In order to implement the "Central Government, the State Council on deepening the reform of the medical and health system of the opinions" (China Development [2009] No. 6) and "the State Council on the issuance of the reform of the medical and health system of the near future focus on the implementation of the program (2009-2011) of the notice" (National Development [2009] No. 12) of the spirit of the reform of the formation mechanism of the price of medicines and medical services, the following views are proposed (A) the guiding ideology
In accordance with the implementation of the scientific concept of development and the requirements of building a harmonious socialist society, the development of China's pharmaceutical industry from the current situation and the characteristics of medical services, give full play to the role of price leverage regulation, rational regulation of the level of prices of medicines and medical services, and to promote the healthy development of health care and the pharmaceutical industry, to meet the growing demand for medical care and health care for the masses of the people.
(B) the basic principles
One is to adhere to the combination of government regulation and market regulation. In accordance with the requirements of the establishment of a socialist market economy, according to the characteristics of the public welfare of health undertakings, in strengthening the government supervision of pharmaceutical prices at the same time, pay attention to give full play to the role of the market mechanism, to promote the production and management of enterprises and medical institutions to strengthen the management and improve efficiency, the formation of an open, fair, just and orderly competition in the market of medicines and medical services.
The second is to encourage research and development and innovation and the use of essential drugs and appropriate technology. Pharmaceutical price setting should be conducive to stimulate enterprises and medical institutions to improve innovation and motivation, research and development of new products and new technologies, to protect and support the development of traditional Chinese medicine, and improve the overall competitiveness of the pharmaceutical industry, while taking into account the level of economic development, the level of basic medical care and affordability of the masses to encourage the use of essential medicines and appropriate technology, to alleviate the unreasonable burden of the masses of medical costs.
Third, to promote enterprises and medical institutions to continuously improve product quality and service level. The government to set prices for drugs and medical services, to reflect the quality difference, encourage enterprises to improve product quality, and promote medical institutions to improve medical service conditions and diagnostic and treatment technology, to meet the public's multi-level demand for medicines and medical services.
Fourth, the pharmaceutical price reform and medical and health system reform to promote coordination. Pharmaceutical price reform should be conducive to promote the reform of the medical and health system, and related policies to coordinate and promote synchronization. Price adjustments should take into full consideration the interests of all aspects of society and the public's ability to afford, balanced, and gradually channel the contradictions.
(3) Targets and Tasks
By 2011, the government's method of managing pharmaceutical prices will be further improved, the price behavior of enterprises and medical institutions will be more standardized, the order of market prices will be gradually improved, the price of medicines will be rationalized, and structural contradictions in the price of medical services will be significantly alleviated. By 2020, the establishment of a sound combination of government regulation and market adjustment, in line with the laws of medicine and health care development of pharmaceutical price formation mechanism; pharmaceutical prices can objectively and timely reflect the changes in the cost of production and services and market demand and supply; pharmaceutical price management system is perfect, the regulation method is scientific; the pharmaceutical price order is good, the behavior of market competition is standardized.2009-2011 The main tasks:
--Improve pharmaceutical price management policy. Adjust the scope of government-administered prices of medicines and medical services, improve the methods of price management, further improve the price decision-making process, and enhance the scientific and transparent nature of price regulation.
--Rationalizing drug prices. On the basis of the comprehensive approval of government-administered drug prices, further reduce the prices of drugs that are on the high side, and appropriately raise the prices of cheap drugs that are clinically necessary. Scientific formulation of national basic drug prices.
--Further rationalize the price relationship of medical services. On the basis of standardizing the price items of medical services, the prices of clinical diagnosis and treatment, nursing care, surgery and other medical services reflecting the value of the technical labor of medical personnel will be appropriately raised, while the prices of large-scale medical equipment for examination and treatment will be lowered. Strengthening the supervision of the price of high-value medical devices such as implants (intermediaries).
--Strengthening cost and price monitoring and supervision and inspection. Improve the drug cost and price monitoring system, strengthen the analysis of the drug price situation, publicize market price information, and play the role of public opinion supervision. Regularly carry out medicine price inspection, standardize the production and management enterprises, medical institutions price behavior. Further improve the list system of medicine costs in medical institutions, and increase the transparency of fees. (d) Adjusting the scope of government-managed drug prices. Government-managed drug prices focus on national essential medicines, the national basic medical insurance drugs and production
Operation has a monopoly of special drugs. Other drugs to implement market-adjusted prices, of which the clinical use of large quantities of prescription drugs, through pilot projects to gradually explore effective ways to strengthen price regulation.
(E) the price of drugs to implement hierarchical management. The State Council department in charge of price is responsible for the development of drug prices, policies, principles and methods; the development of national essential drugs, the national basic medical insurance drugs in the prescription drugs and production and operation of monopoly prices of special drugs. The price authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for setting the prices of non-prescription drugs (excluding national essential drugs) and locally supplemented medicines for medical protection in accordance with the unified national policy. Non-profit medical institutions to dispense their own drug preparation prices, by the provinces, autonomous regions and municipalities directly under the Central Government in accordance with the local situation to determine the price management authority, form and content.
