Medical Equipment (Russian Market)

The main articles are:

• Medical Devices Market in Russia
• Medical Equipment (Global Market)
• Artificial lung ventilation devices (Russian market)
• Rehabilitation equipment
• Medical equipment production in Russia

2023

Named the top 20 manufacturers of medical devices in Russia

In 2023, medical equipment worth 50.3 billion rubles was produced in Russia. For comparison, in 2018, this figure was 18.5 billion rubles. Thus, over five years, the volume of the market in question has increased 2.7 times. The corresponding data are reflected in the review of the audit and consulting group "Business Profile," published on May 27, 2024.

According to the Ministry of Industry and Trade, the share of domestic medical equipment in 2023 reached 29% in Russia. A year earlier, the value was 25%, and in 2021 - 20%. At the same time, RBC analysts calculated that in physical terms, domestic production is significantly less than the volume of imports of medical equipment.

Medical equipment worth 50.3 billion rubles was produced in Russia

In connection with the current geopolitical situation since 2022, the import of foreign medical equipment in. Russia We are talking primarily about products from states. European Union As such, there is no direct ban on the import of medical goods from Western countries, but there are reasons that complicate this process. Among them are named the entry of parts for medical equipment into the category of dual-use goods (their import into Russia is limited due to sanctions); difficulty in making bank transfers; disruption of logistics routes. At the same time, the process of increasing the domestic production of medical equipment and other products takes time, so Russia is increasing the volume of supplies from alternative importing countries, primarily from. China The most popular Chinese brands of medical equipment presented on the Russian market are (Mindray anesthesiological and surgical consoles), (SonoScape ultrasound devices), Zoncare Bio-medical Electronics (electrocardiographs, as well as ultrasound imaging systems), etc.

As for domestic production, it is concentrated mainly in several regions. As of 2023-2024, these are Moscow and St. Petersburg, Tyumen and Nizhny Novgorod regions and the Republic of Bashkortostan. For example, in Moscow, more than 200 enterprises are engaged in the production of medical goods. They specialize, in particular, in the production of ventilators, equipment for cardiopulmonary resuscitation, pulse oximeters, first aid kits, etc.

The rating of the 20 largest Russian companies for the production of medical equipment and instruments in 2023 is headed by the Moscow Prosthetic and Orthopedic Enterprise with revenues of about 17.78 billion rubles. This organization makes prosthetic upper and lower limbs, orthoses, corsets, bandages, reclinators, orthopedic shoes and insoles. In second place is Icraft with a turnover of 4.72 billion rubles: the specialization of the enterprise is ophthalmic glasses, optical glasses, lenses. The DNA-Technology company closes the top three with revenues of approximately 3.32 billion rubles: it supplies equipment and reagents for molecular genetic studies by PCR. All three named organizations are based in Moscow. The top 20 manufacturers of medical equipment in Russia also include:

4. Optik-Vision LLC - 3 billion rubles;

5. JSC "CITO" - 2.89 billion rubles;

6. LLC Medstalctruction"" - 2.03 billion rubles;

7. Ekoten LLC - 1.84 billion rubles;

8. JSC "Radieprom" - 1.754 billion rubles;

9. LLC Medplant"" - 1.75 billion rubles;

10. LLC "Ortorent" - 1.58 billion rubles;

11. JSC "First Moscow Instrument-Making Plant named after V.A. Kazakov" - 1.46 billion rubles;

12. LLC company Triton-ElektronikS"" - 1.43 billion rubles;

13. CJSC "Aprelevsky Plant of X-ray Engineering" - 1.41 billion rubles;

14. LLC "Medical Production Company Yelets" - 1.405 billion rubles;

15. LLC "Labromed" - 1.265 billion rubles;

16. Surdex LLC - 1.21 billion rubles;

17. Dixion LLC - 0.999 billion rubles;

18. Bebig LLC - 0.96 billion rubles;

19. JSC "R-Vasculary" - 0.93 billion rubles;

20. LLC "Orthos" - 0.92 billion rubles.^[1]

The volume of public procurement of medical equipment decreased by 9.6% to 129.4 billion rubles

According to Headway, which researches the market for public procurement of drugs, medical equipment and medical products, the volume of purchases of therapeutic and diagnostic equipment and rengen equipment decreased from 143.2 billion rubles in 2022 to 129.4 billion rubles in 2023 (or 9.6%). Experts explain this by public procurement cycles, which depend on the timing of the warranty work of medical equipment, after which there is a massive replacement of outdated equipment, and then there is a pause. The warranty terms of work of large medical equipment are 8-10 years, the average - 5 years. Thus, due to the cyclical nature of purchases, the transition to domestic medical equipment, if available, will not be simultaneous.

Of the total amount of state purchases of medical equipment for 2020-2023, most of it fell on diagnostic equipment - 48% and devices with X-ray or alpha, beta, gamma radiation - 41%, the network publication Farmedprom reported on May 6, 2024 with reference to the Medical Bulletin^[2]

Thanks to the rules "second extra" (Decree of the Government of the Russian Federation No. 102 of 05.02.2015) and "third extra" (Decree of the Government of the Russian Federation No. 878 of 10.07.2019), the share of imported mammography devices in the total amount of purchases of this type, for example, decreased from 42% in 2020 to 14% in 2021 and to 12.8% in 2022.^[3] A similar situation is with a share in physical terms.

The largest foreign supplier of mammograms in 2020-2023 was South Korean Genoray. Among Russian companies, Ltd Medical Technologies JSC (MTL) was in the lead, which cooperates with GE Healthcare, including in the field of localization of production in Russia.^[4]

To illustrate the changes, Headway experts analyzed several procurement segments in the Ulyanovsk region. In other regions, in their opinion, the situation is similar.^[5]

In 2023, in the Ulyanovsk region, the volume of purchases did not decrease due to the purchase of equipment for the oncology center of the Federal Scientific and Clinical Center for Medical Radiology and Oncology of the FMBA. In general, the region spent 1.3 billion rubles on medical equipment, including:

• Mammographs: During the period 2020 - early 2024, 18 mammography devices were purchased in the Ulyanovsk region, of which one was a mobile complex. The total amount of purchases amounted to 319.7 million rubles. In total, 28 mammographs are used in the region, 14 of which are manufactured by MTL.

• Infusion pumps: The main purchases of infusion pumps in the region were carried out in 2020, in 2022 there was one large purchase for equipping the Central City Clinical Hospital of Ulyanovsk with 100 syringe pumps with a decrease in the initial auction price by more than 50%. Under the contract, the VivaVesta brand of the Chinese manufacturer Kelly Med was delivered. Taking into account this auction, the average purchase price in 2022 decreased to 54.7 thousand rubles. Almost half of the purchased infusion pumps are products under the brands of the German company B.Braun, the second half of the equipment is produced by various Chinese companies.

• Transfusiology: In the Ulyanovsk region there are nine devices of autotransfusion (reinfusion) of blood, all of them are foreign-made. Among them are the brands Electa (Sorin Group), C.A.T.S. (Fresenius), Cell Saver Elite (Haemonetics) and XTRA (Sorin Group). The Ulyanovsk region spent 28.8 million rubles on consumables for transfusiology in 2023. The main supplier of consumables is Maco Pharma (France). Other major manufacturers include American, Chinese, Polish companies. There is also a company from Russia - Hemojenix LLC.

• Endoscopic equipment: In 2020 - 2023, 15 medical institutions of the Ulyanovsk region purchased endoscopic imaging systems and individual endoscopes for 315 million rubles. 179 million rubles were allocated for the purchase of surgical endoscopic devices; for 146 million rubles. endoscopic diagnostic complexes were purchased, which included 17 gastroscopes, 14 colonoscopes, nine bronchoscopes. About half of the purchased endoscopic equipment is occupied by the equipment of the Chinese manufacturer SonoScape. In monetary terms, the share of this company is more than 30%. The company's equipment belongs to the low-cost segment.

Sales of blood pressure measuring devices in Russia for the year increased by 30%

At the end of 2023, approximately 6.1 million tonometers were sold in Russia. This is 30% more than the result for the previous year, when the market size was estimated at about 4.4 million units. Such data at the end of February 2024 are given in a study by RNC Pharma. Read more here.

Sales of medical thermometers decreased in Russia

In 2023, about 9.9 million medical thermometers were sold on the retail market of Russia (including online channels), which is 12% less than in the previous year. In monetary terms, sales decreased on an annualized basis by 15.7% - to 3.3 billion rubles, as stated in the report of the analytical company RNC Pharma dated February 13, 2024. Read more here.

