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    Home > Medical News > Medical World News > Briefing of the State Council Information Office: Centralized procurement of proprietary Chinese medicines will be expanded this year, and the lowest price will not be pursued

    Briefing of the State Council Information Office: Centralized procurement of proprietary Chinese medicines will be expanded this year, and the lowest price will not be pursued

    • Last Update: 2022-03-07
    • Source: Internet
    • Author: User
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    On February 11, the State Council Information Office held a regular briefing on the progress of the reform of centralized procurement of medicines and high-value medical consumables.
    The relevant person in charge of the Supervision and Administration Bureau introduced the progress of deepening the reform of the centralized procurement of drugs and high-value medical consumables, and answered questions from reporters
    .
    Chen Jinfu, the focus of this year's centralized procurement, said that the next step will be to implement the decisions and arrangements of the State Council and the central government's decisions with relevant departments, unswervingly promote reforms, improve policies and measures, and carry out regular and institutionalized procurement of drugs and high-value medical consumables
    .
    General considerations: First, consolidate the new normal and promote the acceleration of centralized procurement and expansion
    .
    The centralized procurement of medicines is carried out in an all-round way in the three major sectors of chemical medicines, proprietary Chinese medicines and biological medicines.
    High-value medical consumables focus on orthopedic consumables, drug balloons, dental implants and other varieties, and strive to purchase through national organizations and provincial alliances by the end of 2022.
    , to achieve an average coverage of more than 350 drug varieties per province, and more than 5 varieties of high-value medical consumables, making it a new normal for centralized procurement, so as to achieve the purpose of stabilizing social expectations and stabilizing the industry ecology
    .
    The second is to create a new ecology
    .
    Through continuous improvement measures, especially incorporating relevant factors such as supply, quality, and credit into the centralized procurement rules, the ecological environment of pharmaceutical circulation will be purified from the system and mechanism, that is, the sales with gold will be radically eliminated, and the industry ecology will be purified, thereby encouraging enterprises to regulate competition, Promote the rectification of the circulation industry
    .
    The third is to build a new pattern
    .
    Improve the functions of the centralized pharmaceutical procurement platform, accelerate the standardization, standardization, and professional construction of the platform, improve the level of medical price governance, and promote the high-quality development of the pharmaceutical industry and medical institutions through multi-departmental policy coordination
    .
    At the same time, it will more effectively reduce the burden on the masses and help achieve common prosperity
    .
    At present, the seventh batch of national mining is on the way
    .
    Judging from the situation in the past three years, including local centralized procurement, the average number of centralized procurement varieties in each province has reached 50, and the number of high-value medical consumables has reached 3..
    Chen Jinfu revealed that this year, he will guide local governments to check and fill vacancies according to clinical needs, focusing on large varieties and common diseases, and strive to achieve more than 100 provincial-level centralized collection varieties in each province and 5 high-value medical consumables.
    variety
    .
    The original centralized procurement mainly focused on chemical drugs, and last year it expanded to insulin and artificial joints
    .
    This year, in accordance with the principle of "one product, one policy", we will carry out centralized procurement of high-value medical consumables with large quantities of consumables that have received much feedback from the masses and have large room for price adjustment
    .
    At the local level, further exploration in other areas
    .
    Chen Jinfu pointed out that the scope of proprietary Chinese medicines should be further expanded in an orderly manner this year, based on the fact that some provinces have organized alliance procurement last year
    .
    Regarding the varieties of orthopaedic consumables, drug balloons, dental implants and other consumables that were emphasized at the executive meeting of the State Council, Chen Jinfu said that last year, artificial hip and knee joints were recruited, and this year will be further extended to spinal consumables, basically realizing the main body of orthopedic consumables.
    cover
    .
    At present, spine consumables are undergoing thorough research
    .
    Recently, we will conduct a special study with the joint procurement of high-value medical consumables, extensively listen to the opinions of clinical experts and enterprises, and strive to formulate a set of preliminary plans in the first half of the year.
    If the conditions are mature, the bid opening can be carried out smoothly this year
    .
    Drug balloons are important consumables in the Department of Cardiology.
    Last year, the centralized collection of drug balloons was carried out in Jiangsu and other places.
    This year, it will be expanded to cover the whole country and block the space of false heights
    .
    Dental implants are an important treatment for missing teeth and have great social needs
    .
    Starting from local exploration last year, Sichuan organized an inter-provincial alliance to study the procedures for the centralized collection of dental implants.
    Now the plan is basically mature
    .
    It is planned to launch the alliance reform method of local centralized procurement in the first half of this year
    .
    Do not pursue the lowest price At present, there are more and more local alliances in centralized procurement.
    Chen Jinfu said that more and more varieties of provincial alliances are recruiting and purchasing.
    This is an inevitable trend and a mainstream trend. .
    Will these be included in the national centralized procurement in the future? There are two situations.
    If the inter-provincial local recruitment exploration is successful, it is possible that other provinces will follow up.
    If the purpose of selection is achieved, the price is reasonable, and the clinical needs are met, it is not necessary for the state to organize centralized procurement
    .
    If the inter-provincial alliance is explored, but the competition pattern is not sufficient, the varieties are not many, and the total volume is not very large, on the basis of the successful exploration mechanism, the state will organize centralized procurement, so that the effect of this reform system can quickly benefit the whole country.
    , serving the clinic
    .
