News Digest 28.06.2024 — 01.07.2024

Regulators

Mandatory labeling of medical gloves to begin in 2025

Mandatory labeling of medical gloves will begin on March 1, 2025. This was reported by the press service of CRPT, the operator of the state labeling system "Honest Sign". Resolution No. 860 of June 26, 2024 was signed by Prime Minister Mikhail Mishustin.

Initially, the Ministry of Industry and Trade proposed to apply identification means to medical gloves as early as March 1, 2024. Then the press service of the ministry stated that the market participants themselves asked for the inclusion of this type of medical products. The reasons for this were the large share of counterfeit products on the market and the loss of the sales market by suppliers due to unscrupulous "repackagers".

"We have repeatedly encountered counterfeit products of the plant and price dumping due to unscrupulous participants. According to our estimates, the volume of illegal turnover of medical gloves can reach 40%, and in monetary terms, only under government contracts - more than 10 billion," the press service of the CRPT quotes the words of the executive director of the Samara Plant of Medical Products Vyacheslav Egupov.

This is the seventh type of medical products included in the SMDLP. Codes are already applied to recirculators, orthopedic shoes, hearing aids, tomographs, coronary stents, sanitary and hygienic products.

Source: https://pharmvestnik.ru/content/news/Obyazatelnaya-markirovka-medicinskih-perchatok-nachnetsya-v-2025-godu.html

The European Union has imposed sanctions on intellectual property

The European Union has imposed a ban on accepting applications and registering intellectual property rights (IP) from Russian citizens and companies. The restrictions are included in the 14th package of sanctions. We are talking about trademarks, patents, industrial designs, utility models (minor inventions), names of places of origin of goods and geographical indications.

According to EU documents, the reason for the introduction of sanctions were the actions of the Russian government and the courts, which "unlawfully deprived owners of EU intellectual property rights of their protection."

A joint application for registration of IP rights will be rejected if it is submitted with the participation of a Russian citizen or legal entity. It will be impossible to challenge the rejection of such an application. Companies operating in the European Union will also have to include in agreements with partners in "third countries" a ban on the use of IP rights of commercial secrets or information protected by IP rights or protected as a transferred commercial secret. This measure is associated with the likelihood of exporting or selling "high priority goods" to Russia. The restriction will not affect contracts concluded before June 25, if the agreement contains a ban on the use of IP rights. As Yulia Kuzmenko, senior lawyer at the law firm Liding, told FV, the potential impact of the 14th package restrictions may affect manufacturers of medical devices and dual-use goods, since the Regulation sets restrictions on the use of IP rights that are associated with common high-priority goods subject to sale, supply or export to Russia or for use in Russia.

Source: https://pharmvestnik.ru/content/news/Evrosouz-vvel-sankcii-v-otnoshenii-intellektualnoi-sobstvennosti.html


Market news

Multifunctional resuscitation beds have arrived at the Svetlovskaya Central District Hospital in the Kaliningrad Region

The Federal Service for Surveillance in Healthcare is constantly monitoring the implementation of the National Project "Healthcare" in all regions of the country. According to the Territorial Authority of Roszdravnadzor for the Kaliningrad Region, eight electric intensive care beds, the total cost of which is 2.4 million rubles, were delivered to the hospital thanks to the regional project "Modernization of Primary Health Care" within the framework of the national project "Healthcare".

The design of specialized medical furniture simplifies care for patients with disabilities, reduces the risk of complications, provides a feeling of comfort, holding the body in a comfortable position.

The sections are moved using a control panel, which allows the patient to change the position of his body without resorting to outside help.

The beds also have a mechanical lever for emergency transfer to a horizontal plane, a button for emergency power off, an infusion stand with telescopic height adjustment and a radiolucent bed compatible with a C-arm.

Source: https://t.me/roszdravnadzor_official/2641


Other

The UK Ministry of Health has announced 6 strategic principles for the implementation of artificial intelligence in healthcare

The UK National Health Service (NHS) has presented the main principles for the implementation of artificial intelligence (AI) in local healthcare to better understand the regulator's plans for healthcare managers and the medical community. What is it about:

  1. The request for the use of AI must come from the public, patients and the medical profession sonal to ensure it works for them. This means understanding demand from patients and the health system as a whole, and then sawing through AI solutions.
  2. The NHS must focus AI development and implementation in the right areas. That is, not AI for the sake of hype, but AI to solve pressing problems.
  3. The NHS needs data and digital infrastructure that will allow it to benefit from the potential of AI. Without hardware, advanced IT infrastructure and high-quality data, AI will not fly.
  4. The use of AI in the NHS must be supported by high-quality testing and evaluation. AI solutions need public evaluation by the medical community. Ideally, we need ratings and expert opinions on each solution.
  5. The NHS needs a clear and consistent regulatory regime for AI. Without a legal framework, nothing happens. This is the pain of all health systems around the world!
  6. Healthcare workers must have the necessary skills and abilities to benefit from AI. In order for doctors to understand the benefits of AI, it is necessary to explain to them why it is needed and what problems it can solve. A doctor who was given an AI service without an explanation of the details and logic of its work will not be able to trust it with part of his routine. It is important that the medical community understands the capabilities and limitations of AI.

Source: https://www.health.org.uk/publications/long-reads/priorities-for-an-ai-in-health-care-strategy#lf-section-220761-anchor

A robotic "guide dog" for the visually impaired has been created in China

Researchers from Shanghai are testing a robot dog that navigates in space using cameras and sensors, and also listens to and analyzes the commands of a visually impaired user using built-in AI. The "guide dog" will be able to plan a route and recognize traffic lights. Such a development, according to scientists from Shanghai Jiaotong University, will allow people with visual impairments to live more autonomously.

Although similar robots are being tested in other countries, there is a particular shortage of them in China – there are only 400 real guide dogs for 20 million people. Therefore, developers believe that robotic analogues of animal assistants will be in great demand in the Chinese market.

Source: https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-robot-guide-dog-aims-improve-independence-visually-impaired-2024-07-01/

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