Growth in the production of medical equipment by 14.6% to 50.3 billion rubles

The production of medical equipment in Russia in 2023 reached 50.3 billion rubles, which is 14.6% more than a year earlier. Rosstat published such data in February 2024.

It also follows from the materials of the department that equipment and devices used for medical purposes for diagnosis, radiation, rehabilitation and therapy in December 2023 were issued by 7.1 billion rubles, which is 1.5% more than in December 2022, and 17.2% higher than the result of November 2023.

The production of medical equipment in Russia in 2023 reached 50.3 billion rubles

Against the background of Western sanctions against the Russian Federation, after which some foreign producers reduced their business on the Russian market, import substitution processes in the field health care intensified. The load of all enterprises that produce medical equipment in Russia has increased sharply. An additional catalyst for growth was the expansion by the Government of the Russian Federation of the program of state guarantees of free medical care - by 14% increased the volume of funding for primary health care, as well as by 35% - rehabilitation programs in inpatient conditions, clinics and day hospitals.

Moscow Mayor Sergei Sobyanin also repeatedly mentioned that the capital's production of medical devices is gaining momentum. Among the medical products produced by Moscow are mentioned: first aid kits, pulse oximeters, artificial lung ventilation devices (IVL), hemostatic products, cardiopulmonary resuscitation equipment, specialized medical furniture. All in 2023 produced more than 100 Moscow enterprises.

According to the plans of the Ministry of Industry and Trade, by the end of 2023, the share of domestic medical equipment was supposed to be 29%. The department believes that for the more active development of domestic production of the necessary medical equipment, it is necessary to develop a strategic document in which to determine, taking into account the needs of medicine, the direction of development of the industry, providing for defecturing, technological difficulties and decomposing everything in time.^[6]

Growth in sales of tonometers by 29% to 6 million units

At the end of 2023, sales of tonometers in Russia increased by 29% compared to 2022 and exceeded 6 million units. Such data was presented by RNC Pharma in its study at the end of January 2024.

In 2023, 6.03 million tonometers were sold on the retail market in Russia for a total amount of 11.87 billion rubles. If sales growth in units amounted to 29%, then in ruble terms the indicators increased by 10%. RNC Pharma explained this difference by the rapid reduction in device prices. On average, the price of a tonometer decreased by 15%.

According to analysts, the fall in the average price is associated with an increase in the share in the market of non-branded products - in 2023, 56% of goods in the market of tonometers were non-branded (in 2022 this figure was 31%). In addition, many manufacturers also use a dumping strategy.

Sales of tonometers in the online trading sector grew 2.4 times, while sales of offline products increased 2.1%. According to analysts, the online trading sector does not select customers from the traditional method of purchase, but develops its own market, attracting new consumers. At the same time, as analysts at RNC Pharma note, this process is inevitable, especially since in other sectors of the medical technology market, customers regularly use the online method of purchase and purchase branded products.

The leader in the tonometer market in Russia is the Japanese company A&D - its sales amounted to 25.1% of the entire market and 29.2% in monetary terms. The second in terms of revenue is Omron Corporation. The maximum growth compared to 2022 was shown by the Chinese company Jamr Technology - its sales increased 14.1 times. The manufacturer supplies its products to the Russian market under the SberZdorovye brand. ^[7]

Sanctions and price increases cannot justify the non-delivery of medical equipment to clinics

In August 2023, the Ninth Arbitration Court of Appeal upheld the decision of the first istat, according to which sanctions and price increases cannot justify the non-delivery of medical equipment to clinics. We are talking about the proceedings between the N.V. Sklifosovsky Research Institute of Emergency Medicine and the supplier company A-Compr. Ru. Read more here.

Roszdravnadzor allowed the use of non-original spare parts for the service of medical equipment

In early June 2023, it became known that Roszdravnadzor approved the requirements for the procedure for submitting documents and recognizing non-original spare parts as compatible with medical equipment for repair or service. The regulations will be valid from September 1, 2023.

The process will consist of two stages. At the first, the applicant must submit a special package of documents to Roszdravnadzor. At the second stage, the All-Russian Research and Testing Institute of Medical Engineering (VNIIIMT) will conduct its own study of components for compatibility.

As stated in Roszdravnadzor, the possibility of repairing medical devices using non-original components will not affect their safety and quality, "since the safety of sharing alternative components or accessories of a medical device will be confirmed by tests on the basis of the All-Russian Research Institute of Medical Technology" Roszdravnadzor. "

Roszdravnadzor notes that the document is aimed at simplifying the circulation of components or accessories for medical devices of foreign production on the territory of the Russian Federation, which will avoid the risks of shortage and will contribute to the development of the production of components and accessories for medical equipment in our country.

Sergei Proskuryakov, President of the Russian Association of Medical Equipment Sales and Repair Enterprises, also said that the association supports the Roszdravnadzor initiative, which will become a kind of airbag "for both patients and Russian manufacturers who manufacture components for medical devices. Russian manufacturers are ready to produce the necessary components, he added.^[8]

The United States has limited the export of medical equipment to Russia and Belarus

The United States has limited the export of American medical equipment to Russia and Belarus. This became known on May 19, 2023.

According to TASS, citing a statement by the US Department of Commerce, the sanctions, among other things, relate to orthopedic, ophthalmic and dental equipment. In particular, about some dental mumblers and their parts, ophthalmic equipment, orthopedic devices, their parts and components.

Computed tomography machines and X-ray generators also appear on the black list. The list also contains general surgical consumables, including syringes, cannulas, catheters, as well as components for medical equipment, including X-ray tubes and X-ray generators.

The supply of these goods did not fall under a direct ban, but now the supply or re-export of medical equipment will require obtaining a license from the American regulator. The regulation retains the possibility of supplying medical equipment and medical devices after obtaining permission if it is intended for medical care.

A total of 1,224 names were added to the list of industrial goods that will require licenses for export, re-export and transfer through Russia and Belarus in May 2023.

At the same time, earlier the US Treasury lifted sanctions on transactions for the production, manufacture, sale or transportation of drugs, medical products, spare parts and components for them, as well as software updates for medical devices. In addition, activities related to the prevention, diagnosis or treatment of COVID-19, including clinical trials of drugs for this disease, were added to the list of exceptions.^[9]

How to choose the right service contractor for a medical institution

This issue is facing each medical institution, because the conclusion of an agreement for the maintenance of medical equipment is one of the mandatory conditions for obtaining a license for medical activities. In addition, introduced in 2022 against Russia, the rupture of supply chains and problems with international foreign exchange operations caused interruptions in the supply of imported medical products and components for them. In this regard, the problem of service becomes especially urgent. Read more here.

In Russia, begin to train medical engineers

Speaking at one of the forums in St. Petersburg in March 2023, Viktor Fomin, Vice-Rector of the University for Clinical Work and Additional Professional Education of the Sechenov University of the Ministry of Health of Russia, said that the First Moscow State Medical University begins training medical engineers. The program aims to form graduates not only engineering thinking, but also the ability to work in a team with clinicians, as well as knowledge of the basics of personalized medicine, he said.

The training program for medical engineers at PMGMU will be aimed at ensuring that the graduate has not only engineering thinking, but also the ability to work in a team with clinicians, a real understanding of the needs of the industry and a specific patient, as well as knowledge of the basics of personalized medicine, Fomin emphasized. It is planned that in the first years of training, future medical engineers will be provided with access to clinics and the opportunity to participate in processes related to the operation of medical equipment. Viktor Fomin said that by March 2023, there is a shortage of medical engineers in Russia.

There were forecasts that with the withdrawal from our market of foreign companies engaged in the production and supply of medical devices, personnel will be released, and we will be able to attract qualified medical engineers who previously worked in these companies to the staff. We tried to start this work in our.. clinical center, and these predictions did not materialize. Most of the employees of these companies are highly qualified "readers" of standard errors in the operation of medical equipment. And the second thing they know how to do is to select a part that requires replacement from the catalog as soon as possible. They have no competence to independently carry out repairs, and even more so to develop medical equipment, "Fomin explained.

