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为何“集采非新药 新药不集采”?三“问”第十一批国家组织药品集采
Yang Shi Wang· 2025-08-08 03:38
Core Viewpoint - The eleventh batch of national organized drug procurement introduces significant changes aimed at protecting innovation in the pharmaceutical industry while enhancing drug accessibility for patients [1]. Group 1: Changes in Drug Procurement Rules - The emphasis on "procurement not for new drugs, new drugs not for procurement" aims to protect the innovation incentives within the industry, ensuring that innovative drugs have a reasonable return during their initial market period [3]. - The procurement process has excluded drugs with narrow therapeutic windows and those with high risks of substitution or adverse reactions, focusing instead on drugs with procurement amounts exceeding 100 million yuan in 2024 [5]. Group 2: Pricing Mechanism Adjustments - The new procurement does not rely on the lowest price as a reference, which helps avoid the elimination of normal-priced companies due to abnormally low bids, leading to an expected increase in average key price levels [7]. - A mechanism has been introduced to allow non-selected companies to regain eligibility by voluntarily lowering their prices, promoting rational competition among manufacturers [7]. - All bidding companies are required to commit to not quoting below cost, with small enterprises needing to justify their lowest bids to prevent malicious price competition [7]. Group 3: Enhancing Patient Accessibility - The eleventh batch of procurement respects clinical needs by allowing procurement based on brand volume, thereby improving drug accessibility for patients [9]. - The inclusion of pharmacies in the procurement process broadens the sales channels for procured drugs, making them more accessible to the public [9]. - A special independent grouping for pediatric drugs has been established to enhance the accessibility of medications for children [9].