8 departments including health and Family Planning Commission solve the problem of supply guarantee of commonly used low-cost drugs

Source: National Health and Family Planning Commission, April 15, 2014, head of relevant departments of national health and Family Planning Commission answered questions from reporters on ensuring the supply of commonly used low-cost drugs Recently, the state health and Family Planning Commission, the development and Reform Commission, the Ministry of industry and information technology, the Ministry of finance, the Ministry of human resources and social security, the Ministry of Commerce, the State Food and Drug Administration and the Chinese medicine bureau jointly issued the notice on printing and distributing the opinions on ensuring the supply of commonly used low-cost drugs (gwyzf [2014] No 14) (hereinafter referred to as the opinions) The head of the relevant department of the national health and Family Planning Commission answered the reporter's questions 1、 Background for the issuance of the opinions? A: some commonly used clinical drugs, especially some classic old drugs, are in short supply or even out of supply, which is a long-standing problem and has not been fundamentally solved Especially in recent years, the shortage of some drugs is particularly prominent, such as protamine necessary for heart surgery, methimazole for hyperthyroidism treatment, ketamine for anesthesia and so on Some drugs even have the phenomenon of "one drug is hard to find" The media has repeatedly reported that some classic old drugs are hard to buy or even disappear from the market To solve the problem of drug shortage has also become the focus of hot discussion among the representatives of the two sessions in recent years The people have a strong response, and the community has paid wide attention to it The leaders of the State Council have made instructions for many times, asking relevant departments to work together to properly solve the problem There are many reasons for the shortage of drugs, such as the reduction of raw material output, the shortage of API supply, the small dosage of some drugs and the uncertainty of clinical demand, which make it difficult to effectively connect the production and demand, and the renewal of clinical medication Especially in recent years, with the improvement of quality standards, the rise of prices of raw materials and labor, and the improvement of production line requirements, the production cost of enterprises has been increasing year by year, and the profit space of low-cost drugs has been constantly compressed Under the influence of tender price and retail price can not be increased flexibly, the willingness of production and supply of low-cost drugs has declined, which is "supplemented by drugs" The lack of enthusiasm of using low-cost drugs in hospitals leads to the phenomenon of clinical out of stock and out of stock of some commonly used low-cost drugs Since the second half of 2013, the national health and Family Planning Commission, in combination with the Ministry of industry and information technology, the development and Reform Commission, the food and Drug Administration and other departments, has strengthened research, actively coordinated, printed and issued policies and measures to ensure the production and supply of methimazole, effectively solving the problem of drug shortage for patients with hyperthyroidism In this process, the relevant departments have reached a consensus To solve the problem of shortage of commonly used low-cost drugs, we must establish a long-term mechanism, strengthen the cooperation between departments, and implement comprehensive policies to jointly ensure the supply of commonly used low-cost drugs With reference to the practice of solving the shortage of methimazole production and supply, the eight departments jointly drafted the opinions and solicited local opinions for many times, which were finally deliberated and approved by the plenary meeting of the leading group of medical reform under the State Council 2、 What is the significance of printing and distributing the opinions? A: drug shortage directly affects patients' clinical treatment and endangers people's health and life safety To ensure the supply of commonly used low-cost drugs is closely related to the vital interests of the people It is an important livelihood work and a popular project to meet the needs of the people, respond to social concerns in a timely manner, and reduce the burden of the people's medical expenses It is an important content of deepening the reform of the medical and health system, an important measure to consolidate and improve the national basic drug system, and an important measure to realize everyone's access to basic medical care The fundamental guarantee of health service is to benefit the country and the people Implementing the spirit of the Third Plenary Session of the 18th Central Committee of the Communist Party of China, the opinions embodies the general requirements of giving full play to the decisive role of the market in resource allocation and the role of the government It is conducive to the formation of policy guidance to encourage the production and supply of low-cost drugs, the full mobilization of the enthusiasm of enterprises in production and supply, the guarantee of clinical drug demand, and the better maintenance of people's health and life safety All in all, it is conducive to deepening the three medical linkage reform, promoting rational drug use, reducing the burden of people's medical expenses, and improving the national drug policy 3、 What measures should be taken to ensure the production and supply of commonly used low-cost drugs? A: the object and scope of low-cost drug management are drugs included in the national and local list of low-cost drugs List management and dynamic adjustment shall be carried out for low-cost drugs The national development and Reform Commission formulates the standard of daily average cost of low-cost drugs and selects and determines the list of low-cost drugs within the range of government pricing According to the standard of daily average cost of low-cost drugs formulated by the state and combined with the local actual situation, all localities determine the list of low-cost drugs within the pricing range of their own province (District, city) and implement dynamic management Low cost drugs include both essential and non essential drugs The opinions put forward policy measures to ensure the production and supply of commonly used low-cost drugs from many aspects, such as improving price management, improving procurement methods, establishing normal shortage drug reserves, and increasing policy support In terms of improving price management, in order to establish a pricing mechanism that can more sensitively reflect cost changes and market supply and demand, ensure a reasonable profit space for low-cost drugs, mobilize the enthusiasm of enterprises in production, cancel the maximum retail price limit for each specific variety of low-cost drugs, and allow producers and operators to make their own prices according to the cost of drug production and market supply and demand within the standard of daily average expenses Set or adjust retail prices The drug pilot countries with small dosage and short market supply shall be designated for production and unified pricing In terms of improving the procurement methods, for the drugs included in the list of low-cost drugs, the centralized drug procurement institutions of all provinces (districts and cities) shall directly link up the network to the production enterprises that have passed the corresponding qualification examination, and the medical institutions shall conduct online transactions on their own, purchase in the sunshine, so as to enhance the participation of the medical institutions in the