As deputy State Dumas Leonid Ogul noted to Parlamentskaya Gazeta, today our country needs specialists who will be able to create competitive medical equipment and maintain its work at the proper level. In a letter addressed to the deputy chairman, the Governments Tatyana Golikova deputy stressed that the issue of "training specialists who are ready to develop and implement engineering solutions for to medicine the diagnosis, prevention and treatment of diseases" is very relevant. The document notes that for this it is necessary to introduce a new specialty "medical engineer."^[10]

2022

For 3 years, state-owned clinics in Russia spent 3.3 billion rubles on leasing medical equipment

In the period from 2020 to 2022, state medical organizations in Russia spent approximately 3.3 billion rubles on leasing medical equipment. Such data are given in the opinion of the Accounts Chamber of the Russian Federation published on July 3, 2023 on the report on the implementation of the budget of the Federal Compulsory Health Insurance Fund (Compulsory Medical Insurance) for 2022. Read more here.

The Ministry of Industry and Trade softened the conditions for granting grants for components for medical equipment

In early December 2022, it became known about the new rules developed by the Ministry of Industry and Trade for the provision of grants for the development of design documentation for domestic components, including for the needs of the pharmaceutical and medical industries.

Previously, up to 70% of the grant size was allowed to be used to pay employees, up to half of the grant - to spend on material costs for the very development of design documentation, a third - to pay for the services of companies involved in individual work, rent or purchase comparison products, a fifth - for the maintenance of research equipment. In addition, 10% of the grant is allowed to be directed to expenses for registration of a patent based on the results of the development of components. The Ministry of Industry and Trade decided to cancel these restrictions.

Instead of the number of sets of design documentation developed during the projects, the amount of documentation accepted by the grant operator, ANO Agency for Technological Development, will be counted as an indicator.

In addition, the new version of the resolution will provide for the opportunity to spend a grant to compensate for expenses incurred before the date of receipt of funding. The Ministry of Industry and Trade justifies this measure by the fact that the delivery time of raw materials, materials, equipment "under conditions of external sanctions restrictions" can take a long time, and the period for the implementation of the grant project is limited.

In total, by December 2022, the government plans to allocate at least 3.6 billion rubles for grants in the next three years. The amount of grants in each area will be determined by ANO Agency for Technological Development (Institute for the Development of the ВЭБ.РФ Group). The maximum amount of financial support is 100 million rubles, the grant is provided for no more than two years.^[11]

Hospitals and clinics in Moscow will receive more than three thousand units of medical equipment for diagnosing heart disease

Hospitals and clinics will receive more than three thousand units of medical equipment for diagnosing heart disease. This became known on November 18, 2022.

Some of them have already been delivered, and some will arrive in the coming months.

For the cardiological services of Moscow polyclinics and hospitals in 2022, more than three thousand electrocardiographs and daily blood pressure monitoring devices were purchased.

We are systematically updating medical equipment in our hospitals and clinics - we are changing outdated medical equipment to new ones, including digital. So, in 2022, more than three thousand electrocardiographs and daily blood pressure monitoring devices were purchased for city medical institutions, some of which have already been delivered, and some will arrive in the coming months. Technical equipment allows you to improve the quality of diagnostics and treatment, including heart and vascular diseases, - said Anastasia Rakova, Deputy Mayor of Moscow for Social Development.

In total, medical organizations of the city health care system will receive over 1.5 thousand modular systems for registration and remote transmission of ECG and more than 1.5 thousand systems for daily monitoring of blood pressure.

The city continues to update the park of medical equipment hospitals and clinics. There are supplied devices, CT, MRI- X-ray devices, angiographs, mammographs, as well as devices for functional diagnostics, monitoring the state of patients and rehabilitation. The equipment meets the latest standards for equipping medical institutions.

This technique is also received by polyclinics, which are included in the overhaul program according to the new Moscow standard. Equipment is purchased with pre-fixed delivery times so that it comes directly to the opening of updated buildings. All head departments are equipped with MRI, CT, densitometers, ULTRASONOGRAPHY expert-class devices, equipment for monitoring the condition of patients with coronary heart disease, patients after a heart attack or surgery on heart vessels. Mammographs, X-rays, ultrasound, ECG devices and much more are installed in the branches.

Digital technologies are actively being introduced into the work of medical institutions. The equipment is integrated with a single digital healthcare platform. Thanks to this, medical professionals can quickly receive research results in electronic form. Artificial intelligence helps them decrypt radiation images.

Moscow has been engaged in the digitalization of the health care system for more than 10 years. The basis of this process is a single digital healthcare platform, which is being developed by the complex of social development of Moscow and the Moscow Department of Information Technologies. It provides personalized management of each patient at all stages - from diagnosis and treatment to follow-up. Thanks to the platform, all data on the state of health of citizens are available online to both doctors and patients themselves^[12].

Polyclinics and hospitals in Moscow will receive about 12 thousand pieces of equipment by the end of the year

Since January 2022 clinics and hospitals Moscow , more than 10 thousand pieces of equipment have been delivered medical to. In accordance with the plan, by the end of the year, the capital's medical organizations will receive more than 11.7 thousand pieces of equipment. This was announced on August 18, 2022, by Anastasia Rakova the Deputy Mayor of Moscow for Social Development.

City medical organizations are not experiencing any shortage of equipment. Since the beginning of the year alone, metropolitan hospitals and clinics have received over 10 thousand units of equipment. Of these, 176 units are heavy diagnostic equipment for high-precision studies: CT, MRI, mammographs, X-ray machines of the "C-arc" and "U-arc" types and much more. We update the equipment in the capital's medical organizations as planned. In addition, we equip the city polyclinics and hospital buildings with the latest equipment after major repairs, as well as all the medical facilities built in them, "she said.

All types of equipment are purchased with pre-fixed delivery times so that the equipment comes to the opening of new or updated facilities.

In accordance with the updated Moscow standard of polyclinics, all analog medical equipment is gradually replaced by digital equipment, which allows it to be integrated into a single medical platform and improve the quality of diagnostics. All head buildings of polyclinics are equipped with MRI, CT, densitometers, ULTRASONOGRAPHY expert-class devices, equipment for monitoring the condition of patients with coronary disease, hearts patients after heart attack or surgery on heart vessels.

Endoscopic centers and multidisciplinary hospitals use gastroscopes, colonoscopes, bronchoscopes, endoscopic stands for surgery and other types of equipment.

The equipment is also used in diagnostic studies and operations at large cancer centers, helping doctors detect tumors in the early stages.

In 2019-2022, within the framework of life cycle contracts (LCC), more than 5.5 thousand units of medical equipment were purchased - ultrasound, endoscopic equipment, radiographic devices such as C-arc and U-arc, computer tomographs, magnetic resonance imaging, angiographs, mammographs, X-ray densitometers, incubators for newborns and more.

This procurement technology first began to be used for urban health at the end of 2019. Within the framework of the LCC, the supplier guarantees the operability of the equipment during the entire life cycle, performs its maintenance throughout the entire service life. Thanks to this, the equipment can be used without interruptions for repair or maintenance, which increases the availability and quality of medical care for patients. The long-term nature of the contracts obliges the supplier to take an even more responsible approach to the quality of the supplied equipment and almost completely eliminates equipment downtime.

The United States lifted the ban on the supply of medical equipment to Russia

The Office of Foreign Assets Control (OFAC) Ministry of Finance USA has authorized Russia transactions related to the supply of medical equipment and a number of other devices.

In order to ensure that these sanctions and bans have an impact on the planned goals and minimize unintended consequences for third parties, OFAC publishes a number of exceptions, the US Treasury said (quoted by RIA Novosti).

As follows from the document, agricultural and medical trade is not the subject of sanctions imposed by the United States against Russia. Thus, financial institutions of the country can process transactions related to the supply of drugs or medical devices in or from the Russian Federation. Certain operations related to the processing of medical goods in the port of Novorossiysk are also allowed.

The full list of sanctioned goods and services includes medicines, medical devices, spare parts, components and software updates for medical devices.

In addition, restrictions are relaxed on operations regarding the prevention, diagnosis or treatment of the coronavirus COVID-19. This applies to research, including clinical, ongoing clinical trials and other medical research.

Since March 2022, foreign ones states began to introduce "restrictive measures of an economic nature" against Russia. In parallel, during this period, by mid-July 2022, more than 15 large foreign pharmaceutical companies limited their activities in the Russian Federation. Some of them, for example,, and the AmericanEli Lilly, AbbVie the BritishGSK partially refused to supply their products to the country. The same companies, along with Swiss, Novartis Japanese Takeda the AmericanPfizer and refused to initiate new CTs in Russia and stopped recruiting participants in current studies. US^[13]

55% of representatives of the Russian medical equipment service market believe in its growth under sanctions

Okdesk on May 19, 2022 shared the results of the All-Russian study "Service and repair of medical equipment under sanctions." The study was carried out with the support of the industry community: service companies, vendors and distributors of medical equipment of various scales from all over the Russian Federation, which have a license for the maintenance of medical devices. 78% of respondents are executives or owners of companies.

