The Office of the Leading Group of the State Council for Deepening the Reform of the Pharmaceutical and Health Care System held a meeting on August 18 to officially launch the implementation of the national essential drug system, and issued the Implementation Opinions on the Establishment of the National Essential Drug System, the Measures for the Administration of the National Essential Drug Catalog (Provisional), and the National Essential Drug Catalog (Grassroots Level Part).
Q: What are national essential drugs and the national essential drug system?
A: The concept of "essential drugs" was put forward by the World Health Organization (WHO) in the 1970s as the most important, basic and indispensable medicines to satisfy people's needs. At present, more than 160 countries around the world have formulated their own Essential Medicines List, and 105 of them have formulated and enacted national essential medicines policies.
The establishment of a national essential drug system is one of the five key tasks to be carried out in the near future for the reform of the medical and health system. In China, essential medicines are those that are adapted to the needs of basic medical and health care, in appropriate dosage forms and at reasonable prices, and whose supply can be guaranteed and equitably accessible to the public. Government-organized primary health care institutions are all equipped with and use of essential drugs, and all other types of medical institutions must also be required to use essential drugs.
China's national essential drug system refers to a system that effectively manages the selection, production, circulation, use, pricing, reimbursement, monitoring and evaluation of essential drugs, and is linked to the public *** health, basic medical services, and basic medical security systems.
Q: How to correctly understand and recognize the principles, objectives and significance of the establishment of the national essential drugs system?
A: The establishment of the national essential drugs system should follow the basic principles of adhering to the people-oriented, based on the national conditions of the country; adhere to the government-led, play the market mechanism; highlight the focus of the reform, active and steady implementation; innovative institutions and mechanisms, and widely mobilized participation.
The national essential medicines system has as its overall goal the continuous improvement of people's health, the satisfaction of the public's basic medical needs, the realization of a basic health care system covering urban and rural residents, and the promotion of basic health care for all. By 2011, a national basic drug system will be initially established; by 2020, a standardized national basic drug system covering both urban and rural areas will be fully implemented.
Establishing a national essential drug system requires the formulation of relevant policies for multiple links involving essential drugs, to ensure the production of essential drugs, improve the accessibility of essential drugs to the public, and promote the rational use of medicines. At present, the policy framework of China's essential drugs system mainly includes the management of selection and adjustment of the national essential drugs catalog, guaranteeing the production and supply of essential drugs, rationalizing the price of essential drugs and implementing zero-differential rate sales, promoting the priority and rational use of essential drugs, improving the reimbursement of essential drugs, strengthening the quality and safety supervision of essential drugs, and soundly improving the performance evaluation of the essential drugs system.
The establishment of the national essential drugs system is a project implemented by the CPC Central Committee and the State Council to safeguard people's health and protect the public's rights and interests in basic medicines, and it is a major institutional reform in the field of medicine and health, which is important for guaranteeing the adequate supply and rational use of essential drugs, reforming the mechanism of "medicines supplementing medical care" in healthcare institutions, and reducing the burden of basic medicines on the public. It is of great significance to ensure the adequate supply and rational use of essential medicines, reform the mechanism of "medicines for doctors" in medical institutions, reduce the burden of basic medicines on the masses, and promote the further optimization and integration of the resources of drug production and circulation enterprises.
Q: the initial establishment of the national essential drugs system, what are the main tasks this year?
A: This year's task is to release the national essential drugs directory; approved and announced the price of essential medicines; no later than December this year, each province (autonomous regions and municipalities) in 30% of the government-run urban community health service institutions and counties (grass-roots medical and health care institutions) to implement the basic drug system, including the implementation of the provincial level of centralized online public bidding and procurement, unified distribution, all equipped with the use of essential drugs and realize zero-differential rate sales; all essential drugs are included in the basic medical insurance drug reimbursement catalog, and the reimbursement rate is significantly higher than that of non-essential drugs.
Q: Please tell us about the development of the national essential drugs catalog in 2009.
A: The 2009 National Essential Drugs Catalog was formulated in full consideration of China's current stage of the basic national conditions and the ability of the basic medical security system to protect, in accordance with the principles of prevention and treatment of essential, safe and effective, reasonably priced, easy to use, equal emphasis on Chinese and Western medicines, basic protection, and the first choice of clinics, combined with the characteristics of China's medicines and the requirements of the primary medical and health care institutions equipped with them, and with reference to the international experience, the varieties and quantities were rationally determined. Reasonably determine the varieties and quantities.
