The State Council recently issued the "Several Opinions on Improving the Drug Price Formation Mechanism", emphasizing the need to improve the market-oriented drug price formation mechanism, support the high-quality development of the pharmaceutical industry, and ensure that the people have access to high-quality and affordable drugs. On April 15th, the State Council Information Office held a regular briefing on State Council policies to introduce relevant information. Shi Zihai, Deputy Director of the National Medical Insurance Administration, introduced a series of reform measures throughout the entire cycle, channels, and fields. Since June 2015, except for anesthetics and Class I psychotropic drugs, all other drugs have abolished government pricing and implemented market regulated pricing, with enterprises setting their own prices. The actual transaction prices are mainly formed by market competition. We adhere to the principle of combining an effective market with a proactive government, and propose a series of reform measures from the perspectives of the entire cycle, channels, and fields. The whole cycle is based on the different stages of drug launch, and the price policy is improved accordingly. Opinions on classifying and implementing policies for the full cycle drug prices, leaving sufficient space for high-level innovative drugs, and encouraging enterprises to continue to do a good job in research and development innovation; We have established rules for independent pricing of other drugs, guiding companies to set fair and reasonable prices. Omnichannel refers to encouraging relevant parties to participate in the formation of drug prices based on different channels of drug circulation. Opinions encourage all parties to participate in the formation of drug prices, making drug price information from different channels more open, transparent, and comparable, so that the public can compare prices from three different sources, see clearly, and buy with confidence. The whole field guides drug prices to maintain a reasonable level based on the different categories of drugs they belong to. The opinions have standardized the pricing, supply, and payment of drugs in key areas, making medication more accessible to the public and at a more reasonable price level. The opinions put forward a package of reform measures in guiding the reasonable formation of drug prices, regulating price order, and collaborative governance. ”Shi Zihai said that the proposal of new measures ultimately aims to promote stable market operation, maintain good price order, and ensure the safety of medication for the public. Precise measures to support the development of innovative drugs and encourage their development are important measures to improve the quality of clinical medication and enhance the health and well-being of the people. Li Jiangning, Director of the Drug Supervision and Administration Department of the National Medical Products Administration, introduced that in recent years, the national drug review institutions have continuously improved their review efficiency and ability to serve pharmaceutical innovation. The average review time for clinical trials of innovative drugs has been shortened by 71% compared to the 13th Five Year Plan period, and the average time for priority review and approval of innovative drugs has been shortened by 42%. According to Wang Xiaoning, Director of the Medical Pricing and Tendering Procurement Department of the National Medical Insurance Administration, as of February this year, the medical insurance fund has accumulated a total expenditure of 504.8 billion yuan on negotiated drugs during the agreement period, driving sales of 740 billion yuan and benefiting 1.17 billion people. The total profit of the pharmaceutical industry has grown at an average annual rate of 11.3%, and the R&D investment has grown at an average annual rate of 23%. After the innovative drug is approved for market, precise support measures will be proposed in various stages based on opinions. In the initial stage of drug launch, Innovation Opinion proposes to optimize the initial launch price mechanism. Currently, the National Healthcare Security Administration is studying and formulating a document on the initial launch price mechanism of drugs, exploring the implementation of enterprise self-evaluation of clinical value and innovation level, actively supporting high-level innovative drugs with high innovation level and clinical value. These drugs can be priced appropriately for high investment and high risk in the early stage of market launch, and this price will remain relatively stable for a certain period of time. When drugs enter the medical insurance stage, opinions emphasize the need to optimize the adjustment rules of the medical insurance catalog, take into account patient benefits and encourage innovation. The negotiated medical insurance payment standards should reasonably reflect the clinical value of drugs, and the sales price of negotiated drugs in non designated medical institutions may not be constrained by the medical insurance payment standards. During the stage of drug participation in centralized procurement, the opinions emphasize the need for centralized quantity based procurement of drugs with diverse supply and years of market experience. It is particularly clear that centralized procurement does not involve innovative drugs, that is, "innovation does not involve centralized procurement, and centralized procurement is not innovation". During the regular online stage, suggestions were put forward to promote the reasonable price gradient of reference preparations and generic drugs, reflecting support for innovative research and development. Further improving the mechanism for forming