Deep Thinking . . . The new pattern of the pharmaceutical industry after the normalization of drug collection.

Author. Cai Haiqing has carried out two batches of three rounds of drug collection work in more than a year since the state launched the pilot work of "4 plus 7" drug collection in November 2018, and the third batch of drug collection has also entered the practical stage.
drug collection from the pilot to the national expansion, and then immediately into the normal operation stage, the reform presents a comprehensive trend, will inevitably bring profound impact on the development of pharmaceutical enterprises and even the whole industry, a new pattern of the pharmaceutical industry to adapt to the new requirements of the development of the times is about to take shape.
, from the pilot to the expansion of the siege: the new model of drug collection gradually matured since the State Medical Insurance Administration began to start the national organization of centralized procurement of drugs, has carried out two batches of three rounds of drug collection work, from the "4 plus 7" pilot to the comprehensive expansion of the siege, the national organization collection work is getting deeper and more mature.
(i) the first round of the "4 plus 7" pilot on November 15, 2018, the newly established National Health Insurance Administration began the first round of the first round of centralized drug procurement pilot work, that is, "4 plus 7" drug collection pilot. On December 6,
, the State began to organize a purchase price for 31 types of drug belt.
was officially announced on December 17th, with the final 25 varieties selected, six streaming marks and a record drop of 96%.
January 1, 2019, the General Office of the State Council issued the Pilot Program for the Central Procurement and Use of Drugs organized by the State Organization (hereinafter referred to as the Pilot Program).
the "Pilot Program" to select 11 cities in Beijing, Tianjin, Shanghai, Chongqing and Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xi'an to select the pilot varieties from generic drugs corresponding to generic drugs that are evaluated for quality and efficacy consistency.
all production enterprises approved by the State Drug Administration and within the collection and collection of drugs listed in the Chinese mainland (the national general agent of imported drugs is regarded as a production enterprise) may participate in the pilot work.
the overall idea is: "national organizations, alliance procurement, platform operation."
mainly take the following four measures, namely: first, the volume of procurement, to exchange prices, second, one to ensure the use of one, third, to ensure quality, to ensure supply, and fourth, to ensure repayment, reduce transaction costs.
from the pilot effect, the pilot work is generally stable, the implementation progress exceeds expectations, the public opinion response is good, the burden of patients' drug costs significantly reduced.
by the end of 2019, the 25 selected drug procurement sourcing sourcing scored 183 per cent, accounting for 78 per cent of the same generic drug procurement volume.
recruitment work really did "belt quantity procurement", "recruitment and one", out of the drug "price reduction death" cycle, out of a tender, procurement, use, payment through the new road.
the results of the pilot mid-term assessment conducted by third-party agencies showed that the burden of drug costs for patients was reduced, especially for chronic diseases and seriously ill patients, with more than 90% of patients in favour of the pilot policy;
(ii) the first second round: expand the scope of the pilot in order to promote the national collection model, and to carry out comprehensive drug collection and collection work to accumulate experience, but also to solve the pilot cities and other regions due to the price difference caused by many problems, September 25, 2019, the National Health Insurance Administration and other nine departments jointly issued "on the national organization of centralized procurement and use of drugs to expand the regional scope of the implementation of the implementation of the first round of the implementation of the work" (hereinafter: "the implementation of the second round of the implementation of the "e."
the Implementation Opinion, on the basis of continuing the first round of collection ideas, the pilot scope will be extended to the country's pilot cities outside the relevant areas, to form a provincial unit alliance.
after the expansion of the collection allows a number of pharmaceutical enterprises to choose, each drug selection enterprises generally not more than 3.
at the same time, according to the number of selected enterprises according to the previous year's historical procurement volume of 50%-70% to determine the agreed purchase volume, in order to obtain the corresponding market share.
the first batch of the second round of collection, a total of 77 eligible enterprises to participate in the declaration, and eventually 45 enterprises (including 6 original research enterprises and an Indian generic pharmaceutical enterprises) to obtain the right to be selected, indicating that the national collection is more and more attention by more and more pharmaceutical enterprises, participation is also getting higher and higher.
the total number of drugs selected in this year is 60 product regulations, compared with the lowest purchase price of the same drug in the expanded area in 2018, the average price of the winning price decreased by 59%, compared with the first batch of pilot, an average decrease of 25%.
