Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): Officials from the Department of Health are here today to update the Committee on Brexit developments.

I welcome Ms Cathy Harrison, the Chief Pharmaceutical Officer (CPO); Ms Patricia Quinn-Duffy, the EU exit lead on reciprocal healthcare and workforce issues; Ms Fiona Taylor, the EU exit lead on medicines, who is joining us via video link. Sorry, Fiona. Fiona is here in person with us. We are being joined on video link by Mr Brendan O'Neill, the head of information governance. I see that Brendan has joined us on video. Do we have Eimear Smyth? Eimear Smyth, who is also appearing via videoconferencing, is the head of medicines policy and EU exit transition.

Good morning, everybody. You are very welcome, and it is good to see you in person. Thank you for coming along in person. It is probably easier for all concerned if we can facilitate that, and I appreciate that you have done so. Cathy, please go ahead and give us you briefing, and we will take it from there.

Ms Cathy Harrison (Department of Health): Thank you, Chair, and thanks for the opportunity to come today and for facilitating a face-to-face meeting. That is better, given the size of the brief. We provided a briefing for the Committee, and I hope that it was helpful. I will talk very briefly to that briefing and summarise the key points, and then we will be available for questions. I have most of my team here today to answer questions for the Committee.

I will start with a little bit of background. The UK left the European Union on 31January 2020 and moved into a transition period that runs until 31 December. The transition period will not be extended. At the moment, the UK Government and the EU Commission are still involved in negotiations to secure a free trade agreement, and there is a possibility that a full deal may not be agreed by the end of the transition period.

During the transition period, the UK has continued to follow EU law and regulatory processes, but I remind the Committee that that will change from 1 January 2021, when the Northern Ireland protocol to the withdrawal agreement will take effect in Northern Ireland.

We have been working on EU exit and EU transition for a number of years and have identified the potential risks, which cover a broad range of health areas. I will talk through those and give you updates since the last time we appeared.

Northern Ireland is part of a UK-wide medicines supply chain, and we are also part of a national medical supplies contingency programme. That is being led by the Department of Health and Social Care (DHSC) but with the full involvement of the devolved Administrations. The UK-wide contingencies are basically to address the primary risk to the healthcare supply chain, which has been identified as disruption to the supply chain at the short straits in the English Channel that could arise as a result of no deal. During the past two years, extensive national plans have been developed to mitigate possible disruption to medical supplies that could arise as a result of no deal. That has resulted in the development of what is known as a multilayered approach to UK-wide contingencies. That involves a range of activities that are now ready. We are now at the point at which those will start to be used. That includes active support for trader readiness for businesses that trade with the EU; buffer stocks that are being held in the UK of at least six weeks' additional stock of medicines and additional supplies of other goods; and extra ferry capacity, with different routes available and an express freight service from the EU.

On 13 October, the UK Government announced that they had signed agreements with four ferry operators to provide capacity equivalent to over 3,000 HGVs a week for the transportation of category 1 goods. It is indicated that those contracts will be in place for up to six months after the end of the transition period. Category 1 goods include all our medical goods, our medicines and other medicine supplies.

In addition to that, across the UK, enhanced arrangements are now operating for the surveillance of the whole medical supply chain, and there are associated shortage management systems in place that are now active.

The Medicines and Healthcare products Regulatory Agency (MHRA) has provided a very detailed raft of guidance that covers the whole of the UK, with specific guidance for Northern Ireland where needed. That is available on the GOV.UK website. Regulatory flexibilities have been agreed by the MHRA that will enable medicines and medical devices to continue to be placed on the market in the UK, including a two-year standstill period for medicines and a two-and-half-year acceptance of conformité Européenne (CE) marks for medical devices. Those are the national contingencies, which form the basis of our preparedness in Northern Ireland.

I will talk now in more detail about the Northern Ireland protocol. The UK is currently aligned with the EU acquis for medicines and medical devices. As I said, that will change after transition when Northern Ireland will remain aligned with the EU and Great Britain will not. There are implications for us in Northern Ireland. Things will change with the regulation and supply of our medical goods; that change will be permanent. In time, we will have to approach a new normal.

