State Administration issued a document: Strengthening the normalization of drug prices and improving the shortage of drug supply systems

Source: Xinhuanet, China Government Network

Recently, the General Office of the State Council issued the "Opinions on Further Improving the Work of Stabilizing the Supply of Shortage Drugs" (hereinafter referred to as the "Opinions").

The "Opinions" pointed out that 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 problems such as insufficient supply and price monitoring, timely and sensitive drug procurement, use, storage, and price supervision.

In order to further improve the supply of shortages of medicines and to ensure the basic needs of the people, the "Opinions" propose the following corresponding policy measures.

In terms of guarantees, the first is to strengthen collaborative monitoring. Establish a multi-source information collection platform for national shortage medicines, establish a synergy monitoring mechanism, and realize information sharing between raw materials and preparations in terms of registration, production, procurement, and price, and improve the sensitivity and timeliness of monitoring and response. The second is to do a good job in managing the shortage of drugs. Implement a shortage of drug list management system, develop a list of key monitoring lists of clinically essential and vulnerable drugs at the national and provincial levels, and a list of shortages of drugs, and adjust them dynamically. The third is to implement a report on the suspension of drug shortages. If the holder of the drug marketing license stops producing the shortage of drugs, it shall report to the drug regulatory authority in accordance with the regulations. The medical security department timely reported to the lead unit of the same-level linkage mechanism the impact of the suspension of production on the market supply situation, and the health and health department timely investigated the risk of drug shortage. The fourth is to implement the direct network and self-recording procurement policies. For the varieties in the shortage of drugs list, 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; for the drugs in the shortage list and the key monitoring list, the medical institutions can search for the drug production offline. Enterprises, in the provincial drug centralized procurement platform for independent filing. The fifth is to establish and improve the normal reserve mechanism for shortage of drugs. Optimize the central and local pharmaceutical reserve structure, give full play to the provincial-level pharmaceutical reserve function, and screen a batch of drugs that are clinically necessary, uncertain in quantity, and prone to shortages, to be included in the reserve, and to clarify the procedures for invoking the shortage of drugs.

In terms of price stability, the first is to strengthen the monitoring and early warning of abnormal drug prices. Regularly monitor the changes in the purchase price, and if there is abnormal fluctuation in the price, timely understand the situation and prompt the warning. The second is to strengthen the regulation of the normalization of drug prices. Improve the working mechanism of drug price and cost investigation, and establish a credit evaluation system for price and bidding procurement. For drugs that have a price increase or frequency anomaly and a large difference in price between regions, comprehensive measures such as cost investigation and suspension of network connection are used to restrict. The third is to increase the enforcement of illegal activities. Establish a departmental collaborative linkage working mechanism, carry out multi-sectoral joint rectification, and rectify the results to the public in a timely manner. Criminal responsibilities that constitute crimes shall be investigated in accordance with the law, and relevant responsible persons shall be resolutely disposed of to form an effective shock.

The "Opinions" emphasizes that it is necessary to do regular reports, strengthen supervision and accountability, and in a place where work is not effective, timely talk about and urge rectification to ensure that relevant measures are effective. Strengthen publicity and guidance, regularly report the situation of shortage of drugs to ensure stable prices, and actively respond to social concerns.

The following is the original text of the document:

Opinions of the General Office of the State Council on Further Doing a Good Job of Stabilizing the Supply of Shortage Drugs

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 implemented according to the law; if the price increase is unreasonable but it does not constitute an illegal act, the interview urges the enterprise to take the initiative to correct it, and if necessary, adopt measures such as public exposure, suspension of the network, and disciplinary action. (The General Administration of Market Supervision and the National Medical Insurance Bureau are responsible respectively, and all relevant departments are involved). Before the end of December 2019, we urged a group of enterprises to take the initiative to correct the misconduct price behavior, suspend the registration of a batch of abnormally price-up drugs, and punish a batch of Enterprises suspected of price violations, fraudulent fraud or serious dishonesty have exposed a number of typical cases of abnormal price increases and monopoly, so that the excessively high price of drugs has been curbed. (The General Administration of Market Supervision and the State Medical Insurance Bureau are responsible respectively, and all relevant departments participate)

