News Digest 12.02.2024 — 14.02.2024


Regulators

Putin instructed to continue the modernization of primary healthcare

President Vladimir Putin instructed the government to continue implementing measures to modernize primary healthcare. The list of instructions following the press conference of the head of state on December 14, 2023 was published on the Kremlin website.

Prime Minister Mikhail Mishustin must, by October 15, submit proposals for modernizing the “primary” system based on the results of monitoring the implementation in 2022–2023 of the main activities provided for by regional programs.

In addition, the Cabinet of Ministers was instructed to provide further funding for measures to combat cardiovascular diseases provided for by the state program “Health Development”. The President expects a report on this issue until June 20.

The government has budgeted 80 billion rubles for the modernization of the primary infrastructure in 2024, MV reported. Territories where the regional program operates will be able to receive the subsidy. Starting next year, within its framework, regions will be able to purchase mobile medical complexes for the first time.

The federal project for the modernization of primary healthcare until 2025 includes plans to carry out major repairs at 3,973 healthcare facilities and build 7,324 new ones, equip medical institutions in settlements with a population of up to 50 thousand people, and purchase 130 thousand units of equipment. 550 billion rubles were allocated for these purposes (from 2021 to 2025). According to Deputy Prime Minister Tatyana Golikova, if the end date of the program is moved to 2030, the amount of funding could reach 1.3 trillion rubles.

Source: https://medvestnik.ru/content/news/Putin-poruchil-prodoljit-modernizaciu-pervichnogo-zvena-zdravoohraneniya.html

Roszdravnadzor has resumed the rules for issuing permits for the export of a number of medical devices

Roszdravnadzor has updated the procedure for issuing permits for the export of certain types of medical devices to the EAEU countries. The corresponding order No. 39 dated January 15, 2024 is posted on the legal information portal. According to the document, this procedure is extended until December 31, 2025. The previous order was valid until the end of 2023.

According to the order, the application is drawn up in Russian, drawn up on the applicant’s letterhead, signed by him, certified by a seal, contains the date and registration number. The application, which is submitted through the automated information system of Roszdravnadzor, is signed with an enhanced qualified electronic signature.

The application must indicate, for example, data such as the name of the legal entity and the product, information about whether the product is a medical device, as well as the code of the medical device. The application is accompanied by copies of contracts or supply agreements, a certificate of the product, and a completed draft permit for its export.

Grounds for refusal to issue an export permit may be the applicant’s failure to eliminate violations identified by the supervisory authority, as well as the presence or threat of a critical shortage of goods in the country. An export permit is issued separately for each shipment within the framework of one supply contract (agreement).

In December 2023, the government adopted a resolution to extend restrictions on the export of a number of goods and equipment from Russia. The ban will remain in effect until the end of 2025.

In January, the Ministry of Industry and Trade published an order approving the procedure for issuing permits for the export of certain types of industrial products to the EAEU countries. It will also be valid until December 31, 2025.

Source: https://pharmvestnik.ru/content/news/Roszdravnadzor-vozobnovil-deistvie-pravil-vydachi-razreshenii-na-vyvoz-ryada-medizdelii.html


Market news

Clinics will increase the cost limit for the purchase of fixed assets in the tariff structure

The Ministry of Health initiated amendments to the Program of State Guarantees for the provision of free medical care to citizens for 2024 and for the planning period of 2025 and 2026. The draft government resolution was published on the portal regulation.gov.ru.

Due to the inclusion in the basic compulsory medical insurance program of 23 methods of high-tech medical care in six profiles of medical care (obstetrics and gynecology, ophthalmology, pediatrics, cardiovascular surgery, traumatology and orthopedics, urology), when paying for these types of care, a differentiation coefficient will be applied to the share of wages fees as part of the standard financial costs per unit of volume.

In addition, it is proposed to include in the structure of the tariff for payment of medical care the costs of medical organizations for the maintenance and repair of fixed assets. At the same time, the maximum costs for the purchase of fixed assets (equipment, production and household inventory) will be increased from 100 thousand rubles. up to 400 thousand rubles. for a unit.

Source: https://medvestnik.ru/content/news/Klinikam-uvelichat-limit-rashodov-na-priobretenie-osnovnyh-sredstv-v-strukture-tarifa.html

A new tomograph at NSU will speed up trials of another cancer treatment method

Novosibirsk State University has received a new tomograph, which will significantly speed up the development and testing of an innovative method of treating cancer. Scientists are optimistic about upcoming preclinical studies of neutron capture therapy (NCT) thanks to this breakthrough.

