Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome Mr Vincent Ramirez, head of infected blood and urology services inquiries oversight, and Mr Eddie Murphy, acting head of medicines legislation unit. We have your papers. I will hand over to you for some brief opening remarks, and then we will take questions.

Mr Vincent Ramirez (Department of Health): Thank you very much. First, I thank the Committee for the opportunity to brief it today at relatively short notice on the UK Government's Health Bill and the associated implications for transferred matters. The Department is conscious of the importance of the Committee's scrutiny in the legislative consent process, and we hope that the briefing will prove informative and help members to appreciate the issues arising from the Bill. I work in the healthcare policy group, and I have been coordinating the Department's assessment work on the Bill's devolution implications. I am joined by my colleague Eddie Murphy from the pharmacy directorate, who has been advising on the Bill's provisions that relate to the Medicines and Medical Devices Act 2021 (MMDA) and Medicines and Healthcare products Regulatory Agency (MHRA) powers.

The Health Bill is a wide-ranging UK Government Bill that underpins a significant programme of reform and restructuring of the National Health Service (NHS) in England. The Bill is intended to support the UK Government's wider health reform agenda, which includes the abolition of NHS England and the transfer of its powers and functions to the Secretary of State for Health and Social Care and, in some cases, to integrated care boards. It includes reforms to health information systems that include provisions that relate to the single patient record in England and changes that relate to medicines and medical devices regulations.

The Bill was introduced at Westminster on 14 May this year and completed its passage through the House of Commons on 8 September. It received its First Reading in the House of Lords on 9 September, and the Second Reading is scheduled for 13 October, with the intent to obtain Royal Assent by the end of the year. The remaining parliamentary timetable is therefore quite compressed, which is why we welcome today's opportunity to engage with the Committee.

While the vast majority of the Bill relates to health and social care arrangements in England, a number of provisions either extend to Northern Ireland or interact with transferred health and social care matters involving Northern Ireland. It is those provisions that the Department has examined through the lens of legislative consent. Having undertaken a policy analysis and considered advice from the Departmental Solicitors' Office (DSO), the Department's current assessment is that the legislative consent process is engaged in relation to over a dozen clauses of the Bill.

The recent paper was provided to the Committee quite late, and we appreciate the opportunity to present a synopsis of the Department's position on each of those clauses. Broadly speaking, they fall into three categories. In the first category are the clauses required to ensure continuity following the abolition of NHS England, including the transfer of functions and consequential legislative changes. The second category covers provisions that relate to information-sharing arrangements, information systems and the continuation of existing mechanisms that support cooperation and service delivery across the health systems. The third category covers provisions concerning medicines and medical devices regulations. The Bill was identified as a vehicle to reform significant MHRA powers, and it proposes amendments to the existing UK-wide legislative framework established under the Medicines and Medical Devices Act 2021.

The Department's overall policy position is that the provisions are largely intended to preserve continuity, maintain legal clarity and ensure that existing arrangements can continue to operate following the abolition of NHS England. In most cases, the powers are permissive and agreement-based, rather than mandatory, meaning that Northern Ireland would continue to decide whether and how particular arrangements are entered into in practice. There are, however, some areas where the Department considers that amendments should be sought from the UK Government, particularly in clauses 2 and 61, which could include an explicit Northern Ireland consent requirement, whereas the amendments that focus on clause 63 are of a more technical nature in order to ensure that all relevant Health and Social Care (HSC) arm's-length bodies are properly captured in the Bill's definitions. The Department's view, supported by legal advice, is that clause 54 does not engage the legislative consent process because it relates to health and social care services in or in respect of England and does not in itself confer any function, duty, cost or liability on bodies in Northern Ireland. Engagement on those matters continues with the Department of Health and Social Care (DHSC) Bill team.

On the legislative consent process, as you know, the Bill was introduced in May, and a memorandum was laid before the Assembly under Standing Order 42A(4)(b) on 29 May indicating that consent was not being sought at that time. That allowed the Department to fully engage and consider the devolution analysis and its implications. Subject to the necessary Executive approvals, which are currently being sought, Minister Butler will be in a position to consider laying a legislative consent memorandum (LCM) before the Assembly to seek consent on the proposed motion around those clauses, after which the Committee will, of course, have a formal role in scrutinising the proposed consent motion and reporting to the Assembly.

Chair, that concludes my opening remarks. Eddie and I will do our best to answer your and members' questions.

The Chairperson (Mr McGuigan): You said that you are seeking a couple of amendments: are there no other concerns about the impact of the Bill on devolution and the powers that the Department has?

Mr Ramirez: Nothing has been flagged. It is the Department's understanding that the Bill as a whole is quite consequent and really extends to services in England. The main link to Health and Social Care in Northern Ireland is about the interactions and interfaces that were with NHS England previously, the powers for which are being transferred back to the Secretary of State. With the way that the Bill is written — the couple of points that we raised — the Department understands that it is preserving that autonomy for Northern Ireland Health and Social Care, as things stand.

