Today the United Kingdom became the first country in the West to clinically authorise a vaccine protecting against Covid-19, after the medicines regulator, the MHRA, said the Pfizer/BioNTech vaccine was safe to use.
The announcement puts Britain ahead of Europe when it comes to rolling out the vaccine, as the EU’s own regulator, the European Medicines Agency (EMA), has not yet approved the vaccine. While Britain will begin administering Pfizer’s vaccine next week, countries like Belgium have announced that they will start their vaccination campaigns in January, subject to EMA approval.
When it comes to vaccines, a few weeks of delay can make a big difference, given the economic and health costs of the pandemic. So it is perhaps not surprising that many people are wondering if Brexit gave Britain the freedom to approve the vaccine before the EU.
Today’s Financial Times carried the headline, ‘regulatory delays to leave Europe trailing US and UK in vaccine race’. And this morning, the Health Secretary Matt Hancock, suggested the UK’s success was at least partly down to Brexit:
‘whilst until earlier this year we were in the European Medicines Agency (EMA), because of Brexit we’ve been able to make a decision to do this based on the UK regulator, a world-class regulator, and not go at the pace of the Europeans, who are moving a little bit more slowly.’
But is he correct?
Until January, the UK is still bound by the EU’s rules, which means that biotechnological medicines – and therefore candidate Covid-19 vaccines – still need to be authorised in the UK via the European Medicines Agency. But in the EU rules there is an exemption, allowing countries to grant a ‘temporary authorisation’ if there is a compelling case on public health grounds.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has said this is the legal route they used:
‘We have been able to authorise the supply of this vaccine using provisions under European law, which exist until January 1st’
This does not necessarily prove Matt Hancock wrong. The Health Secretary has pointed out that ‘we do all the same safety checks and the same processes, but we have been able to speed up how they’re done because of Brexit.’ In other words: the UK is still bound by the EU’s rules, but the body applying those rules is a UK institution.
According to Health Minister Nadine Dorries, a change in the UK rules a month ago was instrumental in:
‘exempt[ing] us from requiring EU approval. We would still be waiting if we hadn’t. Thanks to Brexit we can now move ahead swiftly and safely.’
It is also the case that no other country has used the quicker procedure yet, as Britain did.
It may be because there has been strong political pressure on the EU side not to use the quicker procedure. At least, that is what German Health Minister Jens Spahn suggested:
‘We have member states, including Germany, who could have issued such an emergency authorisation if we’d wanted to. But we decided against this and what we opted for was a common European approach to move forward together.’
The reason, according to Spahn, was to make sure that ‘all 27 member states will have access to vaccines at the same time’ as ‘otherwise some member states may have been able to procure vaccines at an earlier stage that others.’ Who knows if Britain would have been subject to the same political pressures if it still were a member of the EU. Brexit definitely made it politically easier for the UK to ‘go it alone’.
This is of course not a British vaccine. It will be produced by Pfizer in Belgium and it was developed by children of Turkish immigrants to Germany. It is the result of an admirably international ecosystem, and shows how globalisation can save lives.
If there is a lesson to be learned from the vaccine approval process, it should be that Brexit can enable the UK to become more agile, freed from the regulatory and political shackles of the EU, so it can better enjoy the fruits of globalisation.
Regulatory flexibility and regulatory competition are surely a good thing. Although the EMA seems to have reacted with annoyance to the UK approving the vaccine (claiming its own procedure is ‘the most effective regulatory mechanism’) it may make the regulator less inclined to drag its own feet. As long as the highest safety standards are met, regulatory competition is also a good thing for EU citizens.
Members of the European Parliament – not known for their love of regulatory competition – have also lashed out at the UK’s authorisation, with a lawmaker from Angela Merkel’s CDU party, Peter Liese, calling it ‘problematic’ and a ‘hasty emergency marketing authorisation of a vaccine.’ At the moment we cannot know if he is right or wrong. But that is the beauty of allowing different approaches. Through ‘trial and error’, we’ll learn what is the best regulatory approach.
As the terms that will define EU-UK trade for decades are being negotiated as we speak, this is something UK negotiators must keep in mind: regulatory flexibility and competition is not only a great thing for Britain. It’s a great thing for the people of mainland Europe as well.
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