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33 batches of shortlisted drugs launched for centralized procurement

来源: 证券时报 2019-12-30 10: 44: 44Source: Securities Times

On December 29, the National Organization for Centralized Drug Purchasing and Use (hereinafter referred to as the "Joint Procurement Office") issued a national bid for centralized drug purchase, and the second batch of national drug purchase and use was officially launched!

33 varieties shortlisted

The announcement shows that in order to implement the decision-making and deployment of the CPC Central Committee and the State Council on expanding the scope of centralized procurement and use of pharmaceutical products of national organizations, in accordance with the "Notice of the General Office of the State Council on Printing and Distributing Pilot Programs for Central Organization of Pharmaceutical Procurement and Use" (State Office issued [2019 ] No. 2) and the "Secretary's Opinions on Implementation of National Organizations' Centralized Drug Procurement and Use Pilot Expansion of Regional Expansion of the National Medical Security Bureau" (Medical Insurance [2019] No. 56) related to the spirit of comprehensively deepening the reform of centralized drug procurement and use, Establish a standardized and normalized centralized drug procurement model to further reduce the burden of drug use by the masses. The second batch of state-organized centralized drug procurement and use is now underway.

Each province (autonomous region, municipality directly under the Central Government) and Xinjiang Production and Construction Corps appointed representatives to form a national organization for the centralized procurement and use of pharmaceutical procurement offices, and to carry out some centralized drug procurement on behalf of public medical institutions, military and social medical institutions in various regions. The Municipal Pharmaceutical Centralized Bidding and Purchasing Management Office undertakes the daily work and implements it concretely. According to the expert's argument, the second batch of national drug collection collections selected 33 varieties, covering the therapeutic fields of diabetes, hypertension, anti-tumor and rare diseases, involving more than 100 pharmaceutical manufacturers. According to the data submitted by the various alliance regions, the base of the purchase amount is 12.4 billion pieces (bags / piece), and the agreed purchase amount of each variety is 50% to 80% of the purchase amount base, which is determined according to the number of selected companies. According to the centralized procurement work arrangement, the bid will be opened on January 17, 2020, and the results will be selected. Patients across the country will use the second batch of centralized drugs to purchase selected drugs in April next year.

According to the procurement catalog, common drugs such as abiraterone, amoxicillin, azithromycin, acetaminophen, cefradidin, isoniazid, and indapamide were shortlisted. According to the previous centralized procurement situation, the short-listed drugs are expected to reduce prices significantly. It is reported that the second batch of national organizations for drug collection and procurement adhere to the "4 + 7" pilot and expansion of basic principles, main policies and organizational operating models, and further improve relevant rules to promote the normalization of the centralized drug procurement system, no longer Select pilot projects in some cities and implement them all at once across the country. At the same time, adhere to the "national organization, alliance procurement, platform operation" working mechanism, adhere to the professionalism and stability of platform operations, the Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office is responsible for the specific implementation.

Changes in recruitment rules

Compared with the first batch, the new batch of procurement rules has changed.

For declaration of enterprise qualifications, domestic drug manufacturers that provide drugs and accompanying services, holders of drug marketing authorization, and domestic distributors of imported drugs are deemed to be manufacturing companies. The declared products belong to the scope of procurement of the product catalogue and are listed in the domestic market, and meet the requirements of one of the following requirements: 1. The original research drug and the reference drug for the consistency evaluation of generic drugs issued by the State Drug Administration. 2. The generic drugs that have passed the consistency evaluation of the quality and efficacy of generic drugs by the State Drug Administration. 3. According to the Announcement of the State Food and Drug Administration on the Issuance of the Work Plan for the Reform of Registration of Chemical Drugs [No. 51 of 2016], generic drugs approved according to the new registration of chemical drugs. 4. Drugs included in the "China List of Listed Drugs". In addition, the reporting enterprise is also required to ensure that the agreed purchase volume of selected drugs in the supply region is met during the procurement cycle. The varieties supplied should include all specifications of the "reported variety qualifications" produced by the enterprise in the catalog of purchased varieties and shall comply with the Patent Law. And relevant laws and regulations, and bear relevant legal responsibilities. Not all eligible applicants can be shortlisted: when there are 3 to 5 companies, the maximum number of shortlisted companies is “n ~ 1”; when there are 5 to 6 companies, the maximum number of shortlisted companies is 4; When there are 7 to 8 companies, a maximum of 5 companies will be shortlisted; when there are 9 or more companies applying for the company, a maximum of 6 companies will be shortlisted.

There are also detailed regulations on the procurement cycle: the actual selected enterprises in the country are one variety, and the round of procurement is in principle one year; the actual selected enterprises in the country are two or three varieties, and the round of procurement is in principle two years. ; The actual selection of enterprises in the country is 4 or more varieties, and the procurement cycle of this round is in principle 3 years. The purchase agreement is signed annually during the purchase cycle. When renewing the purchase agreement, the agreed purchase amount shall in principle not be less than the agreed purchase amount of the selected drug in the previous year.

If the agreed procurement volume for the year is completed in advance during the procurement cycle, more than the selected enterprises will still supply at the selected price until the procurement cycle expires. During the procurement cycle, medical institutions will prioritize the use of drugs selected in this centralized drug procurement and ensure that the agreed procurement volume is completed. On the basis of prioritizing the use of the drugs selected in this centralized drug procurement, medical institutions can purchase other drugs of the same variety and price at an appropriate amount in accordance with the relevant provisions of the local centralized drug procurement management.

According to this batch of procurement rules, the first year's agreed purchase amount for each variety and each locality is determined according to the following rules: if there is one selected company in the country, it will be 50% of the calculated base of the agreed purchase amount in the first year; there will be two companies selected 60% of the calculated base of the first year's contracted procurement; 3 selected companies in the country for the first year; 70% of the calculated base of the first year's contracted purchases; 4 or more selected companies in the country for the first year's contracted calculation 80% of the base. This means that up to 4 selected companies can share 80% of the national hospital market. For other unsuccessful bidders, the market space will shrink sharply and even withdraw from the market.

The winning company will not be too easy, and the market share will increase, but the price will drop significantly, testing the production cost. The volume purchase data completed in September this year showed that a total of 77 companies participated, generating 45 companies to be selected and 60 products to be selected. Compared with the 2018 minimum purchase price in the Alliance region, the average purchase price of this purchase decreased by 59%; compared with the "4 + 7" pilot selection price, the average price decreased by 25%.

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