In order to better adapt the National Essential Drug List to the needs of the construction of the primary medical and healthcare service system and the reform of public hospitals, the 2009 edition of the National Essential Drug List includes a section for primary medical and healthcare institutions as well as a section for other medical institutions. On the basis of the principles set out, opinions from the grassroots, medical institutions at all levels and all sectors of society were fully listened to and absorbed, and the 2009 edition of the National Essential Drugs Catalogue (grassroots section) was formed after repeated expert screening and validation and examination by the National Essential Drugs Working Committee, identifying 307 varieties of medicines, including traditional Chinese and Western medicines, which have been announced to the public in the form of a ministerial decree of the Ministry of Health. For the time being, the basic drug management of Chinese medicinal herbs is carried out in accordance with the policy provisions of the relevant departments of the State Council concerning the pricing, procurement, distribution and use of Chinese medicinal herbs, as well as the payment of basic medical insurance. The National Essential Drugs Catalog (Other Parts) is an expansion of the grassroots part of the catalog, and will be developed and introduced as soon as possible in conjunction with the pilot public hospital reform.
The National Essential Drug List is subject to dynamic adjustment management. According to the economic and social development, the level of medical protection, changes in the disease spectrum, basic health care needs, scientific and technological progress, and the establishment of basic drugs cost-effective economic evaluation system, and constantly optimize the basic drug varieties, categories and structure of the proportion. In principle, the national essential drugs catalog is adjusted once every three years. If necessary, the National Working Committee on Essential Drugs organizes adjustments at the appropriate time.
Q: Which drug varieties are not included in the selection of the national essential drugs catalog?
A: "National Essential Drugs Catalog Management Measures (Interim)" provides that drugs belonging to the following situations will not be included in the selection of the national essential drugs catalog: containing national endangered wildlife and plant medicinal materials; mainly used for nourishment and health care, easy to abuse; non-clinical treatment of first choice; due to serious adverse reactions, the State Food and Drug Administration expressly suspended the production, sales or use of It is against national laws and regulations, or does not meet ethical requirements; and other cases stipulated by the National Working Committee on Essential Drugs.
Q: What are the basic ideas and specific measures for setting the prices of national essential drugs?
A: Basic drugs will all be included in the scope of government pricing, basic drug pricing should not only take into account the enterprise has a reasonable profit margin, to encourage enterprises to produce basic drugs, but also to effectively reduce the price of basic drugs, so that the general public benefit.
The main measures: First, the basic drugs by the state by generic name to develop a unified retail guide price, operators within the scope of the government's guide price, in accordance with the relevant provisions of the actual purchase and sale prices. Second, the government price authorities to set retail guide price, based on the average cost of society, and take into account market supply and demand and other factors. Enterprise distribution costs are strictly controlled, and sales margins are appropriately relaxed. Third, the rate of markups in the distribution chain of basic medicines is controlled, and unreasonable markups in the distribution chain are curbed. For basic drugs purchased through bidding by government-run medical institutions, only logistics and distribution fees are added to the circulation chain. Fourth, the government-run primary medical institutions selling basic drugs to implement zero-differential rate, other non-profit medical institutions to gradually reduce the existing level of markup rate.
Q: Will the price of essential drugs fall in areas where the national essential drug system is implemented?
A: Essential drugs are safe, effective and reasonably priced medicines. The state will set a unified retail guide price for essential drugs. The people's governments at the provincial level will determine the unified purchase price of essential drugs for government-run medical institutions in their regions through public bidding within the range specified by the national guideline price. The State encourages localities to explore procurement methods that further reduce the prices of essential medicines. At the same time, government-run primary medical institutions are implementing zero-differential rate sales. Through these measures, the prices of essential drugs should be reasonably reduced, thus reducing the burden of basic medication on the public.
Q: How to ensure the production and supply of essential drugs?
A: to ensure that the basic drugs in a timely manner, in sufficient quantities, quality supply, is to establish a basic drug system, to protect the masses of basic medication is an important link. Mainly from the following four aspects of production and supply: First, to strengthen the industry management, to understand the production of basic drugs to grasp the status quo, to encourage the advantageous enterprises to carry out technological transformation, to improve the production and supply of basic drugs capacity. The second is to actively organize qualified production enterprises and distribution enterprises to participate in the bidding and procurement of essential drugs, and to focus on monitoring the production and marketing situation of the winning enterprises, to regulate the production order, and to coordinate their normal production and supply of the winning products. Third, to improve the national basic drug reserve system, the relevant departments *** with collaboration to solve the clinical necessity, irreplaceable, the amount of uncertainty, the enterprise does not always produce the supply of basic drugs. Fourth, improve the pharmaceutical industry policy and industry development planning, and promote the pharmaceutical enterprises to improve independent innovation and optimization and upgrading of the structure of the pharmaceutical industry, and continuously improve the production and supply of essential drugs to ensure the ability.
