News Digest 05.06.2024 — 07.06.2024
Regulators
The Ministry of Industry and Trade has proposed introducing criminal liability for importers of unmarked goods
The Ministry of Industry and Trade has developed a draft federal law on amending Article 171.1 of the Criminal Code of the Russian Federation. The document is at the public discussion stage until July 2.
The article deals with the production, acquisition, storage, transportation or sale of goods and products without marking and (or) application of information stipulated by Russian legislation. The draft law proposes adding the words "import into the territory of the Russian Federation". Thus, if the amendments are approved, criminal liability will be introduced for importing goods without marking.
The clause on developing a bill on introducing criminal liability for importers for importing unmarked goods into Russia was contained in the amendments to the plan for implementing the strategy to combat illegal circulation of industrial products until 2025.
In addition, amendments will be developed to the regulations governing the disposal of unmarked goods seized during inspections. In order to prevent them from entering secondary circulation, their destruction or disposal is planned, the Ministry of Industry and Trade reported.
Market news
1 billion rubles to be invested in a project to manufacture medical devices in Krasnodar Krai
More than 1 billion rubles will be invested in a project to manufacture disposable catheters and other special medical devices in Krasnodar Krai. The trilateral agreement was signed at the St. Petersburg International Economic Forum (SPIEF) by the region's vice-governor Alexander Ruppel, the head of the Seversky District Andrei Doroshevsky and the founder of the April company Valery Chagin, the press service of the regional administration reported.
The project is being implemented with the financial support of the regional authorities. Last fall, the company received a preferential loan of 184 million rubles from the Industrial Development Fund (IDF) of Krasnodar Krai. According to Ruppel, in 2024, the IDF will allocate another 190 million rubles for the construction of the plant.
Chagin said that when the enterprise reaches its design capacity, it will be able to produce more than 50 million medical devices per year. According to him, more than 50% of such products are currently supplied to the Russian market from abroad. The project's initiators expect to fully cover the needs of medical institutions in the Southern Federal District for disposable catheters.
He did not specify the launch date of the plant.
The Ministry of Health updates the list of equipment in perinatal centers
The provision of medical care to newborns in the profile of "neonatology" will be extended to premature babies over 28 days old, in the intensive care units and intensive care units, the rates of a neonatologist will be introduced, the rates of a pediatric cardiologist and a specialist in functional diagnostics will be added. Such changes are provided for in the updated version of the specialized order, work on the draft document is almost complete, the chief researcher of the department of pathology of newborns and premature babies of the NMIC of Obstetrics, Gynecology and Perinatology named after. Academician V.I. Kulakova Elena Baibarina at the meeting "Preservation and restoration of female fertility as a tool for increasing the birth rate in the Russian Federation", the correspondent of "MV" reports.
According to the expert, the addition of new specialists to the regular equipment of the departments is due to the fact that "more children with heart defects are being born." The document more clearly regulates the process of routing newborns. In preparation for the implementation of the president's order to re-equip perinatal centers, the list of equipment has been updated. About 30-40% of the equipment in the neonatal departments of obstetric hospitals has expired, and from 7 to 10% of the equipment is no longer working.
Other
The Federal Compulsory Medical Insurance Fund (FCHIF) will expand the scope of AI application in radiation diagnostics using compulsory medical insurance funds
The Federal Compulsory Medical Insurance Fund (FCHIF) and the Ministry of Health are considering the possibility of including in the State Guarantees Program (SGBP) the description of chest fluorography and computed tomography of the brain using artificial intelligence (AI), the head of the FCHIF, Ilya Balanin, told TASS.
According to him, the expanded use of AI will help improve the availability and quality of medical care, as well as reduce the burden on health workers and the healthcare system. "Therefore, the FCHIF, together with the Ministry of Health, is assessing the possibilities of replicating artificial intelligence technologies in real practice," the head of the fund said.
Balanin added that the development and use of AI in medicine, especially in the field of breast cancer diagnostics, is a priority for the FCHIF. According to him, since the beginning of the year, more than 300 thousand studies of mammographic images have been conducted using artificial intelligence.
Participants of SPIEF-2024 were presented with the possibilities of artificial intelligence in the pharmaceutical industry
According to the expert, the use of artificial intelligence will determine the further development of healthcare and will increase the availability of drugs.
In particular, the use of artificial intelligence technologies is possible to solve a number of administrative issues related to the storage and analysis of large amounts of data, he specified. Including when forming patient registries in order to improve the efficiency of drug provision. As an example, we can consider the situation with patients with chronic non-communicable disabling diseases. Such patients can receive preferential drug provision only if they have a disability. At the same time, one of the goals of therapy is to prevent disability. In addition, there are cases when patients who have restored their functions thanks to successful treatment and, accordingly, “lost” their disability status can no longer receive therapy that ensures rehabilitation.
To prevent such situations, it is necessary to develop a mechanism for preferential provision of patients with drugs at an early stage. To implement this in practice, the first step may be to create a register of patients at risk of disability. And here AI technologies can help: they can be used to assess the data of patients' electronic medical records for this risk.
Another possible area of application of artificial intelligence is the identification and monitoring of patients with non-infectious diseases from high-risk groups for complications or death. This is one of the main tasks that is set for all subjects of the healthcare system. The use of AI-based algorithms would allow integrating electronic medical record data, stratifying patients automatically, routing them and monitoring the quality of medical care.
In addition, the introduction of artificial intelligence in the process of searching for and developing domestic drugs can reduce the time it takes to introduce innovative drugs into circulation. Today, this requires enormous time and material resources. The use of technologies will reduce the time it takes to study drugs by years. Thus, the companies R-Pharm and Sber are already implementing fundamental projects in the field of introducing artificial intelligence into the process of developing the structure of medicinal molecules for the treatment of socially significant diseases.
The expert also noted that the introduction of technologies into real practice is impossible without improving the regulatory framework and government support.
“The digital transformation of healthcare is not only the introduction of many systems and programs, but also a change in people's consciousness and the transition to making decisions based on data,” said Alexander Bykov.
At the same time, the representative of the R-Pharm company noted that, with all its capabilities, artificial intelligence will not replace doctors and pharmaceutical industry specialists. AI technologies are another tool to help doctors and researchers. The final decision and control should remain with humans.
New registered medical devices
We publish a list of new medical devices registered from 05/31/2024 to 06/07/2024
Link to the list: [see. table in attachment]
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