News Digest 05.02.2024 — 07.02.2024
Regulators
The Ministry of Health intends to expand the list of medical products for palliative care at home
The Ministry of Health plans to make changes to the list of medical products intended to maintain the functions of organs and systems of the human body, provided to the patient during the provision of palliative care for use at home. The draft order was published on February 6 on the regulation.gov.ru portal.
It was proposed to supplement the list with 28 items, including a high-frequency electrically driven mechanical ventilation device, a respiratory oxygen therapy system, a hydraulically driven bed, a parapodium-verticalizer, etc. New groups and subgroups of medical products are being introduced: the subgroup “Urological Catheters and Related Products” of the “Urological Medical Products” group; subgroup “Infusion sets and related products” of the group “Cardiovascular medical products”; subgroup “External prostheses/orthoses” into the existing group “Rehabilitation and medical devices adapted for people with disabilities.”
The State Duma opposed the introduction of an excise tax on ethanol
Participants in the meeting in the State Duma, held on the initiative of the Committee for Protection of Competition, opposed the introduction of an excise tax on ethanol. This was reported by the press service of the Public Council under Roszdravnadzor.
An excise tax is an indirect tax added to the price of goods produced in the country, and, accordingly, its introduction will affect the final cost of the goods, the meeting participants noted. The pharmaceutical industry is already experiencing a serious financial burden due to the rise in prices of excipients, pharmaceutical substances and intermediates, packaging materials and software, the complexity of logistics schemes, the increase in the exchange rate, and the issue of increasing the cost of pharmaceutical inspections is also being discussed. All this negatively affects the cost of pharmaceutical products, reducing the profitability of pharmaceutical production and making the production of pharmaceuticals in the low price segment unprofitable, which in turn leads to their “washing out” from the market, the report says.
Source: https://pharmvestnik.ru/content/news/V-Gosdume-vystupili-protiv-vvedeniya-akciza-na-etanol.html
The Public Chamber of the Russian Federation plans to restore order in cosmetology devices
Members of the Russian Public Chamber called for updating the legislation regulating the provision of cosmetic and cosmetology services, as well as toughening penalties for the sale of unregistered medical products, writes RG.
This topic was discussed at a meeting of specialists and experts at the Public Chamber of the Russian Federation. Its participants are concerned that cases of sale of unregistered and low-quality devices that are used to provide cosmetic services have become more frequent on Internet platforms. First of all, the round table participants drew attention to the gaps in the legislation, which allows illegal products to get into beauty salons.
According to Muslim Muslimov, a member of the Public Chamber of the Russian Federation Commission on Health, if you enter the words “medical equipment” into a search engine, any user will receive a lot of links to sites where unregistered medical equipment is sold. It is not difficult to purchase it, but the use of such devices in salons and clinics is potentially dangerous for the consumer, and also contributes to unhealthy competition.
Alexey Grebnev, Chairman of the Committee on the Medical and Pharmaceutical Industry of the National Association of Healthcare Managers (NAUZ), also drew attention to the gaps in the legislation regulating the market for these services. He clarified that not all consumers understand the difference between cosmetology services, which are medical, and cosmetic services, which are not. Cosmetology services can only be provided by medical organizations, while cosmetic services are available in beauty salons. Alexey Grebnev believes that these types of services need to be clearly distinguished. There are many different “beauty” institutions in Russia. Certified “smart” devices for rejuvenation are expensive, so not all entrepreneurs work with official distributors. Experts propose to tighten penalties for the circulation of unregistered and low-quality medical products. The functioning of online pharmacies and marketplaces also needs to be regulated. “There is equipment that is imported as non-medical products and then sold on the Russian market through marketplaces as equipment not related to medicine. It is bought by beauty salons and used by non-medical organizations. But Roszdravnadzor and the Russian Ministry of Health cannot influence this situation,” says Alexander Aronov, chairman of the committee for legal support of NAUZ. He believes that there should be criminal liability for the illegal sale and use of unregistered medical equipment.
Muslim Muslimov noted that based on the resolution adopted at the round table, in March 2024 this topic could be discussed in the State Duma expert council.
Earlier, PharmMedProm wrote that the country is increasing the number of institutions where it is allowed to test medical devices to check their quality and safety. In April 2023, Sechenov University received the right to conduct pre-registration tests of new medical devices on its site.
Market news
The production of suture material and needles for surgery will be launched in the Moscow region for 500 million rubles
In Podolsk, in 2024, a plant will be launched for the production of surgical suture material used in surgical interventions to connect tissues and stop bleeding, the press service of the Moscow Region Development Corporation (KRMO) reported. The Integral Medical company will invest more than 500 million rubles in the project.
At the enterprise with an area of more than 4.3 thousand m2, the installation of sterile premises is being completed and preparations for commissioning work are underway. The launch of the plant is scheduled for the third quarter.
The production is intended to fill the shortage of sterile suture materials that arose on the Russian market after the departure of European manufacturers, said General Director of Integral Medical Artur Siliverstov. He added that the company also plans to launch the production of a line of surgical needles from domestic raw materials.
It is specified that the suture material produced in the Moscow region will allow for complete regeneration of sutures. It can be used by specialists for any surgical interventions, including cancer patients.
After reaching full capacity, the enterprise will be able to produce at least 10 million sterile threads and needles per year. The products will be supplied to medical institutions throughout Russia
The government launched venture funds for student startups
Venture funds specialize in providing investments for the implementation of risky, innovative projects. According to Chernyshenko, the new support measure will help student startups develop a clear educational path for further development.
Professional investors will be able, through venture funds, to support student projects when entering the market not only with financial investments, but also with their own business competencies. According to the General Director of the Fund for Infrastructure and Educational Programs Ruslan Titov, university venture funds will be able to introduce the practice of supporting student projects with a high level of risks into the Russian investment market.
The work of venture funds was launched under the federal project “Platform of University Technological Entrepreneurship”, implemented by the Ministry of Education and Science. The project is being implemented by the Fund for Infrastructure and Educational Programs together with leading Russian investment companies operating in the field of high technology. The list of such companies has not yet been specified.
Nowadays, students in Russian medical universities create many projects. Thus, the “TOP 1000 University Startups”, prepared by the Ministry of Education and Science of the Russian Federation and released in November 2023, included 105 projects related to healthcare, three of them were in the TOP 50. The highest position in the ranking was taken by the project of a student of the First Moscow State Medical University named after. THEM. Sechenova Maxim Suchkova Save My Milk, the goal of which is to create a compact pasteurizer for express disinfection of breast milk. The startup took 15th place.
Other
Sechenov University and Yandex will develop AI for the pharmaceutical industry
Sechenov University and Yandex will jointly develop AI for the pharmaceutical industry; they have signed a strategic cooperation agreement. In particular, the university and the IT company will use big data processing technologies to automate the collection and processing of information during clinical trials.
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