    For example, the centralized procurement of insulin, which was explored in Wuhan the year before last, was quickly organized at the national level to conduct centralized procurement based on the successful experience of the exploration.
    This is a two-way system coordination
    .
    Regarding the centralized procurement price competition that the industry is concerned about, Chen Jinfu made it clear: "We do not pursue the lowest price, and we are firmly opposed to running bidding
    .
    We do not particularly anchor the international lowest price, because China is moving towards the path of common prosperity, and we Chinese can also eat it.
    With good medicine, medical insurance funds can also afford this kind of medicine at a reasonable price
    .
    Therefore, the design of this competition rule actually has a mechanism for reasonable price adjustment, how to make the market discover value and make it more reasonable for enterprises to compete fairly
    .
    ” The rule level is to set bidding rules for specific varieties and competition patterns
    .
    For example, the bidding rules, the volume ratio, and the agreement period
    .
    For varieties with sufficient competition, such as chemical drugs, the agreed purchase volume basically reaches more than 80%
    .
    At the same time, it is necessary to moderate competition according to the market supply situation
    .
    Chen Jinfu said that the earliest "4+7" pilot was to select only one company and win the bid at the lowest price, so the competition was very fierce, there was no substitute for the supply, and there was little room for clinical choices
    .
    In the second and third batches, gradually optimize, relax the competition pattern, balance the use and supply, and properly maintain the competition rate, so that the price can reach a reasonable return. .
    For special varieties, such as insulin in clinical substitution, in some cases, it is still in its infancy and is basically occupied by several suppliers.
    Therefore, in the bidding rules of insulin, the first concern is clinical substitution, and the second concern is is productivity
    .
    Therefore, in terms of bidding rules, it is necessary to enable all mainstream products and new products to enter in time, have a place for competition, and at the same time have a stable supply of production capacity
    .
    These aspects are reflected in the specific bidding rules
    .
    "For example, there is no consistency evaluation of Chinese patent medicine, so is there no quality assurance? Who will determine the quality assurance? We choose products according to the clinic and the hospital, just like we vote.
    The more people vote, the more recognition
    .
    These are all It is to study the rules among specific varieties that are more in line with clinical needs, promote enterprise competition, and promote the return of reasonable prices to ensure such a system effect
    .
    " Chen Jinfu said
    .
    Text Record<<< Deputy Director of the Information Bureau of the State Council Information Office, Press Spokesperson Shou Xiaoli: Ladies and gentlemen, good morning! Welcome to the regular briefing on policies of the State Council
    .
    Recently, the executive meeting of the State Council decided to carry out the normalized and institutionalized procurement of medicines and high-value medical consumables in batches to further reduce the medical burden on patients
    .
    Today, we are very pleased to invite Mr.
    Chen Jinfu, deputy director of the National Medical Security Administration, to introduce the progress of deepening the reform of centralized procurement of medicines and high-value medical consumables, and answer your questions of interest
    .
    Also present at the regular policy briefing today are: Mr.
    Zhou Jian, head of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, Mr.
    Wang Xuetao, head of the Drug Administration Department of the National Health Commission, and Mr.
    Li Maozhong, head of the Drug Administration Department of the State Drug Administration
    .
    Let us first invite Mr.
    Chen Jinfu to make an introduction
    .
    Chen Jinfu, Deputy Director of the National Medical Security Administration: Dear friends from the press, hello everyone! Thank you very much for your concern and support for the centralized procurement of medicines
    .
    The centralized procurement of medicines and high-value medical consumables is a major reform task deployed by the Party Central Committee and the State Council.
    General Secretary Xi Jinping has made important instructions on many occasions, emphasizing the need to persevere and coordinate the promotion of "three medical linkages", and promote the centralization of medicines and consumables organized by the state.
    Procurement reform with volume
    .
    At the beginning of 2021, the executive meeting of the State Council deployed the normalization and institutionalization of centralized and volume-based procurement of medicines.
    At the beginning of this year, the State Council held the executive meeting of the State Council again for special deployment.
    Below I will briefly introduce the relevant situation
    .
    Since 2018, the National Medical Insurance Administration, together with the relevant state departments, has promoted the reform of the procurement of medicines and high-value medical consumables by volume.
    After three years of hard work, the reform of centralized procurement with volume has entered a new stage of normalization and institutionalization.
    So far, six batches of drug purchases have been carried out, with a total of 234 kinds of drugs purchased, and the amount involved accounts for 30% of the total annual drug purchases of public medical institutions
    .
    At the same time, special procurement of insulin will be launched in 2021, expanding centralized procurement from chemicals to biological drugs for the first time
    .
    The centralized procurement of high-value medical consumables has focused on the two areas of greatest concern to the public: cardiology and orthopedics.
    The centralized procurement of cardiac stents has been running smoothly for a year, with a total of 1.
    69 million sets of stents selected, reaching 1.
    6 times the annual agreement procurement volume
    .
    Last year, a state-organized centralized procurement was carried out for more complex orthopedic consumables
    .
    From the current point of view, national organizations and alliance procurement have formed a normalized pattern, and centralized procurement bidding regulation, quality, supply, distribution, and use of guarantee mechanisms and supporting policies have also been improved and optimized
    .
    At the same time, while participating in the centralized procurement organized by the state, local governments also carried out different forms of provincial and inter-provincial alliance centralized procurement.
    From the perspective of procurement varieties, the three major drug sectors of chemical drugs, Chinese patent medicines and biological drugs are involved.