At the fourth meeting of the Specialised Committee on the ProtocoI on Ireland/Northern Ireland on 5 November, the UK Government and the EU Commission reached an agreement to allow the pharmaceutical industry 12 months from 1 January 2021 to comply with the new regulatory requirements that apply only to Northern Ireland and are as a consequence of the Northern Ireland protocol. That includes the requirements for the falsified medicines directive, qualified person, batch testing and importation requirements. That is a critical decision for Northern Ireland and will allow a phase-in period for the pharmaceutical industry and, critically, will allow more time for our wholesaler chains and pharmaceutical industries to make the necessary business decisions in order to adapt their distribution and logistics arrangements. That was considered to be a positive outcome for us. It is expected to reduce vastly the risk of short-term disruption to the medicines supply chain that may have occurred immediately in the aftermath of the end of the transition period in Northern Ireland.

That was not our only contingency, and we were not fully reliant on achieving the 12-month phase-in period. We had already secured some legal advice on goods on the market, which would have provided another layer of contingency, should we have needed it. That would have allowed medicines that were already placed on the market by the end of the transition period to flow without impediment across the UK. We do not think that we will have to rely on that, but it could still be quite useful in some product lines.

We are still working with the Department of Health and Social Care, and we are waiting for much more detail about the decision that was made on 5 November. When that is received, detailed guidance will be needed for the industry and service. There are still unresolved issues. We are in a very active period. I told you that the last time. We have had significant progress — I hope that you agree — since the last time that I was here, but we are still waiting for some critical decisions to be made. One of the issues that we are very focused on now in Northern Ireland is the whole issue of the flow of our goods into Northern Ireland. Medicines and medical products are not the only issue; you know that it is much wider. We are actively working across Departments on some of those issues.

I will now move from healthcare supplies to access to healthcare and workforce. I will, first, talk about the reciprocal healthcare agreement. A range of areas is relevant to accessing healthcare after EU exit, including continued access by UK citizens to emergency healthcare in the Republic of Ireland. The Department and the Department of Health in Dublin are working on an enduring reciprocal healthcare agreement between the UK and Ireland. That will not impact on any current North/South health services that are based on a memorandum of understanding or a service level agreement. The cross-border healthcare directive enables UK citizens to access healthcare in any EU country and to be reimbursed for that care abroad by their home country. At the end of the transition period, that facility will no longer apply in the UK. If someone has already applied to use the cross-border healthcare directive before the end of the transition, their treatment will be honoured for up to one year, based on certain conditions. The Department of Health here is considering the policy around the application of the principles after the end of the transition period; we are still working on that.

The withdrawal agreement provides a framework for the continued legal residence and rights of EU citizens living in the UK and UK nationals living in the EU at the end of the transition period. Westminster is coordinating the application of citizens' rights for access to healthcare. The Department of Health is working with DHSC to understand fully what the agreement means for EU citizens.

The Committee may be aware that a new points-based immigration system will be in place from January 2021. In terms of the mutual recognition of professional qualifications, citizens' rights agreements are now in place for all current professional registrants and those applying before the end of the transition period. The future arrangements are part of the UK-EU negotiations; longer-term arrangements are still under negotiation. It is important to note that the UK and Ireland have made a commitment in the common travel area that comprehensive measures will continue to be in place to allow for the recognition of qualifications. In the event of no future agreement, the UK has provision in place to allow, for up to two years, all EEA automatically recognised professions to continue to be automatically recognised.

I am getting close to the end. The next issue is that of data transfer. UK Government-led discussions continue on the UK achieving an adequacy decision on data sharing; that is an important decision, and they are still working towards it. Without it, North/South data sharing for health and social care and public services would be subject to additional scrutiny. We already have arrangements in place through standard contractual clauses to cover data sharing. If you require further information or have more detailed questions on that, Brendan is best placed to provide it or to answer them.