drug procurement prices and optimizing drug procurement is an important aspect of improving the mechanism for forming drug procurement prices. Shi Zihai stated that the National Healthcare Security Administration will work with relevant departments to adhere to the principles of "stabilizing clinical practice, ensuring quality, combating internal competition, and preventing bid rigging", and further improve the mechanism for forming drug procurement prices. One is to optimize the centralized procurement rules based on the characteristics of different types of drugs. According to the characteristics of different kinds of drugs, such as chemical drugs, biological drugs, traditional Chinese patent medicines and simple preparations, Chinese herbal pieces, etc., improve the procurement rules. Including optimizing the selection of different types of drug procurement varieties, bidding qualifications, and reporting methods, improving the matching degree between centralized quantity based procurement and clinical selection, and better adapting to the multi-level medication needs of the masses. Optimize the selection rules and use various methods such as bidding, inquiry, and comprehensive evaluation to guide enterprises to compete rationally. Optimize the execution and monitoring of selected results to promote orderly connection of supply, use, settlement, and other aspects. The second is to strengthen the implementation of the results of centralized procurement selection. Strengthen the collaborative linkage between medical care, medical insurance, and pharmaceuticals, enhance departmental synergy, and form a comprehensive effect. The main guidance for medical institutions is to prioritize the use of selected products according to regulations and reporting quantities. Outside the centralized procurement agreement, medical institutions can use other non selected products, including original drugs, to avoid a one size fits all approach in the clinical selection process. The third is to strengthen guidance for local centralized procurement work. Encourage each province to adopt the inter provincial centralized procurement model of "one province leading, national participation", coordinate the relatively unified procurement rules of inter provincial alliances, comprehensively improve the standardization level of centralized procurement, and reduce the burden of enterprise bidding affairs. We will also strengthen guidance for local governments to carry out procurement after the expiration of the agreement, promote stable clinical drug use, stabilize market expectations, and stabilize price levels. We have the ability to firmly guard the 'medicine box' of the people. ”He Yaqiong, Director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, introduced that currently there are about 160000 drug approval numbers in China, which can produce and provide all types of pharmaceutical products, basically meeting the daily medication needs of the masses. The innovation capability has significantly increased. The number of new drugs under development in China accounts for about 1/3 of the global total. By 2025, the total amount of overseas authorized transactions for innovative drugs in China will exceed 130 billion US dollars, setting a new historical high. The industrial foundation continues to consolidate. The advantages of integrating raw materials and formulations continue to expand, and breakthroughs have been made in the research and industrialization of classic Chinese medicine formulas. The precise service of "one person, one prescription" is gradually being realized. Leading companies in the industry are accelerating their rise, with China accounting for 6 of the top 50 pharmaceutical companies in the world. Supply guarantee has stronger resilience. The national medicine reserve system continued to improve, and the six small drug production guarantee consortiums that the Ministry of Industry and Information Technology focused on tracking were very awesome. The work was deepening day by day, effectively easing the supply shortage of more than 130 clinical essential drugs. Gong Xiangguang, Director of the Drug Policy and Essential Medicines System Department of the National Health Commission, stated that in recent years, the shortage of drugs in China has been greatly alleviated, and patients who urgently need medication in clinical practice have received basic guarantees. The centralized procurement of drugs continues to deepen, and the public is very concerned about the quality of drugs. Li Jiangning stated that the National Medical Products Administration adheres to the "two full coverage" of inspection of selected enterprises and sampling of selected varieties, and has "zero tolerance" for risk issues. The inspection and sampling work has covered 490 varieties and over 800 selected enterprises from all 11 batches of national centralized procurement. In recent years, the overall pass rate of drug sampling in China has remained above 99%. Yao Lei, Director of the Price Supervision and Inspection and Anti Unfair Competition Bureau of the State Administration for Market Regulation, stated that the market supervision department actively supports and cooperates with the National Medical Insurance Administration to improve the mechanism for drug price formation, draw regulatory red lines and bottom lines, severely crack down on price and monopoly violations in the drug field, punish illegal business entities in accordance with the law, protect the legitimate interests of honest and law-abiding business entities, effectively maintain market order in the drug field and the legitimate rights and interests of the public in drug use, and promote the sustainable and healthy development of the industry. (New Society)