    The two varieties of coronary balloon and ophthalmic intraocular lens have also achieved full coverage in the province
    .
    Judging from the results achieved, the centralized procurement rules have been continuously optimized, the quality supervision has become more rigorous, the supply guarantee has become more stable, and the use policy has been improved
    .
    First, the price has returned to a reasonable level, and the masses have benefited significantly
    .
    The first six batches of centralized procurement of medicines dropped by an average of 53%, heart stents by an average of 93%, and artificial hip joints and knee joints by an average of 82%
    .
    Judging from the cumulative results of the three-year reform, the state organized centralized procurement to save more than 260 billion yuan
    .
    The overall drug price level shows a trend of stability and decline.
    According to the drug price monitoring data carried out by the Medical Insurance Bureau, the overall drug price level will continue to decline in 2019 and 2021, with an average annual rate of about 7%
    .
    Second, the quality of drugs and consumables for clinical use has been steadily improved, and the demand for clinical services has been fully released
    .
    From a statistical point of view, among the varieties of centralized procurement, the share of people using original research drugs and drugs that have passed the consistency evaluation of quality and efficacy has increased from 50% before centralized procurement to more than 90%
    .
    Taking heart stents as an example, 1/3 of the stents used to be stainless steel, but now they are basically eliminated, and the utilization rate of the selected chrome alloy has reached 95%
    .
    Then there is the imatinib in "I'm not the God of Medicine".
    After the centralized collection, its usage has increased to 35%, so that patients who need treatment have been fully guaranteed
    .
    The third is to promote the formation of a new pattern of industry development driven by fair competition, quality assurance and innovation
    .
    Through open, transparent, fair and just competition, centralized procurement has gradually improved the market-oriented price formation mechanism in the pharmaceutical field, guided enterprises to strengthen quality and cost control, actively carry out product research and development and consistency evaluation, and through innovation-driven and quality assurance, Make the pharmaceutical industry enter the track of high-quality development
    .
    The fourth is to promote the "three medical linkages", through intensive medical insurance fund purchases, including medical insurance prepayment, a series of measures to effectively promote the internal management of medical institutions and the high-quality development of public medical institutions
    .
    In the next step, we will work with relevant departments to implement the decisions and arrangements of the State Council and the decisions of the central government, unswervingly promote reforms, improve policies and measures, and carry out regular and institutionalized procurement of drugs and high-value medical consumables
    .
    General considerations: First, consolidate the new normal and promote the acceleration of centralized procurement and expansion of coverage
    .
    The centralized procurement of medicines is carried out in an all-round way in the three major sectors of chemical medicines, proprietary Chinese medicines and biological medicines.
    High-value medical consumables focus on orthopedic consumables, drug balloons, dental implants and other varieties, and strive to purchase through national organizations and provincial alliances by the end of 2022.
    , to achieve an average coverage of more than 350 drug varieties per province, and more than 5 varieties of high-value medical consumables, making it a new normal for centralized procurement, so as to achieve the purpose of stabilizing social expectations and stabilizing the industry ecology
    .
    The second is to create a new ecology
    .
    Through continuous improvement measures, especially incorporating relevant factors such as supply, quality, and credit into the centralized procurement rules, the ecological environment of pharmaceutical circulation will be purified from the system and mechanism, that is, the sales with gold will be radically eliminated, and the industry ecology will be purified, thereby encouraging enterprises to regulate competition, Promote the rectification of the circulation industry
    .
    The third is to build a new pattern
    .
    Improve the functions of the centralized pharmaceutical procurement platform, accelerate the standardization, standardization, and professional construction of the platform, improve the level of medical price governance, and promote the high-quality development of the pharmaceutical industry and medical institutions through multi-departmental policy coordination
    .
    At the same time, it will more effectively reduce the burden on the masses and help achieve common prosperity
    .
    I will introduce these first, thank you, and my colleagues and I are willing to answer the questions that reporters are concerned about
    .
    "The executive meeting of the State Council proposed to promote the normalization and institutionalization of centralized and volume-based procurement, and proposed the concept of speeding up and expanding the coverage.
    What are the specific plans and considerations for the speed-up and expansion of drugs and high-value medical consumables in the next step? Thank you
    .
    Chen Jinfu: Thank you, speeding up and expanding coverage is the proper meaning of normalization and institutionalization, which is mainly reflected in the following three aspects: First, the speed
    of variety.
    The variety truly reflects the clinical needs.
    In terms of the speed of variety, we are currently planning This is the seventh batch of centralized procurement of medicines
    .
    From the perspective of the situation in the past three years, including local centralized procurement, the average number of varieties of centralized procurement in each province has reached 50, and the number of high-value medical consumables has reached 3. .
    This year, we will guide the local governments to make progress based on the clinical needs, focusing on large varieties and common diseases, to check and fill in the gaps, and strive to achieve more than 100 provincial-level centralized collection varieties in each province, and high-value medical consumables can cover 5 varieties.

    .
    Second, the expansion of the coverage area of ​​centralized procurement
    .
    The original centralized procurement mainly focused on chemical drugs, and last year it expanded to insulin and artificial joints
    .
    This year, in accordance with the principle of "one product, one policy", we will carry out centralized procurement of high-value medical consumables for the varieties of consumables that are widely reflected by the masses and have large room for price adjustment.
    This year, we plan to conduct centralized procurement of orthopedic spinal consumables
    .
