First, essential drugs are drugs that meet basic medical and health needs, have appropriate dosage forms, are reasonably priced, can guarantee supply, and can be obtained fairly by the public. All primary medical and health institutions organized by the government are equipped with and use essential drugs, and other medical institutions must also use essential drugs according to regulations.
The national essential drug system is a system that effectively manages the selection, production, circulation, use, pricing, reimbursement, monitoring and evaluation of essential drugs, and is connected with public health, medical services and medical security systems.
Second, the National Essential Drugs Working Committee is responsible for coordinating and solving relevant policy issues in all aspects of the formulation and implementation of the national essential drugs system, determining the framework of the national essential drugs system, determining the principles, scope, procedures and work plans for the selection and adjustment of the national essential drugs list, and reviewing the national essential drugs list. The Committee consists of the Ministry of Health, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Supervision, the Ministry of Finance, Ministry of Human Resources and Social Security, the Ministry of Commerce, the State Food and Drug Administration of the United States, state administration of traditional chinese medicine and other departments. The office is located in the Ministry of Health and undertakes the daily work of the National Essential Drugs Working Committee.
Three, formulate and publish the national list of essential drugs. On the basis of fully considering China's current basic national conditions and the guarantee capacity of the basic medical security system, according to the principles of prevention first, safety and effectiveness, reasonable price, convenient use, equal emphasis on Chinese and Western medicine, basic guarantee and clinical priority, combined with the characteristics of the use of traditional Chinese medicine and the requirements of primary medical and health institutions, and referring to international experience, the varieties (dosage forms) and quantities of basic drugs in China are reasonably determined. In 2009, the national list of essential drugs was published.
Four, on the basis of maintaining a relatively stable quantity, the implementation of dynamic adjustment and management of the national essential drugs list. According to the economic and social development, medical security level, disease spectrum changes, basic medical and health needs, scientific and technological progress and other conditions, we will continue to optimize the varieties, categories and structural proportions of essential drugs. The national list of essential drugs is adjusted once every three years in principle. When necessary, the National Essential Drugs Working Committee will organize adjustments in due course.
Five, under the macro-control of the government, give full play to the role of the market mechanism, standardize the production and circulation of essential drugs, improve the pharmaceutical industry policy and industry development planning, promote pharmaceutical enterprises to improve their independent innovation ability and optimize and upgrade the pharmaceutical industry structure, develop modern pharmaceutical logistics and chain operation, and promote the integrated development of pharmaceutical production enterprises and circulation enterprises.
Six, the basic drugs used by medical and health institutions organized by the government, the provincial people's government designated the government-led drug centralized procurement related institutions in accordance with the relevant provisions of the "Bidding Law" and the "Government Procurement Law", the implementation of provincial centralized online public bidding. The pharmaceutical production enterprises selected through bidding, pharmaceutical trading enterprises with modern logistics capabilities or other qualified enterprises shall be uniformly distributed. The cost of drug distribution is determined by bidding. The purchase of essential drugs by other medical institutions and retail pharmacies shall be determined by the state itself.
Seven, all localities should focus on the product quality, service and security capabilities of enterprises, and formulate the qualifications for enterprises to participate in the bidding for essential drugs. Drug bidding and purchasing should adhere to the principle of "quality first, reasonable price", adhere to the national unified market, and enterprises from different regions and different ownership should participate equally and compete fairly. Fully rely on existing resources, and gradually form a national centralized procurement information network for essential drugs.
Eight, improve the national drug reserve system to ensure the production and supply of essential drugs that are clinically necessary, irreplaceable, uncertain in dosage and not often produced by enterprises.
Nine, strengthen the management of basic drug purchase and sale contracts. Production enterprises, business enterprises and medical and health institutions shall, in accordance with the Contract Law and other provisions, sign contracts according to the results of centralized procurement, and perform the responsibilities and obligations stipulated in the drug purchase and sale contracts. The contract shall specify the variety, specification, quantity, price, repayment time, performance method, liability for breach of contract, etc. Health administrative departments at all levels shall, jointly with relevant departments, conduct supervision and inspection.
Ten, the national development and Reform Commission to develop the national retail price of essential drugs. When setting retail guidance prices, we should strengthen the monitoring of market purchase and sale prices and circulation costs such as cost investigation, supervision and examination, and bidding prices, and reduce unreasonable marketing costs on the basis of maintaining reasonable profits of production enterprises. In principle, the retail guidance price of essential drugs is formulated and published according to the generic name of the drug, without distinguishing specific production and operation enterprises.
