Appeal Court confirmed FAS conclusions on substitutability of medicinal drugs with different presentations
On 21 July 2016 the 9th Arbitration Appeal Court reversed the judgment of Moscow Arbitration Court and rules that the Federal Antimonopoly Service (FAS Russia) legitimately refused to agree upon the maximum ex-works prices for “Clotrimazole” made by “Anzhero-Sudzhensky Chemical-and-Pharmaceutical Plant” Ltd.
The reason for FAS refusal was that the price suggested for state registration was 8.6 times higher that the registered prices for the drug analogues. FAS decision established the grounds for the Ministry of Health Care to refuse to register the maximum ex-works prices for “Clotrimazole”.
The manufacturer disagreed with the arguments put forward by the authorities and filed a lawsuit. Moscow Arbitration Court supported the arguments of the drug producer. Having considered all case circumstances, the Appeal Court disagreed with the Court of First Instance and passed a new judicial act on the case, fully dismissing the claim.
Therefore, FAS prevented a manufacturer’s attempt to register a vital drug at the price nearly 9 times higher than the maximum registered prices for an analogue drug.
“The process was very complicated because for the first time we had to prove at Court the equivalence of different preparations. We, however, were guided by the Norms of the Law on drug circulation (1) and the clinical tests. The ruling of the Appeal Court confirming the rightness of FAS approaches to economic analysis is the best gift to the antimonopoly body for the anniversary (2) of transferring the powers to negotiate drug prices to FAS”, commented Deputy Head of FAS Department for Control over Social Sphere and Trade, Maxim Degtyaryov.
Reference:
1. Under Clause 2 Part 1 Article 27.1 of No. 61-FZ Federal Law “On Drug Circulation” of 12.04.2010, equivalent preparations means different preparations with the same modes and routes of administration.
2. No. 373 Decree of the President of the Russian Federation “On some issues of public administration and control in the field of antimonopoly and tariff regulation” of 21.07.2015 abolished the Federal Tariff Service and transferred its functions to FAS.