PHP64 - ALLOWABILITY OF OUTCOMES-BASED RISK-SHARING SCHEMES IN RUSSIA WITHIN CURRENT LEGISLATIVE HURDLES

Abstract

There is strict and robust regulation of drug provision in Russia which can be a visible hurdle for outcomes-based risk-sharing schemes (OBRSS) introduction. The objective of our qualitative research is to find legal basis for OBRSS within current regulation. Data sources included legislative documents of different level authorities (e.g. civil code, federal laws, government decrees, orders and official letters), juridical comments, actual routine practice of drug procurement, and expert opinion which was collected during consultations with experienced legist in the field of drug procurement. We searched in centralized legislative databases “Garant” and “ConsultantPlus”. Possible schemes were presented as consecutive block-schemes, which were discussed with experts. During the research and discussion series we realized that key hurdle for OBRSS introduction is that drugs must be purchased only using robust competitive procedure of auction. Considering this we developed next schemes which were aligned with current legislation and routine practice. within one contract with drug supplier where health outcomes (HOs) are considered as unexpected deferred conditions (unknown will it happened or not, civil code, article 157). It can include compensation or proportional decrease of contract total price. All specific outcomes and contract terms limits have to be clearly stated in initial contract. within several consecutive purchases of the drug where HOs are considered as a basis for review of starting terms for the next auction. This option implies preliminary local act with detailed description of the scheme. This option is most risky for the industry pricing. within separate agreements. HOs compensation agreement (or HOs risk insurance agreement) with third party (e.g. industry) can be separated from supply contract with drug supplier auction winner. We found at least three possible options for OBRSS introduction in Russia wich can help to overcome legislative hurdle.