On 7 June 2019, a law establishing new needs for the re-registration of costs for essential drug list medicines came into force in Russia.
The law provides for the mandatory re-registration of prices for all EDL medicines in 2019 and 2020. It also establishes stricter requirements for marketing authorization holders about monitoring EDL medicine prices and applying for changes to the Register of Registered Prices.
By the law, prices of drugs registered by manufacturers re-registered in 2019 and 2020 by the procedure to be approved by the Russian government. Re-registration of prices for generic and biosimilar medicines will be carried out automatically, without the marketing authorization holder having to make a re-registration application to the Russian Ministry of Health.
The Russian government will establish a re-registration procedure and announce when the selling of drugs whose prices have not been re-registered will be prohibited.
This measure is aimed at reducing the costs of registered medicines. At present, prices that have not been updated for several years and were registered when various rules and techniques were in force are included in the Register of EDL Medicine Prices. As a result, drugs are often sold at unreasonably high prices which reduces the availability of EDL medicines for patients.
Mandatory reduction of registered prices for marketing authorization holders is obliged to reduce the registered price of a drug at their initiative if:
the price of a drug in a foreign currency is reduced in the reference state;
the price of the reference drug decreases;
The new obligation to observe costs and scale back registered costs of their medicine can chiefly affect drug makers who should currently monitor each cost in reference countries and their competitors’ costs for reference and generic medicine.