    In the local area, further exploration in other areas
    .
    Including proprietary Chinese medicines, on the basis that some provinces have organized alliance procurement last year, the scope will be further expanded in an orderly manner this year
    .
    In this way, the three major fields are fully covered, and there is no living space for lucky sales
    .
    Third, continue to increase efficiency and expand the benefits of the common people
    .
    In the past three years, the speed of progress in various regions is still relatively fast, but among the regional alliances and provincial alliances, there are already developed regions with a relatively high benefit rate for the masses, but the prices of others that have not participated in the alliances cannot be reduced, and the centralized procurement price reduction system The effect will not benefit the local people
    .
    Therefore, we want to gradually implement the follow-up and coordination of other provinces for the varieties that have already been collected, so that the coverage can be quickly expanded to other regions
    .
    These aspects are the major areas and key points of this year's work
    .
    Thank you
    .
    "In the long run, the number of drugs and consumables included in centralized procurement continues to increase, and the supply guarantee of centralized procurement products is particularly important.
    How should we ensure the stable supply of selected drugs and high-value medical consumables? Thank you
    .
    Ministry of Industry and Information Technology Consumer Goods Industry Zhou Jian, person in charge of the company: Thank you for your question.
    I will answer your question just now
    .
    The Ministry of Industry and Information Technology attaches great importance to deepening the reform of centralized procurement of medicines and high-value medical consumables. .
    In accordance with the decisions and arrangements of the Party Central Committee and the State Council, we will actively carry out the production and supply guarantee of the selected products, mainly in three aspects: First, carry out dynamic monitoring of the production of drugs that are centrally purchased by the state
    .
    We organize the bid-winning companies to submit the production, sales and inventory data of the centrally sourced drugs every month, dynamically grasp the production and supply situation, analyze and judge in a timely manner, and ensure that the bid-winning drugs can be supplied stably as agreed
    .
    The second is to coordinate and solve the practical difficulties faced by enterprises
    .
    We timely understand and help coordinate and solve some problems encountered by enterprises in the process of production and operation, strengthen the guarantee of production factors, and ensure the stable production of selected varieties
    .
    The third is to continuously improve the national centralized procurement of pharmaceutical production and supply guarantee capabilities
    .
    Promote the construction of large-scale and intelligent production lines of centralized procurement varieties by the state, and support the selected enterprises to technically transform existing production lines or build new production lines to achieve continuous production process, maintain product quality consistency, and improve production intelligence and production.
    quality level
    .
    In the next step, the Ministry of Industry and Information Technology will continue to do a good job in ensuring the production and supply of products selected for centralized procurement in accordance with the deployment of the State Council executive meeting
    .
    The first is to continue to carry out the dynamic monitoring of the national centralized procurement of drugs, to timely detect and coordinate the resolution of emerging problems that may affect the production and supply, and to ensure that the selected varieties can be supplied to the market stably
    .
    The second is to effectively urge enterprises to do a good job in the production and supply of the selected varieties, support enterprises to carry out technological transformation, and improve their production and supply guarantee capabilities
    .
    The third is to focus on tackling the shortcomings of the pharmaceutical industry, support a group of high-quality projects that solve key common technologies and have strong demonstration and driving effects, and guide enterprises to achieve new breakthroughs in the blank areas of production technology, high-end excipients, and pharmaceutical equipment
    .
    That's all I have to answer, thank you
    .
    " Excuse me, what are the specific arrangements for this year's orthopaedic consumables, drug balloons, dental implants and other consumables that were highlighted in the State Council executive meeting? Thank you
    .
    Chen Jinfu: Thank you for your question. .
    This year mainly includes several categories, orthopedic consumables.
    Last year, we recruited artificial hip joints and knee joints.
    At the same time, last year, the Henan Alliance has carried out recruitment and procurement in the trauma category.
    This year, it has further extended to spinal consumables.
    Such consumables The largest plate in orthopedics, this consumable basically covers the main body
    .
    Spine consumables are currently undergoing thorough research, information standardization, including research on its rules
    .
    Because the clinical needs of orthopedics are very large, but the standards are different, especially the composition of the products is very complex, so how to form a procurement product group according to the needs of clinical medical care, which involves a high technical link, and is now researching plans, recently We will conduct a special study with the joint procurement of high-value medical consumables, and extensively listen to the opinions of clinical experts and enterprises, and strive to have a set of preliminary plans in the first half of the year.
    If the conditions are mature, the bid opening can be carried out smoothly this year
    .
    The drug balloon is an important consumable in cardiology department
    .
    After the stents were recruited the previous year, there was a situation that the use of stents increased, reaching 1.
    6 times the agreed purchase volume
    .
    At the same time, the use of drug balloons has also risen substantially over a period of time
    .
    There are also clinical reports that the price of stents has come down, and doctors don’t need stents anymore.
    Of course, this statement is self-defeating, because patients need it.
    It turns out that stents are excessively abused.
    He has no cheap to take up, so he will not abuse them
    .
    At the same time, because the drug balloon is not included in the centralized procurement, there is room for price, so this piece also has an artificially high component
    .
    Last year, we launched the centralized procurement of drug balloons in Jiangsu and other places.
    This year, we will expand to the whole country to block the space of false heights
    .
    The third piece is dental implants.
    This piece is very controversial and criticized a lot
    .
    It now appears that dental implants are an important treatment for missing teeth, and the social demand is also great
    .