(iii) Second batch: After accumulating the above-mentioned experience in collection and collection of varieties, in order to enable the reform results achieved by drug collection and use pilot to benefit more people and form a stable expectation of the reform of the social and industrial sectors, the State Council has decided to continue to promote the centralized procurement of drugs, and expand the scope of varieties of centralized procurement and use of drugs.
January 13, 2020, the National Health Insurance Administration and other departments issued the "Notice on the implementation of the second batch of national organizations of drug centralized procurement and use of the work" (hereinafter referred to as the "Notice").
the Notice, the second batch of collection will no longer select some areas to carry out the pilot, by the national provinces and Xinjiang Production and Construction Corps to form a procurement alliance, the alliance area of all public medical institutions and military medical institutions all participate, medical insurance fixed-point social medical institutions, medical insurance fixed-point retail pharmacies may voluntarily participate.
joint procurement office according to the number of selected enterprises according to 50% to 80% of the total procurement demand to determine the agreed procurement volume, the implementation of the volume of procurement.
the results of centralized procurement of the alliance, it is implemented simultaneously throughout the country.
the second batch of selected drugs from the first batch of 25 varieties to 33 varieties, pharmaceutical companies allow a maximum of 6 home selection, the same drug different in-choice enterprises allow edifice differences, but the lowest price 1.8 times the fuse mechanism.
at the same time, the Notice for the first time proposed "the implementation of medical institutions balance retention" and other incentives.
drug collection pilot after two batches of three rounds, from the regional perspective to cover all 31 provinces of the Chinese mainland, the selection of varieties from 25 to expand 33, has formed from point to face, comprehensive promotion, the national linkage situation, the reform of the initial results of the initial appearance, the implementation of drug collection work of the normal operation has become inevitable.
the second and third batch of collection: from the pilot to the normal important symbol June 15, 2020, the State Health Insurance Bureau Hu Jinglin in the deepening of the medical security system reform training course clearly pointed out that "in the future, centralized procurement will gradually achieve normal operation, policy standardization, operation standardization, team specialization", and said that "according to the normal trigger mechanism, the recent launch of the third batch of state-organized drug procurement will be the beginning of the regular collection of drugs".
the so-called normalization of collection work is the relative curing of policy provisions, trigger mechanisms, operating mechanisms and organizational frameworks, so that all stakeholders, including pharmaceutical enterprises, medical institutions, insured people, etc., have a stable psychological expectation. the
is mainly reflected in the following three aspects: First, the institutionalization of collection work.
to raise the experience of the pilot and the methods explored to the national system, fix the collection provisions of the winning bid conditions and competition rules in the form of documents, and ascend to the basic basis for promoting the reform of the recruitment system, so as to maintain the continuity and stability of the collection policy.
specifically, that is, "five adhere", that is: 1. adhere to "tape procurement", 2. adhere to "should be harvested", both including the variety of drugs, categories should be harvested (from drugs to consumables, from consistency evaluation to unevaluated, from Western medicine to Traditional Chinese medicine, from chemical composition to plant preparations, etc.), including The procurement subject's "should be harvested"; 3. adhere to the "market discovery price"; 4. adhere to the improvement of safeguard measures, including incentive and restraint mechanism, emphasize the responsibility of all parties, mobilize the enthusiasm of all parties, to ensure the quality, supply, use, return of the selected drugs; 5, adhere to and improve the recruitment operation mechanism, namely: "national organizations, alliance recruitment, platform operation."
