Clifford Chance

New pricing system for drugs in Russia within sight

31 May 2019

Major pricing reform in Russia's pharmaceutical sector has long been mooted. The necessary legal framework is still being finalised, but amendments to the Pharmaceuticals Law will take effect in June 2019, bringing the reform a considerable step closer to reality.

BACKGROUND

Russia's Essential Drugs List (the "EDL") currently contains 735 products and the pricing reassessment campaign (the "Reassessment") aims at lowering prices for many or even most of them. The Reassessment is contemplated to begin in the second half of 2019 and be completed by 1 January 2021.Most importantly, once the Reassessment is finished, pharmaceutical companies will have a new, recurrent obligation to decrease prices following any price decrease for the same products outside Russia.As a first step for preparing the Reassessment, a price calculation methodology was approved in October 2018 (the "Methodology"). Amendments to the framework Pharmaceuticals Law were finally approved by the State Duma on 23 May 2019 and will take effect in June 2019. These amendments will essentially authorise the Russian Government to establish the necessary procedures and deadlines for the Reassessment. A government decree setting out the details of the Reassessment procedure, deadlines for submissions, the timing when the new prices will take effect, etc. (the "Draft Decree") is anticipated to be approved in the next few months and to take effect by the end of 2019. A revised version of the Draft Decree was published on 29 May 2019.

Download PDF