The UK approved fewer new medicines than the EU and 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 in the UK just 35 new medicines were approved for use 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 a negative impact on the UK’s role in scientific research and development (R&D).
Steve Bates, chief executive of Britain’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) to recommend whether Medicines should be available in the NHS.
He said the rollout of Covid-19 vaccines has been rapid and the question is, “How do we make that happen in other areas?”
All novel medicines in the UK have had to be scrutinized and authorized by the UK Medicines and Healthcare Products Regulatory Authority (MHRA) since early 2021, when the country surpassed the European Medicines Agency (EMA), the EU medicines regulator, following the Brexit vote .
The EMA moved from London to Amsterdam in March 2019, closing its office in Canary Wharf, east London, which employed 900 people. This means pharmaceutical companies have to spend more money and deal with additional paperwork to get new medicines approved in the EU and UK.
James Barlow, a professor of health technology and innovation management at Imperial College Business School who co-authored the analysis, said the findings raise questions about whether the UK will remain attractive to international drugmakers in the long term.
“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 is even bigger. We’re an increasingly smaller player,” he said.
Barlow said Brexit has created another layer of bureaucracy for drugmakers seeking regulatory approval 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 over the past year, he said it was “too early to say if this is a post-Brexit blip or a longer trend” but “if it is indeed a trend, then it is a trend that goes in the wrong direction”.
Sign up for the daily Business Today email or follow Guardian Business on Twitter at @BusinessDesk
–
“The other concern is that R&D will shift out of the UK,” he warned. “Right now the UK has a very strong research sector in life sciences. If drug manufacturers become increasingly disinterested in bringing medicines to market in the UK, this may affect their willingness to invest in research and development in the UK.”
The MHRA said: “This analysis focuses on short-term activity and only looks at regulatory approvals of new medicines. The MHRA’s work to support innovation in established medicines that can save lives for many people is not included.
“The Covid-19 pandemic – during which we were the first regulator in the world to approve the Covid-19 vaccines manufactured by Pfizer/BioNTech and AstraZeneca – has shown that we are an innovative and agile regulator.”
A year ago, the UK government presented a 10-year strategy for life sciences, saying the MHRA “can act as an independent, sovereign regulator with great agility, focused on getting vaccines, medicines and technology to patients as safely as possible.” bring and as soon as possible”.
The life sciences sector employs more than 250,000 people and generates sales of £80 billion each year in the UK.
David Watson, Executive Director of Patient Access at the Association of the British Pharmaceutical Industry, said: “Since the UK left the EU, the MHRA has introduced new programs and partnerships aimed at giving patients faster access to innovative treatments enable.
“However, companies still face significant uncertainty as to whether medicines approved by the MHRA will be made available to patients in the UK. We need all parts of the system to work together to ensure NHS patients get the latest treatments.”
–
