Policy Interpretation of the Opinions on Improving the National Essential Drug System


I. What is the background and significance of the formulation and promulgation of the Opinions on Improving the National Essential Drug System (hereinafter referred to as the Opinions)?

The implementation of the basic drug system is an important strategic plan made by the CPC Central Committee and the State Council in the field of health. Since the launch of the new round of deepening healthcare reform, the national essential drug system, as a major livelihood project, has experienced the development of system innovation and continuous improvement of supporting policies, and has played a fundamental role in improving the drug supply guarantee system and guaranteeing the basic use of medicines by the people, and has played a positive role in deepening the healthcare reform, lowering the price of medicines, reducing the burden of medicines on patients, and alleviating the problem of "expensive treatment". It has played a positive role in deepening the medical reform, reducing drug prices, alleviating the burden of patients and easing the problem of "expensive treatment". However, with economic and social development and the deepening of health care reform, the current basic drug system has failed to meet the people's growing needs for a better life and health needs, highlighted in the basic drugs can not be fully adapted to the basic clinical needs of medication, the lack of incentives for the use of the mechanism, generic varieties of the quality of the original varieties of the therapeutic efficacy of the gap between the supply of supply and ensure that the supply mechanism is still not sound and so on, the need to comply with the new situation in the new era and new requirements, strengthen the top-level design of the system, and further improve the system. Strengthen the top-level design of the system and further improve relevant policies.

Improving the national essential drug system is an important initiative to deepen medical reform and strengthen basic public services in healthcare. The Outline of the "Healthy China 2030" Plan and the "13th Five-Year Plan for Health and Wellness" explicitly propose to consolidate and improve the basic drug system, and the deepening of healthcare reform in 2018 will make the formulation of a guiding document for improving the national basic drug system a key task to be arranged. tasks to be arranged. According to the decision-making deployment of the CPC Central Committee and the State Council and the arrangement of deepening healthcare reform, since this year, the National Health Commission has drafted the Opinions on Improving the National Essential Drug System in conjunction with the relevant departments on the basis of in-depth research and listening to the opinions of various parties. In accordance with the spirit of the meeting of the State Council Leading Group of Healthcare Reform, the opinions and suggestions of relevant national departments, provincial health departments, industry associations, research institutions, medical institutions and other aspects were widely solicited and fully absorbed, and were considered and adopted in principle by the State Council at its 22nd executive meeting on August 30th.

The Opinions strengthens the functional positioning of essential drugs as "highlighting the basic, preventing and treating the essential, guaranteeing supply, prioritizing the use, ensuring quality, and lowering the burden", and improves the policies on the selection, production, circulation, use, payment, and monitoring of essential drugs, focusing on the convergence with the reform of the three medical institutions, which is not only conducive to the construction of the essential drug system itself, but also drives the construction of the drug supply and guarantee system. It is not only conducive to the construction of the basic drug system itself, but also to drive the comprehensive promotion of the construction of the drug supply guarantee system, to ensure that the drugs are safe and effective, reasonably priced, and adequately supplied, and also conducive to the promotion of the interface between the upper and lower levels of health care institutions, to promote the establishment of a system of hierarchical diagnosis and treatment, and conducive to deepening the supply-side structural reform, and to promote the structural adjustment and transformation of the pharmaceutical industry.

Second, compared with the current policy of the basic drug system, what are the characteristics and highlights of the Opinions?

