Deputy Director and Spokesperson of the Information Bureau of The State Council Information Office

Xing Huina

Good afternoon, ladies and gentlemen. Welcome to the regular policy briefing of The State Council. Recently, The General Office of the State Council issued the "Key Tasks for Deepening the Reform of the Medical and Health System in 2024". To help you better understand the relevant situation, we have invited Mr. Li Bin, Deputy Director of the National Health Commission, Mr. Huang Huabo, Deputy Director of the National Medical Insurance Administration, Mr. Shen Hongbing, Deputy Director of the National CDC, Mr. Huang Guo, Deputy Director of the National Food and Drug Administration, to the briefing today. They are invited to brief you on the relevant information and answer your questions.

Thank you for your question. First of all, I want to explain a problem, the price reduction space of selected products with centralized volume procurement mainly comes from the saving of marketing costs of enterprises. The logic is as follows: by collecting the demand of medical institutions across the country to form a procurement target, guiding enterprises to compete fairly and produce reasonable prices. Once selected, the products can be directly sold to hospitals according to the procurement contract. The hospital promises to complete the agreed purchase on time in accordance with the promised purchase volume, and gives priority to the purchase and use of selected products, which greatly reduces the marketing costs of drug manufacturers. At the same time, there is another measure that requires medical institutions to settle the enterprise loan in time, and to support it through the advance policy of the medical insurance fund, which effectively solves the problem that the original payment cycle is particularly long and saves a lot of capital costs for enterprises. The cost savings in these circulation links are the main room for price reduction. Let profits go to the people through price competition.

At the same time, in order to ensure that the price of selected products does not reduce the quality, mainly adopted three aspects of measures. First, set the quality entry threshold. The state has stipulated the qualification of enterprises and products in the organization of drug collection, and adopted the consistency evaluation of quality and efficacy as the threshold for generic drugs to participate in the collection, so as to avoid the phenomenon of bad money driving out good money in competition. Second, establish a collaborative mechanism for quality supervision. The information of the selected enterprises in the national and local gathering will be shared with the drug regulatory departments, and the drug regulatory departments will include the selected products in the focus of supervision. For the quality-related problems of the selected products organized by the state, the Medical Insurance Bureau and the Food and Drug Administration jointly carried out the disposal, took disciplinary measures such as cancellations of the selected qualifications and inclusion in the "violation list", and continued to release the signal of "zero tolerance" for quality problems. Third, conduct real-world studies of clinical efficacy and safety. Commissioned more than 30 large Grade III hospitals across the country to carry out real-world studies on the clinical efficacy and safety of selected generics in two phases of collective collection, currently covering 37 kinds of widely used drugs in the first 3 batches. The results showed that the selected generic drug and the original drug were equivalent in clinical efficacy and safety, indicating that the quality of domestic generic drugs had been tested on the whole. Now the third phase of clinical efficacy and real-world studies is under way, covering more than 20 varieties from the fourth and fifth batches, and we will continue to publish the results. thank you.

China Youth Daily

With the gradual deepening of the aging of the population, all walks of life are more and more concerned about the "one old and one small" related work, this year's medical reform work on the elderly health services and infant care work how to make specific arrangements? thank you.

Deputy Director of the National Health Commission

Li Bin

Thank you for your question. Let me introduce you. The "one old and one small" problem is related to the happiness of thousands of households, and is one of the most realistic, urgent and prominent important livelihood issues at present. Promoting the reform of "one old and one young" is of great significance for actively responding to the aging population and promoting the long-term balanced development of the population.

In terms of elderly health services, the main work arrangements this year are, first of all, to improve the level of elderly health services and management, implement the elderly health literacy promotion project, carry out the National Elderly health Publicity Week, widely popularize the elderly health knowledge, and improve the elderly's awareness and ability to take the initiative in health. We will carry out campaigns to promote the health of the elderly, as well as special campaigns to improve their oral health, nutrition, psychological care and dementia prevention and treatment, so as to solve the special health problems of the elderly. The second is to strengthen the construction of the service system. Strengthen the standardized construction of geriatric medicine in general hospitals, accelerate the construction of geriatric friendly medical institutions, promote the construction of geriatric hospitals, rehabilitation hospitals and nursing homes, and promote the evaluation of comprehensive geriatric health technologies in medical institutions. China has established and improved a comprehensive and continuous health service system for the elderly covering both urban and rural areas, including health education, preventive health care, disease diagnosis and treatment, rehabilitation nursing, long-term care and hospice care, and strives to provide high-quality health services for the elderly. At the same time, it will also actively improve the health service guarantee for the elderly, and implement training programs for geriatric medicine talents, the ability of hospice care talents to improve, and the ability of combining medical and nursing services to improve the health service capacity for the elderly. To increase the protection of elderly health services in the promotion of prices and medical insurance policies. We will carry out health services for disabled elderly people and increase the supply of health services for disabled elderly people.

