
Medical devices approval market overview
Being involved in the field of MD registration for more than 15 years, we realize how crucial it is to get a comprehensive picture of the market before launching such a difficult process as a product registration. In this regard, we decided to use our expertise to help our current and potential partners to learn more about the Russian market of medical devices and healthcare systems.
If you are thinking about placing your product, we can provide you with the most recent and accurate information, regulations, statistics and analysis.
We help manufacturers and distributors to take the right step!
In congruity with our new business line we provide the following data on an openly published basis and would like to start with some figures of the Federal Budget allocations to the healthcare segment. These are the amounts approved for 2023 and planned for the next 2 years – a bit less than 1,5 trillion rubles with an increasing trend. As you can see, the government spends about 5% of the whole country budget to the healthcare segment, but these are just some general figures: small in terms of percentage, big in terms of overall numbers. However, the most interesting and self-explanatory parts are hidden inside. Details can make all the difference.
From this data we can see the budget in 2023 to be divided in 2 parts – the main of them is the State program named “The Development of healthcare sector”. Unlike the National project “Healthcare”, quite a big part of money from the State program are dedicated to the capital costs: building infrastructure and new clinics, renovating hospitals and wards.
In this diagram we can see the split in the State program – traditionally more money is being allocated to the ambulatory care because statistically there are much more people who need out-patient treatment. Also the government is aimed to develop the primary health care and sets KPI for preventive maintenance.
A 20% piece of “cake” named “The development of healthcare sector” goes to different Federal projects – almost 243 billion rubles has been divided among 17 various types of medical care and services. These projects have quite wide coverage from hospitals infrastructure to precise group of diseases or range of problems. In addition to allocations directly from the Federal budget usually most of the Federal projects are followed by dotations from regional and (or) Compulsory Medical Insurance (CHI) funding. Diversity of the projects can also refer to issues in medical system that government acknowledges and willing to solve.
With the next graphics step by step we will reveal more details about each project and its aim.
The first Federal project we would like to uncover is the neonatal screening – its aim is to detect congenital diseases or hereditary conditions during the first 10 days of a baby’s life. When it comes to such heavy diseases it important to diagnose them and start the treatment as soon as possible in order to prevent nonreversible complications and improve quality of life. The yearly budget of the project in total is more than 2 billion and as you can see at the infographic
– this sum has been divided among 85 regions and in very average each recipient would have about 27,5 million rubles.
Statistically speaking the birth rate in Russian Federation has been decreasing over the last years: according to the latest official database, with 145,5 mln of population, there are 9,6 babies per 1000 people and 1,5 babies per fertile woman. As mentioned previously 2,34 bln rubles allocated for neonatal screening are distributed among 85 regions. At the graphic
you can see TOP5 regions-recipients – in terms of percentage these territories get twice more than statistical average. Surprisingly, there is no correlation between infants birth and mortality rate in a region and amount of allocation. However a trend with correlation of density and overall population and wealth being of a region can be seen. Although Moscow and saint Petersburg have birth rates higher than regions 2, 4 and 5 from the graphic, you will not find them among TOP5 recipients because they also have other sustainable sources of budgeting.
Previously neonatal screening was limited to 5 diseases, but starting from the beginning of this year, it was expanded up to 40. Being a very generous increase the expanded neonatal screening is planned to be integrated in all regions which inevitably should attract additional investments. So far, with a help of regional budgets, new diagnostic technologies were settled at least in 11 medical centers that has already run blood tests for expanded neonatal screening. Meanwhile the average costs of screening in TOP5 regions shown at the graphic, apparently doesn’t have regard to any extension meaning that either more regional budgets will be attracted or more allocations from the federal budget should be expected in future.
The next Federal project we would like to reveal is the Modernization of primary care. The main goal of the project is to make a primary care available for each group of population. For this purpose the government allocated almost 90 billions divided among 84 regions meaning that each recipient will receive slightly more than 1%. This is a very average meaning, in reality these funds are distributed uneven and unequal. Nevertheless these money should be spent on various things:
- to build new rural health posts in hard-to-reach or isolated areas
- to attract professionals to work in provinces
- to totally renovate hospitals
- to substitute outdated medical equipment
According to this project by 2025 in total there will be built or reconstructed and renovated almost 9000 rural posts and hospitals all over Russia.
