WAS THE UK’S medical regulator able to approve the Pfizer-BioNTech vaccine against SARS-CoV-2 before the European Union’s regulator because of Brexit?

The British Health Secretary Matt Hancock made this claim on Times Radio; the claims have been repeated by a small number of political colleagues of Hancock, though not by his senior Cabinet colleagues.

The UK became the first Western country to clinically approve a vaccine for use against SARS-CoV-2 after the Medicines and Healthcare Products Regulatory Authority (MHRA) approved the Pfizer-BioNTech vaccine on Wednesday.

China and Russia have already approved vaccines for use in specific groups without waiting for large-scale clinical results known as Phase 3.

This article examines the statement by Hancock, the response of the British Prime Minister and the head of the MHRA, the British domestic legislation referenced in relation to this, and whether they support the claim made by Hancock and others.

The facts from those pieces of evidence show that any European Union member state – including the UK – had the option to authorise vaccines itself at a national level, rather than working en masse with the rest of the EU. 

This rule still applied to the UK, even though it has technically left the EU, because it’s still in the transition period. 

In other words: even if Brexit had never  happened, the UK regulator would still have been able to make this decision to approve the vaccine because it was already allowed under EU law. 

The Claim

Here are the comments by Hancock that we are factchecking:

“The reason we’ve been able to move this fast – and the UK is the first country in the world to have a clinically authorised vaccine – the reason is twofold: firstly, because the MHRA has done a great job of working with the company to look at that data as it’s come through, and do things in parallel, rather than one after the other as they normally would. 

“The second reason is because until earlier this year we were in the European Medicines Agency, the 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. We do all the same safety checks and the same processes, but we’ve been able to speed up how they’re done because of Brexit.”

The UK’s junior health minister Nadine Dorries echoed his comments on Twitter: 

“No one should be in any doubt about how it is that we can start rolling out the vaccine next week. A month ago, we changed the regulations to exempt 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.”

Tory MP and ardent Brexiteer Jacob Rees-Mogg said on Twitter:

“We could only approve this vaccine so quickly because we have left the EU. Last month we changed the regulations so a vaccine did not need EU approval which is slower.”

Reactions

At the time of writing, senior British government figures have avoided repeating Hancock’s claim when it was put to them, and the head of the UK regulator that authorised the vaccine appeared to refute his comments.

MHRA chief executive June Raine made two important points on this issue at a press briefing on Wednesday. The first was that the UK regulator approved the vaccine under European law (ie, not because European law no longer applied); and the second was the role of the “rolling review” in allowing the Pfizer vaccine to be approved quickly.

A “rolling review” is where a medicine is assessed on a staggered basis, with packages of data from ongoing studies sent to regulators as they become available instead of waiting for all trials to conclude before sending all the data.

“We have been able to authorise the supply of this vaccine using provisions under European law, which exist until 1 January,” Raine said.

When UK Prime Minister Boris Johnson was asked about Brexit’s role in approving the vaccine at a briefing yesterday (at 32:22 in this video), he didn’t say that Brexit was a reason why the vaccine was approved so fast in the UK.

He said: “…The UK seeming to get the vaccine soon [or] early, perhaps ahead of many other countries, I think that’s really down to the vaccine taskforce and the way they’ve gone out to organise that.”

All seven of the vaccines “backed” by the UK are “global efforts”, Johnson added.

When it was put to British Education Secretary Gavin Williamson that it happened because of Brexit, he twice avoided answering the question directly on LBC, and instead said that the UK has “the best regulators” in the world, ‘better than the French, Germans or the Americans’.

At a briefing between the Prime Minister’s spokesperson and journalists, the spokesperson is quoted as having emphasised the ‘hard work’ of the MHRA and those who took part in the vaccine trials, rather than affirming that it was because of Brexit.

The Facts

When the UK medicine regulator approved the use of the Pfizer vaccine, it made a decision that is available to all EU member states.

There is provision in European law, still in effect in the UK now, to allow temporary and limited use of a non-EMA approved vaccine (or other medicine) in limited cases such as to fight a pathogen or a nuclear incident.

Recent changes in British domestic law were not to allow the vaccine to be approved quicker or easier, but instead clarified how the vaccine can be used post-approval.

The EU rules

The UK has ‘officially’ left the EU, meaning that its MEPs and Commissioner have left European Union institutions, but as agreed by both sides, the UK remains under some EU rules until the end of the transition period on 31 December. 

One of these rules is Directive 2001/83/EC, which has also been drafted into UK domestic law and came into effect in the UK in 2012. 

Article 5(2) of that directive states:

Member States may temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

This means that during public health emergencies (such as a pandemic or a nuclear disaster), EU countries can ask the EMA for a conditional authorisation to use an ‘unapproved’ medicine.

An official from the European Medicines Agency (EMA) said that the Pfizer vaccine received a “temporary authorisation” for supply and use in the UK in “specific batches”.

It’s worth noting that the EMA has also been conducting a “rolling review” of the Pfizer data; it’s due to meet on 29 December to decide whether to grant it conditional approval. After the UK regulator approved the Pfizer vaccine for use, the EMA said that it has the “most appropriate” process to approve a vaccine “in the current pandemic emergency”.

UK domestic law

Both Dorries and Rees-Mogg referred to how the UK government changed its legislation last month as a key reason why the UK was able to approve the vaccine quickly. 

The legislative change can be seen in Regulation 174 of the Human Medicines Regulations (UK gov press release here).

In that press release, it states: “Until the end of December, and as part of the transition period, vaccines must be authorised via the European Medicines Agency and that authorisation will automatically be valid in the UK. 

However, if a suitable Covid-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.

“After the transition period ends in January 2021, the MHRA will have new powers to approve medicines, including vaccines, and will have greater flexibility to do this in a shorter time, while maintaining the highest standards of safety, quality and effectiveness.”

Legislative changes made by the UK government recently did expand the scope of what the UK can do with vaccines not yet licensed by the EU, such as allowing more people to administer them, and granting the vaccine producers with immunity from legal liability. 

As stated by legal expert and Financial Times columnist David Allen Green here, this Regulation 174 instrument does not change the EU directive, making it “irrelevant” to the debate on whether Brexit had a role in approving the vaccine for use. 

The changes made were not to allow the MHRA to approve use of the vaccine separately to the EU’s regulator, but to widen the scope of how an unapproved vaccine can be used.

The Verdict

The claim made by Health Secretary Matt Hancock that Brexit was one of two reasons why the UK became the first country to approve a Covid-19 vaccine for use hasn’t been publicly echoed by the UK Prime Minister, nor the head of the regulatory body which approved the Pfizer vaccine.

The UK didn’t choose to wait for the EU regulator to approve the vaccine, the way EU member states like Ireland did, but instead used a European law still in effect in the UK to default to its own regulator for temporary and limited approval.

It could be argued that this is part of the process of the UK leaving the EU – that the UK is distancing itself from EU institutions as part of Brexit. 

But the choice made by the UK would have also been available to them if they hadn’t left the EU in January.

It may be the case that the MHRA becomes faster at approving new drugs than the EMA after the transition period ends, because it decides on new standards and processes to approve vaccines and other medicines.

But it’s incorrect to say that Brexit was the reason, or part of the reason, for the UK becoming the first country to clinically approve a Covid-19 vaccine. This is supported by EU and UK legislation, and the statement from the head of the MHRA.

The claim that the UK approved the Pfizer vaccine before the EU because of Brexit is FALSE.