Upcoming reforms in Russia’s pharma environment. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
An automated system of monitoring the movement of drugs from the manufacturer to the end user has been launched to protect the population from counterfeit drugs and the rapid removal of counterfeit and substandard drugs from circulation.
Drugs for the purpose of the experiment are marked with a two-dimensional bar code on a secondary drug labeling, which makes possible to monitor drug’s movement from manufacturer to end-consumer.
2. When are they likely to come into force?
Starting from January 01, 2020 requirement on two-dimensional bar code on a secondary drug labeling will become obligatory.
3. Alterations to admission to public procurement
Alterations to admission to public procurement of vital and essential drugs, set forth by Government Decree dd 30.11.2015 No. 1289, are adopted by Government Decree dd 12.05.2018 No. 572. A public customer shall decline applications to supply vital and essential drugs originated from foreign countries, which are not Eurasian Economic Union members, if at least one application to supply vital and essential drugs originated from Eurasian Economic Union member state is filed. All manufacturing stages of such drug, including molecule synthesis for API, shall be operated within the territory of Eurasian Economic Union member states. Such API shall be included into Marketing Authorization for the drug. The amendments are effective 01.01.2019.