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- Operational confusion: Russia wants to limit the use of imported catheters and stents
Operational confusion: Russia wants to limit the use of imported catheters and stents
The Ministry of Industry and Trade proposes to impose restrictions on government purchases of imported catheters and stents for arteries. And this is despite the fact that the share of foreign products in this medical practice is 75-80%. The agency believes that the measure will stimulate the growth of domestic production — there are already seven enterprises producing such medical products in the Russian Federation. Experts believe that the increase in the Russian segment may amount to 30-35%. The draft resolution is already undergoing the necessary procedures, after which it will be submitted to the government, the ministry said. They added that in certain cases, foreign companies will also be allowed to participate in the competition. The government's proposal may affect the quality of medical care, doctors say, but they do not see any other way to develop the production of such products in the Russian Federation. At the same time, according to the Ministry of Health, the number of "adverse events for Russian-made products does not exceed the number of adverse events for imported ones."
Why do they want to limit government purchases of imported medical products
Russian hospitals and medical clinics may be restricted from purchasing foreign catheters and stents for coronary arteries. According to the idea of the authorities, if there are applications from domestic manufacturers of these medical products in public procurement, then any imported ones should be rejected. The Ministry of Industry and Trade has prepared a draft government decree with amendments to the list of foreign goods, works and services prohibited or restricted for import. Izvestia has reviewed the document.
The national regime in public procurement, which regulates the list of foreign goods prohibited or restricted for import, was introduced on January 1, 2025 by Government Decree No. 1875. It already applies to certain product categories. This is a set of rules that restrict the participation of foreign goods in tenders, creating advantages for domestic products. We are talking about three regulatory mechanisms. Firstly, the complete exclusion of the possibility of purchasing goods of foreign origin. Secondly, about the limited admission of foreign goods, which can be purchased only in the absence of Russian analogues. That is, if a domestic version is presented in public procurement, the institution will have to abandon the foreign manufacturer. Thirdly, the provision of price advantages for goods of Russian origin (reduction of the offer price by 15% for the purpose of evaluating applications).
The document, developed by the Ministry of Industry and Trade on its own initiative, provides for the addition of a list of foreign goods, works and services, which are subject to restrictions on purchases for state and municipal needs. The list will include the following items: "Standard balloon catheter for angioplasty", "Stents for coronary arteries that secrete a drug, stents for coronary arteries, metal uncoated".
The agency reported that currently there are at least seven manufacturers of these medical devices in the Russian Federation. Among them are: "R-Vascular", "Angiolain", "Stentonic", "NanoMed", "NPC "EviPro", "RK Group" and "Stentex".
"The production capacities of Russian enterprises amount to more than 700,000 coronary stents and 650,000 balloon catheters per year. It is noted that according to the information provided by Nanomed, the market needs in 2021 and 2022 for coronary stents were about 300 thousand and 330 thousand, respectively, and 489 thousand and 537 thousand balloon catheters. This confirms the ability of domestic enterprises to meet the needs of the healthcare system in the relevant products in full," the explanatory note to the document says.
The Ministry of Industry and Trade believes that such a measure will provide support to Russian manufacturers. In particular, it will stimulate an increase in the production of domestic medical products and the opening of new enterprises without the risk of meeting the needs of healthcare systems, the agency believes. The Ministry of Industry and Trade also believes that this will lead to lower prices due to the production of catheters and stents in Russia and minimize the use of a procurement mechanism for expensive imported products.
Currently, a draft resolution proposing the addition of stents and catheters to the list of restrictions is undergoing the necessary conciliation procedures, after which it will be submitted to the government, the Ministry of Industry and Trade told Izvestia. The initiative is also aimed at building the technological and production potential of the domestic medical industry.
— At the same time, all restrictions stipulate that if at least one established requirement is not met, then purchases are carried out without granting preferences to local producers and all participants are allowed to participate in the competition. If there are specific justifications, the customer may specify additional information, as well as additional consumer, functional, technical, and qualitative characteristics of the product that are not provided for in the catalog of goods, works, and services, the department said.
In 2020, the Ministry of Industry and Trade already proposed to limit access to public procurement of foreign stents and catheters for coronary arteries for two years, but then the initiative was not accepted.
The press service of the Ministry of Health informed the editorial board that the initiative does not imply a ban on the purchase of foreign products and is aimed at supporting domestic manufacturers to stimulate the technological and production potential of the medical industry.
