[The legal status of off-label preparations and legal aspects of their application in The Russian Federation].

Abstract

For many years, the medications "outside of instruction" (the so-called "off-label" ones) had no single-valued legal status in the Russian Federation and other countries that entailed number of problems. Most of them had to do with schemes and tactics of treatment of patient, impossibility of proper medical care support, legal responsibility of physician for applying medications outside of attached instruction. The important move in resolving mentioned problem became adoption of the Federal Law "On entering changes in the Federal Law "On Fundamentals of Health Care of Citizen in The Russian Federation" that became first step on the path leading to acquisition by "off-label" its legal status. The analysis of relevant normative legal acts, the Criminal code of the Russian Federation was carried out. The basic conclusions related to application of medications in medical institutions in Russia, to physician strategy in cases requiring application of of medications "outside of instruction" were formulated. In case of applying medications "outside of instruction" without informed voluntary agreement of patient, without utmost necessity, single-handed instead of decision of medical commission or in situations which could be managed without this kind of medications i.e. under unfounded risk the physician can be prosecuted since treatment with off-label medications is considered as insecure according to legislative base currently in force.