At the graphic below we show TOP5 regions-recipients.
Having said previously that in average each region receives from the federal government about 1% of the project’s budget, these regions are definitely being set aside as they get almost 20% of money. These regions have a lot of primary care organizations of course, but also a combination of high level of population and hard-to-reach areas, so that all these 3 criteria are higher than average. For example, Moscow and Krasnodar regions have almost the same amount of allocations from the budget, but in the Moscow region it is almost 30% more population than in the Krasnodar region. And even though Krasnodar region has only 36% of primary care institutions compared to Moscow region, Krasnodar also has more isolated areas and more ramshackle buildings – meaning that more rural health posts should be built and more hospitals or polyclinics shall be renovated.
In total there are more than 21 thousand of out-patient and polyclinic institutions all over Russia – these institutions are dedicated to the primary care, and among them there are those that require renovation.
Statistically speaking, according to the Federal plan 30% out of alike institutions should be totally renovated or reconstructed by 2025. If we have a look at the graphic with average budget allocation per OPI (outpatient and polyclinic institutions), we’ll see that the final amount is quite modest: e.g. in Moscow region it is less than 3 mln RUB to each institution, which is absolutely not enough. Even 8 mln for Krasnodar region is insufficient. However, along with the Federal project there are supplementing regional projects for the primary care modernization – and this is how some regions can get Federal plans done. Each region also allocates money for the same purposes, but depending on its prosperity. Traditionally Moscow (city and region) and St. Petersburg have big regional budgets and their allocations to this project are almost twice bigger than the amount they receive from the Federal budget. At the same time, Yulianovsk region (Volga federal District) adds only 5% to this project’s budget, which means that renovations, new posts, equipment and professionals can only be paid by the Federal government.
Another important project is the Prevention the spread of and treatment of socially significant diseases (SSD). According to the Government Decree there are several diseases considered to be socially significant:
- tuberculosis
- sexually-transmitted infections
- hepatitis (B, C)
- HIV
- cancer
- diabetes
- mental and behavioral disorders
- hypertensive heart diseases
The graphic shows number of patients with socially significant diseases – statistically there is almost 20% of the population in Russia. However, this project is focused on suspending the diseases which are spread among only 1% of the population: hepatitis, tuberculosis, STI and HIV. Other SSD have their own programs and financial support on federal and regional levels.
The main goal of the program and its KPI is to decrease the morbidity rate of hepatitis C to 5,1 case, tuberculosis to 25 cases and HIV to 40 cases per 100 000 people (e.g. now it is 48,7 HIV cases). To support this purpose this year the government allocated almost 2,5 billion rubles to 84 regions under the terms of co-funding along with the local regional budgets.
As we usually mention, in average each region would have received almost 27,6 mln rub which is equal to 1,19% of the federal budget for the project. This money shall be spent on purchasing diagnostic materials to detect tuberculosis, HIV and hepatitis and to organize various activities aimed at prevention of HIV and hepatitis. In order to calculate the size of subvention to a region, the government compares a yearly increase of patients with active form of tuberculosis in each region-recipient.
At these graphics we see TOP5 regions-recipients and its numbers of patients with active form of tuberculosis registered for the first time during the last year.
Three of TOP5 regions are located in the Siberian Federal District – due to historical reasons, it has always had a bigger number of some SSD, especially tuberculosis. In general, big number of infected people in these regions can be explained by low percentage of screening, checkups and preventive care: there are a lot of backlands, and people rarely come to a hospital for checkups and chest X-ray, so they end up at TB specialist only when they already have an advanced case. While in Russia average percent of the first time registered patients with active form of TB is 0.03%, in Siberian regions this figure is two times higher. Nevertheless, due to the significant reduction of the infection’s spread over the last decade, in 2021 WHO excluded Russia from the list of countries with high level of TB burden.
If we calculate an average amount of money that can be spent for a patient to diagnose TB, we will see quite high figures.
