News Digest 17.05.2024 — 20.05.2024
Regulators
The regulator has changed the procedure for issuing a document to receive benefits for components for medical products
The Ministry of Industry and Trade has introduced amendments to the procedure for generating a document confirming the intended purpose of raw materials and components - such permission is necessary to obtain tax benefits. First of all, the regulator redistributed or adjusted the functions of subordinate departments responsible for issuing the document. A conclusion on the intended use of raw materials for the production of medical equipment and medical products is issued if there are no domestic analogues of the materials.
New changes to the department expand the functions of the Department for Development of the Pharmaceutical and Medical Industry; now it will be able to issue documents for medical goods registered in accordance with the rules of the EAEU or the legislation of the Russian Federation, for technical means of rehabilitation (TSR), as well as for prosthetic and orthopedic products and raw materials for them manufacturing.
From the powers of the Department of Radio-Electronic Industry, the Ministry of Industry and Trade removed the issuance of certificates for electronic thermometers that are not combined with other devices, installations for filtering or purifying air, and ventilators. At the same time, this structural unit of the ministry will be responsible for the approval of TSRs containing electronic devices, as well as consumable components used for operation, repair, maintenance and modernization of the corresponding medical products.
Other amendments include the addition of the Department of Light Industry and Forestry to the list of license issuers. He will be responsible for protective clothing and educational games for the disabled. The Department for the Development of the Industry of Socially Significant Goods, in turn, no longer performs the function of issuing documents for some medical products and raw materials for their production, according to the changes.
According to the Tax Code, some types of raw materials and components that are used for the production of medical goods are not subject to collection. Thus, the tax is not imposed on raw materials for the production of prosthetic and orthopedic products and materials that can be used exclusively for the prevention of disability or rehabilitation of disabled people. The full list of products is contained in the Decree of the Government of the Russian Federation dated September 30, 2015 No. 1042.
From February 1, 2024, updated rules for confirming the compliance of R&D performed with the list of studies that are subject to tax benefits came into effect. In this mechanism, the government included the recently created specialized information system EGISU R&D.
Roszdravnadzor again allowed the use of Botkin.AI
Roszdravnadzor canceled the letter on suspension of the use of software for visualization and image processing based on artificial intelligence technologies Botkin.AI. The reversal of the regulator’s previous decision is related to the corrective measures taken by the medical device manufacturer Intellogik regarding the development, as well as their subsequent expert assessment by VNIIIMT. The suspension of the operating permit was valid for 6 months - from November 2023.
The medical decision support service (MDSS) Botkin.AI, developed by the Russian company Intellogic, received a registration certificate in November 2020. At the same time, the software was allowed to circulate on the domestic market. Subsequent testing of the system took place at the Center for Diagnostics and Telemedicine of the Moscow Department of Health during the COVID-19 pandemic using images of the lungs, after analyzing which Botkin.AI was supposed to diagnose organ damage.
Later, Botkin.AI began to be actively implemented in the healthcare system: the service was used in the project of the Ministry of Health of the Tula Region and in the medical centers of the Open Clinic network.
In November 2023, Roszdravnadzor issued an information letter on the suspension of the use of the medical device due to the lack of response from Intellogic to the regulator’s “repeated demands” to provide reports on post-registration monitoring of the safety and clinical effectiveness of the development. Then Roszdravnadzor initiated independent monitoring and detected deviations in the results of Botkin.AI from the parameters declared by the service manufacturer.
In December 2023, the company of Igor and Vladimir Chernin, Medical Screening Systems, acquired 100% of the Intellogic company. The purchasing company had experience in developing a similar DSS system – Celsus.
Source: https://vademec.ru/news/2024/05/17/roszdravnadzor-snova-razreshil-ispolzovanie-botkin-ai/
Market news
The cost of construction of the Kamchatka Regional Hospital exceeded 13 billion rubles
The government will allocate more than 925 million rubles. for the construction of the Kamchatka Regional Hospital. The funds will be allocated from the reserve fund. With this money, by the end of 2024, in particular, engineering infrastructure facilities, as well as treatment, diagnostic and clinical buildings will be built.
Prime Minister Mikhail Mishustin, at a meeting with deputy prime ministers on May 20, indicated that Deputy Prime Minister Marat Khusnullin should personally monitor the implementation of the plan.
At the beginning of January, the Cabinet of Ministers already allocated 2.2 billion rubles. for this construction site. Taking into account that tranche, the cost of constructing the hospital’s treatment block exceeded 12 billion rubles, and now - 13 billion rubles. The government has previously repeatedly increased subsidies for this facility, and at the end of 2023 it ordered a $10 billion advance to the contractor. Even taking this into account, the hospital’s delivery dates have been shifted: instead of the end of 2023, they were first moved to the beginning and then to the end of 2024. Most likely, this is not the last shift in the project’s delivery deadline: the government is now indicating that, thanks to the new subsidy, only “at least 80%” of the facility should be ready by the end of the year.
One of the largest Russian developers, Crocus International JSC, part of the Crocus Group, is building a Kamchatka hospital at the expense of the state program “Health Development”. The company is managed by Araz Agalarov, one of the “kings of Russian real estate,” according to Forbes.
The Moscow company was unable to recover its equipment worth 30 million rubles from the Irkutsk Ministry of Health
The Arbitration Court of the Irkutsk Region did not satisfy the claim of the Moscow company Advanta Group demanding the return of medical equipment worth 30.3 million rubles, supplied under a contract with the regional Ministry of Health in 2022. Advanta Group appears in the criminal investigation against former Minister of Health Yakov Sandakov.