    Of course, there are also many services provided by medical institutions. .
    Therefore, we thought, starting from local exploration and deploying from the beginning of last year, Sichuan organized an inter-provincial alliance to study the procedures for the centralized procurement of dental implants.
    In half a year, we strive to be able to launch such an alliance reform of local centralized procurement
    .
    In fact, in the future, the more important thing for centralized procurement is the rules.
    The characteristics of different tenders are very complex, and they need to meet the requirements of product quality and clinical needs, and also effectively allow enterprises and patients to share the results of the reform
    .
    That's all I have to answer, thank you
    .
    "At present, there are more and more local alliances in centralized procurement.
    How should you evaluate the significance of such alliances? Will the varieties of local alliances be included in local centralized procurement in the future? Thank you
    .
    Chen Jinfu: This is a good question.
    In fact, the country Organization of centralized procurement is the centralized procurement of local alliances
    .
    We are talking about centralized procurement of drugs with volume, which involves several concepts
    .
    First, we still represent public medical institutions to conduct centralized bidding and procurement
    .
    Where is the centralized bidding and procurement of public medical institutions? What about the level? It used to be at the prefecture level, but later at the county level.
    In order to reduce the circulation links, blooming in various places, different rules, and especially some improper transfer of interests
    .
    Before the state organized centralized procurement, the original health and health commission department carried out drastic measures.
    Reform, optimize rules, and build a platform for centralized procurement.
    A provincial-level centralized procurement model has been formed.
    The bidding and procurement of public medical institutions in a province is centralized on the provincial-level platform.
    This has several advantages.
    Unified rules, centralized procurement volume, Reduce the burden of enterprises
    .
    Therefore, the provincial alliance should be said to be the main body of centralized procurement
    .
    On this basis, for some large varieties and some areas where it is difficult to explore the reform of centralized procurement with volume, the form of national organization of provincial alliances has been adopted.
    So this bidding is called "national organization, alliance procurement, platform operation"
    .
    Alliance recruitment is a main body, which is the provincial alliance. .
    The state, on behalf of the national provincial-level alliance, organizes the procurement of certain varieties, the Shanghai Pharmaceutical Office operates the medicines, and the Tianjin Pharmaceutical Purchasing Center operates the consumables.
    In fact, the main body of the alliance is still the province
    .
    It is impossible for the state to recruit all the varieties.
    We still have to serve clinical services, because the varieties purchased by public medical institutions are very complicated.
    If hospitals purchase all of them at this time, there will be many loopholes and disadvantages in the circulation
    .
    Therefore, it is still necessary to recruit a large number of provincial-level alliances, and some even require third-party recruitment, such as small consumables, including some procurement by hospitals, so this system model still needs to serve and benefit medical institutions.
    Operations and Clinical Services
    .
    Now our main pattern is the recruitment of national organizations and inter-provincial alliances.
    These two patterns remain unchanged
    .
    Just now you mentioned that more and more varieties of provincial alliances are recruited.
    This is an inevitable trend and a mainstream trend
    .
    Will these be included in the national centralized procurement in the future? There are two situations.
    One is the successful exploration of local recruitment among provinces.
    It is possible that other provinces will follow up.
    If the purpose of selecting the best is achieved, the price is reasonable, and the clinical needs are met, it is not necessary for the national organization to gather.
    If the inter-provincial alliance is explored, but the competition pattern is not sufficient, there are not many varieties, and the total amount is not very large.
    On the basis of the success of the exploration mechanism, we will promote the national organization of centralized procurement to make the effect of this reform system.
    Quickly benefit from the country and serve the clinic
    .
    At this time, there is a linkage between upper and lower
    .
    For example, the centralized procurement of insulin, we conducted an exploration in Wuhan last year, and based on the successful experience of the exploration, we quickly organized the centralized procurement at the national level.
    This is a two-way system coordination
    .
    Thanks for your question
    .
    "The quality and safety of selected drugs and high-value medical consumables in centralized procurement is the focus of public attention and a hot topic of discussion.
    What measures have relevant departments taken to strengthen the quality supervision of selected products in centralized procurement to ensure that prices are not reduced in quality? Thank you
    .
    Li Maozhong, head of the Drug Administration Department of the State Drug Administration: The State Food and Drug Administration has always regarded the quality supervision of the products selected for centralized procurement as the top priority of drug supervision, and has taken multiple measures to strengthen quality supervision and fully implement the State Council's centralized procurement work.
    The normalized and institutionalized work deployment will serve the reform of "three medical linkages"
    .
    In terms of the consistency evaluation of generic drugs: First, a green channel has been established for the registration application for consistency evaluation, which will be reviewed upon arrival and strictly inspected on site
    .
    By the end of 2021, a total of 693 varieties have passed the consistency evaluation
    .
    The second is to strictly control the technical standards for quality consistency evaluation of generic drugs
    .
    In line with international requirements, technical review standards and a series of guidelines for bioequivalence and pharmaceutical quality control have been issued
    .
    The third is to formulate the "Selection and Determination Procedures for Reference Preparations of Chemical Generic Drugs", and organize an expert committee to strictly select and release reference preparations
    .
    By the end of 2021, a total of 49 batches of reference preparation catalogs with a total of 4,677 product specifications have been released, basically covering most of the commonly used clinical varieties
    .