70% of respondents felt a shortage of spare parts for medical equipment due to failures and restructuring of their supply chains.

Despite the possible difficulties with the supply of spare parts, 85% of respondents believe that service contracts concluded before February 22, 2022 will be fully fulfilled.

47% of respondents believe that retention of current customers is the most important component for maintaining financial stability. In second place (27%) is cost reduction.

74% of respondents assume that the cost of repair and maintenance services for medical equipment will increase by no more than 60%. Of these, 27% of respondents believe that the growth will be no more than 20%. 22% of respondents believe that the growth will be 20-40%. 25% believe that the growth will be 40-60%.

Most respondents are optimistic about the prospects for the development of the medical equipment service market. Thus, 55% of respondents believe that the market will grow, because it is cheaper to repair and extend the service life of old medical equipment than to buy a new one.

The purpose of our study is to give an objective picture of what is happening and predict future changes in the industry thanks to the opinion of those who are engaged in the maintenance of medical equipment every day, - said Dmitry Nikolaev, deputy head of industry development at Okdesk . - I am sure that the results obtained will help service companies to navigate and increase the planning horizon and open up new opportunities in the context of sanctions restrictions.

Issue of recommendation on operation of medical devices connected to the Internet

In April 2022, the Federal Service for Supervision of Healthcare (Roszdravnadzor) issued recommendations for the operation of medical devices connected to the Internet. The main provisions of this document are as follows:

• if two-way information exchange is required, medical devices shall be interfaced with external networks using a firewall configured in accordance with the rules defining network interaction exclusively by 1P addresses, source ports, receivers, protocols and other parameters necessary for the correct functioning of medical devices, as well as using a secure communication channel;

• if one-way exchange of information from medical devices to external networks is necessary, technical means of unidirectional data transmission shall be used, excluding transmission of control commands;

• in the absence of technological necessity of interaction with external networks of medical devices, medical devices shall function as part of the technological network;

• in the event that a medical organization is unable to use a secure data network, the medical device must either function as part of an isolated technological network, or the transfer of information between different components of medical devices (for example, between the operator's workstation and the doctor's workstation) must be carried out using portable information storage devices (for example, CD and DVD disks, flash cards, external hard drives, etc.);

• before updating the medical equipment software, it is necessary to ensure the creation of backups of the version used software to be able to return to its previously installed version.^[14]

The limit on the purchase of medical equipment at the expense of compulsory medical insurance has been increased 10 times

In March 2022, Prime Minister Mikhail Mishustin signed a decree that expanded the capabilities of medical organizations to purchase medical equipment for medical interventions, laboratory and instrumental research at the expense of the Compulsory Health Insurance Fund.

According to the press service of the Cabinet, hospitals and clinics operating under the compulsory medical insurance system will be able to purchase medical products worth up to 1 million rubles (per unit), and not up to 100 thousand rubles, as it was before.

The limit of funds for compulsory medical insurance Campus Management has been increased tenfold. This means that regardless of the sanctions, doctors will have everything they need to help the patient, "explained the first deputy head of FMBATatyan Yakovleva.

The new scheme, as reported in the government, "will ensure the financial stability of medical organizations in the context of Western sanctions imposed on Russia," and "hospitals and clinics will be able to update equipment in a timely manner, improving the quality of assistance to citizens."^[15]

The structure of the tariff (what medical organizations can spend the proceeds from compulsory medical insurance) in the same form, adopted back in 2012, was recorded in two other documents - the 326-FZ "On compulsory medical insurance" and the rules of compulsory medical insurance. It assumes that the cost of a unit of any fixed assets (medical equipment and medical devices) is limited to 100,000 rubles. The tariff also includes salaries, the purchase of medicines, consumables, tools, reagents, food, transport and utilities, property maintenance and more.

Tatyana Yakovleva recalled that earlier in March 2022, Russia was banned from exporting medical devices delivered from countries that joined anti-Russian sanctions abroad. The list includes heavy medical equipment, including devices for radiation therapy, medical equipment for artificial ventilation of the lungs, as well as personal protective equipment and consumables (bandages, cotton wool, gauze, gloves, shoe covers, bathrobes).

2021

Accounts Chamber: Suppliers of equipment to combat COVID-19 sold it at a reduced cost

Suppliers of medical equipment used to combat the COVID-19 coronavirus do not receive additional profits, and sales of devices are carried out at a reduced cost relative to prices on the market in 2020. This was announced on December 21, 2021 by the auditor of the Accounts Chamber (JV) of the Russian Federation Andrei Perchyan during the government hour in the State Duma.

According to him, the joint venture checked the supply of heat and television recorders, contactless thermometers, air disinfection plants, artificial lung ventilation devices and extracorporeal membrane oxygenation. Perchyan noted that almost all this equipment, except for thermometers, was produced by Russian companies.

At the same time, the suppliers did not receive any super-profits. Supplies of ventilators were carried out at a price twice as low as that recorded in 2020, he said.

The auditor of the Accounts Chamber noted that the purchase of medical devices and equipment to combat infection was carried out by the Ministry of Industry and Trade from the only suppliers. This made it possible to quickly resolve issues related to providing consumers with vital equipment and equipment, at the same time support Russian manufacturers, he pointed out and added that the supplied equipment is in demand and used for its intended purpose.

On December 22, 2021 Russia , the simplified procedure for the import of medical devices intended to combat the COVID-19 coronavirus into the country was extended. This order will be valid until January 1, 2025. In addition, prior to this period, temporary registration certificates and permits for the use of these medical devices will be valid.

In January-September 2021, state customers purchased medical equipment and medical products worth 347.5 billion rubles (purchases under 44-FZ/94-FZ). Compared to the same period in 2020, the volume of purchases decreased by 14%.^[16]

In the Irkutsk region bought 15 tomographs and 20 mammographs

In the Irkutsk region in 2021, 12 devices for magnetic resonance imaging (MRI), three computer tomographs ( MSCT) and 20 digital mammographs were purchased . In addition, 129 million rubles were allocated for the repair of high-tech diagnostic equipment. This was announced on October 20, 2021 by the Minister of Health of the Irkutsk Region Yakov Sandakov.

According to the deputy of the Legislative Assembly Irina Sintsova, special attention should be paid to remote northern territories, where there are often no conditions for installing equipment in existing hospital buildings, but people need diagnostics. Yakov Sandakov explained that the regional Ministry of Health is engaged in the issue of equipping the northern territories with equipment for computer diagnostics. Funds are provided for the reconstruction of a medical facility in Zheleznogorsk-Ilimsky. In Zhigalovo, it is planned to build an infectious diseases hospital, which can also accommodate devices. For institutions where it is not yet possible to carry out reconstruction, digital X-ray installations are purchased.

ZS deputy Artem Lobkov said that an outpatient oncological care center was opened in Ust-Ilimsk two years ago, but due to the lack of equipment, people still cannot undergo research. The Ministry of Health plans to consider this issue in 2022. However, Artem Lobkov believes that the problem requires an urgent solution.

In addition, parliamentarians will continue to monitor the implementation of the project for the construction of the radiological building of the East Siberian Cancer Center in Irkutsk. For October 2021, construction of a zero cycle is underway. All work should be completed in 2024. They are carried out under a concession agreement, which was signed in 2018 between the Irkutsk region and JSC Rusatom Healthcare.

Deputy Alexander Gaskov stressed that in some regions, for example, in the Krasnoyarsk Territory and in the Republic of Buryatia, the construction of similar health care institutions is supported by funding from the federal budget. The Irkutsk region did not receive such assistance in this case. Alexander Gaskov said that the experience of other regions may be useful in the future, so it must be carefully^[17].

Start of supplies of defibrillators to Russian dentistry

On February 26, 2021, the Shvabe holding announced the supply of more than 240 ANDA A15 defibrillators in dentistry in the Sverdlovsk, Kemerovo and Novosibirsk regions. By the end of the year, clinics will receive another 1,200 units of such medical equipment. Deliveries are carried out on a competitive basis. Read more here.

