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A few days ago, China Business Daily interviewed Miao Xianfeng
, executive vice president of the Folite Creation Industry Research Institute, on the development of the high-value consumables industry.
, executive vice president of the Folite Creation Industry Research Institute, on the development of the high-value consumables industry.
Recently, the National Medical Insurance Bureau's repeated statements on innovative medical devices have received widespread attention
from the market.
On September 3, the National Medical Insurance Bureau said in its reply to Recommendation No.
4955 of the Fifth Session of the 13th National People's Congress that because the clinical use of innovative medical devices is not yet mature, the amount of use is temporarily difficult to predict, and it is still difficult to implement the method
of carrying volume.
In addition, on August 24, the National Medical Insurance Bureau said in its reply to Recommendation No.
8013 of the Fifth Session of the 13th National People's Congress that a certain market should be set aside in addition to centralized procurement to provide space
for innovative products to open up the market.
The Orient Securities report pointed out that this time or will be the National Medical Insurance Bureau's clear answer to "innovative medical devices are temporarily not included in the collection", to a certain extent, alleviating the panic of "medical device collection" that is generally recognized by the market, the policy support for innovation and development is becoming more and more clear, and the innovation space of the industry is expected to continue to open
.
In recent years, three types of high-value consumables such as coronary stents, artificial joints and orthopedic spine implants have been included in the national collection, and the price of post-harvest products has dropped by about
80%.
A few days ago, Miao Xianfeng, executive vice president of the Industrial Research Institute under the modern industrial data service provider Flint Creation, said in an interview with the reporter of China Business Daily:
A few days ago, Miao Xianfeng, executive vice president of the Industrial Research Institute under the modern industrial data service provider Flint Creation, said in an interview with the reporter of China Business Daily: "The domestic high-value medical consumables industry started relatively late, and the current market development speed is very fast, but there is still a big gap
with the international market.
" The domestic high-value medical consumables industry is still in the early stage
of relatively fragmented development.
The collection policy will have an impact on the market size of high-value medical device products that are relatively mature and more competitive, and at the same time will promote the restructuring of the industry pattern, promote the improvement of industrial concentration, promote enterprises in the industry to accelerate product research and development innovation, and also promote enterprises to expand their markets
overseas.
The National Medical Insurance Bureau and local medical insurance bureaus have left a certain market space for innovative medical devices in policies such as collection and procurement and DRG/DIP, which is conducive to the innovative development of
the medical device industry.
Encourage innovation
Encourage innovation According to the Special Review Procedure for Innovative Medical Devices promulgated by the State Food and Drug Administration in November 2018, medical devices that meet a number of requirements can be included in the special examination procedures for innovative medical devices, including core technology invention patents with novelty and inventive step, completed pre-product research and basic stereotyped products, and
significant clinical application value.
According to the data disclosed on the website of the State Food and Drug Administration on June 15 this year, at present, more than 383 products have entered the green channel of innovative medical devices, and 155 products with strong innovation, high technical content and significant clinical value have been listed
.
In its reply to Recommendation No.
8013 of the Fifth Session of the 13th National People's Congress, the National Medical Insurance Bureau said that since the implementation of the "13th Five-Year Plan", the National Health Commission, the Ministry of Science and Technology, the State Food and Drug Administration and other departments have been establishing a clinical research system system, building a clinical medical research center, and strengthening scientific and technological support for innovative medical devices
.
In terms of collection, the focus is on some medical consumables with large clinical consumption, high procurement amount, mature clinical use and sufficient market competition into the scope of procurement, and through open and transparent competition rules, the price returns to a reasonable level, and at the same time, enterprises can obtain clear market expectations
.
In the process of centralized belt procurement, the medical institutions determine the demand according to the historical usage, combined with clinical use and medical technology progress, and reasonably determine the proportion of the amount according to factors such as clinical use characteristics, market competition pattern and the number of selected enterprises, and leave a certain market in addition to the centralized belt quantity procurement, so as to provide space
for innovative products to open up the market.
In response to the medical insurance payment of innovative medical consumables, the National Medical Insurance Bureau said that at present, it is studying and improving relevant policies to guide all localities to timely include qualified innovative medical consumables in the scope of medical insurance payment according to procedures, and steadily improve the level of
insurance for insured patients.
At the same time, in promoting the reform of medical insurance payment methods, determining the payment standards by disease diagnosis related grouping (CHS-DRG) and paying by disease score (DIP), etc.
, innovative medical consumables are supported
in accordance with relevant regulations and procedures.
On July 13 this year, the Beijing Medical Insurance Bureau issued the Notice on Printing and Distributing the Administrative Measures for the Exception of New Drugs and New Technologies for CHS-DRG Payment (for Trial Implementation), and some innovative drugs and medical devices that meet the requirements of the document can be paid separately from the DRG payment
.
The document states that its purpose is to stimulate the innovation momentum
of new drugs and new technologies while giving play to the role of CHS-DRG in guiding and regulating medical behavior.
Miao Xianfeng introduced that at present, the collection of high-value medical consumables has shown a trend
of scientific enhancement of rules, alliance procurement into the mainstream, expansion of procurement varieties, and expansion of the proportion of belts.