The Opinions is the inheritance and development of the current essential drugs system, focusing on the following five aspects of adjustment and improvement: First, in the catalog selection, pay more attention to highlighting the clinical value of medicines, and adhere to the dynamic adjustment and transfer in and out of the same emphasis. Newly approved and marketed medicines with precise efficacy, reasonable prices and better results, which can better meet the needs of disease prevention and treatment, may also be considered for inclusion in the catalog. At the same time, taking into account the basic drug system has been in the government-run primary health care institutions to achieve full coverage, allowing local supplementation of drugs is the system of construction of the initial transitional measures, the "Opinions" clear that, in principle, the localities do not supplement the drugs, which also facilitates a comparative analysis of the use of basic medicines in local medical institutions. Secondly, in terms of guaranteeing supply, more attention has been paid to giving good play to the roles of both the government and the market, summarizing and drawing on the effective experience and practices of centralized and classified procurement of medicines and solving the shortage of medicines in recent years, and making systematic arrangements for encouraging enterprises to technologically transform, improving the procurement and distribution mechanism, and strengthening the early-warning response to shortages. In particular, it emphasizes the need to prevent drug shortages in advance, to respond early to drug shortages through monitoring and early warning, and to ensure that essential drugs are not out of stock or out of stock through multiple channels and methods. Thirdly, in terms of provision and use, more attention has been paid to linking the use of medicines at the grass-roots level with that of medical institutions above the second level, and to assisting in the construction of a hierarchical diagnosis and treatment system, emphasizing that medical institutions at all levels should be fully equipped with, and should give priority to, the use of essential medicines, and standardizing the varieties, dosage forms, and specifications of medicines used in upper and lower-level medical institutions, so as to achieve upward and downward linkages, and to provide medication safeguards for grass-roots primary diagnosis, two-way referrals, and for the return of minor illnesses to grass-roots level and rehabilitation to the community. At the same time, through the reform of health insurance payment methods and financial subsidies, a mechanism of incentives and constraints for rational diagnosis and treatment and rational use of medication by medical institutions and medical personnel has been established. Fourth, in terms of quality assurance, more attention has been paid to linkage with the consistency evaluation of the quality and efficacy of generic drugs, emphasizing that drug varieties that have passed the consistency evaluation should be prioritized for inclusion in the basic drug catalog in accordance with the procedures, and that generic varieties of basic drugs that have not passed the consistency evaluation should be transferred out of the catalog step by step, so as to further enhance the fact that basic drugs are "safe drugs", The characteristics of "safe drugs" and "assured drugs" have been further strengthened. Fifth, to reduce the burden, pay more attention to the health insurance payment reimbursement policy to do a good job of convergence, taking into account the needs of public health, disease prevention and control, etc., clear basic drug catalog within the therapeutic drugs, the health insurance department in the adjustment of the health insurance catalog, in accordance with the procedures of the eligible will be prioritized to incorporate into the scope of the catalog or to adjust the classification of the A and B, and gradually increase the level of actual protection, to maximize the reduction of patients' expenditure on medicines, and to enhance the sense of access to the masses. The implementation of the Opinions will be a major step forward in the development of the health insurance system.

Third, the implementation of the "Opinions", will bring the masses what good benefits?

The national basic drug system is the basis of the drug supply guarantee system, is an important element of the basic public services in the field of health care, related to the healthy development of medical and health undertakings, related to the interests of the people. The implementation of the Opinions will benefit the people in the following ways. First, the national essential drugs cover a wider range, the number of varieties not only to meet the main clinical needs of common diseases, chronic diseases, emergency rescue, etc., but also focus on cancer, children, hepatitis C and other diseases, providing a variety of medication options for patients with different diseases. Secondly, to better meet the needs of hierarchical diagnosis and treatment, medical institutions at all levels have unified the implementation of centralized purchasing of varieties, dosage forms, specifications, manufacturers and prices, which solves the problem of non-convergence of the use of medicines in upper and lower levels of health care institutions, and provides more convenience for patients to seek medical treatment near the grass-roots level, and allows patients to travel less and spend less money. Third, the quality of essential medicines is more guaranteed. For varieties that have passed the consistency evaluation of the quality and efficacy of generic medicines, it is clear that priority should be given to the inclusion of the essential medicines catalog, and medical institutions are encouraged to give priority to the procurement and use of such medicines, and at the same time, through the implementation of sampling inspections for the whole variety of essential medicines coverage, and the strengthening of supervision and inspection of the production process, and other measures, we are able to provide patients with medicines of trustworthy quality and safety. Fourth, the supply of essential medicines is more secure; on the basis of effectively addressing the supply of medicines that are "already in short supply," we have particularly strengthened the monitoring and early warning of the risk of medicines that are "prone to shortages," and have taken early precautions as an important measure to address the incipient problem of shortages, so as to provide patients with a continuous supply of essential medicines, so that patients will no longer have to pay for the supply of essential medicines. We are also making early prevention an important measure to address the incipient problem of shortages, so as to provide patients with a continuous supply of essential medicines, so that they will no longer have to worry about not being able to buy them. Fifth, to promote more effective reform linkage, centralized band purchasing to reduce drug prices, rational use of medicines to reduce drug costs, in the medical insurance and financial support and protection at the same time, to encourage localities to give priority to the use of essential medicines under the premise of guaranteeing the effectiveness of medicines in the management of hypertension, diabetes mellitus, serious mental disorders and other chronic illnesses, and to gradually increase the level of protection of essential medicines in real terms, so that patients will be willing to use essential medicines.

