Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome Ryan Wilson, director of secondary care in the Department of Health, and Brenda McGilligan, head of EU future relations branch in the Department of Health, who are, by this stage, regular guests of the Committee. I hand over to you.

Mr Ryan Wilson (Department of Health): Thank you, Chair, and good morning, members. Thank you for the opportunity to return to provide the Committee with further detail on the UK Government's explanatory memorandum (EM) on regulation (EU) 2024/1938 on substances of human origin (SoHO).

The Department of Health received the explanatory memorandum last week, as did the Committee, and we have had a chance to review it. We welcome the clarity that the explanatory memorandum contains about the UK Government's position on SoHO, particularly the view that the regulation is unlikely to prevent the movement of SoHO from Great Britain to Northern Ireland. That view stems mainly from the fact that there are existing high standards applied across the UK and from the contributory role that the UK Government have played in developing the new European-wide standards that underpin the EU regulation in this area. The UK Government have also committed in the EM to ensuring the smooth flow of SoHO between GB and Northern Ireland and, if needed, will take action to support GB to NI movement.

It remains our position that the SoHO regulation is positive, as it aims to raise the minimum safety and quality standards of SoHO materials intended for human application, supports the continuity of supply and extends protection for patients and donors.

It has been over 20 years since the blood tissue and cells legislation was revised, and there have been significant scientific, technical and medical advances in transfusion and transplantation since that time. That trend is set to continue.

As outlined at last week's Committee meeting, the crux of the detail and any impact in Northern Ireland will not be known until the technical detail has been progressed by the European Commission through the SoHO coordination board and guidance has been shared. It is our understanding that that board is expected to be set up by the end of 2024. The detailed programme of work will commence shortly after that to ensure that the technical details are advanced and clarity is provided to all stakeholders. Whilst the UK Government will be a third country, it remains a member of the European Directorate for the Quality of Medicines and HealthCare (EDQM). That group will develop the technical guidelines and will be consulted on guidance produced by other bodies, including the European Centre for Disease Prevention and Control (ECDC).

From the evidence that we have provided to the Committee through the completed template prior to last week and in our oral evidence session last week, it is evident that Northern Ireland is self-sufficient in a number of SoHO materials. The reliance on importing materials from Great Britain is relatively minimal in overall numbers, although it is significant for the patients who depend on the specialist treatments that those materials facilitate. That is further supported by the analysis in the explanatory memorandum, and I refer members to paragraphs 79 to 87 for more detail on that.

Our Department welcomes the UK Government's position, which is to continue to engage with the European Commission on any updates to the standards and requirements and keep them under close review. As referenced last week, there are common frameworks in place across the four regions of the UK for organs and non-reproductive tissues and cells, blood safety and quality and food and feed safety and hygiene. Those are provisional common frameworks, although they have been successfully operating since March 2020. The frameworks have been jointly developed by the UK and devolved Governments. The Executive Office is leading on work across the Northern Ireland Civil Service to agree the final products for all common frameworks at Executive level.

The common frameworks programme continues to progress towards completion, and the UK Government aim to fully implement the vast majority of common frameworks soon.

The provisional common frameworks, as they stand, are working effectively and there are no concerns regarding final adoption. They will continue to be used to discuss potential regulatory divergence issues in relation to human breast milk, blood, blood components and non-reproductive tissues and cells. Should there be divergence in the future between regions of the UK, the common frameworks will form the basis of a mechanism by which to ensure consideration by the four UK Governments. That will facilitate consideration of any changes and enable open discussion and the exchange of information, allowing each of the Governments to determine any impacts and the subsequent actions arising. It is important to note that there is a dispute resolution process and intergovernmental mechanisms to escalate issues, should they occur.

The provisional common frameworks reflect the specific circumstances that arise as a result of the Windsor framework, reiterating the commitment to a UK-wide approach to decision-making, continuity of supply and dispute resolution. As further details of the EU's approach to implementation become known and should there be any potential impacts for Northern Ireland, there are existing EU-UK structures in place through which issues can be escalated and discussed. The Joint Consultative Working Group is the formal mechanism for that. Northern Ireland will continue to have access to information through the EU-UK structures that were set up as a result of the Windsor framework.

Whilst there are no common frameworks in place for some areas, including reproductive tissues, intestinal microbiota and blood preparations that are not used for transfusion, there is close collaboration and working between the UK and all the devolved regions. That is supported by the UK-wide regulators at national and local level. Should the circumstance arise where Northern Ireland needs urgently to import a substance from Great Britain and there is regulatory divergence, the SoHO-competent authorities can, in that case, grant a derogation from the requirement for an importing SoHO establishment authorisation. For example, in an event where there is an emergency need for a blood product to be brought to Northern Ireland and there is regulatory divergence, the Medicines and Healthcare products Regulatory Agency, as the competent authority, would, in that case, have the authority to issue a healthcare exemption to allow the substance to move. That is in the unexpected circumstance where there is divergence.

Finally, we have received assurance from the Department of Health and Social Care (DHSC) in England that, should Great Britain adopt more stringent measures relating to any substance of human origin, Northern Ireland can apply those higher standards.

We will now take any questions that members may have.

The Chairperson (Mr McGuigan): OK. I will just alert the four members who are online that they must raise their hand or indicate if they want to ask a question.