In terms of infant and child care, this year's work is to actively carry out legislative research and cooperate with the legislature to speed up legislation on childcare services. We will steadily advance the "14th Five-Year Plan" project to expand the effective supply of childcare services. We will implement demonstration projects on the development of inclusive childcare services supported by the central government, guide 30 project cities to speed up construction as required, and focus on exploring and innovating in terms of convenience and accessibility, affordable prices, and guaranteed quality. Jointly with the All-China Federation of Trade Unions to carry out the national vocational skills competition for childcare service, and improve the professional quality and service level of childcare service personnel. Select and publish a number of national caring childcare employers, and actively support employers to build childcare service facilities to meet the needs of employees and the masses. Actively carry out the promotion month of childcare services to improve the public's recognition and trust in childcare services. thank you.

Reporter for China Daily

The prescribing power of public health doctors is a matter of concern to everyone. Some cities in China are exploring the prescribing power of public health doctors. Please give us some information about this.

Deputy Director of the National Health Commission

Li Bin

Comrade Shen Hongbing of the National Bureau for Disease Control and Prevention.

Deputy Director, National CDC

Shen Hongbing

Thank you for your attention to the drug supervision work. Your attention is the support and motivation for us to do a good job. As we all know, innovation is a key factor in promoting the high-quality development of the pharmaceutical industry and meeting the increasing drug demand of the masses. In recent years, by deepening the reform of the drug review and approval system, the State Food and Drug Administration has encouraged, guided and served drug innovation and research and development, constantly improved standards, optimized procedures, improved efficiency, and improved services, released the policy dividend of accelerating the listing of "new good drugs", and a large number of innovative drugs and innovative medical devices have been approved for listing. Here is a set of data, according to statistics, so far in 2022, a total of 82 approved innovative drugs, 138 innovative medical devices, only the first five months of this year has approved 20 innovative drugs, approved 21 innovative medical devices, which both of us are more concerned about like CAR-T, monoclonal antibodies and other new biotechnology products, but also innovative proprietary Chinese medicine, It also includes artificial heart products using full magnetic levitation technology and CT image-assisted detection software using artificial intelligence technology. Both in terms of quantity and quality, it is at the forefront of the world. It can be said that the development momentum of innovative drugs in China is strong and the future is promising.

The main measures we have taken are as follows: First, to improve the mechanism for encouraging innovation. For key products, in accordance with the principle of "advance intervention, one enterprise, one policy, full guidance, research and review linkage", under the premise of not reducing standards and procedures, improve and strengthen communication and exchange services, so that registration applicants can consolidate the research foundation as early as possible, and can "less detours". At the same time, we continue to work through four fast channels, such as "breakthrough treatment drugs", "conditional approval", "priority review and approval" and "special approval", to accelerate the review and approval of new drugs in urgent clinical need and the prevention and treatment of major diseases.

Secondly, in the service of clinical drug needs. We will include urgently needed medicines in short supply, medicines for children, medicines for rare diseases, medicines for major infectious diseases, vaccines urgently needed for disease prevention and control, and innovative vaccines in the scope of accelerated review and approval, and encourage clinically-oriented and patient-centered drug research and development. Here is another set of data, such as rare disease treatment drugs that we are more concerned about, 3 approved in 2022, 45 approved in 2023, and 24 approved in the first five months of 2024, it can be said that the number of rare disease treatment drugs on the market has increased significantly, so that many rare disease patients are no longer without drugs, and can effectively benefit.

