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What We’ve Got Here Is a Failure to Communicate

19 October 2015

Federal Anti-Monopoly Service pointed out their disagreements with Eurasian Union partner countries

At the moment the issue of creating a single pharma market is discussed and is causing a lot of tension in Eurasian Union comprises of Russia, Byelorussia, Kazakhstan, Armenia and Kirgizia.

Russia disagrees with partner countries on several points. The disagreements concern such terms as the original or reference medical product. Russian legislation has rejected the term “original medical product”. This term is not used in the developed countries’ legislation.

Nonetheless, as a result of lengthy discussions Russian party chose the term “reference product” as the more appropriate one, even though it came as a surprise to the EEU partner countries: they had used the term “original product” for 23 years.

The second difference of opinions concerns the term “interchangeability”. In Russia the term is used, the criteria of interchangeability have been worked out and their implementing procedures are discussed now at the government level. The partner countries have not started discussing the issue yet.

The third difference of opinions occurred when it came to the concept of pharmacopoeia. Particularly it is discussed what should serve as a basis: the former Soviet republics’ pharmacopoeia or international practices.

RPhG Company’s commentary

However, let us take into account that Russian market amounts to 90% of the market share occupied by the Eurasian Union partner countries, so when we build the future single pharma market, Russia’s opinion is to prevail over others when important decisions are made.

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