Item 12 on our agenda is the legislative consent motion on the Medicines and Medical Devices Bill, and I call on the Minister for Health and Social Services to move that motion—Vaughan Gething. 

Motion NDM7542 Vaughan Gething

To propose that the Senedd, in accordance with Standing Order 29.6 agrees that provisions in the Medicines and Medical Devices Bill, in so far as they fall within the legislative competence of the Senedd, should be considered by the UK Parliament.

Motion moved.

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.

Thank you. Can I now call on the Chair of the Health, Social Care and Sport Committee, Dai Lloyd?

Thank you very much, Deputy Presiding Officer. The LCM on the Medicines and Medical Devices Bill was referred to the health committee in July of last year. The committee ran an open call for written evidence and we heard back from BMA Cymru, the Welsh NHS Confederation and the Royal College of Nursing Wales. We also wrote to the Minister for Health and Social Services for further information on a number of outstanding concerns identified in the memorandum itself, and we held a scrutiny session with the Minister on 30 September.

At the time of producing our report, the Minister had been able to secure an agreement from the UK ministerial lead on the Bill to table an amendment that would require consultation with Welsh Ministers and other devolved administrations when making regulations for the introduction of a medical device information system. However, the Minister said that he was seeking more than this. His officials were working on a set of broad principles that would shape the regulations in a way that would be acceptable to the devolved administrations collectively. If everyone could agree on these principles and if they were reflected in the regulations, the Minister said that it would largely address his concerns, as he has repeated again today.

When we published our report, discussions on these principles were at an early stage, with much of the detail still to be resolved. As we did not have all the information needed to come to a view on the merits of the LCM, we did not make a recommendation to the Senedd about whether we should support the LCM or otherwise. Since that report, the Welsh Government has laid the supplementary LCM before us today. In addition, last week, the Minister wrote to me to provide an update on his discussions with the UK Government and to share a draft memorandum of understanding that includes a number of assurances relating to the operation and governance of the medical device information system. In the time available, the committee has not been able to consider formally either the supplementary LCM or the Minister’s letter. Therefore, we have not updated our earlier report and we are not able to offer any further view, other than to note the position of the Welsh Government, as set out in the supplementary LCM, that it supports the policy underpinning the Bill, and the position of the Minister, which is set out in his letter to me, that the draft memorandum of understanding represents a positive compromise approach that provides him with sufficient assurance to enable him to recommend that the Senedd approves the supplementary LCM, although the governance arrangements for medical advice systems do not go as far as he would wish in terms of joint ministerial governance. Thank you very much.

Thank you. Can I now call the Chair of the Legislation, Justice and Constitution Committee, Mick Antoniw?

Diolch, again, Dirprwy Llywydd. Our report on the original legislative consent memorandum for the Bill was laid in the Senedd October last year, and we laid our report on the supplementary LCM for the Bill just before the Christmas recess. Our first report noted the Welsh Government's assessment that clause 16, which, as has been mentioned, is now clause 18 of the Bill, requires consent, and Welsh Government's reasons as to why, in its view, making provision for Wales in the Bill is appropriate. Members may be aware that the power contained in clause 18 is broad. The Minister has confirmed that. It could be used to make regulations about information systems for the purpose of safety of patients, or the purpose of improving patient outcomes, both of which are devolved matters. Members are also aware that both the Welsh and UK Governments are in agreement that legislative consent should be sought for this cause, and our first report acknowledged the Welsh Government's outstanding concerns in respect of a number of areas of the Bill and, in particular, with regard to certain aspects of what is now clause 18. As such, a supplementary legislative consent memorandum was anticipated. 

In our second report, on the supplementary LCM, we acknowledged that an amendment was made to clause 41, now clause 43, of the Bill, replacing the former general power to consult with a specific requirement that the devolved administrations are to be consulted before any regulations are made in the UK by Ministers under what is, again, clause 18.

In addition, our second report welcomed the fact that the views we set out in our first report are acknowledged in the supplementary LCM whilst also noting that discussions between the Welsh and UK Governments were ongoing. Now, on this latter point, we welcome the recent letter—the Minister referred to it—that we received from him, which includes an update on those particular discussions. However, I do wish to draw attention to the fact, once again, that the Welsh Government has accepted the development of a memorandum of understanding as a means of resolving a dispute with the UK Government. Furthermore, in his letter to us, the Minister said that the agreed arrangements have not gone as far as he would've wished but that he considers the MOU—that's the memorandum of understanding—to be a positive compromise. Nonetheless, I believe that we should welcome the fact that the MOU has been made publicly available in advance of the Senedd's consideration of this consent motion. This is important and has often in the past not been the case. Diolch, Dirprwy Lywydd.

Thank you. Rhun ap Iorwerth.

I have no further comments to make. Apologies. I've nothing to add to the comments made by the Chair of the health committee, of which I am a member. Thank you, Deputy Presiding Officer.

Thank you very much. I have no people who want to intervene, so, therefore, I call on the Minister for Health and Social Services to reply to the debate—Vaughan Gething.

I thank Members for their comments, which I think fairly reflect the correspondence and the course of discussions that have taken place on this matter. As ever, we're left with a practical consideration. If we could have our ideal format, then we'd have a different arrangement in front of the Senedd, but we have to balance what I think are the clear benefits to the public and to patients from having an improved medical device information system right across the UK that we participate in as fully as possible. And I believe that we should move forward on the basis that we now have.

It is, of course, possible that we may be able to do more, but as I've indicated in my correspondence, Northern Ireland and Scotland already gave consent before the memorandum of understanding was developed—that came directly from the conversations that I had with the UK Government. So, there has been progress. We are further forward along the road of effection than we were several months ago, and I believe that it is appropriate for the Senedd to give its consent and for us to not just engage in Government-to-Government engagement, but, as I've indicated in correspondence to the Health, Social Care and Sport Committee, this would allow reporting on a regular basis to the Parliament as well about the function of the new system, and I think that oversight from the parliamentary scrutiny side is just as important here as it is in any other Parliament within the United Kingdom. I ask Members to support the motion before us.

Thank you very much. The proposal is to agree the motion. Does any Member object? I see no objections, therefore, the motion is agreed in accordance with Standing Order 12.36.

Motion agreed in accordance with Standing Order 12.36.

In accordance with Standing Order 12.18, I will suspend the meeting before we proceed to voting time. So, the meeting stands suspended.

Plenary was suspended at 18:13.

The Senedd reconvened at 18:20, with Llywydd in the Chair.