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Compulsory licensing of remdesivir a feasible option?

, July 9, 2020, 0 Comments

coronavirus-remdesivirBottlenecks in the production of antiviral drug remdesivir have led to policymakers threatening compulsory licensing and economic sanctions. It’s a foretaste of what may come when a coronavirus vaccine becomes available.

Last Friday, the European Union allowed the use of remdesivir to treat COVID-19 patients — so far the only drug approved for the purpose in the bloc.

The company behind the medication, Gilead Sciences, is finding it next to impossible to meet demand, though. Since Washington said it had secured all of the company’s supplies until September, some European nations have also been pulling out the big guns.

“We’re livid at US President Donald Trump — ‘America first’ is a bad slogan anyway, and in this particular case it comes across even worse,” Peter Liese from the European People’s Party (EPP), the largest group in the European Parliament, told DW.

“But we’re also cross with Gilead,” he added. “Why did it file for marketing approval of remdesivir in the EU if it can’t ensure supplies,” Liese asked.

Gilead concedes there’s a bottleneck but says it’ll boost production capacities as soon as possible. “If there’s no dramatic change in the COVID-19 situation, we assume our supplies can meet global demand by the end of September,” Gilead spokesperson Martin Flörkemeier told DW.

‘Bringing Trump to his knees’

In the opinion of Peter Liese, that’s not fast enough and he’s threatening to introduce compulsory licensing, meaning that the medication would be produced by others against the will of Gilead. The parliamentarian said this would be technically feasible as the company had to provide all the necessary production details in its patent filing documents.

As a matter of facts, compulsory licensing is possible under World Trade Organization rules, should prior negotiations with the patent holder fail to achieve a compromise. And compulsory licensing is definitely possible in the case of national emergencies and situations of extreme urgency as laid down in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

“If you don’t see such an emergency right now, I wouldn’t know when to ever apply this rule,” Liese said.

He added he’d like to see Gilead cooperate voluntarily and let European pharmaceutical companies help with the production of remdesivir. Liese also brought into play sanctions against the US. “If the European Union makes a joint stand, we can bring Donald Trump to his knees.”

The German government for its part has been trying to keep a low profile. Prior to the official approval of remdesivir in the EU, Germany had already received some supplies from Gilead meant to last for quite a while, should the situation not become considerably worse.

In the past couple of months, some 200 therapy cycles have been initiated for treatment,” a spokesperson for the German Health Ministry said in an email to DW. “Our reserves would allow for another 600 to 1,000 therapy cycles, depending on the duration of individual treatments.”

The Health Ministry expects Gilead to expand its production capacities and be able to send sufficient supplies to the European market in due course. “Hence there’s currently no reason to debate any licensing talks or compulsory licensing for that matter,” the spokesperson noted.

That’s exactly the kind of statement that Gilead wants to hear. The company claims compulsory licensing could even exacerbate the supply situation as there’d be a real danger of supply chains being thrown into chaos over scarce raw materials and other resources.

“Since early February we’ve set up a production network involving up to 120 firms to ensure the availability of raw materials and base materials needed for the medication,” Gilead spokesperson Flörkemeier said. “The network also includes some German companies.”

Generic drugs in 127 nations

Gilead insists that compulsory licensing is not even necessary for countries that cannot afford the costs of remdesivir. It said it had reached licensing agreements with nine producers of generic drugs to ensure the medication can be sold for less money in 127 countries.

A generic drug version of remdesivir has just been approved in India, at $64 ($56) per dose (100-mg vial).

So, are compulsory licensing threats and talk about sanctions just a tempest in a teapot? Or do they just go to show that in the Trump era threats have become a standard policy tool in Europe, too?

There’s no doubt that Gilead Sciences has a vested interest in seizing the opportunity and selling as much remdesivir as possible. The medication can potentially shorten the period of illness for people with the novel coronavirus, but it doesn’t impact people’s chances of survival.

Demand is bound to go down rapidly when a better therapy is found, or better still, a vaccine for COVID-19 comes on the market.