Post-Brexit medicine approvals: what we know

Has the UK fulfilled its ambition to break free from Brussels and give patients faster access to new drugs as they emerge? Or has Brexit only increased red tape and made the UK a less attractive market for innovation?

While the UK has been slower than the EU to approve some novel medicines, and still relies heavily on EU decision-making, there have also been encouraging results from the early steps made to fast-track new drugs.

In our research, we’ve investigated official records of drug approvals and drawn comparisons between the performance of the UK regulatory body, Medicine and Healthcare products Regulatory Agency (MHRA), and its international counterparts in the EU, US and Switzerland.

Our review reveals that fewer novel drugs were authorised by the MHRA in 2021 – its first year of independence – than by the European Medicines Agency, with 35 approved in the UK, compared to 40 in Europe and 52 in the US.

Of five new drugs that were approved in Europe but not the UK in 2021, two were given the UK’s green light in spring and early summer of 2022, while three have yet to be approved.

International recognition framework

The number of UK approvals of new drugs appears in line with those of Switzerland, which acts independently of EU regulations, and also approved 35 in the same year. But these figures mask a relative lack of independence; nearly 70 per cent of new drugs authorised by UK authorities relied upon the EU’s approval process, despite a post-Brexit vision of sovereignty.

In 2021, the MHRA stipulated it would rely on EU medicine approval procedures for two years in order to maintain stability and continuity. The UK extended this in January 2023, with the aim of introducing a new international recognition framework in 2024, taking into account EU regulatory decisions, as well as those of other international regulatory bodies.

The reasons for these delays and lack of approvals since Brexit aren’t entirely clear at this stage. The UK is now slightly behind Europe in the queue to get medicines approved, and both Europe and the UK are behind the US, where drug markets function differently with faster access to innovation.

The number UK approvals of new drugs appear in line with those of Switzerland

But we lack more detailed information. For example, we don’t yet know enough about what’s going on behind the scenes at the MHRA to assess the cause of the delays. There might also be other factors at play like hitches in manufacturing or different marketing strategies.

Nor do all regulatory decisions follow international trends. One drug not yet approved in the UK is Vorositide, a treatment for achondroplasia, the most common form of dwarfism. Although it’s already in use in the US and parts of Europe, the jury is still out – amid doubts expressed by experts and people with dwarfism alike – about its impact and benefits. Even if a drug is licensed in the UK by the MHRA, it still has to jump the hurdle of approval by the National Institute for Health & Care Excellence to ensure use within the UK's National Health Service (NHS).

More troubling are suggestions that pharmaceutical companies may judge it not to be worth the effort to seek UK approval, given the size of the national market and doubts over approval and NHS commitment. After all, the UK has a relatively small share of the global pharmaceutical market (2.4 per cent).

Is Brexit an opportunity for innovation?

But Brexit was also hailed as an opportunity for the UK to innovate alongside international partners, and here the UK has made progress. A number of schemes to fast-track promising drugs have borne fruit: in 2021, four innovative new cancer drugs were approved in the UK via an international scheme, Project Orbis, coordinated in the US with other non-EU partners. Additionally, the national Early Access to Medicines Scheme, which allows UK medics to prescribe before formal MHRA approval, saw another four medicines fast tracked for patients.

Nearly 70 per cent of new drugs authorised by UK authorities relied upon the EU’s approval process

We’ve excluded COVID-19 vaccines and medicines from our research and, here, UK authorities were faster than the EU to approve two leading vaccines in late 2020. While this is often cited as proof that Brexit has allowed greater independence and speed over national health matters, these decisions were in fact made while the UK was still under EU jurisdiction – they were allowed thanks to a legal clause in EU law that permits exceptional use in response to disease.

So, it is a mixed report for the UK authorities’ first year of independence: the MHRA is weathering a stormy transition amid political and institutional changes but has made a start on innovating with international partners.

This article draws on findings from "Regulatory Policy and Pharmaceutical Innovation in the United Kingdom After Brexit: Initial Insights" by Imperial College London's Matthias P. Hofer, Paola Criscuolo, Nilay Shah , Anne L. J. ter Wal and James Barlow.