(F) the government to develop and publish the guide price of drugs, production and management units to determine the actual purchase and sale prices. Included in the scope of government price management of drugs, in addition to the national immunization program and family planning medicines to implement government pricing, other drugs to implement the government guide price. Narcotic drugs and Class I psychotropic drugs are changed from government-priced to government-guided prices, and the upper limit of the price difference between purchase and sale is set for the distribution chain according to national wholesale and regional wholesale. For drugs with government-guided prices, production and operation units shall independently determine the actual purchase and sale prices in accordance with market supply and demand, on the premise that the government-guided prices will not be exceeded.
(VII) the government to set the price of drugs in principle, in accordance with the generic name to set a uniform price. The government to set drug prices, in general, without distinguishing between specific production and operation of enterprises, in accordance with the generic name of drugs to develop a unified guide price. Has been developed for specific enterprises, the price, and the unified guide price has a large price difference, to increase the adjustment efforts, and gradually narrow the price difference. In the future, in line with the national policy of encouraging and supporting the development of medicines with significantly different quality standards, can be based on the principle of price according to quality, the implementation of differential pricing policy.
(H) the government to set drug prices based on the average cost of society, taking into account other relevant factors. The government to set drug prices, should follow the basic principles of "compensation costs, reasonable profitability, reflecting supply and demand", while taking into account the level of socio-economic development, the level of basic medical care, affordability of the masses, the national macro-control and industrial development policies, the clinical value of drugs and other factors. For ordinary drugs that are clinically necessary but whose supply cannot be guaranteed by the market, the price can be raised appropriately.
(ix) Scientifically determining the differential price relationship between medicines. Further improve the drug price difference than the price rules, and reasonably determine the representative dosage form specifications and prices of the same type of drugs, the price of other dosage form specifications in accordance with the provisions of the differential price or price relationship between the formulation. Pricing of alternative and innovative medicines is gradually introduced into the method of economic evaluation of medicines, so as to promote the maintenance of a reasonable price relationship between different kinds of medicines.
(j) Encouragement of drug research and development innovation. On the basis of a reasonable review of the cost of medicines, and according to the degree of innovation of medicines, differential control of sales profits. Allow more innovative drugs to maintain higher sales margins within a reasonable period of time, and promote the development of innovative drugs.
(xi) Guiding the orderly production and competition of generic drugs. In the future, the price of the first domestic generic drugs on the market will be set with reference to the price of the generic drugs; if the generic drugs are not yet on the market in China, the price of the first generic drugs will be set on the basis of their reasonable costs. The prices of the drugs to be imitated and listed on the market shall be set at a certain percentage lower than the prices of the first imitated drugs. When the number of enterprises producing the same kind of generic drugs reaches a certain number, a uniform price shall be set in accordance with the average social cost and other circumstances.
(xii) to encourage the production and supply of essential drugs. In accordance with the generic name to rationalize the development of basic drugs retail guide price, without distinguishing between specific production and management enterprises. Approved retail prices of essential drugs, to strictly control marketing costs, compression of the circulation chain price differential rate. Maintain the relative stability of basic drug prices, to ensure the normal production and supply of national essential drugs.
(xiii) control the circulation of medicines price differentials. Gradually reduce the circulation of government-guided price differential rate of medicines, the circulation of the differential rate (amount) of the implementation of the upper limit control, and high-priced and low-priced medicines to implement differential rate control, low-priced medicines from the high price differential rate of high-priced medicines from the low rate of differential rate of the use of price leverage to promote the circulation of medicines in the field of mergers and reorganization, expanding the scale of intensive operation, reduce costs, reduce the cost of circulation costs.
(xiv) Reform of medical and health institutions, drug sales mark-up policy. In accordance with the requirements of the "separation of medicine", the reform of the compensation mechanism of medical institutions, and gradually abolish the sales of drugs in medical institutions. During the transition period of the reform, to gradually reduce the rate of drug markups in medical institutions, on the premise that the overall not to exceed 15%, according to the price of the implementation of differential markup policy. If necessary, the maximum markup on high-priced medicines will be limited. The standardized markup rate for Chinese medicinal herbs is appropriately relaxed. Localities are encouraged to coordinate the zero-differential-rate reform of drugs sold in public hospitals in conjunction with the pilot reform of public hospitals. Public hospitals to abolish the drug markup after the reduction of income, can increase financial subsidies, improve the price of medical services and the establishment of "pharmaceutical service fee" program and other measures to provide the necessary compensation.