"About 350,000 percutaneous coronary interventions with implantation of over 500,000 coronary stents are performed annually in the Russian Federation," the press service emphasized. — Russian manufacturers are able to meet the demand of the healthcare system for appropriate products.
They also noted that domestic and imported coronary stents and catheters are currently used in medical practice, while "the number of adverse events for Russian-made products does not exceed the number of adverse events for imported products."
Izvestia also sent inquiries to domestic manufacturers.
The Russian market of stents and catheters
If we talk about the catheter market as a whole, imported products predominate in the Russian Federation: they account for about 75%. The share of domestic producers is gradually growing, but at a moderate pace. Growth to 30-35% of the market is possible over the next five years, Businessstat, an analytical company that researches industrial and consumer markets, told Izvestia.
— For individual items, in particular, balloon catheters, the share of imported products in the domestic market reaches 80-90%. At the same time, the range of Russian manufacturers is dominated by simpler, basic models, and imported products cover the needs of all segments — from simple to specialized high—quality products, the analysts explained.
As for coronary stents, Russian manufacturers are, in fact, only getting close to mass production of such products, the company said.
— According to the most ambitious estimates, the share of domestic products accounts for no more than 10% of the market, and most likely even less. As in the case of catheters, so far the focus is on simpler models, which are easier to mass—produce, but in parallel, our own development of more complex and technologically advanced stents is underway," Businessstat said.
According to data from Cursor, an IT company in the segment of collecting and analyzing tender purchases of medicines and medical devices, domestic manufacturers currently cover only 18-20% of the needs for products used in cardiovascular surgery, with the rest coming from foreign manufacturers.
Doctors also share the opinion of market analysts.
— Catheters and stents are mostly imported now. Both goods are supplied either by the West or China. Without goods from China, we may be left without a significant share of supplies in cardiovascular surgery," Vladimir Khoroshev, a military doctor and cardiovascular surgeon, told Izvestia.
Oleg Volkov, Medical director of Plastis-M, a domestic manufacturer of unique embolization particles and silicone implants, agrees with this opinion. According to him, in order to meet the demand of the market, enterprises will have to significantly increase the volume of production of their products.
A source in medical circles told Izvestia that if a complete ban is imposed, there may be a shortage of these medical products in the country. As for the restriction procedure, it is still difficult to assess the impact of this decision, since Russian analogues are still inferior in quality to foreign ones.
Is it possible to increase the volume of domestic production
Stanislav Goldberg, Chairman of the Opora Russia Medical Device Management Commission, agrees that domestic stents and catheters are still inferior in quality to foreign ones, but work is already underway to remedy this situation.
— It is not easy for Russian enterprises to get into the register of manufacturers of the Ministry of Industry and Trade. To do this, they will need to prove that their product is of high quality and provide all the necessary documentation for it," he said. — Products used in cardiovascular surgery belong to the 3rd risk class. This means that complex clinical trials need to be conducted to register it.
According to him, only those companies that are able to produce such goods in the required quantity will be included in the register.
— Russia has no other way to increase its own production. There is always the possibility that the West will refuse to supply us and without preparation we will find ourselves in a vacuum," added Stanislav Goldberg.
He believes that the changes proposed by the Ministry of Industry and Trade will encourage Russian companies to invest in domestic production.
The document appeared recently, so it will take time for the expert community to evaluate the proposal, Sergey Vanin, executive director of the Association of International Manufacturers of medical devices IMEDA, told Izvestia.
— During the examination, we will base on the results of research on the use of domestic consumables, in particular, stents, in clinical practice. Only after that it will be possible to evaluate the initiative," he added.
Preferences in medicine often lead to a decrease in the quality of goods and an increase in their cost. This may concern cardiovascular surgery, according to a source from Izvestia at the Rostov Clinical Hospital of the Southern District Medical Center of the Federal Medical Service of Russia.
— Previously, it was possible to choose in favor of high-quality goods, which, of course, are more expensive. Preferences to Russian enterprises will deprive us of such an opportunity," he said.
In his opinion, providing advantages to domestic manufacturers may lead to the fact that companies will not invest in development, improve the quality of materials or new engineering solutions, because the choice in public procurement is almost guaranteed to be in their favor.
At the same time, experts interviewed by Izvestia believe that the outflow of foreign companies will be insignificant. According to them, they can switch from government contracts to private medicine.
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