Ryan, thank you very much. You and Brenda have been before us at least twice to talk about this. We have heard the evidence, and your contribution is very useful in setting out, in layperson's language, exactly what is going on with this legislation.

Since you have now had a further week to look at the detail of the EM, can I summarise what you are saying as follows: the legislation needs to be updated and is being updated; on the whole, it will be positive for the North; there are no negative impacts that you can see, but the technical detail has not been worked out yet and will not be worked out within the duration of our inquiry; and there are mechanisms to sort out any issues that may arise from that? Is that a simple summation of your evidence?

Mr Wilson: You have summed it up concisely. That is our position and understanding. At this point, I suppose that our concern would have been in the event of some divergence arising. Through our engagement with the Department of Health and Social Care, which is leading on this for the UK Government, we have received assurances, both through the template that has been provided and now the updated explanatory memorandum, that there is an intention to ensure.

That is underpinned by the fact that the UK expert bodies have been involved in the development of the new standards that have supported the regulation, and there is further assurance in the fact that there are mechanisms in place that are working well to ensure that any issues that arise have a route through which they can be discussed and resolved.

The Chairperson (Mr McGuigan): Grand job. Thank you.

Ms Bunting: I have some concerns about this, because there are substantial unknowns, even around cost. There is no common framework on some issues even in the UK. Whilst I understand that the Department is taking some comfort from the fact that the Government have said that they will move to cover any difficulties, it is not clear how that will be done beyond using what is already in place. I am not clear how they would do that or how quickly they would move to do it. I know that you have taken some comfort from the fact that they have said that, should emergency products be required, there would be derogations and so on, but we do not have a time frame, so if, for example, somebody needed blood urgently, how quickly could all that be resolved?

My fear — I ask for the Department's views on this — is that, by the time all this is agreed and the finer detail is worked out, we will be past the post of being able to do anything, we will be past the point of our inquiry and we will likely be past the point of using brakes. In practice, how will it work out for supply chains, hospitals and patients? Will there be any additional burden on people? Do we know how it will work in practice in terms of the finer detail and the substantial number of unknowns, including cost?

Mr Wilson: Thank you for the questions. I will start, and Brenda can come in if there is anything to add. There are a number of things that we just cannot know the detail of at this stage, unfortunately. Our position of feeling relatively assured at this stage comes from the fact that there are processes and mechanisms in place, particularly with regard to any cost that might arise for a Northern Ireland body or a competent authority operating here, and there is a process to apply through Treasury for any additional funding that would be required to implement it.

In our evidence last week, we set out some of the detail of the programme of work that now needs to commence, and that will be led by the SoHO coordination board. The detail will come from that. As we get into the period when that will start, the UK Government are saying clearly in the explanatory memorandum that they will go into it with the position of intending to ensure that there is alignment and no disruption, particularly with regard to GB-NI movement. Unfortunately, I do not think that we can provide more detail at this stage, but I return to the fact that the coordination board will be the key to figuring out that detail.

Brenda, is there anything that we could add?

Ms Brenda McGilligan (Department of Health): That is very much it. We are very much depending on the SoHO coordination board getting set up and the technical detail that will then come from it. We put the question about finance to DHSC this week, and it referenced the funding settlement agreement that is in place between Treasury and DOF. That would allow the competent authorities in Northern Ireland to bid for moneys, should they have pressures and additional workloads.

Ms Bunting: Honestly, I do not take much comfort from that. It is all fair enough for the Government to say that they will take steps to do what is necessary, but we have seen thus far that, while any Government can say what they like, it is about what the EU allows them to do in their own country. That is the problem with all this. I am not sure whether I take much comfort from that at this point. There are far too many unknowns in this. We are entirely dependent on what the board might say and when it might report. Do we have any time frames for when it might report?

Ms McGilligan: We have been advised that the coordination board will be set up by the end of the year. From 2025 onwards, it will look at progressing the technical details and sharing that out.

Ms Bunting: Have the Government given any indication of whether they will set up a common framework in the UK and what the time frames might be for the things that have not been included thus far?

Ms McGilligan: We put that question to them. They came back to say that common frameworks are in place for a couple of the areas and there is open dialogue among the four nations' Governments.

Ms Bunting: OK. Folks, thank you very much. I appreciate your candour in all of that.

The Chairperson (Mr McGuigan): Thank you, Joanne. No other members have indicated that they want to ask any questions — sorry, Stephen Dunne has just indicated.

Mr Dunne: Thanks for the presentation. I understand that the regulation would also lead to some changes around the donation of SoHO and so on, particularly when it comes to commercial settings and the advertisement of compensation and payments. Have you done any assessment at this stage of the impact that that would have on establishments here?

Ms McGilligan: It would not be for our Department to lead on that work; it would be for DHSC. That work will come down to knowing what is in the technical detail, so the response is this: not at the moment.

Mr Dunne: OK. I echo my colleague Joanne Bunting's comments about the lack of clarity at this stage and for the future about such a technical issue. It is right that we are concerned and that we keep our eyes closely on the matter.

The Chairperson (Mr McGuigan): Thanks, Stephen. Those are all the questions from the members. I thank Brenda and Ryan once again for coming to the meeting and providing thorough evidence to us. Thank you very much, and apologies for the slight delay.

Mr Wilson: No problem. Thank you.