On May 19 GEROPHARM took part in the round table "Harmonization of the
requirements for drug circulation within the territory of the Eurasian
Economic Union" that was held in the framework of the IVCongress of the
Euro-Asian Society for Infectious Diseases. Dmitry Chagin, the Chairman
of the Board of the Association of Pharmaceutical Manufacturers of the
Eurasian Economic Union, was the moderator of the event.
The discussion raised such issues like drugs interchangeability,
pricing methods, protection of intellectual property rights, compliance
with GMP regulations and state inspection strategy of external sites of
The Economic Security Director Andrey Akhantiev noted that the most
pressing issue for company is the compliance with the law "On the
contract system", which is often violated - tenders are announced on the
basis of trade names or other kinds of protection, leading to the
procurement of a particular drug by its trade name. Following the
results of 2015, only one third of all tenders were carried out in
accordance with the law on trademarks. When the law violations are
considered in the regions, the customers often promote the idea that
insulin drugs are not interchangeable. "We hope that the procedure
supposed to identify drug products interchangeability, which has been
already implemented in the Russian legislation, will help to deal with
the law violations and deprive customers of the opportunity to refer to
the problem of insulin non-interchangeability," said Andrey Akhantiev.
"Of course, the procedure should beclearly set out, and a number of
amendments to the law on drug circulation is required, so that patients
could have some guarantee that they get good-quality and effective
drugs, and manufacturers could not face additional difficulties and
administrative barriers. So, there should be, for example, stop time for
the period when additional tests for interchangeability confirmation
are carried out. On the whole, this procedure is extremely necessary,
and I hope that the legal succession will be respected during the
transition to the single market of the Union".
At the conclusion of the round table, the key messages,focused on the strengthening of interactionbetween the Association and the medicaland patientcommunities, were formulated, and the main stages, necessary for the creation of National Drug Policy, were defined.