The U.K. could by then be outside the authority of the EU’s medicines regulator when a coronavirus vaccine arrives | Jalaa Marey/AFP via Getty Images Brexit could delay UK access to a coronavirus vaccine Outside EU drug approval and procurement schemes, the UK could pay more for a vaccine and receive it later.

LONDON — The U.K.’s efforts to "take back control" may have yet another unintended consequence — compromising the country’s ability to secure a coronavirus vaccine quickly and cheaply.

Current best estimates put the delivery date for a vaccine over a year away. That’s beyond the Brexit transition period, meaning that the U.K. could by then be outside the authority of the EU’s medicines regulator, the European Medicines Agency.

If the ongoing negotiations don't result in some form of alignment with the EMA’s approvals, the U.K. could come off as second best, with drugmakers prioritizing the EU market rather than submitting their drug to the U.K.’s Medicines and Healthcare products Regulatory Agency first.

"The European Medicines Agency is representing a patient pool of 500 million-odd patients," said Olivier Wouters, assistant professor of health policy at the London School of Economics. "That seems like a more lucrative market for a drug company or a vaccine-maker to prioritize."

What some lawmakers, such as Green peer Natalie Bennett, want to know is whether the government plans to seek special access to the EMA’s rapid approval system.

The U.K. is already outside the EU’s joint procurement of medical countermeasures.

The EMA has an emergency procedure for the fast-track approval of a new vaccine in the event of a pandemic. Under the system, authorization takes around 70 days instead of the usual 210 days. While a pandemic has yet to be officially declared, the EMA has already kicked its plan for emerging health threats into gear.

Asking for special access to this system is "theoretically possible," said Wouters. But he has reservations about how well this would go down with the EU.

"I'm not sure that the European counterparts would accept the U.K. authorities cherry-picking where they want to be part of European legislation and take part in European initiatives," he said.

Mark Flear, a reader at Queen’s University Belfast’s School of Law, said that the EMA might not even legally be able to grant a third country this kind of selective access.

Flear sees another possibility: The U.K. could "mirror" the EMA’s decisions rather than going through the regulatory steps on their own. But this isn't likely, he believes.

"The problem is that the U.K. government keeps saying that it wants to ensure that it can take back control and it does not want to be aligned closely with EU rules," he said.

Furthermore, Boris Johnson’s government — determined to show the U.K. is standing on its own two feet post Brexit — has more broadly eschewed engagement at EU level on the coronavirus response. Instead, it has focused on bilateral contacts and global forums like the World Health Organization.

The government has said it wants to collaborate with the EU on pharmaceuticals, but the just-released negotiating objectives only go so far as to mention manufacturing practice, drug testing and information sharing.

Buying power

There is another problem.

The U.K. is already outside the EU’s joint procurement of medical countermeasures that enables EU member countries to combine their buying power to secure access to vital medicines and medical products in the event of a threat to human health. During the coronavirus outbreak, the mechanism has been activated to procure public protective equipment such as masks.

The EU hasn't exercised this power yet with respect to a vaccine or treatment for the virus, because none exist. However, Malta's Health Minister Chris Fearne has called for the EU to jointly procure a vaccine.



Wouters said that banding together gives Europe more leverage and buying power when negotiating a price with companies, even though some countries, such as Sweden, have a record of keeping medicine prices low all on their own.

Flear also agreed that being outside the joint procurement system "could mean higher costs and less rapid access to medical countermeasures."

"This could have a knock-on effect on the ability of the U.K. to respond to the coronavirus or indeed anything else that arises," he said. "That could mean that it makes it harder for the U.K. to contain the virus."

Another route: Medicines can be given to a limited number of patients before being authorized under “compassionate use” measures that were used, for example, with cystic fibrosis drug Orkambi. Compassionate use programs usually apply to the highest risk or sickest patients. It's possible that countries could put in place such measures to get any coronavirus vaccine to their population before formal regulatory approvals are in place.

Probably the closest the U.K. government goes in its Brexit negotiating mandate with regard to cooperation on public health is saying that it is “open to exploring cooperation between the U.K. and EU in other specific and narrowly defined areas where this is in the interest of both sides, for example on matters of health security.”

But this cooperation between the U.K. and the EU will be "vital" in some areas, said Richard Torbett, chief executive of the pharma lobby group, the Association of the British Pharmaceutical Industry.

"We want to see an agreement which protects patient safety and public health, and sees both sides work together on aspects of medicines regulation," he said.

Jillian Deutsch contributed reporting.

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