The UK has become the first country in the world to authorise the Pfizer/BioNTech vaccine for use, with the rollout due to start next week. Amid the excitement, Matt Hancock told an interviewer:
“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. So because we’ve left the EU, we’ve been able to move faster.”
But it’s not correct. Here’s why.
Today’s decision comes from the UK’s independent Medicines and Healthcare products Regulatory Agency (MHRA). It’s long worked in tandem with the European Medicines Agency (EMA) deciding which drugs are safe for use.
When we were part of the EU, the EMA had areas of jurisdiction that meant only it could make decisions about certain types of medicine, including vaccines. National regulators like the MHRA couldn’t get involved.
When the UK left the EU on 31 January this year, we entered the “transition period”, which means the European regulations we adopted during our time in the trade bloc are still in effect until the end of 2020.
That includes the rule that says vaccines generally must be authorised by the EMA instead of national regulators.
But as a UK government press release from 23 November 2020 states: “if a suitable COVID-19 vaccine candidate, […] becomes available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.”
So even if we were still a member of the EU, the UK regulator would have been able to take this decision on its own because EU law already allows it. Incidentally, that legislation took effect in the UK in 2012, long before Brexit was on the cards.
Asked whether Brexit had sped up the process, the head of the MHRA, Dr June Raine, said today: “We have been able to authorise the supply of the vaccine using provisions under European law which exist until 1 January.”
She added that the regulator’s “speed or our progress has been totally dependent on the availability of data in our rolling review, and the rigorous assessment and independent advice we have received”.
What about that new legislation Matt Hancock mentioned?
In October 2020, the government announced it would amend regulation 174 of the Human Medicines Regulations (the same piece of EU-derived law discussed today).
But, as the government’s own consultation document set out, the amendments would only “clarify” the situation because the existing law was already adequate for coronavirus vaccines.
Here’s what the government said: “If the need arises, regulation 174, in its present form, could be used to authorise nationwide distribution and supply of an unlicensed COVID-19 vaccine (or treatment) in the UK, as well as other potential products.
“In practice, this means that, if a suitable COVID-19 vaccine candidate – with strong supporting evidence of safety, quality and efficacy – became available before the end of the transition period but it had not yet been licensed by the European Medicines Agency, regulation 174 could be used to enable temporary UK-only deployment.”
3 December update
Since we published this article, we’ve been asked by several readers: didn’t EU nations decide to “move as one” when it came to vaccines? Wouldn’t that have slowed the UK down if we were still a member?
In October, the European Commission issued a “Communication” after EU countries agreed that no individual national regulator would move faster than the EMA.
It’s true that if Britain were still part of the trading bloc, we’d have been under political pressure to be part of that arrangement.
But the European Commission confirmed to FactCheck that “there was no legal obligation to sign up to the Strategy”.
The German health minister, Jens Spahn said yesterday that it was a matter of choice: “We have member states including, Germany, who could have issued such an emergency authorisation if we’d wanted to. But we decided against this and what we opted for was a common European approach to move forward together”.
So even if Brexit hadn’t happened, we’d still have been entitled, under EU law, to opt out of the joint system and “go it alone” with the Covid vaccine.