ABHI Regulatory Conference 2021 - Reflections from the Chair
On Monday 22nd November 2021, I was delighted, once again, to chair the annual ABHI Regulatory Conference.
It will, hopefully, be the last held virtually, but virtual or not, the event attracted its usual high quality of presentations and speakers. With the MHRA still accepting responses against the consultation, this year’s themes were more strategic than operational, discussing what we should be doing in the next 5-10 years to ensure the success of our newfound sovereignty, post-Brexit.
Success cannot happen for our industry however, if we do not have the confidence of our main customers, the patients themselves. Baroness Cumberlege, as our keynote speaker this year, delivered a speech which added focus and context in this respect. As Chair of the panel that delivered the ‘First Do No Harm’ report, the recommendations from which will influence our regulations and operations for years to come, gave a powerful message that ran a thread through all the day’s presentations delivered by regulators, conformity assessment bodies and industry alike.
The industry need for a future UK regulatory process that ensures safe and effective for ? innovative and existing HealthTech, was expertly outlined by Sharon Lamb (Partner at law firm McDermott, Will & Emery), James Shearn (Head of Regulatory Affairs at Oncimmune), Steve Lee (Director of IVD Regulation at ABHI) and Phil Kennedy (Managing Director at Eschmann Technologies). These presentations not only contextualised the UK as a market for health technologies, they also described the key areas of regulation that can be enhanced to further the patient experience and ensure that innovation does not leave the UK behind. These messages were also captured by MedTech Insight’s Ashley Yeo, in his write-up of the event (requires subscription).
As Sharon adds: “A safe, clear and responsive regulatory framework lies at the heart of making the UK a globally preferred place for medical device innovation and investment.”
It is easy however, to think of the UK in isolation now that we have left the European Union. Importantly, there are many manufacturers with international operations and ambitions, so whilst discussions focused on the UK market, Diana Johnson (Vice-President of Regulatory Affairs at Medtech Canada) and Oliver Bisazza (DG of Industrial Policy at MedTech Europe) provided an international flavour. Diana described the positive consequences of Health Canada’s decision to mandate the Medical Device Sigle Audit Program (MDSAP) as route to the Canadian market, and the potential overlaps with similar ongoing discussion in the UK. Oliver then updated the audience on CE marking and central activities within the European Commission, all of which will ultimately influence to a greater or lesser extent, the UK regulation.
ABHI has always been extremely fortunate in having speakers from the regulators and conformity assessment bodies and this year was no exception. Gary Slack (Senior VP of Global Medical Devices at BSI) described the issues facing conformity assessment bodies (CABs), not only in the UK but also in Europe. Constantly beleaguered, CABs and notified bodies face their own challenges particularly around capacity and increasing competent authority expectations and requirements. By providing the view from the CAB, Gary provided a vision that demonstrated that future regulation has many stakeholders, and that many challenges are shared challenges.
The MHRA are also going through a post-Brexit period of transition. Whilst regulations change, so are the regulators themselves, as described in recent business plans aimed at ensuring their future post-Brexit viability. It was a particular pleasure to welcome Dr Alison Cave (Chief Safety Officer), Camilla Fleetcroft (Interim Group Manager for Devices) and Jeanette Kusel (Director for Scientific Advice at NICE) to discuss many of these changes, again picking up on the keynote themes of patient safety. Alison described the new processes for vigilance and databasing, whilst Camilla and Jeanette focused on new ‘Innovative Device Access Pathway (IDAP)’, being developed to encourage innovation of new devices, whilst simultaneously ensuring patient access.
New regulations will ensure that safe and effective products will reach the UK patient in a timely fashion. But the UK will only prosper in the post-Brexit environment if that regulation allows for onward and inward trade and investment. Jessica Kirby from the Office for Life Science, the department that links the MHRA with the Business departments of government, was on-hand to explain this important role. The Office for Life Science has a pivotal role in taking the industry, regulator and CAB messages to business leaders – to make the UK that attractive place to conduct health technology research, manufacturing and marketing, thereby ensuring our HealthTech futures.
No doubt, next year’s conference will be more operationally focused, as the route to CA marking will be much clearer and many of the guidance and rules to make it a success, will be developing. In the meantime, however, the messages delivered throughout the 2021 conference provided a constant theme and reminder of our obligations to patient safety and innovation, both in terms of products and regulation.
As the conference was recorded, attendees have the opportunity to listen to these key messages again, and for those unable to join us, a recording can be purchased here.
