OBJECTIVES : Over the past few years, risk-sharing schemes have gained a significant position in drug supply in developed and developing countries. In the Russian Federation, the introduction of innovative drug supply models (IDSM) has been underway for the past few years. Aim of the study is presentation of the algorithm for developing the necessary documents for the introduction of risk-sharing schemes in today's Russian legal environment.

METHODS : The analysis of foreign and Russian scientific literature, Russian federal and regional legal acts was conducted in the search for existing innovative schemes for providing patients with the necessary medical technologies that have issues about their effectiveness and / or their costs.

RESULTS : As a result of the analysis, it was found that currently there is no officially approved algorithm for the implementation of risk-sharing schemes in Russia, and also to organize and conduct a valid IDSM, the following documents will need to be developed: agreement, requirements for the formation of a patient register, the form of inclusion in patient register, performance evaluation procedure, product specifications, invoice, acceptance report, delivery notes, and software for monitoring the results of IDSM (in the case of pay for result type of agreement).

CONCLUSIONS : Documentary support for conducting IDSM in the Russian Federation is a task requiring serious legal support.