Breaking the fatal "drug shortage" and expanding the production base to 6

January 9, medical network news: "since the release of drug price control in China, there has been a shortage of drugs This phenomenon is becoming more and more serious " On January 2, Shan Gaosheng, executive chairman of Shaanxi drug quality management association, told reporters that this was mainly because the existing price mechanism did not play its due regulatory role, and the market lacked strict supervision and management mechanism, resulting in malicious monopoly of APIs According to the reporter, since 2019, Guizhou Province, Hunan Province, Guangxi Zhuang Autonomous Region and many other places have continued to release the list of drugs in short supply   In response to the drug shortage, the general office of the Ministry of industry and information technology, the general office of the national health and Health Commission, the general office of the national development and Reform Commission, and the comprehensive Department of the State Food and Drug Administration jointly issued the notice on publishing the list of construction units of the second batch of small drug (short drug) centralized production base (hereinafter referred to as the "notice") on December 31, 2019, and the second batch of small drug (short drug) was published List of construction units of centralized production base They are: consortiums led by Yuanda Pharmaceutical (China) Co., Ltd and Guangzhou Pharmaceutical Group Co., Ltd.; consortiums led by Northeast Pharmaceutical Group Co., Ltd.; consortiums led by North China Pharmaceutical Group Co., Ltd and Shiyao Holding Group Co., Ltd 2020 is the year of the big test to solve the problem of medicine shortage In October 2019, the general office of the State Council issued the opinions on further ensuring the supply and price stability of drugs in short supply, which pointed out that measures should be taken from the aspects of drug production, purchase, use, storage and price supervision, aiming to achieve stable production and supply of 100 kinds of small drugs (drugs in short supply) by 2020 Shi lichen, head of Beijing Dingchen medical management consulting center, said in an interview that the shortage of drugs in China is generally due to the low price and the drugs in the medical insurance catalog However, due to various reasons such as small profits or less demand, the pharmaceutical enterprises are unable to continue production or unwilling to produce, resulting in market shortage The six major production bases are in place As the name suggests, the selected enterprises should complete the construction of the centralized production base of small product drugs (short drugs) to ensure the stable production and supply of small product drugs (short drugs) In order to ensure the supply of drugs, in January 2018, the Ministry of industry and information technology of the people's Republic of China, together with the health and Health Commission, the development and Reform Commission and the drug regulatory bureau (four ministries and commissions), jointly organized the construction of the centralized production base of small drug varieties, and ensured the supply of short drugs by coordinating and solving such problems as the transfer of small drug varieties (short drugs) number, entrusted production, centralized procurement, supply and demand docking In January 2019, the list of the first batch of centralized production bases for drugs in short supply was released A consortium led by Shanghai Pharmaceutical Group Co., Ltd., China Pharmaceutical Group Co., Ltd and Chengdu Beite Pharmaceutical Co., Ltd will be established to build a centralized production base for small drug varieties (short drugs) to ensure the supply of short drugs Shan Gao said that enterprises entering the construction list must have experience in the production and supply guarantee of small drugs (short drugs) and have a certain number of production document numbers   Previously, the notice on organizing the construction of the centralized production base for small varieties of drugs (drugs in short) issued by the four ministries and commissions specified the selection criteria of the centralized production base: the enterprises constructing the centralized production base for small varieties of drugs should be top 100 enterprises in the pharmaceutical industry, with more than 20 production numbers of small varieties of drugs and supporting production capacity of APIs, which conforms to the pharmaceutical (vaccine) dosage forms in production Full, strong quality control ability, wide distribution network and other requirements, able to fulfill the responsibility of stable production and supply Shan Gao pointed out that the construction of the centralized production base of short drugs is conducive to ensuring the supply of short drugs At the same time, if an enterprise enters the list of construction units of the centralized production base of small drugs (short drugs), it can enjoy certain preferential policies and guarantee the profits of the enterprises producing small drugs To some extent, the problem of drug shortage has been alleviated by the establishment of "drug consortia" and the construction of a centralized production base for drugs in short supply Gu Haoliang, vice president of Shanghai Pharmaceutical Group and director general of the joint venture of supply and guarantee of small drug varieties (short drugs), said in an interview with the media that after the establishment of the joint venture, it will establish the list of short drugs according to the production and supply of the member units of the joint venture, and each enterprise will be responsible for the production and supply of different varieties "If there is any shortage of medicine supply within the country, the Ministry of industry and information technology will communicate with us (drug consortia) to prepare goods in advance and guarantee the supply." To solve the problem of "one medicine is hard to find" from the source, although the construction of the centralized production base of short drugs is conducive to alleviating the problem of "drug shortage", the problem of drug shortage still exists for a long time The single increase explained that after the drug price liberalization, from the API manufacturer to the drug manufacturer, all stakeholders are no longer satisfied with the production of low-cost drugs The higher the drug price, the greater the profit Therefore, the more malicious monopolies there are "The production technology requirements of many medicines in short supply are not high, and the APIs are not expensive Through the monopoly operation of this kind of APIs, the non-performing enterprises have led to the cut-off of supply in the market, with the purpose of raising the prices of medicines." Shan Gao said In fact, in recent years, the news of the soaring price of APIs is constantly emerging In 2015, the price of inosine, an API used for leukopenia, various heart diseases, chronic hepatitis, cirrhosis, etc., rose rapidly from 92-95 yuan / kg to 200 yuan / kg, with an increase of more than 100%; in 2018, chlorphenamine maleate, also known as chlorphenamine, rose from 400 yuan / kg to 23300 yuan / kg in one month, with an increase of 58 times Hu Jiqiang, chairman of Kangenbei, said publicly in 2018 that the price of many APIs has increased by 20-30 times compared with the previous years The price of uric acid APIs was 30-40 yuan / kg a few years ago, and it once rose to 900 yuan / kg in the past two years Finally, the production could continue only after the intervention of the government departments The fluctuation of upstream API prices has brought many impacts on downstream supply and sales The national development and Reform Commission has repeatedly cracked down on malicious monopoly and issued huge fines, but they are still banned repeatedly Shan Gao pointed out that at present, the punishment for the monopoly behavior of API is relatively light, "compared with the profit increment brought by the price increase of API, the penalty of hundreds of thousands of yuan and millions of yuan is too little, and the punishment is not enough." In addition, he pointed out that the definition of monopoly behavior is still vague "The risk and cost of" doing evil "in the monopoly behavior of bad enterprises are far lower than the huge profits brought by the rise of drug prices, so the regulatory authorities should strengthen the supervision and punishment of monopoly behavior." From the perspective of enterprises, Mr Shi said: "the problem of drug shortage should not be solved only at the supply side." Shi lichen said that to solve the problem of drug shortage, we should see the demand of reasonable profit space of drug manufacturers in short supply In terms of specific measures, we should solve the current situation of long-term rigid local bidding price, realize flexible quotation, and improve the enthusiasm of enterprises in production In addition, to form a whole chain monitoring system, not only to ensure the production and supply of drugs in short supply, but also to ensure that enterprises can get the hospital's payment in time and maintain a reasonable profit space.