News Digest 18.10.2024 — 25.10.2024
Regulators
Discrepancies in the nomenclature classification of medical devices cannot serve as grounds for rejecting a supplier's application
The Ministry of Health of the Russian Federation and the Federal Antimonopoly Service issued a joint letter explaining the procedure for customers in the event of a discrepancy between the codes of the nomenclature classification of medical devices (NCMID) in the procurement documentation and the supplier's offer - https://fas.gov.ru/documents/689698.
As noted in the letter, customers should be guided by the provisions of No. 44-FZ "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs", which require a full description of the procurement object in terms of characteristics. In turn, the application of the procurement participant must also contain the characteristics of the offered goods that correspond to the indicators specified in the procurement description.
The provisions of the catalog of goods, works, services to meet state and municipal needs allow the description of items to include, among other things, reference information, which includes NCMIDs. However, such reference information, the authors of the letter point out, does not apply to the description of the procurement object in accordance with Art. 33 No. 44-FZ.
Thus, the regulators believe that the difference in the codes of the nomenclature classification of medical devices of the procurement participant and the customer cannot serve as grounds for refusing the contractor to participate in the tender. The main condition is that the characteristics of the medical device offered by the contractor must meet the requirements stated by the customer.
Source: https://t.me/MedTechIndustry/1361
Market news
Charity funds complained about the shortage of medical devices due to sanctions
Charity funds faced problems in purchasing and repairing medical equipment against the backdrop of sanctions. The difficulties are caused by the departure of foreign companies from Russia, as well as by the rise in the price of medical products due to forced changes in supply logistics, RBK was told by the children's hospice "House with a Mayak", as well as the funds "Vera" and "Life as a Miracle".
Thus, "House with a Mayak" is experiencing a shortage of gastrostomy bags. The hospice purchases American-made systems from an official distributor, but the wait for deliveries stretches from six months to ten months.
In addition, the funds are having difficulty purchasing artificial lung ventilation devices, including non-invasive ones (NIVL). For patients who need constant ventilation, such equipment was purchased from several foreign companies.
There are also difficulties with servicing equipment that patients use at home, for example, with stationary oxygen concentrators manufactured in China, as well as pumps for enteral nutrition. The Life as a Miracle charity foundation has encountered difficulties in purchasing devices for measuring blood ammonia levels, as well as test strips for them. There are long pauses in deliveries.
Alfaplastik expanded production of rubber for medical devices for 50 million rubles
The Alfaplastik company launched a new rubber compound workshop for the production of medical devices at a plant in the Oryol region. The company invested at least 50 million rubles in the opening of the facility, received in the form of a joint loan from the regional and federal industrial development funds. In 2025, they plan to begin production of disposable catheters, probes and Esmarch mugs there.
The opening of the new workshop will increase the enterprise's production capacity by 30% and reduce logistics costs within the enterprise.
Currently, the enterprise in the Oryol region employs more than 200 people. According to the results of work for the first nine months of 2024, the volume of manufactured products amounted to 493 million rubles. The enterprise produces hemostatic tourniquets, rubber PVC heating pads, syringes, catheters and probes for operating rooms, products for the care of bedridden patients, rehabilitation products and medical plugs.
"Alfaplastik" cooperates in the field of import substitution with the company "SIBUR PolyLab" (Skolkovo) and the Russian National Research Medical University named after N.I. Pirogov.
According to SPARK-Interfax, the legal entity of the plant - Oryol rubber products plant LLC "Association" Alfaplastik "- was registered in the Oryol region in 2015, is 100% owned by the LLC of the same name and is its branch. Yuri Smirnov owns 94% of Alfaplastik Association LLC, with Irina Shaposhnikova owning the remaining 6%. There is no information on the company's revenue or profit. In 2022, Alfaplastik signed a government contract for the supply of 1,750 Esmarch tourniquets for a total of 207 thousand rubles for the needs of the Regional Center for Social Protection of the Population of the Oryol Region. In April 2024, it became known that Kaspis Bio Tech intends to implement a project in the Voronezh Region to create a plant for the production of medical Foley catheters in the Center SEZ. The investor estimates the investment at 285 million rubles. According to the company, full-cycle production will be the first in Russia and will make it possible to manufacture 5 million catheters per year.