    In terms of strengthening the quality supervision of selected drugs in centralized procurement: firstly, a work plan was issued, and a full-coverage supervision and inspection of selected enterprises in centralized procurement was deployed, and a full-coverage sampling inspection of selected products was carried out, and the selected enterprises were supervised in strict accordance with the approved drug standards and production process organization.
    Production, strictly abide by the quality management standards for drug production, and urge the implementation of the main responsibility of the enterprise and the responsibility of territorial supervision
    .
    The second is to establish a drug variety file information system, share basic information such as drug production process and quality standards with the provincial drug supervision and management departments, and further improve the pertinence of supervision and inspection
    .
    The third is to steadily promote the traceability management of selected drugs from centralized procurement, and gradually realize the traceability of the whole process after the drugs selected from centralized procurement are listed
    .
    Fourth, the management measures for post-marketing changes of drugs and related technical guidelines were issued to standardize the management of post-marketing changes
    .
    Fifth, strictly implement the "four strictest" requirements, and urge enterprises to rectify the defects found in the supervision and inspection;
    。,,
    。     :、2021,
    。,,
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    。     ,,,,
    。,
    。      “     ,,?
    。     :     ,
    。,,,,,,、、“”,、、“”

    。     ,,,,,,,
    。,,、、
    。,,,,,
    .
    These can not be deviated from now or in the future, especially the procurement with quantity is the core of the system
    .
    If they "follow the price but not the volume", the company cannot compete with the price, and it is impossible to implement effective cost accounting.
    It has to go to the hospital, which increases operating costs and leaves room for profit-seeking
    .
    Second, at the rule level, it is to serve the system level, and set bidding rules for specific varieties and competition patterns
    .
    For example, the bidding rules, the volume ratio, and the agreement period
    .
    In the middle of the amount, who will report the amount and who will choose the amount, these must be carefully designed for the variety
    .
    For varieties with sufficient competition, such as chemical drugs, basically the agreed purchase volume reaches more than 80%
    .
    At the same time, it is necessary to moderate competition according to the market supply situation
    .
    As we all know, in the earliest "4+7" pilot program, only one company was selected and the bid was won at the lowest price, so the competition was very fierce, there was no substitute for the supply, and there was little room for clinical choices
    .
    In the second and third batches, it is gradually optimized, the competition pattern is relaxed, the use and supply are balanced, and the competition rate is properly maintained, so that the price can be returned to a reasonable level
    .
    We do not pursue the lowest price, and we are firmly opposed to running bidding, so that the balance of multiple dynamic goals cannot be achieved
    .
    We are not particularly anchoring the international lowest price, because China is moving towards the path of common prosperity, we Chinese can also take good medicine, and medical insurance funds can also afford this kind of reasonably priced medicine
    .
    Therefore, the design of this competition rule actually has a mechanism for reasonable price adjustment, how to make the market discover value and make fair bidding more reasonable for enterprises
    .
    Of course, for special varieties, such as the clinical substitution of insulin, in some cases it is still in its infancy and not very mature, especially the follow-up maintenance.
    There is still a lot of controversy in the clinical aspect, and the reality is unbalanced.
    It is basically occupied by several suppliers, so in the bidding rules of insulin, in fact, our first concern is clinical substitution, and our second concern is production capacity
    .
    We jointly purchase each company to see its workshop.
    If you gain a certain market share, the production capacity cannot keep up with the follow-up supply, which will affect the clinical practice
    .
    Therefore, in terms of bidding rules, it is necessary to enable all mainstream products and new products to enter in time, have a place for competition, and at the same time have a stable supply of production capacity
    .
    Therefore, these aspects are reflected in the specific bidding rules
    .
    For example, there is no consistency evaluation of Chinese patent medicine, so is there no quality assurance? Who determines quality assurance? We choose products by clinical and hospital, just like we vote.
    The more people vote, the more recognition they are
    .
    These are the rules that are more in line with clinical needs, promote competition among enterprises, and promote the return of reasonable prices in specific varieties to ensure that such a system effect is achieved
    .
    Thank you
    .
    " May I ask how to promote the priority and rational use of the national centralized procurement of selected drugs and high-value medical consumables in the next step? Thank you
    .
    Chen Jinfu: There is a concept here.
    We do not conduct centralized procurement independently of medical institutions, but on behalf of medical institutions.
    Therefore, medical institutions are the main body of use
    .
    First of all, in terms of demand, we avoid the concept of external imposition on medical institutions
    .
    The second concept is that medical institutions report the volume according to the actual historical volume and change according to the price.
    There may be a trend of forecasting and forecasting
    .
    Therefore, the demand is determined by the medical institution according to the actual use demand, which is an objective demand
    .
    Third, we are in the middle of some specific products, in the middle of studying the bidding rules, fully Considering the feasibility and safety of medical institutions in the clinical alternative products, medical institutions have the most important voice in this regard
    .
    Fourth, as the demand side, medical institutions purchase on behalf of others.
    Institutions and suppliers sign agreements
    .
    In a sense, this kind of centralized procurement with quantity is a price discovery mechanism and a commercial procurement mechanism, which must conform to the spirit of commercial contracts
    .
    Therefore, from the perspective of system, principle and demand, these articles fully ensure that medical institutions can give priority to the use of the winning products
    .
    Of course, in the actual operation, there are also some immature aspects of operation.
    For example, some medical institutions rigidly stipulate that the winning product should be used up first, and then use other products.
    We do not agree with this, because the winning product is one piece.
