The UK’s Chief Scientific Adviser, Sir Patrick Vallance, has written to the Chancellor with interim recommendations as part of his review on pro-innovation regulation for the life sciences. The report is expected to be published by early May, and is gathering input from ‘industry champions’ across several fields.
In his letter, Sir Patrick acknowledged the MHRA as a global leader in life sciences regulation but urges the UK to be even more ambitious and to deliver a more progressive UK regulatory offer to unlock innovation in diagnostics, drugs and medical technologies.
Sir Patrick emphasised that a major focus for UK regulators should be to enable the best innovations to be delivered safely and rapidly to patients through the creation of innovation pathways for MedTech, diagnostics and drugs. He stated that regulators therefore need to concentrate on domains where truly novel and transformative therapies are emerging, interacting with innovators from a very early stage to define a route to approval, and ensure that regulators play an enabling role throughout the journey to approval.
In order to achieve this aim, however, regulators require sufficient funding, capacity and capability to deliver on this ambitious project.
NICE and the MHRA could make specific changes immediately to help free up resources to focus on the most innovative products, Sir Patrick claimed. MHRA and NICE should adopt a broader approach to the mutual recognition of products already approved by trusted international partner organisations, particularly for well-established technologies, paired with a rigorous surveillance process. This recommendation was implemented by the Chancellor in this week’s Budget.
Moreover, Sir Patrick declared that for MedTech and In-Vitro Diagnostics, a new risk-based recognition route to market should be introduced soon to ensure continued supply of safe devices. This approach would operate in parallel to the domestic route, allowing for the MHRA and approved bodies to focus on supporting innovation elsewhere in the market, as well as clinical trials & investigations and post market monitoring.
He went on to state that the MHRA and the Approved bodies should establish new ways of working in partnership, given their roles as joint ‘gate keepers’ of access to the UK market. However, recognition should not be seen as a simple shortcut or a ‘quick fix’, but should instead be a robust and sustainable process that allows the MHRA to monitor effects in clinical practice and take proactive action as necessary.
Lastly, funding will be required for regulators to allow them to work in this way and attract the appropriate skills.
We await clarity on further recommendations in Sir Patrick’s final report, however he did highlight better data-sharing between regulators and the improved use of AI to support human health outcomes as areas likely to be featured in those future recommendations.