Q: How to purchase and distribute national essential drugs?
A: government-run medical institutions use the national essential drugs, province for unit, by the provincial people's government to designate the government-led centralized procurement of drugs related institutions, in accordance with the "Bidding and Tendering Law" and "Government Procurement Law" of the relevant provisions of the implementation of the centralized online purchasing by bidding for the selection of drug production and management enterprises or other enterprises with the conditions of unified distribution. Bidding and purchasing shall be directly oriented to qualified medicines produced by drug manufacturers throughout the country, supporting and encouraging equal participation and fair competition among enterprises from different regions and different ownership systems. Encourage localities to explore procurement methods to further reduce the price of essential drugs under the premise of ensuring product quality and distribution service level.
The State will issue a guidance document on the procurement and distribution of essential medicines, and localities should further refine the specific operational details and management methods of bidding and procurement and unified distribution. Taking an integrated approach, making full use of existing resources, not duplicating the setup of bidding and purchasing organizations, to ensure that the bidding process is open, fair and impartial, to strengthen the supervision and inspection of the implementation of the contract for the purchase and sale of basic medicines to ensure that the quality and quantity of basic medicines, and timely distribution to each health care institution, so as not to run out of stock, without stopping the file.
Q: What are the specific requirements for medical and health institutions at all levels to be equipped with the use of basic drugs?
A: The realization of primary health care all equipped with the use of basic drugs, is the establishment of the national basic drug system is a key link. Government-organized urban community health service centers (stations), township health centers and other primary health care institutions are fully equipped with and use of national essential drugs.
Other types of medical institutions should also provide basic drugs as the first choice of drugs to patients, and the use of basic drugs should reach a certain percentage. The health administrative department combined with the local actuality and the pilot reform of public hospitals, reasonably set the proportion of the use of basic drugs in different levels and categories of medical institutions.
At the same time, medical institutions should regulate the prescription behavior of doctors in accordance with the clinical application guidelines and prescription sets of essential drugs formulated by the state and the state regulations on the use of drugs in medical institutions, so as to ensure the priority and rational use of essential drugs.
Q: Can government-organized primary health care institutions be equipped with the use of drugs outside the catalog?
A: In view of China's urban and rural, regional economic and social development level of imbalance between the level of medication, there are differences in the level of local habits, in the early stage of the establishment of the national system of essential medicines, the government-run primary health care institutions need to be equipped with the use of non-national catalog of essential medicines, the people's government at the provincial level to determine the unified, and the implementation of the national system of essential medicines and related policies and regulations. In ethnic autonomous regions, the people's governments of the autonomous regions shall formulate appropriate management measures for the provision and use of ethnic medicines other than those on the national essential medicines list. Patients may also purchase non-essential medicines from retail pharmacies on prescription, and non-essential medicines included in the reimbursement catalog may still be reimbursed. This not only makes the local according to the local needs and affordability have a certain adjustment space, to give patients a certain choice of medication, but also to ensure that the framework of the national system of essential medicines does not go out of shape, not deformed.
Q: After the implementation of the basic drug system, primary health care institutions are equipped with the use of basic drugs and the implementation of zero-differential rate sales of drugs, primary health care institutions will not be able to get through the sale of drugs to increase the price of drugs, the government in the input of primary health care institutions, what support measures?
Answer: According to the opinions and implementation programs of the health care reform, in the areas where the basic drug system is implemented, the income of the government-run primary health care institutions will be reduced after the zero-differential-rate sale of medicines according to the purchase price. For this reason, the primary health care institutions to implement zero-differential rate sales of basic drugs at the same time, will strictly limit its service functions and the use of technology, equipment, construction scale, reform the operating mechanism, improve the compensation mechanism, the implementation of government investment to ensure its normal operation.
Specifically, the government's investment in primary health care institutions is mainly used in four areas: First, the primary health care institutions in accordance with the national provisions of the approved capital construction, equipment acquisition expenditure. Second, the basic public **** health service funds by the government through the purchase of services to give subsidies. Thirdly, the expenditure on retirement fees for retired staff in accordance with national regulations. Fourth, the differential subsidy after the authorized income and expenditure. The approval of the difference in subsidies should take full account of a variety of factors, such as zero-differential rate sales of basic drugs and the implementation of performance pay.
The state will implement performance pay for public *** health organizations and primary health care institutions later this year. In addition, while rationalizing the price formation mechanism for medical services, the government will also increase financial subsidies for basic medical insurance systems such as the New Rural Cooperative Medical Insurance, urban residents' medical insurance, and urban and rural medical assistance, so that more people can enjoy medical insurance, and thus also indirectly support primary medical and health care institutions in obtaining reasonable compensation through medical insurance payments.
