Russian government issues its first health-related compulsory license

A new year signals a new approach to access to medicines in the Russian Federation. Remdesivir, a drug patented by Gilead, can now be procured from a more affordable generic producer for use in the country, due a compulsory license (CL) enacted by the Prime Minister – following lobbying from the generic industry and our partner ITPCru.

Remdesivir has shown to have “some” efficacy in the treatment of COVID-19 according to some studies. It is available for ‘compassionate use’ in many countries. However, other trials suggest that remdesivir has “little or no effect on mortality in patients who are hospitalised with COVID-19” (Solidarity trial). A round-up of research findings is available here.

Even in light of the data, Gilead’s pricing still puts remdesivir out reach for many countries. The price charged by Gilead for a 5 day course is $2,340 (USD). Prices offered by generic companies vary between $229 to $960 for the same 5 day treatment.

On 31 December 2021, Mikhail Mishustin, the Prime Minister of the Russian Federation signed a state order to allow the procurement of a generic version of remdesivir, citing the interest of national security.

Although remdesivir may not be significant in the treatment of COVID-19, the action of the Russian Prime Minister is:

“This is a groundbreaking step,” says Sergey Golovin, Make Medicines Affordable coordinator for Eastern Europe and Central Asia (EECA) at ITPCru. “This action has been available through the TRIPS Agreement since 1995, yet it is the first time the Russian Federation has taken this step. It has taken COVID-19 to highlight the inequities that already existed. If remdesivir was selected for use in Russia, Gilead’s pricing would be prohibitive. This paves the way for Russian citizens to have access to the same treatment as people in high-income countries.”

A precedent for essential drugs, for all illnesses

“We would now like to see this legitimate tool used more routinely, rather than as the exception, both for COVID-19 treatments but for all essential medicines where the price of patented drugs means people are not offered the chance offered by optimal treatment and therefore have a lower chance of survival”, says Golovin.

How Russia’s Civil Code was used

According to the text, a Decree of the Government of the Russian Federation No. 3718-r, published on 5 January 2021, a generic company, Pharmasyntez, has obtained the right to use inventions EA 025252, 025311, 028742 and 029712 (references to patents protecting remdesivir) for the period of one year, in order to provide the population of the Russian Federation with remdesivir without the permission of the patent holder.

Pharmasyntez is a Russian generic drug company. It has developed its own version, Remdeform, which is ready to be launched, pending the results of further trial data.

This permission was granted in accordance with Article 1360 of the Civil Code of the Russian Federation. It is the first time this code has been applied with regards to medicines, and amounts to the same action as a compulsory license (CL).

Both Gilead and Pharmasyntez’s versions of remdesivir have been registered in Russia. However, until the Prime Minister took action, only Gilead had the ‘right’ to supply to Russia. The patent holder, Gilead, will receive ‘proportionate compensation’ for the use of its intellectual property. The amount of compensation will be determined within three months.

Option available to all countries – for all essential drugs

ITPCru has previously published a detailed analysis of the legal options and arguments for issuing a compulsory license for remdesivir, and called for the use of a compulsory license if remdesivir is proven safe and effective for treating COVID-19.

Make Medicines Affordable advises all countries to use all the tools, or ‘flexibilities’, available to them under the TRIPS Agreement, the World Trade Organization agreement which introduced patents on medicines.

“The patent system needs changing, restoring essential medicines to a public good, instead of the commodity that they’ve become. Until that happens, countries have to exercise the rights available to them on a national level,” says Golovin.

Read the original statement in Russian.
Article updated, 22 Jan 2021, to add additional links to research findings on remdesivir.