Vaccine approval isn’t quicker because of Brexit

“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.”

In an interview on Times Radio, the health secretary Matt Hancock incorrectly claimed that the UK was able to approve the use of the Pfizer/BioNTech coronavirus vaccine more quickly because of Brexit. Similar claims have also been made by other MPs including the leader of the House of Commons Jacob Rees-Mogg, health minister Nadine Dorries and the MP Michael Fabricant. This is not correct. 

Regulation 174 of the Human Medicine Regulations 2012

The facts behind this story lie with regulation 174 of the Human Medicine Regulations 2012. 

Until the Brexit transition period ends on 31 December, vaccines in the UK are supposed to be authorised via the European Medicines Agency (EMA). However, since 2012, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been free, under regulation 174, to give temporary approval to an unlicensed medicinal product in the case of certain types of public health threat, such as a pandemic.

When the MHRA approved the Pfizer/BioNTech coronavirus vaccine for use in the UK on 2 December, the government press release accompanying this announcement made clear that approval was given under regulation 174.

The government has previously said that “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 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.”

This is clear that using regulation 174 is implementing EU legislation.

Were the rules going to change?

It is true that the government has consulted on and made changes to the Human Medicines Regulations 2012. We have written about this before.

However, the consultation document did not propose any changes to the regulations which would have accelerated the approval of the Pfizer vaccine.

It 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.”

The head of the MHRA, Dr June Raine, has been clear that the vaccine was approved under EU law. Asked directly whether Brexit made the process quicker, she said: “We have been able to authorise the supply of the vaccine using provisions under European law which exist until 1 January.”

What about the EU?

Countries in the EU have agreed to work together in their approach to dealing with the pandemic

In June, the European Commission called for a “common strategy” between member states and proposed a “central procurement process” for purchasing vaccines. In October, it said it was “imperative that member states follow a common vaccination strategy for vaccine deployment [...] Coordination at EU level is required to align our efforts, to ensure and to show solidarity, and to best ensure the full functioning of the internal market, good public health management for Covid-19 matters and beyond, and the protection of all EU citizens no matter where they live.”

If the UK was not leaving the EU, the country may have chosen to follow this “common strategy” and move at the same pace as other members. However, it is not a legal requirement. The EMA has said it plans to make a final decision on whether to authorise the Pfizer/BioNTech vaccine by 29 December at the latest.