Restoring regulatory excellence “central” to UK life science competitiveness

A new report, ‘Enhancing the role of UK medicine regulation’ by the Association of the British Pharmaceutical Industry (ABPI) explores the key role that regulatory excellence has in driving innovation and early treatment access for patients, as well bringing investment into the UK.

It provides key recommendations aimed at rebuilding the UK’s world-class reputation in regulatory science, medicines’ development and licensing, driving economic growth, ensuring earlier patient access to innovative treatments, while also driving inward investment into the UK life sciences ecosystem, according to ABPI.

Summary of ABPI’s recommendations

• Enhancing communications, transparency, and accountability
• Improving resourcing and expertise to support its regulatory functions
• Strengthening the regulatory framework with flexible licensing routes, expedited clinical trial approvals and horizon scanning capabilities.

Events in recent years, such as becoming a sovereign regulator post-Brexit, COVID-19 pandemic and its organisational restructure, “have tested [the Medicines and Healthcare products Regulatory Agency (MHRA’s)] resilience and capabilities,” Richard Torbett, ABPI’s Chief Executive commented.

The ABPI’s report highlighted that challenges such as these have impacted performance, particularly “from a UK competitiveness perspective”.

Future of UK medicine regulation

However, Torbett explained that the report “sets out a clear roadmap for the MHRA’s incoming leadership to ensure the UK can operate as a leading authority that supports the development of new medicines and can safely and swiftly bring new innovations and treatments to patients. The recommendations in our report will allow the MHRA to emerge stronger and more capable of delivering on the government’s vision for a thriving life sciences sector.”

As such, ABPI’s report noted that for the MHRA to “compete with the world’s leading medicines regulators, capacity issues should continue to be addressed with a clearer narrative and focus on regulatory science and delivering statutory functions”.