Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): The Department advises that the three statutory instruments (SIs) amend current legislation to provide for the continued application of three EU directives under the European Union (Withdrawal) Act 2018 and the protocol on Ireland and the North of Ireland. The Department advises that the current legislation will be amended as follows.

The current regulators will continue to act as the competent authority for the North and will continue to fulfil EU requirements, such as reporting requirements for NI. Regarding import/export provisions, the commitment to unfettered access means that there will be no additional checks or processes imposed by GB on blood, organs, tissues or cells moving from the North to Britain. NI establishments receiving blood, organs, tissues and cells from Britain will be required to treat them as imports, which means some additional administrative steps, and establishments here will be required to continue using the single European code for tissue and cells from 1 January 2021 to ensure traceability.

I advise members that a departmental official is available should members wish to raise any issues in relation to the SIs. I will check that Patricia is on the line. Go ahead, Pam, with your question to Patricia.

Mrs Cameron: Thank you, Chair. Is Patricia on OK?

The Chairperson (Mr Gildernew): Are you hearing us, Patricia? OK. There seems to be a time lag in the audio. We will try now with Pam's question.

Mrs Cameron: Thanks, Patricia, for being here.

Ms Patricia Quinn-Duffy (Department of Health): I have had to put it on on my laptop. Can you hear me?

Mr Buckley: This will be awkward.

The Chairperson (Mr Gildernew): We will have to suspend, because there is a significant time lag and it is causing some confusion. I will suspend the session.

The Chairperson (Mr Gildernew): Patricia, are you online with us? I am checking again if you can hear us over the videoconference system.

Ms Quinn-Duffy: I can hear you now.

The Chairperson (Mr Gildernew): We are hearing you now.

I will go first to our Deputy Chair, Pam Cameron, for a question on this statutory instrument.

Mrs Cameron: Thanks, Chair and thanks, Patricia. Hopefully you can hear us OK now.

In relation to the import-export provisions, the commitment to unfettered access means that there will be no additional checks or processes imposed by GB on bloods, organs, tissues or cells moving from NI to GB, but with no such protection for GB to NI movements. Will you give assurances that delays will be avoided and patient outcomes protected as a result of the new layer of checks east-west? That is my first question.

My second is about the administrative steps that are mentioned. Will the NHS have to foot the bill for those administrative steps?

Ms Quinn-Duffy: I understand that most of the places in Northern Ireland that import blood products from the UK already have import arrangements in place. There are imports of blood and blood products from GB, but that is rare because Northern Ireland is almost self-sufficient in blood products. Given the few times that those come into Northern Ireland, we do not believe that there should be any risk to patients. What we are possibly looking at, which is highlighted as a risk for exit day, is transport, because they come by road and boat. We need to ensure that there are no problems in getting those products across from GB to Northern Ireland. Organs predominantly move the other way. We do kidney transplants in Northern Ireland, but all other transplants are carried out in the rest of GB. So, we do not expect there to be patient impact in those areas.

On the administrative steps, we are still waiting on the Department of Health and Social Care (DHSC) in England to provide us with the guidance for the administrative procedures. The trusts etc already import products. The Northern Ireland Blood Transfusion Service (NIBTS) also occasionally imports products from the Republic. So, the processes are in place already. Again, we expect that they understand the administrative procedures. We understand that there is one tissue establishment that may need to implement new administrative procedures. We have asked where the financial impact will be borne, but we do not have an answer to that yet.

Mr Buckley: I deeply regret the need to look at these regulations. It outlines quite clearly the very damaging impact of the Northern Ireland protocol. We are talking about, and the words in the statutory instrument treat, blood, organs, tissues and cells coming from GB to NI as "import", which I think is quite insulting. The briefing paper states that the Northern Ireland hospitals or facilities that receive blood or organs from GB will need to go through extra administration. If this is the case when EU and GB rules are the same, how much worse would the impact be if standards eventually diverge and further checks are needed?

