[Ip-health] Politico: Europe must be ready to act if US grabs medicine supply, MEP says

Dimitri Eynikel Dimitri.Eynikel at msf.org
Thu May 7 02:28:31 PDT 2020



Europe must be ready to act if US grabs medicine supply, MEP says

-- By Carlo Martuscelli
5/6/20, 6:30 AM CET | V

The European Union must stand ready to respond if the U.S. seizes control of COVID-19 medicines for itself, Peter Liese, an MEP and health spokesman for the European People’s Party, said Tuesday.

This could include the EU manufacturing its own versions of patented drugs, he said.

His comments come after the U.S. Food and Drug Administration said it will allow the emergency use<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=c018857b6a&e=3e18834ce6> of remdesivir<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=043e4a093f&e=3e18834ce6>, an experimental COVID-19 therapy made by Gilead, in a move that puts the U.S. government in charge of the drug’s distribution<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=8b27779849&e=3e18834ce6>.

The news could further spook EU leaders already unnerved by reports<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=c4a322f53d&e=3e18834ce6> that the U.S. government approached German pharmaceutical business CureVac in an attempt to secure exclusive rights to a coronavirus vaccine it is developing.

On Monday, the World Health Organization’s Executive Director for Health Emergencies Mike Ryan said the global body would speak to both Gilead and the U.S. government to ensure a wider availability for remdesivir.

In a written statement, Liese said he saw a danger that U.S. President Donald Trump would impose an “America first” principle on the supply of medicines. “We must be prepared for such a case,” Liese said.

The MEP for the European Parliament’s largest party told POLITICO that compulsory licensing, where countries circumvent patent protection under urgent circumstances, could be one solution to any restrictions in the supply of remdesivir. This would allow local pharmaceutical companies to begin producing their own copies of the drug using Gilead’s recipe.

Though Gilead would receive compensation for remdesivir, it would lose its control over the supply.

Compulsory licensing is enacted at a national level, so it would be up to individual EU countries to decide whether to go ahead with the procedure. However, Liese said he saw a role for the European Commission to coordinate across the bloc.

“Member states should have a common strategy. That would give a very clear message,” he said.

The sentiment was echoed by Yuanqiong Hu, senior legal and policy adviser for Doctors Without Borders (MSF), who said the organization supported the procedure.

“In a pandemic we think the primary responsibility to respond and control lies with the government,” she explained. “Of course, industry develops the drugs but it’s a government’s responsibility to make sure they’re reaching the people who need them.”

Asked about a potential U.S. move to prioritize the country’s needs over foreign markets, Gilead’s chairman and CEO Daniel O’Day told CBS<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=ebeb0b1df6&e=3e18834ce6>: “In terms of the allocation question, I think we’re aligned with the U.S. government to both serve the patients here in the United States and then to be able to also make sure … that we can serve other countries around the world as well.”

Some countries are more prepared than others to act. Germany<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=0206f991a4&e=3e18834ce6>, for example, recently amended its legislation to facilitate compulsory licensing.

The sooner they start preparing the better, Yuanqiong Hu said.

“Not all countries have enough flexibility in their national laws,” she noted. “When the situation arises everything needs to happen quickly, and you can’t make a law overnight.”

Others are less sanguine. Duane Schulthess, managing director of consultancy Vital Transformation, advised European countries to tread carefully. He said the use of compulsory licensing could do more harm than good as it could undermine investor confidence and hurt local industry.

“You can do it, but it’s a Rubicon of sorts. Once you do it, the genie is out of the bottle and you’re trampling all over someone’s personal property,” said Schulthess.

Ultimately, the concerns may prove unfounded.

The European Medicines Agency said last week it will begin a rolling review<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=14945e254b&e=3e18834ce6> of remdesivir, which has yet to complete a successful clinical trial for COVID-19.

Gilead has announced some positive data<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=dd5024ec60&e=3e18834ce6> from one U.S. study where remdesivir was able to shorten the average recovery time for infected patients, but it failed<https://politico.us8.list-manage.com/track/click?u=e26c1a1c392386a968d02fdbc&id=ab4741cb2d&e=3e18834ce6> to produce benefits in another study in China.

Sarah Wheaton and Sarah Owermohle contributed reporting.



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