Review and summarize the characteristics of national collection and speculation a new round of trends

The State Council of the CPC Central Committee issued the Opinions on Deepening the Reform of the Medical Security System, which pointed out that the reform of the centralized band procurement system for pharmaceutical and medical supplies should be deepened, emphasizing the leading role of centralized quantity procurement in medical reform1and 3 collection achievements China's "patent cliff"from the 4 plus 7 pilot (hereinafter referred to as the pilot), to 25 provinces and cities of the Union of drugs centralized procurement (hereinafter referred to as alliance procurement), to the second batch of centralized procurement of national drugs (hereinafter referred to as collection II), the third batch (hereinafter referred to as collection II), the national centralized collection of generic drugs gradually become a normalAt the4 plus 7 pilot press conference, the head of the pilot office said: "The purpose of the national organization drug centralized procurement pilot is to enable the people to use higher-quality drugs at relatively low prices." "
1Unlike Europe and the United States, China has not yet achieved the "patent cliff"the overall low quality level of generic drugs, it is difficult to compete fairly with the original drug at the same quality level, the price of the original research drug has been significantly higher for a long time, and the "patent cliff" has not occurred in Chinathree progressive collectionfrom "pilot varieties, pilot cities", to "do not change the procurement varieties, expand the scope of urban procurement", to "procurement varieties change, national collection", step by step, to promote the process of maturity, norms, enhance enterprises and the public from the phenomenon to the essence of the understanding3This year, the range of collection varieties will continue to expand
continue to promote the collection process of two aspects: narrowing the price gap between different enterprises of the same common name;the future, the ultimate goal of centralized drug procurement will be not only generic drug price reduction, original research drugs and exclusive high-quality high-demand drugs will also be the normal centralized procurementtwo and three collection characteristics: expansion, stability1The state collection and harvesting trend(1) participation in enterprises soaring
pilot participation enterprises unknown, the alliance procurement of 77 participating enterprises, collection II directly soared to 122The increase in the number of participating enterprises, on the one hand, reflects the consistency of generic drug evaluation results highlighted, the large increase in over-evaluation enterprises, on the other hand, shows that the country's influence of collection and harvest ingress, enterprise awareness is positive(2) more beneficiary enterprisesthe pilot selection of 25 enterprises, the alliance procurement of 45, the collection of 77 selected, the number of enterprises increased, so that more enterprises benefit from the collection(3) the selected varieties gradually increased
from the pilot, alliance procurement to collection II, the increase of selected varieties is not large, only increased by 7, but of great significance, the collection of II mark drug national collection model formed2From exploration to mature collection(1) coverage and use of drug demand
the pilot collection and the procurement of the alliance have not formed a policy document, the pilot covers 4 and 7 cities of public medical institutions, the alliance procurement of drugs demand conditions remain unchanged, the scope of expansion of 25 provinces and cities, but in the alliance procurement results announced On the same day, September 30, 2019, "the State Medical Security Administration and other nine departments on the national organization of centralized procurement and use of drugs pilot expansion of the regional scope of implementation opinions", notice issued, marking the collection model mature, for the collection of II to promote the promotion of good policy endorsementcollection II, clear lying that the country's public and military hospitals must participate, private hospitals and pharmacies to participate voluntarilyIndicates that the Joint Procurement Office shall determine the agreed procurement volume according to 50%-80% of the total procurement demand according to the number of selected enterprises, and implement the band purchase(2) The scope of drug varieties is clear
