UKCA Health inequalities – can the regulations do more?
Health inequalities is one of the five pillars the MHRA are building their future framework on. This has a particular focus on reducing bias in the development of medical devices.
How will the consultation response support the Governments goal to remove bias from the medical product lifecycle?
Committing to addressing bias and diversity through regulations and guidance
The key references are to research of medical devices and IVDs – setting out that the participants in research should be representative. This received significant support during the consultation.
The government commits to addressing bias and diversity in regulations and supplementary guidance on medical devices. They committed to working with the Health Research Authority and the Devolved Administrations to develop this guidance.
Supporting the Independent review on Equity in medical devices.
MHRA will continue to support the upcoming independent review being led by Professor Dame Margaret Whitehead. The review has been commissioned to look at the extent and impact of potential ethnic and other unfair biases in the design and use of medical devices. This welcome review will deliver next year in 2023.
The review will also address the regulatory framework and will consider the proposed changes within the MHRA’s consultation response. They will form a view on whether further changes and actions are required.
Just one part of the solution…
What MHRA seem to be proposing is a regulatory steer that, rightly requires ALL intended populations are represented in the data supporting the product. This seems a pragmatic approach, balancing regulation with guidance.
Over regulation could in fact cause inequalities in another way. If regulation enforces highly specific rules, it may be deemed too difficult to achieve, we see this now with the implementation of EU MDR & IVDR requirements, products could have their intended use reduced, or be removed from market. This in turn removes supply and choice for patients and the healthcare system.
The regulations certainly need to do more but regulations alone cannot fix this.
What is needed is a system wide approach, and it is clear MHRA intended to develop this further in partnership with the Health Research Authority and the Devolved Administrations.
This is a positive direction, but it needs to go beyond that still to not only improve product development, but to address wider factors including:
• ensuring greater trust in the system,
• better engagement in research,
• better reporting and
• continuing transparency across the health care system.
This will require partnership with patients, the public and the wider healthcare system.
There should not be ukca health inequalities, the system should recognise and treat all as equals, we are disappointingly far from this reality.
What next?
The system needs to demonstrate continued commitment to addressing this critical issue. The publication of the independent review in 2023 will be another important juncture – one that needs to be considered and acted on MHRA need to fulfil their commitments in the response – the patient and public voice needs to be heard and listened to.
The healthcare system is here for all, there should not be bias or inequalities. This is a important opportunity for long overdue change – partners need to work beyond regulation to ensure that healthcare system offers safe and appropriate medical devices to all.
We hope this post was of interest, we are certainly facing a time of great change in the UK. If you would like to hear more, please do get in touch: Camilla.fleetcroft@eclevar.com
Please keep an eye out for more posts on the UKCA mark.
