Regulatory renewal needed for UK life sciences ambitions

As the Medicines and Healthcare products Regulatory Agency (MHRA) enters a new era under new leadership, rebuilding UK excellence in medicines regulation will be central in securing UK life science competitiveness.

Excellence in medicines regulation is a pre-condition for any country seeking to be a global leader in life science research and development.

Reaffirming the MHRA’s status as a world-class regulator will be a key objective for its incoming new Chair, Professor Anthony Harnden, and its new Chief Executive, when appointed. [2]

In a new report ‘Enhancing the role of UK medicine regulation’ [1] the Association of the British Pharmaceutical Industry (ABPI) explores the crucial role of regulatory excellence in driving innovation and early access, supporting patient trust, and attracting investment into the UK.

Drawing on evidence from the life sciences community, the report sets out key recommendations in the following areas to rebuild the UK’s world-class reputation in regulatory science, medicines’ development and licensing:

• 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.

These recommendations are designed to support the government’s ambitions for economic growth, ensuring earlier patient access to innovative treatments, while also driving inward investment into the UK life sciences ecosystem.

Over recent years the MHRA has faced an unprecedented set of challenges, including becoming a sovereign regulator post-Brexit, navigating the COVID-19 pandemic, and undergoing significant organisational restructuring.

While some of these developments have pushed the agency to perform at its best, as seen during the pandemic, others have impacted its performance and undermined its global reputation as a leader in cutting edge regulatory science.

Richard Torbett, Chief Executive of the ABPI said: “The MHRA has long been regarded as a well-respected, global leader in medicines regulation, underpinned by solid expertise and innovative approaches. However, events in recent years have tested its resilience and capabilities.

“Our industry wants to support the MHRA to regain its world-class reputation. This 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.”