I understand that you will receive a direct briefing from the Food Standards Agency (FSA), but, just for completion, I included a few paragraphs on that in the briefing. I will not go into those in detail. There are four common frameworks that are relevant to health and social care. They are progressing well. The Department has already shared the framework summary with the Committee for blood safety and quality, and for organs, tissues and cell frameworks. We expect to update the Committee on the other two frameworks shortly. Three other common frameworks are led by the Food Standards Agency.

The current EU transition legislative programme includes 11 statutory instruments, six of which have been laid and four of which will be laid before the end of the year. There has been agreement that the electronic commerce directive will be postponed until January 2021.

I will give you an update on what we are doing on guidance on core readiness. In August last year, we provided health and social care providers and organisations with detailed EU exit operational guidance. We have been able to update that now given recent developments. That is in the final stages of being approved through the Department. We hope to get that guidance out by the end of this week or early next week.

The Committee may be interested in a number of things about how we will handle the EU transition. It is upon us and it is happening, so we are now very much moving out of a planning phase and into a response phase. The tone in the operational guidance will be to get ready for leaving and to update plans where needed.

A lot of things have not changed — for example, we still have the risk of a no deal, which was the basis of the original plans — so we are not anticipating radical changes. The key principles on which we are advising are, first, how any issues that arise relating to EU exit in the health service will be handled through the incident response structures, battle rhythm sitreps and the emergency response, which are already in place for COVID-19 and all of which are working well. That will allow health and social care (HSC) organisations to escalate quickly, if they need to, any issues through sitreps on a daily basis right up to two strategic cells that I chair. One is looking at all our supplies issues, and the second one is looking at the wider context of EU transition. That will allow for rapid decision-making. The strategic cells in which I am involved with my team are linked in with national strategic cells and national planning, should we need to respond to unforeseen issues. Obviously, we do not know what is coming, so it is best to be prepared and to have a plan.

We will be advising that extensive national contingencies are in place to ensure healthcare supplies. The huge amount of work that is going on with the pharmaceutical industry and wholesalers means that we are not asking front-line services to stockpile or take additional action unless asked to do so. We are going into an intensive period in the next few weeks of speaking to stakeholders to understand specific risks and deal with those in our final planning stages.

Patients and carers can be advised and reassured that they do not need to order additional prescription medicines, and prescribers do not need to overprescribe or provide additional quantities.

We are asking all Health and Social Care organisations and providers to put in place enhanced arrangements to monitor their business, as they already have for COVID, to be aware of issues that arise in relation to the EU and to pay particular attention to and monitor supply chains. The Department will provide advice on handling shortages if they occur to ensure continuity of treatment for patients.

We are happy to take questions.

The Chairperson (Mr Gildernew): Thank you for that wide-ranging presentation, Cathy. There is an increased note of concern around the level of complexity that we were dealing with here.

I welcome the fact that the medicines issue was addressed by way of additional time. That is important, but, after listening to your presentation, it is clear that that is only one part of one issue in a range of issues.

I am genuinely concerned that it would appear that Brexit, from what you say, is now moving onto an emergency basis, on top of COVID, which we are already dealing with, in that it is being dealt with through incident response structures. Is it fair to say that the health service is already struggling to such a degree with COVID that to add the second major ongoing incident of Brexit will, potentially, push the health service beyond breaking point?

Ms Harrison: That is correct: it is complex We are dealing with complexity. What we are dealing with is multifaceted. My emphasis for the Committee on our preparedness approach is to provide you with the assurance that we already have very well established systems in place in the health service to deal with COVID. The intention to include the EU in those is to avoid additional work for health and social care relating to the EU and to allow any issues that emerge to be rapidly identified and dealt with. We are taking a step forward and a pragmatic approach, and my intention in all this planning is definitely not to increase any pressure on health and social care. Most of the work that is going on in the background on the contingencies, particularly on supplies and also in all other areas, is being done away from the front line. That is being done intentionally to prevent additional pressure on those organisations at this time. We are working very closely with all the arm's-length bodies, and we will continue to do that in the coming weeks. I think that it is helping the arm's-length bodies, and it was welcomed by them that we were not setting up a parallel system but would use the existing systems that have been tried and tested since March and that are working well.

