国家医保局：本次集采不再简单选用最低报价，要求企业不低于成本报价

Core Viewpoint - The National Healthcare Security Administration (NHSA) has released the 11th batch of centralized drug procurement documents, emphasizing principles of stabilizing clinical needs, ensuring quality, preventing collusion, and countering excessive competition. Group 1: Stabilizing Clinical Needs - The primary goal of the procurement is to ensure clinical medication needs, with a focus on optimizing procurement measures. Medical institutions can report quantities based on either generic names or specific brands, with 77% of reported quantities specified by brand [4]. - The procurement volume agreed upon by medical institutions is set at 60% to 80% of reported quantities, allowing for flexibility in brand selection for the remaining portion [4]. - A new selection rule encourages companies with high demand but non-winning bids to match the winning bid price for a chance to be selected, enhancing clinical supply [4]. - Special attention is given to the supply of pediatric medications, with adjusted pricing rules for small specifications to encourage supply [4]. Group 2: Ensuring Quality - The procurement process has incorporated feedback from regulatory bodies, raising quality control standards for bidding companies [2]. - Companies must have at least two years of production experience for similar dosage forms, and their production lines must pass GMP compliance checks [4]. - The quality assessment now extends to the production line's compliance history, prioritizing companies with stable quality and clinical recognition [4]. Group 3: Preventing Collusion - Measures to prevent collusion have been enhanced, including treating closely related companies as a single entity during bidding [4]. - A "first to report leniency" mechanism has been introduced to encourage reporting of collusion, with leniency for those who provide evidence [4]. - Stricter penalties will be applied to companies found colluding, including being placed on a "violation list" and facing severe consequences under pricing and procurement credit evaluation systems [4]. Group 4: Countering Excessive Competition - The procurement process will implement a "weak elimination" rule to prevent extreme price hikes, with the highest valid bid price serving as a safeguard against excessive pricing [5]. - Companies are required to submit bids that are not below their production costs, with explanations needed for any bids below the established price anchor [5]. - The procurement will strengthen the execution of selected results, holding selected companies accountable for timely order fulfillment and requiring medical institutions to prioritize selected products [5].