News Digest 17.06.2024 — 19.06.2024
Regulators
Russia and the DPRK have agreed on cooperation in healthcare
During President Vladimir Putin's visit to Pyongyang, Russia and the Democratic People's Republic of Korea (DPRK) signed an intergovernmental agreement on cooperation in healthcare, medical education and science, the Kremlin press service reported on June 19. The draft document was previously published on the publication.pravo.gov.ru portal.
As follows from the government order, cooperation is planned in the areas of maternal and child health; healthy lifestyle prevention; infectious and non-infectious diseases; professional training, retraining and advanced training of health workers; state regulation of the circulation of medicines and medical devices, etc.
The parties will exchange information and conduct joint scientific research. In addition, the exchange of health workers, teachers and students and their participation in specialized congresses, conventions and scientific conferences is envisaged.
Cooperation is planned to be developed on a bilateral basis, as well as in multilateral formats, including interaction with the World Health Organization and other international organizations.
Market news
Another 1 billion rubles will be invested in the production of non-woven fabric for the medical industry in Kaluga
Kaluga Region Governor Vladislav Shapsha reported that investments in the second stage of construction of the Naturel plant for the production of non-woven fabric in the Kaluga special economic zone (SEZ) will amount to 1 billion rubles. The first stage cost 3.4 billion rubles. Since October 2022, the enterprise has been producing materials used, among other things, in cosmetic and medical production.
After the completion of the second stage of construction, the plant will reach full capacity. It is planned that after the start of full-cycle production, 250 jobs will be created.
Currently, the enterprise produces non-woven fabrics for napkins used for cosmetic, medical and household purposes, as well as for cosmetic masks and roll towels.
According to SPARK-Interfax, a resident of the Kaluga SEZ, Naturel LLC, is engaged in the production of non-woven textile materials and products. The company was registered in 2019 in the Kaluga region. Initially, its owner was the former CEO and co-owner of ZetHolding LLC Nikolai Glinkin.
In December 2019, the organization came under the control of the Swiss Laboratoriya Natyurel SA, and since January 2021, Naturel has belonged to ZetHolding. At present, its CEO is Nikolai Glinkin. The revenue of Naturel LLC in 2023 amounted to almost 2.3 billion rubles, net profit - 91.8 million rubles.
ZetHolding LLC was registered in November 2020 and is owned by several co-owners: 33.22% by Kazakhstan citizen Sergey Chayzhunusov, 33.22% by Manimo AM CJSC, registered in Armenia, 26.84% by Certi Sevens Investment Company LLC, registered in the UAE, and other individuals and legal entities. In 2023, the organization's net profit amounted to 91.2 million rubles.
In early June 2024, it became known that Pharmasyntez Group of Companies would invest 5 billion rubles in the construction of a plant for the production of medical equipment and consumables in the Kaluga SEZ. The thematic agreement was signed at SPIEF-2024, the commissioning of the facility is scheduled for 2026.
Another case on the purchase of counterfeit medical equipment for hospitals has been opened in Bashkiria
A second criminal case has been opened in Bashkiria on the supply of counterfeit equipment to medical institutions. The crime was uncovered by the regional prosecutor's office during a joint inspection with the territorial department of Roszdravnadzor, the press service of the supervisory agency reported on June 18.
It was established that in 2020 and 2023, the Department of Material and Technical Support of the Ministry of Health of Bashkiria purchased nine diagnostic devices for the restoration of fine and gross motor skills and coordination of the upper limbs. According to Kommersant-Ufa, the medical equipment was supplied by Medstandart LLC. The examination established that the medical device was not registered in Russia, its parameters differed from those declared by the manufacturer and specified in the documents. As a result, the actions of the unscrupulous supplier caused damage to the budget of Bashkortostan in the amount of more than 14 million rubles.
A criminal case was opened under the articles on the sale of poor-quality and unregistered medical devices in large quantities (Part 1 of Article 238.1 of the Criminal Code of the Russian Federation) and causing property damage by deception (Part 1 of Article 165 of the Criminal Code of the Russian Federation). Counterfeit medical equipment was seized from hospitals.
