Development and Reform Commission Health and Family Planning Commission Ministry of Human Resources and Social Security
Ministry of Industry and Information Technology, Ministry of Finance, Ministry of Commerce, General Administration of Food and Drug Administration of the United States
Notice on Issuing the Opinions on Promoting Drug Price Reform
Development and Reform Price [20 15] No.904
Development and Reform Commissions of all provinces, autonomous regions and municipalities directly under the Central Government, Price Bureau, Health and Family Planning Commission (bureau), Human Resources and Social Security Department (bureau), Industry and Information Technology Department (bureau), Finance Department (bureau), Commerce Department (bureau) and US Food and Drug Administration:
According to the spirit of the Third Plenary Session of the 18th CPC Central Committee and the general requirements of medical and health system reform, the National Development and Reform Commission, the National Health and Family Planning Commission, Ministry of Human Resources and Social Security, the Ministry of Industry and Information Technology, the Ministry of Finance, the Ministry of Commerce and the General Administration of Food and Drug Administration of the United States formulated the Opinions on Promoting Drug Price Reform, which are hereby printed and distributed to you with the consent of the State Council. Please comply with it and notify the relevant matters as follows:
1 .201June 51day, except narcotic drugs and psychotropic drugs of category I, the drug prices set by the former government will be cancelled. Anesthesia and psychotropic drugs of category I are still managed by the National Development and Reform Commission for the time being, with the highest ex-factory price and the highest retail price.
Two, the previous policies and regulations on drug price management, which are inconsistent with the provisions of this notice shall be abolished, and the provisions of this notice shall prevail.
Third, local price, health and family planning, human resources and social security departments should study and formulate specific policies and measures in accordance with the Opinions on Promoting Drug Price Reform, strengthen the comprehensive supervision of medical expenses and price behaviors, do a good job in policy interpretation and public opinion guidance, and ensure the smooth progress of the reform.
Development and Reform Commission, Health and Family Planning Commission
Ministry of Industry and Information Technology of Ministry of Human Resources and Social Security
Ministry of Finance and Commerce
General Administration of Food and Drug Administration of the United States
2065438+May 4, 2005
Opinions on Promoting Drug Price Reform
Promoting drug price reform and establishing a scientific and reasonable drug price formation mechanism is an important content of promoting price reform and an important task of deepening medical and health system reform, which is of great significance for accelerating the improvement of modern market system and transforming government functions, promoting the healthy development of medical and health undertakings and pharmaceutical industry, meeting people's growing medical and health needs and reducing patients' unreasonable medical expenses burden. In order to speed up the reform of drug prices, with the consent of the State Council, we hereby put forward the following opinions:
I. General requirements
Thoroughly implement the spirit of the 18th National Congress of the Communist Party of China and the Second, Third and Fourth Plenary Sessions of the 18th National Congress, conscientiously implement the decision-making arrangements of the CPC Central Committee and the State Council, and gradually establish a market-oriented drug price formation mechanism in accordance with the requirements of making the market play a decisive role in resource allocation and giving better play to the role of the government, so as to minimize direct government intervention in drug prices. Adhere to the combination of release and management, strengthen the policy convergence of price, medical insurance, bidding and procurement, give full play to the role of market mechanism, simultaneously strengthen the comprehensive supervision of medical expenses and price behavior, effectively regulate the price behavior in the pharmaceutical market, and promote the drug market price to maintain a reasonable level.
Second, reform the drug price formation mechanism.
Except narcotic drugs and psychotropic drugs of category I, the government pricing of drugs should be abolished, the drug procurement mechanism should be improved, and the role of medical insurance in controlling fees should be brought into play. The actual transaction price of drugs is mainly formed by market competition. These include:
(a) for the drugs paid by the medical insurance fund, the medical insurance department shall, jointly with the relevant departments, formulate the procedures, basis, methods and other rules for the formulation of medical insurance drug payment standards, and explore the establishment of a mechanism to guide the rational formation of drug prices.
(two) patent drugs, exclusive production of drugs, the establishment of an open and transparent, multi-party negotiation price formation mechanism.
(3) Blood products not listed in the medical insurance catalogue, immune drugs uniformly purchased by the state, AIDS antiviral drugs and contraceptives free of charge by the state shall be priced through bidding or negotiation.
(four) narcotic drugs and psychotropic drugs of category I are still subject to the maximum ex-factory price and maximum retail price management for the time being.
(five) other drugs, by the producers and operators according to the production and operation costs and market supply and demand situation, independently set the price.
Three, strengthen the comprehensive supervision of medical expenses and price behavior.
