[King of the week] are major pharmaceutical companies worried about the new action of the country? With a heavy fist, the grass-roots medicine is full of smoke and gunpowder; the sale and production of fake drugs, as well as the collection of indictments from the Procuratorate by pharmaceutical enterprises

This week's point 1 Why are major pharmaceutical companies worried? They are all DRG's "pots"? 2 After 2020, the grassroots drug terminal market may be filled with "it" 3 Is the task volume of nearly half a year completed in Xiamen in February under estimated? In April and may, the eventful autumn of Tiansheng Pharmaceutical Co., Ltd The General Administration wants to know why major pharmaceutical companies are worried They are all DRG's "pots"? On May 24, 2019, the National Health Insurance Bureau held a video conference on "launching the pilot work of DRG payment countries", which released the list of 30 pilot cities in DRG payment countries, and briefly introduced the main contents of DRG payment countries' pilot work At the same time, the pilot work is required to be carried out orderly in three years according to the "top-level design, simulation operation and actual payment" Through the pilot work, the goal of "five ones" is achieved, that is, to formulate a set of standards, improve a series of policies, establish a set of procedures, train a team and create a batch of sample boards The DRG pilot work in 30 cities, all of which are national key economic and political centers, has finally been implemented since the notice on applying for the pilot countries to pay by disease diagnosis at the end of last year However, for pharmaceutical enterprises, it is a sad news DRGs, originated in the United States in the 1980s, is a package payment system, which can make rational use of health resources, reduce over prescribing, over checking, over prescribing, and eliminate kickbacks In 2017, after the implementation of pilot DRGs in Yuxi City, the results showed that after DRGs payment, the growth rate of medical insurance fund expenditure of 10 hospitals was only 5%, nearly 60% lower than the growth rate of medical insurance fund expenditure of 12% in the city; in addition, after deducting the non payment fee of 3.39 million yuan from the payment audit, that is to say, the 3.39 million yuan is likely to come from the profit ratio of pharmaceutical enterprises or the "middle price difference" of dealers At last, the experts made a conclusion about the effect of the pilot hospitals from 2014 to 2016: the pilot hospitals are better than the control hospitals in the growth rate of medical expenses, medical efficiency and treatment effect After 2020, the grass-roots drug terminal market may be filled with "it" On May 28, the national health and Health Commission issued the notice on promoting the construction of close county medical and health community, clearly accelerating the hierarchical diagnosis and treatment, and promoting the construction of close county medical and health community By the end of 2020, a new County medical and health service system with clear objectives, clear rights and responsibilities, and division of labor and cooperation will be initially established in 500 counties, and a community of services, responsibilities, interests and management will be gradually formed Each prefecture and city shall select a county to carry out the pilot project of close medical community, and encourage the comprehensive promotion of the project with Prefecture and city as the unit At the same time, in the "guidance" issued on the same day, it is proposed to strive to achieve 90% of the county-level medical treatment rate and 65% of the county-level medical treatment rate by the end of 2020, and the technology and projects that the grass-roots medical and health institutions have the ability to carry out are increasing Unified management of drug consumables, unified drug catalog, unified procurement and distribution, and unified payment for goods The centralized procurement of drugs originally based on "province" is likely to sink to "county" with the establishment of county medical community So far, there are 2856 county-level administrative divisions in China, with 500 counties accounting for about 17.5% Compared with 17% of the market, what's more important is that the marketing organizational structure, resource allocation and marketing methods of pharmaceutical enterprises will change accordingly after the national market is based on the cities and counties It's a choice to establish a grass-roots sales team or cooperate with the local grass-roots team In addition, hypertension, diabetes and other chronic diseases are highlighted in the instruction, which means that the market share of grassroots chronic diseases will change greatly Data shows that in 2017, the sales terminal market of antidiabetic drugs in China has exceeded 50 billion yuan In the past, under the framework of China's medical security system, state-owned public medical institutions were the main market for diabetes drugs, accounting for 62% of the total market share, 24% of the retail terminal market, and 14% of other consumer terminals However, in the future, most of the public hospitals will be transferred to the grass-roots level "Real world research" has brought a real road to the rise of traditional Chinese medicine On May 29, the drug evaluation center of the State Food and Drug Administration issued the notice on public consultation This is the first time that real world evidence has been presented in an official document on how to use it in drug development Real world study (RWS) is a practical clinical trial, which is characterized by a large sample size, selection of treatment measures according to patients' actual conditions and wishes, long-term evaluation, and focus on meaningful outcome treatment In the document, 6 cases of real world evidence supporting drug development and regulatory decision-making are listed: treatment drugs for rare diseases, revision of indications or combination of drugs, re evaluation of drugs after marketing, clinical research and development of traditional Chinese medicine hospital preparations, guidance of clinical research design and accurate positioning of target population, of which the most concerned is "clinical research and development of traditional Chinese medicine hospital preparations" ”Real world research is available Because traditional Chinese medicine has no obvious clinical evidence support in clinical treatment and research, and the clinical data indicators are not scientific, leading to the research results can not be widely recognized; in addition, the indicators lack of practicability and large differences, also leading to the research results can not reflect the needs of patients, clinicians or policy makers, similar research results can not be compared horizontally or combined for analysis, etc., if