Opinions of the General Office of the State Council on Improving the National Essential Drug System

(Guo Ban Fa [2018] No. 88)
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 national essential medicine system is the basis of the medicine supply security system and an important part of the basic public service in the medical and health field. Since the new round of medical reform, the establishment and implementation of the national essential medicine system has played an important role in improving the drug supply security system, ensuring the basic use of drugs by the masses, and reducing the burden of drug use for patients. At the same time, there are also problems such as not fully adapting to the needs of clinical basic drug use, lack of use incentive mechanism, the gap between the quality of the imitation products and the original research varieties, and the imperfect supply mechanism. In order to implement the National Health and Wellness Conference, the "Health China 2030" Planning Outline and the requirements for deepening the deployment of the medical and health system reform, and further improve the national essential medicine system, with the consent of the State Council, the following opinions are proposed.
First, the overall requirements
Fully implement the spirit of the 19th and 19th Central Committees of the 19th Party and the 19th Central Committee of the Communist Party of China, and take Xi Jinping's new era of socialism with Chinese characteristics as the guide, adhere to the people's health as the center, and strengthen basic medicines to "emphasize basics, prevent and control, and ensure supply, The functional positioning of priority use, quality assurance and burden reduction, improve policies from the selection, production, circulation, use, payment and monitoring of essential drugs, comprehensively drive the construction of drug supply security system, and strive to ensure safe and effective drug prices and reasonable prices. The supply is sufficient to alleviate the problem of “expensive medical treatment”. Promote the use of drugs in the upper and lower medical institutions, assist in the construction of graded diagnosis and treatment systems, and promote the transformation and upgrading of the pharmaceutical industry and structural reforms on the supply side.
Second, dynamic adjustment and optimization of the catalog
(1) Adapt to basic medical and health needs. In order to meet the needs of basic drug use for disease prevention and treatment, according to the characteristics of disease spectrum and drug use in China, we should fully consider the basic national conditions and support capabilities at the current stage, adhere to the principles of science, openness, fairness and justice, and adopt the guidelines for diagnosis and treatment, clinical diagnosis and treatment guidelines and expert consensus. According to the principle, both Chinese and Western medicines are equally important, and the appropriate number of essential medicines are selected to meet the main clinical needs of common diseases, chronic diseases, emergency rescue, etc., taking into account the special needs of children and other public health prevention and treatment drugs. Strengthen evidence-based decision-making, highlight the clinical value of drugs; standardize the dosage form specifications, can not be intramuscular injection, can not intramuscular injection. Support the development of Chinese medicine and encourage the research and development of the pharmaceutical industry.
(2) Improve the management mechanism of the catalogue adjustment. Optimize the selection and adjustment procedures for essential drug catalogues, comprehensive clinical drug application practices, changes in drug standards, new drug listings, etc., and regularly evaluate and dynamically adjust the list of essential drugs. The adjustment cycle should not exceed 3 years in principle. For new drugs that are approved for listing and have a significantly improved efficacy compared with the listed drugs, and reasonable prices, the transfer procedure can be initiated in due course. Adhere to the emphasis on transfer and transfer, prioritize the selection of drug products with clear evidence of effectiveness and safety and significant cost-benefit ratio; focus on recalling those who have been delisted, have serious adverse reactions, and are not suitable for basic drugs after evaluation. And drugs that are more cost-effective or cost-effective than alternative varieties. In principle, there is no supplementary medicine in various places, and a small number of ethnic medicines can be supplemented in minority areas.
Third, effectively guarantee production and supply
(3) Improve the effective supply capacity. The implementation of the basic drug system as an important part of improving the pharmaceutical industry policy and industry development plan, encourage technological advancement and technological transformation of enterprises, promote the production quality system of advantageous enterprises and the international advanced level, and enhance the production and supply capacity of essential drugs. Conducting a survey on the status quo of production enterprises, for the essential drugs that are in short supply in the market due to factors such as clinical necessity, small amount or low transaction price, and insufficient production power of the enterprise, the government can build a platform to determine reasonable purchase prices, fixed-point production, and unification through market matching. Measures such as distribution and inclusion of reserves ensure supply.
(4) Improve the procurement and distribution mechanism. Fully consider the special commodity attributes of drugs, give play to the role of the government and the market, adhere to the direction of centralized procurement, implement the procurement of drugs, and guide the formation of reasonable prices. We will do a good job in linking medicines between lower and upper-level medical institutions, promote the centralized procurement of public medical institutions in the city (county), promote the price of drugs, regulate the varieties, dosage forms and specifications of basic drug purchases, and meet the needs of the masses. Encourage specialized hospitals such as cancer to carry out cross-regional joint procurement. As the first responsible person to guarantee the supply and distribution of essential drugs, production enterprises should earnestly perform the contract, especially to ensure the distribution of drugs in remote and inaccessible areas. Due to the shortage of medication caused by the enterprise, the enterprise shall bear the liability for breach of contract, and the relevant departments and units shall promptly include the record of loss of trust. The medical insurance agency shall, in accordance with the agreement, timely allocate medical insurance funds to the medical institution. The medical institution shall settle the payment in time in strict accordance with the contract; if it delays the payment, it shall be notified of the notification and ordered to rectify within a time limit.
