News Digest 15.11.2024 — 22.11.2024
Regulators
The Ministry of Health intends to adjust the rules for working with medical devices for in vitro diagnostics
The Ministry of Health intends to amend the RF Government Resolution No. 2026 of 24.11.2021 "On unregistered medical devices for in vitro diagnostics". The draft resolution is under public discussion until December 2.
As follows from the explanatory note, the draft resolution reduces the timeframes for procedures within the framework of considering applications for the provision, confirmation, renewal and cancellation of permission to use medical devices that are intended to diagnose diseases by conducting research on samples of human biological material outside the body. Thus, the period for making a decision on granting permission or refusing it is reduced from 33 to 28 working days. The period for making decisions on confirming permission or refusing it is reduced from 14 to 13 working days.
Currently, applications for granting or confirming permission and the documents attached to it must be sent to a single identification and authentication system; the authors of the draft resolution propose replacing it with a public services portal. The possibility of submitting applications on paper is excluded.
In addition, the document provides for the possibility of interdepartmental interaction with the Federal Tax Service (FTS) to obtain the necessary information from the agency's information system.
It follows from the explanatory note that it is difficult to conduct a statistical analysis of the current situation. The reason is that permissions are currently issued:
- Federal State Budgetary Institution "V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Health of the Russian Federation (a reagent kit for high-throughput sequencing of human biological material in order to identify a wide range of hereditary monogenic diseases KlinExom);
- LLC "NCGI" (a reagent kit for determining polymorphisms in 60 DNA loci by PCR with hybridization-fluorescence detection of results in real time, designed to identify predisposition to diseases and genetic disorders of metabolic processes in the human body Metabolic kit 60);
- JSC "CGRM "Genetico" (a reagent kit for non-invasive prenatal genetic screening of fetal DNA in the mother's blood for the risk of variations in the number of DNA copies by the method of massive parallel sequencing "Prenetix");
- Federal State Budgetary Scientific Institution "Academician N.P. Bochkov Research Center for Medical Genetics" (panel "Hereditary metabolic diseases": analysis of 71 genes by high-throughput sequencing).
Previously, the government excluded the requirement to publish clinical case studies in scientific journals posted in Scopus or Web of Science databases when including an off-label drug in standards of medical care for children and clinical guidelines. Now, publications are required not in international databases, but in journals from the "White List".
Deputies proposed to reduce VAT on medicines and medical devices
Deputies submitted to the State Duma bill No. 772998-8, which proposes to amend Article 164 of the second part of the Tax Code in terms of reducing the value-added tax rate for certain types of socially significant goods. As follows from the explanatory note, the authors of the document intend to reduce the value-added tax (VAT) for certain socially significant goods from 10 to 5%. At the same time, if the inflation rate for the previous year exceeds the inflation rate for all groups of goods, the VAT rate for socially significant goods in the next tax period is set at 0%.
It is proposed to establish such a taxation system, including for the following medical goods of Russian and foreign manufacture:
- medicines (including pharmaceutical substances, drugs for clinical trials and drugs manufactured by pharmacies);
- medical devices (except for medical devices, the sale of which is exempt from taxation in accordance with subparagraph 1 of paragraph 2 of Article 149 of the Tax Code of the Russian Federation).
The explanatory note states that the inflation rate will be calculated on the basis of official statistics published annually by the Federal State Statistics Service. The increase in prices for groups of goods will be determined in accordance with the All-Russian Classifier of Products by Type of Economic Activity.
The authors of the document noted that the increase in the VAT rate from 18 to 20% from January 1, 2019, to increase funding for national projects “did not justify itself.” “The taxes that placed an additional burden on the entire economy and citizens of the country went to additional payments in the above-mentioned areas, which, even without this increase in income, are the most profitable and have the highest wages in the country,” the explanatory note states.
In July, the president approved amendments to the Tax Code, agreeing which will have changing tax rates from next year. Everyone will have to face increased deductions: large chains — with the growth of income tax, medium and small — with the advent of VAT, individual entrepreneurs — with a progressive scale of personal income tax rates. According to AlphaRM, from next year, more than 13.3 thousand pharmacies will pay VAT at a rate of 5% and 4 thousand pharmacies — at a rate of 7%.
Source: https://pharmvestnik.ru/content/news/Deputaty-predlojili-snizit-NDS-na-lekarstva-i-medizdeliya.html
Market news
New generation drugs and medical devices will be created within the framework of a new national project
The government has formed a list of national projects on technological leadership, to which 3 trillion rubles will be allocated from the budget until 2030. As reported by First Deputy Prime Minister Denis Manturov during a meeting with President Vladimir Putin, eight national projects have been approved.
"We have done a lot of work with the regions, constituent entities of the Russian Federation, with business circles, with science, and each project was put through a strategic session chaired by Mikhail Mishustin," Manturov shared.
One of the national projects is aimed at providing the healthcare system with advanced solutions.