Also, in terms of integrating with international review standards. Since we joined the International Technical Coordination Committee for the Registration of Medicinal Products for Human Use (ICH) in June 2017, we have adopted and implemented all 68 ICH guiding principles, which means that the technical requirements of China's drug review are fully in line with international standards. It also means that China's drug regulatory authorities, pharmaceutical companies, research and development institutions can be more involved in the whole process of international rules and standards from formulation to implementation, but also means that the global synchronous research and development of new drugs can be in accordance with the same rules, synchronous declaration in China, synchronous listing. At present, there are already innovative drugs using international multi-center clinical data to achieve "global initial listing" in China, which can allow Chinese patients to enjoy the latest global drug research and development results earlier and faster.

On the basis of the above work, in the next step, the State Food and Drug Administration will continue to promote the reform of the drug review and approval system, continue to optimize and improve the drug review and approval work, and strive to run the "acceleration" of supporting the listing of new and good drugs, serving to support the high-quality development of the pharmaceutical industry, and ensuring the safety and effectiveness of drugs for the people.

That's all. Thank you.

Southern Daily Southern + reporter

As mentioned in this year's key tasks, "promoting collective mining to improve quality and expand coverage", can you brief us on specific measures? Which areas of drugs and consumables will enter the collection this year? thank you.

Deputy Director of the National Health Commission

Li Bin

Comrade Huabo, please brief us on this.

Deputy Director, State Medical Insurance Bureau

Huang Huabo

Thank you for your question. In 2024, we will continue to vigorously promote the centralized procurement of medicine and emphasize overall coordination in the selection of collective-harvested varieties. We will focus on carrying out work at the national and local levels, so that the national and local levels complement each other and continue to expand the coverage of collection. At the national level, at least one batch of drugs and a batch of high-value medical consumables will be collected. The national organization of drug collection continues to focus on drugs with adequate competition through consistent evaluation of generic drug quality and efficacy. The national organization of high-value medical consumables collection, we will focus on clinical must, there are high prices, the masses reflect more strong varieties, at the local level mainly cover the national organization collection, the purchase amount of large, covering the population wide "large varieties". The National Medical Insurance Administration will focus on guiding local alliance procurement, including Hubei to lead the collection of proprietary Chinese medicines, Henan to lead the national organization to purchase alternative drugs, Sanming Alliance to lead the collection of drugs for cancer and respiratory diseases, Jiangxi and Anhui to lead the collection of in vitro diagnostic reagents. Fujian led the collection of vascular tissue closure with ligature clips, and Hebei led the collection of vascular interventional consumables. At the same time, the provinces are required to make up for the shortage, the collection of drugs and high-value medical supplies that have been carried out in many provinces, and the price is fully competitive. It is expected that by the end of this year, the collection of drugs at the national and provincial levels will reach a total of 500, and the goals and tasks of the "14th Five-Year Plan" will be completed in advance.

While vigorously promoting centralized procurement, in accordance with the deployment of the Government Work Report and the requirements of the key tasks of medical reform in 2024, it will take multiple measures together with relevant departments to further improve the collective mining system, consolidate and deepen the achievements of the collective mining reform, and better benefit the masses, and increase work efforts from three aspects:

First, improve the system and standardization of local alliance procurement. The provincial alliance procurement where conditions are met will be upgraded to the national alliance procurement, the leading provinces will clarify the rules in the key links such as quantity management, agreement volume implementation, and non-selected products hanging on the network, and the participating provinces will do a good job of systematic coordination. At the same time, we will further standardize the collective mining rules, treat all types of business entities fairly, and require that discriminatory rules should not be set in terms of enterprise income system, place of registration, size, domestic and foreign investment. By expanding the scope of alliance procurement, reducing the cost of repeated bidding by enterprises, and helping the formation of a unified national market.

Second, strengthen the fine management of the collection and mining implementation process. The national organization of collective procurement joint procurement office and the lead provinces of interprovincial alliance procurement will earnestly perform their duties to supervise and monitor the implementation of the selected results of collective mining. Local medical insurance departments in the region of medical institutions selected products into the hospital to investigate, smooth the channels of selected products into the hospital, to ensure that selected products priority use. At the same time, at the national and local levels, improve the feedback mechanism for the implementation of collection issues, for the supply and quality problems of selected products reflected by medical institutions, selected products reflected by selected enterprises into hospitals and medical institutions, etc., smooth feedback channels. All provinces should communicate with medical institutions and selected enterprises in a timely manner, and carefully check and deal with relevant departments.