drug procurement The provincial drug purchase administration shall do a good job in service and supervision Production enterprises choose the best distribution enterprises to ensure the distribution enterprises' operating interests and ensure the distribution in place All localities regularly publish the list of distribution enterprises and their certification, reputation, service and other information on the purchase platform, so as to provide services for drug buyers and sellers to select and evaluate distribution enterprises We should strengthen policy guidance and improve the distribution concentration of drugs incorporated into the designated production of the state In the aspect of establishing the shortage drug reserve, we should further improve the drug reserve system and establish the normal shortage drug reserve at the central and local levels The central medicine reserve is mainly for the shortage drugs with uncertain dosage, while the local medicine reserve is mainly for the shortage drugs with definite dosage Relevant departments shall jointly organize the selection of reserve varieties, reasonably determine the reserve quantity, arrange the collection and storage funds, and ensure that the shortage drug reserve is in place in a timely manner In terms of increasing policy support, we should actively guide common low-cost drug manufacturers to carry out technological transformation, improve their supply assurance capacity, and speed up their passing of the new GMP certification Priority shall be given to the review and approval of the application for registration of generic drugs urgently needed in clinical practice Accelerate the reform of medical insurance payment mode, make drugs become the operating cost of medical institutions, mobilize the enthusiasm of medical institutions and medical personnel to actively save costs and give priority to the use of low-cost drugs At the same time, we should carry out dynamic monitoring of the shortage of drugs, improve the early warning mechanism of the shortage of drugs, and prevent it from happening We will strengthen comprehensive supervision, strictly implement the system of good faith record and market clearance, and effectively implement the supply guarantee of commonly used low-cost drugs After the issuance of the opinions, relevant departments are studying and refining the implementation methods The national development and Reform Commission will determine the standard of low-cost drugs and publish the list of low-cost drugs; the national health and Family Planning Commission will formulate specific guidance on the purchase and use of commonly used low-cost drugs in combination with the consolidation and improvement of the basic drug system and the new mechanism of grass-roots operation, and do a good job in the connection with the current purchase policy; the Ministry of industry and information technology will speed up the construction with the Ministry of finance, the national health and Family Planning Commission and other departments Establish a normal shortage drug reserve system 4、 How to link the purchase of commonly used low-cost drugs with the current drug purchase policy? Answer: all localities should adhere to the direction of centralized drug procurement with the province (District, city) as the unit, further improve the procurement methods, strengthen the capacity-building of procurement institutions, expand the functions of the provincial centralized procurement platform, strictly check and verify, directly link the commonly used low-cost drug manufacturers with corresponding qualifications, and supervise them to implement policies and perform procurement contracts for drug manufacturers Production and operation enterprises and medical and health institutions provide services We should give full play to the leading role of provincial drug centralized procurement institutions and properly solve relevant problems The commonly used low-cost drugs used by public hospitals shall be negotiated and concluded by medical institutions and direct online production enterprises Online transactions and sunshine procurement shall be carried out to ensure the openness and transparency of procurement process and information and enhance the participation of medical institutions in drug procurement Encourage public hospitals to jointly purchase and give full play to the advantages of batch purchase For the commonly used low-cost drugs used by the government run primary medical and health institutions, the provincial purchasing institutions shall summarize the quantity purchased at the primary level, select the suppliers according to the quantity purchased, or select the suppliers based on the regions (provinces, cities and counties) with centralized payment, and encourage the improvement of concentration Provinces that have completed a new round of centralized procurement of essential drugs or are in a procurement cycle shall, in principle, continue the signed contracts 5、 What measures encourage medical institutions and doctors to use commonly used low-cost drugs? A: most of the commonly used low-cost drugs are classic old drugs In order to encourage the enthusiasm of medical institutions and doctors to use commonly used low-cost drugs, we should guide them from the following four aspects: first, guide medical institutions at all levels to improve the use of commonly used low-cost drugs, and incorporate the use into the performance assessment Second, we should accelerate the reform of medical insurance payment mode, make drugs become the operating cost of medical institutions, improve the awareness of medical institutions and medical personnel to actively save costs and control costs, and mobilize their enthusiasm to give priority to the use of low-cost drugs Third, we should implement the regulations on rational drug use in medical institutions, give full play to the role of pharmacists, guide medical personnel to use cheap and high-quality drugs as much as possible, use cheap and inexpensive drugs, use generic drugs instead of original research drugs, and encourage the use of commonly used low-cost drugs Fourth, we need to accelerate the reform of public hospitals, eliminate the need to supplement medicine with medicine, rationalize the price of medicine, establish a scientific compensation mechanism and a personnel compensation system that adapts to the characteristics of the industry, and make medicine return to its original nature 6、 How to treat the price fluctuation of commonly used low-cost drugs after the issuance of the opinions? A: an important goal of the opinions is to correct the price distortions of commonly used low-cost drugs After the issuance of the opinions, some drug prices may fluctuate, which is a normal phenomenon and in line with the law of market economy First of all, low-cost drugs are managed through the list, and the scope and boundary of the list are clear Secondly, the price is controllable by setting the standard of daily average cost of commonly used low-cost drugs Third, most of the commonly used low-cost drugs are produced by multiple companies, which have strong market competitiveness Through orderly competition, it is conducive to the rational return of drug prices Only when the drug price returns to a reasonable range, can the enterprise organize production according to the production cost and market supply and demand, continuously guarantee the supply, make a reasonable profit, be able to improve the production conditions, ensure the quality of drugs, carry out drug research and development and innovation, repay the environmental debts, and ultimately benefit the majority of patients Fourth, price authorities at all levels will strengthen the supervision of market price behavior, and do a good job in monitoring the production cost of low-cost drugs and the actual purchase and sale price