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Brexit means that the coronavirus vaccine will be slower to reach the UK | Coronavirus outbreak

Coronavirus outbreak

Sat 14 Mar 2020 15.10 EDT

The UK has to wait longer and pay more to acquire a coronavirus vaccine because it has let the EU, health experts and international legal experts warn today.

In an article published today on the Guardian website, academics and lawyers say that Boris Johnson’s determination to “go it alone”, free from EU regulation, after Brexit means that the UK will likely have to join others non-EU countries in a row to acquire the vaccine after EU Member States have had it and on less favorable terms.

Authors include Martin McKee of the London School of Hygiene and Tropical Medicine and legal academics Anniek de Ruijter of Amsterdam Law School and Mark Flear of Queens University, Belfast.

The United Kingdom will leave the European Medicines Agency (EMA), the body responsible for the scientific evaluation, supervision and monitoring of the safety of medicines, at the end of the transition period on 30 December. This means that it will no longer be part of the EU regulatory regime, which allows for an “accelerated assessment” of products developed by pharmaceutical companies during a pandemic.

The UK has already withdrawn from the EU’s mass purchase mechanism for vaccines and medicines, under which Member States enter into collective agreements with pharmaceutical companies, which accelerates their access to the latest products during a crisis.

The academics write: “For all these reasons … the United Kingdom is likely to have to join the queue to access other countries outside the EU and pay more than it would otherwise be as an EU member state.

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“Looking further, this problem will not be limited to emergencies and the UK can expect slower and more limited access to medicines, especially those for rare diseases or those used to treat children, where the market is small.”

They argue that the UK could still avoid the worst by agreeing to fully align with EMA regulations outside the EU. But they say Johnson has so far indicated that his team has no intention of doing so and does not want to operate as “rule observers”.

While it appears that the UK government wants to move forward with its own regulatory system and rapid market authorization system for emergencies, experts say it will be next to impossible to implement in time for a new Covid-19 vaccine, which is expected in about a year.

Even then the opinion in medical circles is that pharmaceutical companies will likely look first to the EU for regulatory approval and a sales agreement, given the size of the market in which they would sell.

Olivier Wouters of the London School of Economics and Political Science said: “After the transition period for Brexit, the UK will no longer be part of the EMA and will therefore have to make its own regulatory decisions, unless negotiations are obtained. EU-United Kingdom trade agreements in progress in alignment with European standards.

“The UK could, in theory, choose to recognize any EMA approval decision to prevent delays, but this appears to run counter to the British government’s commitment to” take back control. ” decide to establish a separate review and approval process for medicines and vaccines, which may delay access to new coronavirus therapy.

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“The country may face disruptions as the medicines and health products regulatory agency (MHRA), the country’s counterpart to the EMA, works to bridge the gap left since the EMA’s departure.

“Vaccine manufacturers and pharmaceutical companies may decide to seek approval from the EMA, which represents approximately 500 million patients, before obtaining approval from the UK’s MHRA, which covers a smaller patient pool. “

Asked about the prospect that the UK should pay higher prices for a vaccine, he said, “If a coronavirus vaccine is developed, EU countries can choose to come together to jointly procure the vaccine. This would give EU countries more bargaining power over a vaccine manufacturer to try and guarantee a lower price. If the UK is excluded from a joint supply scheme, the UK may end up paying a higher price than the EU for the same vaccine. “

The EMA is based in London until January of last year, when Brexit saw it move to Amsterdam.

A spokesman for the Department of Health and Welfare said: “The UK, our friends and partners across Europe are part of a concerted international effort to combat the threat of COVID-19. We are confident that our current close working relationships will continue as we prepare for all eventualities. We fully support the UK’s leading disease research sector to play a key role in the global effort, with £ 40 million in new funding for rapid virus research. “

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