Brexit means coronavirus vaccine will be slower to reach the UK – The Guardian

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

In an article published today on the Guardian website, the academics and lawyers say Boris Johnsons determination to go it alone, free of EU regulation, after Brexit means the UK will probably have to join other non-EU countries in a queue to acquire the vaccine after EU member states have had it, and on less-favourable terms.

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

The UK has already withdrawn from the EUs emergency bulk-buying mechanism for vaccines and medicines, under which member states strike collective agreements with pharmaceutical companies, which speeds up their access to the latest products during a crisis.

The academics write: For all these reasons ... the UK is likely to have to join the queue for access with other countries outside the EU, and to pay more than it would otherwise as an EU member state.

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

They argue that the UK could still avoid the worst by agreeing to align fully with the EMAs regulations from outside the EU. But they say Johnson has so far indicated that his team have no intention of doing so and do not want to operate as rule takers.

While it appears the UK government wants to press ahead with its own regulatory system and rapid market authorisation system for emergencies, the experts say this will be all but impossible to put in place in time for a new Covid-19 vaccine, which is expected in about a year.

Even then the view in medical circles is that pharmaceutical companies are likely to look first to the EU for regulatory approval and an agreement on sale, given the scale of the market they would be selling into.

Olivier Wouters of the London School of Economics and Political Science, said: After the Brexit transition period, the UK will no longer be part of the EMA and will therefore have to make its own regulatory decisions, unless ongoing EU-UK trade negotiations result in the UK aligning itself with European rules.

The UK could, in theory, choose to recognise any approval decision made by the EMA to prevent delays, but this seems at odds with the UK governments pledge to take back control. If the UK authorities instead choose to set up a separate review and approval process for medicines and vaccines, then it might delay access to a new coronavirus therapy.

The country could experience disruptions as the Medicines and Healthcare products Regulatory Agency (MHRA), the countrys counterpart to the EMA, works to fill the gap left by the departure of the EMA.

Vaccine makers and drug companies may decide to first seek approval from the EMA, which represents some 500 million patients, before seeking approval from the UK MHRA, which covers a smaller patient pool.

Asked about the prospect of the UK having to pay higher prices for a vaccine, he said: If a coronavirus vaccine is developed, EU countries may choose to band together to jointly procure the vaccine. This would give EU countries more bargaining power against a vaccine maker to try to secure a lower price. If the UK were excluded from such a joint procurement scheme, its possible that the UK would end up paying a higher price than the EU for the same vaccine.

EMA was based in London until January last year, when Brexit saw it relocate to Amsterdam.

A Department of Health and Social Care spokesperson said: The UK and 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 ready ourselves for all eventualities. Were fully supporting the UKs world-leading, disease research sector to play a key role in the global effort, with 40 million of new funding for rapid research into the virus.

Read this article:

Brexit means coronavirus vaccine will be slower to reach the UK - The Guardian