The Russian Government passed the decree in December 2019, which amends the rules on the state regulation of ceiling prices for drugs included on the ‘Vital and Essential Drugs List’. This list includes over 700 products and is approved annually.

The decree means foreign originator products must keep their prices in Russia in line with the lowest price in any of the 12 foreign reference states (Belgium, Czech Republic, France, Greece, Hungary, Poland, Romania, Slovakia, Spain, The Netherlands, Turkey, and the country of origin of the drug). The holder of the marketing authorization (MA) for the originator drug in Russia must apply for a decrease of the ceiling price to the Russian Ministry of Health within 30 days of the decision on the price decrease.

For generic and non-originator biological drugs, prices must follow those of reference products, minus a reduction coefficient, which is calculated in accordance with the ‘Methods of Calculation of Ceiling Prices of Drugs Included in the Vital and Essential Drugs List’. This rule does not apply to orphan drugs.

Registration of a second generic, which will generally have a lower price than the first, will trigger a reduction of the registered ceiling price of the first generic (provided they have the same International Nonproprietary Name (INN) and similar dosage/dosage forms). Applications for such a reduction must be filed with the Ministry of Health within 30 days of registration of the ceiling price.

All pharmaceutical companies wishing to sell their products in Russia, whether foreign or local, must go through a one-time mandatory ceiling price adjustment for all essential drugs. Failure to go through this price adjustment will debar the drug from sale from 2021. This does however exclude immunobiological, narcotic and psychotropic drugs, and those in the low-price (less than RUB 100, or Euros 1.4) segment.

In 2018, a Moscow court was the first to approve a compulsory licence [1]. The licence was granted to a Russian drugmaker to make a generic version of a blood cancer drug and was an attempt to stimulate the local drug market in Russia, where most drugs are made from active ingredients sourced overseas.

Related articles
Non-originator biologicals approved in Russia

US Senators reveal plans to lower drug prices

WHO essential medicines list: new lung cancer medicines rejected

Pilot procurement scheme in China cuts drug prices

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Russian court approves first compulsory licence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Policies-Legislation/Russian-court-approves-first-compulsory-licence

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. 

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.