1 1. Within the scope stipulated by the national retail guidance price, the provincial people's government determines the specific retail price of essential drugs in medical and health institutions organized by the local government according to the unified purchase price, distribution cost and drug addition policy formed by bidding. Encourage all localities to further reduce the price of essential drugs and set the basic price of essential drugs to avoid vicious competition among enterprises on the premise of ensuring product quality and distribution service level.
Twelve, the implementation of the basic drug system in counties (cities, districts), the basic medical and health institutions organized by the government are equipped with the use of basic drugs to implement zero-difference sales. All localities should implement relevant government subsidy policies in accordance with state regulations.
Thirteen, the establishment of priority rational use of essential drugs system. All grass-roots medical and health institutions organized by the government are equipped with and use national essential drugs. In the early days of the establishment of the national essential drug system, if the grass-roots medical and health institutions organized by the government really need to equip and use non-listed drugs, the provincial people's government shall temporarily determine them and report them to the National Essential Drug Working Committee for the record. Drugs not listed in the catalogue shall be equipped and used in accordance with the relevant policies and regulations of the national basic drug system. Other types of medical institutions should also take essential drugs as the first choice and reach a certain proportion of use, and the specific proportion of use shall be determined by the health administrative department.
Medical institutions should strengthen the management of rational drug use in accordance with the national guidelines for clinical application of essential drugs and the prescription set of essential drugs to ensure the standardized use of essential drugs.
Fourteen, the grass-roots medical and health institutions organized by the government to increase the number of non-listed drugs, should adhere to prevention first, control is necessary, combined with local financial capacity and basic medical security level to strictly control. The specific varieties are selected by the provincial health administrative department in conjunction with the development and reform (price), industry and information technology, finance, human resources and social security, food and drug supervision, traditional Chinese medicine and other departments. , from the national basic medical insurance drug list (a), or from the list (b) if it is really necessary to treat local special diseases. More medicines should be produced by many enterprises.
Grass-roots medical and health institutions organized by the governments of ethnic autonomous areas are equipped with ethnic medicines that are not listed in the national essential medicines list, and the people's governments of the autonomous regions shall formulate corresponding management measures.
Fifteen, patients can buy drugs in retail pharmacies with prescriptions. Retail pharmacies must be equipped with licensed pharmacists or other qualified pharmaceutical technicians according to law, provide consultation and guidance on drug purchase for patients, review the legality and rationality of prescriptions, and correctly allocate and sell drugs according to prescriptions.
Sixteen, all essential drugs are included in the basic medical insurance drug reimbursement list, and the reimbursement ratio is significantly higher than that of non-essential drugs. Specific measures shall be implemented in accordance with the relevant provisions of medical security.
Seventeen, strengthen the quality and safety supervision of essential drugs. Improve the quality standards for the production and circulation of essential drugs, carry out regular sampling inspection of the quality of essential drugs, and announce the sampling results to the public in a timely manner. Strengthen and improve the monitoring of adverse drug reactions of essential drugs, establish and improve the mechanism of drug safety early warning and emergency disposal, improve the management system of drug recall, and ensure the safety of drug use.
Eighteen, strengthen the performance evaluation of the basic drug system. Make overall use of existing resources, improve the information management system of purchasing, distribution, use, price and reimbursement of essential drugs, give full play to the role of administrative supervision, technical supervision and social supervision, evaluate the performance of the implementation of the essential drug system, issue monitoring and evaluation reports and other related information, and promote the continuous improvement of the essential drug system.
19.2009, 30% government-run urban community health service institutions and counties (primary medical and health institutions) in all provinces (autonomous regions and municipalities) implemented the basic drug system, including centralized online public bidding and procurement at the provincial level, unified distribution, all equipped with basic drugs and zero-difference sales; By 20 1 1, the national basic drug system will be initially established; By 2020, the standardized national essential drug system covering both urban and rural areas will be fully implemented.
Twenty, the national essential drug system is a brand-new system, it is necessary to strengthen the publicity and education of rational drug use, improve the awareness and trust of the whole people on essential drugs, and create a good social atmosphere.
In accordance with the overall requirements of medical and health system reform, all localities should implement government responsibilities, earnestly perform their duties, pay equal attention to reform and investment, and actively and steadily establish and implement the national essential drug system in light of local conditions.