Real world research can help clinical research of traditional Chinese medicine, and perhaps the rise of traditional Chinese medicine is also possible The policy of prescription drugs for chronic diseases is relaxed, will the next step be the Internet On May 24, a notice on strengthening the management of licensed pharmacists in drug retail enterprises in Shaanxi Province pointed out that "drug retail enterprises should establish a file management system for patients with chronic diseases Licensed pharmacists should establish files for patients with chronic diseases based on patients' prescriptions, diagnosis certificates, etc for those who purchase drugs for treatment of chronic diseases within half a year, they can directly purchase drugs without prescriptions according to the file records Buy it " In fact, it is also a kind of relationship maintenance between drugstores and patients with chronic diseases, which can facilitate the purchase of drugs by patients with chronic diseases, and also is equivalent to the implementation of "member" management It can also collect big data of pathological information for various research statistics In mid June 2017, Guangdong food and Drug Administration issued a document for the first time stating that under the premise of drug safety, prescription drugs can be sold with the first retained prescription At the beginning of 2018, the notice on Further Strengthening the management and supervision of prescription drugs in retail pharmacies issued by Chongqing food and drug administration also said that "pharmacies are encouraged to establish drug use files for chronic diseases to guide patients to use drugs reasonably." On April 3, 2018, the notice on doing a good job in the signing service of family doctors in 2018 issued by the national health and Health Commission proposed that under the premise of "reasonable, safe and effective", the single dose of drugs could be extended as appropriate for the patients with stable condition and good compliance with the contract Is Xiamen's task volume of nearly half a year in February underestimated? On May 29, the official website of Fujian Provincial Health and Health Commission released news that at the just concluded teleconference of promoting medical reform in the whole province, many departments and regions summarized the phased results of "three medical linkage" As the first city to carry out the national "4 + 7" pilot procurement reform in China, the price of 25 selected drugs in Xiamen dropped by 52% on average and 96% at the maximum, with a total of many parties The results are remarkable As of May 15, the total purchase quantity of 25 selected drugs in Xiamen was 12.67 million (tablets / piece), 59% of the agreed purchase quantity in the region has been completed The planned purchase volume of one year is nearly 60% in two months? Theoretically, the use of clinical drugs will not change significantly in a short period of time If the inventory and distribution of medical institutions are excluded, is there any error in the estimation of annual clinical use of drugs in pilot cities? Is the purchase volume forecast too conservative? According to the data of Xiamen, it may be able to eat twice the dosage This may be good news for pharmaceutical companies After all, quantity is the key to success But at the same time, the number of drugs passing the consistency evaluation is also rising in a straight line Before purchasing, 95 varieties passed the consistency evaluation, only 31 were shortlisted, and 25 were selected successfully Up to now, the total number of varieties that have passed the consistency evaluation has exceeded 200, and the number of varieties purchased with volume has become more sufficient, which means that although the total number has become larger, there are also more competitors If you want to stand out in a large number of competitors, how to choose will be waiting for the future Enterprise information China biopharmaceutical's first quarter report, with revenue growth of 33.4% A few days ago, China biopharmaceutical released its first quarter performance announcement in 2019, with revenue of 6.208 billion yuan, a year-on-year increase of 33.4%; net profit of 857 million yuan, a year-on-year increase of 11.1% Among them, the sales of 16 products exceeded 100 million yuan, new product sales accounted for 17.7% of the total revenue; R & D expenditure was 865 million yuan, accounting for 13.9% of the revenue The key points are: in the first quarter, China biopharmaceuticals obtained 2 clinical approvals, 3 production approvals, 2 consistency evaluation drugs, 4 chemical drugs and class 1 new drugs, and 6 consistency evaluation drugs May is the eventful year of Tiansheng pharmaceutical On the evening of May 27, Tiansheng pharmaceutical announced that the company had received the indictment from the first branch of Chongqing People's Procuratorate, suspected of the crime of producing and selling fake drugs Liu Qun, the actual prosecutor of the company, was suspected of the crime of producing and selling fake drugs, the crime of occupation, the crime of misappropriating funds and the crime of false litigation Li Hong, the former general manager of the company, was suspected of the crime of producing and selling fake drugs, the crime of occupation and the crime of misappropriating funds The total amount of property given to several national staff members is 14.748 million yuan, including 9.707 million yuan given to national staff members by Liu Qun on behalf of Tiansheng pharmaceutical Property to state-owned institutions totaled 4.05 million yuan, including 2.6 million yuan from Liu Qun on behalf of Tiansheng pharmaceutical On the 29th of the same month, Tiansheng pharmaceutical received a letter of concern from the Shenzhen Stock Exchange: previously, the company and its controlling shareholders received the indictment that they were suspected of the crime of unit bribery and the crime of producing and selling fake drugs, and the relevant parties had been transferred for examination and prosecution Shenzhen stock exchange requires the company to explain the process, amount and result of suspected production and sale of fake drugs and the impact of the above-mentioned matters on the company's production, operation and legal liability; specifically, the specific situation of Liu Qun and Li Hong suspected of duty embezzlement and embezzlement, the amount and method of Embezzlement or embezzlement, the impact on the listed company and the company's proposed solutions; and The impact of the above matters on the production and operation of the company and the stability of the management Information source: Source: yaozhi.com, cypress blue, pharmaceutical economic news, Sina pharmaceutical, China Pharmaceutical News, e-pharmaceutical manager, announcement statement of relevant enterprises: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.