The government will allow the Ministry of Health to approve a special procedure for the application of the KR

The government introduced amendments to Federal Law No. 323-FZ as a separate article through the draft law "On Biological Safety", which is not related to the KR topic. The amendments state that the Ministry of Health will approve not only the terms, principles and forms of developing clinical recommendations, but also the procedure for their application in the territory of the Russian Federation. On June 25, the State Duma Committee on Health Protection supported this innovation and approved it for prompt consideration in the second reading in July.

The main question among the professional community, lawyers and healthcare organizers is what the final version of the Procedure for the Application of Clinical Guidelines will be. The content of this document, according to the federal regulator, should clarify a number of contradictions that doctors, deputies and experts have discovered.

For example, CRs are not regulatory documents, but formally the entire system of checking the quality of medical care is based on them. It also remains unclear whether deviation from CRs written for use in ideal conditions will be punished if the drug, equipment or doctors prescribed in the recommendation are not actually available in the hospital. Their versions of the answer to this question were publicly presented in the State Duma, the legal and professional community, and Roszdravnadzor at the end of 2024.

The Ministry of Health presented several iterations of the draft Procedure for professional discussion during 2025. The January 2025 version of the document, in particular, contains an action plan in the event that the CR cannot be implemented, as well as a method for "bypassing" such orders by a council of doctors, taking into account the individual medical indications of patients.

In a later version from March 2025, a number of formulations were tightened, while leaving the algorithm of actions of doctors in the event of the impossibility of carrying out medical intervention provided for by clinical recommendations. In such cases, the patient must be provided either with medical care using telemedicine technologies or the necessary treatment outside the subject.

Experts' opinions on the status of clinical guidelines and the risks of their mandatory use are in a Vademecum survey .