To promote drug price reform, we must give full play to the role of the government and the market and establish a scientific and reasonable price formation mechanism. After the abolition of government pricing of drugs, we should fully learn from international experience, do a good job in linking up with reform policies such as drug procurement and medical insurance payment, and strengthen comprehensive supervision over medical expenses and price behavior. In accordance with the requirements of "overall consideration and steady progress", we will strengthen supervision from the following four aspects, promote the establishment of a normal market competition mechanism, and guide the rational formation of drug prices.
(1) Improve the drug procurement mechanism. Health and family planning departments should adhere to the direction of centralized drug procurement in accordance with the relevant requirements and measures for standardizing drug procurement in public hospitals and primary medical and health institutions, implement classified procurement according to drug characteristics and market competition, promote market competition, and reasonably determine drug purchase prices. It is necessary to mobilize the enthusiasm of medical institutions, pharmaceutical production and marketing enterprises, medical insurance agencies and other parties, and guide all kinds of market players to compete in an orderly manner.
(2) Strengthen the role of medical insurance in controlling fees. The medical insurance department shall, jointly with the relevant departments, formulate the payment standard of medical insurance drugs on the basis of investigating the actual market transaction price of drugs, taking into account factors such as medical insurance funds and patients' affordability. Before the new payment standard for medical insurance drugs is formulated and published, the medical insurance fund will temporarily pay according to the current policy. Do a good job in the connection between medical insurance and bidding procurement policies, and promote medical institutions and retail pharmacies to actively reduce the purchase price. Designated medical institutions and pharmacies shall submit the actual purchase price, retail price, purchase quantity and other information to the medical insurance and price departments. Simultaneously promote the reform of medical insurance payment methods, establish an internal incentive mechanism for rational drug use and diagnosis and treatment in medical institutions, and reduce the burden of patients' expenses. Ministry of Human Resources and Social Security, the Health and Family Planning Commission shall, jointly with relevant departments, issue detailed rules for the formulation of payment standards for medical insurance drugs before the end of September 2065438+2005.
(3) Strengthen the supervision of medical behavior. Health and family planning departments should establish a scientific and reasonable assessment and reward system, strengthen the management of medical institutions' diagnosis and treatment behavior, control the unreasonable use of drugs and medical devices and excessive examination and treatment, and strengthen the control of medical expenses. It is necessary to gradually disclose the indicators such as the average cost of outpatient (emergency) consultations, the average daily cost of hospitalization, and the proportion of inspection income in medical institutions, and incorporate them into the target management responsibility system and performance appraisal objectives of medical institutions. Accelerate the construction of drug supply safety information platform and promote the disclosure of price information.
(4) Strengthen the supervision of price behavior. The competent pricing department shall, by formulating the rules of drug price behavior, guide producers and operators to reasonably set prices according to the principles of fairness, legality, honesty and credibility, standardize the drug market price behavior, and protect the legitimate rights and interests of patients. It is necessary to improve the drug price monitoring system, explore the establishment of a unified information platform across departments, grasp the real transaction price data, focus on the monitoring and information release of the ex-factory (port) price and actual purchase and sale price of drugs with insufficient competition, and conduct timely research and analysis and special cost price investigation for those whose prices change frequently or greatly, or differ greatly from international prices, prices of similar varieties and prices in different regions. It is necessary to give full play to the role of 12358 national price reporting management information system, establish an all-round and multi-level price supervision mechanism, and actively guide the market price order. Severely punish price fraud, price collusion and monopoly according to law.
In addition, relevant departments should conscientiously perform their supervisory duties, strengthen supervision over the whole process of drug production, circulation and use, and effectively ensure the quality and safety of drugs.
Fourth, strengthen organization and implementation.
(1) Strengthen organizational leadership. All regions and relevant departments should fully understand the importance and urgency of promoting drug price reform, further unify their thinking, strengthen leadership and make careful arrangements. All localities should formulate specific implementation rules and refine policies and measures to ensure that the reform is effective. All relevant departments should strengthen cooperation, strengthen supervision and guidance on local reform work, and ensure that the reform is carried out in a solid and orderly manner.
(2) Establish an evaluation mechanism. Drug price reform is closely related to the vital interests of the masses, with strong policy and wide coverage. All localities should establish an evaluation mechanism for drug price reform, strengthen the follow-up evaluation of reform, sum up experience in time, and improve policies. We should pay close attention to the changes in drug prices and medical expenses after the reform, and timely study and put forward policies and measures to solve new problems in the reform.
(3) Strengthen publicity and guidance. All localities should do a good job in publicity and explanation through various means, explain clearly to the broad masses the significance, contents and expected goals of drug price reform, respond to hot issues of social concern in a timely manner, strive for the understanding and support of all sectors of society, gather the understanding of all parties, form a joint force of reform, and ensure the smooth progress of the reform.