News Digest 12.07.2024 — 15.07.2024
Regulators
Overview of industry regulations
Order No. 3239 of 25.04.2019 "On approval of the administrative regulations of the Federal Service for Surveillance in Healthcare for the provision of a public service for receiving and recording notifications about the commencement of activities in the field of circulation of medical devices (except for clinical trials of medical devices, their production, installation, adjustment, use, operation, including maintenance, as well as repair)". Roszdravnadzor has canceled the administrative regulations for receiving notifications about the commencement of work with medical devices. Now notifications must be submitted to each new address. This can be done through the public services portal.
Source: https://pharmvestnik.ru/content/news/Obzor-otraslevyh-normativno-pravovyh-aktov-293.html
Putin signed the law on tax reform
Russian President Vladimir Putin signed a law on the introduction of a progressive personal income tax scale with rates from 13 to 22%, it will come into effect in 2025. The document was published on the official portal of legal acts. It will come into effect on January 1, 2025.
According to the law, the personal income tax rate will be increased from 13 to 15% for Russians with incomes of 200 thousand rubles per month (2.4 million rubles per year), up to 18% for those earning from 5 to 20 million rubles per year, up to 20% for those with incomes from 20 to 50 million rubles per year, up to 22% for those receiving more than 50 million rubles. per year.
The law also provides for the introduction of excise taxes on the pharmaceutical substance ethyl alcohol. In order to prevent the growth of prices for medicines, it is proposed to accept the excise tax on the pharmaceutical substance ethanol for deduction in the production of certain medicines and drugs specified in the relevant lists, as well as products with an ethyl alcohol content of less than 20% by volume (not containing alcohol) and medical devices. According to the law, excise tax rates will have an increasing coefficient: from January 1 to December 31, 2025 inclusive, they will be equal to 673 rubles; from January 1 to December 31, 2026 - 700 rubles; from January 1 to December 31, 2027 - 728 rubles.
Production facilities that use less than 50 thousand decaliters of ethanol per year are entitled to a deduction regardless of whether they are included in the list of manufactured products and without the need to provide documents confirming the intended use of the pharmaceutical substance. Enterprises using the pharmaceutical substance in excess of the specified volume will receive a deduction if they provide supporting documents.
In addition, the innovation implies an increase in the corporate income tax — from 20 to 25%. An amnesty is being introduced for businesses that are ready to abandon splitting schemes. For small and medium-sized businesses, the thresholds for applying the simplified taxation system (STS) will be gradually increased for incomes up to 450 million rubles per year (currently they are about 265 million rubles), and for fixed assets — up to 200 million rubles (currently around 150 million rubles).
The law also introduces a tax cashback for families with two or more children and with incomes less than 1.5 times the regional subsistence minimum, the establishment of a profit tax for IT companies at 5% until 2030, and the introduction of a tourist tax, the decision on the introduction of which can be made by municipalities. Putin proposed introducing a progressive personal income tax scale in Russia during his address to the Federal Assembly on February 29. The Ministry of Finance submitted amendments to the bill to the government, FV wrote. The document was adopted by the State Duma and approved by the Federation Council on July 10. The president of the Active Component company, Alexander Semenov, told FV that at a meeting with the new Minister of Industry Anton Alikhanov, they managed to develop a compromise on the issue of introducing excise taxes on ethanol, and a total of about 1.5 million dal of alcohol will be exempt from taxation.
Source: https://pharmvestnik.ru/content/news/Putin-podpisal-zakon-o-nalogovoi-reforme.html
Samara State Medical University received the right to conduct clinical trials of medical devices for their subsequent sale in the EAEU countries
Samara State Medical University of the Ministry of Health of the Russian Federation received approval for certification within the framework of the Eurasian Association for Conformity Assessment and Certification (ECA). The order of Roszdravnadzor included SSMU in the list of medical organizations that have the right to conduct clinical and (or) clinical laboratory studies of medical devices to assess their safety and clinical efficacy. Now SSMU has the opportunity to provide services to companies that are interested in the subsequent promotion of their products in the markets of the countries of the Eurasian Economic Union (EAEU). In addition to Russia, these are the Republic of Belarus, Kazakhstan, Armenia and the Kyrgyz Republic. Information on the certification is posted on the official website of Roszdravnadzor and submitted to the Eurasian Economic Commission.
Source: https://samsmu.ru/news/2024/02072/
Market news
Turner NMIC transferred patents for two developments to a medical device manufacturer in the Urals
Turner NMIC of Pediatric Traumatology and Orthopedics transferred two of its developments under license agreements to the Yekaterinburg manufacturer of metal structures OOO Medin -Ural". This step contributes to the introduction of technologies into widespread clinical practice and reduces dependence on foreign suppliers, the center's press service reported on July 12.
