News Digest 21.08.2024 — 23.08.2024
Regulators
Pre-trial appeal will become mandatory in disputes over issuing permits for clinical trials of medical devices
The Government of the Russian Federation has approved an order according to which the pre-trial appeal procedure will become mandatory from September 1, 2024, when challenging the actions of state and municipal authorities related to the provision of a number of licenses and permits. For example, the measure will apply to disputes over the issuance by Roszdravnadzor of permits to conduct clinical trials (CT) of medical devices.
In addition, the order will affect disputes when Roszdravnadzor issues a certificate for the right to import (export) narcotic drugs, psychotropic substances and their precursors, permits for the use of medical devices intended for diagnosing diseases, for the import of medical devices into Russia to provide medical care for vital indications of a specific patient, and for the implementation of retail sale of medicinal products for medical use remotely.
The measure will also affect the issuance of permits for the import and export of potent substances and medical devices, conclusions for obtaining a license for the right to import and export human organs and tissues, blood and its components, biomaterials, stem cells, bone marrow, germ cells and embryos to the territory of the Russian Federation, as well as the issuance of permits for the introduction of a series or batch of an immunobiological drug into civil circulation.
The pre-trial appeal procedure will also be applied in disputes over the issuance of a sanitary and epidemiological conclusion by the Federal Medical and Biological Agency (FMBA).
In total, the order lists 202 types of permitting activities. From September 1, 2024, pre-trial appeal will become mandatory for 194 types, and from December 31 - for the remaining eight. Among the agencies covered by the order, in addition to Roszdravnadzor and the Federal Medical and Biological Agency, are the Ministry of Justice of Russia, the Federal Tax Service, Rostrud, the Ministry of Culture, the Ministry of Industry and Trade, the Ministry of Emergency Situations, as well as the state corporation Rosatom and other federal organizations.
According to Deputy Prime Minister Dmitry Grigorenko, "businesses and citizens have begun to more actively use the opportunity for pre-trial appeal on Gosuslugi; this online format is really more convenient than appealing decisions or actions of permitting authorities in court." "The service significantly reduces both time and financial costs. Therefore, we decided to more actively move from an experiment to a permanent format, and this year the pre-trial appeal procedure will become mandatory for a number of permits," the Deputy Prime Minister explained.
In March 2024, Roszdravnadzor presented a draft administrative regulation on issuing permits for the import of medical products for their subsequent registration in Russia. The document establishes a notification procedure for importing medical products using the public services portal, in connection with which the time for providing the service - the formal receipt and processing of the notification by Roszdravnadzor - will be from zero to eight hours. At the moment, the project is at the stage of independent anti-corruption expertise.
Market news
A hospital for participants of the Special Military Operation (SVO) will be built in Omsk for almost a billion rubles
The Governor of the Omsk Region, Vitaly Khotsenko, announced the creation of a hospital for veterans in Omsk for participants of the special military operation (SVO) in Ukraine. The medical organization will appear on the site of the former maternity hospital No. 5. According to the governor, "the hospital will provide the most modern methods of diagnostics, treatment and medical rehabilitation to SVO participants." The total cost of the facility is estimated at 900 million rubles: about 400 million rubles are allocated from the federal budget, and about 500 million rubles were allocated from the regional budget. In May 2024, the Ministry of Health adopted regulations for the operation of hospitals for war veterans - such medical institutions should appear in each region and, in addition to treatment, provide "organizational and methodological support" to other medical institutions. In addition, the regions are launching the construction of other centers that indirectly meet the needs of SVO fighters. For example, three specialized centers for providing medical care to the adult population with primary traumatic and non-traumatic amputations of limbs will appear in Moscow. Also in 2023, some of the geriatric beds in Russia were repurposed for the needs of the SVO, MV reported. According to the Ministry of Health report, as of the end of 2023, there were 8,331 gerontological beds in the country, of which 7,858 were functioning normally - thus, almost 500 beds are either not functioning or "temporarily repurposed to provide assistance to participants in a special military operation." In an interview with MV, the head of the N.N. Priorov National Medical Research Center of Traumatology and Orthopedics Anton Nazarenko said that "any kind of military operation is an epidemic of injuries," and the problem is related to the fact that a significant percentage of patients who have such an injury are then observed for a very long time. These are, as a rule, young people, they live for many more years, but all these years the consequences of the tra vm are saved.
Other
The most promising medical AI startups have been named
In Russia, a rating of the most effective companies developing IT products for medical institutions has been compiled. The authors were the company "Digital Medicine" together with the information and analytical project in the field of telemedicine Ever Care. The list was headed by the Russian company - a leader in the field of designing systems to support medical decision-making Webiomed, developers of medical image analysis systems "Celsus" and the "Third Opinion" Platform (MV has a copy of the study).
- Webiomed is a leader in the field of systems to support medical decision-making and analysis of electronic medical records. It has a good revenue figure for 2023 and attracted investments in the amount of 128.9 million rubles. It is successfully expanding its geographic presence by concluding large contracts with key regions of Russia.
- Celsus is a leader in the field of medical image analysis. It has a record figure for attracted investments (252 million rubles) thanks to the acquisition of Botkin.AI. It actively concludes contracts with various medical institutions and strengthens its position in the medical image analysis market.
- The Third Opinion platform successfully adapts its modules for analyzing various medical images and has concluded 13 contracts for the supply of its system. It showed a net profit of 102 million rubles in 2023.
Newly registered medical products
We publish a list of new medical products registered from 08.16.2024 to 08.23.2024
Link to the list: [see table in the attachment]
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