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

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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 national essential drug system is the foundation of the drug supply guarantee system and an important part of basic public services in the medical and health field. Since the new round of medical reform, the establishment and implementation of the national essential drug system has played an important role in improving the drug supply guarantee system, ensuring the basic drug use of the masses, and reducing the burden of patients. At the same time, there are still some problems, such as not fully adapting to the needs of basic clinical drugs, lack of incentive mechanism for use, gap between the quality and curative effect of imitation varieties and original research varieties, and imperfect guarantee supply mechanism. In order to implement the National Health and Health Conference, the "Healthy China 2030 Plan" and the deployment requirements for deepening the reform of the medical and health system, and further improve the national essential drug system, with the approval of the State Council, the following opinions are hereby put forward.
General 1. requirements
Fully implement the spirit of the 19th National Congress of the Communist Party of China and the Second and Third Plenary Sessions of the 19th Central Committee of the Communist Party of China, guided by Xi Jinping's thoughts on socialism with Chinese characteristics in the new era, adhere to the people's health as the center, and strengthen the basic medicines. The functional positioning of "priority use, quality assurance, and burden reduction" improves policies from the selection, production, circulation, use, payment, and monitoring of essential drugs, we will comprehensively promote the construction of a drug supply guarantee system, strive to ensure the safety and effectiveness of drugs, reasonable prices and adequate supply, and alleviate the problem of "expensive medical treatment. We will promote the convergence of drug use in upper and lower medical institutions, help build a graded diagnosis and treatment system, and promote the transformation and upgrading of the pharmaceutical industry and supply-side structural reform.
2. Dynamic Adjustment Optimization Catalog
(I) adapt to basic medical and health needs. Guided by meeting the needs of basic drug use for disease prevention and treatment, according to the disease spectrum and drug use characteristics of our country, fully considering the basic national conditions and guarantee capabilities at this stage, adhering to the principles of science, openness, fairness and justice, based on diagnosis and treatment standards, clinical diagnosis and treatment guidelines and expert consensus, with equal emphasis on Chinese and Western medicine, and selecting an appropriate number of essential drug varieties to meet the main clinical needs of common diseases, chronic diseases, chronic diseases and emergency rescue, taking into account the needs of special populations such as children and public health prevention and treatment. Strengthen evidence-based decision-making, highlight the clinical value of drugs, standardize the dosage form specifications, can be orally not intramuscular injection, can intramuscular injection not infusion. Support the development of Chinese medicine and encourage research and innovation in the pharmaceutical industry.
(II) improve the catalog adjustment management mechanism. Optimize the selection and adjustment procedures of the essential drug catalog, integrate factors such as clinical application practice of drugs, changes in drug standards, and new drug listings, and regularly evaluate and dynamically adjust the essential drug catalog. In principle, the adjustment cycle should not exceed 3 years. For newly approved drugs on the market, the efficacy of which is significantly improved and the price is reasonable, the transfer procedure can be initiated in due course. Adhere to the transfer and transfer, give priority to the transfer of effectiveness and safety evidence clear, cost-benefit ratio of the drug varieties. In principle, all localities do not supplement drugs, and minority areas may supplement a small amount of ethnic drugs.
3. ensure production and supply
(III) improve the effective supply capacity. Take the implementation of the essential drug system as an important part of improving the pharmaceutical industry policy and industry development plan, encourage technological progress and technological transformation of enterprises, promote the construction of superior enterprises to build a production quality system in line with the international advanced level, and enhance the production and supply capacity of essential drugs. To carry out a survey on the current situation of production enterprises, for essential drugs that are clinically necessary, small dosage or low transaction price, and insufficient production power of enterprises, the government can build a platform to determine reasonable purchase prices, fixed-point production, unified distribution, and inclusion in reserves through market matching to ensure supply.
(IV) improve the procurement and distribution mechanism. Fully consider the special commodity attributes of drugs, give full play to the role of the government and the market, adhere to the direction of centralized procurement, implement classified procurement of drugs, and guide the formation of reasonable prices. We should do a good job in linking up the use of drugs by higher and lower medical institutions, promote the centralized procurement of public medical institutions in the city (county) region, promote the reduction of drug prices, standardize the varieties, dosage forms and specifications of essential drugs, and meet the needs of the masses. Encourage oncology and other Junior College hospitals to carry out cross-regional joint procurement. As the first person responsible for ensuring the supply and distribution of essential drugs, production enterprises should earnestly perform the contract, especially to ensure the distribution of drugs in remote and inconvenient areas. If the shortage of drugs is caused by the enterprise, the enterprise shall bear the liability for breach of contract, and the relevant departments and units shall promptly include it in the record of breach of trust. Medical insurance agencies shall allocate medical insurance funds to medical institutions in a timely manner in accordance with the agreement. Medical institutions shall settle the payment for goods in a timely manner in strict accordance with the contract; those who delay the payment for goods shall be given a notice of criticism and ordered to make rectification within a time limit.