The Chairperson (Mr Gildernew): Eimear Smyth, can you please indicate whether you can hear us? We cannot hear Eimear. IT will look into seeing whether we can get Eimear on the line, and we will continue. If there are any questions that are specific to Eimear, we can maybe come back to them.

In light of that overarching concern, Cathy, are there any other areas on which you are recommending that we seek additional and extended time, similar to the medicines issue?

Ms Harrison: I will ask Patricia to comment in case there is anything on her side, but, on the supply side, no. I am looking for confirmation from the European Commission on the detail of the decision around the 12-month phase-in period. That was a major decision, which we had requested some months ago, because I had referred to it. With that assurance and detail, those are major steps forward for us, Chair. They really are.

The Chairperson (Mr Gildernew): Since probably July or August a year ago, you and I have been discussing other related issues around qualifications and the supply of isotopes. Some stakeholders, including the Royal College of Radiologists and Diabetes UK, have recently expressed concerns about contingency plans for imported isotope supplies. Those are equally concerning. Do they also require a robust framework to be put in place to protect our population here?

Ms Harrison: Medical radioisotopes are short-life products that cannot be stockpiled. They are received into the health service in Northern Ireland, and they are sometimes used on the same day, Chair. This was one of the areas that we looked at as part of our planning, possibly over a year ago. Northern Ireland benefits from having all our radioisotopes flown in. I can assure you that that has been reviewed again in recent months, and we are assured that those systems are robust. There is no concern in that area. We have been through it in the past and revisited it recently. There is no additional ask on that issue. You are enquiring about the big asks. Those big asks were for the European Commission; they were significant, and they were secured for us. Other things such as medical radioisotopes were operational matters that we could handle, and we have handled them.

The Chairperson (Mr Gildernew): I want to come on to members' questions. I have another couple of questions, and I will hopefully come back to those. You said that legal advice had been taken on ensuring the flow without impediment, and I am very conscious that we are talking about a buffer stock that is held somewhere in Britain and that additional problem with the short straits, which we have already identified, could come in again. It is also a very complex supply chain, with temperature control and issues like that. I am also deeply conscious that these issues are as a result of Brexit. The desire of Britain to leave the European Union is leaving us with these problems. You said that legal advice ensured that flow of goods without impediment. Is that legal advice related to the Internal Market Bill, which sets out that Britain was prepared to break the law?

Ms Harrison: No. That was a legal interpretation of article 41 of the withdrawal agreement, which relates to goods on the market. The advice that we received was that medicines that were placed on the market by 31 December could continue to flow across the UK. That was an important interpretation of the law for us. It meant that, had we not secured the additional 12-month phase-in period, we would not have had an immediate crisis in our medicine supply chain, and medicines would have been able to flow. There are so many products involved in the medicine supply chain, and that may still be useful to us because the pharmaceutical industry has 12 months to respond to and comply with the Northern Ireland protocol. There could still be instances in which we may need to use that legal interpretation. It is nothing to do with the Internal Market Bill.

The Chairperson (Mr Gildernew): Thank you. I will go to members. I have Pam on the phone.

The Committee Clerk: Some members are having difficulties with StarLeaf, Chair.

The Chairperson (Mr Gildernew): OK. I will go to members in the Chamber and come back to other members when StarLeaf is operating again.

Mr Buckley: Cathy, thank you for your wide-ranging brief. I could ask a number of questions. The briefing later on the legislative consent motion may cover many of those, so I do not know whether to direct those questions —

The Chairperson (Mr Gildernew): Sorry, Jonathan. Just a second.

The Committee Clerk: I have been advised that we need to suspend the meeting briefly to restore StarLeaf.

The Chairperson (Mr Gildernew): OK. We will suspend the meeting.

The Chairperson (Mr Gildernew): Thank you, members. We are back in session. Just before I go back to Jonathan, you said, Cathy, that you would check with Paula whether, on the workforce, anything is needed from her side. Can we pick up on that before we move on?

