News Digest 28.08.2024 — 30.08.2024
Regulators
The Ministry of Finance has proposed applying the national regime to the procurement of medical devices and drugs
The Ministry of Finance of the Russian Federation has developed a draft government resolution extending the national regime to the procurement of goods, works, and services to meet state and municipal needs, as well as to the procurement of goods by certain types of legal entities. Thus, the regulator proposes to limit or prohibit the procurement of foreign goods and give preference to goods of Russian origin. If the draft document is adopted, the restrictions will also apply to the procurement of medical devices and drugs.
Among the foreign medical devices that may be subject to restrictions if the initiative is approved are medical gauze, anti-bedsore orthopedic mattresses and pillows, containers for collecting biomaterials, and other products. The restrictions may also affect all drugs.
The draft resolution states that the ban and restrictions will not affect goods manufactured in the member states of the Eurasian Economic Union (EAEU), as well as works and services performed and provided by persons registered in such states. In addition, the advantage of Russian goods, regulated by the draft resolution, also applies to products from the EAEU member states. Also, when individual customers reach the minimum mandatory share of purchases of goods of Russian origin, goods from the EAEU member states will be taken into account with them on equal terms. According to the text of the draft, when purchasing such products as medical gauze, medical clothing, non-woven surgical disposable sterile products, antiseptic and disinfectant drugs, a certificate of origin of the goods issued by an authorized body of the EAEU member state will be required. With regard to another group of medical products, which includes containers for the preparation, storage and transportation of donor blood and its components, urine bags and ostomy bags, in addition to the certificate, it will be necessary to provide an expert report of the Chamber of Commerce and Industry of the Russian Federation, details of the document confirming the compliance of the production of medical products with the requirements of GOST. When purchasing medicines, a certificate of origin issued by an authorized body of a member state of the EAEU, or a conclusion confirming the production of industrial products in the territory of the Russian Federation, issued by the Ministry of Industry and Trade of Russia before July 1, 2024, is also required. In addition, a thematic document will need to confirm that all stages of drug production, including the synthesis of the active substance molecule in the production of pharmaceutical substances, were carried out in the territories of member states of the EAEU. In addition, it is necessary to provide the details of the document issued by the Ministry of Industry and Trade of the Russian Federation containing information on the stages of the technological process for the production of drugs. In case of failure to provide the required documents confirming that the drug involved in the purchase was produced in the EAEU countries, the drug will be considered a supply from a foreign state.
Public discussion of the draft resolution will last until September 9, 2024.
In July 2024, the Government of the Russian Federation updated the rules for the formation of the list of vital and essential drugs (VED). According to the new regulations, Russian medicines or drugs whose production is localized in the country will receive priority when included in the list.
Market news
NIOPIK plant to be reconstructed in Dolgoprudny for 3.4 billion rubles
Dolgoprudny Urban District Head Vladislav Yudin, at a working meeting with the region's governor Andrei Vorobyov, announced plans to implement 22 investment projects in the municipality that are at different stages of readiness. These include the reconstruction of the state scientific center NIOPIK plant, which produces materials for medical devices and drugs (in particular, the drug Alasens for metabolic fluorescence diagnostics). The total investment in the work at the facility is estimated at 3.4 billion rubles, and its completion is scheduled for the end of 2025.
The plant's upgrade will create more than a hundred jobs.
The total investment, which will be directed to the implementation of 22 investment projects, will amount to about 11 billion rubles. According to Yudin, this amount includes both the construction of new facilities and the expansion of production in existing ones. Due to this, about 1,650 jobs will be created in Dolgoprudny.
According to SPARK-Interfax, JSC NIOPIK, which is associated with the Ministry of Industry and Trade of Russia, was registered in 1993 in Dolgoprudny. The head of the legal entity is Antonina Melnichenko. In 2021, NIOPIK's revenue amounted to 217.5 million rubles, loss - 37 million rubles, authorized capital in 2022 - 1.26 billion rubles. Financial indicators for 2023 are not indicated. JSC NIOPIK, among other things, is engaged in the production of pharmaceutical substances, medicinal products used in medicine. for medical and veterinary purposes, as well as dyes, pigments and organic surfactants.
In December 2023, it became known about NIOPIK's intentions to sell an office in the center of Moscow to the construction company Politekhstroy, which won the auction. Thus, Politekhstroy offered 3.64 billion rubles for the asset, while the starting price on the website of the Sber-A electronic trading platform was 2.2 billion rubles.