Even though this money shall be also shared with HIV and hepatitis IVD, in reality, the healthcare system spends much more money in relation to SSD. Every baby shall get a vaccine against TB in maternity hospital – according to the latest data every 9 out of 10 babies actually received it. The treatment of SSD diseases is completely covered by general insurance which is free of charge: hospital stay, medicines and even rehabilitation afterward. According to the Ministry of Health 86,2% of HIV patients registered in hospitals as subjects of regular checkups, received medical treatment last year – this is 56,4% of all people with detected disease while the level of diagnosis was up to 28%. Also, there are other programs and separate budgets dedicated to cancer, heart diseases and diabetes. For example, in 2021 early diabetes diagnostics was included in regular health assessment and this year an experimental project of remote patient management has been launched.
The Federal project High-tech medical care covers very special modern and the most expensive ways of treatment which are not included into the basic program of compulsory health insurance (CHI). The government started to allocate budgets for this purpose in 2017, in 2023 annual budget for the clinics in Russia is up to almost 6,25 billion rubles.
The Medical care that is being financed by this project is not included in the basic insurance program, but is still available for Russian citizens on a free-of-charge basis – the main requirement for patients is that they have to be eligible according to the disease and personal health conditions. Though this high-tech medical care is very limited by number of patients that can receive the treatments, it includes less widespread and more complicated therapies for severe diseases, such as radio / proton / radioligand cancer therapy, robotics-assistant surgery, organs and bone marrow transplantation, neurorehabilitation, etc.
As always, in each Federal project, we highlight the top 5 regions that receive more money—you can see them in the picture below—and they were allocated almost 40% of financing.
In this case, the volume of financing doesn’t depend on the population or number of clinics in the region, most likely it depends on the number of these very special procedures that a limited number of hospitals can technically carry out. In 2023 clinics in all regions have an assignment to carry out more than 300 thousand of hospital admissions. Also this year at least 3 new therapies were added to the oncology and transplant specialties, such as nuclear therapy with lutecium or treatment of complications after transplantation of hematopoietic stem cells in an early period.
At the very beginning high-tech medical care was available only in federal clinics, started from 2020 private medical hospitals managed to join federal clinics in this project and to receive financing via the Federal Foundation of Compulsory Health Insurance. The list of certain federal and private clinics eligible to provide certain treatments is published and being updated each year by a governmental decree. The Government Decree #518н dated by 29.07.2022 consists of the list of hospitals that can provide high-tech medical care not included in the basic program of CHI: nowadays there are 142 federal clinics and 89 private hospitals in this list.
It means that only these clinics are able to get financing under this federal project. At the graphic above, you can see a number of such hospitals in TOP 5 regions. In terms of numbers, Moscow is an absolute record holder – there are 63 hospitals, but they all receive only about 2,5% of the federal budget while they can be also supported by the local funding.
In this graphic you can see how much money a clinic in each TOP 5 regions receives – although it is a statistical average, it gives a notion of approximate figures. Of course it also depends a lot on the type of medical care provided by a clinic. The Government Decree #2497 dated by 29.12.2022 states a list of certain medical aid included into the high-tech medical care project. In total there are 97 groups of such care dedicated to different medical specialty – at the next graphic you can see the most fulfilled specialties with statistically average cost per one procedure.
For example, in cardiovascular specialty there are 16 different treatments with a stated cost per each treatment that the government reimburses to a clinic: the cheapest one is the correction of heart rhythm disorder without pacemaker implantation for 330 thousand rubles, while the most expensive one is the surgical treatment for children with congestive heart failure – every operation costs almost 11 million rubles.
In addition, started from the last year, according to new regulations if there is some balance left after the state assignment is completed, the clinics got an opportunity to spend money received under this project on any other purposes.
The next Federal project that we are going to demonstrate as a part of the state program “Development of healthcare sector” is dedicated to the donation of human organs for the purpose of transplantation. In 2023 the government allocates almost 150 mln rubles for this project, which is a quite a small amount of money, especially comparing to the other federal projects.
However the number of transplanting operations in Russia is also small – you can see statistical data for the last year that covers all types of procedures.