(xv) standardize the drug market transactions price behavior. Pharmaceutical production and management units should be in accordance with the principle of honesty and trustworthiness of the purchase and sale of prices set reasonably, to strengthen industry self-discipline, open price information, improve the transparency of price formation, prohibit price fraud, price monopoly, price discrimination, and other harm to the legitimate rights and interests of consumers. (Sixteen) medical service prices to implement the government-guided price and market-adjusted price combination of management. Non-profit medical institutions to provide basic medical services, the implementation of government-guided prices; for-profit medical institutions to provide a variety of medical services and non-profit medical institutions to provide special medical services to implement market-regulated prices.
(xvii) The prices of medical services are subject to a uniform policy and hierarchical management. The competent price department of the State Council, in consultation with the relevant departments, formulates policies on medical service prices as well as items, pricing principles and methods, and strengthens the guidance and coordination on the formulation of medical service prices at the local level. The guideline prices for basic medical services shall be formulated by the competent price department at the provincial or municipal level in conjunction with the health and human resources and social security departments at the same level.
(xviii) the price of basic medical services to reflect the nature of public welfare. Basic medical service prices in accordance with the "reasonable compensation for costs, taking into account the masses and the basic medical insurance affordability" principle of approval. Set the price of basic medical services based on the reasonable cost, in accordance with the deduction of financial subsidies, medical institutions selling drugs and medical equipment (consumables) price differentials accounted for.
(xix) reform of medical services pricing. According to the development of medical technology and clinical diagnosis and treatment needs, improve the price of medical services project specifications, the reasonable establishment of medical service price items. Strictly control the new medical examination and test items simply in the name of new equipment, new reagents, new methods, etc., and further standardize the name of medical service price items and service content. Gradually reforming the item-based pricing method for medical services, and actively exploring medical service pricing methods that are conducive to cost control, openness and transparency, and ease of operation. Community, township health centers and other primary medical institutions to carry out personalized services for the convenience of the people, can be set in accordance with the service time, the number of services and other ways to set prices.
(xx) the reasonable setting of prices for services of different levels of medical institutions and different grades of physicians. According to factors such as the level of medical institutions, the level of physicians and market demand, different guide prices can be set for medical services. The price gap should be gradually widened to promote the rational triage of patients.
(xxi) to raise the price of medical services reflecting the value of technology and labor. In accordance with the requirements of medical services to compensate for reasonable costs, combined with the government's financial input, reasonable adjustment of basic medical service prices for non-profit medical institutions, and gradually increase the prices of traditional Chinese medicine and the value of the technical labor of medical personnel, such as diagnosis and treatment, surgery, nursing and other items.
(xxii) Reduce the price of large-scale medical equipment for examination and treatment. Strengthen the price monitoring of medical examination and treatment equipment. Improve the service cost review method, medical examination and treatment equipment depreciation costs measured by the rated workload. Reduce the high price of medical equipment examination and treatment, and promote the intensive use of medical examination and treatment equipment.
(xxiii) Strengthening the management of medical equipment prices. Reasonable control of medical services price items outside the scope of separate charges for medical equipment. Separate charges for varieties, to establish a catalog for management. For high value, especially the implant (intermediary) class medical devices, can be through the restriction of the circulation of the differential rate, the release of market price information and other measures to guide the reasonable formation of prices. (xxiv) Strengthening price evaluation and improving the cost survey and price monitoring system. Improve the price review system for medicines and medical services, strengthen the construction of expert teams for price review, and improve the costing methods for medicines and medical services. To establish and improve the pharmaceutical market price survey, monitoring and information collection and analysis system.
(25) Further improving price decision-making procedures. Publicize government pricing procedures and methods, and enhance the transparency of price decision-making. Establishing a dynamic adjustment system for the prices of medicines and medical services. Improve the mechanism for coordinating the exchange of information on medicine prices between regions. The formulation and adjustment of prices should widely listen to the views of production and management enterprises, medical service units, medical insurance agencies, consumers and relevant departments, and fully mobilize the various aspects of society to participate in the management of drug and medical service prices.
(26) Actively exploring the establishment of a mechanism for negotiation between the supply and demand sides of pharmaceutical costs. On the basis of the government's setting of prices for medicines and medical services, it is reforming the payment methods of medical insurance, and gradually implementing payment by type of disease, payment by service unit, and total prepayment. It is actively exploring ways for medical insurance organizations to negotiate with medical institutions (hospital associations) and drug suppliers to reasonably determine medical costs and payment methods. Places with the necessary conditions are encouraged to carry out pilots of payment methods and fee negotiation mechanisms.
(27) Strengthening price supervision and inspection. To further strengthen the work of medicine price marking, the full implementation of medical institutions, medical services, medical equipment and drug price disclosure and hospitalization costs "one-day list" and other systems. Special inspections of pharmaceutical prices are conducted on a regular basis. Research and explore the establishment of long-term mechanism for the supervision of pharmaceutical prices, standardize the production and operation of enterprises, medical and health institutions price behavior.
National Development and Reform Commission
Ministry of Health
Ministry of Human Resources and Social Security
November 9, 2009