Medicines and Medical Devices Bill — House of Lords, 2021-01-14
Topic: Health
Andrew Lansley (Conservative, Centre-right): My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a very welcome move on the Government’s part. The analogy with the Commission on Human Medicines is helpful. As regards translating the Devices Expert Advisory Committee into a statutory role, in effect, in the process, as the noble Lord, Lord Hunt, suggested, there is considerable scope to think about how the Government’s new and expanded roles in the regulation of medical devices can be supported by the advisory committee I have a number of points. The first reflects the point made by the noble Lord, Lord Hunt, which is that the MHRA has an enviable reputation as a regulatory authority for the approval of medical devices. If I recall correctly, among the European regulatory bodies something like 40% of the most important or significant medical devices were authorised by the MHRA. Other regulatory authorities in other countries will seek to supplant that. However, our reputation should enable us to establish an international position, and I hope that the advisory committee will not be confined to expertise from within the United Kingdom. There is a lot to be said for positioning the MHRA as a body providing internationally recognised authorisations for medical devices, and its scientific evaluation in that respect should be something that others look to. I therefore hope that that will assist if we have some international participation in the advisory committee structure Secondly, I recall, not least in the context of the vexed experience of the PIP breast implant issues back in 2010-11, that the role of notified bodies is very important. Hitherto they have, in essence, been regulated by the European Commission, not by the UK Government, but they fall to be UK-regulated in future. There are not many of them, but there is considerable benefit in there being an advisory committee sub-committee which is focused on the work of the notified bodies. That was the weak link that probably led to the PIP breast implant problems. The regulation is all very well but we have to have bodies that we are confident are able to deliver on these things. The few notified bodies we have in this country are highly respected but we want to make sure that that is maintained even as further notified bodies are authorised Thirdly, I recognise that the Devices Expert Advisory Committee has leading clinicians from Scotland and Wales in its membership. However, this must be a UK advisory function, as the MHRA is. I wonder whether it would be appropriate for there to be in addition a Northern Ireland representative on the committee and for there to be perhaps some specific mechanisms to ensure that Scotland, Wales and Northern Ireland are represented in the regulations that establish the advisory committee I have one further point, which is that I hope that the various categories of medical devices are very carefully examined and the relevant expertise is available in relation to those. So, for example, on digital devices it is important that we have not only the clinical expertise to deal with the safety of medical devices we have at the moment but the technical expertise in the advisory committee to understand how digital devices will work in the future. That must also be the case in the special interests section related to in vitro diagnostic devices. I hope that that also will have its own special advisory committee function.