Fourth, the basic drug system has a long chain, many links, involving many departments, coordination of the heavy task, what measures to ensure the smooth implementation of the Opinions?

From the practical experience in recent years, consolidation and improvement of the basic drug system, it is necessary to play the central and local enthusiasm, the implementation of the government's responsibility, so that there are goals, plans, division of labor, implementation, inspection, evaluation and improvement. To this end, the "Opinions" clearly require: First, strengthen organizational leadership, governments at all levels will be the implementation of the basic drug system into the government performance appraisal work system, all relevant departments to refine the policy measures, clear work requirements, strengthen collaboration and cooperation, and improve the long-term working mechanism. Second, 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 improve the basic drug system related policies in a timely manner according to the results of supervision and evaluation. Third, strengthen publicity and guidance, adhere to the correct orientation of public opinion, strengthen the interpretation of policies, through television, radio, newspapers and magazines, the network of new media and other forms, to fully publicize the objectives and positioning of the basic drug system, the significance of the policy measures, and to create a good social atmosphere for the implementation of the basic drug system.

Fifth, the selection and adjustment of the essential drugs catalog is of great concern to all walks of life, what are the innovations in the Opinions to strengthen the management of the essential drugs catalog?

The essential drugs catalog is the leading and implementation vehicle of the essential drugs system, and the number of varieties of essential drugs and the structure of the categories are closely related to the effect of the implementation of the essential drugs system. The Opinions summarize the practical experience of formulating and adjusting the catalog in the past, refer to the WHO essential drugs catalog and the selection procedures and principles of the drug roster of relevant countries (regions), and put forward the following initiatives for the management of the essential drugs catalog: firstly, adhering to the necessity of prevention and treatment, and guided by the need to satisfy the basic needs of medication for the prevention and treatment of diseases, the number of varieties of essential medicines is able to satisfy the main clinical needs of common diseases, chronic diseases, emergency rescue and rescue and the special populations such as children and public hospitals. The number of varieties of essential drugs can meet the main clinical needs of common diseases, chronic diseases, emergency rescue and other major clinical needs, as well as the needs of children and other special populations and public health control. Secondly, evidence-based decision-making should be strengthened, and equal emphasis should be placed on transferring drugs in and out, highlighting the clinical value of drugs, and prioritizing the transfer of drug varieties with clear evidence of efficacy and safety, and significant cost-benefit ratios on the basis of diagnostic and therapeutic norms, clinical diagnostic and therapeutic guidelines, and expert consensus. Focusing on the transfer out of the withdrawn, the occurrence of more serious adverse reactions, the assessment of the inappropriateness of the basic drugs, as well as the risk-benefit ratio or cost-benefit ratio of better varieties of alternative drugs. Thirdly, the catalog will be adjusted dynamically, with the basic drug catalog assessed regularly and adjusted dynamically, and the adjustment cycle will not exceed three years in principle. For newly approved and listed medicines with significantly improved efficacy and reasonable prices, the transfer process may be initiated in due course. In addition to ethnic minority areas that can be supplemented with a small number of ethnic medicines, in principle, no medicines will be supplemented in any place. Fourth, to strengthen the interface between the upper and lower levels of medical institutions, to adapt to the needs of the construction of a hierarchical diagnosis and treatment system, to promote the city (county) area of public medical institutions to centralize the volume of procurement, standardization of basic drug procurement of varieties, dosage forms, specifications, to meet the needs of the masses.

