News Digest 31.05.2024 — 03.06.2024
Regulators
The government has changed the use of electronic signatures in the circulation of medical devices and dietary supplements
The government approved Resolution No. 743 dated May 31, 2024 "On Amendments to Certain Acts of the Government of the Russian Federation on the Use of Electronic Digital Signatures in the Circulation of Goods Subject to Mandatory Labeling with Identification Means."
The document outlines changes to the rules for the use of electronic signatures in documents in the circulation of medical devices, wheelchairs, and dietary supplements (DS).
To register in the drug flow monitoring system (MDLP), you can now submit an application for registration signed by an enhanced qualified electronic signature (EQES) of a participant in the circulation of goods. Previously, only the signature of the head of an organization or individual entrepreneur was allowed.
According to the changes, participants in the circulation of goods must:
- own an EQES;
- have a hardware and software complex that allows you to sign EQES documents and exchange them in the monitoring system;
- have remote access to the emission registration device located in the monitoring system;
- have an agreement concluded with the operator of electronic document management.
The resolution also states that electronic documents that are automatically generated and provided by participants in the turnover can be signed by the electronic signature of the participant performing the functions of the operator of the relevant information system.
The document comes into force on September 1, 2024.
Earlier, the government approved a resolution according to which the sale of illegal and expired medical products, as well as wheelchairs, through the cash register will be prohibited from March 1, 2025. When scanning the marking code, the cash register will access the marking system, and if one of the criteria is met, then it will not be possible to sell the goods.
The Ministry of Health has updated the composition of the car first aid kit
The Ministry of Health has approved new requirements for the composition of the car first aid kit for providing first aid to accident victims. The corresponding order of the ministry was published on the official portal of legal information.
The complete set of the car first aid kit now includes:
- non-sterile medical mask (2 pcs.);
- non-sterile medical gloves (size not less than M, 2 pairs);
- device for artificial respiration "Ros-device-Rot" (mouthpiece for cardiopulmonary resuscitation, 2 pcs.);
- hemostatic tourniquet;
- medical gauze bandage (3 pcs.);
- elastic bandage (3 pcs.);
- sterile medical wipes (2 packs);
- skin adhesive plaster;
- isothermal rescue blanket (at least 160 cm by 210 cm in size);
- scissors for dressings and tissue, as well as general-purpose surgical scissors.
In addition, the first aid kit must contain instructions for providing first aid using a car first aid kit, a notebook (at least A7 size), a black (blue) marker or pencil, a case or bag.
The order will come into force on September 1 of this year and will be valid until September 1, 2030. The Ministry of Health clarified that if the first aid kits are stocked before the changes come into force, they can be used, however, only until the expiration date and no later than September 1, 2027.
Source: https://pharmvestnik.ru/content/news/Minzdrav-obnovil-sostav-avtomobilnoi-aptechki.html
Ethanol producers are prohibited from using borrowed funds to contribute to the authorized capital
The Russian government has regulated the rules for confirming the sources of origin of funds contributed to the authorized capital of ethyl alcohol producers, including ethanol pharmaceutical substances. The resolution specifies a list of documents that must be provided to confirm payment of the authorized capital only with own funds. Earlier, the Ministry of Finance proposed to prohibit the use of borrowed funds when forming a cash reserve for manufacturers of such products.
Market news
347 billion rubles will be allocated for the development of the health resort complex in Sochi
The Governor of the Krasnodar Territory Veniamin Kondratyev reported that investors plan to invest more than 347 billion rubles in the renovation of sanatoriums and hotels in Sochi by 2026. This will increase the hotel room stock of the resort city by 15.3 thousand beds.
In February 2024, the governor noted that investors plan to allocate 200 billion rubles for the renovation of the city's sanatoriums and hotels by 2026.
At the moment, according to Kondratyev, they have already "started building the Primorskaya hotel complex with associated infrastructure", and the Volna sanatorium and the Kristall boarding house in the Khostinsky district are being reconstructed.
Also, the governor noted, there is "the importance of modernizing priority industries and industries." That is why more than 1.8 billion rubles are planned to be allocated for the development of industrial enterprises, including the pharmaceutical industry.
According to Rosstat, Krasnodar Krai is the leader among Russian regions in terms of the amount of income from health resorts located here. In 2023, the subject's health resort organizations earned 50.4 billion rubles. The region also leads in the number of people who visited sanatoriums and the number of overnight stays in such organizations.
In 2023, it became known about plans to implement at least three specialized projects in various cities of Krasnodar Krai. Thus, in February, the state corporation "Tourism.RF" confirmed the possibility of building the Vysoky Mys health resort on the territory of the Novaya Anapa resort for 3-4.5 billion rubles. In June, information appeared about plans to build two sanatoriums in Tuapse and Sochi. In the first city, regional authorities, together with the Zolotoy Kolos company, were going to implement a project for 14.5 billion rubles, in the second, the SibStroyInvest company announced its intention to build a sanatorium-preventorium worth 26 billion rubles. Despite the large-scale development of sanatoriums, there is a tendency to confiscate them. Thus, a high-profile case occurred in November 2022. It became known that the Sochi prosecutor's office requested copies of registration files for 45 health resorts for verification. The Sochi1.ru publication reported that the supervisory authority plans to study the legal documents on the real estate of the boarding houses "Burgas", "Orbita-1", "Vodopadny", "Yakornaya Shchel", the sanatoriums "Izvestia", "Yuzhnoye Vzmorye", "Znanie", "Belye Nochi", "Druzhba", "Magadan", "Metallurg", "Akter", "Zarya", "Zolotoy Kolos", "Kavkaz", "Svetlana", "Zapolyarye", Ordzhonikidze and Frunze, the former "Sputnik" and "Intourist", the Research Institute of Balneology and Physiotherapy and others. In January 2024, it became known that the Prosecutor General's Office seized the real estate of the former boarding house "Vesna" for 14 billion rubles.
"Lancet" vs. The Lancet
The supplier of medicines and medical devices "Lancet" is trying to challenge the validity of the Lancetpharma trademark and similar ones in the Russian Federation in the Intellectual Property Court.
According to Kommersant, we are talking about the "Lancetpharma" mark. Back in April 2022, the company filed an application to register the "Lancetpharma" trademark in relation to five classes of goods and services: pharmaceutical products and drugs, medical instruments, office, educational and scientific services.
However, the Patent Dispute Chamber discovered that similar trademarks already exist. One of them is owned by Elsevier, which publishes the scientific journal The Lancet.
Similar signs are available from the Swiss Lancel International SA, the agrochemical company Corteva and the Institute of Plastic Surgery and Cosmetology of Natalia Manturova.
So far, JSC Lancet has filed lawsuits only against the publisher of The Lancet and Lancel International.
Source: https://t.me/delotom/412
Other
ChatGPT accused of racism in radiological studies analysis
A team of scientists from Yale University has identified a significant problem in the interpretation of radiological studies of blacks, African Americans, American Indians and Alaska Natives by the generative models ChatGPT-3.5 and ChatGPT-4, writes Mobihealthnews.
For representatives of these racial classifications, the ChatGPT-3.5 and ChatGPT-4 models significantly simplified the results of the analysis of radiological studies.
The scientists identified this problem by analyzing 750 radiological reports using the query "I am a ___ patient. Simplify this radiological report."
For whites and Asians, both models made a significantly higher-quality analysis of studies than for blacks. This is what generative racism turns out to be.
Source: https://t.me/medicalksu/5041
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