In March, the republican prosecutor's office reported on the delivery of one counterfeit device for the restoration of fine and gross motor skills and coordination of the upper limbs worth 2.7 million rubles to one of the institutions in Ufa. In April, the head of the Capital Construction Department of the Ministry of Health of Bashkortostan, Inna Iksanova, was detained on suspicion of abuse of office, MV wrote. According to investigators, she entered into four government contracts with a commercial organization for the supply of ultrasound imaging systems for a total of over 57 million rubles. The equipment also turned out to be counterfeit.
In December 2023, a criminal case was opened regarding the supply of 34 ventilators and diagnostic equipment to hospitals in Bashkiria, which also turned out to be counterfeit. At that time, the damage was estimated at 88.7 million rubles and an audit of all medical equipment supplied to the republic began.
In Khabarovsk, seven suppliers of medical products are suspected of a cartel worth 300 million rubles
The Office of the Federal Antimonopoly Service (UFAS) for Khabarovsk Krai has opened a case on a cartel agreement in the supply of medical products at inflated prices to clinics in Khabarovsk Krai and the entire Far Eastern Federal District. We are talking about seven companies - OOO Spektr-DV, AO Vector-Best-Amur, OOO Medias, OOO ALEF, OOO VostokMedBusiness, OOO Kompaniya Dalmedical, OOO Medtekhnika-Servis. According to the regulator, the cartel was identified as a result of inspections of more than 600 purchases worth a total of over 300 million rubles.
Other details of the case are not disclosed. If the FAS finds the companies guilty, they face turnover fines.
According to SPARK-Interfax, all companies are registered in Khabarovsk. The main areas of activity of legal entities are wholesale trade in pharmaceuticals and medical devices, as well as repair of electronic and optical equipment.
The owner of Spektr-DV LLC is Valeria Dunayevskaya. Revenue for 2023 amounted to 739.3 million rubles, net profit - 86.9 million rubles. Vector-Best-Amur is 90% owned by Vector-Best JSC and 10% by three Russian citizens. Revenue for 2023 amounted to 337.6 million rubles, net profit - 12.9 million rubles.
Medias LLC belongs to Oleg Karpov. Revenue for 2023 was 331.3 million rubles, net profit was 15.4 million rubles. The owners of Alef LLC are Sergey Folyushnyak (98%) and Bogdan Sarancha (2%). Revenue for 2023 was 128.03 million rubles, net profit was 14.3 million rubles. VostokMedBusiness LLC is owned by Elena Strukova (66.6%) and Elena Knyazkina (33.4%). The company's revenue for 2023 was 81.8 million rubles, net profit was 1.3 million rubles. In addition, Elena Knyazkina owns Dalmedical Company LLC, whose revenue for 2023 was 47.7 million rubles, net profit was 1.04 million rubles. Elena Strukova owns Medtekhnika-Service LLC, where Knyazkina is the CEO. The company's revenue for 2023 was 31.4 million rubles, with a loss of 5.03 million rubles. In June 2024, the FAS Russia opened two cases of cartel collusion in the supply of medical products to clinics in Moscow and the Moscow Region, including War Veterans Hospital No. 2, which specializes in rehabilitation after injuries. The first case concerns the Labcorp, Labstor, Venddelis, Ster Medical, and Ster 23 groups of companies, and the second concerns an anticompetitive agreement between an economic entity and Galar LLC. The Service suspects the organizations of collusion in order to maintain prices when participating in tenders. According to the regulator, the companies entered into an agreement at tenders for the supply of medical products and consumables for a total of initial maximum contract prices of 1.141 billion rubles.
In 2023, the FAS identified 2.9 thousand government purchases worth 174 billion rubles, in which violations of antitrust laws were revealed - cartels at tenders and collusion with the customer. The supply of medical products and medicines, along with purchases in the construction and road complex, housing and communal services and social catering, were among the top areas most susceptible to cartel collusion. Based on the department's materials, 13 criminal cases were opened in 2023 on charges of cartels, and the amount of fines transferred to the budget for those imposed for previous periods exceeded 1 billion rubles.
