A draft 02/08/02-25/00154538, which is intended to update a procedure for the establishing and functioning of a medical panel in healthcare organisations (“Draft”), has been placed on the Federal Portal of Draft Regulatory Legal Acts.
Presently, these issues are regulated by Order of the Ministry of Health and Social Development of Russia No. 502n dated 05.05.2012. The proposed Draft largely duplicates the provisions of the current procedure but provides for several clarifications.
The Draft proposes expanding the list of functions of the medical panel (40 bullets instead of 25), including, among others:
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making a decision on the need to conduct additional tests for a patient outside the healthcare organisation;
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deciding on the need to prescribe medicines that are not included in the Vital and Essential Medicines List;
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making a decision on the prescription of a biomedical cell product specially produced for an individual patient directly in the healthcare organisation;
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if a decision is made to prescribe a pharmaceutical not registered in Russia, determining the procedure for its use based on or taking into account the instructions for use in the Russian language;
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deciding on the prescription and use of medical devices and specialised therapeutic nutrition products in the presence of medical grounds (individual intolerance, for vital conditions);
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decision-making on the prescription of medical devices not registered in Russia in the presence of medical grounds (for vital conditions);
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decision-making on issues of prescribing and correction of treatment to register patient data when providing pharmaceuticals in accordance with Russian legislation.
Separately, we note the clarified wording regarding the prescription and use of pharmaceuticals in the presence of medical grounds (individual intolerance, for vital conditions). The medical panel shall make a decision regarding pharmaceuticals:
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not included in the relevant medical care standard or not provided for by the relevant clinical recommendation (previously - only in relation to pharmaceuticals not included in the relevant medical care standard);
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by trade names (in case of absence of the international non-proprietary name and group or chemical name of a pharmaceutical) (previously there was no clarifications provided);
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not registered in the Russian Federation in cases of (1) absence of analogues of pharmaceutical that are registered in Russia, (2) absence of effect from the conducted therapy and progressive deterioration of the patient's health condition, (3) absence of alternative (non-medication) methods of prevention, treatment and medical rehabilitation, (4) individual intolerance to analogues of pharmaceuticals registered in Russia (previously this item was absent).
The Draft also stipulates that an extract from the minutes of the decision of a medical panel may be provided not only to the patient and his/her legal representative, but also to another person specified in a written consent to disclosure of information constituting a medical secret or informed voluntary consent to medical intervention.
At the same time, the request and the extract itself may also be provided in electronic form.
If adopted, the Draft will enter into force on 1 September 2025.