Third, strengthen supervision and management, give play to the role of medical insurance fund flight inspection. The implementation of the selected results of the collection will be included in the content of the flight inspection of the national and provincial medical insurance departments, focusing on the inspection of the selected products have not been admitted to the hospital, the purchase amount of the agreement has not been completed, the high proportion of high-priced non-selected products, and the abnormal increase in the use of high-priced alternative varieties, so as to ensure the implementation of the selected results in place. thank you.

A bad news reporter

We have noted that the document proposes to further promote the experience of Sanming medical reform. What specific measures will be taken this year to promote this work? thank you.

Deputy Director of the National Health Commission

Li Bin

Thank you for your question. Let me introduce the relevant work. The experience of Sanming medical reform is explored, formed and developed in the long-term reform practice, and can withstand theoretical scrutiny and practical test. In late May this year, the National Health Commission held a press conference to introduce the relevant work to promote the experience of Sanming medical reform. Recently, we have carried out special research and deployment on further promoting the experience of Sanming medical reform. In 2024, we will focus on the following aspects of work: First, strengthen policy support. We will further summarize the good experience and good practices of Sanming and other typical areas, study and draft policy documents to further promote the experience of medical reform in Sanming, redeploy, re-strengthen and further improve the experience of medical reform in Sanming and other places nationwide, increase the promotion of typical experience, and expand the demonstration effect. Second, strengthen guidance. Organize training courses to promote the experience of Sanming medical reform, train comrades responsible for medical reform work at the provincial level and key cities, guide all localities to deeply understand the essence of Sanming medical reform, further increase innovation efforts, and deepen reform in key areas and key links. Organize work scheduling meetings and exchange meetings to learn and promote Sanming's experience, and schedule and guide the promotion of Sanming's medical reform experience around the country. We will strengthen reform exchanges among localities and promote mutual learning and common improvement. Third, dig deeper into the archetypes. Overall consideration of the eastern, central and western regions to dig deep into the typical practices of medical reform, sum up the experience of deepening medical reform in different regions of economic and social development, so that each place has a role model to learn, and further enrich and expand the connotation of Sanming medical reform experience. At the same time, increase efforts to publicize the practice and experience of typical areas, and create a strong atmosphere of learning Sanming and catching Sanming through these measures. In addition, we will organize relevant fields to guide Sanming City to further increase the exploration and innovation of medical reform, further deepen, further expand, and further improve the aspects of further deepening the reform to promote the coordinated development and governance of the "three medical", improve the system coordination ability, and give full play to the informatization enabling medical reform, so as to continue to travel the road for the national medical reform, as a demonstration, and as a model.

That's all I have to say. Thank you.

Red Star News

My question is also about the quality of the drugs selected in the collection. The quality of drugs is directly related to public health and life safety. What is the consideration of the State Food and Drug Administration in strengthening the quality and safety supervision of selected drugs? thank you.

Deputy Director of the National Health Commission

Li Bin

Please answer Comrade Huang Guo from the Food and Drug Administration.

Deputy Director, State Drug Administration

Yellow fruit

Since the collection work was carried out, the State Food and Drug Administration has always regarded the selected products as the top priority and continued to strengthen supervision. We believe that this is the bottom line of good drug quality and safety for medical reform.

We emphasize full regulatory coverage. For selected drugs and medical devices collected by the state, the implementation of production inspection and product sampling inspection of two 100% "full coverage". Production inspection is for enterprises, product sampling is for listed products, and the inspection covers more than 600 drug manufacturers and more than 200 medical device manufacturers and their products selected by the national collection. The drug regulatory authorities immediately took measures to suspend production, import and sales of the non-compliance of individual enterprises and the unqualified products found in random inspections, and seriously dealt with them and publicly exposed them. Members of the press can read some of the information we have released on the Internet.

We continue to carry out special operations. Since 2022, we have successively organized and carried out special drug safety rectification and drug safety consolidation and improvement actions nationwide, focusing on the collection of selected products, deploying drug regulatory departments at all levels to be problem-oriented, organizing enterprises to implement quality responsibility, investigating risks and hidden dangers, and focusing on resolving risks and hidden dangers in the bud.