Ms Patricia Quinn-Duffy (Department of Health): Most of the workforce issues are already captured, predominantly, in the withdrawal agreement. A lot of the issues were originally around the ability to maintain and recognise qualifications in a no-deal scenario. The withdrawal agreement sets out that anyone who is already here or has applied beforehand is able to maintain the recognition of their qualifications. The UK has laid legislation that will unilaterally allow anyone with an automatically recognised qualification for up to two years to have that qualification recognised, so if any Europeans come into Northern Ireland after January, particularly in healthcare — doctors and nurses — their qualifications will be automatically recognised. It means that those qualifications will continue to be so.

The general assessment of qualifications will be different. Social workers, for example, would previously have gone through the general assessment, but they will now have to go through the assessment that the rest of the world's nationals have to go through for registration. Obviously, the recognition of professional qualifications is still part of the negotiations, so there may still be a negotiated outcome that is different to that, but there is contingency in place. We are speaking to our Irish counterparts about cross-border services. Healthcare cooperation is very important and has been well established to ensure that those services continue.

The Chairperson (Mr Gildernew): Apologies, I should have said Patricia, of course, rather than Paula. Again, there is a partial fix in place, and that is welcome, as far it goes. Are you concerned that that will provide a chill factor in terms of us competing to attract much-needed staff? People might say, "I might be OK for two years. Do I want to take a chance that I will be OK beyond that point?". Given how hard it is to compete for staff in the world market, do you have concerns about that?

Ms Quinn-Duffy: No concerns have been raised about qualifications in the context of attracting staff. Obviously, we are in a very different environment with COVID in attracting staff, but the UK Government have put in place additional factors on immigration. Currently, health and care staff can apply through a health and care visa, which is a shorter, quicker route to get a work visa to work in health and social care, and they have also waived the immigration health surcharge for health and social care staff, which, again, makes it slightly more attractive. The Europeans who come after January will have to apply through that process, but it means that there is a level playing field because they do not have to pay an immigration health surcharge, which they would in other professions. It is slightly more attractive for health and social care professions than it would be for other professions post 31 December.

Mr Buckley: Second time lucky. Thank you for your presentation. The joint agreement on the time extension for the phased implementation of the falsified medicines directive (FMD) and batch testing is welcome news. It will give businesses some reassurance and time to prepare for what is to come. However, it is still unclear whether this will fully mitigate the risks of the declarations of tariffs from 1 January on some medicines moving between GB and NI. I know that this is the intention, but it is imperative, and I want to put it on the record, that the Department of Health use this grace period to press the UK Government to ramp up the case for mutual recognition between the EU and the UK in the medium to long term. That is essential. We have a grace period, but we need to use it to best effect.

Over this past week or so, I have engaged with some GB suppliers of medicine, and there is real concern at the economic threat of GB firms no longer seeing Northern Ireland as an attractive or viable market from 2022 and that that will cause significant pressure on supply chains. Will the shift, or potential shift, in supply chains pose risks to or problems for our health service?

In relation to the cross-border element, the uncertainties, the lack of clarity on the way forward and the fact that Northern Ireland will be tied to the EU regime on medicines and a vast range of other products, yet is unable even to access cross-border healthcare under an EU directive after the transition period, highlight that the protocol is certainly not the best of both worlds, as some had championed. Northern Ireland consumers and patients got a raw deal. Is there a risk that, when the agreed medicines derogation ends in 2022, the friction between trade moving from GB to NI will ultimately lead to local hospitals and pharmacies sourcing products from the Republic and, indeed, the rest of the EU, thereby putting pressure on existing supply chains?

Ms Harrison: Having those twelve months is a significant step forward. The pharmaceutical industry asked for it and sees it as an opportunity to put in place measured changes to its supply and logistics arrangements.