pilot and alliance procurement to determine the original research drugs, reference preparations and through consistency evaluation of generic drugsDetermine 25 varieties, specify specifications and agreed purchase volume collection II requires the evaluation of generic drugs through consistency, focusing on the selection of more competitive varieties (large varieties, large areas), taking into account the clinical efficacy of drugs, adverse reactions, batch stability and other factors (3) the first year of procurement volume and procurement cycle pilot is new, so in the time to consider the cycle of one year, taking into account the situation varies from place to place, there is no provision for procurement volume, take the form of local reporting Therefore, by the end of 2019, the pilot area average procurement implementation progress of 183%, has significantly exceeded the agreed procurement volume, it is necessary to make clear that this part is not incremental Alliance procurement of selected enterprises and procurement volume innovation methods, corresponding to 1 / 50%, 2 / 60%, 3 / 70%, the winning enterprises and procurement cycle corresponding to no more than 2 / 1 year, 3 / 2 years, the procurement cycle can be extended by one year depending on the situation collection II basically adopts the alliance procurement model, the procurement volume increases by 4 / 80%, the procurement cycle fine-tuning of the selected enterprises and procurement cycle corresponding to 1 / 1 year, 2 or 3 / 2 years, 4 / 3 years 3 Prices continued to decline, the overall stability of the three catch-up prices to control the decline of 52%-59%, the highest decline is more than 90% (1) the pilot compared with the pilot city in 2017 the minimum purchase price of the same drug, the average price of the proposed selection decreased by 52%, the highest (2) alliance procurement compared with the 2018 minimum purchase price of the same drug in the expanded area, the average price of the proposed selection fell by 59%, compared with the price of 4-7 by 25% (
3) the average price reduction of the III, COLLECTION III, IV, V of the idea "On deepening the reform of the medical security system" document, pointed out that we should give full play to the drug, medical supplies centralized band procurement in deepening the medical service supply-side reform of the leading role, promote medical insurance, medical, medical and related reform system integration, strengthen policy and management coordination, to ensure that the masses to obtain high-quality and affordable medical services the leading role of centralized procurement foreshadows the succession of collection III, IV and V 1 The time is faster
from the pilot to the collection II, the collection scheme is published to the results are published, the time has been shortened from 32 days to 22 days, the time is greatly compressed Pilot to the alliance procurement interval of nearly 9 months, and the alliance procurement to the collection II interval of only 3 months, perhaps the original plan in March this year should be announced collection III, affected by the outbreak collection III may be two after the second meeting, the network spread the third batch of collection or will start in July, the specific time, it remains to be seen 2 A wider range of there is no doubt that from the mature collection rules and the successful implementation of the first batch of the results of the collection, collection III, and even collection IV, V-range ratio will be expanded, and even achieve full coverage According to public data, the number of varieties through consistency evaluation is currently 212, of which 155 varieties have not yet been included in the national drug centralized procurement, it can be seen that the sequel picks or will become their performance highlight moment, in other words, it is only a matter of time before entering the collection 3 More vigorous collection has not yet involved injections, with the "injection consistency evaluation requirements" officially released, injection band procurement is not far away, especially intravenous anti-infective drugs, this area share of public medical institutions procurement amount of 20%, the future will be the focus area of collection 4 The form of stable from the coverage and use of drug demand, drug range, centralized procurement rules, the first year agreed procurement volume and procurement cycle, through the first three gradual collection, the collection mode basically remained stable, the practice proved that the model can ensure that the masses to obtain high-quality and affordable medical services thus, the author boldly predicts collection III: from the collection plan published to the collection results published or will be less than 20 days, July or will open the third batch of band procurement, more than that there is hope to start collection IV, the shortlistmay may be less than 50, the price decline may remain between 50-60% drug centralized procurement is not new, has gradually become a normal chinese pharmaceutical industry, but still the pharmaceutical industry, especially the focus of pharmaceutical enterprises Therefore, for the general direction of pharmaceutical enterprises need to adjust the business strategy, the National People's Congress representative, Hengrui Pharmaceutical Chairman Sun Flutter called at the two meetings, "recommended the "drug test data protection implementation measures (provisional)" to be revised, in the protection of the object to increase the protection of improved new drugs, for the general improved new drugs can be given 3 years of data protection, the new indications of which part of the consideration to give 4 years of data protection." "
the future, the collection or will focus on the layout of innovative drugs, step by step to develop improved new drugs, the appropriate amount of imitation of generic drugs And innovation and improvement will become the main theme, high-quality and efficient use of generic drugs in the future of low prices are visible