YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Last month, the Russian government passed a decree (the Decree) amending the rules on state regulation of ceiling prices for drugs included into the Vital and Essential Drugs List, which is approved annually.

Under the Decree, foreign originators are required to constantly keep their prices in Russia in line with the lowest price in any of 12 foreign reference states, while the prices of generics and biosimilars should follow the prices of their reference drugs, less a reduction coefficient (except for orphan generics and biosimilars).

In addition, the Decree requires foreign and local pharmaceutical companies to go through a one-time mandatory ceiling price adjustment for all essential drugs in 2019-2020, except for immunobiological drugs, narcotic and psychotropic drugs, and drugs in the low-price segment (i.e., if the price does not exceed 100 Russian rubles), which are produced in the Eurasian Economic Union. A failure by the producer to go through the mandatory ceiling price adjustment will debar its drug from sale from January 1, 2021.

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