There is not a single approach that the pharmaceutical industry currently uses in supply chains. I have been meeting individual companies and attending national meetings. My understanding is that they are considering a range of options for what the new normal will look like for Northern Ireland in the long term. Had some of those options had to be rushed, yes, we could have been in a much riskier position. However, the 12-month grace period is significant. Some companies tell me that 12 months is not a long time. I am working with the Department of Health and Social Care to make sure that we are not stopping this work. All the work that has been going on in recent months will continue. We will continue to work, at pace, with industry to understand what its preferred model is. If you are interested, I can describe a number of models that it is considering. Ultimately, the industry will make business decisions on those models. My goal is that we continue to have access to all the medicines to which we have access at the moment and that our patients and citizens in Northern Ireland have equity of access to all new and other medicines in future. That is how we are entering those talks with the DHSC. It knows that that is where we are starting our negotiations with the pharmaceutical industry. My engagement with the pharmaceutical industry has been very positive.

You are right, Mr Buckley, that there are issues, but the industry now has more time to work through those, and it will have Government support for this as well, if it needs it. However, we will not switch from the one system that we have now to one single system.

Mr Buckley: Is the Department, or the Northern Ireland Executive as a whole, attempting to use this grace period to further engage with central Government and the EU Commission on mutual recognition? That is the best route to ensure security of supply for medicines.

Ms Harrison: The mutual recognition agreement is still under consideration. The pharmaceutical industry is very keen to secure it. It is very important to the industry. The agreement does not address the issues relating to the Northern Ireland protocol, in that a falsified medicines directive and checks by a qualified person are needed, and the agreement does not resolve those issues.

Mr Buckley: Thank you

The Chairperson (Mr Gildernew): Can you forward the Committee the models, rather than going into detail? You said that there is information on the various models.

Ms Harrison: There is not that much information. I am happy to say what they are. There are three options. There is no detailed modelling at this stage.

The Chairperson (Mr Gildernew): OK. I will move to Paula Bradshaw, who is on the phone.

Ms Bradshaw: Good morning. Thank you very much for the presentation.

I want to follow on from Colm's question about healthcare professionals coming to Northern Ireland. I appreciate that it involves immigration issues, which are very much the responsibility of the UK Government. As health is a devolved matter, are there any measures that we can put in place to make working in Northern Ireland more attractive?

My second question relates to the cross-border healthcare directive. You said that the Department of Health is considering the policy on the application of the principles for the post-transition period. Given that we are about six weeks from the end of the year, how soon will we see the outworkings of the negotiations with the South?

Ms Quinn-Duffy: Thank you, Paula. Yes, you are correct: the regulations and policy on professional regulation are devolved to Northern Ireland. So, potentially, there are some routes for us to look at. Currently, that has not been part of the programme. We will, of course, take that away and consider it further.

At the moment, the healthcare professions are, predominantly, nationally regulated. The only two that are locally regulated are the Pharmaceutical Society of Northern Ireland and the Northern Ireland Social Care Council (NISCC) for social workers. All of the other healthcare professionals are nationally regulated. There is the potential that, if we were to defer or move away from the rest of the UK, that would make it more difficult even for the internal market. There are considerations that will need to be looked at, but we will take that away and consider it.

Ms Bradshaw: Sorry, Patricia, before you move on, the question was not so much about the regulation or the terms under which people come to work in the United Kingdom. The question was really more about the terms and conditions or remuneration that those healthcare workers could be offered. There are many shortages, vacancies and pressures in our health service, and the question was more about that side of it.

Ms Quinn-Duffy: I will have to take that away and come back to you on the workforce issues. With Agenda for Change, many contracts and arrangements are centrally organised. We are aware that there is almost an attractiveness to working in the different regions. I will come back to you on that point.

Ms Harrison: You might be interested to know that we are targeting interest in the pharmacy workforce. I am sure that that will be mirrored across other healthcare professions as the health and social care workforce strategy is implemented. Last week, we launched a massive campaign to promote Northern Ireland as a place to study pharmacy and come to work in pharmacy. There was a deliberate attempt to draw back pharmacists who, like me, studied in England — I have managed to get that plug in for our campaign. We recognise that attention needs to be given to promoting Northern Ireland as a good place to come to work and build a career. There are other factors involved there. Thank you.

