medical institutions. The provincial pharmaceutical reserve management department shall notify the leading unit of the provincial linkage mechanism of the shortage of drug reserve varieties. In the event of a shortage of relevant drugs, the call shall be made in accordance with the procedure according to the opinions of the leading unit of the provincial linkage mechanism. (The Ministry of Industry and Information Technology and the National Health Commission are respectively responsible) Encourage and guide large-scale pharmaceutical circulation companies to actively fulfill their social responsibilities and play the "reservoir" function. (The Ministry of Commerce and the State-owned Assets Supervision and Administration Commission of the State Council are respectively responsible for) Encourage large-scale pharmaceutical circulation enterprises to set a reasonable inventory warning line for drugs that are commonly used in clinical emergency (rush) rescue drugs and other easy-to-shortage drugs. (State-owned Assets Supervision and Administration Commission of the State Council)
 
(16) Improve the production and supply capacity and quality level of drugs. Combined with the demand for drug supply security and the national layout, the construction of two more centralized production bases for small varieties of drugs (shortage drugs) will be promoted in 2019 to achieve stable production and supply of 40 more small varieties of drugs (shortage drugs). By 2020, to achieve stable production and supply of 100 small varieties of drugs (shortage of drugs). (The Ministry of Industry and Information Technology is responsible, with the participation of the National Development and Reform Commission, the National Health Commission, and the State Food and Drug Administration) using investment within the central budget to support the improvement of the ability to guarantee the supply of drugs in shortage. (The National Development and Reform Commission and the Ministry of Industry and Information Technology are respectively responsible) Promote the quality and upgrading of the pharmaceutical industry and optimize the production and supply of drugs by increasing support and guidance, promoting the evaluation of the quality and efficacy of generic drugs, and improving drug procurement policies. Capacity and quality. (The National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Medical Insurance Administration, and the State Food and Drug Administration are respectively responsible)
 
(17) Increase the effective supply of medicinal raw materials. We will promote the formation of supply alliances between preparation enterprises and API enterprises, integrate upstream and downstream high-quality industrial resources, guide API enterprises to supply directly to preparation enterprises, and encourage the integrated production of API and preparations. (The Ministry of Industry and Information Technology is responsible for the Ministry of Industry and Information Technology, with the participation of the State Drug Administration, etc.) to implement policies and measures related to the optimization of the registration and review and approval procedures for APIs, etc., to continuously deepen the reform of "release and management", and to improve the efficiency and level of review and approval of APIs, etc. (State Food and Drug Administration)
 
6. strengthen the organization and implementation
 
(18) Make regular reports. The lead unit of the national linkage mechanism shall establish a task list in accordance with the requirements of this opinion. Each member unit of the national linkage mechanism and each provincial linkage mechanism lead unit report the shortage to the national linkage mechanism lead unit on a quarterly basis.DrugsProgress in price stabilization and drug shortages, price-related monitoring and response. On a quarterly basis, the lead unit of the national linkage mechanism will inform the relevant departments of the state and provinces (autonomous regions and municipalities) of the work of ensuring the supply and price stability of drugs in shortage, as well as the monitoring and response of drug shortages and prices, to the people's governments of all provinces (autonomous regions and municipalities) and the member units of the national linkage mechanism, and focus on reporting the relevant situation of localities and departments that fail to complete tasks on time or do not work effectively. (The National Health Commission, relevant departments and provincial people's governments are respectively responsible for the implementation before the end of December 2019)
 
(19) Strengthen supervision and accountability. Where the work related to the supply and price stabilization of shortage drugs is not carried out effectively, timely interviews and supervision of rectification. (the National Health Commission and relevant departments are respectively responsible for) the people's governments of all provinces (autonomous regions and municipalities) should strengthen the supervision and accountability of the work related to ensuring the supply and price stability of drugs in shortage in their respective regions. (All provincial people's governments are responsible) The leading units of the national and provincial linkage mechanisms report their duties and work to the State Council and the people's governments at the same level before the end of December each year. (The National Health Commission and the provincial people's governments are responsible respectively, and all relevant departments participate)
 
(20) Strengthen publicity and guidance. Set up a column on the official website of the National Health Commission to regularly report the work of ensuring the supply and price stability of drugs in shortage, and gradually form a reasonable notification frequency. In principle, the lead unit of the national linkage mechanism publishes authoritative information on the supply and price stability of drugs in shortage at least once a quarter to guide reasonable expectations. (The National Health and Health Commission is responsible for implementation before the end of December 2019) Establish a normalized public opinion monitoring mechanism, actively respond to social concerns, and promptly respond to and clarify false information and malicious hype through mainstream media and other channels. (National Health Commission, the relevant departments are responsible for)