2020

The Government of the Russian Federation introduced the minimum shares of the purchase of domestic medical equipment

In early December 2020, the Government of the Russian Federation established a minimum share of purchases of goods of domestic origin, including medical equipment. The share is determined as a percentage of the volume of goods, works, services of the corresponding type carried out by the customer in the reporting year (from 2021 to 2023). Read more here.

By 2023, all outdated medical equipment in clinics will be replaced by digital

By 2023, all outdated medical equipment in polyclinics will be replaced by digital. This became known on November 25, 2020.

In three years, the city authorities will 100% update medical equipment in hospitals and clinics. As of November 2020, more than 80% of all diagnostic equipment in the capital is digital. This allows you to include it in a single digital medical space of the capital and improve the quality of diagnostics.

The total database has already collected more than six million digital images, their number is constantly growing.

Many cities and countries around the world create electronic archives of X-ray and tomographic images. This makes life easier for patients, since you do not need to carry many different documents with you by doctors and undergo duplicate research^[18].

The Ministry of Health of the Russian Federation ordered suppliers to provide medical institutions with keys to access to medical equipment

In mid-October 2020, the Ministry of Justice of the Russian Federation registered an order of the Ministry of Health "On Amendments to the Standard Contract for the Supply of Medical Devices, Commissioning of Medical Devices, Training in the Rules of Operation of Specialists Operating Medical Devices and Specialists Performing Maintenance of Medical Devices."

In accordance with the order, the manufacturer must provide the customer (recipient) with the information necessary for working with the medical device, including keys, access passwords, programs and other information necessary for installation, adjustment, use, operation. Also, the manufacturer of medical devices is obliged to train persons involved in their maintenance.

The Supplier shall provide the Customer with information on consumables and reagents of other manufacturers authorized by the equipment manufacturer.

The initiative to oblige suppliers to transfer access keys and passwords for servicing medical equipment was previously made by the Federal Antimonopoly Service (FAS). According to the deputy head of the department, Andrei Tsyganov, due to the lack of access to the service, recipients of equipment are dependent on suppliers, at whose discretion prices, deadlines for the work and the composition of repair and maintenance performers are formed.

The regulator proposed to normatively consolidate the obligation of the manufacturer (supplier) of a medical device to transfer, together with a medical device, the information, keys, passwords, etc. necessary for its repair and maintenance, thereby ensuring the right of the owner - a medical organization - to fully own, use and dispose of his property - a medical device, as well as choose suppliers of services for installation, adjustment, repair and maintenance of equipment.^[19]

Over the year, the volume of life cycle contracts exceeded 31 billion rubles

Over the year, the volume of life cycle contracts in healthcare exceeded 31 billion rubles. This was announced on October 7, 2020 by the Department of Investment and Industrial Policy of the city of Moscow (DIiPP).

At the end of 2019, the city began to conclude life cycle contracts in the field. health care Over the year, contracts for the supply and maintenance of medical equipment for city institutions were concluded with well-known world manufacturers of equipment,, for Philips Siemens GE Canon a total amount of more than 31 billion rubles, said Deputy Mayor for Moscow Economic Policy and Property and Land Relations Vladimir Efimov.

Life cycle contracts provide for the purchase of goods with further maintenance and repair by the supplier during the entire service life of the specified goods.

Life cycle contracts provide the best value for money for the equipment, and include its service by the manufacturer. As part of such contracts, the city not only acquires high-tech goods, but also its performance for the entire period of operation. RCC has already proven its effectiveness transport in the field of and, and since HOUSING AND PUBLIC UTILITIES 2019 we have begun to conclude such contracts in healthcare. The total volume of the LCC Moscow today is about 515 billion rubles, of which to medicine more than 31 billion rubles, "said Vice Mayor Vladimir Efimov.

The use of life cycle contracts also significantly reduces the initial price of equipment.

{{quote 'Moscow continues to implement a large-scale program for the purchase of medical equipment under life cycle contracts. In October 2020, we began the second stage of the program - purchases for the conclusion of contracts for mammographs and digital X-ray machines have already been announced or have taken place. According to the already completed competitive procedures, the average decrease in the initial price was about 47%. Thanks to the LCC in healthcare, the capital will receive equipment with a 10-year service from manufacturers who have not only production capacity, but also relevant experience in the service. As the results of the competitions showed, from 2 to 7 offers from different manufacturers of medical equipment were submitted for each lot. Competition made it possible to significantly reduce the price of the contract. The maximum decrease at the auction reached 70%, - said Anastasia Rakova. }}

The tender documentation established technical requirements that meet medical equipment for 2020. As a result of the conclusion of contracts, the latest models of equipment registered by the winning manufacturer will be delivered to medical institutions in Moscow.

In addition, Moscow is holding tenders for the purchase of medical equipment together with other regions. Such cooperation of customers at the interregional level allows not only to purchase equipment by 50% cheaper compared to the initial price, but also to be able to sign contracts directly with manufacturers of medical equipment, which are responsible not only for its supply, but also for performance, "said Alexander Prokhorov, head of the investment and industrial policy department.

Saratov OFAS saw the cartel at the auction for the supply of X-ray equipment for LPU

On January 24, 2020, TAdviser became known that the Saratov OFAS saw signs of a cartel conspiracy between SMS Technologies LLC and NIPK Electron CJSC at the 2018 auction for the supply of X-ray equipment for LPU Saratov region. Read more here.

2019

Russia lags behind in the share of medical equipment in the healthcare market

In Russia, unlike some other countries, the main share of medical and pharmaceutical production falls on drugs, and not on medical equipment.

The Moscow government saved up to 50% on the purchase of medical equipment

On January 20, 2020, the Department of Investment and Industrial Policy of the city of Moscow reported that at the end of 2019, as part of the conclusion of life cycle contracts (LCC), Moscow purchased 42 angiographs with a total value of 2.9 billion rubles, 101 MRI devices with a total value of 11 billion rubles, 116 CT devices worth 5.5 billion rubles. This was announced by the Deputy Mayor of Moscow for Economic Policy and Property and Land Relations Vladimir Efimov.

Lifecycle contracts are a new format for purchasing equipment. We buy not just equipment, but enter into a long-term partnership. This allows us to reduce costs, minimize risks and achieve the maximum result. So, at the last auction, the city managed to save 11.6 billion rubles. At the same time, the supplier guarantees the operability of the equipment throughout the life cycle. After one day of downtime, in the absence of prompt repair, the monthly payment under the contract is not paid, and a fine is charged to the supplier, " noted' Anastasia Rakova, Deputy Mayor of Moscow for Social Development

"Leading medical institutions around the world are moving from a mechanism for awarding separate short-term contracts for the supply and service of equipment to awarding life-cycle contracts. The LCC includes the supply and service of equipment during the life cycle of the equipment. As for the experience of Moscow, for the first time the KZhC began to be introduced when supplying metro cars. As of January 2020, this mechanism is used for the purchase and maintenance of buses, electric buses, trams. The total volume of life cycle contracts concluded by Moscow is 486.1 billion rubles, " noted Vladimir Efimov, Deputy Mayor of Moscow for Economic Policy and Property and Land Relations

At the end of 2019, the average price reduction during trading was 42%. In particular, during competitive procedures for 4 lots for the supply of angiographs, the price reduction was 46%, which saved 2.6 billion rubles. As part of the procurement procedures for MRI, the savings amounted to 41% (savings of 7.5 billion rubles), CT - also 41% (savings of 3.9 billion rubles).

According to Vladimir Efimov, the financial model of the KZhC is drawn up in such a way that the purchase of equipment is carried out in installments for 3 years, which allows you to direct the saved budget funds for other purposes.

Commenting on the procedure for choosing potential performers for the LCC, the head of the Department of Investment and Industrial Policy of Moscow, Alexander Prokhorov, noted that cost and non-cost criteria are taken into account when determining the winners. Among the non-permanent ones are the availability of equipment production, the presence of experience in performing the CC, as well as lowering coefficients for indexing the cost of service and the rate for installments.

"The life cycle contract that we are playing under 223 federal laws can almost halve the cost of equipment purchases. The LCC contract implementation period is 10-13 years depending on the equipment delivery period. For 3 years, the customer pays for equipment in installments, the rate for installments is equal to the key rate of the Central Bank of the Russian Federation, taking into account the reduction factor, which is the criterion of the competition. During the LCC period, the Contractor is obliged to ensure the operability of the equipment with a minimum downtime. As the experience of holding competitions has shown, the performers are ready to reduce the downtime to the minimum values ​ ​ (1-3 days per quarter). In addition to supplying the equipment and ensuring its operability, the contractor is also responsible for training doctors and specialists-engineers of the customer, for updating the equipment software, " noted Alexander Prokhorov, Head of the Moscow Department of Investment and Industrial Policy

The developed criteria allow you to choose the contractor who offered the best financial conditions for the execution of the contract and has the necessary competence, which was confirmed by the experience of holding tenders in 2019. For each lot, the world's leading manufacturers won: Siemens, Philips, GE, Canon.

