How will the new regulations for mass procurement be implemented by the National Health Commission and the supporting policies?

The purchase policy of the third wheel belt quantity is about to be officially implemented On December 19, according to e-drug managers, all members of the state health insurance bureau sent out to organize and hold a drug volume purchasing conference in Shanghai According to the schedule, Fujian Medical Insurance Bureau, Shanghai Medical Insurance Bureau, Shanxi Medical Insurance Bureau, Shandong Medical Insurance Bureau and Liaoning Medical Insurance Bureau will first introduce the pilot and expansion work, and jointly report the progress of the pilot and expansion work In the afternoon, joint procurement members and liaison officers will discuss and sign centralized procurement documents According to e-medicine manager's on-site understanding, the meeting was postponed until after 5pm According to the notice of the meeting, the reason for the signing of the discussion document is that a new round of belt purchasing will introduce a number of new rules, close the loopholes in the current bidding rules, and increase the degree of fierce competition In June this year, the general office of the State Council issued the key tasks of deepening the reform of the medical and health system in 2019, which proposed to formulate 15 policy documents by the end of this year, involving drug procurement, health China action, etc It is worth noting that in this task list, the Secretariat of the leading group of the State Council for medical reform should take the lead in formulating policy documents to further deepen medical reform through centralized drug procurement and use This is the only one of the 15 documents led by the Secretariat of the leading group of medical reform of the State Council, which shows that its specifications are different from others According to several policies and measures to further deepen the reform of the medical and health system through the breakthrough of centralized purchase and use of drugs, centralized purchase of drugs is not only an important reform of the drug purchase mechanism, but also will play a positive role in promoting the deepening of medical reform, consolidating the achievements of public hospitals to supplement medicine with drugs, and promoting the healthy development of the pharmaceutical industry "Several relevant measures" requires to promote the linkage of medical treatment, medical insurance and medicine through the centralized purchase and use of drugs It can be predicted that in 2020, volume procurement will continue to have a profound and long-term impact on the pharmaceutical industry, and the third wheel volume procurement plan formed by the meeting of the state health insurance bureau will also play a role as a wind vane for pilot exploration in various regions According to the industry, 35 varieties, including abitrone and adefovir dipivoxil, are likely to become the final three rounds of centralized collection On December 6 this year, relevant enterprises were also required to report the capacity reserve of varieties at the Shanghai Symposium of volume purchasing enterprises But in fact, this catalogue has caused a lot of discussion in the industry First of all, the 35 products are more than 2 enterprises through consistency evaluation, and the competition is fierce In contrast, the 25 varieties purchased by the first tire quantity include exclusive varieties and only one variety passing the consistency evaluation An executive of a volume purchasing related enterprise told e pharmaceutical Manager: "including the exclusive varieties that pass the consistency evaluation is conducive to the rapid release of the first imitated varieties, which is a good thing for the first imitated varieties To some extent, it is conducive to stimulating enterprises to carry out the consistency evaluation as soon as possible, and is conducive to the progress of China's consistency evaluation." However, in terms of the current varieties, the first imitated varieties are not supported to a certain extent, which will inevitably crack down on the enthusiasm of enterprises for "first imitations" The year 2020 will be a year of expanding varieties, expanding areas and fully flowering According to the requirements of several relevant measures, we will build a nationwide public procurement market and a multi-party linkage procurement pattern Relying on the provincial drug centralized procurement platform, and drawing on the experience of centralized procurement and use of drugs organized by the state, we will take independent or cross regional alliances and other ways to increase reform and innovation in the scope, qualification criteria, and centralized procurement forms of drugs At present, Hebei Province, Jiangxi Province and Wuhan City have taken the lead in carrying out pilot projects of belt purchase, for example, Hebei Province has carried out belt purchase for 15 varieties of "two diseases" Jiangxi Province has also made it clear that some generic drugs corresponding to generic drugs that have never passed the consistency evaluation of quality and efficacy should be selected for drugs with large clinical dosage, high purchase amount and full competition, and organized and implemented with quantity purchase Under these circumstances, will the seminar of the national health insurance bureau change the original rules of belt purchase? What will be the impact of the national version of the centralized procurement plan on the next pilot projects? These answers will be announced soon! On December 19, the general office of the national health and Health Commission issued the notice on further completing the