Sixth, drug shortages in recent years is a hot issue of general concern to all walks of life, the reasons for shortages are complex, what are the measures to ensure a sustained and stable supply of essential medicines?

Guaranteeing production and supply is the basis and prerequisite for improving the accessibility of essential medicines. Guaranteeing the supply of medicines in short supply is a long-term task, and this problem is not unique to China, but is a recurring problem in the process of market development and a common problem faced by all countries. The CPC Central Committee and the State Council attach great importance to it, and the Opinions fully draw on and absorb the Opinions on Centralized Purchasing of Medicines for Public Hospitals, the Implementation Opinions on Reforming and Improving the Mechanism for Shortage of Medicines Supply Guarantee, the Opinions on Reforming and Improving the Policy on Supply Guarantee and Use of Generic Medicines, and the Guidelines for the Development Planning of the Pharmaceutical Industry, etc., and put forward a series of reform initiatives focusing on preventing and solving the problem of shortage of medicines. Reform initiatives. First, formulating support policies to enhance production and supply capacity. By improving the pharmaceutical industry policy and industry development planning, we encourage the technological progress and technological transformation of enterprises of basic medicines, promote the construction of production quality systems by advantageous enterprises that are on a par with the international advanced level, and promote enterprises to become better and stronger. At the same time, medical institutions are encouraged to prioritize the procurement and use of basic drugs that have passed consistency evaluation and are priced appropriately. Second, improve the procurement mechanism to enhance the production and supply momentum. Implementing classified procurement of drugs, adopting centralized bidding and banded procurement, gradually reducing the number of successful supplier enterprises through competition, improving industry concentration, and guiding enterprises to reasonably reduce prices. At the same time, the strict agreement and contract implementation, health insurance agencies to medical institutions in a timely manner to pay health insurance funds, medical institutions in a timely manner to settle payments with the enterprise, mobilize enterprises to produce and supply incentives. Thirdly, strengthening the information connection and enhancing the risk prevention ability. Through the National Shortage Drug Monitoring and Early Warning System, information is collected from the research and development, production, circulation and use of drugs, and direct reporting of shortage of drugs is realized at all levels of medical institutions, so as to track and monitor the supply of raw materials and drugs, the inventory of enterprises and the behavior of market transactions, etc., to comprehensively study and judge the factors and trends of potential shortages, discover the risk of shortages as early as possible, and respond to the causes of shortages in a classified manner. Fourth, strengthening government-led efforts to enhance the ability to guarantee supply. For clinical necessity, small amount or low transaction price, enterprise production incentive factors such as market supply of essential medicines prone to shortages, can be built by the government platform, in the protection of reasonable profits of enterprises, the production of market aggregation through the market to determine a reasonable purchase price, fixed production, uniform distribution, into the reserve and other measures to ensure supply.

In addition, the "Opinions" on the enterprise put forward specific requirements, clear production enterprises as the first responsibility for ensuring the supply and distribution of essential medicines, to effectively fulfill the contract, in particular, to protect the remote, inconvenient areas of the distribution of medicines. If there is a shortage of medicines due to the enterprise, the enterprise should bear the responsibility of breach of contract and be included in the record of breach of trust. Monopolizing the raw material market and pushing up the price of drugs leading to drug shortages, suspected of constituting monopoly agreements and abuse of dominant market position behavior, according to the law to carry out anti-monopoly investigations, and increase penalties.

Seventh, in promoting medical institutions at all levels to fully equipped, prioritize the use of essential medicines, "Opinions" what specific initiatives?