We believe that through the above measures, the normal operation of primary health care institutions will be strongly and effectively ensured.
Q: How will the basic medical insurance system do a better job of converging with the national basic drug system?
A: "China **** Central State Council on deepening the reform of the medical and health system" clearly states that: basic drugs are all included in the basic medical insurance drug reimbursement catalog, the reimbursement rate is significantly higher than non-basic drugs. This means that the drugs included in the national essential drugs catalog will enter the basic medical insurance, the new rural cooperative medical care and other basic medical insurance drug reimbursement catalog, the reimbursement rate is higher than the non-essential drugs, in order to reduce the proportion of out-of-pocket payments by the public. In order to do a good job of connecting the basic medical insurance system with the national essential drug system, after the release of the national essential drug catalog, the relevant departments will organize the adjustment of the basic medical insurance drug catalog and related policies in accordance with procedures. The adjustment of the basic medical insurance drug catalog will be completed by the end of November this year, released to the public.
Q: How to ensure the quality of essential drugs and strengthen the regulation of essential drugs according to law?
A: With the implementation of the national system of essential drugs, essential drugs will present a large production, large circulation, the use of a large number of characteristics, to strengthen the awareness of the quality and safety responsibilities of pharmaceutical enterprises, and clarify the regulatory responsibilities of the drug supervision departments at all levels, to further strengthen the quality of the key links in the supervision. In the production link to establish a quality authorized person system, in the circulation, the use of the link to the implementation of regular sampling and testing of essential drugs, and timely publication of the results of sampling and testing of essential drugs to the community and other measures to strengthen the quality of essential drugs to ensure that the quality of essential drugs.
To regulate the production and operation of essential drugs in accordance with the law, to improve the quality standards of essential drugs, to strengthen the monitoring of adverse reactions to essential drugs, to establish and improve the mechanism for early warning of drug safety and emergency response, and to improve the system of recall management of drugs, so as to ensure the safety of medication.
Q: the establishment of the national essential drugs system, the general public in what areas can be benefited?
A: The establishment and implementation of the national essential drugs system is from the practical point of view of our country, focusing on the realization of the goal of basic medical and health services for all, and at the same time focusing on solving the problem of expensive medical treatment for the people, to reduce the burden of basic medicines for the masses, to protect the interests of the people through each link of the construction of this system, so that the masses of the people can get the benefits.
Specifically: the state unified development of basic drugs retail guide price, drug prices compared to the previous will be reduced; in the bidding procurement and distribution links, the provinces (autonomous regions and municipalities) in the range of the national retail guide price to determine the region's unified procurement price of basic drugs, which includes the distribution costs, to reduce the intermediary links; in the use of basic drugs link, the state requires that the basic medicines at the grass-roots medical and health institutions are equipped with the use of all the other basic medicines, the other In the use of essential medicines, the state requires that essential medicines be fully equipped for use in primary medical and healthcare institutions, and other types of medical institutions must use and determine the proportion of use in accordance with the regulations, which will certainly promote the priority and rational use of medicines in medical institutions, standardize the behavior of medicines, and avoid the abuse of medicines, and at the same time, the zero-differential-rate sales in government-run primary medical and healthcare institutions, and the reduction of the proportion of mark-ups in other medical and healthcare institutions, reform the "medicines for doctors At the same time, the government-run primary health care institutions zero-differential rate sales, other health care institutions to reduce the proportion of markups, reform the "medicines for doctors" mechanism, reduce the people's unnecessary burden of medication; in the payment and reimbursement link, the basic drug reimbursement rate should be higher than the non-basic drugs, reduce the proportion of personal payment; in the quality of drugs, the state of the jurisdiction of the production and use of basic drugs varieties to implement regular sampling, to ensure that the masses of basic medication more secure.
Lastly, the relevant departments responsible for the establishment of the national essential drugs system is related to the people's immediate interests, is the focus of the reform of the medical and health system, but also the focus of social concern, but also a complex systematic project involving production, distribution, pricing, equipped with the use of reimbursement, as well as zero-differential rate sales policy and other aspects, which is not in place in the implementation of the link, not on the interface All will affect the implementation of the national essential drugs system. Therefore, we must fully estimate the long-term implementation of the system, the enormity and complexity, strengthen the publicity and guidance, mobilize the enthusiasm of all parties, and strive for understanding, cooperation and support of society as a whole, to ensure the smooth implementation of the national system of essential drugs.