Arbitration Court confirmed FAS conclusions on substitutability of medicinal drugs with different pharmaceutical forms

FAS managed to prevent an attempt to register a vital drug at the price 8 times higher than the maximum registered price for an analogue

On 29 November 2016, Moscow District Arbitration Court pronounced legitimacy of a refusal by the Federal Antimonopoly service (FAS Russia) to approve the ceiling ex-works price for the “Clotrimazole” medicinal drug (the International Non-Proprietary Name - Clotrimazole) manufactured by “Anzhero-Sudzhenky Chemical-and-Pharmaceutical Works” Ltd. Thus, the Arbitration Court dismissed a cassation appeal.

The reason for FAS refusal was that the price applied for state registration had been 8 times higher than the registered prices for the analogue drugs. The FAS was decision formed the grounds for the Ministry of Health Care to refuse state registration of the ceiling ex-works prices of the “Clotrimazole” medicinal drug.

FAS established and the Ministry of Health Care confirmed the equivalency of various pharmaceutical forms, enabling to compare prices, applied by “Anzhero-Sudzhenky Chemical-and-Pharmaceutical Works” for state registration, with the earlier registered prices for equivalent drugs of other manufacturers.

“We established that to increase price tenfold the manufacturer withdrew the earlier registered price for the medicinal drug (18 RUB) less than a month before filing documents to register the overrated price (183 RUB). The attempt of the manufacturer to increase the drug price was prevented successfully. The Court supported the decisions of the antimonopoly body and the Ministry of Health Care not to register the unreasonably overrated “Clotrimazole” price, based on the norms of the Law on medicinal drugs circulation  and confirmed by the clinical studies’ findings”, emphasized Deputy Head of FAS Department for Control over Social Sphere and Trade, Maxim Dyagterev.