NEW: MHRA issues statement to me on whether or not Brexit accelerated the Pfizer vaccine licencing process.

They confirm licencing has taken place under provisions as set out in EU law.

By extension Brexit hasn't (as some ministers have claimed) allowed us to licence early.
In the EU, drugs are licensed by the European Medicines Agency.

But since 2012 the UK MHRA has been allowed (using Regulation 174 of the Human Medicine Regulations 2012) to give temporary approval to an unlicensed product in the event of a pandemic or public health emergency.
That's been the case as part of the EU. Indeed, that Reg comes via European directive 2001/83/ECAs transposed into EU law. That's why the MHRA says: "These provisions are compliant with existing European law, and will remain in place after the end of the Brexit transition period"
Problem is, several prominent ministers have said something quite different.

Matt Hancock told Times Radio that “Because of Brexit we’ve been able to make a decision [to approve the Pfizer vaccine] 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.”
As the MHRA are saying this isn't right. It would always have been possible for the UK to do this under Regulation 174.

It's possible that once we've left the EU we...
...might be able to distribute the vaccine differently, separated from EU law. That's a point Matt Hancock was asked about in the House and which may well be right.

But that's a different point to whether the licensing was done more quickly because of Brexit, because it wasn't.
This should be obvious because we are still obeying EU law because the transition period isn't over yet.

Several other ministers were more explicit than Hancock. Nadine Dorries said: "A month ago, we changed the regs 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."

The first part is true, we did change the regs to be exempted from EU approval. We would still be waiting if not. But the second part isn't true. It's not thanks to Brexit that we can do that.
Because- to repeat, we haven't really Brexited yet, because we're still subject to EU law.

If the referendum had never happened, we could have done this (indeed, one can imagine clamour from Eurosceptic Tory MPs who would have insisted on it).
It's possible that had we still been a full member, the government of the day might have chosen to stick with the EMA process and not move more quickly. But they might not. The point is Brexit hasn't allowed us to do something we couldn't have done.
Indeed, Hungary (a full EU state) is doing it to licence the Russian Sputnik vaccine, to the EU's chagrin, but they're doing it.

Then there were Jacob Rees Mogg's comments: "We could only approve this vaccine so quickly because we have left the EU..." https://www.politico.eu/article/commission-hungary-can-use-russian-coronavirus-vax-but-will-be-liable/
"Last month we changed the regulations so a vaccine did not need EU approval which is slower."

This time the truthful part of the statement is inverted. The second part is right, the first wrong. Yes the regs allowed licensing, no we didn't approve it so quickly...
...because we have left the EU. Because, again for regulatory purposes we haven't, which ministers should probably know and understand.

The govt itself as acknowledged this. On 23rd November the DHSC welcomed the MHRA review into the Pfizer vaccine in a press release...
....they acknowledge this grace period. They confirm that EU legislation (in UK law) permits emergency approval of a vaccine, via a Regulation 174.

It says after the transition period ends the MHRA will have new powers to act more quickly. But that's not what's happened now.
This is presumably why the Prime Minister, despite entreaties to suggest this was a "Brexit bonus" declined to endorse what his ministers had said in his briefing earlier this week, but he didn't directly contradict them either.
This has been fact checked by others but this isn't really a story about Brexit anyway at this point. Rather given the MHRA's quite clear statement (buttressing what their Director has said in public) it's about ministers being accurate in what they're saying about...
important matters of public policy. Pg 27 of the ministerial code is clear. It carries an annex of The Seven Principles of Public Life and says officeholders should be "truthful". Truthful implies correcting the record even if a mistake has been made, which these may have been...
But it hasn't happened yet.

I've approached the Department for Health and Social Care and Number 10 for a comment or to provide an explanation for how their ministers' statements tally with what the MHRA has told me but so far they've declined to do so.
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