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How Has Brexit Affected Drug Regulatory Decisions in the UK?

Editor's note: Shortly after posting this story, the Government announced £10 m in additional funding to the MHRA to fast-track drug approvals. We have updated the story to include this announcement.

The effects of Brexit on subsequent UK drug regulatory decisions have caused "delays and lack of approvals", according to an analysis by Matthias Hofer, PhD, a research associate in biopharma innovation at Imperial College London's (ICL) Business School. However, it has also led to a fast track for "quicker authorisation of some innovative medicines for cancer and other areas of unmet need".

In an article for the Business School this week, Dr Hofer asked: "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?"

Possible answers draw on a policy brief he wrote, in collaboration with colleagues from ICL, which was published in Frontiers in Medicinein December.

MHRA Remained Reliant on EMA Decisions

The brief noted that since the beginning of 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) had operated as the UK's independent regulatory agency but "remained reliant on EU regulatory decision-making for novel medicines". 

Post-Brexit, the UK Government and the MHRA had set out "a vision for a sovereign and independent regulatory system" that would be innovative, deliver rapid assessments, capitalise on national and international cooperation, and promote access to pharmaceutical products as early as possible.

The Association of the British Pharmaceutical Industry (ABPI) also advocated for an internationally competitive regulatory framework with a focus on innovation.

New International Framework Anticipated for 2024

In 2021, the MHRA had said that it would rely on EU medicine approval procedures for 2 years, "in order to maintain stability and continuity". In January this year, this was extended with the aim of introducing a new international recognition framework in 2024, which would take into account both EU regulatory decisions and those of other international regulatory bodies. The aim, it said, was "to extend the countries whose assessments we will take account of, increasing routes to market in the UK".

Meanwhile, the MHRA said EMA applications that received a Committee for Medicinal Products for Human Use (CHMP) positive opinion before the end of 31 December 2023 would be eligible to be submitted for MHRA approval via the current European Commission Decision Reliance Procedure route. 

At the time, the ABPI welcomed the decision. David Watson, ABPI's executive director for patient access, described the  MHRA's decision as "pragmatic", and said: "Pharmaceutical companies now have the clarity needed to inform their regulatory decisions for the year."

Asked to comment by Medscape News UK, a spokesperson for the ABPI said: "We look forward to working with the MHRA on the development of their new international recognition framework that will come into force from 2024 onwards."

In their policy brief, the ICL team presented results of their study analysing the first year of independent regulatory activity by the MHRA in the context of this new vision for pharmaceutical innovation, and compared it with the decisions of regulatory agencies in the US (Food and Drug Administration [FDA]), EU (European Medicines Agency [EMA]), and Switzerland (Swissmedic), based on data from public repositories provided by these regulatory agencies.

They reported that in 2021, the MHRA granted 1374 licenses for 561 medicinal products. The majority of licensing activity concerned medicines with known active substances, but 44 medicinal products (8%) were novel and contained new active substances.

MHRA Approved Fewer Novel Therapeutics Than EMA or FDA

For international comparisons, approval decision numbers were adjusted to exclude diagnostics, vaccines including COVID-19 vaccines, COVID-19 therapeutics, source plasma products, and medicinal products that were associated with negative appraisals/withdrawals, generics, or reference approvals for other countries/regions.

On the adjusted figures, the MHRA and Swissmedic both authorised 35 novel drugs in 2021, compared with 40 in Europe and 52 in the US. Dr Hofer pointed out that the figures masked "a relative lack of independence" for the MHRA – nearly 70% of new drugs it authorised in the study period relied upon the EU's approval process, despite the post-Brexit vision of sovereignty.

Dr Hofer noted that of five new drugs approved in the EU but not the UK in 2021, two were approved by the MHRA in spring and early summer of 2022, while three have yet to be approved. "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 study authors said that although there were "significant regulatory delays for a small number of novel medicines in the UK", the reasons for that were "so far unclear". Dr Hofer noted that as well as regulatory delays, "there might be other factors at play, like hitches in manufacturing or different marketing strategies".

Faster Authorisation for Innovative Medicines 

Contrasted to these delays however, the briefing authors noted: "The MHRA introduced innovation initiatives, which show early promise for quicker authorisation of innovative medicines for cancer and other areas of unmet need."

Dr Hofer said: "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."

Brexit was hailed as an opportunity for the UK to innovate alongside international partners, he said, "and here the UK has made progress", with a number of schemes to fast-track promising drugs now bearing 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."

He concluded: "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."

To further this aim, it was announced on Wednesday that the MHRA is to receive an additional £10 million of Government funding over the next 2 years "to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally".

This will be achieved through "a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK’s healthcare priorities".

In addition, the money will support an international recognition framework, allowing the MHRA to capitalise on the decisions of "trusted regulatory partners", starting with the FDA in the US and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Steve Barclay, Secretary of State for Health and Social Care, said: "Technology is transforming our care for patients, delivering faster and more accurate diagnoses. This new funding will accelerate the delivery of cutting-edge treatments like cancer vaccines and new artificial intelligence technology that will make therapy more accessible to those who suffer from mental health conditions."

Medscape News UK has approached the MHRA for comment.

This research was funded by the Gatsby Charitable Foundation's programme on Sectoral Systems of Innovation and the UK's Competitiveness. The authors declared no conflicts of interest.