11-10-2018 | 09:37

The competition authority abolished 2010 decisions of the Federal Tariff Service on approving the ceiling ex-work process for a medicine manufactured by German “Desma GmbH”


On 29 September 2018, Moscow Arbitration Court pronounced legitimacy of the actions of the Federal Antimonopoly Service that had abolished decisions on approving prices [1] for “Akineton” medicine [2].


As FAS established, when registering the medicine in 2010 “Desma GmbH” submitted incorrect information. There were no data on the medicine prices in the reference countries – Austria, the Czech Republic and Switzerland, the ex-works prices for which were significantly lower that the prices announced for registering in the Russian Federation. Thus, unreasonably high prices were registered in Russia.


FAS actions related to abolishing registration of prices for “Akineton”, resulted in reducing the registered prices threefold for all commercial names with the “Bipereden” International Non-Proprietary Name – to the level of minimum ex-works prices for the medicine in the reference countries for Russia.


“Desma GmbH”however, disagreed with the FAS decision and filed a lawsuit. Court of First Instance, the Appeal Court and now the Cassation Court confirmed legitimacy and reasonableness of FAS actions.


[1] Guided by Clause 25 of the Rules for official registration and re-registration of the ceiling ex-works prices set by medicine manufacturers for the medicine included in the list vital and essential medicines, approved by No. 865 Decree of the Government of the Russian Federation of 29.10.2010, FAS abolishes the earlier decisions on approving manufacturer ceiling ex-works prices for the medicine, if after such decisions are made the regulator discovers that a holder or an owner of registration certificates for medicine had submitted incorrect data affecting the decision outcome


[2] “Bipereden” International Non-Proprietary Name, included in the list of vital and essential medicines

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