The Chairperson (Mr McGuigan): We are not handing any devolved power that the Minister of Health currently has to the Secretary of State.

Mr Ramirez: Sorry?

The Chairperson (Mr McGuigan): Through the Bill, powers currently carried out by the Department through the Minister or the Minister through the Department are not being ceded to the Secretary of State.

Mr Ramirez: No, not that we have identified.

The Chairperson (Mr McGuigan): With cervical smears, we had evidence of tests being sent to parts of England. Is there any issue with tests such as that, given that there is information on patients and data protection considerations, that go outside here and are tested elsewhere, particularly in England?

Mr Ramirez: That is operational detail that has not really been touched on in the Bill. The Bill looks at continuity mostly from a legislative point of view. The operational aspects of that should not alter any arrangements that are currently in place other than migrating any power that NHS England will be dispatching to the Secretary of State. Our understanding is that that transition will be

clarity and continuity of those arrangements, and how they evolve will be dealt with from an operational perspective. That has not been identified through our engagement and analysis at this point.

The Chairperson (Mr McGuigan): You do not see it as a problem or an issue.

Mr Ramirez: Pardon?

The Chairperson (Mr McGuigan): You do not see any issues arising from that.

Mr Ramirez: Our main concern has been to ensure that we did not overlook any aspects that were given to the Bill, which then led us to a couple of amendments about making sure that consent was explicit and not assumed. Other than that, from an operational perspective, nothing has been raised.

The Chairperson (Mr McGuigan): There is another example of an operational issue. At times, people from here receive treatment in England: are there any issues with that?

Mr Ramirez: Again, the treatment arrangements that currently exist with that, with the extra contractual referrals or any service-level agreements with different bodies in England, Wales or Scotland, are being preserved. They would have been entered through commissioning colleagues in the strategic planning and performance group (SPPG) to identify a service provider in England. Those arrangements would not be altered by that, because either they did not interface with NHS England and were done straight with the NHS organisation that is providing the service or the powers will be migrated to the Secretary of State, who will then delegate to the appropriate body to dispatch those.

The Chairperson (Mr McGuigan): In a sense, to break it down, with regard to data or patients going over, is there no concern in the Department about oversight being ceded from here to the Secretary of State?

Mr Ramirez: Not at this stage, no.

Mr McGrath: I want to follow up on the point that you made about people who transit from here to the UK. Are there any issues with the technology and being able to access the likes of MyChart, Encompass and other systems? Will those systems be able to integrate with each other, or is that something that would follow afterwards?

Mr Ramirez: Thanks for your question. Yes, that is one of the considerations. Concerns have been raised on various occasions about the interoperability of the systems. As you said, that will be considered from an operational perspective down the line. We have My Care set up, which is where information can be found about patients who are receiving health and social care in Northern Ireland and which gives access to providers. The Health Bill contains provisions to allow the Secretary of State to establish a single patient record. The trigger for that would be people who are receiving health and social care in England or through English provision. At that point, a patient from Northern Ireland who is receiving care there may have their information and data put into their system in time. However, any concerns about integration and interoperability would have to be worked out through the arrangements that would need to be put in place when the operationalisation of such a system is begun. The Bill does not allow for that to happen on an operational basis; it allows it on a legislative basis.

Mrs Dodds: I want to ask about the issue of blood safety: can you explain that for us? The Bill states that the Secretary of State is the "commissioning authority": I presume that that is the Secretary of State for Health and Social Care in England. Can you elaborate on that so that we can understand it a little more?

Mr Eddie Murphy (Department of Health): Are you talking about clause 77?

Mrs Dodds: Yes. Well, clauses 77 and 78.

Mr Murphy: Yes, the two of them overlap. Clause 77 will change the parliamentary procedure for certain medicines and medical devices regulations from the draft affirmative to the negative procedure, as set out in the Medicines and Medical Devices Act 2021. It aims to enable greater use of the parliamentary negative procedure for certain amendments to UK-wide human medicines legislation where appropriate, so that joint parliamentary scrutiny in both Houses of Parliament and in the Northern Ireland Assembly is proportionately focused on more substantive or controversial legislative changes and reforms. At the moment, all legislation is draft affirmative, so what they are looking at is progressing minor technical amendments by way of negative resolution. That is more proportionate in terms of what the amendment is trying to achieve. The draft affirmative procedure will still be there for more substantial matters such as new policies, fee regimes or whatever, but the choice will be there to use the negative resolution procedure for technical amendments.

Mrs Dodds: Will that apply only to minor technical amendments?

Mr Murphy: It is for minor technical amendments, yes. The draft affirmative procedure will still be there.

Mrs Dodds: I just wanted to build on the point that you made.

The Chairperson (Mr McGuigan): That is a good point. Whose judgement is that based on? I could have a different judgement as to whether an amendment is technical and minor. Some technical amendments can have consequential differences. Whose judgement is applied there?

