Brexit makes no legal difference to the United Kingdom being able to authorise the new coronavirus vaccine

3rd December 2020

For the launch of any vaccine, credibility is essential.

And so senior government ministers and other politicians should not be lying about the regulatory aspects of the new vaccine so to score points for Brexit.

This is the Leader of the House of Commons, the cabinet minister responsible for the government’s legislative programme.

This is a health minister.

And this is a government-supporting backbencher.

You will see these statements are not about Brexit allowing the United Kingdom to authorise the new vaccine more quickly as a matter of policy.

Each statement directly and expressly attributes the speed of the authorisation to a change in the law made possible by Brexit.

This, however, is false.

The Medicines and Healthcare products Regulatory Agency confirmed yesterday it was acting under EU law when it it made the authorisation.

Even the Prime Minister did not endorse the claim that Brexit made any legal difference.


The fact is that Brexit made no legal difference to the authorisation of the new vaccine.

Such an authorisation was (and is) possible under European Union law.

The relevant provision is Article 5(2) of the Directive 2001/83/EC.

Here is the proof in back and white.

European Union Directives do not necessarily need to be implemented to have legal effect, but for completeness the implementing domestic legislation for Article 5(2) is Regulation 174 of the Human Medicines Regulations 2012.

Until 31 December 2020 under the Brexit transition arrangements, Article 5(2) has legal effect in the United Kingdom – and even after 1 January 2020 Regulation 174 would still be part of domestic law.

Brexit therefore made no legal difference.

So what is the recent amendment mentioned by the politicians?

That appears to be a reference to the The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020.

But those regulations do not amend or directly affect Regulation 174 – you will see they skip straight over it and add supplementary provisions.

The recent amendment is thereby irrelevant to the legal ability of the United Kingdom to authorise the vaccine.


The cabinet minister responsible for the government’s legislative programme and health ministers would know that Brexit made no legal difference to the United Kingdom’s ability to authorise the new vaccine.

They would know the correct legal basis for authorisation of the new vaccine: that is their job and they would have been briefed.

But they chose to knowingly promote a falsehood instead, just to score a point for Brexit.

This was dangerously irresponsible, given that any false statements about the new vaccine may be exploited by anti-vaxxers.


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16 thoughts on “Brexit makes no legal difference to the United Kingdom being able to authorise the new coronavirus vaccine”

  1. You’ve nailed the lie very comprehensively with this post. Let’s see if your point gets taken up by any other commentators and influencers.
    Nevertheless, the really big difference Brexit has made here is the desperate urgency of the UK govt. to get a vaccine authorised before the corresponding EU authorisation. Why? Perhaps because they are about to announce a trade deal with the EU that effectively backs down from all the bravado talk about retaining sovereignty and not being subject to laws made elsewhere. Perhaps because most of the UK population will soon be suffering from the worst act of national self-harm ever inflicted on itself by a supposedly-developed country.
    Anyway there is a big difference between authorising the vaccine and getting it administered to enough people to stop the contagion. This govt. has not shown itself to be very good at implementation.

  2. This is “EU Bans Bent Bananas!”-grade lying, the mainstay of Johnson’s “Telegraph” columns – make a claim that is premised upon the governing power being an unthinking grey bureaucracy, as if in all the lengthy debating and drafting of such legislation nobody thought to build in mechanisms to cope with crises or the unforseen.

    Shame on them, and kudos to David for holding them to account with this chapter-and-verse reference.

  3. Thank you for this. The fact that the Prime Minister declined to endorse his colleagues’ false statements shows just how far from acceptability they have gone. Yes, politicians will lie – sorry, apply terminological inexactitudes – but the ‘why’ is important and it is clear that there is increasing panic among Ministers and Brexiters that there will be NOTHING to show for this turmoil and trauma.
    It was also interesting yesterday to hear fishermen and fish traders at Newlyn (Cornwall), Brexit-voters to a man, start to realise that the right to fish exclusively in British waters is not worth much if they then cannot sell the fish to those who want them – in France and beyond.
    We’ve seen nothing yet.

  4. Thank you for confirming my suspicions about this.

    Here in N Ireland, many see no “upside” to Brexit; and many equally have little or no confidence or even trust in the actions or words of the UK government.

    It’s no surprise, sadly, to read of further deceit and boosterism about Brexit. Are these people really sincere in their beliefs, sincere about getting “good news” messages across, or are they trying to polish their egos with this talk? You could be forgiven for thinking that they don’t actually believe a word of it themselves.

  5. Indeed. Perhaps someone could just ask the politicians which amended regulation they were referring to, and how the changes make regulatory approvals any quicker?

    It is certainly not new regulation 174A of the Human Medicines Regulations 2012 (which just makes it clear that a temporary authorisation under regulation 174 can be subject to conditions on use, provides an exemption from liability, and requires review of the temporary authorisation within a year).

