Part of the debate – in the Senedd at 6:01 pm on 12 January 2021.
Thank you, Deputy Presiding Officer. I'm pleased to move the motion on the Medicines and Medical Devices Bill and to explain why I believe the Senedd should approve it. The Bill's purpose is to bring medicines, veterinary medicines and medical devices that were formerly subject to European Union regulation under UK law following Brexit. It is enabling legislation that will then be implemented in detail through regulations.
The focus of our debate today relates to clause 18 of the Bill, which enables the setting up of one or more medical device information systems operated by NHS Digital to collect data from each of the UK's nations. Also, clause 43, which is an amendment that I sought by way of assurance to strengthen the general powers to consult with devolved Governments, particularly on the medical devices system, before any regulations are made irrespective of whether the proposed regulations are seen as relating primarily to specific device safety matters or supporting the wider healthcare system.
Although medical device safety and regulation is reserved, patient safety information systems and health data are devolved responsibilities that fall within the legislative competence of the Welsh Parliament. The medical device information system is a response to a Cumberlege report recommendation and would allow for the prompt investigation, patient identification, follow-up and recall of devices, and changes in the clinical techniques employed. It would also allow patients and clinicians to identify the risks associated with specific devices, enable them to select the best treatments and to give their informed consent before undertaking clinical treatments.
The advantages for Wales of collaborating and working alongside the other UK nations, rather than doing it alone, will be the larger number of patients, devices and procedures involved to enable the earlier discovery of problems and enhancing the potential for learning. There are clear benefits to and for patients from acting and collaborating across the four UK nations. It also, of course, reflects the reality that patients don't always stay within one part of the United Kingdom.
A UK-wide approach is also, in practical terms, likely to be cheaper and quicker to implement, rather than developing a separate arrangement for Wales with our devolved powers and then having different relationships with those reserved matters. Scotland and Northern Ireland have already signed up to the information system and have given legislative consent to the Bill's proposal.
Finally, I'd like to thank the Health, Social Care and Sport Committee and the Legislation, Justice and Constitution Committee for their scrutiny of the legislative consent memorandum and the supplementary memorandum. The committees requested further information on the assurances given by the UK Government, and I sent details of those to the committees and Senedd Members last week. They were contained within Lord Bethell's letter to me on 14 December last year following my meeting with him a few days previously. Lord Bethell's letter and commitment to further joint work, the clause 43 amendment and others, go a long way to meeting my earlier concerns about the information system. I move the motion and ask Members to support it.