First, gradually incorporate comprehensive considerations of price, supply, quality, credit and other dimensions, improve the scientific nature of the selection rules, simplify the procurement process, and improve the implementation rules
.
Second, from the perspective of the collected projects that have been completed so far, the form of the alliance has obtained a greater scale effect, which is of great significance for accelerating the reform process and expanding the reform results, and the procurement methods of the alliance will be more diverse
.
Third, the expansion of collection varieties is closer to the direction of clinical demand, not limited to varieties with high localization rate, such as regional collection of cardiac pacemakers, electrophysiology, neurointervention and other domestic varieties with a relatively low proportion of domestic products, and consumables that are not included in medical insurance, such as oral implants and other products
.
Fourth, the purchase volume increased from 80% of the national collection of coronary stents to 90%
of the national collection of artificial joints.
After the early collection of experience, medical institutions can basically predict the changes in patient demand after the price is reduced, have the basis for expanding the proportion of the band, increase the "volume for price" chips, and improve the procurement effect
.
Follow the trend
Follow the trend It is understood that high-value medical consumables refer to medical consumables that act directly on the human body, have strict requirements for safety, have a large amount of clinical use, have a relatively high price, and have a heavy burden on the masses
.
According to the "China Medical Device • High-value Consumables Industry Report" (hereinafter referred to as the "Report") created by Flint Creation, high-value consumables account for about 20% of the medical device market and have the characteristics
of value and high technical content.
China's high-value consumables market is growing faster than the global market, with an average growth rate of about
20% from 2015 to 2019.
In 2020, affected by factors such as the collection and mining of some varieties of high-value consumables and the epidemic, the growth rate fell to 4.
07%.
By the end of 2021, the number of valid registration approvals for domestic high-value consumables was 16653, classified according to product management categories, 9145 Class II medical devices and 7508 Class III medical devices
.
Among them, the three types of high-value consumables have high barriers to entry and are at the core of
high-value consumables.
The Chinese production of second-class consumables registration approval accounts for 94%, and the domestic quantity is dominant; The three types of high-value consumables registered and approved by China account for 45%, and the number of imports is dominant
.
China's high-value consumables are mainly concentrated in Jiangsu, Beijing, Shanghai, Guangdong, Zhejiang, Tianjin, Shandong and other provinces and cities with
developed economies and rich R&D and innovation resources.
However, Miao Xianfeng pointed out to reporters that from the overall perspective of the high-value consumables industry, there is still a big gap between domestic high-value consumables and imports, mainly reflected in the fact that there are fewer original innovative products and high-end products are mainly imported
.
In terms of market structure, a few foreign companies occupy a large market share and are in an oligopolistic position; The domestic market "a hundred schools of thought" also reflects the characteristics
of the initial stage of industry development.
.
Miao Xianfeng introduced, to the cardiac pacemaker products as an example, the current domestic pacemaker is better for the dual-chamber MRI compatible cardiac pacemaker, the function only has the cardiac pacing function, and the imported pacemaker has more types of advanced procedures, in addition to the anti-MRI function, but also has anti-average attenuation, defibrillation and other functions, in addition to imported products have wireless pacemakers, these functions domestic pacemakers do not have
.
The "Report" shows that in July 2019, Anhui took the lead in purchasing
high-value consumables.
By the end of 2021, regional collection has covered 31 provinces across
the country.
The national collection of high-value consumables currently involves three categories: coronary stents, artificial joints and orthopedic spine implants
.
Judging from the results of national collection and regional alliance collection, most of the collection and mining are carried out according to 60% to 90% of the previous year's consumption, and the price of products collected in previous collections has generally decreased by more than
80%.
Under the collection policy, the performance of many listed companies related to the high-value medical consumables business is under pressure
.
Dabo Medical(002901.
SZ) as an example, in the first half of 2022, the provinces began to gradually implement the post-harvest price of orthopedic trauma consumables and joint consumables, and the gross profit margin of orthopedic trauma products fell by 3.
66% due to the impact of collection, and revenue fell by 23.
18%
year-on-year.
Dabo Medical said that the promotion of orthopedic consumables collection is conducive to the long-term healthy development of the orthopedic consumables industry and the transformation
of orthopedic consumables enterprises to standardization and scale.
At the same time, the collection of consumables will adversely affect the performance of the failed bidders, and the winning bidders will also face the risk of a significant decline in the terminal price of
the product.
Blue Sail Medical (002382.
SZ) 2022 semi-annual report shows that due to the impact of the new crown pneumonia epidemic and the collection of collections, the company's cardiovascular and cerebrovascular business profitability in 2020 and 2021 plummeted
.
In addition, minimally invasive medical treatment (00853.
HK) 2022 semi-annual report shows that its domestic orthopedic business revenue is about US$8 million, down 43.
9% from the same period last year, mainly due to the decline in product prices caused by artificial joint collection and the impact of
the epidemic.
Miao Xianfeng believes that enterprises should adapt to the trend
of high-value consumables collection.
First of all, we should strengthen R&D investment, expand product lines, and reduce the risks
caused by single varieties.
Secondly, it is recommended that enterprises pay attention to the technological development and changes of their own products, keep up with technological iterations, and strengthen product competitiveness
.
Finally, encourage the acceleration of overseas layout and balance market risks
.
of high-value consumables collection.