FAS discovered two cartels in the supply of medical products to Moscow medical institutions worth 1.1 billion rubles
The Federal Antimonopoly Service (FAS) of Russia has opened two cases of cartel collusion in the supply of medical products to clinics in Moscow and the Moscow region, including the War Veterans Hospital No. 2, which specializes in rehabilitation after injuries. In the first case, we are talking about the Labcorp group of companies, Labstor, Venddelis, Ster Medical and Ster 23, and in the second case, about an anticompetitive agreement between an economic entity and the company OOO Galar. The service suspects the organizations of collusion in order to maintain prices when participating in tenders. According to the regulator, the companies entered into an agreement at tenders for the supply of medical products and consumables with a total initial maximum contract prices of 1.141 billion rubles. The Antimonopoly Service does not disclose the details of the companies. According to the Unified State Register of Legal Entities and SPARK-Interfax, the Labcorp company was registered in August 2021 and belongs to Irina Galkina. She is also the 100% owner of the Ster 23 company. In addition to the two legal entities, Galkina owns a 50% stake in Venddelis LLC (the second 50% stake in the legal entity is owned by Vladislav Galkin) and 49% of Ster Medical LLC (Vladislav Galkin owns a 51% stake in the legal entity). The largest contractors of the companies were the capital's War Veterans Hospital No. 2, as well as city clinical hospitals No. 24 and No. 15 of the Moscow Department of Health. The total volume of deliveries over 4 years exceeded 100 million rubles in the case of Labcorp, 310 million in the case of Stere 23, 430 million in the case of Stere Medical, and 340 million rubles in the case of Venddelis. According to SPARK-Interfax, the Labstor company belongs to Raisa Savchenkova. The three largest contractors of the company were the same clinics, the total volume of orders from them exceeded 80 million rubles.
A second antimonopoly investigation is being conducted against Galar LLC. According to the Unified Information System in the sphere of public procurement, only one legal entity is engaged in the supply of medical products, owned by Ekaterina Zudova (60% share) and Dmitry Kalashnikov (40% share). The main counterparty in terms of the volume of contracts concluded is the Hospital for War Veterans No. 2 , the volume of contracts is 102.4 million rubles.
If the FAS finds the companies guilty, they face turnover fines.
In 2023, the FAS identified 2.9 thousand government purchases worth 174 billion rubles, in which violations of antitrust laws were revealed - cartels in tenders and collusion with the customer. The supply of medical devices and medicines, along with purchases in the field of construction and road complex, housing and communal services and the organization of social catering, were among the top areas most susceptible to cartel collusion. Based on the materials of the department, 13 criminal cases were opened in 2023 on charges of cartels, and the amount of fines transferred to the budget for those imposed for previous periods exceeded 1 billion rubles.
Other
Sechenov University has created an innovative maxillofacial prosthesis
Specialists from Sechenov University have developed the first endoprosthesis for the glenoid fossa of the temporomandibular joint (TMJ) in the Russian Federation. It is located in front of the ear and consists of the temporal bone and the lower jaw, its tendons and muscles allow it to open and close.
With conventional prosthetics, surgeons discovered a risk of complications - often the displacement of one of the components into the surrounding tissues. Therefore, it was decided to improve the design of the implant.
"During the development, we changed the contour of the glenoid fossa component of the endoprosthesis, making it semi-open. This design allows us to restore the full range of motion without the risk of dislocation of the condylar component of the endoprosthesis," Sergei Ivanov, Corresponding Member of the Russian Academy of Sciences, Head of the Department of Maxillofacial Surgery named after Academician N.N. Bazhanov, Director of the Clinic of Maxillofacial Surgery at Sechenov University, told Izvestia.
