With the MHRA now solely responsible for granting marketing authorization for new medicines, how has Brexit impacted patients’ access to the latest cancer treatments in the UK? The UK officially concluded its 47-year membership in the EU on January 31, 2020. As a result, the Medicines and Healthcare products Regulatory Agency (MHRA) disengaged from the European Medicines Agency (EMA). Throughout the last three years, operating as the UK’s independent regulator, the MHRA has implemented numerous changes. However, significant developments on January 24 and March 21, 2023, mark the most significant overhaul of trial regulation in two decades.

The decision by the MHRA to overhaul trial regulation is a welcome development. New measures will include streamlining clinical trial applications by combining regulatory and ethics reviews, implementing a maximum timeframe of 30 days for application reviews and 10 days for final decisions, and introducing a legal mandate requiring trial registration in a WHO-compliant public register and publication of a summary of results within 12 months of the end of the trial. Further important changes are the extension of the European Commission Decision Reliance Procedure (ECDRP) to the end of 2023, and the introduction of a new international recognition framework from Jan 1, 2024. The ECDRP has been a crucial stop-gap measure after Brexit to allow the MHRA to rely on EMA decisions until an alternative framework was put in place to provide a long-term solution. Taken together, these measures should increase the number of treatments gaining market authorisation, which ultimately helps more patients. There was industry concern that drug approvals in the UK would slow considerably after Brexit, but fortunately this has been mitigated, much to the relief of the trade body, the Association of the British Pharmaceutical Industry.

After Brexit, the MHRA needed to evolve to ensure that regulatory processes are robust yet remain highly competitive on an international stage beyond the EU. The MHRA alone, however, cannot have sweeping effects on the medical landscape. Drug development and patient access are complex and multifactorial issues. Amid continuing uncertainties about the UK’s involvement in Horizon Europe (the EU’s €95·5 billion research and innovation programme), the number of clinical trials done in the UK is decreasing due to the cost and administrative benefits of globalised patient recruitment. National Institute for Health and Care Excellence authorisation of new drugs for use in the National Health Service after MHRA approval still takes a long time despite a fast-track process (about 9 months in the best-case scenario). The lack of urgency in developing a new national cancer plan for England undermines scientific and clinical prioritisation essential for the regulatory environment to work in tune with national interests. Finally, challenges with trial design are gaining attention due to increasing disquiet around the use of surrogate endpoints that are arguably less meaningful for patients, but more helpful in clearing regulatory hurdles.1

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References

  1. Oncology, N. L. (2023). Access to cancer medicines in the UK. Lancet Oncology, 24(5), 415. https://doi.org/10.1016/s1470-2045(23)00109-2

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