Practices
Industries

Key Developments in Russian Pharma — 2019

14 February 2020

The year 2019, which continued the trend of rapid and numerous changes in healthcare regulations, was rich on expectations, events and legislative proposals aiming to reverse pharmaceutical industry: medical drugs labeling, reform of price determination, new procedure of entry into drugs civil circulation, amendments to regulatory framework of the Eurasian Economic Union, etc. This trend is likely to continue in 2020 as well.

Simplification of the procedure of including IP objects to the Customs Register

13 February 2020

According to Chapter 57 of the Federal law No. 289-FZ dated 03.08.2018 “On Customs Regulation in the Russian Federation and on amending certain legislative acts of the Russian Federation” (Law on customs regulation) a rightholder is entitled to file to the Customs Service an application for including their IP objects to the Customs Register seeking rights protection.

Track and trace for Medicines. Amendments 2019

27 December 2019

Under the Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 (hereinafter — Decree No. 1556), monitoring system of the medical drugs circulation should become effective from the January 2020 with the exception of medical drugs for healing high-cost ICD diseases, which have already been monitored from October1, 2019.

Liability for non-compliance with the requirements on the localization of personal data of Russian nationals to become more stringent

16 December 2019

On December 2, 2019, Federal Law No. 405-FZ entered into force. This act significantly increases administrative liability for violations of the requirements on the localization of databases containing personal data of Russian nationals. The localization requirement was first introduced into the Russian legislation in 2014 and imposed an obligation to locate servers with the personal data of Russian nationals only in the territory of the Russian Federation.

The Supreme Court explained the procedure for compensation of damage caused by a former employee to employer

09 September 2019

On June 3, 2019, the Judicial Chamber on civil cases of the Russian Supreme Court issued a ruling in a case between «Ormatek-Privolzhie» Limited liability company (“Company”) and Ramazanova I.N. in connection with the concluded refund agreement. This ruling reflects the Supreme Court’s opinion on the procedure for compensation of damage caused to employer by its former employee.