V. Improve the multi-level supply system for shortage drugs

(15) Establish and improve the normal reserve mechanism for shortage of drugs. Optimize the structure of central and local pharmaceutical reserves and increase the shortage of drug reserves. Give full play to the provincial-level pharmaceutical reserve function, and screen a batch of drugs that are clinically necessary, uncertain in dosage, and prone to shortages. (The Ministry of Industry and Information Technology, the provincial people's governments are responsible for each, the Ministry of Finance and other parties, and implemented before the end of June 2020) to clarify the procedures for the storage of short-selling drugs to facilitate the procurement and use of medical institutions. The provincial medical reserve management department shall notify the lead unit of the provincial linkage mechanism to the shortage of drug reserve varieties. In the event of a shortage of related drugs, according to the opinion of the lead unit of the provincial linkage mechanism, the paid call shall be made according to the procedure. (Ministry of Industry and Information Technology and National Health and Health Committee are responsible for each other) Encourage large-scale pharmaceutical circulation enterprises to actively fulfill their social responsibilities and play the role of “reservoir”. (Ministry of Commerce and the State-owned Assets Supervision and Administration Commission of the State Council are responsible for each) Encourage large-scale pharmaceutical circulation enterprises to set reasonable stock warning lines for short-term drugs such as emergency (rush) and rescue drugs commonly used in clinical practice. (SASAC is responsible)
(16) Improve the production and supply capacity and quality level of pharmaceuticals. In combination with the demand for supply of medicines and the national layout, in 2019, the construction of two small-type medicines (short-term medicines) centralized production bases will be promoted, and 40 kinds of small-type medicines (short-term medicines) that achieve stable production and supply will be added. By 2020, 100 kinds of small variety drugs (short-term drugs) will be stably supplied. (The Ministry of Industry and Information Technology is responsible for the participation of the National Development and Reform Commission, the National Health and Health Commission, and the State Food and Drug Administration, etc.) to support the shortage of pharmaceutical supply security through the use of central budgetary investment. (The National Development and Reform Commission, the Ministry of Industry and Information Technology are responsible for each) to promote the upgrading of the pharmaceutical industry and optimize the promotion of pharmaceutical production by increasing support and guidance, promoting the evaluation of the quality and efficacy of generic drugs, and improving drug procurement policies. Supply capacity and quality. (Responsible for the National Development and Reform Commission, the Ministry of Industry and Information Technology, the State Medical Insurance Bureau, and the State Food and Drug Administration)
(17) Increase the effective supply of medicinal raw materials. Promote the pharmaceutical companies to form a supply alliance with the raw material drug companies, integrate the upstream and downstream high-quality industrial resources, guide the raw material drug enterprises to directly supply to the preparation enterprises, and encourage the integrated production of raw materials and preparations. (Responsible for the Ministry of Industry and Information Technology, the State Food and Drug Administration, etc.) Implement policies and measures to optimize the registration and review and approval procedures for APIs, continue to deepen the reform of “distribution services”, and improve the efficiency and level of review and approval of APIs. (Responsible by the State Food and Drug Administration)
6. Practically strengthen organizational implementation
(18) Do a regular report. The lead unit of the national linkage mechanism shall establish a list of tasks in accordance with the requirements of this opinion. The member units of the National Linkage Mechanism and the leading units of the provincial linkage mechanism report to the lead unit of the National Linkage Mechanism on a quarterly basis the progress of the shortage of drug supply and stability, as well as drug shortages, price-related monitoring and response. The lead unit of the National Linkage Mechanism will inform the provincial (district, municipal) people's governments and countries on a quarterly basis of the relevant state departments, provinces (autonomous regions and municipalities), shortage of drugs, stable price work, drug shortages, price-related monitoring and response. All member units of the linkage mechanism shall give priority to the relevant local and departmental departments that fail to complete the tasks on time or work in a weak manner. (The National Health and Health Commission, relevant departments, and provincial governments are responsible for implementation, before the end of December 2019)
(19) Strengthen supervision and accountability. Where the work related to the shortage of medicines is not effective, it is timely to talk about and urge rectification. (The National Health and Health Commission and the relevant departments are responsible for each) The provincial (district, municipal) people's governments should increase supervision and accountability for the work related to the shortage of prices for drugs in the region. (Responsible by the provincial people's governments) The leading units of the national and provincial linkage mechanism report to the State Council and the people's government at the same level each year before the end of December each year. (The National Health and Health Commission, the provincial people's governments are responsible for each, and the relevant departments participate)
(20) Strengthen publicity and guidance. Set up a column on the official website of the National Health and Health Commission, regularly report the situation of the shortage of drugs to ensure the stable price, and gradually form a reasonable frequency of notification. In principle, the lead unit of the national linkage mechanism will release at least one authoritative information on the price of shortage of drugs in the quarter, and guide reasonable expectations. (Responsible by the National Health and Health Commission, implemented before the end of December 2019) Establish a normalized public opinion monitoring mechanism, actively respond to social concerns, and promptly respond to clarification of false information and malicious speculation through mainstream media and other channels. (The National Health and Health Commission and the relevant departments are responsible for each)