The Ninth Arbitration Court of Appeal confirmed the decision of the first instance court by recognizing the legality of actions implemented by the Federal Antimonopoly Service (FAS) of Russia to invalidate the decisions of the Federal Tariff Service (FTS) of Russia adopted in 2010 on approval of maximum ex-works prices for Akineton (INN Biperiden).
FAS Russia found that, at the registration of prices in 2010, the applicant failed to provide information on prices in such reference countries as Austria, Czech Republic, and Switzerland, where the manufacturer’s ex-works prices for Akineton were significantly lower than those submitted for registration in the Russian Federation.
The actions of the FAS of Russia related to the cancellation of registration of Akineton price resulted in a 3-fold reduction of registered prices for all trade names involving INN Biperiden, i.e., down to the level of minimum ex-works prices for this drug in the reference countries recognized by Russia.
“Despite the elapsed period of time, any submission by the applicants of incomplete and inaccurate information on prices in other countries that affected the registration of inflated prices in Russia will always become evident. The sources in reference countries include historical information that enables the FAS of Russia to prove the inaccuracy of information used for the registration of prices,” said Nadezhda Sharovskaya, Deputy Head of the Department for Control over Social Sphere and Trade.