Access to cancer medicines in the UK

Abstract

On Jan 31, 2020, the UK formally ended it's 47-year membership of the EU. As a part of this, the Medicines and Healthcare products Regulatory Agency (MHRA) withdrew from the European Medicines Agency (EMA). Over the past 3 years, and as the UK's standalone regulator, the MHRA has implemented many changes, but announcements on Jan 24 and March 21, 2023, herald the largest shake-up of trial regulation in 20 years. With the MHRA solely at the helm of marketing authorisation of new medicines, how has Brexit affected access to the latest cancer treatments for patients in the UK? 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. The latest adaptations to the MHRA's processes follow three other improvements that were introduced immediately after the UK's exit from the EU, which have increased the number of new medicines licensed in the UK: the Innovative Licensing and Access Pathway to accelerate time to market (which has proved very popular, with 164 applications), Project Orbis—a global collaborative regulatory review programme led by the US Food and Drug Administration (FDA) with the goal of accelerating approvals of innovative cancer medicines among international partners, and membership of the ACCESS Consortium, in which various regulatory authorities work together to achieve better collaboration and alignment. In a discussion with Mark Lythgoe as part of The Lancet Oncology's recent podcast, we learned that Project Orbis alone facilitated MHRA approval of 11 novel cancer drugs in 2022; comparing favourably with the 12 drugs approved by the EMA and FDA in the same timeframe. In the absence of a national cancer plan, only time will tell if there will be a divergence between treatments approved on the basis of industry priorities versus national priorities. Brexit has brought many challenges and uncertainties, which have been complicated by political turmoil, high interest rates and an energy crisis, the COVID-19 pandemic, and the war in Ukraine. Nevertheless, the MHRA has shown good leadership in making the most of the new realities; seizing opportunities that were previously unavailable while negotiating solutions to mirror important aspects of EMA membership. Together, these actions appear to be alleviating some of the consequences of Brexit while preserving access to the latest cancer treatments in the UK.