Uncertain benefits Russian authorities issue first-ever compulsory license for controversial coronavirus treatment

For the first time ever, the Russian government has invoked compulsory licensing “in the interests of national security,” giving the domestic pharmaceutical company Pharmasyntez permission to mass produce its generic of the antiviral drug remdesivir. The American company that developed this coronavirus treatment — and owns the patent for it — didn’t consent to this decision. Moreover, studies of the drug’s effectiveness against COVID-19 have yielded mixed results.

Playing the ‘compulsory licensing’ card

On December 31, 2020, Russian Prime Minister Mikhail Mishustin signed an order allowing the Russian pharmaceutical company Pharmasyntez to produce a generic of remdesivir — an antiviral drug used to treat the coronavirus — in the new year. This was reported by the industry publications Vademecum and Pharmvestnik.ru on January 5. This order allows Pharmasyntez to manufacture the drug without the consent of Gilead Sciences, the American biopharmaceutical company that developed remdesivir and owns the patent for the original medication. As underscored by the Russian business news website VTimes, this is the first time that the authorities have applied in practice the compulsory licensing “in the interests of national security” provided for in Russian legislation.

Pharmasyntez founder Vikram Punia’s plans to ask the Russian government for a compulsory license for remdesivir became known in September 2020. And Punia promised to start mass production of the drug in October or November of that same year. Pharmasyntez developed its generic of remdesivir back in February 2020, giving it the trade name Remdeform. 

The selling price of Remdeform will be capped at 7,400 rubles (about $100) per vial (excluding VAT) — a single course of the treatment requires 6 to 11 vials of the drug.

The Americans aren’t mad, they’re just disappointed

“To date, the company Gilead Sciences hasn’t taken any measures to make remdesivir available on the market,” Vikram Punia told Meduza back in September. “I don’t know how important the lives of Russian citizens are to Gilead Sciences, but they are important to us. We want us to also have the opportunity to receive effective treatment and a chance for a full recovery.”

When appealing to the Russian authorities in November 2020, Pharmasyntez promised to produce 200,000 vials of the drug per month (and, if necessary, increase output to 300,000 vials). “Thus, during the first half of 2021 we are prepared to produce and ship 1.2 million vials,” the company said in its letter to the government, as quoted by Pharmvestnik.ru. 

Pharmasyntez will have to pay compensation to the drug’s patent holder within three months: Punia told VTimes that the amount of compensation will be based on international practices — meaning either 1–1.5 percent of the proceeds from the sale of the medication or a one-time fixed payment.

Nevertheless, Gilead Sciences told Vademecum that they are “disappointed” with the Russian government’s decision: “We consider this decision unnecessary and counterproductive, since the price set by the company for the drug allows any country in the world to reduce spending on the fight against the coronavirus.”

WHO has its doubts

Remdesivir has been touted as promising treatment for COVID-19 and reportedly has shown encouraging results. However, interim data from the World Health Organization’s (WHO) Solidarity clinical trial for coronavirus treatments, which has been ongoing since March 2020, tell a different story.

According to interim data published on October 15, 2020, 11,330 people were involved in the study up until October 4; 2,750 of them were given remdesivir, 954 received hydroxychloroquine, 1,411 were given lopinavir/ritonavir (brand name Kaletra), and 2,064 received Interferon beta-1a; 4,088 test participants were given a placebo.

None of these drugs proved more effective than the placebo in terms of mortality, time to recovery, or duration of hospital stay, the WHO reported.

As of January 2021, the clinical resource UpToDate indicates that the “optimal role” of remdesivir in coronavirus treatment “remains uncertain” Based on existing studies, the database advises using remdesivir “for hospitalized patients with severe COVID-19 because data suggest it reduces time to recovery,” which can be regarded as a “clinical benefit.” 

That said, there is no reliable data suggesting that remdesivir reduces mortality from the coronavirus or the number of patients who need mechanical ventilation.