Regulation matters: major report launched by Birmingham Health Partners

laboratory technician

Experts in regulatory science from Birmingham Health Partners (BHP) have called for a coherent and specific national strategy for regulatory science – including training, funding and cross-disciplinary working – in a new report launched today.

The BHP Centre for Regulatory Science and Innovation was established in 2020 to support the development and delivery of novel therapeutics and medical devices in the UK, through advanced regulatory standards and tools. Its first publication, ‘Advancing Regulatory Science and Innovation in Healthcare’, examines the UK’s ability to adapt its regulatory frameworks in healthcare in response to innovation, through the lens of both Brexit and COVID-19.

The pace of emerging medical innovations and the current pandemic make regulatory science innovation a global issue, but leaving the European Union adds a significant, specific national need for change, carrying opportunity and risk that must both be carefully managed. Regulatory science – which can be defined as applying biological, medical or sociological sciences to enhance the development and regulation of medicines and devices in order to meet appropriate standards – will be crucial to these endeavours.

Life sciences is critical to the UK’s economy, but faces unprecedented challenges in both near-term business viability and long-term sector sustainability due to regulatory uncertainty. Noting that the UK has a clear opportunity to be a global leader in regulatory science, the report argues that to achieve this, we should take a coordinated approach to foster and prioritise innovation in regulatory science and build a corresponding workforce to ensure its sustainability and continuing evolution.

Professor Melanie CalvertReport co-author and Director of the Centre for Regulatory Science and Innovation, Professor Melanie Calvert, explained: “Regulatory science is more important than ever before. With our departure from the EU, we must strike the right balance between taking control of regulatory frameworks without adding any delay or further risks to patients receiving new interventions, diagnostics and treatments, as well as avoiding adding unwarranted cost to R&D. We have a clear opportunity to capitalise on the collaborative working and regulatory flexibility demonstrated through clinical, industry, academic, public and policy responses to the COVID-19 pandemic, but must ensure patient safety is protected.”

“Developing a national strategy for UK regulatory science will allow us to be both globally competitive and internationally collaborative. Enabling ground-breaking products developed here to be efficiently deployed around the world will not be straightforward, and finding the best outcomes will rely on forward-thinking UK innovation in regulatory science.”

The report concludes that establishing a robust strategy for regulatory science will put the UK in a position of international leadership and therefore attract the most exciting ideas and key resources from global industry, as well as further accelerating the co-creation and adoption of innovation by the NHS.

Professor Calvert added: “It is also important that such a strategy embeds the support and guidance of our patients, communities and citizens through a clearer, central voice in the design, development and delivery of innovative new treatments, diagnostics and medical devices.”

Click here to download the full report as a pdf