The arbitration court of Moscow upheld the position of the FAS in a dispute with “Velform”: the company tried to challenge the refusal of the Antimonopoly authority in the approval of maximum selling prices of drugs Loperamide Welfarm (loperamide) and Welfarm Doxycycline (doxycycline). In the course of economic analysis of the FAS revealed that submitted for approval the manufacturer’s price were calculated incorrectly, leading to a substantial overstatement of was the reason for refusal in their agreement.
As explained by the Deputy head of Department for control over social sphere and trade FAS of Russia Nadezhda Sharovskaya, the calculation of maximum sale prices, the company used information about the maximum selling prices for the reference drugs for them. However, in both cases the maximum selling prices for the reference drugs in our country were not registered, as evidenced by the data of the state register of maximum sale prices.
In case of absence in Russia was a maximum sales price for a reference product, the calculation of maximum sales price for a generic drug is based on the maximum registered prices for the same medication within the same international nonproprietary names (INN), pharmaceutical form and dosage. At the same time, not allowed arbitrary choice of dosage form, the FAS explained.
FAS sent OOO “Velform” request for revised calculations that would meet the requirements, but the pharmaceutical manufacturer they are not presented. In this connection, the Agency denied approval of maximum selling prices of drugs. However, the manufacturer of the drugs did not agree with the decision of the Antimonopoly service and tried to challenge it in court.
“The arbitration court has supported our position and confirmed the correct application of office Methods and, consequently, the legality and validity of decisions of FAS of Russia about the refusal to approve the limit prices of the manufacturer,” – said Artem Molchanov, head of the Legal Department of the FAS Russia.