Moreover this donation is aimed only at procedures for organs recovery from donors meaning that these money will only be spent on organs’ procurement – transplant operations itself are covered by hi-tech medical care program of compulsory health insurance (another federal project that we published previously). At the second graphic we show a statistically average amount of money from this project that can be used for the organs removal procedure. The calculated number takes into consideration the statistical data revealing that a multi-organ recovery took place in 73,7% of all procedures with an average number of 2,8 organs from one effective donor. In addition, more than 66% of all removals are carried out postmortem.
At these graphics we can see top 5 regions – recipients of the federal project’s allocations. Moscow has the first place with a huge difference from the second place taken by Moscow region. This difference is clearly explained by the fact that Moscow carries out more than 50% of all procurement (removal) and transplant operations – you can see the figures at the second graphic.
The level of donor activity in Russia is 5,2 donors per 1 million of population while in Moscow it is 26,3 donors per 1 mln. Besides the point, special recommendations to all regions for improvement of medical activities related to the donation of human organs, clearly say that a target figure of donor’s activity shall become at least 15 per 1 mln during the next 5 years – which is still less than Moscow’s current results. In general Moscow and Moscow region together carried out more than 52% of all renal transplantation procedures and almost 65% of all operations for other organs transplantation. Nowadays, at this point we can surely see a strong centralization, but there is a process of geographic growth of transplant centers.
Speaking of geography, at the following graphic we can see the number of hospitals that perform organs procurement (removal) and transplant operations in top 5 regions and in total. In some cases same hospital that procures organs can carry out a transplant operation because it has all the necessary equipment and well-trained medical specialists. At the same time, it is recommended to organize donation and transplantation within one hospital in a way that responsibility for these services could be divided among different specialists in order to exclude conflict of interest. As far as financing under this project is concerned, the hospitals have to transfer back to the federal budget any amounts that were not spent to the related medical activity and more likely this will cause reducing of the allocation to next year – this means that all hospitals will do their best to complete their plans. In conclusion, it is worth mentioning that over the last year 5 new centers of transplantation were opened and the potential of old centers is not even close to the limits so it is possible to expect an increase of all numbers related to organs’ donation and transplantation.
One of the interesting projects that can be reviled is the Creation of digital environment in healthcare segment on the basis of the Unified State Health Information System (USHIS). The federal budget allocates almost 0,5% out of the yearly amount for the state program “Development of healthcare sector”. This amount is almost twice bigger than allocations for neonatal screening and prevention the spread of socially significant diseases and just a little bit smaller than expensive project for hi-tech medical care. At the same time this is one of the most transforming project over the last few years and indeed it has a very big job behind this transformation. As one of the results, next year all clinics and hospitals all over the country shall be transmitted to electronic medical records: it’s hard to believe but in 2023 there are still quite a lot of patients that have to take care about their physically printed medical records and make sure that it is not lost or damaged at their clinic’s admission desk.
The main idea of the project is to create mechanisms of digital interactions among hospitals and clinics on the basis of the USHIS which is a special secure platform created in 2018. Results of this projects which lasts till 2024 will be evaluated based on several factors and for 2023 the targets are the following:
- 100% of clinics and hospitals shall use the USHIS to provide medical services
- 100% of clinics and hospitals shall use centralized regional subsystems to provide transitions of medical care
- 84% of clinics and hospitals shall use electronic medical records and other documents – as mentioned earlier this share shall be extended to 100% by the end of next year
At this point it is worth to mention that in total there are 5072 hospitals and 21616 clinics in Russia.
Another index taken into consideration is number of people using electronic services for medical care: in 2023 almost 22% of all population are expected to do so – in comparison with 2019 when this project has been started, this number was 10 times lower.
Traditionally we highlight Top 5 regions-recipients of the allocations under this project, but it can be seen that compared to the other projects, this time allocations are divided among 85 regions much more equally than usual. Along with the federal allocations, each region has to provide money from its own regional budget for the same project: among other things, this money had to be spent on purchasing sufficient computer equipment in order to provide access to the USHIS.
The state informational healthcare systems include the following services:
- Management of emergency aid
- Telehealth (telematic) consultations
- Laboratory assessments
- Central archive of medical images
- Management of preferential medicines’ provision
- Control of patients flow
Also with the help of the system and technology, by this year every region is able to monitor patients medical state under several disease profiles, such as oncology, cardiovascular, obstetrics and gynecology, neonatology and health checkups.