The Future of UK Regulation - ABHI's Weekly Update for Members
Just before Christmas, we highlighted plans for the accelerated delivery of future UK HealthTech regulatory arrangements. As Peter indicated last week, there is a need to make swift progress, and to ensure members are engaged, we will be issuing a weekly communication on developments.
Members of the Secretary of State led Life Sciences Council have established an advisory group, consisting of the heads of MHRA, Office for Life Sciences, the Department of Health and Social Care MedTech Directorate and ABHI, which will agree on aligned proposals to deliver the UKCA process effectively. This detail will be published by the end of February 2023 and will focus on three priority areas: international recognition, routes for innovation and system capacity. A delivery group, co-chaired by MHRA and ABHI, will help to inform this work by collating feedback from various channels and stakeholders. This includes our standing ABHI member groups, the wider Trade Association community, and an additional expert group, made up of regulatory professionals from industry, notified bodies and academia. A series of meetings have been scheduled which will allow for broad feedback, and will ensure that the new regulatory process is proportionate and appropriate for our industry, without compromising on safety.
The recommendations from our own regulatory survey, published in October 2022, will also feed into this work, and later today you will see a communication from Richard detailing a flagship SME landscape report. This is part of the output from the Health Technology Regulatory and Innovation Programme, a joint initiative by ABHI and CPI, funded by Innovate UK. It includes a series of evidence-backed recommendations on regulation, and SME support more broadly, and will again help inform thinking.
In the Chancellor's 2022 Autumn Statement, it was also announced that Sir Patrick Vallance would lead work to consider "how the UK can better regulate emerging technologies, enabling their rapid and safe introduction.” Just before the Christmas break, the Terms of Reference for this programme were released, and state that it will focus on growth sectors, including digital technology, life sciences and green industries. This is running concurrently to the UKCA programme we have detailed, and input into the life sciences element is being led by Professor Sir John Bell and Dr Camilla Fleetcroft. We are meeting them this Friday to begin our process of engagement with the work.
An outline of the process as described above, can be viewed in diagram form here.
We will be running a series of update webinars for members over the next two months to keep you further appraised of developments, and on Thursday 19th January 2023, we will kick of this series. You can register for this here.
As ever, if you have any questions, please do write to us at phil.brown@abhi.org.uk / steven.lee@abhi.org.uk.