The Chairperson (Mr Gildernew): Thank you. Is there growing concern about the ability of the common travel area to deal with longer-term issues for workers, particularly North/South workers? Is that likely to become an issue, Patricia?

Ms Quinn-Duffy: Is in everyone's interest that the arrangements for professional qualifications within the common travel area are of mutual benefit. We are working with the DHSC and Ireland on the mutual recognition of qualifications. Regulators will also need to work very closely together, as they do already. We also have the North/South arrangements for healthcare cooperation in place, and it is very clear from the UK and Ireland that those are important, that they are not EU-based and that they should continue under the Belfast Agreement. In the absence of EU considerations, those arrangements need to continue, develop and grow.

Mrs Cameron: I thank the members of the panel for their attendance at the Committee. I apologise for missing quite a bit of the presentation.

Will the panel tell me what proportion of food or feed that enters Northern Ireland from Great Britain is usually subject to controls related to the FSA or its labs in Northern Ireland? By how much will that increase from January 2021?

Ms Harrison: Chair, we will have to come back to Mrs Cameron on that. We know that you get direct briefings from the Food Standards Agency, and I do not have that detail in today's briefing.

Mrs Cameron: I appreciate that. Thank you.

Mr McGrath: I may also have missed quite a bit of the presentation and questions, so I apologise if I repeat something.

I want to pick up on the North/South reciprocal health arrangements and, more broadly, whether there is any update on what will happen with European health insurance cards (EHICs). People are getting confused. They think that things will still happen North/South but that they will not be able to use those cards in the rest of Europe. They may not realise that there will be no cards. Can the panel give any clarity on what the general rules will be for European health insurance cards?

Ms Quinn-Duffy: The UK and Ireland are in fairly advanced negotiations on North/South reciprocal healthcare to make sure that arrangements continue in the common travel area. You are quite correct that that will not continue in Europe.

Anyone who falls under the withdrawal agreement will still be able to maintain their rights. Any frontier workers, Europeans who live here or UK citizens who live in Europe will be able to maintain their current reciprocal healthcare rights, and they will be able to have and use an EHIC. For everyone else, the EHIC is still part of the negotiations with Europe. The outworkings of that have not yet been confirmed, so I cannot give any update.

The current advice is that anyone who travels over the end of the year will still, as part of the withdrawal agreement, be able to use their EHIC until the end of their visit. Therefore, a student, for example, will still be able to use their EHIC if they have been in Europe since before the end of December, even if they have come home for a holiday. However, any new people will not be able to use their EHIC until the outcome of the negotiations is known. Of course, anyone travelling should also have travel insurance.

Mr McGrath: If you are living in Europe at the moment or are a student, regardless of whether you come home and go back to Europe, your European health insurance card will be good. However, if you are a new person going on holiday or travelling abroad after 1 January, there is no provision in place unless something comes out of the negotiations.

Ms Quinn-Duffy: Yes. That is correct.

Mr McGrath: OK. Thank you very much.

Ms Flynn: Thank you, Cathy and Patricia. Cathy, I want to pick up on your earlier remarks. You said that disruption could arise in the English Channel and that the contingency plans that you have been working on are now ready and starting to be used. Have you already identified any shortages in medicines or forecast the potential shortages should that disruption arise in the English Channel?

You mentioned that discussions were ongoing on the data-sharing issues. I am conscious that this has been an issue. As with the COVID pandemic, we are hearing feedback that data sharing on the island, North and South, has been a problem. Can you go into more detail on what the problem is in this context and whether the delay in sorting out these data issues could put patients at risk in any way?

Finally, Cathy, you mentioned that you were still waiting for a number of critical decisions to be made. In your opinion, in the here and now, what is the most prominent of those decisions?

Ms Harrison: Thank you. I will take questions one and three and hand over to Brendan to advise on the data question, if that is OK.