The constituent entities of the Russian Federation can also conclude a CFC for medical equipment, including by holding joint tenders with Moscow. The head of the Department of Investment and Industrial Policy gave an example of the Perm Territory. "During trading, the decline was 50% of the initial value. In fact, the Perm Territory purchased equipment twice as cheaper, "said Alexander Prokhorov.

The aggregation of the needs of several customers is used when purchasing medical equipment through a life cycle contract. Consolidation of customer needs at the interregional level can act as an additional driver of cost efficiency, said Gennady Dogtev, head of the Moscow City Department for Competitive Policy.

"In 2019, an interregional joint open tender was held in electronic form for the right to conclude an agreement on the supply, installation of medical equipment for angiography. The average rate of decline in unit trading was more than 40 percent of the starting price. You can establish feedback on the readiness of the regions to join joint trading through the project website mos-tender.com/lcc, " noted Gennady Dögtev, Head of the Moscow City Department for Competition Policy

According to Deputy Mayor Vladimir Efimov, the economic attractiveness of KZhC for manufacturers is the long-term loading of the production base and guaranteed cash flow when quality indicators are achieved.

"We expect that the regions will join Moscow in 2020 to conduct joint tenders for the right to conclude a WCC in relation to medical equipment," noted Vladimir Efimov, Deputy Mayor of Moscow for Economic Policy and Property and Land Relations

Russia has created a list of medical equipment that can be imported without registration for scientific purposes

At the end of October 2019, it became known about the creation in Russia of a list of medical equipment that can be imported without registration for scientific purposes. The Minister of Health of the Russian Federation Veronika Skvortsova spoke about this at a meeting of President Vladimir Putin with representatives of the public in the Kaliningrad region.

The event was attended by the managing partner of 3D Bioprinting Solutions Youssef Hesuani, who, addressing the president, said that the purchase of foreign scientific equipment uses federal law No. 127 ("On Science and State Scientific and Technical Policy").

But if you need medical equipment - [we fall] under 323-FZ, and we must already register such equipment, although we use it for scientific purposes, and not for medical ones. Many scientific organizations have such a problem. Recently discussed with colleagues from Skolkovo. We offer for medical equipment, which will be used for scientific purposes, to introduce special labeling, and this will allow us to use the equipment within the 127-FZ, "Hesuani said (quoted by Vademecum).

According to Veronika Skvortsova, within the framework of the Eurasian Council, an act was introduced stating that for scientific purposes medical equipment is not subject to registration and "can be imported as you say."

And now in order to harmonize our legislation to the Eurasian one, we have prepared a bill and submitted it to the government... There will be a list of the equipment that is used for scientific purposes, and it can be imported without registration, she said.

According to information from the Roszdravnadzor website, in accordance with the FZ-127 of state registration, those medical devices that are originally intended for scientific research by the manufacturer at release are not subject to, and the circulation of other products is carried out on a general basis.^[20]

In Samara, all persons involved in the conspiracy case in the purchase of medical equipment worth 4 billion rubles were convicted.

On July 31, 2019, it became known that the Samara District Court sentenced all seven defendants in the case of conspiracy at tenders for the maintenance and repair of equipment in medical institutions of the Samara region with a contract worth 4 billion 253.8 million rubles.

Thus, the former Deputy Minister of Health of the Samara Region Albert Navasardyan was sentenced to 3 years in prison in a general regime colony. Maxim Kolobov, head of the department for organizing the provision of medical equipment of the regional Ministry of Health, was sentenced to 2 years of suspended imprisonment. Director of the winning LLC "Modern Medical Technologies" (SMT, Samara) Sergey Shatilo received 3.5 years in prison in a general regime colony. His deputy Alexei Sankeev - 2.5 years of suspended imprisonment. Read more here.

2018

Medical equipment suppliers in Russia may be obliged to transfer keys to customers for repairing devices

At the end of November 2018, the Federal Antimonopoly Service (FAS) of the Russian Federation proposed to oblige manufacturers and suppliers of medical equipment to transfer passwords and access keys to customers for maintenance and repair of equipment. This initiative was voiced by the deputy head of the antimonopoly service Andrei Tsyganov.

The market for maintenance and repair of medical devices remains relatively closed, <…>since suppliers of medical devices do not fully provide the necessary information, software, keys and passwords not only to third-party contractors for performing the necessary technical maintenance and repair, but also to the buyers themselves - medical organizations that own the corresponding medical devices. Tsyganov said at a meeting of the Competition Committee of the Organization for Economic Cooperation and Development (OECD).

According to him, hospitals are dependent on distributors, at whose discretion prices, terms of work and the composition of repair and maintenance performers are formed. The deputy head of the FAS called this situation "artificial monopolization of the market," due to which the quality of services may decrease, since giving any service organization exclusive rights does not always mean that this organization is the best.

To solve this problem, according to the antimonopoly regulator, it is necessary to normatively fix the obligation of the manufacturer or supplier to transmit, together with the medical device, the information, keys, passwords necessary for its repair and maintenance. In addition, the FAS proposes to fix the right of medical institutions to independently choose suppliers of services for the installation, adjustment, repair and maintenance of equipment.^[21]

FAS revealed a cartel of suppliers of medical equipment

In November 2018, the Federal Antimonopoly Service (FAS) announced the disclosure of a cartel of medical suppliers. Participants in the conspiracy supported prices at a high level at the auction, the Prime agency reports, citing a statement from the antimonopoly regulator.

Aksonmed, Division, Intermediate, Lotus and Satori are suspected of concluding and implementing an anti-competitive agreement. Their price conspiracy acted within the framework of electronic auctions for the supply of tools, equipment, consumables and other medical devices for the needs of state and municipal health care institutions.

Bidding dating from 2015-2016 took place in eight Russian regions and ended with a minimum decrease in the initial price of contracts, the FAS notes.^[22]

The amount of damage caused by the cartel is not called, but the suspects in the company's conspiracy, according to the public procurement portal, in 2015-2016 received supply contracts worth from 0.5 million to 16 million rubles each. According to preliminary data, we are talking about 19 auctions.

Such crimes are committed quite often in Russia. In 2017, the number of cartel collusions identified by the FAS in public procurement of medicines and medical products reached 19% of all cartel cases. More violations were found only in the construction market.

In August 2018, the antimonopoly service reported that it had identified a cartel conspiracy when bidding for the supply of medical devices and drugs for Khakassia. Then 13 companies were suspected of collusion, which, according to the department, entered into an oral agreement to maintain prices at the auction, as a result of which the auctions ended with a minimum decrease in the contract price.

In 2018, the FAS developed and submitted to the Government of the Russian Federation a bill to tighten liability for participation in a cartel conspiracy.

Medical equipment in Russia is becoming more expensive due to VAT

On August 6, 2018, it became known that manufacturers and distributors of medical equipment asked the Russian government to revise the VAT conditions for them. The corresponding letter was sent to the first deputy chairman of the government and Minister of Finance Anton Siluanov, Minister of Health Veronika Skvortsova and Minister of Economic Development Maxim Oreshkin, Vedomosti writes.

It follows from the document that with the transition to a new classifier of medical devices OKPD-2 in January 2017, equipment that was subject to VAT at a preferential rate of 0 or 10% began to be subject to a standard rate of 18%. In particular, we are talking about tomographs, electrocardiographs, ultrasound diagnostics, pacemakers, lasers. This is due to the fact that products that appeared on the market after 2017 are assigned new codes, because of this, companies are forced to pay VAT in full.

This prevents suppliers from bringing new products to the market, which are technologically better, but from a price point of view, it becomes less competitive, and medical institutions do not purchase it, "Yuri Matvienko, General Director of Medrelis LLC, explained to the publication.

Manufacturers are not motivated to register new equipment, says Andrei Starostin, General Director of CJSC Cardioelectronics. Otherwise, it turns out that almost the same models will differ in price by 20%, and foreign goods often simply do not have categories, which is why they have to be distributed in categories subject to VAT without benefits, he points out.