Basic drugs as a clinical shou choice, medical institutions are willing to allocate, medical staff are willing to prescribe is to ensure that patients can use, use the key link of basic drugs. The Opinions clearly adhere to the dominant position of essential drugs, with medical institutions rationally equipped and prioritize the use of essential drugs as the main line, with the establishment of incentives and constraints mechanism as the focus, summarizing and absorbing the experience and practices of various places in the implementation of the essential drugs system in the process of promoting the priority use of essential drugs, fully respecting the laws of medicine and the clinical demand for medication, and comprehensively exerting the leverage of medical insurance, financial and other policies to promote the priority use of essential medicines, from a variety of perspectives proposed reform measures. Reform measures to promote the priority use of essential medicines have been proposed from a variety of perspectives. The first is to improve the use of essential drugs, emphasizing that essential drugs are applicable to medical institutions at all levels, including large hospitals, and the Opinions require that the proportion of essential drugs used in public medical institutions be clarified on a province-by-province basis, and that the use of medicines in upper and lower levels of medical institutions be well articulated. Secondly, to improve the recognition of essential drugs, the centralized drug procurement platform and medical institutions information system should be marked with essential drugs, prompting medical institutions to give priority to the purchase and use of doctors. Third, it has increased training in basic drugs, requiring physicians, pharmacists and management personnel to generally carry out training in the basic drug system and the clinical application guidelines and prescription sets for basic drugs, so as to comprehensively improve the rational use and management of basic drugs. Fourth, strengthen the clinical use of monitoring, the establishment of a sound monitoring platform for the use of drugs at the national and provincial levels, as well as the monitoring network system at the national, provincial, municipal and county levels, focusing on monitoring the provision of varieties of essential medicines in medical institutions, the use of quantities, the purchase price, the supply of distribution and other information, as well as the prescription of medicines in line with the norms of diagnosis and treatment, and the review of the prescription of essential medicines found to be notified of not choosing them without a justifiable reason. Fifth, to enhance the endogenous motivation of medical institutions, by deepening the reform of the health insurance payment method, to establish and improve the incentives and risk-sharing mechanism of "retaining the balance and sharing the reasonable cost overruns" between the health insurance management organization and medical institutions. The use of essential medicines is linked to the allocation of subsidies for the implementation of the essential medicines system at the grass-roots level. Sixth, to strengthen the performance evaluation of the use of essential medicines, to carry out a comprehensive clinical evaluation of medicines focusing on essential medicines, and to implement dynamic monitoring of the entire process of essential medicines from the supply of raw materials to the production, circulation, use, price, reimbursement, etc., not only to guide the safe and rational use of medicines in clinical practice, but also to provide an objective basis for dynamic adjustments to the catalog of essential medicines, assess the effectiveness of the system in benefiting the people, and improve the policies and measures.

VIII. What measures are in place to better safeguard the quality, safety and reliability of essential medicines?
The national drug safety plan has always prioritized the development of essential medicines, continuously improving the quality and efficacy of essential medicines, and effectively guaranteeing the safety of medicines for the people. The Opinions clearly require that a variety of measures be taken to ensure the quality of essential medicines from production, procurement, use, evaluation, supervision and other aspects. First, increase product sampling efforts, the implementation of sampling of essential medicines to cover all varieties, to the community to timely announce the results of sampling. The second is to strengthen on-site quality supervision, focusing on the production of essential medicines to carry out supervision and inspection, urging enterprises to comply with production, quality and quantity. Third, accelerating the improvement of drug quality, promoting the consistency evaluation of the quality and efficacy of generic drugs, and encouraging enterprises to carry out post-launch re-evaluation of drugs. Fourth, establish a mechanism for the elimination of the best and the worst, and prioritize the inclusion of drug varieties that have passed the consistency evaluation into the basic drug catalog in accordance with procedures. For generic drugs that have been included in the basic drug catalog, enterprises are encouraged to carry out consistency evaluation, and basic drug varieties that have not passed consistency evaluation are gradually transferred out of the catalog. Medical institutions are encouraged to prioritize the procurement and use of basic drugs that have passed consistency evaluation and are priced appropriately. Fifthly, the monitoring of adverse reactions has been strengthened, and drug safety early warning and emergency response mechanisms have been reinforced.

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