(5) Strengthening the early warning response to shortages. Establish and improve a nationwide shortage of drug monitoring and early warning systems, strengthen multi-source information collection for drug research and development, production, circulation, and use, accelerate the implementation of direct reports on drug information networks at all levels of medical institutions, and track and monitor the supply of raw materials, enterprise inventory, and market transactions. In the case, comprehensively judge the potential shortage factors and trends, identify the shortage risks as early as possible, and classify and respond to different shortage reasons. For the monopoly raw materials market and pushing up drug prices to lead to drug shortages, suspected of forming a monopoly agreement and abuse of market dominance, conduct anti-monopoly investigations in accordance with the law, and increase penalties. Incorporate the shortage of drugs required by the military into the national emergency drug emergency protection system, and establish a coordinated and coordinated mechanism for the shortage of urgently needed drugs through military-civilian integration to ensure the urgent shortage of troops and the supply of emergency combat reserve medicines.
Fourth, full priority use
(6) Strengthening the use and management of equipment. Adhere to the dominant position of essential drugs, strengthen the management of basic drug use in medical institutions, and clarify the proportion of basic drugs used in public medical institutions by the province as a unit, and continuously increase the use of basic drugs in medical institutions. Public medical institutions rationally equip basic drugs according to functional positioning and scope of diagnosis and treatment to ensure the basic needs of clinical drugs. The centralized drug procurement platform and the medical institution information system should mark the essential drugs, prompting the medical institutions to prioritize procurement and doctors to give priority to use. The use of essential drugs is the focus of prescription reviews, and notifications are not recommended for basic drugs without justified reasons. Physicians, pharmacists and management personnel will increase the training of basic drug systems and clinical application guidelines and formulas for essential drugs, and improve the rational use and management of essential drugs. Encourage other medical institutions to use essential medicines.
(7) Establish a priority use incentive mechanism. The medical institution scientifically sets the basic drug use indicators of the clinical department and is included in the assessment. Linking the use of essential drugs to the allocation of subsidies for the implementation of the basic drug system at the grassroots level. Deepen the reform of medical insurance payment methods, and establish and improve the incentive and risk sharing mechanism between “salary retention and reasonable over-spending” between medical insurance agencies and medical institutions. Guide medical institutions and medical personnel to rational diagnosis and treatment and rational use of drugs by formulating payment standards for medical insurance.
(8) Implement clinical use monitoring. Relying on existing resources, we will establish and improve national and provincial drug use monitoring platforms as well as national, provincial, prefecture, and county monitoring networks. We will focus on monitoring the types of essential drugs, the quantity used, the purchase price, and the supply and distribution of medical institutions. And whether the prescription medication meets the medical treatment norms. Carry out clinical comprehensive evaluation of drugs focusing on essential drugs, and guide clinical safe and rational use of drugs. Strengthen inter-departmental information interconnection and conduct dynamic monitoring of essential drugs from raw material supply to production, circulation, use, price and reimbursement.
Fifth, reduce the burden of the mass drug
(9) Gradually increase the actual level of protection. Improve the medical insurance payment policy. For the therapeutic drugs in the essential medicines list, when the medical insurance department adjusts the medical insurance catalogue, the eligible conditions will be included in the catalogue or adjusted in accordance with the procedures. For national immunization program vaccines and basic drugs for major public health prevention and treatment such as anti-AIDS, tuberculosis and parasitic diseases, increase government investment and reduce the burden of drug use for the masses.
(10) Exploring effective ways to reduce the burden on patients. Encourage local governments to combine basic drug systems with graded diagnosis and treatment, family doctor contract services, and chronic disease health management. In the management of chronic diseases such as hypertension, diabetes, and severe mental disorders, priority should be given to the use of essential drugs under the premise of ensuring efficacy, minimizing The patient's medical expenses will increase the sense of gains.
6. Improve the quality and safety level
(11) Strengthen quality and safety supervision. Conduct full-scale sampling inspection of essential drugs, and release the results of random inspections to the society in a timely manner. Encourage enterprises to conduct re-evaluation after listing drugs. Strengthen the monitoring of adverse drug reactions of essential drugs, and strengthen the mechanism for early warning and emergency response of drug safety. Strengthen supervision and inspection of the production of essential drugs, urge enterprises to comply with laws and regulations, and ensure quality.
(12) Promote the consistency evaluation of the quality and efficacy of generic drugs. The drug varieties that passed the consistency evaluation were prioritized into the essential drug list according to procedures. For generic drugs that have been included in the list of essential drugs, enterprises are encouraged to carry out consistency evaluations, and the basic drug varieties that have not passed the consistency evaluation are gradually transferred to the catalogue. Medical institutions are encouraged to prioritize the procurement and use of essential drugs that are consistently evaluated and affordable.
Seven, strengthen organizational protection
(13) Strengthen organizational leadership. The implementation of the national essential medicine system is an important arrangement made by the Party Central Committee and the State Council in the field of health and health. Governments at all levels must implement leadership responsibilities, guarantee responsibilities, management responsibilities, and supervisory responsibilities, and incorporate the implementation of the national essential medicine system into the government performance appraisal system to ensure Get results. All relevant departments should refine policy measures, improve long-term mechanisms, strengthen coordination and cooperation, and form a joint effort.
(14) Strengthen supervision and evaluation. Establish and improve the supervision and evaluation system for the implementation of the basic drug system, give full play to the role of third-party evaluation, strengthen the use of results, and timely improve the policies related to the basic drug system based on the results of supervision and evaluation. Encourage local integration with practice, focus on ensuring the supply and priority use of essential drugs, reduce the burden on the masses, explore effective practices and models, and summarize and promote them in a timely manner.
(15) Strengthen publicity and guidance. Through the various channels such as television, radio, newspapers and periodicals, and new media, the target, significance and policy measures of the basic drug system will be fully publicized. Adhere to the correct direction of public opinion, strengthen policy interpretation, properly respond to social concerns, reasonably guide social expectations, and create a good social atmosphere for the implementation of the basic drug system.
  Office of the State Council
September 13, 2018