On November 28, 2018 the Federal law of November 28, 2018 No. 449-FZ “On amendments being made to separate legal acts regarding introduction of drugs into commercial turnover” (the “Law”) was published on the official web portal of legal information.

On October 18, 2018 new wording of the Rules of state registration and re-registration of maximum sale prices established by drug manufacturers for those drugs, that are included in the vital and essential drugs list (“the Rules” and “the Drugs” correspondingly) has been enacted with the amendments introduced by the Russian Government Decree of 08.10.2018 No. 1207 “On amendments to the Russian Government Decree of October, 29 2010 No. 865 and of September, 15 2015 No. 979” (“the Decree”).

Federal Antimonopoly Service (FAS of Russia) has issued Letter No. АЦ/49132/18 dated 29 June 2018 in which expressed its opinion regarding selling prices for drugs, included in the List of vital and essential drugs (the “Essential drug list”). FAS indicated that these prices, when set by wholesale and retail organizations, shall be dependent on the terms of their purchase.

On 24 April 2018 the Intellectual Property Court published its Decision in case A41 85807/2016 between Swiss-based Novartis AG and local generic Nativa LLC.

At present, the direction of medicine, such as telemedicine, becomes more and more known and the number of questions about the procedure of providing medical assistance using telemedicine is also growing.

The Ministry of Healthcare of the Russian Federation (the “Minzdrav”) has developed draft law aimed to improve regulation of drugs circulation, namely in respect of the determination of drugs interchangeability (the "Draft Law“).

On April 13, 2018 the draft law (hereinafter — the “Draft law”) imposing measures (countermeasures) in response to the hostile acts of the USA and (or) other foreign countries has been introduced to State Duma by both State Duma’s chairman and parliamentary leaders.

On January 19, 2018 State Duma has passed in the first reading the introduced by Russian Government draft law (hereinafter — the “Draft law”) providing changes to the Federal law dated 12.04.2010 No. 61-FZ “On drugs (medicines) circulation” (hereinafter — “61-FZ”).