New amendments affecting the pharmaceutical market in Russia – key points highlighted

03 April 2020
  • New amendments to the Law on the Circulation of Medicines were introduced in December
  • The implementation of a 'trace and track' system requiring the marking of medicines circulated on the Russian market was extended until 1 July 2020
  • The protection of trade names through trademark registration has become even more important as a result of the amendments

Russia's Law on the Circulation of Medicines is probably one of the country's most frequently amended laws - and certainly one of its most debated. However, new amendments introduced in December concerning obligatory marking have been largely welcomed by the local pharmaceutical community.

The changes extend the implementation of a 'trace and track' system requiring the marking of medicines circulated on the Russian market until 1 July 2020. Although this system imposes additional organisational and financial burdens on pharmaceutical companies, it is supported by the majority of them as an important anti-counterfeiting measure. Together with properly implemented brand protection, the 'trace and track' system should increase the circulation of medicines with confirmed safety and efficacy parameters.

The obligatory marking does not apply to medicines included in the "seven nosology" list and manufactured prior to 31 December 2019, and to other medicines, if produced prior to 1 July 2020, for the rest of their shelf life.

Other changes affect the handling of generic drugs. The process used to approve generic medicines has been widely criticised by the medical community. As a result, in February Russian Prime Minister Mikhail Mishustin instructed the overseeing health authority, Roszdravnadzor, to conduct a comparative analysis of generic versus reference medicines for cancer treatment, including an inspection of the quality of the pharmaceutical components used in the manufacturing of generic drugs. This was reportedly triggered by numerous complaints from medical opinion leaders, who claimed that the treatment of oncological patients by Russian generics is considerably less effective, especially in treating cancer among paediatric patients.

The prime minister also instructed the Ministry of Health to prepare, by 14 March 2020, a revised list of medicines for cancer treatment to be purchased through state procurement tenders by using their trade names. If the government adopts such a list, it should become possible for hospitals to place orders for particular medicines produced by the manufacturer of original (reference) medicines, instead of purchasing medicines under their international non-proprietary name (INNs). This would be a significant change in the state procurement tender procedure where the 'three is a crowd' rule currently applies.

This rule often leads to situations where foreign originator companies are kicked out of the tender as soon as two Russian generic companies submit bids for the same purchase order.

Another change is the introduction of a new legal category, 'original medicine', effective from 1 March 2020. 'Original medicine' refers to medicine with a new active substance first registered in Russia or other countries on the basis of pre-clinical and clinical trials confirming quality, efficacy and safety.

The definition of 'reference medicine' has also been amended to include both (i) an original medicine and (ii) the first generic medicine registered on the basis of bio or therapeutic equivalence studies (in comparison to the original), where the original medicine is not registered in Russia or is not available on the market.

There is a tendency from Russian generic companies to mimic foreign trade names in their trademark registrations, in both their Cyrillic and Latin-character variations. This tendency may become even more popular if purchasing by trade names (instead of INNs) is permitted by the government. It is therefore advisable to protect both the Latin and Cyrillic-character transliteration of a trade name in order to avoid its misappropriation by competing generic companies.

All in all, the proper specification of trade names and their protection through trademark registration, either by extending international registrations or through regional or national registrations, has become more important as a result of these amendments.

This article first appeared on WTR Daily, part of World Trademark Review, in March 2020. For further information, please go to www.worldtrademarkreview.com.


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