The Future of UK Regulation - ABHI's Weekly Update for Members
Following our update last week, we will continue our series of deep dive sessions with stakeholders to look at the critical topics of regulatory system capacity, with practical elements such as labelling. We have also inputted into the Treasury led review, aiming to ensure future regulatory issues such as data governance and the rationale for conformity assessment bodies are understood.
Through sustained engagement across the breadth of our stakeholder network, we are working to build a set of key messages from industry that can be progressed through these regulatory workstreams. From our extensive engagement with members and other stakeholders, these should, we believe, align with your own priorities, and are further supported by reports we have written, and contributed to, in recent years. Details can be found below, and we will refine these messages as things develop.
We have also had a high-level meeting between the MHRA executive committee, including their Chair, Stephen Lightfoot, and CEO, Dame Dr. June Raine, during which we discussed MHRA future plans for enhancing public trust, achieving timely patient access, providing global leadership, ensuring that the MHRA is a great place to work and developing operation excellence. We expect more details will be made public by the MHRA in the coming weeks.
This week has also seen the MHRA fees consultation response published. We will provide you with a more detailed analysis very soon.
Key Messages
Recognition - Continue the current standstill period for recognition of the European CE mark indefinitely and urgently deliver workable domestic assurance routes with trusted jurisdictions such as the US, Canada, Australia and others.
Routes for HealthTech Innovation - Ensure appropriate focus and support for the development of innovative technologies by delivering ambitious innovation routes and supporting clinical investigations and performance studies. This should include an ambitious IDAP process, use of sandboxing and early communication with innovative products. This should avoid complicating an already crowded policy space and support should be developed to help companies navigate what is available.
Roadmap - Providing a comprehensive UK roadmap of activities and milestones to develop UK regulatory infrastructure that will provide the much needed regulatory reassurance to HealthTech businesses wishing to operate in the UK.
Reduce Duplication and Undue Burden - Ensure all regulation of HealthTech is delivered through the UKCA system, managed by MHRA to reduce duplication and undue burden through schemes such as CTDA.