We focus on strengthening smart regulation. On the one hand, strengthen the construction of the drug traceability system in the whole chain, urge the holder of the drug marketing authorization to give the drug traceability code to the selected drugs in accordance with the regulations, which is like the electronic ID card of the drug, and establish a sound information traceability system. This work is being studied together with the National Medical Insurance Bureau to further improve and further promote. On the other hand, in some key areas, IT will promote the transformation and upgrading of drug production. On the basis of the basic completion of the digital transformation of vaccine production in the early stage, recently, the State Food and Drug Administration issued the three-year Action Plan for the intelligent supervision of blood products Production, from now to the end of 2026, all blood products manufacturers will gradually establish an information management system covering the whole process of production and testing in accordance with the plan, and effectively improve the efficiency of blood products supervision. To provide a higher level of guarantee for the quality and safety of blood products.

We continue to strengthen departmental linkages. The State Food and Drug Administration and the State Medical Insurance Administration have established a daily communication and quality information feedback mechanism on collected varieties, and timely joint disposal of problems found, in a word, "zero tolerance" for quality problems. Secretary Wapo has already made a brief introduction and will not repeat it here.

With the advancement of the above regulatory measures, on the whole, the quality of selected products in China has remained stable and reliable.

In the next step, the drug regulatory department will continue to consolidate the main responsibility of quality and safety of enterprises with strong supervision, guide enterprises to improve the quality management system and comply with production and operation. At the same time, consolidate the regulatory responsibility, continue to strengthen supervision and inspection, quality sampling, adverse reaction monitoring and other work, cooperate with the medical insurance department to continue to optimize and improve the recruitment policy, so that enterprises with reliable quality and standardized management highlight their competitiveness in the recruitment, so that the people can use more and better assured drugs. thank you.

China News Service reporter

The pilot work of the disease control supervisor system in medical institutions has been carried out in many places. How is the progress of this work at present? What results have been achieved in the implementation process? thank you.

Deputy Director of the National Health Commission

Li Bin

Thank you for your attention to this issue. Comrade Shen Hongbing will brief us on this issue.

Deputy Director, National CDC

Shen Hongbing

Thank you for your question. Exploring the establishment of a system of disease control supervisors in medical institutions refers to the establishment of full-time and part-time disease control supervisors in public hospitals, grass-roots medical and health institutions and social hospitals to supervise the development of disease prevention and control work in medical institutions, and urge the implementation of the responsibility of reporting infectious disease outbreaks and public health emergencies, which is to move the threshold of disease control supervision work forward. This is a new system design, there is no mature experience to learn from. In 2023, the National CDC, together with the National Health Commission and the State Administration of Traditional Chinese Medicine, will first carry out pilot work in nine provinces, including Shanghai, Zhejiang, Anhui, Henan, Hubei, Guangdong, Sichuan, Shaanxi and Gansu. With the joint efforts of all parties, positive results have been achieved.

First, explore how to select disease control supervisors. Pilot areas should adapt to local conditions, fully mobilize the enthusiasm of all parties, enrich personnel selection channels, and explore ways to optimize the number and combination of personnel allocation. For example, Zhejiang Province explored the implementation of "one member, more than one point" for small and medium-sized medical institutions, the implementation of "one member, more than one point" for large general hospitals, and the deployment of different forms of disease control supervisors for medical communities.

The second is to explore the main responsibilities of disease control supervisors. The CDC, together with the NHC and the National Administration of Traditional Chinese Medicine, issued a list of Responsibilities for the Prevention and Control of Infectious Diseases in medical institutions, putting forward 33 specific tasks, clarifying the responsibilities of medical institutions in the prevention and control of infectious diseases and other public health services, and providing policy basis for how disease control supervisors perform their duties.

Third, explore and promote medical and prevention coordination and integration. In the pilot, disease control supervisors actively played a role in promoting medical institutions to implement early detection, early reporting and early disposal of infectious diseases. For example, Hubei Province gives full play to the role of disease control supervisors, "spotters", "communicators" and "instructors", and urges medical institutions to investigate abnormal signals of monitoring and early warning and carry out risk research and judgment through inspections. In Sichuan Province, disease control supervisors have penetrated medical institutions through on-site inspections and participation in hospital-level meetings, extending the tentacles of supervision to the "last meter."

On the whole, the first phase of the pilot work has achieved positive results. On the basis of the pilot work last year, we will further expand the scope of the pilot work this year, and carry out the pilot work in all provinces and Xinjiang Production and Construction Corps, so as to achieve a steady and steady progress from local to overall, and ensure tangible results. thank you.

Deputy Director and Spokesperson of the Information Bureau of The State Council Information Office

Xing Huina

One last question.

21st century