According to the First Deputy Prime Minister, the main emphasis in the program is on the creation of new-generation medicines and medical devices. The drugs and medical devices developed within the framework of the project should be aimed at treating socially significant diseases. In addition, the development of technologies for the treatment of cognitive diseases was included in the priority agenda.
Earlier, the Ministry of Industry and Trade announced that medical devices based on biohybrid, bionic and neurotechnologies will become a priority. In support of Russian products, the State Duma plans to consider a bill to abolish the preferential VAT rate for foreign-made medical devices.
New regions will receive 751 million rubles for the purchase of medical equipment
The Russian government will allocate 751 million rubles from the reserve fund to purchase medical equipment for the needs of clinics in the new regions - the DPR, LPR, Zaporizhzhya and Kherson regions. The funding will allow for the purchase of 29 units of equipment, including mammographs and magnetic resonance tomographs.
Russian Prime Minister Mikhail Mishustin noted that federal funds will speed up the renewal of infrastructure in clinics and hospitals in the new regions. Stationary X-ray machines, mammographs, CT and MRI scanners are planned for purchase.
The Russian Ministry of Health has been instructed to ensure that agreements are concluded with regional authorities within 30 calendar days after the order is issued. The department must also monitor the targeted and effective use of budgetary allocations and submit a report to the government by March 1, 2025.
According to the government order, the largest tranche is provided for the Luhansk People's Republic - 320 million rubles, the Zaporizhia region will receive 255.5 million rubles, the Donetsk People's Republic - 160 million rubles, and 15.5 million rubles are provided for the Kherson region.
In April, the Russian Government allocated 679.17 million rubles to support the work of mobile teams and field multifunctional hospitals in the DPR, LPR, Kherson and Zaporizhia regions. The funds were distributed between federal medical centers, including for the purchase of medicines, medical devices and disinfectants.
MIM invested 269 million rubles in expanding the production of medical devices in Tyumen
The Tyumen Plant of Medical Devices (MIM) opened a new building for the production of disposable syringe manometers and polymer devices for installing a catheter in the pleural cavity for long-term drainage. The project has been implemented since 2020, the total investment was estimated at 269 million rubles.
The new production site with a total area of 4.5 thousand square meters is located in the village of Malkovo, Tyumen District. Two medical products will be manufactured there - a syringe-manometer for stent installation operations, used in endovascular surgery, as well as the Plevrokat product, designed to install a catheter in the pleural cavity for long-term drainage.
The new production is more than 80% based on Russian raw materials, including, in terms of medical plastics and polymers, on the products of the Sibur company. Thanks to import substitution, it was possible to build a cost-effective model based on full-cycle production, development and testing of products in cooperation with Tyumen doctors.
The volume of investment in the project is estimated at 269 million rubles, part of the funds is used to purchase equipment. An additional 140 employees have been attracted to the new site.
The MIM company is a manufacturer of single-use medical products for gynecology, urology, surgery, proctology, otolaryngology and cosmetology, founded in 1991. The product line includes injection needles and syringes, gynecological kits, products for surgery, proctology, ENT offices and more. In addition to Russian regions, MIM products are exported to the EAEU and CIS countries - Kazakhstan, Uzbekistan, Armenia, Belarus and Kyrgyzstan.
According to SPARK-Interfax, MIM LLC is owned by 17 individuals, the largest owners are Vladimir Malyugin (share of 34.8%), Natalya Pozdnyakova (8.6%) and Nadezhda Kosolapova (7.5%). In 2023, the company earned 458.3 million rubles, net profit amounted to 198.2 million rubles.
MIM announced the investment project in the fall of 2017. Initially, it was supposed to implement the third stage of the plan for expansion and modernization of production, during which it was planned to build a building with an area of 2,212 square meters. Then it was calculated that the volume of investments in the project would amount to 100 million rubles. In December 2020, MIM began producing aspiration tips for drying the surgical field, and in July 2021, syringe manometers. In November 2021, it became known that MIM would invest another 90 million rubles in increasing capacity and modernizing the production of disposable medical products.
Other
Russians are cautiously optimistic about the use of AI in medicine
In 2024, Russians became slightly more optimistic about the use of artificial intelligence (AI) in medicine compared to last year, according to a survey by the All-Russian Public Opinion Research Center (VTsIOM). At the same time, only four out of ten respondents (43%) believe that this will lead to an improvement in patients' health.
The number of Russians who are optimistic about the use of AI in healthcare has grown by 3 percentage points over the year. Four out of ten respondents (41%) are convinced that AI will reduce the number of medical errors, 33% expect improvements in the security of personal medical records. Another 24-30% believe that the situation will not change, and 17-18% believe that it will get worse.
At the same time, when it comes to the health of the respondents themselves and the use of AI, optimism becomes more reserved. About half of Russians (53%) would feel uncomfortable if a doctor relied on AI when diagnosing and preparing treatment recommendations. This figure has grown by 4 percentage points over the past year, which may indicate wariness about the new technology when it comes to their own health.
Newly registered medical devices
We publish a list of new medical devices registered from 11/15/2024 to 11/22/2024
Link to the list: [see table in the attachment]
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