Mr Murphy: That will be the judgement of the MHRA initially. Any MHRA amendments to medicines regulations are made jointly with the Department and this Health Committee, for example, even where negative resolution procedure regulations are produced. The consultation will be done jointly, and the regulations will always come to the Health Committee, whether by draft affirmative or negative resolution.

Mr Donnelly: I find all of this quite complex. It appears to be quite legalistic. I am a bit confused: we should agree the LCM, as was mentioned, but we also need amendments that are minor and technical, which may come about through draft affirmative procedure. Why should we agree this today, when we will also need amendments?

Mr Ramirez: It is about the timelines and the process. We have been trying to get a policy position on the few clauses for which the Secretary of State and the Minister of State for Health (Secondary Care) have asked Minister Butler to engage the LCM process for the Assembly. That analysis has to happen while the Bill is being introduced. They have sought to move at pace to deliver the abolition of NHS England on 1 April, which means that Royal Assent should be sought at that point. It has been tricky to properly align where the process overlaps with the Northern Ireland Assembly statutes, which means, at the point that there is a finalised position, seeking approval from the Executive, drafting the motion and laying the memorandum accordingly.

Amendments are still being sought at Westminster. From my engagement with DHSC, I know that it is still working on amendments to some of the clauses, particularly to clause 2, with regard to express consent. It is working to put something together on its side, and we are monitoring that. At the same time, we have to engage with the Assembly and the Committee to get to an end point, which will be to have a plenary debate at which a vote will be taken on the LCM. That has to take place before Third Reading in the House of Lords. We are doing that without any such understanding or knowledge of what is happening until the passage through Westminster, if you know what I mean.

The amendments going through Westminster, particularly with regard to the MHRA powers, came at a late stage, and they had to be taken into account before we could initiate the LCM process. That is why we laid a memorandum that did not seek consent at that time: we had 10 working days following the Bill's introduction in which to lay a memorandum, without having any devolution analysis in place or any policy understanding from the DHSC perspective that was comprehensive enough for us to be able to address that. There have been a few challenges in navigating the parallel timelines to make sure that everything fell into place at the right time. It is still fluid, to a certain extent, when it comes to some of those points, so it may change. By the time Minister Butler gets Executive approval and lays the draft motion, some of those points may have changed.

Mr Donnelly: If amendments are made at Westminster, that could affect the outcome of the LCM —

Mr Ramirez: Potentially. It cannot —.

Mr Donnelly: — that would be laid by the Minister.

Mr Ramirez: Sorry. It cannot be excluded. The engagement means that most of those amendments will, at this stage, go the way that the discussions have gone. Until they are effective and tabled — until the Minister has informed us of such amendments being drafted and tabled by the UK Government — we cannot amend the draft proposed motion. It is a bit of a juggling exercise to make sure that we follow the Northern Ireland Assembly statutes while trying to allow Westminster to do its job.

Mr Donnelly: We are being asked to agree it with the understanding that amendments may be made. What will the impact be on us if they are not made?

Mr Ramirez: If, at that point, the Executive agree the current policy position as we have presented it to the Committee today, the Committee will be formally asked to scrutinise that motion. It will have 15 working days in which to do so, plus another five working days in which to report. A plenary debate in the Assembly cannot be sought until that time. There may be quite a bit of toing and froing with the Committee during that time, as amendments come in, as the Bill has its Second Reading in the Lords and when, later in the month, the Committee Stage in the House of Lords brings changes. Once we have been informed of those changes, we will inform the Committee of them as swiftly as we can. It will be a tricky couple of weeks.

The Chairperson (Mr McGuigan): To clarify, Danny, we are not being asked to agree anything today.

Vincent, I will finish on what you were saying. Outline the timeline for the LCM for us.

Mr Ramirez: Minister Butler has sought Executive approval to lay a memorandum. That will contain a draft motion that will refer to those clauses and to the policy position that we explained. The Committee will then have 15 working days to consider that motion and the contents of the memorandum, which should reflect the briefing that we have provided to the Committee today.

The Committee will report on the basis of the findings and its engagement, including any additional evidence that it needs to take from some of our colleagues in the Department and DHSC. That report will inform any potential changes that the Committee will ask for from the Minister. Minister Butler will then bring the motion to the Assembly for a plenary debate. Including the planned recess period at the end of October, the soonest that a plenary debate can be held will be a month from now. However, that has to happen before the Third Reading in the House of Lords, which is our time constraint at this point. It may take a bit of negotiation with our colleagues in DHSC to get them to schedule that Third Reading for a bit later to ensure that the LCM process can be completed.

The Chairperson (Mr McGuigan): That is 100%. Sorry, Danny, I interjected. I do not know whether you had more questions.

Mr Donnelly: You are grand, Chair, thank you.

The Chairperson (Mr McGuigan): OK. Thanks, Danny.

That has been useful. To be clear, we are not agreeing anything today, and we will be kept informed of how the process is going. I appreciate your coming before the Committee today.

Mr Ramirez: Thank you for your time. Thanks very much.

Mr Murphy: Thank you.