The representative of the Ministry of Finance, in a conversation with Vedomosti, promised that the letter from manufacturers and suppliers of medical equipment would be considered, and the Ministry of Economic Development that it was being considered by early August 2018.^[23]

2017: Collusion of suppliers of medical equipment for 2.5 billion rubles

On December 5, 2017, the Federal Antimonopoly Service (FAS) of Russia announced the identification of one of the largest collusions in the Russian market for medical equipment for the treatment of cardiovascular diseases.

According to the antimonopoly regulator, Invamed LLC , Micromed LLC, Medprolife LLC, Prommedzakupka LLC and Medtorg LLC were found guilty of violating the law on protection of competition. These companies, according to the FAS, entered into an anti-competitive agreement in order to support the prices at the auction for the supply of medical instruments, equipment, consumables and pacemakers for the needs of Russian healthcare institutions in 2015-2017. 

It is reported that the cartel participants who distributed the winners of the auction among themselves covered a total of 360 transactions, and the total amount of state contracts concluded exceeded 2.5 billion rubles.

Companies that conclude government contracts for the supply of products for medical care in violation of antimonopoly laws, pursuing only their own benefits, should be aware of their responsibility for the damage they cause to the life and health of the population, "said State Secretary - Deputy Head of the FAS Russia Andrei Tsarikovsky.

All the defendants in the case admitted to violating antitrust laws and refused to further participate in the cartel conspiracy, the FAS said in a statement.^[24]

According to Andrei Tenishev, head of the FAS anti-cartel department, from 2015 to 2017, in the field of the supply of pharmaceuticals and medical equipment, the service revealed cartels during 6 thousand trades, the total amount of the initial maximum prices of contracts for which exceeded 23 billion rubles.

2016

A quarter of medical equipment expires

As of July 2016, about a quarter of medical equipment working in state hospitals and clinics and mainly updated since 2006 within the framework of the national project will expire in the near future, according to Kommersant^[25]. Neither the federal budget nor the FFOMS have funds for a large-scale renewal of the medical equipment fleet, as in 2006-2010 and 2011-2012.

In 2016, the compulsory medical insurance system may celebrate its anniversary - ten years ago, the government began updating the fleet of medical equipment in state hospitals and clinics. First, in 2006-2010, within the framework of the national project "Health" worth more than 400 billion rubles, and then - during the program of transition to insurance principles in compulsory medical insurance (2010-2013). Then at least 15% of 460 billion rubles were spent on the purchase of tomographs, X-ray rooms and the additional equipment of surgical centers. Its budget, that is, about 70 billion rubles. The official data that the Ministry of Health provided at the request of Kommersant cover only 2007-2012. During this period, as reported by the department, regional and federal institutions purchased and installed more than 389 thousand pieces of equipment, including more than 700 magnetic resonance and computer tomographs, more than 6.5 thousand pieces of X-ray equipment and angiographs.

The service life of such medical equipment, according to Sergei Chiryev, head of the Cardiology department at Philips, does not exceed seven to eight years on average.

"Since massive purchases of medical equipment began ten years ago, it is partially already starting to fail," he

says.

According to Andrei Vilensky, head of the Meditex marketing company, the share of medical equipment, the service life of which will be released by the end of 2016, is about 20%. According to David Melik-Huseynov, head of the State Budgetary Institution of Healthcare Organization, the volume of such equipment is even greater - up to 40%.

Similar information "Kommersant" provided regional Ministry of Health. According to the Minister of Health of the Ulyanovsk Region Pavel Degtyar, "part of the equipment purchased at that time is already being decommissioned," but this is not only about medical equipment. First of all, these are ambulances, "the service life of which has already ended." The head of the Ministry of Health Veronika Skvortsova also pointed out the excessively long service life of medical equipment - citing tomographs as an example, she said that "if one should work for five to seven years, then we have actually worked for ten years." However, the Ministry of Health officially estimates the average age of medical equipment in the compulsory medical insurance system at 4.6 years. At the same time, when asked about the characteristics of certain types of equipment, the department told Kommersant that the average age of tomography devices is 6.5 years, and the share of radiation diagnostics equipment that has been in operation for more than ten years reaches almost a quarter of its total. "6.5 years is the average age not only of tomographs, but also of all equipment, the purchases of which started ten years ago," says Mr. Melik-Huseynov. Kommersant called the same figure "as more realistic," asking not to name his position, the interlocutor in the Ministry of Health.

According to Mr. Chiryev, modern medical equipment has significantly affected the decline in mortality in the country over the past few years.

"For example, the reduction in cardiovascular deaths is the result of the construction across the country of specialized vascular centres with new equipment. But as soon as the medical equipment starts to fail, the mortality rate will begin to rise, "he

says.

However, based on the parameters of the state program "Development of Health Care 2013-2020," in the next four years it is planned to update only certain types of equipment - for childbirth, the development of the blood service and hepatitis testing. Note, however, that the peculiarities of the government's work on the budget of 2017-2019 imply a massive revision of state programs. In the budget designs submitted by the Ministry of Finance to the government, the maximum expenditures of the federal budget for the state program "Development of Healthcare" are 15-35% lower than those indicated in its passport; in these conditions, it is not necessary to assume that there will be funds for previously not planned purchases of medical equipment that has risen in price as a result of the devaluation of the ruble.

Some share of the costs of repair and purchase of new equipment are borne by regional budgets. Since 2017, the line of equipment costs will also appear in the budget of the FFOMS - due to a reduction in payments to medical insurance companies for conducting examinations. Insurance organizations themselves estimated their future losses at 2 billion rubles. - However, of these funds, which in themselves are not comparable to the costs of a decade ago, territorial compulsory medical insurance funds will also pay for educational certificates of doctors.

In such a situation, another problem - the insufficiently high level of equipment load recorded by Roszdravnadzor - begins to look different. The low efficiency of using expensive medical equipment can be the factor that will extend its service life. But the level of research on population diseases, the expansion of which was called one of the main goals of equipment modernization, will remain relatively low.

In most of the regions surveyed by Kommersant, the medical authorities admit that medical equipment from the first wave of renewal - its constituent entities of the Russian Federation received within the framework of the Zdorovye national project - is coming to the end of its service life and is either being withdrawn from circulation, or continues to work after repairs at the expense of territorial branches of the MHIF.

St. Petersburg

Maria Khitarishvili, a specialist in the press service of the St. Petersburg Health Committee, told Kommersant that the bulk of the diagnostic equipment within the framework of the Health national project was purchased in 2006-2007. In 2006, 193.5 million rubles were allocated for equipping outpatient and polyclinic institutions with diagnostic equipment at the expense of the federal budget, 242 pieces of equipment were delivered, 236 million rubles were allocated in 2007, 278 pieces of diagnostic equipment were delivered. In 2006, 50 million rubles were allocated for the purchase of sanitary vehicles. Funds from the federal budget, 87 cars were bought, in 2007 for 61.7 million rubles. 88 cars were bought. Purchases were formed on the basis of applications from districts, since the main goal was to equip outpatient institutions. At the end of 2013, the district prosecutors of St. Petersburg conducted eight inspections of the effectiveness of the use of expensive equipment, downtime and inefficient use were not identified.

The press secretary of the committee, Evgenia Semenova, added that X-ray endiagnostic equipment, equipment for ultrasound, ECG, laboratory complexes were sent to city clinics and women's consultations:

"It

was good new equipment. At that time, this was a good re-equipment for polyclinics. Of course, the city could not pull such millions of sums then. In addition, within the framework of the national project, money was allocated not only for the technical re-equipment of clinics, but also for the training of specialists to work with new equipment, as well as for raising salaries for doctors and nurses. "

According to her, the service life of the equipment purchased ten years ago could reach 20 years. At the same time, the head of the health department of the Central District Administration, Sergei Bezhenar, said that some equipment had already worked out its term. For example, the life of X-rays is coming to an end. In one of the district polyclinics, one device has already been replaced.

Stavropol Territory

According to the Ministry of Health of the Stavropol Territory, within the framework of the national project "Health," the Territory in 2006-2007 received medical equipment from Moscow, where auctions were held. At the moment, since ten years have passed, most of the equipment received under this program is already working "at the limit of capabilities." However, according to the regional Ministry of Health, in 2011-2013, equipment was modernized in the region. The regional government adopted a program of "modernization of health care in the Stavropol Territory," about 2.2 billion rubles were spent on it. from the compulsory medical insurance fund and the regional budget.

