Arj Singh www.huffingtonpost.co.uk
Matt Hancock kicked off the debate, suggesting that “because of Brexit” the UK has been able approve the vaccine more quickly than if it was an EU member.
The EU has yet to approve the vaccine for use in member states.
“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,” the health secretary said on Wednesday morning.
But his claim was quickly shot down by the Medicines and Healthcare products Regulatory Authority (MHRA), which actually granted the temporary authorisation of the Pfizer/BioNTech jab for use in the UK.
“We have been able to authorise the supply of this vaccine using provisions under European law which exist until January 1,” June Raine, chief executive of MHRA, told a Downing Street briefing.
Later, No.10 repeatedly refused to endorse Hancock’s claim.
“I think the important point is that we are clearly the first (western) country in the world to approve a vaccine, it’s obviously a very positive move forward,” a spokesperson told reporters.
And yet – of course – the row continues online, with Leaver talking head Darren Grimes claiming “Brexit is vindicated” and arch-Remainer Lord Adonis accusing Hancock of being “utterly juvenile”.
So who is right?
The clue is in a consultation document put out by Hancock’s own Department for Health and Social Care (DHSC) earlier this year, which makes clear that Brexit has nothing to do with it.
The department stated that until the end of the Brexit transition period on December 31, during which the UK follows Brussels rules, “EU legislation requires biotechnological medicines (which would include candidate Covid-19 vaccines) to be authorised via the European Medicines Agency”.
But it also stressed an exemption in EU law which allows the MHRA to issue a temporary authorisation “if there is a compelling case, on public health grounds, for using a vaccine before it is given a product licence”.
This is backed up in the UK’s own Human Medicines Regulations 2012, which allows the domestic regulator to permit a “temporary authorisation for the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat”.
The law then copies language from directly from Article 5(2) of the EU Medicines Directive 2001/83, which states that “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.”
In October, the UK then went on to amend this law.
Health minister Jo Churchill explained in a written ministerial statement these were simply “technical” changes to “make sure that any unlicensed products that the government recommends for deployment in response to certain public health threats must meet required safety and quality standards”.
When Pfizer reported on November 18 that its vaccine had 95% efficacy, the MHRA put out a statement making clear that if “strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need”.
Mark Dayan, head of public affairs at the healthcare think-tank Nuffield Trust, told HuffPost UK: “I don’t really see any grounds on which you can say Brexit has facilitated this.
“We’re in this transition period at the moment where legally speaking for things like medicines there’s absolutely no change to what the situation was in 2012 or before the referendum or when we were full members.
“So I don’t really understand the mechanism by which Brexit could have accelerated this.”
On November 20, Hancock “formally asked the MHRA to assess the Pfizer/BioNTech vaccine for its suitability for authorisation”.
On Wednesday, the MHRA made history by granting that temporary authorisation.
And it had nothing to do with Brexit.
The DHSC has been approached for comment.