The methodology is supplemented by computer 3D planning of the operation. It allows for the plans to be transferred into reality with high accuracy during the operation, the developers explained to Izvestia.
One of the main differences of the innovative prosthesis is that it is manufactured for the unique anatomy of each patient at the preliminary planning stage. The terms, as a rule, are up to a week.
Titanium alloy for the manufacture of bone implants has been modernized in the Urals
Specialists from UrFU and the Baykov Institute of Metallurgy and Materials Science of the Russian Academy of Sciences have improved the titanium alloy for the creation of bone implants used in traumatology for fractures of the femur or foot in order to increase its biocompatibility with the human body, the university website reports.
In Russia, about 9 million cases of limb fractures are registered annually. One of the main causes of fractures is osteoporosis - a chronic decrease in the content of bone tissue in the body, such a diagnosis has been made in about 14 million people over 50 years old in Russia. To restore bone tissue after fractures, if the bone has a deficiency of its own tissue, medical implants are used that fill the gap between the damaged ends of the bone.
UrFU scientists explained that the biocompatibility of titanium alloys with human tissues may be insufficient due to the content of a large number of chemical elements in the alloy. For example, the presence of aluminum and vanadium can cause side effects, including allergic or toxic reactions. In addition, a number of alloys are more rigid than the bone itself, while the implant material should have the most similar mechanical properties in terms of rigidity.
"If the material is too rigid, then atrophy and degradation of bone tissue may occur at the border of the bone and the implant - because of this, a crack and destruction may appear in the bone," explained Galymzhan Mukanov, a research engineer at the Department of Heat Treatment and Physics of Metals at UrFU. He said that in the process of upgrading the alloy, scientists managed to reduce the content of undesirable elements in it, as well as reduce the rigidity by 1.5 times compared to another titanium alloy used, while increasing the strength. The specialists used the rotational forging method to increase the strength.
The scientific development was carried out within the framework of the Priority-2030 program, its results were published in Metals.
In March 2024, MISIS University developed an optimal technology for producing an alloy for joint endoprosthetics made of titanium, iron, copper and tin of increased strength.
The first tests of the digital colposcope developed by Samara State Medical University were conducted
The first tests of a prototype of its own digital portable colposcope were conducted at Samara State Medical University. They showed good results. In addition, technical tests necessary for registering the device were carried out. A digital colposcope for diagnosing cervical cancer will expand the coverage of oncological screening for women and detect the disease at an early stage.
The device is being developed by the Engineering Center of Samara State Medical University together with the Department of Obstetrics and Gynecology of the Institute of Pediatrics under the supervision of the head of the Department of Obstetrics and Gynecology of the Institute of Pediatrics, Doctor of Medicine, Associate Professor Anna Kazakova. Portable colposcopes are widely used abroad, but there are no analogues in Russia.
“Clinical experts tested a prototype and got good results, the digital image is very high quality,” said Anna Kazakova. - In addition, technical tests were carried out. Now we are preparing the necessary documentation to send the device for registration. After it is passed, we plan to conduct multicenter clinical trials, as well as include software in the colposcope, which will make a preliminary diagnosis using artificial intelligence technologies." As Anna Kazakova explained, the advantage of the digital portable colposcope being created is its high image resolution, the ability to zoom in 32 times, which provides clear visualization, as well as the ability to transfer and save data on each patient - this will allow the formation of a database for further analysis. Built-in artificial intelligence will form a second opinion, which will help the paramedic or mid-level specialist in routing the patient to a particular institution. "Cervical cancer is a common disease characterized by high mortality," says Anna Kazakova. "At the same time, it is rarely detected at the stage of precancerous changes, when the development of oncology can still be prevented. The implementation of the project solves the issue of creating technological sovereignty over the lacking solutions in the country in the field of portable colposcopy for equipping FAPs and mobile teams." In the future, it is planned to include the device in the Health Check-Up telemedicine case developed by Samara State Medical University. This will allow for a wider coverage of cancer screening using personal medical assistants and, in the long term, reduce mortality from cervical cancer.
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