"The process of upgrading equipment, which can naturally age and break, is constantly going on with us. Funding sources are different, including the territorial medical insurance fund, budget, maternity certificates, paid services and even donations, "the ministry

said.

However, in connection with the approval by the federal Ministry of Health of the standards of medical care, according to the table of equipping medical institutions with the necessary equipment, the region additionally needs to spend more than 4.5 billion rubles in order to comply with these standards.

Nizhny Novgorod region

The government of the Nizhny Novgorod region, in response to a request from Kommersant, reported that computer and magnetic resonance imaging devices, as well as stationary angiography devices, had been actively purchased since 2009. In total, 30 computer, six magnetic resonance tomographs and four angiographs were purchased for trauma centers, vascular centers, primary vascular departments, as well as for the regional cardiac surgery hospital and oncology center. The regional Ministry of Health noted that "the service life of medical equipment is defined in the technical documentation and depends both on the operating conditions, the regularity of technical repairs, and on the operational resource laid down by the manufacturer. Repair of medical equipment is carried out at the expense of the regional budget, as well as the standardized insurance stock of the TFCMI in accordance with the decree of the federal government. "

Rostov region

The Ministry of Health of the Rostov Region told Kommersant-Yug that the bulk of the complex medical equipment (tomographs, X-ray machines, etc.) was purchased by large medical organizations in the city from 2011 to 2014. Warranty service for all devices ranges from three to five years.

Ulyanovsk region

As part of the priority national project "Health" in 2007, about 300 units of diagnostic equipment worth 245 million rubles were received in the Ulyanovsk region. (ultrasound devices, endoscopic racks, neonatal screening laboratory, etc.), also within the framework of the national project, the region's ambulance service received an additional 56 specialized vehicles. According to the regional Minister of Health Pavel Degtyar, "part of the equipment purchased at that time is already being decommissioned" - these are primarily ambulances, "the service life of which has already expired." Heavy diagnostic equipment "mainly works," small - obsolete and replaced as much as possible. "As part of the regional health development program, we are carrying out the necessary repairs of equipment, purchasing new ones," says Mr. Degtyar. He also explained that under the new federal program for the modernization of health care, new ambulances will be received in 2016.

According to the minister, so far, despite the regional budget deficit, it is possible to maintain the efficiency of the equipment and ensure its timely replacement.

"Moreover, all pieces of equipment supplied within the framework of the national project are under the control of the supervisory authorities - the prosecutor's office and Roszdravnadzor, and we report to them in a monthly format," Mr. Degtyar explained

.

The Minister also noted that at the expense of the regional budget, the range of diagnostic equipment will be expanded, and funds for this will be sought, since "the governor has declared priorities, 2016 has been declared the year of health care." "But if there is support for the federal budget, then it will be great for us," he added.

Kemerovo region

According to the press service of the administration of the Kemerovo region, in 2015, 408 units of modern medical equipment were purchased from medical institutions in the region, from 2011 to 2013 - 5.5 thousand units as part of the regional program for the modernization of regional health care. As explained in the press service of the regional department of health protection, it is for this period and the program that accounts for the bulk of the modern expensive equipment purchased in the last decade. The previous peak was in 2006-2007. Regarding the wear of equipment, the press service clarified that the average service life of expensive medical equipment is 8-10 years, after which replacement or overhaul with a long stop is required, since the necessary parts can be waited for several months.

Bashkiria

According to the Ministry of Health of Bashkiria, the bulk of the complex technical medical equipment - about 5 thousand units - was also purchased in 2011-2013 as part of the federal modernization program. It was difficult to name the terms of its operation.

Perm Territory

As explained to Kommersant in the regional ministry, for 2006-2012, within the framework of the Zdorovye national project, medical organizations of the Perm Territory received various medical equipment (X-ray equipment, fluorographs, mammographs, digitizers, ultrasound and IVL devices, equipment for neonatal and audiological screening, equipment for blood service, equipment for health centers, etc.). In 2006, 104 cars were purchased. How many of them are still operated, the Ministry of Health did not specify. But the interlocutor of Kommersant, familiar with the situation, believes that currently it is unlikely that more than a third of them are on the move.

"On average, the mileage of an ambulance is 150 km per day, which is 50-60 thousand km per year. For ten years - 500-600 thousand km. Our engines are unable to do this, "he said

.

In total, federal funds totaling 1.4 billion rubles were raised to equip medical organizations of the Perm Territory with equipment and sanitary vehicles. Most of the medical equipment received as part of the priority national project "Health" is in working order and in operation, the Ministry of Health said. Some of the equipment from the 2006-2007 deliveries has already been decommissioned due to the expiration of its service life.

Trans-Baikal Territory

The Trans-Baikal Territory within the framework of the national project "Health" in 2006-2007 purchased 520 units of equipment and sanitary vehicles for 400 million rubles. - among them are electrocardiographs, X-ray machines, ultrasound systems and endoscopes.

The 149 sanitary cars purchased at the same time completely renewed the fleet - and it was they who were the first to fail. "For ten years, the depreciation period for vehicles has come out, and given the state of roads in the Trans-Baikal Territory, even earlier," Elena Ovcharenko, press secretary of the regional Ministry of Health, told Kommersant. Different situation with medical equipment.

"In the districts, the load on them is low, the wear and tear of equipment is small, it can work for another twenty years," said Ms. Ovcharenko

.

She added that after the national project "Health," a federal modernization program was launched, within its framework the fleet was also significantly updated and a large number of medical equipment was purchased.

The Government of the Russian Federation allocated 15 billion rubles for import substitution in medicine

In July 2016, it became known that the Russian government allocated 15 billion rubles for the development of import substitution in medicine. This was reported by Interfax with reference to Russian Prime Minister Dmitry Medvedev.

As part of the import substitution action plan, 208 projects are now being implemented in the medical industry, more than half of them have already been completed. In accordance with the state program, we allocated 15 billion rubles from the budget for these purposes, "Medvedev said during a meeting of the government commission on import substitution on July 8, 2016.

The prime minister also noted that support for the medical industry should not be limited only to the allocation of funds. In his opinion, medicines produced on the territory of the EEC member countries, as well as medical devices, should have priority in public procurement.

Including it is necessary to strive for it to be on the territory of the entire Eurasian Economic Union, because we now have a common market, - said Dmitry Medvedev[26] have been[27] the[28].

In 2015, the domestic production of medical devices in Russia increased by about 10%, and the volume of the pharmaceutical industry increased by 24%. The list of vital drugs in Russia produces about 70%, by the end of 2016 the Ministry of Industry and Trade promises to bring this level to 76%, and by 2018 - to 90%.

In May 2016, sales showed that 56% of drugs are domestic. However, due to the cheapness in the total cost, their share was only 26%.

Medvedev stressed that Russia needs to "develop its own production, maintain the localization of the production of foreign drugs in our country." He drew attention to the fact that in the sectors of production of medicines and medical equipment there are plans of measures for import substitution, which complement the previously existing FTP in these areas. In total, according to the prime minister, last year and this year, through the Industrial Development Fund, Russian pharmaceutical manufacturers received loans in the amount of about 3 billion rubles, manufacturers of medical equipment - in the amount of about 2 billion rubles.^[29]

Dmitry Rogozin proposed to produce medical equipment based on the defense industry

On April 19, 2016, Deputy Prime Minister Dmitry Rogozin proposed using enterprises of the military-industrial complex (MIC) for the production of medical equipment and other civilian products.

The fact that the defense industry complex should be involved in the production of civilian products, Rogozin said at the congress of the Union of Machine Builders Russia in, the To Moscow agency reports. Interfax

How do we use - not as it was done in the 1990s under the guise of a conversion program - according to the mental technology, competence and a decent level of organization of the business that has developed in the military-industrial complex in the interests of the civil industry, - said the Deputy Prime Minister.

He said that in June 2016, a conference of the military-industrial commission will be held in Tula, during which it is planned to raise issues of manufacturing modern medical equipment and tools based on the defense industry complex.

According to Dmitry Rogozin, requests made to the customs authorities showed that huge amounts of money are spent on the purchase of such healthcare equipment abroad, which is "unacceptable neither economically nor politically."

Rogozin assured that the enterprises of mechanical engineering and the military-industrial complex are already ready to independently produce medical equipment and fulfill other civilian orders.

"The creation of an institute of general designers and general technologists will be a powerful help to answer all difficult questions," the statesman added.

Notes