No, the Pfizer/BioNTech coronavirus vaccine was not approved by the UK faster than the European Union because of Brexit.
First published in December 2020.
The UK has become the first country in the world to approve a Covid-19 vaccine after clinical trials on Wednesday, following a thorough review carried out by the UK Medicines and Healthcare products Regulatory Agency (MHRA) that regulates medicines, medical devices and blood components for transfusion in Britain. The Pfizer/BioNTech jab for immunising against coronavirus will soon be available for the first round of inoculations.
However, the long-expected news was overshadowed early on Wednesday morning by shameless government ministers and members of parliament trying to make baseless political points on the back of what can undoubtedly be called a historic public health announcement.
Alok Sharma, Secretary of State for Business, Energy and Industrial Strategy, tweeted:
“The day the UK led humanity’s charge against the disease”, really? Who are you kidding? The UK has authorised the Pfizer/BioNTech vaccine, not created it.
Later, Health Secretary Matt Hancock, when asked on TalkRadio if this announcement had been a “benefit of Brexit”, answered, “Well, that’s right. It is absolutely clear that because we’ve left the EU, I was able to change the law so that the UK alone could make this authorisation decision.
“Because we’ve left the EU, we’ve been able to move faster yet it still be done with all of the safety checks which would have been done anyway. So, we’ve got a faster approval because of Brexit, which is obviously good news for everyone.”
Matt Hancock later repeated the claim on Times Radio, “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. That’s the first reason.
“The second reason is because, 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.
“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 fact, the MHRA’s decision to approve the Pfizer/BioNTech vaccine ahead of the European Union’s own regulator is down to a longstanding provision, the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, which allows an individual Member State to diverge from the European Medicines Agency in the case of urgent public need.
George Peretz QC explained it very well on Twitter, “The UK is still entirely within the EU medicines regime. Under that regime, licensing of the Covid-19 vaccines is reserved to the EMA (technically the Commission advised by the EMA, but let’s simplify). Only the EMA can license biotechnological products for medical use.
“However, the Medicines Directive (2001/83) allows national medicines regulators (the MHRA) to approve unlicensed products for use in response to the spread of pathogens (Article 5(2)).
“That is what the MHRA has done here. It is therefore incorrect to say that what has happened is something that could not have happened while we were in the EU (which we essentially still are, for these purposes).”
“What will happen after 31/12/2021 is that the MHRA will be the body that decides whether to grant a full licence to the vaccines (though any full licence granted by the EMA before then will continue to apply in the UK as a matter of UK law).”
This was actually confirmed earlier at a briefing in Downing Street by Dr June Raine, the Chief Executive of the MHRA, who, when asked how the UK was able to authorise the vaccine before the EU regulator, answered, “We have been able to authorise the supply of this vaccine using provisions under European law which exist until the 1st of January.
“So, our speed or our progress has been totally dependent on the availability of data in our rolling review and the rigorous assessment and independent advice we have received.
“So, I hope that clarifies the point about the European relationship.”
In a nutshell, Matt Hancock’s assertion that Brexit had facilitated the vaccine approval is totally wrong and should be treated as dangerous misinformation, especially as it gets repeated consciously and to make irrelevant political points.
The MHRA never had to wait for the EMA to take a decision because EU law allows individual Member States to authorise drugs and vaccines in times of health crisis. One could even go as far as to argue that the EU somehow facilitated the speedy approval of the Pfizer/BioNTech vaccine in the UK.
Interestingly, even though Matt Hancock’s claim was an outright lie debunked by the MHRA boss herself, it didn’t take long for the Brexit minions and their friends in government to take this opportunity as well to assert the very same lie that their beautiful Brexit was the main reason for the speedy approval of the vaccine by the MHRA.
Lord of the Manor, Jacob Rees-Mogg, Leader of the House of Commons, tweeted:
Conservative backbencher MP Michael Fabricant:
Nadine Dorries, Minister of State for Mental Health, Suicide Prevention and Patient Safety:
All these ugly lies obviously backfired.
People, politicians, business owners, celebrities immediately called them on their lies. Here are some of their brilliant replies:
As Stephen Reicher, social psychologist, brilliantly put it this morning on Twitter, “Yesterday we saw the best and the worst of communications around the COVID vaccine. First, the independent regulator: honest, open and, above all, reassuring us that the key criteria are our health and safety. As Sky put it ‘gloriously dull’...
“Then, the Health Secretary, Matt Hancock claimed the vaccie as a victory for Brexit: triumphalist, divisive and worst of all, increasing suspicions that the early roll-out ignored health and safety was all about gaining political advantage...
“An unforgivable act of sabotage in the midst of the greatest crisis we have faced in decades. And, not for the first time in this pandemic, putting narrow political advantage before people’s lives. Indeed so crass that, this time, even Boris Johnson was forced to distance himself.”
So far, Downing Street has not chosen to back the Health Secretary’s claim about Brexit.🔷
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use | EMA
- MHRA briefing on the UK’s approval of Pfizer/BioNTech’s vaccine (video) | Reuters
- Vaccine approval isn’t quicker because of Brexit | Full Fact
J.N. PAQUET, Editor of PMP Magazine.
Check their Voting Record:
🗳️ Alok Sharma
🗳️ Matt Hancock