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Thu, 21 January 2021

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The Boss Of The UK's Vaccine Regulator Has Contradicted Matt Hancock’s Claim We Approved A Covid Jab Before The EU Due To Brexit

The Boss Of The UK's Vaccine Regulator Has Contradicted Matt Hancock’s Claim We Approved A Covid Jab Before The EU Due To Brexit

Matt Hancock's claim that Brexit was a factor in the speed of the Covid vaccine's approval was contradicted by Dr Jun Raine from the MHRA (PA/Sky News)

5 min read

Matt Hancock’s claim the UK has approved a vaccine for Covid-19 before the EU because of Brexit has been contradicted by the chief executive of the government’s medical regulator.

The health secretary claimed the reason the Medicines and Healthcare products Regulatory Agency (MHRA) had been able to “move this fast” was because its decision-making has been disentangled from the European Medicines Agency.

But Dr June Raine from the MHRA said the process they had followed to give the Pfizer/BioNTech vaccine the green light to be rolled out was “using provisions under European law which exist until January 1”.

After it was revealed Britain was the first country in the world to approve a jab for immunising against coronavirus Mr Hancock said they would not have been in a position to do so with such speed had it still been a member of the EU.

Asked on TalkRadio if this had been a “benefit of Brexit”, he replied: "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."

Repeating the claim on Times Radio the minister explained: "And 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 MRHA 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."

Fellow Cabinet minister Jacob Rees-Mogg, a strong supporter of Brexit, also suggested the speed of vaccine’s approval was down to exiting the EU.

He tweeted: “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.”

But it appears the UK’s decision to approve the vaccine ahead of the EU is down to the use of a longstanding provision which allows an individual country to diverge from the EMA in the case of urgent public need. 

And as the UK is still operating under the EU regulatory framework until the end of the Brexit transition period on 31 December the decision on the Pfizer jab was not due to the decision to leave the continental trading bloc.

And at a briefing in Downing Street this morning Dr Raine was asked how the UK was able to authorise the use of a vaccine before the European Union.

She replied: "We have been able to authorise the supply of this vaccine using provisions under European law which exist until January 1.

"Our speed or our progress has been totally dependent on the availability of data in our rolling review and the independent advice we have received."

“So I hope that clarifies the point about the European relationship.”

And the German MEP Peter Liese, who sits on the European Parliament's Committee on the Environment, Public Health and Food Safety, said it was "not a Brexit issue”.

He told the BBC his country could also have approved the vaccine themselves but EU member states had decided to wait for the EMA to make a ruling, excluding Hungary which is planning to use the Russian Sputnik V vaccine.

Mr Liese said: "Other member states decided not to go for a national emergency authorisation. The other member states think that it is necessary to look more carefully."

The Department for Health has pointed to changes made to the Human Medicines Regulations 2012, which took effect on October 16, which “bolster existing powers that enable the MHRA to authorise temporary supply or any treatments vaccine to respond to a public health need”.

It adds: “This means that if a vaccine has been found to meet the safety, quality and effectiveness standards by the MHRA then vaccinations can begin without needing to wait for the European Medicines Agency who – up until the end of the transition period in 2021 – would have been the only body able to grant a licence.”

But another government document last month stated: “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 allows for temporary authorisation of supply in the UK, based on the public health need.”

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