In Kursk, the Federal Antimonopoly Service has uncovered a cartel in the supply of medical equipment worth 55 million rubles
The Kursk Office of the Federal Antimonopoly Service (FAS) has uncovered cartel agreements in the supply of medical equipment worth more than 55 million rubles. Information about a possible collusion between participants in procurement for the needs of the Kursk Regional Hospital was received from the regional prosecutor's office, the press service of the FAS clarified.
When examining the case materials, it was established that a group of entrepreneurs united by family and financial and economic ties acted in concert when concluding and executing government contracts for the repair and supply of medical equipment for the needs of the hospital. The business entities participated in the formation of the highest possible contract price by submitting commercial offers at inflated prices. Inflated offers for the price of contract execution were also submitted when the customer selected suppliers.
Then the entrepreneurs involved direct contractors in the execution of the state order. According to the FAS, the actual cost of delivery and adjustment of medical equipment was two times lower than the cost of the concluded contracts.
The total amount of government contracts concluded and executed under this scheme exceeded 55 million rubles. The actual cost of the delivered equipment and work on its adjustment was about 29 million rubles.
The names of the business entities are not disclosed. As specified by the FAS, the cartel participants face administrative fines. In addition, taking into account the amount of damage caused, their actions may be considered for the purpose of committing a criminal offense.
Khabarovsk Regional Children's Clinical Hospital will receive 300 million rubles from the federal budget to upgrade medical equipment
The Russian government has allocated 300 million rubles from the reserve fund to purchase medical equipment for the A.K. Piotrovich Regional Children's Clinical Hospital (RCCH) in Khabarovsk. At least 47 units of medical products will be purchased with these funds.
The funding will allow the medical institution to purchase a spiral CT scanner, magnetic resonance imaging scanner, as well as endosurgical video systems, X-ray navigation systems, and anesthesiology and resuscitation equipment. The medical equipment should be put into operation in 2025.
The Russian Ministry of Health has been instructed to conclude an agreement with the government of the Khabarovsk Territory on the use of subsidy funds no later than 30 days after the publication of the order. The department must also monitor the targeted and effective use of budgetary allocations and submit a report by April 1, 2025.
Prime Minister Mikhail Mishustin promised to finance the purchase of medical equipment for the children's surgical center in Khabarovsk in mid-July 2024, when he visited the regional clinical hospital during a working trip. At that time, employees of the medical institution reported that the hospital, which provides care to children from all over the Far Eastern Federal District, does not have its own MRI machine, which is why patients have to be transported long distances for examination. Health workers explained that the medical institution needs to update the spiral CT scanner, re-equip the intensive care and operating units, and new endosurgical equipment. Mishustin gave the Ministry of Health an order to prepare a list of medical equipment for additional equipment of the Khabarovsk Regional Clinical Hospital in August. The department, together with the Ministry of Finance, was instructed to ensure the allocation of funds for these purposes in 2024.
Other
The Federal Compulsory Medical Insurance Fund confirmed plans to expand the use of AI at the expense of compulsory medical insurance funds
The Ministry of Health and the Federal Compulsory Medical Insurance Fund (FCI) positively assess the possibility of replicating artificial intelligence (AI) technologies in real practice. Along with mammography, it is planned to pay for chest fluorography and computed tomography of the chest organs and brain with systems to support medical decisions from compulsory medical insurance funds, said the head of the FCI Ilya Balanin.
According to him, from January to July 2024, about 600 thousand mammographic examinations were conducted using AI technologies. “We see that they provide higher accuracy in making diagnoses and prescribing the most effective treatment,” Balanin emphasized. He recalled that Roszdravnadzor has already registered 27 medical devices with AI (according to the Ministry of Health, there are 37 of them. - Ed.).
Balanin first announced plans to expand the use of artificial intelligence in the analysis of radiation studies at the expense of compulsory medical insurance funds in June 2024. He noted that this will help increase the availability and quality of medical care, as well as reduce the burden on health workers and the healthcare system.
Services of which developers will be used y for this and what are the estimated amounts of expenses for AI, the head of the fund did not specify.
The expenses of the MHIF will grow by 15.4% in 2025 compared to the current ones. More than 80% of these funds will be directed in the form of subventions to the regions.
Newly registered medical devices
We publish a list of new medical devices registered from 10.18.2024 to 10.25.2024
Link to the list: [see table in the attachment]
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