    The 2020 regulations also switch off various other regulatory rules (see, for example, new regulations 247A and 291A), and there is an amendment to regulation 345, which extends immunity from civil liability, but none of that is to do with timing.

    There has been a cataract of “(Coronavirus)” and “(EU Exit)” statutory instruments (approaching 600 of the former across the UK, and 900 of the latter) but I was looking in vain yesterday for one that would make any difference to the regulatory approval for this vaccine (developed in large part by a Turkish-German company, funded by the EU amongst others, and packed by Pfizer in Belgium, because its UK cold chain facility in Havant was closed earlier this year – but we are assured that Brexit played no part in Pfizer’s decision to close down a UK plant that it only opened in 2012, but keep another in Belgium in operation, rather than the other way around).

    I did wonder if Hancock might have been referring to some sort of non-statutory internal regulation of the MHRA, but it is hard to see what Brexit would have to do with that either.

    Perhaps the politicians are just mistaken, but this has the flavour of a Trumpian falsehood: if repeated often enough, loudly enough, people might just believe it. Or indeed politicians saying different things at different times, so people will hear what they want to hear.

  6. These are the folk who have spent years rubbishing experts and encouraging others to do so.

    I did think it rather ironic a few years back when some Brexiteers started citing experts as evidence as to why X company reducing its workforce was not down to Brexit.

    They had, after all, won the referendum by mostly putting forward arguments rooted in emotion and, in the case of our fishing industry, seemingly vital to our economy, pure nostalgia.

    It was rather delicious then to note vox popped Birmingham voters putting the transfer of all Landrover production to Slovakia down to Brexit. Brexit may well have been a factor in the decision, but probably not the over riding one.

    And, of course, we have a Cabinet dominated by arts graduates.

    Thatcher, curse her, a science graduate and research chemist, would have taken the pandemic seriously from the outset and I’d have trusted her, if she said the vaccine was safe.

    As an aside, Thatcher’s chemistry research at Oxford resulted in the the formula for Mr Whippy ice cream or so it has been said.

  7. It seems likely that this Brexit angle has deprived us of any useful debate over whether it was right of the government to use this emergency procedure in the first place. The EMA has criticised the decision and so have American authorities. They might be expected to say that, given that they are simultaneously defending their own methods, but it does illustrate that there is a real balance to be struck between speed and safety. Whichever way the government chooses to strike that balance, it should be transparent and part of public debate. So far this has not been the case and a similar request to use Regulation 174 to accept the Oxford vaccine is also not being given much scrutiny.

    If the whole pandemic had been delayed by a year, and this were taking place in December 2021, would we still be arguing about whether it’s a benefit of Brexit? What about in 2022? We can live in hope.

  8. “The Ministry of Peace concerns itself with war, the Ministry of Truth with lies, the Ministry of Love with torture and the Ministry of Plenty with starvation. These contradictions are not accidental, nor do they result from from ordinary hypocrisy: they are deliberate exercises in doublethink.”


    “The very concept of objective truth is fading out of the world. Lies will pass into history.”

    George Orwell

  9. Sorry, we can’t go on like this any more. Our MPs, but especially Ministers, must be made to take an IQ test … or something!

  10. “I just reckon we’ve got the very best people in this country and we’ve obviously got the best medical regulator, much better than the French have, much better than the Belgians have, much better than the Americans have… That doesn’t surprise me at all, because we’re a much better country than every single one of them.” (Gavin Williamson, who is the ‘education secretary’, apparently).

    We British people used to laugh (arrogantly, perhaps) at countries where governments displayed such levels of nationalist insecurity. The UK, by comparison, exuded quiet confidence, even during its ’70s post-imperial nadir.

    I’m half expecting that, when Brexit comes apart at the seams, UK government ministers will be heard on the BBC denouncing ‘foreign devils’ and the ‘Gang of Four’.

  11. In this morning’s highlights in the New York Times: “Several top British lawmakers have also incorrectly cast the country’s split with the European Union as the reason it authorized a vaccine first. In fact, Britain remains under the bloc’s regulatory umbrella and was able to move more quickly because of an old law enabling it to make its own determinations in public health emergencies.”

  12. The falsehoods about Brexit making it possible to produce the vaccine are pathetic and annoying. More seriously when politicians treat public health issues as political issues, it makes it harder to make progress. As a result of this “Britain is best” nonsense, the cynicism about vaccine safety that some people have is further reinforced. It is seriously unhelpful in encouraging take up of the vaccine which in turn results in more death, misery and economic damage.

    1. Vaccine cynicism is a manifestation of Conspiracy Theories. Such theories in the area of public health are dangerous. We have barely recovered from the anti-vaxx around MMR. And yet there are already Conspiracy Theories about the coronavirus vaccines floating around. For example, the Astra/Oxford one is made with an inactive chimpanzee cold virus, so there are those saying that it will turn us into chimps. And Michael Gove’s remark about “not needing experts” is deeply unhelpful; in these situations, experts are exactly what we need.

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