News Digest 15.07.2024 — 17.07.2024
Regulators
The Ministry of Health will receive additional funds from the federal budget
Russian President Vladimir Putin signed Federal Bill No. 175-FZ dated July 12, 2024, amending the law "On the federal budget for 2024 and for the planning period of 2025 and 2026." The document entered into force on the day of signing.
According to the bill, a total of 521.6 billion rubles will be allocated as part of the change in the departmental structure of federal budget expenditures. Of these funds, 484 million rubles will be allocated to the Ministry of Health, 121 million rubles will be allocated to the Federal Medical and Biological Agency (FMBA), and 787 million rubles will go to healthcare.
The following state programs, projects, and events will be financed from the federal budget:
- "Healthcare Development";
- "Healthcare Infrastructure Development";
- "Education Development";
- "Healthcare Human Resources Management";
- "Scientific and Technological Development of the Russian Federation";
- "Medical and sanitary support for certain categories of citizens";
- "Medical science for humans";
- "Ensuring chemical and biological safety of the Russian Federation";
- "Organization of state sanitary and epidemiological supervision and ensuring sanitary and epidemiological well-being of the population".
Mandatory labeling of technical rehabilitation equipment was introduced on September 1
The government approved amendments to the list of goods subject to mandatory labeling. The list was expanded with 77 new items. The corresponding order No. 1765-r dated July 4, 2024 was published.
The following technical rehabilitation equipment (TRE) were added to the list:
- sanitary and hygienic products used for incontinence;
- support and tactile canes, crutches, supports and handrails;
- parts and accessories of prostheses, functional units and orthoses;
- anti-decubitus mattresses and pillows;
- special means for disorders of excretory functions;
- chairs with sanitary equipment;
- wheelchairs related to medical products.
The specified items, as well as drugs for veterinary use, will need to be labeled from September 1 of this year. In addition, medical gloves are also subject to labeling from March 1, 2025.
At the end of June 2023, the Ministry of Industry and Trade proposed to conduct an experiment on the labeling of certain types of technical rehabilitation equipment. At that time, it was proposed to include functional units of prostheses, special means for disorders of excretory functions and a number of other products in the list. The pilot began on October 15, 2023, it will last until August 31, 2024.
Market news
Ultrasound equipment manufacturers have difficulty accessing the register of electronic products
Favorable conditions are developing in the market for Russian manufacturers of medical equipment - confidence in the devices manufactured in the country is growing, there are opportunities to participate in tenders and government procurement. But not all market participants can take full advantage of the situation.
In order to participate in government procurement, it is necessary to fulfill a number of requirements, one of which is presence in the unified register of Russian electronic products, created by the Ministry of Industry and Trade by RF Government Resolution No. 878 dated 10.07.2019. It provides advantages for government procurement and tenders with large companies - it is important for them that the manufacturer is on this list.
To be included in the register, you need to meet a number of requirements and score a certain number of points. Currently, the point assessment system is used for 20 types of electronic products, with a minimum number of points being introduced for each category separately, which is planned to be gradually increased. Thus, in 2023, companies producing ultrasound diagnostic equipment needed to score 65 points, in 2024 - 75, and in 2025 - 80. Requirements for scoring: the presence of a legal entity in Russia that is not controlled by foreigners, own patents and rights to technology, design and technical documentation for the design and production of products, the place of development and production of the components that make up the product, the degree of localization of technological processes. The more a company meets these requirements, the more points it can score.
The main snag is that Russian components are most often not used on the medical ultrasound equipment market, since they are not produced in the country - accordingly, companies cannot provide documents, it is more difficult for them to score the required number of points and get into this register. Despite the fact that the Ministry of Industry and Trade recently changed the rules and now documentary evidence of the purchase of Russian components is no longer required for inclusion in the register, but only a report on the shipment of products is sufficient, the point system has remained the same.
This means that Russian manufacturers of ultrasound equipment are still in a difficult position. There have already been news on the market that bypassing the requirements and illegally entering the register could lead to problems with the law and a blow to reputation.
According to experts, a loyal reduction in the entry point threshold will be a logical continuation of the abolition of document confirmation and will help domestic manufacturers conclude profitable contracts and equip medical institutions with their equipment. In addition, this will give a head start to Russian production over imported ones.
The Innovation Assistance Fund will allocate 150 million rubles to student startups in medicine
The Innovation Assistance Fund has approved 2 thousand projects - winners of the 2024 Student Startup competition, each of which is provided with a grant of 1 million rubles. More than 150 initiatives of the total number relate to medicine, pharmaceuticals and health preservation. Among the winners are projects from Sechenov University, Pirogov Russian National Research Medical University, Lomonosov Moscow State University, Pavlov First Saint Petersburg State Medical University, Siberian State Medical University, Kazan State Medical University and other universities. Eight projects from Sechenov University won the competition, two projects from RNRMU, 52 projects from Lomonosov Moscow State University, six of which relate to medicine and health preservation, one project from Pavlov First Saint Petersburg State Medical University, five projects from Siberian State Medical University and seven from Kazan State Medical University. The projects that will be implemented using grant funds include: the creation of implants and exoskeletons to restore fine motor skills (SibSMU), the development of a mobile application to help with panic attacks (Orenburg State Medical University), a system for intraoperative monitoring of blood flow in the thyroid and parathyroid glands during surgical interventions (I.S. Turgenev Oryol State University), the use of artificial intelligence to predict dental treatment (Sechenov University), the development of an online medical service TeleDiet using AI technologies and a telemedicine module to solve problems related to nutrition (N.I. Pirogov Russian National Research Medical University), and others. In addition, the Foundation for Assistance to Innovations has published another list containing information about the competition participants with whom an agreement for the provision of a grant may be concluded in the second round - in the event that the winners from the first list refuse to sign such an agreement. The list includes 375 initiatives, 11 of which (creation of an AI-based medical image analysis system, a digital medical record with analytics and easy addition of documentation, development of an automated device for measuring pressure and permeability of the intervertebral disc, and others) are related to healthcare.
In June 2024, the Presidential Grants Fund sent subsidies to more than 55 non-profit organizations that won the second competition in 2024 for co-financing projects in the profile of "Protection of public health, promotion of a healthy lifestyle." More than 289 million rubles were spent on the implementation of such projects.
Other
A bracelet to stop bleeding from the radial artery has received registration from Roszdravnadzor
The developer of a bracelet to stop bleeding from the radial artery, Newman Technologies LLC, has received a registration certificate for a medical device, the owner of the startup, Dmitry Ognerubov, told TASS.
The device, which was named NewMan (from the English NEW MANner of artery compression - a new method of artery compression), is made in the form of a bracelet made of polypropylene with ports for pumping air. It contains an additional air cushion that compresses the ulnar artery, unlike a bandage, which affects only the radial artery, MV wrote.
The medical device reduces the likelihood of developing radial artery occlusion (closure due to thrombosis) by five times - up to 2.6% of cases. Unlike foreign analogues, the bracelet does not require checking every hour and costs half as much.
A pilot study of the bracelet is being conducted at the Moscow City Clinical Hospital No. 1 named after N.I. Pirogov. The tests are two-thirds complete, Ognegrubov clarified.
At the end of 2022, Ognegrubov told MV about plans to launch a full production cycle of his device in a year. For this, they decided to use the contract manufacturing format in the special economic zone Technopolis Moscow.
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