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Drug approvals hit by Brexit

July 20, 2022

The UK approved fewer new medicines than the US and EU in 2021, the first year after the end of the Brexit transition period.

Drug approvals hit by Brexit. The UK approved fewer new medicines than the US and EU in 2021, the first year after the end of the Brexit transition period.

Since the beginning of 2021, when the UK left the European Medicines Agency (EMA) following the Brexit vote, all new medicines in the country must be approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Now analyses conducted by Imperial College London (ICL) researchers have shown that only 35 new drugs were approved for UK use by MHRA last year, compared with 52 approvals in the US and 40 in the EU.

Steve Bates, chief executive of the UK BioIndustry Association, has said the findings are a ‘wake-up call’ for the UK, and called for the regulator to work closely with the National Institute for Health and Care Excellence (NICE), which recommends whether drugs should be made available on the NHS.

Analysis co-author James Barlow, professor of healthcare technology and innovation management at Imperial College Business School, says the results also cast doubt on whether the UK can remain attractive to international drugmakers. “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.

While it remains to be seen if the drop in UK drug approvals in 2021 is a blip or the beginning of a longer trend, academics are warning that the UK’s role in scientific research and development (R&D) could be adversely affected.

Speaking of the extra expense and bureaucracy facing drugmakers seeking regulatory approval in the UK, Barlow said:  “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 has emphasised that ICL’s analysis, which focused solely on the regulatory authorisation of new medicines, does not consider the work carried out by the MHRA to support established medicines.

In July 2021, the UK government set out a 10-year life sciences strategy to accelerate drug delivery, saying that 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.’

Related: UK research hit by Brexit

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