FAS abolished agreed prices for “Bartizar” medicinal drug

The Federal Antimonopoly Service (FAS Russia) established that the drug manufacturer submitted false information on the prices of raw materials supplies and set an excessive euro exchange rate in its estimates

Registering prices for “Bartizar” medicinal drug (“Bortezomib” International Non-Proprietary Name) manufactured by “Sotex” “PhamFirma” CJSC (Russia) submitted an agreement with the raw materials supplier (“in-bulk”), where the price for the raw material is indicated at 106 euro. According to the customs freight declaration, the actual price for the import of raw materials was 48 euro at the time of price registering. Thus, the pharmaceutical company overrated the raw materials procurement price by 2.2 times.

Moreover, recalculating the contract price for the raw materials in RUB, the drug manufacturer set an excessive euro exchange course, which additionally aggravated the exposed fact of the submitted false information.

Based on Clause 25 of the Rules¹, approved by No. 865 Decree of the Government of the Russian Federation of 29.11.2010, FAS abolished the earlier decisions on agreeing the ceiling ex-works manufacturer prices for “Bartizar” medicinal drug.

Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev commented: “We believe that it will be a clear signal to the companies that submitted unreliable data but hope to register and further maintain overrated prices”.

Reference:

1. Clause 25 of the Rules for state registration and re-registration of the ceiling ex-works prices set by medicinal drug manufacturers for the drugs included in the list of vital and essential medicinal drugs: “The Federal Antimonopoly Service abolishes a decision on agreeing the ceiling ex-works manufacturer price for a medicinal drug if after making such a decision it was established that the holder or owner of the registration certificate for the medicinal drug (a person authorized by them) presented unreliable data that influenced the result of the decision-making.

The Ministry of Healthcare of the Russian Federation abolishes a decision on state registration or re-registration of the ceiling ex-works manufacturer price for the drug if after making the decision it was established that the holder or owner of the registration certificate for the medicinal drug (a person authorized by them) presented unreliable data that affected the result of decision-making by the Ministry, as well as if the Federal Antimonopoly Service reversed a decision on agreeing the ceiling ex-works manufacturer price for the medicinal drug. In these cases the Ministry of Healthcare of the Russian Federation removes the registered (re-registered) ceiling ex-works price from the State Register”.