UK approved fewer new drugs than EU and US in year after Brexit transition

The UK approved fewer new medicines than the EU and the US in 2021, the first year after the end of the Brexit transition period, researchers at Imperial College London have found.

Their analysis shows that only 35 new drugs were approved for use in the UK by the country’s medicines regulator last year, compared with 40 approvals in the EU and 52 in the US.

Members of the academic community warned that there could be negative knock-on effects for the UK’s role in scientific research and development (R&D).

Steve Bates, chief executive of the UK’s BioIndustry Association, said the Imperial analysis was a “wake-up call” for the UK, and stressed the need for the regulator to work closely with the NHS and the National Institute for Health and Care Excellence (Nice), which recommends whether drugs should be available on the NHS.

He said the rollout of Covid-19 vaccines had been fast, and the question was “How do we make that happen in other areas?”

All novel medicines in the UK have to be vetted and approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) since the start of 2021, when the country left the European Medicines Agency (EMA), the EU drugs regulator, on the back of the Brexit vote.

The EMA moved from London to Amsterdam in March 2019, closing its office in Canary Wharf, east London, where 900 people were employed. This means pharmaceutical companies have to spend more money and face extra paperwork to get new medicines approved in the EU and UK.

James Barlow, a professor of healthcare technology and innovation management at Imperial College Business School, who co-authored the analysis, said the findings raised questions as to whether the UK would stay attractive to international drugmakers in the long run.

“Despite the fact that we have 70 million people, it’s still a small market and the EU is a much bigger market and the US even bigger. We are an increasingly minor player,” he said.

Barlow said Brexit had created another layer of bureaucracy for drugmakers seeking regulatory consent for new medicines. “It’s more difficult, more time-consuming and more expensive – and for a smaller market.”

Referring to the lower number of drug approvals in the UK last year, he said it was “too early to tell if it’s a post-Brexit blip or longer trend”, but “if it’s actually a trend, it’s a trend going in the wrong direction”.

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“The other concern is that R&D will shift away from the UK,” he warned. “At the moment, the UK has a very strong life sciences research sector. If drugmakers become increasingly disinterested in launching drugs in the UK, there may be a knock-on effect on their willingness to invest in R&D in the UK.”

The MHRA said: “This analysis is focused on short-term activity and only looks at regulatory authorisations of new medicines. It does not consider the work the MHRA does to support innovation in established medicines which can be life-saving for many people.

“The Covid-19 pandemic – during which we were the first regulator in the world to approve the Covid-19 vaccines made by Pfizer/BioNTech and AstraZeneca – has shown that we are an innovative and agile regulator.”

A year ago, the UK government set out a 10-year life sciences strategy and said the MHRA would be able to “act as an independent, sovereign regulator with great agility and with a focus on getting vaccines, drugs and technologies to patients as safely and quickly as possible”.

The life sciences sector employs more than 250,000 people and generates an £80bn turnover each year in the UK.

David Watson, executive director of patient access at the Association of the British Pharmaceutical Industry, said: “Since the UK’s exit from the EU, the MHRA has introduced new programmes and partnerships, which aim to deliver faster patient access to innovative treatments.

“However, companies still face considerable uncertainty about whether medicines approved by the MHRA will be made available to UK patients. We need all parts of the system to work together to ensure NHS patients can get the latest treatments.”