allocation and use of selected drugs in the centralized purchase of drugs organized by the state (hereinafter referred to as the notice), which indicated that the allocation and use of selected drugs should be done well The notice clearly requires that the policy channels for the use of selected drugs should be unblocked The administrative department of health and medical institutions shall not influence the reasonable use and supply guarantee of the selected drugs on the grounds of cost control, drug proportion, requirements for drug varieties, specifications and quantities of medical institutions, examination and approval of Pharmaceutical Affairs Committee, etc At the same time, medical institutions are required to include the selected drugs in their drug formulary and basic drug supply catalogue The main person in charge of medical institutions is the first person in charge of the allocation and use of selected drugs, and also the key responsible party Therefore, the relevant incentive mechanism and performance appraisal system are also crucial According to the notice, the balance of medical service revenue and expenditure is used for medical staff's salary as a whole in accordance with the requirements of "two permits" In addition, the notice also proposes to gradually extend the index of "proportion of selected drugs in centralized drug procurement organized by the state" to secondary public hospitals As early as May 31 this year, the general office of the national health and Health Commission released 55 indicators for the performance appraisal of the national three-level public hospitals, including the proportion of procurement and use with volume On the one hand, it can expand the clinical use of the winning varieties and pave the way for expanding the varieties and scope of the volume procurement As for the clinical drug use of some special patients, the circular said: encourage the key patients who use the selected drugs to provide pharmaceutical services, such as pharmaceutical outpatient service, drug reorganization, medication care, etc The administrative departments of health and health at all levels should improve their political positions, carry out extensive publicity and training for medical personnel, so as to make them deeply understand the significance of centralized drug procurement organized by the state Even though the price of generic drugs is facing a sharp decline, Chinese pharmaceutical companies are the second largest local drug market in the world According to IMS estimates, the scale of generic drugs in the typical sense of China's drug market in 2019 will be about 37 billion US dollars, and the compound growth rate will remain at 9% from 2015 to 2020 Recent research of Changjiang Securities shows that driven by aging, import substitution and other factors, the domestic generic drug market still has broad growth space, which is conducive to cultivating large local generic drug enterprises in the future In addition to aging, the incidence rate of cancer and chronic diseases has doubled The vast replacement space of expired patent drugs is also the space for rapid growth of local generic drugs Taking valsartan as an example, only 5% of the prescriptions of the original research enterprises in the U.S market after the expiration of the patent, while the proportion of the sales amount of the original research valsartan in the sample hospitals in the Chinese market is still as high as 90%, and the proportion of the prescriptions is more than 50% Valsartan is not a case in point Many of the original large varieties show this situation There is a huge space for the replacement of expired patent drugs In the past few decades, Chinese pharmaceutical companies have taken the local market as their strategic center With the convergence of domestic pharmaceutical policy with Europe and the United States, the technical strength of domestic leading enterprises is gradually complete It is expected that the time for domestic leading enterprises to quickly occupy the global market share of generic drugs has also come This will be a broader incremental space As the largest API base in the world, China is responsible for more than 1 / 3 of the global API supply Compared with the competitors in the global generic pharmaceutical market such as Europe, America and India, API integration has become an important advantage for Chinese pharmaceutical enterprises In recent years, India has purchased about 12 billion yuan of intermediates and APIs from China every year The internationalization process of Chinese generic pharmaceutical enterprises is ready to take off and is affecting the global generic pharmaceutical market pattern In recent years, the number of approved andas of Chinese enterprises in the United States has been in a rapid growth trend In 2018, domestic enterprises obtained 99 andas, accounting for about 10% of the total approved by aDNA in the United States that year, which indicates that the R & D capacity of domestic generic pharmaceutical enterprises has been able to meet the quality standards of Europe and the United States With the barrier of APIs or preparations, Chinese pharmaceutical companies can usually enjoy the profitability higher than the industry average overseas For example, with the help of cyclophosphamide breakthrough in the U.S market, Hengrui pharmaceutical has achieved a significantly higher gross profit margin than its European and American competitors In fact, according to the recent financial reports of Teva and mylan, the Chinese and Indian generic pharmaceutical companies with obvious cost advantages have made a double impact on the market share and price of the large European and American generic pharmaceutical companies.