435 types of drugs - In the past 7 years, the national "group buying drugs" have enabled ordinary people to not only have high-quality and affordable commonly used and life-saving drugs in their medicine boxes, but also to have tangible livelihood guarantees. The 11th batch of national organized drug procurement rules has recently been released to the public, with many noteworthy details: no longer simply selecting the lowest quotation, adding "resurrection" opportunities, and adding three qualification requirements for bidding enterprises... This adjustment aims to build a precise "supply and demand bridge" for pharmaceutical companies, hospitals, and patients, promoting a two-way balance between drug security and industry development. Stable clinical practice ensures a better match between supply and demand, with over 46000 medical institutions participating in the new batch of national drug procurement applications, of which nearly 80% are specific to the required brands. This means that the matching degree between drug supply and clinical demand will be further improved, and the continuity of clinical medication will be more stable, "said Jiang Changsong, assistant dean of the National Medical Insurance Research Institute at Capital Medical University. Generally, 80% of the quantity reported by medical institutions is considered as the agreed procurement quantity. This time, some special varieties will have their agreed purchase quantities appropriately reduced, such as glucocorticoids, antibiotics, restricted indication drugs, key monitored drugs, etc. The proportion of drugs with limited quantities will be reduced to 60% to 70%. It is worth noting that this year, there is a new opportunity for non shortlisted companies to "revive". If a medical institution has a high demand for a certain drug and the company's quotation is not shortlisted, and the company can accept the selected price of the shortlisted company, there is a chance to be selected. After the adjustment of the new rules, the prices of small-sized oral solutions, dry suspensions and other suitable dosage forms for children will be relaxed, encouraging the supply of small-sized medication for children, making it more convenient and safe for them to take medicine. Ensuring quality and adhering to the bottom line of centralized drug procurement. This adjustment has raised the quality "threshold" for bidding enterprises. According to the rules, bidding enterprises or their commissioned production enterprises must have at least 2 years of experience in the production of similar dosage forms; The production line of the bidding drug has passed the Good Manufacturing Practice (GMP) compliance inspection and has not violated GMP within 2 years. The 'upgrading' of bidding qualifications is to more fully reflect the quality control capabilities of enterprises and better take responsibility for patients. ”Zheng Yi, Director of the National Organization Drug Joint Procurement Office, said. When the quotations from enterprises are the same, medical institutions with higher quantities or without significant changes in production processes, raw materials, important excipients, etc. will be given priority in selection. Industry insiders believe that the practice of "anti encirclement labeling" not only affects the price of one or two selected drugs, but also erodes the centralized procurement system and people's livelihood interests. The rules are clear, and for enterprises that have close connections in equity, management, registration approval transfer, commissioned production, etc., they are considered as one company when bidding; For companies engaged in bid rigging and collusion, in addition to being included in the 'violation list', they will also be dealt with according to the strictest regulations based on pharmaceutical prices and procurement credit evaluation systems. This rule innovation introduces the "leniency for first-time offenders" mechanism, which allows for lenient treatment in accordance with the law and regulations for the first enterprise to provide clues and valid evidence of bid rigging, as well as the first enterprise to voluntarily admit to participating in the bid rigging investigation process. This will further break down the interest alliance between the bidding companies. The anti internal competition banner clearly opposes excessive competition. In order to avoid individual companies' ultra-low prices interfering with normal competition, multiple new contents have been added to the rules: when the lowest price is lower than 50% of the shortlisted average price, 50% of the shortlisted average price will be used as the "anchor point" for price difference control; For oral solid preparations less than or equal to 0.1 yuan, small volume injections less than or equal to 1 yuan, etc., a "pocket price" shall be set; Each bidding enterprise shall make a commitment to provide a quotation not lower than the cost, and the enterprise with a quotation that is too low shall explain the reasonableness of the quotation. Zheng Yi introduced that the overall selection rate for this centralized procurement has remained stable at around 60%, and with the addition of revival rules, the actual selection rate will further increase. This adjustment fully solicited opinions and suggestions from all parties, with the ultimate goal of enabling patients to use high-quality and affordable drugs. ”Professor Lu Yun from the International School of Pharmaceutical Business at China Pharmaceutical University, who has participated in multiple seminars, said. The increasing openness and transparency have become a new trend in centralized procurement. The continuously improved centralized procurement rules in practice will be designed with more scientific and reasonable considerations, allowing drug prices to return to value and patients to use medication with peace of mind. ·About 100 rare disease medications will be covered by medical insurance. The 2025 China Rare Disease Conference will be held in Beijing from September 20th to 21st. The data presented at the conference is warm and inspiring: currently, there are 419 hospitals in the national rare disease diagnosis and treatment cooperation network, 626 hospitals in the rare disease direct reporting system have participated in registration, the rare disease catalog has been expanded to 207 diseases, and about 100 rare disease drugs have been included in the national medical insurance drug catalog. The latest data shows that drugs for rare diseases in the national medical insurance drug catalog cover 42 types of rare diseases. In 2024, the medical insurance fund will pay 8.6 billion yuan for rare disease drugs during the agreement period, accounting for approximately 7.7% of the total drug payments during the agreement period. The medical insurance fund adheres to the principle of 'doing our best and acting within our capabilities', but the protection of rare disease medication cannot rely solely on basic medical insurance. ”Huang Xinyu, Director of the Medical Service Management Department of the National Medical Insurance Administration, said that China is building a triple guarantee system of basic medical insurance, major illness insurance, and medical assistance, and actively exploring multiple guarantee paths such as commercial health insurance and social charity. (New Society)