As part of the deal, the rights to use two patents for innovative spinal systems designed for monosegmental correction of severe congenital kyphoscoliosis in children were transferred. Metal structures will be manufactured and sold at the Yekaterinburg enterprise.
In June 2024, the Turner National Medical Research Center, under a license agreement, transferred free of charge to the Federal Center for Traumatology, Orthopedics and Endoprosthetics (Cheboksary) a device that fixes the mutual spatial orientation of bone fragments in an optimal anatomical and functional position during pelvic osteotomy for hip dysplasia. This technology allows for precise positioning of bone fragments in an anatomically correct position, reducing the time of surgical intervention by optimizing the correction process, improving recovery after surgery and reducing the risk of postoperative complications.
Investor to invest 1 billion rubles in healthcare in Tyumen Oblast
Pro-Medicine, a company that produces mobile medical complexes based on the KAMAZ vehicle, will invest 1 billion rubles in healthcare in Tyumen Oblast. This is the amount estimated for investment projects for the construction of a testing and laboratory center and an operating unit with 12 operating rooms in 20 areas in the region, the Tyumen government information center reported.
The regional government will provide comprehensive support to the investor. A search for a land plot is currently underway.
Other
A surgeon from Tyumen patented a dispenser for local anesthesia
A device for local anesthesia - a dual-circuit infiltration dispenser, was developed at the Department of General Surgery of the Tyumen Medical University, the university's website reports. The device can replace imported analogues. The dispenser, developed by Lidiya Komarova, professor of the Department of General Surgery at TMU, is designed to supply a solution for pain relief during surgeries. The author of the invention has already received a patent and is looking for a partner to produce a trial batch. In the improved design, the device is supplemented with a heat exchanger that cools the saline solution and eliminates the need for local anesthetics, which some patients with allergies cannot tolerate. The dispenser is also equipped with a display and ultrasonic sensors, which can be used to block air bubbles, which increases safety during surgery. In addition, the device is equipped with a second pedal, the use of which makes the work of the doctor easier. The developer of the product will present the device at VDNKh as part of the marathon "Russia - the Country of Inventors", held in honor of the Day of the Inventor and Innovator, which is celebrated on June 29. "Participation in the exhibition is an opportunity to show the product in order to find a site for its production and release a trial batch. We have already received a response from the heads of three Russian medical centers who are interested in purchasing the device," said the author of the project.
Source: https://pharmmedprom.ru/news/hirurg-iz-tyumeni-zapatentovala-dispenser-dlya-mestnoi-anestezii/
In Russia, an AI complex has been created that allows preventing the development of a heart attack
A team of students and engineers from the Tyumen Industrial and Tyumen State Universities has developed a device that, using biometric sensors and artificial intelligence (AI) technologies, allows detecting signs of a pre-infarction condition, preventing the development of heart disease. This was reported to TASS by the press service of the National Technology Initiative (NTI) Platform.
"Our solution is a mobile complex for diagnosing pre-infarction conditions. The device [at its core] measures heart rate, electrocardiogram, and body temperature. Artificial intelligence algorithms detect signs of heart disease. [The complex also includes] a mobile application that allows you to track health indicators in real time, receive recommendations and warnings. The application also has a special tracker for medications taken," says project leader Regina Kolchakova, whose words are quoted by the organization's press service.
Source: https://nauka.tass.ru/nauka/21241661
Study: AI can predict the risk of Alzheimer's disease with 78.5% accuracy
Researchers from Boston University used neuropsychological test interviews conducted since 2005. Data from 166 studies was used to train artificial intelligence (AI) people with cognitive impairment, including 59 men and 107 women with an average age of 81. The researchers transcribed audio recordings into text using automated speech recognition software to predict whether a person with mild cognitive impairment would develop Alzheimer's disease within six years.
The researchers also fed the recordings into the AI, supplementing them with data on the patients' age, gender, and education level. The analysis showed that speech characteristics extracted from neuropsychological test recordings were reliable predictors of disease progression. Including only text characteristics outperformed traditional test results and demographic factors. The scientific article indicates that minor changes in speech patterns can provide information about cognitive decline even before the onset of more obvious symptoms. According to the study, the accuracy of the model was 78.5%.
The authors of the project now plan to scale up the development, including data from more natural conversations, and not just structured neuropsychological tests. For this, it is proposed to use a smartphone app. This approach could make the AI model even more accessible and practical for widespread use. Scientists are also planning to consider other types of data to improve the accuracy of the model.
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