The Ministry of Health of the Russian Federation has submitted draft amendments to the Regulation on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation, and medical care, due to the fact that there are currently no provisions for off-label drug use in clinical testing. The document is published on the regulation.gov.ru portal.
The draft amendments are intended to improve the provision of medical care within the framework of clinical testing in medical organizations. If adopted, it will enter into force on March 1, 2022.
According to the document, it is allowed to use in clinical testing medicines and medical devices registered in accordance with the established procedure in the Russian Federation for indications not specified in the instructions for their medical use and/or in the operating manual, by the decision of the council of doctors or the medical commission of the medical organization where the clinical testing is carried out, if there are references in the protocol of clinical testing to effectiveness and safety clinical studies for the dosage regimen of the drug and/or the method of use of the medical device for the corresponding disease, or references to leading domestic and/or foreign peer-reviewed research journals and publications.
A method of prevention, diagnosis, treatment and rehabilitation is considered effective if it has scored at least one point in total for each efficiency indicator specified in the evaluation algorithm, which:
– requires lower financial costs, but at the same time is no less effective for prevention, diagnosis, treatment and rehabilitation compared to the method already used in clinical practice;
– requires more financial costs, but at the same time its additional advantages for prevention, diagnosis, treatment and rehabilitation justify the additional costs.
The discussion of the project will last until September 15.