Ms Quinn-Duffy: You are correct that, at the moment, the arrangements and standards are the same. As you have rightly said, the regulations that are making powers around blood, tissue and organs have come back from Europe to the respective devolved Administrations. Because we, in Northern Ireland, are having to maintain standards with Europe, if there are changes in Europe in any of these areas, Northern Ireland will have to maintain those standards, which will potentially be a divergence from the rest of the UK. GB also has the ability to change and react to potential issues that they may have by amending their quality and safety standards around blood tissue and organs. However, to try to minimise or eliminate that, the devolved Administrations and the DHSC are working together to put forward a common framework, which will be coming to you shortly to give you some indication and outline of what it will entail. It will put in place agreements, communications and consultations around the divergence issue to ensure that, as far as possible, there is no divergence within the UK internal market. It also means that, if the UK is looking to make any trade agreements outside the EU, or in this area where there may be blood products, for example, those will be maintained on a nationwide basis.

Mr Buckley: As a quick follow-up, have the potential implications of the Internal Market Bill and how it would apply to such a statutory instrument, been factored in?

Ms Quinn-Duffy: It is a slightly different definition of "products". We do not expect that there are any implications of the Internal Market Bill in that it is not as good, as such. It is a product of human origin, so it has slightly different quality and safety-in-movement standards, as far as I understand. I will double-check that and come back to you.

Mr Buckley: Thank you.

The Chairperson (Mr Gildernew): Thank you, Patricia. For me, the need for these types of measures flows not so much from the protocol but from Brexit. The protocol is required as a result of Brexit in order to protect our markets, our food production, our health production and all of those important things. Do the SIs ensure that we keep dynamic alignment with European Union law in that area, in line with the protocol?

Ms Quinn-Duffy: Yes. They provide for the ability to make regulations in respect of EU changes. The protocol, itself, sets out that, in Northern Ireland, we and the Secretary of State can make amendments, similarly to the section 2 (2) powers in the European Communities Act 1972, to keep alignment with any new directives or amendments to directives that come in through Europe. Those powers are there to ensure that we can stay in alignment with the EU. That has been included in this. It also has removed —

and, in doing so, has made individually changing regulations in this area to GB alone, which means that, in Northern Ireland, we cannot make any amendments that minimise EU standards.

The Chairperson (Mr Gildernew): It states:

Was that agreed with the EU through the joint and specialised committees or was that a unilateral British Government decision?

Ms Quinn-Duffy: I do not know that answer to that. I can find out and come back to you on that.

The Chairperson (Mr Gildernew): Please do. It also states that:

In your opinion, is six weeks between that SI being laid and the end of the year enough time to provide that work and support, which those establishments will need?

Ms Quinn-Duffy: In my opinion, most of the standards and ability to provide the work that is necessary is already there. DHSC has been in contact with the establishments and will provide support directly to ensure that any other movements are in place before the end of the year. As I have said before, Northern Ireland is predominately self-sufficient in blood. We will, sometimes, bring in blood and blood products from GB, and, very occasionally, from the Republic of Ireland. However, organs predominantly move the other way, from Northern Ireland to GB. Six weeks, while it is a short timescale and is, probably, adding pressure, is doable.

The Chairperson (Mr Gildernew): Will competent authorities take on roles that are similar to those of competent authorities in EU member states?

Ms Quinn-Duffy: Yes. The competent authorities will maintain for Northern Ireland the same conditions that they have currently. Any

that they do for the EU currently, they will maintain for Northern Ireland.

The Chairperson (Mr Gildernew): Will the sum impact of all that be that safety and quality standards remain unchanged with the SI?

Ms Quinn-Duffy: As of 1 January, yes. There may well be amendments in the future. However, that SI will maintain quality and safety standards for blood, tissue and organs as they are currently from 1 January.

The Chairperson (Mr Gildernew): You can make a quick point, Jonathan.

Mr Buckley: I have a brief question. The official may not have it, but is there any breakdown of current provision to Northern Ireland of blood, tissue and organs and whether they have come from GB or, indeed, wider Europe?

Ms Quinn-Duffy: I have some figures. I can provide them to you in a bit more detail. My understanding is that we are predominantly self-sufficient in blood in Northern Ireland, with some movement from GB and a very minimal amount from the Republic of Ireland (ROI). With regard to organs, the UK is predominantly self-sufficient, having included ROI in the agreement on organs and organ transplants. I can probably provide you with more detail on that. I am not aware that Northern Ireland does, but I think that GB does.

The Chairperson (Mr Gildernew): Thank you, Patricia. We look forward to receiving those additional pieces of information. Thank you for your attendance and answers today.

Ms Quinn-Duffy: Thank you.

The Chairperson (Mr Gildernew): No other issues have been raised by members. Are members content to note the SI?