(V) strengthen the shortage of early warning response. Establish and improve the national drug shortage monitoring and early warning system, strengthen the collection of multi-source information such as drug research and development, production, circulation, and use, accelerate the realization of direct network reporting of drug shortage information in medical institutions at all levels, and track and monitor the supply of raw materials, corporate inventories, and market transactions. Situation, comprehensively study and judge potential shortage factors and trends, find shortage risks as soon as possible, and respond to different shortage causes. For monopolizing the raw material market and pushing up drug prices leading to drug shortages, suspected of constituting monopoly agreements and abusing market dominance, anti-monopoly investigations shall be carried out in accordance with the law and penalties shall be increased. Incorporate the shortage of medicines needed by the military into the national emergency guarantee system for shortage of medicines, and establish a military-civilian coordination and linkage mechanism for the shortage of medicines in urgent need through military-civilian integration to ensure the supply of medicines in urgent need and emergency combat reserves.
4. fully equipped with priority use
(VI) strengthen the management of the use of equipment. Adhere to the dominant position of essential drugs, strengthen the management of the use of essential drugs in medical institutions, clarify the proportion of essential drugs used in public medical institutions with the province as a unit, and continuously increase the use of essential drugs in medical institutions. According to the functional orientation and scope of diagnosis and treatment, public medical institutions are reasonably equipped with essential drugs to ensure the basic clinical drug demand. The centralized drug procurement platform and the information system of medical institutions should label essential drugs, prompting medical institutions to give priority to procurement and doctors to give priority to use. The use of essential drugs will be the focus of prescription comments, and those who do not choose essential drugs without justifiable reasons will be notified. We will strengthen the training of doctors, pharmacists and managers on the basic drug system, clinical application guidelines and prescription sets of essential drugs, so as to improve the level of rational use and management of essential drugs. Encourage other medical institutions to be equipped to use essential drugs.
(VII) establish a preferential use incentive mechanism. Medical institutions scientifically set up indicators for the use of essential drugs in clinical departments and included them in the assessment. The use of essential drugs will be linked to the allocation of subsidies for the implementation of the basic drug system at the grass-roots level. Deepen the reform of medical insurance payment methods, establish and improve the incentive and risk-sharing mechanism of "balance retention and reasonable overspending sharing" between medical insurance agencies and medical institutions. Through the formulation of drug medical insurance payment standards and other methods, to guide medical institutions and medical personnel to rational diagnosis and treatment, rational drug use.
(VIII) implementation of clinical use monitoring. Relying on existing resources, we should establish and improve the national and provincial drug use monitoring platform and the national, provincial, municipal and county monitoring network system, focusing on monitoring the information of essential drugs in medical institutions, such as the variety, quantity, purchase price, supply and distribution, and whether the prescription drugs conform to the diagnosis and treatment standards. To carry out a comprehensive clinical evaluation of drugs focusing on essential drugs to guide clinical safe and rational drug use. Strengthen the interconnection of information between departments, and implement dynamic monitoring of the entire process of essential drugs from raw material supply to production, circulation, use, price, and reimbursement.
5. reduce the burden of medical expenses on the masses
(IX) gradually improve the actual level of security. To improve the medical insurance payment policy, for the therapeutic drugs in the basic drug list, the medical insurance department shall, when adjusting the medical insurance list, give priority to those that meet the conditions or adjust the classification of A and B according to the procedures. For the national immunization program vaccines and anti-AIDS, tuberculosis, parasitic diseases and other major public health prevention and control of essential drugs, increase government investment to reduce the burden of drug use by the masses.
(X) explore effective ways to reduce the burden on patients. Encourage local governments to organically integrate the essential drug system with hierarchical 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 drug efficacy, and minimize Patient drug expenses enhance the sense of gain among the masses.
6. improve the quality and safety level
(11) Strengthen quality and safety supervision. The implementation of the whole variety of basic drugs coverage sampling, to the community in a timely manner to publish the results of sampling. Encourage enterprises to carry out post-marketing re-evaluation of drugs. Strengthen the monitoring of adverse drug reactions of essential drugs, and strengthen drug safety early warning and emergency response mechanisms. Strengthen the supervision and inspection of the production of essential drugs, and urge enterprises to produce in accordance with the law and ensure quality.
(12) Promote the evaluation of the quality and efficacy of generic drugs. The varieties of drugs that have passed the consistency evaluation shall be given priority in the list of essential drugs according to the procedures. For generic drugs that have been included in the list of essential drugs, enterprises are encouraged to carry out consistency evaluation, and the varieties of essential drugs that have not passed the consistency evaluation are gradually transferred out of the list. Encourage medical institutions to prioritize the procurement and use of essential drugs that have passed consistency evaluation and are affordable.
7. strengthen organizational security
(13) Strengthen organizational leadership. The implementation of the national essential drug system is an important deployment made by the Party Central Committee and the State Council in the field of health. Governments at all levels must implement leadership responsibilities, guarantee responsibilities, management responsibilities, and supervision responsibilities, and incorporate the implementation of the national essential drug system into the government performance appraisal system to ensure Achieve practical results. All relevant departments should refine policies and measures, improve long-term mechanisms, strengthen cooperation and cooperation, and form a joint force.
(14) Strengthen supervision and evaluation. Establish and improve the supervision and evaluation system of the essential drug system, give full play to the role of third-party evaluation, strengthen the use of results, and improve the relevant policies of the essential drug system in a timely manner according to the results of supervision and evaluation. Encourage local governments to combine actual conditions, focus on ensuring the supply and priority use of essential drugs, and 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 television, radio, newspapers and periodicals, network new media and other channels, fully publicize the goal orientation, significance and policy measures of the essential drug system. Adhere to the correct guidance 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 essential drug system.
General Office of the State Council
   13 September 2018