By its Ruling of 25.09.2023 in case No. A40-185112/2022, the Ninth Commercial Court of Appeal ordered the pharmaceutical company Vertex, the right holder of a series of patents for the drug Trikafta (INN: Ivacaftor+Tezacaftor+Elexacaftor, Ivacaftor), to grant a simple (non-exclusive) license to the Russian pharmaceutical company MIK under Article 1362(1) of the Russian Civil Code (insufficient use of patents).

Decree No. 529 of the Russian Government dated April 3, 2023 entered into force on April 18, 2023. It amends the Rules for Granting Subsidies for Research and Development in the Realization of Innovative Projects, approved by Decree No. 1649 of the Russian Government dated December 12, 2019.

On 22 February 2023 the Government has approved the rules for conducting an experiment on the remote sale of prescription medicines. The experiment is carried out in the territory of Moscow, Moscow and Belgorod regions from 1 March 2023 to 1 March 2026.

The State Duma has adopted in the first reading amendments to article 238.1 of Criminal Code, establishing liability for circulation of unregistered medicinal drugs and devices in Russia.

The bill proposes to exclude from note 3 to the article 238.1 a case of non–criminalization – the existence of a recommendation by the World Health Organization for the use of appropriate unregistered medicinal drugs and devices.

On 8 February 2023 Alexey Repik, the founder of R-Pharm – Russian pharmaceutical company, producing, among other things, drugs for COVID-19 (e.g. coronavir (favipiravir) and artlegia (olokizumab)) was listed in the UK Sanctions List.

Reasoning behind this decision is that he holds the position of the Chairman of the Board of R-Pharm, which receives financing from the Russian Direct Investment Fund – a Government of Russia-affiliated entity. Moreover, Alexey Repik is also designated as a person associated with Vladimir Putin, the Russian President.

On January 17, 2023, a bill was submitted to the State Duma for consideration. This bill establishes higher responsibility for the sale of medicines subject to quantitative accounting without a prescription.

The relevant bill has been introduced in order to combat drug addiction, which is nowadays widespread, including among minors, as stipulated in explanatory note to the bill.

The new General license No 6C published by OFAC on January 1, 2023, establishes exceptions from US sanctions related to the spheres of agricultural commodities, medicine, medical devices, replacement parts and components for medical devices, or software updates for medical devices.

Based on the Government Decree No. 593 of 5 April 2022 Multiagency Commission on the detection of medicines shortage or a risk of shortage included 88 INN in different forms and dosages (97 names in total) in the relevant list.