    It is a contract and also your demand, but if a patient needs to use a non-bidding product, you cannot use it, so there are still requirements for medicine preparation
    .
    There are also requirements in clinical, health management, and medication management
    .
    Of course, in addition to these regular arrangements, there is also a major institutional arrangement, that is, the policy of saving and retaining the surplus.
    Under the condition that medical institutions can rationally use drugs and give priority to use, and ensure the use of the agreed product volume, in accordance with institutional regulations, saving Part of the medical insurance funds are reserved by medical institutions for the incentives of doctors and the realization of the value of technical labor services
    .
    Thank you
    .
    Wang Xuetao, head of the Department of Pharmaceutical Affairs of the National Health and Health Commission: Just now, Bureau Chen answered a reporter's question on the use of centrally-purchased drugs
    .
    Our Health and Health Commission has instructed medical institutions on how to prioritize and rationally use drugs and medical consumables.
    We have done the following work, and we will also inform all reporters here
    .
    The National Health and Medical Commission still attaches great importance to the development of this work.
    We have issued a number of documents to guide medical institutions to prioritize and rationally allocate and use the national centralized procurement of winning drugs to ensure the implementation of this work
    .
    In the past year, we have carried out the following work: First, together with other ministries and commissions, we have issued the "Opinions on Strengthening the Administration of Pharmaceutical Affairs in Medical Institutions to Promote Rational Use of Drugs".
    And require all localities to give priority to the national centralized procurement of winning drugs, in the long-term prescriptions issued by doctors, we also encourage doctors to give priority to the national centralized procurement of winning drugs
    .
    The second aspect of work is to play the role of performance appraisal
    .
    In the performance appraisal system of secondary and tertiary public hospitals, we clearly stipulate the use of the drugs that won the bids from the national centralized procurement, and clearly stipulate the use ratio indicators, and guide and strengthen the use of the national centralized procurement drugs through performance evaluation. .
    Thirdly, we continue to strengthen the management of rational drug use in clinical aspects, and further promote this work through measures such as prescription review, spot checks, pharmaceutical services, and drug monitoring
    .
    Through the above measures, we have achieved good results
    .
    Here are some data that can be shared with you
    .
    In 2020, the monitoring data of drug use in public hospitals shows that about 33,795 of all second- and third-level public hospitals and 55% of primary medical and health institutions in the country will be given priority to use the first batch and second batch of the national centralized procurement of winning drugs
    .
    The above-mentioned medical institutions completed 227.
    1% of the agreed procurement volume of the national batch of selected drugs, accounting for 79.
    1% of the use of the 25 drug varieties in the same year, and completed 168.
    9% of the agreed procurement volume for the second batch, accounting for the total use of the 32 drugs in the same year.
    63.
    6% of the amount
    .
    The monitoring data also showed that the use of the above-mentioned hospitals in a batch of national centralized procurement of the winning drugs increased by 129.
    7%, 143.
    3% and 188.
    6% respectively compared with 2018, and the use of the second batch increased by 114.
    9%, 130% and 135.
    4% compared with 2019
    .
    This data shows that the use of selected drugs, especially in primary medical and health institutions, has greatly increased compared with that before the national centralized procurement
    .
    This also ensures that our people can easily use the medicines collected by these countries
    .
    In addition, in terms of the priority allocation and use of high-value medical consumables, our commission has also successively formulated the "Administrative Measures for Consumables in Medical Institutions (Trial)" and "Administrative Measures for the Clinical Use of Medical Devices" to further standardize the clinical use of devices including consumables.
    It has also formulated operating specifications for hip replacement, knee replacement, coronary stent, and coronary balloon dilation in the procurement of consumables to further standardize the operation of centralized procurement of consumables and ensure medical quality. .
    The centralized procurement of medicines and consumables has entered a stage of normalization and institutionalization.
    In the next step, our committee will actively cooperate with relevant departments to further improve this centralized procurement-related system.
    According to the functions of our committee, through further standardized collection.
    Purchasing the catalogue of medicines and consumables, strengthening performance assessment, formulating and revising some guidelines for clinical medication, further promoting the priority and rational use of medicines and consumables in centralized procurement, and better serving the health needs of the people
    .
    I will add these, thank you
    .
    "Centralized procurement with volume can effectively reduce drug prices, save medical insurance funds, and save residents' expenses
    .
    However, some voices pointed out that the reform may affect the innovation of pharmaceutical companies, as well as their enthusiasm for production.
    How do you think about the impact of the reform on the pharmaceutical industry? The impact of high-quality development? Thank you
    .
    Chen Jinfu: Thank you
    .
    This is also a question we are very concerned about, and it is also the most discussed topic in the pharmaceutical industry since the centralized procurement
    .
    Now we can see from the media's feedback, basically there are such a few large sectors , First, the masses highly recognize the centralized procurement
    .
    Indeed, in some operations, the masses still feel deeply, and there are even social voices, saying whether it is possible to collect certain cosmetics, this is a social effect
    .
    Another The sector is an industry, and some companies are still quite anxious, because they do compete mainly on cost and quality in the middle of fierce competition, and of course they also play the role of a baton of rules.
    This is what your proposed centralized procurement does for pharmaceutical development and high-quality development.
    From the promotion of
    the centralized procurement system, including the setting of specific operating rules, we have always put the three goals of the healthy development of the pharmaceutical industry, the improvement of clinical quality, and the accessibility of medical care for the common people together for an overall balanced consideration.