Source: https://vademec.ru/news/2024/08/29/v-dolgoprudnom-za-3-4-mlrd-rubley-rekonstruiruyut-zavod-niopik/
Rosatom to present the first tomograph based on a Russian emitter by the end of the year
The Rosatom State Corporation intends to present a pilot version of the first domestic CT scanner, created on the basis of a Russian emitter, by the end of 2024. The total project check is not disclosed, but the development of the X-ray emitter alone was estimated at 1.193 billion rubles. Previously registered domestic developments used foreign components, which made users dependent on imported spare parts.
Valentin Smirnov, head of the nuclear medicine department at Rosatom State Corporation, spoke about the completion of the work and the creation of an experimental model of a CT scanner by the end of 2024. According to him, four attempts were previously made in Russia to create a domestic tomograph, but they were unsuccessful.
The project is being implemented by the Rusatom RDS subordinate state corporation. The total project check is not disclosed, but the research and development work on creating an X-ray emitter for the tomograph cost the state corporation 1.193 billion rubles. The contractor of the state corporation, as well as the technical parameters of the tomograph, are not disclosed. In early August 2024, VNIIIMT of Roszdravnadzor validated the emitter developed by the state corporation as compatible components for imported Canon Medical Systems tomographs. The use of the IRT.LUCH-7.000.000 tube is approved for Aquilion 16, 32, 64 slice and Aquilion LB series CT scanners.
Rusatom RDS is an industry integrator of Rosatom State Corporation in the field of manufacturing equipment and electronics. In addition to creating the tomograph, the division is also engaged in other research work in the field of medicine, for example, in terms of biodegradable implants.
The Russian CT market is estimated at 20-30 billion rubles per year. The Russian CT "KTR" of the St. Petersburg manufacturer NIPK "Electron" is registered here, however, as follows from the registration dossier, the "KTR" allows the use of several interchangeable units, for example, a scanner of the Chinese Neusoft Medical Systems or the German Roesys RSGH, an emitter of Dunlee (Germany - USA), or Philips (Netherlands), or Toshiba Canon (Japan), or Varex Imaging Corporation (China). Key vendors - GE Healthcare, Philips and Canon Medical Systems - had plans to localize medical equipment in Russia. Some of them were implemented, as in the case of the assembly of CT Optima, at the facilities of MTL LLC in Malakhovka, Moscow Region. Localization of CMS equipment was also prepared at the facilities of the joint venture R-Pharm and CMS "Arpi Canon Medical Systems". The Dutch vendor Philips expected to start assembling CT at the facilities of JSC Rentgenprom in Aprelevka, Moscow Region. However, all these projects used imported components, in particular, X-ray tubes. After the introduction of strict export control measures in May 2023, they were included in the list of dual-use products, and their supplies to Russia even for medical purposes became more complicated.
Other
The Siberian State Medical University has created the first ultrasonic spirograph for individual use in Russia
The new-generation telemedicine spirograph "Spiro" is a portable device for monitoring the condition of patients with chronic pulmonary pathology and has no analogues in the Russian Federation. The prototype of the product was created by experts from the scientific and technological center "Digital Medicine and Cyberphysics" of the Siberian State Medical University as part of the development program "Priority-2030".
The device is based on the principle of measuring air flow using built-in ultrasonic sensors. The spirograph is designed to measure respiratory parameters and identify disorders in the functioning of the human lungs. The device, developed by experts from the Siberian State Medical University, is universal and can be used as part of telemedicine complexes and as a device for individual use. Built-in sensors provide the ability to transmit respiratory parameters to a mobile device via a wireless communication channel and subsequent assessment by specialists.
"Spiro" will allow patients with chronic obstructive pulmonary disease and bronchial asthma to better monitor their condition, and doctors conducting monitoring will be able to more adequately adjust drug therapy. The device can also be used during respiratory rehabilitation after COVID-19, as prescribed by a pulmonologist.
At the moment, it has no analogues in Russia. The development will be tested ovana based on the clinics of the Siberian State Medical University. At the moment, the MVP (minimum viable product) of the spirograph is ready. Experts plan to obtain a practical product and commercialize the results during 2024. Registration of the medical device is also planned for this year.
Newly registered medical products
We publish a list of new medical products registered from 08.23.2024 to 08.30.2024
Link to the list: [see table in the attachment]
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