Russian doctors may soon have the option to not strictly follow clinical recommendations if doing so is in the patient`s best interest. This change was approved by the State Duma`s health committee.
Deputies and officials emphasize that this is not a permission to disregard medical standards entirely, but rather a way to preserve the possibility of an individual approach to treating specific patients.
On Wednesday, June 25, the State Duma committee on health reviewed government amendments to a bill concerning a unified biological safety registry. Introduced in November 2024 and passed in the first reading on December 10, the bill now includes amendments to the law «On the Fundamentals of Protecting the Health of Citizens in the Russian Federation» for its second reading.
The new provisions relate to clinical recommendations – documents that contain «evidence-based» algorithms for the prevention, diagnosis, treatment, and rehabilitation of patients. Since 2022, medical organizations have been gradually transitioning to providing care based on these guidelines. According to the Ministry of Health, this was intended to guarantee citizens a uniform standard of treatment across all hospitals and clinics.
Starting January 1, 2025, all medical institutions and doctors in Russia were set to be obligated to use clinical recommendations in their work. However, this requirement drew criticism from some professional and expert circles. As reported, doctors warned of the impossibility of strictly adhering to the guidelines in real-world practice conditions and due to insufficient funding. They also complained about the lack of clear legal status for the recommendations, as they are not regulatory legal acts.
According to the government amendments, clinical recommendations will no longer be strictly mandatory. They will be applied under a special procedure to be established by the Ministry of Health.
The bill also clarifies the concept of «clinical recommendations,» excluding «treatment protocols» to avoid misinterpretation. Committee members unanimously supported the amendments, and according to sources familiar with the situation, the document is being prepared immediately for second and third readings.
First Deputy Chairman of the committee, Badma Bashankaev, expressed hope that doctors will now have a clear understanding of how to apply clinical recommendations while maintaining the possibility of an individual approach. «This is especially important for complex cases when a person has several serious conditions requiring a comprehensive solution,» Mr. Bashankaev explained. «We have worked towards this for a long time: discussed, refined, undergone analysis in the Presidential Administration`s main legal department, and today, finally, we have a result. This is not just a bureaucratic change, but a real improvement for doctors and patients. Clinical recommendations will remain a scientifically based guideline, but will not become a rigid, mandatory instruction. We treat the person, not the medical history.» He added that the next step is for the Ministry of Health to finalize the procedure for applying these recommendations so that the «sub-legislative act is in the most agreed-upon version» by the second reading.
Olga Kolsanova, chief freelance specialist in cosmetology for the Ministry of Health in the Samara region, believes that giving clinical recommendations a clear legal status is a step in the right direction that the medical community has long awaited. Defining recommendations «as a guideline» protects both the doctor and the patient from the risks of a formal, «template» approach to treatment. However, she emphasizes that this rule should not be seen as permission to ignore standards: «Any such deviation must be thoroughly documented in the medical records. This increases the doctor`s responsibility: they must clearly understand why in this specific case they are acting within the recommendations or consciously deviating from them in the patient`s interest.»
Ms. Kolsanova notes that the practical implementation will depend entirely on the procedure for application. It is crucial that this procedure does not become «overly bureaucratized» and does not create barriers to clinical decision-making: «Ideally, the procedure should clearly define how and where the justification for deviating from the recommendations is recorded. This directly affects the quality of medical care, the legal protection of doctors, and patient safety.»