    From the very beginning of the system design, this system has been focusing on the problem of inflated drug prices, focusing on providing high-quality drugs for the Chinese people, using price tools, and giving play to the role of market mechanisms
    .
    The system reflects this Several aspects: First of all, we focus on purchasing with quantity.
    In two words, purchasing with quantity and combining recruitment and purchasing are for the consideration of enterprises. .
    What is volume purchase? It turns out that when purchasing medicines, there is only price but not quantity, so he has to achieve sales and run volume.
    In this way, gold sales are implemented, which increases the cost of the enterprise, and indeed increases the uncertainty of the operation of the enterprise
    .
    Therefore, we must be an agency with volume, and it is a combination of recruiting and purchasing.
    When you recruit, you must pick it, and when you pick it, you must use it
    .
    Therefore, this is the most fundamental institutional arrangement for the development of the industry, and it is also the core of this reform
    .
    This method can enable enterprises to go to hospitals in private and become face-to-face quality competition and price competition, thereby further expanding and strengthening large-scale industries and leading enterprises.
    In a large-scale and just-needed market like China, it is possible to Realize the scale development of the enterprise
    .
    In the past, it was relatively low-end competition.
    Only through the competition mechanism of volume procurement and recruitment can companies compete under real market conditions.
    This is an institutional arrangement
    .
    Second, in terms of policy, we first made it clear that medical institutions must ensure that the payment is returned when purchasing medicines
    .
    In order to solve the problem of financial shortage of medical institutions, the medical insurance fund prepays 30%.
    We are also exploring, direct settlement with drug distribution companies and drug supply companies on the recruitment platform, so that the platform can serve enterprises and reduce operating costs.
    This is a policy arrangement.

    .
    We have also allowed some places to further expand the share of medical insurance payment in advance.
    At the same time, in the bidding rules, more and more strict requirements have been made on the repayment of medical institutions, and we have also developed a software system to monitor the process of drug repayment
    .
    We all know that in the pharmaceutical industry, especially in the field of consumables, the backlog of payment is a big problem.
    A large proportion of drugs have not been paid for more than half a year and consumables have not been paid for more than one year.
    After centralized procurement, their payment is guaranteed
    .
    Third, in terms of the system, we try to reduce the administrative cost of enterprises through bidding and procurement, and no longer allow enterprises to go to many places for the same thing.
    If more than 300 places are engaged in centralized procurement, if the enterprise wants to occupy these markets, it must run more than 300 regions
    .
    We vigorously promote the inter-provincial alliance.
    You only need to go to one place, you can obtain the service volume and purchase volume of the alliance area, and reduce operating costs. .
    These influences from the centralized procurement rules themselves on pharmaceutical companies, from the original gold-based sales public relations, to real quality and cost competition, which really promotes it to form a scale effect, and really promotes Chinese generic drugs to enter the leading companies
    .
    Some companies have reported that it is possible to truly become bigger and stronger through centralized procurement, to go international, or even to become a large international generic drug company or a leading company.
    This is a concept and has an institutional impact
    .
    The second concept is that China is building a "Healthy China".
    During the development process, it will effectively improve the medical level of the people.
    Therefore, the medication is just needed.
    Some people worry that no one will provide the medicine after the price goes down.
    In fact, the just need is here.
    The development is here, the profit point of the enterprise is here, and it is impossible for no one to do it
    .
    Looking at the situation since the winning bidder won the bid, the price of medicine has dropped by about 50%.
    This 50% is actually a replacement for its original high sales expense.
    In the past, the sales expense rate of pharmaceutical companies was about 50%, and it appeared after centralized procurement.
    In the downward trend, the sales expenses of listed pharmaceutical companies in 2020 will basically drop by 6 points
    .
    That's also a solid data illustration of squeezing out space
    .
    Since the centralized procurement, the R&D expenses of some enterprises, especially leading enterprises, have gradually increased.
    The R&D expenses of some leading enterprises have risen from 6% or 10% to 20%, especially in the past two years
    .
    what does that mean? On the one hand, leading companies can do imitation, on the other hand, more leading companies should turn to innovation
    .
    So as long as the need is here, as long as the investment in improving China's health and wellness is here, there will definitely be a market
    .
    The third concept, institutional promotion, can truly make Chinese pharmaceutical companies move towards quality maintenance and innovation drive through fair competition.
    This must rely on market mechanisms
    .
    In this case, of course, for individual enterprises, it will definitely be good and bad.
    By using market rules, effective cost control and optimization and quality innovation have been achieved, and it will definitely occupy the future market
    .
    Of course, there are still some enterprises that cannot adapt to this reform, and there is a possibility of survival of the fittest
    .
    This kind of survival of the fittest is a result for enterprises, but for society, it is a more efficient use of resources
    .
    For example, according to the centralized procurement rules, after a number of over-reviewed companies, they will no longer purchase non-over-reviewed products.
    This baton reminds companies that you should stop consuming social resources on this drug, but to develop innovative products and core technologies.
    R&D
    .
    So why did the country mention "specialized new and special elites" last year, to find out your technical hard levers, do Gu Ailing, don't do everything
    .
    In the past, on the one hand, the quality level of the pharmaceutical industry was not improved
    .
    Therefore, I think this is institutional, and it is also an important basic leverage that really promotes the high-quality development of the pharmaceutical industry
    .
    Thank you
    .
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