In November 2023, specialists from the Institute of Nuclear Physics SB RAS announced key achievements in the development of equipment for boron neutron capture therapy (BNCT), a promising method for destroying cancer cells.

The BNCT procedure is aimed at concentrating the stable isotope boron-10 in cancer cells, which, under the influence of neutrons, initiates a nuclear reaction, destroying the tumor from the inside without harming healthy tissue.

Collaborating with the Institute of Nuclear Physics, the researchers began testing the method using accelerators and boron-containing drugs. The first human clinical trials are expected to begin in 2025.

In parallel, an alternative approach to NRT is being tested, using gadolinium as the agent and reactors instead of accelerators for irradiation. This method has already shown promising results in rodents, and now research is expanding to larger animals.

The appearance of a new tomograph at NSU will give an impetus to speed up research, making it possible to more effectively monitor the dynamics of treatment and move on to the next stages of method development. The research is carried out within the framework of the Priority 2030 program.

Source: https://pharmmedprom.ru/news/novii-tomograf-v-ngu-uskorit-ispitaniya-esche-odnogo-metoda-lecheniya-raka/


Other

In 2023, analog mercury thermometers were in greatest demand

In the Russian retail market (including the online channel) in 2023, 9.9 million pieces of medical thermometers were sold worth 3.3 billion rubles. (at retail prices, including VAT). Over the year, physical sales volume decreased by 12%. The ruble dynamics are also going negative, with a drop of 15.7% compared to 2022. Such data are provided by the analytical company RNC Pharma.

The dynamics as a whole were determined by a reduction in demand in the offline channel, where sales volume decreased by 19% in rubles and by 15% in physical units. The e-commerce segment has grown noticeably both in rubles (+16%) and in units (+23%), but the total volume here is still relatively small - online accounts for only 11% of sales, which does not allow for the growth of the retail category as a whole.

There are two key categories of medical thermometers on the market: analog and electronic, both of which showed a decline in demand last year, analysts say. The physical volume of sales of analog devices compared to 2022 decreased by 10.8% in units, electronic devices lost 13.5%. Interestingly, analog devices have fallen noticeably in price in 2023: the average cost has decreased by 7.4%. At the same time, the price tag for the electronic type of thermometers has remained almost unchanged, although here too a negative correction was recorded, but it did not exceed 0.6%.

Source: https://pharmvestnik.ru/content/news/V-2023-godu-naibolshim-sprosom-polzovalis-analogovye-rtutnye-termometry.html

BMS and VantAI will jointly develop small molecule drugs using AI

VantAI, which specializes in drug development using artificial intelligence (AI), and Bristol Myers Squibb (BMS) have entered into an agreement to create molecules that “glue” proteins together. This is stated in a press release published on Business Wire.

As part of the collaboration, the companies are leveraging the generative AI capabilities of VantAI's geometric deep learning platform to design small molecules that hold proteins together. This will help create new small-molecule therapeutics.

As VantAI co-founder and CEO Zachary Carpenter explained in an interview with Forbes, cellular processes produce a lot of waste that is not needed in the body. Autophagy is the body's natural system for getting rid of waste. Pharmaceutical companies are racing to find a way to use these waste-breaking proteins against various diseases.

VantAI will receive up to $674 million for development, clinical trials, regulatory approvals and commercialization of the drug, as well as royalties on sales.

Source: https://pharmvestnik.ru/content/news/BMS-i-VantAI-budut-sovmestno-razrabatyvat-nizkomolekulyarnye-preparaty-s-pomoshu-II.html

Apple Vision Pro will be used for surgical interventions

Experts believe that enhanced virtual reality can become a necessary tool in medicine. Thus, American neurosurgeon Robert Masson performed an operation to reconstruct the spine wearing Apple Vision Pro glasses.

At this stage, digital reality glasses are used only for logistics and organizing procedures. However, GlobalData innovation technology analyst Sourabh Nyalkalkar said innovations in AR (augmented reality) and VR for surgical and ophthalmology applications will see "more widespread adoption in the future."

Also, expanded virtual reality can be used in the future to improve the efficiency of medical institutions. Artificial intelligence will be able to analyze all stages of the operation and transmit information to surgeons about patients.

Source: https://www.medicaldevice-network.com/news/apples-vision-pro-heralds-a-new-world-of-medical-xr/

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