" is the mechanism of the procurement cycle.
means that in the future (including the third batch of drug collection), as long as the quality and efficacy of consistent evaluation of the variety of drugs to reach a certain number, the competitive pattern reached more than 3, should be in accordance with the provisions of the policy to start drug collection work.
this is what Secretary Hu Jinglin said was the establishment of a "normal trigger mechanism". The third
is the stabilization of the organizational framework.
according to the current development trend, I personally think that the joint procurement office is likely to become a permanent office for a long time in the future, accompanied by the departmental coordination mechanism and the division of labor and the normalization of the coordination mechanism between the state and the local, the standardization and standardization of the collection platform will also be put on the agenda, will form a stable situation of the country and local stratification linkage.
three, the normalization of collection: the pharmaceutical industry will usher in a new pattern with the pharmaceutical collection work into the normal operation stage, more and more through the quality and efficacy consistency evaluation of drugs into the collection is a certain fact, the normalization of collection will undoubtedly bring many impacts on the future development of the pharmaceutical industry, the pharmaceutical industry will also usher in a new pattern.
(i) the impact on the enterprise, in the short term, mainly on the current revenue of the enterprise has an impact, different enterprise situation is different, because the enterprise winning the bid although can quickly swallow a large amount of market share, but the price is low price son of the product: for the original market share is large, and the enterprise has a number of heavy drugs of large enterprises, such as: China Biopharmaceuticals, collected to keep its market share, although the collection of drug revenue decline, but the company has other products to follow the overall The impact is not significant; for the original market share is high, but in the short term there is no follow-up heavy products of pharmaceutical companies, although the harvest of more market share, but the increase does not increase; Maybe it's a good chance to overtake a corner.
long-term perspective, the winning enterprise sized in the market share at the same time, with the scale effect gradually appear, each drug sales profit contribution rate will also increase in the future.
and for the failed enterprises, the product market can only watch by other enterprises "occupied", obviously not conducive to the long-term development of enterprises. The impact of
(2) on the industry At present, China's pharmaceutical industry has a large number of small and medium-sized enterprises, low industry concentration of the status quo, the state organization of drug collection and use of the comprehensive implementation will strongly promote the transformation and upgrading of domestic pharmaceutical enterprises, promote drug supply-side structural reform, improve industry concentration.
in general, the pilot expansion will bring the following impact on the pharmaceutical industry: First, to guide the transformation and upgrading of enterprise product structure.
the pilot expansion of the scope adhere to the "consistency evaluation" as a generic drug to participate in the centralized volume procurement of the shortlisting criteria, allowing the adoption of consistency evaluation of generic drugs and the original research drug fair competition, and provide for the same varieties of drugs through consistency evaluation of the production enterprises to reach more than 3, no longer choose the varieties that have not passed the consistency evaluation, the market capacity to be vacated through the consistency evaluation of drugs.
the above-mentioned policy provisions will effectively promote enterprises to improve the quality of drugs, speed up the implementation of consistency evaluation work, guide the upgrading of product structure.
in particular, it is worth mentioning that, in the case of a high degree of concentration of procurement volume distribution, generic drug production enterprises once the bidding failure, bidding cycle must face a great risk of enterprise survival.
the particularity of collection results in such patterns being applied only to competing generics.
thus, the implementation of collection can promote a certain strength of generic pharmaceutical enterprises to avoid corporate risks and transformation from relying on generic drug sales enterprises to rely on innovative drug sales enterprises. The second
is to improve the ecology of the pharmaceutical industry.
pilot expansion adhere to the price of the linked, ensure the use, timely return, will promote the nationwide improvement of drug purchase and sale model, reduce corporate public relations, sales and pressure and other transaction costs, guide doctors and patients rational drug use, purify the pharmaceutical circulation environment, improve the pharmaceutical industry ecology, not only conducive to the standardization of hospital drug procurement and use behavior, but also conducive to fair competition among pharmaceutical enterprises in the industry.
The third is to promote the development of the industry on a large scale.
the pilot expansion, all countries will cover all regions of the country, the quality of enterprises, production capacity supply and cost control requirements are higher, enterprises face greater competitive pressure, will be conducive to promoting industry optimization and restructuring, and gradually change the industry is small, low quality situation, promote industry scale, intensive and modernization.
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