According to the investigation, the leaders of the Advanta Group company (owner Dmitry Kondrashov and commercial director Kristina Kultikhina), as well as Yakov Sandakov and Yan Datskovsky, who from 2011 to 2023 was the director of the Perm Advanta LLC, a subsidiary of the Advanta Group, allegedly entered into a conspiracy, used false commercial offers about the possibility of supplying medical equipment in a short time and inflated the cost of the goods (from 12–14 million to 30 million rubles).
The statement of claim relates to the execution of a contract for the supply of a BactoSCREEN microbiological analyzer to the Irkutsk Regional Clinical Hospital for 30.34 million rubles. The regional Ministry of Health and Advanta Group entered into this agreement at the end of 2021, the contract was completed in 2022. However, the company later decided to terminate the contract, which is why it filed a lawsuit in January 2024.
As stated in the statement of claim, the company intended to reimburse the regional Ministry of Health for the funds paid, as well as return the equipment at its own expense. In addition, Advanta Group demanded that the government contract with the department be terminated “due to significant changes in conditions.”
“By such a significant change, the plaintiff understands the fact that during the investigative measures carried out against the former Minister of Health Sandakov, the investigation established that the actual market value of the medical product “mass spectrometric analyzer” is 14.9 million rubles,” it is indicated in the court decision. However, this point was also considered not to correspond to the “public interests”.
During the court hearing, the plaintiff asked to attach an uncertified copy of the conclusion of the results of the operational investigative activities issued in the criminal case of Sandakov. The court considered such documents to be inadequate evidence. According to the court, the dispute was initiated with the aim of creating the appearance of absence of damage and avoiding liability provided for by law. As a result, the company refused to satisfy the claim in full.
According to SPARK-Interfax, Advanta Group LLC was registered in Moscow on July 31, 2020. The beneficiary of the legal entity is Dmitry Kondrashov, who is also a co-owner of six more companies. In 2023, Advanta Group’s revenue amounted to 178.3 million rubles, loss – 24.3 million rubles.
In 2022, a criminal case was opened against the former Minister of Health of the Irkutsk Region, Yakov Sandakov, on suspicion of taking a bribe. According to the regional department of the Russian Investigative Committee, in February 2022, the official allegedly received funds in the amount of 7 million rubles from the director of an unnamed organization for assistance in concluding a government contract for the supply of an endoscopic system worth 150 million rubles.
In April 2023, it became known that the former head of the Irkutsk Ministry of Health was suspected of receiving another bribe - now in the amount of 1 million rubles - from the head of one of the local medical organizations. In June 2023, the Investigative Committee of the Russian Federation for the Irkutsk Region opened a third criminal case on suspicion of money laundering.
Later, a criminal case of negligence was opened. Investigators believe that Yakov Sandakov, as Minister of Health in 2021, did not provide the necessary medicines and medical supplies to disabled minor children with diabetes.
In addition, according to the Investigative Committee, in the same year, the ex-official allegedly gave information to the commercial organization where he previously worked about purchases planned by the Ministry of Health, and this information allegedly helped the company win the tender and fulfill the order at an inflated cost. The amount of losses for the regional budget was then estimated at 18 million rubles.
Initially, Sandakov was in a pre-trial detention center; the measure of restraint was repeatedly extended, but in November 2023, the Irkutsk Regional Court decided to transfer the ex-minister under house arrest. At the end of December 2023, the investigation of the criminal case in the Investigative Committee was completed. The materials with the indictment approved by the prosecutor's office were sent to the court. According to investigators, the volume of the criminal case amounted to 73 volumes; during the investigation, 86 victims and more than 80 witnesses were questioned, and 10 forensic examinations were conducted.
In January 2024, the court extended Sandakov’s house arrest for six months. A court hearing on the merits of the case was scheduled for January 26, but it was postponed several times. As a result, the meeting will take place on May 22.
Other
The University of the Ministry of Health invented bioresorbable fixation systems for maxillofacial surgery
Specialists from the Russian University of Medicine were the first in the world to develop a screw design for maxillofacial surgery made from a biodegradable magnesium-based alloy. A patent for the invention “Fixator for osteosynthesis” was received, the university press service reported.
When using this product, surgeons will not need to perform a second operation to remove the metal structure after the completion of the bone tissue formation process - the fixing screw will gradually “resolve” inside the bone. According to scientists, the rate of “resorption” will practically correspond to the rate of growth of the bone tissue itself.
The Russian University of Medicine also submitted documents to Rospatent for registration of another type of bioresorbable products - plates. Together with screws and a special tool that scientists are currently developing, they will form a fixation system for maxillofacial surgery. The research team plans to develop a wide range of products made from bioresorbable magnesium for orthopedics, neurosurgery, veterinary medicine, and also for vascular surgery.
Elon Musk's Neuralink is implanted into a second patient
In the United States, the Food and Drug Administration allowed Elon Musk's company Neuralink to implant a chip in the brain of a second patient. On the condition that the company corrects the shortcomings of its first implant.
The first patient, Noland Arbow, lost some of his data because the 85 threads of the chip that attach it to the patient's brain eventually turned off and no longer read the neural signals of his brain. At the moment, only 15% of the threads are working correctly and reading signals. But changes in the software that Neuralink specialists made allowed the chip to function correctly, Noland was able to play chess with it live.
The second operation to implant the Neuralink chip is planned to be carried out in June, and by the end of the year they want to implant chips in 10 people. According to the company, they already have more than a thousand people willing to participate in the experiment and are still receiving applications.
Neuralink in the future may allow the use of any device with the power of thought, and will also significantly improve the quality of life for people with impaired motor functions.
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