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Reassessing the UK's regulatory landscape post-Brexit

In 2020, the UK left the EU, marking a significant shift in its regulatory landscape. During the Brexit negotiations, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) faced challenges in keeping developers informed about future regulations. Post-Brexit, the MHRA had to reduce its workforce by approximately 20% due to the loss of European funding and the need to support infrastructure modernization. This led to delays in regulatory procedures, impacting scientific advice, marketing authorisation applications, and clinical trial assessments.

Despite these initial setbacks, the situation has been improving. June Raine, the outgoing Head of the MHRA, highlighted recent successes, including clearing a backlog of over 1,100 national marketing authorisation applications and nearly 1,000 clinical trial applications. The MHRA has achieved a 98% success rate in meeting a 60-day assessment metric for clinical trial applications. These improvements suggest a positive outlook for the UK's clinical research future.

Benefits of Brexit

The Department of Health and Social Care and the MHRA have sought to capitalize on opportunities presented by Brexit. Key regulatory requirements from European Directives and Regulations have been maintained in UK law. The UK has also recognized EU Good Manufacturing Practice (GMP) standards, despite the absence of a reciprocal Mutual Recognition Agreement. Additionally, the MHRA has introduced several innovative schemes to attract developers:

  • Recognition of European marketing authorisations through less extensive assessments.
  • Parallel review with international regulators via the Access and ORBIS schemes.
  • Innovative Licensing Access Pathway (ILAP) as an alternative to the EU's PRIME scheme.
  • Rapid 150-day marketing authorisation assessment for innovative medicines.

 Several pioneering schemes have evolved to further support drug development in the UK:

  • Extended recognition of marketing authorisations through the IRP scheme, which now includes opinions from leading health authorities like the US FDA and Japan's PMDA.
  • Support for cutting-edge therapies, exemplified by the approval of the first CRISPR-based drug in 2023.
  • Enhanced ILAP scheme, involving collaboration with payers and the NHS to streamline processes and improve timelines.
  • Participation in the Pilot GMP Single Inspection Program with international regulators.
  • Increased Research Spending: The UK government invested £15.5 billion in research in 2022, with significant allocations for medical research and innovation.
  • Competitive Tax Incentives: R&D and clinical development costs may be eligible for tax relief or cash sums for SME developers

The business case for the UK post-Brexit likely goes beyond the regulatory considerations though and includes devaluation of the pound which helps to reduce costs relative to nearby markets; the fact that English is the first language spoken by 91.1% of UK residents proficiently; and, the UK has a highly educated workforce with 57.7% of 25-34 year olds holding a bachelor's degree or equivalent.

The Windsor Framework and Political Stability

The Windsor Framework has simplified border arrangements between Northern Ireland and Ireland, creating a single UK market for drugs. This clarity in the MHRA's role eliminates previous confusion. Additionally, the current political environment in the UK is stable, with no immediate plans to rejoin the EU. This stability provides a predictable regulatory environment, allowing for iterative improvements rather than fundamental shifts.

Conclusion and How ICON Can Help

Given these developments, now is an opportune time for developers to reassess the UK's regulatory landscape. The UK offers innovative regulatory opportunities, a robust research and development environment, government investment, and a highly skilled workforce. ICON Regulatory Consulting Solutions is well-positioned to help developers navigate these opportunities. 

Over the coming year, ICON's experts will be creating a series of blog articles provide insights and examples of how these opportunities can be leveraged. We will help contextualise through examples where and when developers can leverage these benefits.  

We welcome questions from readers and are available to discuss funding opportunities and the benefits of working with highly educated UK clinical development staff. For further information or to discuss these opportunities, please contact ICON Regulatory Consulting Solutions.

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