Prices for essential drug list medicines subject to mandatory re-registration in Russia

On 7 June 2019, a law* establishing new requirements for the re-registration of prices for essential drug list medicines ("EDL 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 authorisation holders in relation to monitoring EDL medicine prices and applying for changes to the Register of Registered Prices.

Mandatory re-registration of prices

In accordance with the law, prices of drugs registered by manufacturers before 7 June 2019 must be re-registered in 2019 and 2020 in accordance with 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 authorisation 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 prices 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

Marketing authorisation holders are obliged to reduce the registered price of a drug at their own 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 registered price of the first foreign made generic drug exceeds the price of the second generic drug (regardless of where this drug was produced); or
• the registered price of the first generic drug produced in a member state of the Eurasian Economic Union exceeds the price of the second generic drug produced in this or another Eurasian Economic Union member state.

Re-registering price increases is only allowed once a year. Conversely, the number of re-registrations aimed at reducing prices is not limited within a year.

Previously, legislation did not explicitly oblige drug manufacturers to re-register prices at their own initiative. The reduction was usually carried out by the marketing authorisation holder upon receipt of an order from the Anti-monopoly Service of Russia. Now, marketing authorisation holders are obliged to monitor price changes in reference countries themselves and to update the registered prices.

Conclusion

The new law affects manufacturers of original drugs and those of generic medicines equally.

Manufacturers of reference drugs should ensure that they re-register prices for their medicines in 2019 and 2020. Otherwise, they will not be able to sell their drugs on the Russian market.

The new obligation to monitor prices and reduce registered prices of their drugs will mainly affect generic drug manufacturers who must now monitor both prices in reference countries and their competitors’ prices for reference and generic drugs.

If you have any questions on this eAlert, do not hesitate to contact CMS Russia experts Vsevolod Tyupa and Alexey Shadrin or your regular contact at CMS Russia.

* In Russian