At the start of this year, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on its proposals for legislative changes to clinical trials. The consultation marks the latest in a series of efforts to reform the UK’s life sciences regulatory landscape post-Brexit and create a “world-class sovereign regulatory environment for clinical trials.” The UK’s life sciences sector is no stranger to a changing regulatory environment. However, as digital health technologies continue to disrupt the market, and as the EU pursues its own pharmaceutical reforms, how will the UK’s changing regulatory environment shape the clinical research industry in years to come?
The EU and UK: diverging priorities in pharmaceutical reforms
The UK government certainly considers there to be significant opportunities for growth in leaving the EU’s regulatory orbit. This was outlined in the 2021 Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report, co-authored by current Minister for Science George Freeman, which argued that the EU’s Clinical Trials Directive was holding back the UK’s potential. Utilising the powers brought in by the Medicines and Medical Devices Act 2021, and with the TIGRR report in mind, the MHRA’s consultation includes proposals to streamline the route to a single UK decision for a clinical trial and allow certain low-intervention trials to proceed without prior regulatory review.
As part of a wider Pharmaceutical Strategy, the EU is also seeking to be a world leader for trials. In January 2022, the EU launched the Clinical Trials Information System (CTIS) portal, which enables sponsors to apply for clinical trial authorisation in up to 30 EEA countries with one single application, making it easier to conduct clinical trials across multiple member states. Countries such as Spain remain some of the highest-performing countries in the world in terms of clinical research and attracting R&D investment. This has been achieved through a mix of streamlined and transparent regulatory processes, alongside clear system leadership to integrate the needs of health providers and researchers.
These dynamics have interesting implications for Contract Research Organisations (CROs) conducting trials across both markets. CROs have already had to contend with numerous regulatory and legal issues as a result of Brexit. UK-based CROs can no longer conduct clinical trials in the EU on behalf of US or other non-European sponsors without a legal representative in an EU-approved country. Additionally, CROs working across the EU and UK must submit parallel pharmacovigilance reports to both regulatory systems, increasing both the workload and cost for businesses.
Growing opportunity in spite of Brexit-induced complexity
Whilst growing regulatory and legal complexities have exacerbated the burden on CROs, there is no sign that interest in the industry is wavering. This has been reflected in the plethora of M&A activity and private equity investment seen in recent years. Many CROs have responded to growing pressures by broadening their offering through acquisition of CROs with access to different markets. Global CRO Veristat’s recent acquisition of Switzerland-based company Solutions for Life Sciences (SFL) is a good demonstration of the need to strengthen regulatory capabilities across the EU, UK and Swiss healthcare markets.
Regulators and businesses are also keen to capitalise on the technological advancements which continue to transform the industry. The pandemic catalysed the implementation of hybrid and decentralised clinical trials, which generated significant opportunities for new approaches to patient recruitment and diversity. The MHRA has already published guidance on decentralised trials and started work on a new, data-enabled service to support diverse patient enrolment as part of efforts to develop a more flexible and patient-centric regulatory framework. Learnings from the pandemic have also led to new types of collaboration between industry and the research community, as seen with the launch of non-profit clinical research organisation Protas, which recently announced its strategic partnership with pharmaceutical company Sanofi.
As the UK approaches a critical inflection point on its post-Brexit regulatory journey, the key question for investors and businesses will be whether the UK's efforts to accelerate regulatory innovation will outweigh the frictions caused by Brexit. In the short- to mid-term, we are likely to see continued consolidation of the CRO market and new ways of working across the sector, bringing with it exciting opportunities for novel approaches to clinical research and design. However, the sustainability of this trajectory will be determined by the MHRA’s ability to keep pace with digital transformation, and how well this aligns with other international regulators, particularly the EU.