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.
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. https://t.co/y2Az7okPdx— Jacob Rees-Mogg (@Jacob_Rees_Mogg) December 2, 2020
This is a health minister.
No one should be in any doubt about how it is that we can start rolling out the vaccine next week. A month ago, we changed the regulations 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— Nadine Dorries 🇬🇧#StayAlert (@NadineDorries) December 2, 2020
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.
Medicines body chief contradicts Hancock over Brexit vaccine claim https://t.co/bxvLHB1MFe— The Guardian (@guardian) December 2, 2020
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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