Picture of the day: digest of the main news from May 7, 2025
Main
#1 The Russian Ministry of Health has updated The procedure for giving informed voluntary consent (or refusal) to medical intervention. The regulation will come into force on September 1, 2025 and will be valid until the same date in 2031. The patient will be able to choose either a paper or electronic version of the document. The latter must be signed using an enhanced qualified electronic signature or simply an electronic signature using a unified identification and authentication system.
#2 FAS Russia has distributed a letter explaining the procedure for purchasing medical equipment under government contracts. According to the document, manufacturers who transfer medical equipment to the customer free of charge receive an advantage over other suppliers in periodic purchases of components for products. This situation can be regarded as a violation of competition. As the service notes, purchasing components from another manufacturer is permissible if the possibility of joint use of medical products is confirmed by Roszdravnadzor.
Exclusively
At the request of Vademecum, the Pharmaceuticals and Healthcare practice of the law firm Verba Legal prepared an overview of the regulatory legal acts that came into force in April 2025 concerning the circulation of medicines and medical devices. In addition, the lawyers spoke about some thematic draft regulatory legal acts that are currently being developed. More details about these documents are in the digest .
Pharmaceutical business
• LLC Farmika (legal entity of the Ryazan network Apteka Pharma) filed a claim against Apteka LLC for the recovery of 1 million rubles for the violation of exclusive rights. According to the plaintiff, the defendant created a complete copy of the Apteka Pharma franchise project, First Management Franchise. Farmika representatives believe that Apteka's actions may "mislead third parties", therefore, possible negative reviews will extend to the activities of the project participants. The plaintiff and market participants associate Apteka with the family of Alexey Chechenkov, the founder of the Sovetskaya Apteka franchise network.
• The Moscow Arbitration Court partially granted claims of the Ministry of Industry and Trade of the Russian Federation and ordered the pharmaceutical company Biocad to pay the department 2.3 million rubles. According to the case materials, in 2015, Biocad received 54.9 million rubles from the state in the form of a subsidy for the development of a drug with adalimumab. The drug was registered in 2019 under the TN Dalibra. In its claim, the Ministry of Industry and Trade insisted that the company failed to meet two targets stipulated by the agreement on the provision of financing and demanded that Biocad pay 15.9 million rubles. However, the arbitration court confirmed the violation of obligations for only one indicator.
Initiatives
The Russian Government does not believe that insurance medical organizations (IMOs) make excessive profits from fines imposed on clinics. The draft law of the New People faction, which proposes to direct part of the IMOs' profits to the needs of clinics, received a negative review from the government apparatus. Insurers make money, among other things, on interest from fines and other sanctions imposed on clinics, which, according to parliamentarians, leads to abuses by auditors and imposes an additional financial burden on clinics. The government, on the contrary, believes that abandoning this scheme will lead to underfunding of insurance experts, and, accordingly, the quality of medical care will decrease. The draft law was not approved by the State Duma Legal Department and the Accounts Chamber.
Medical education
The Ministry of Education and Science of the Russian Federation has updated Federal State Educational Standard for the residency program 31.08.56 "neurosurgery". Now the specialist's training period will be 3 years, the number of credits will reach 180. The decision will be effective from the new academic year. According to the current standard, approved in 2014, the training period was 2 years. The new document, among other things, stipulates a ban on mastering disciplines only in electronic format.
Protection of competition
FAS Russia has identified signs of a cartel agreement between SZ StroykomKrasnodar and an unnamed individual during participation in the bidding for the purchase of 100% of the shares in the authorized capital of Protasovo MG, owned by the S.N. Fedorov National Medical Research Center for Scientific and Technical Complex Microsurgery of the Eye. The agency initiated a case for violation of antitrust legislation against the cartel participants after the Prosecutor General's Office of the Russian Federation became interested in the deal in November 2024 and filed a claim with the Arbitration Court of the Krasnodar Territory to invalidate the auction results. The reason for such a reaction was the unreasonably low price of the transaction: despite the fact that the cost of the lot was estimated at 333.1 million rubles, the asset was sold for 83.6 million rubles. The court declared the transaction invalid, and in March 2025, 100% of the shares were transferred back to the NMIC.
Career
Deputy Governor of the Vladimir Region Konstantin Baranov, who oversees the healthcare sector, is leaving a post he has held since 2021. The official is undergoing approval for employment in one of the federal centers. Vladimir Region Governor Alexander Avdeev reported that during his tenure, Baranov managed to resolve many problems in the industry and restart the work of the regional Ministry of Health. Avdeev especially emphasized that the personnel reshuffle is not related to the corruption scandal in the department - in December 2024, the former head of the ministry, Valery Yanin, was detained.
Infrastructure
The Moscow City Healthcare Development Directorate has published tender for the construction of the Flagship Mental Health Center. The city budget will allocate 2.725 billion rubles for the construction of the facility. The center will appear on Bolshoy Predtechensky Lane and will be the third in the city. Medical institutions of this format are aimed at helping Muscovites with psychosomatic disorders.
Other news:
A draft federal law to determine the legal status of the RSC has been submitted to the State Duma
Novo Nordisk lowers sales growth forecast as Wegovy sales fall
US Pharmaceutical Companies Risk Losing $1 Trillion Over 10 Years Due to Trump's New Initiative
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