First, you asked whether we have identified any shortages at the moment. I chair a shortage response group in Northern Ireland, as I mentioned earlier, which is our strategic cell — we use different words for things. That group of people meets weekly and is responsible for representation from across all of our supply areas. I can report that, this week, we have no supply issues. That is not to say that there are not shortages; there are always interruptions in supply chains, but there are none at present as a result of the EU. There are none that we are concerned about or which we are having to take additional action to address.

What would happen if we had to take action? It is nothing to do with the EU, but supply chains are global, and things can happen at any point in the medicine supply chain. There are some high-profile examples, such as EpiPen, where major interventions are taken if needed. Our extensive national surveillance of the whole medicine supply chain means that we can predict any potential issues, and it allows us more time to put in place plans. The Department sends out supply disruption alerts to our health and social care services. The alerts give detailed advice about medicine availability for prescribers and on whether they have to make a decision to change from one product to another, whilst, at all times, maintaining the risk-free treatment of patients.

Ms Flynn: I would like to come back in on that point, Cathy. The Chair of the Committee got an email from a constituent, either early this morning or late last night, saying that her specialist had told her that her prescribed medication would no longer be available as a result of Brexit. You said that supply disruption alerts are sent out to health and social care agencies. There may be a point to be made about communication to prevent further such examples. If a shortage is down to the global supply chain, we need to ensure that the messaging is clear so that there is no confusion among the public or the pharmacists.

Ms Harrison: I am very interested in that example. If you can share that with me, I will follow it up. I should also advise the Committee that, if a formal decision is made to withdraw a drug from any part of the UK market, six months’ notice has to be given by the company. That means that, to prevent any shocks, the company has to advise the HSC. That comes under UK-wide medicines legislation. I am not aware of the issue that you described, but I will look into it.

Ms Flynn: Which is the most prominent of the critical decisions that you await? Also, I asked about the issue of sharing data, North and South.

Ms Harrison: For me, the most significant supply issue is clarity around the Northern Ireland ports and getting the flow in from Northern Ireland. We have done a huge amount of work. We have never held more medical supplies, at any point in history, than we have now — in the rest of the UK and Northern Ireland. We have additional stock here in our system. We want that flow to continue unimpeded. That is my current focus around supplies.

Patricia, have you anything to add?

Ms Quinn-Duffy: On the workforce side and reciprocal healthcare, an agreement with Europe on the continuation of social security would settle a lot of minds. The common travel agreement is important to make sure that that arrangement is in place. We do not have decisions on those yet. They are not critical, because people will still be able to get healthcare. It will just make things a lot easier and simpler. It will be a continuation of what we have now.

It would be wonderful, quite frankly, if the UK were to come to an agreement with Europe on the recognition of professional qualifications. The mutterings that we have heard to date have not been good, but, if the UK could come to an arrangement, that would solve a lot of issues in that area as well.

The Chairperson (Mr Gildernew): Before I go to Gerry, I want to check back with Paula. Paula, was there an element of the second part of your question that you felt had not been fully addressed?

Paula, can you hear me? OK, I will come back to Paula.

Mr Buckley: Chair, Órlaithí's question about data sharing was to be addressed by another member of the panel.

The Chairperson (Mr Gildernew): Sorry, thank you for that.

Mr Buckley: It was one of my questions as well.

The Chairperson (Mr Gildernew): Go ahead, Brendan, I will bring you in here.

Mr Brendan O'Neill (Department of Health): Thank you, Chair. Thank you for the question, Ms Flynn. No data-sharing issues have been reported through the Department. I work for the chief digital information officer and sit alongside the data protection officer. Processes have been put in place in parallel with the preparation of paperwork. The information governance paperwork can be quite detailed. You may have heard that the paperwork has not been completed or that there are delays in completing it, but there has been no disruption to data flows that we are aware of.

The Chairperson (Mr Gildernew): You say that there have been no disruptions, but are you anticipating difficulties in the future? How are those being addressed, Brendan?

Mr O'Neill: No. As part of the original preparations for the full implementation of the General Data Protection Regulation (GDPR), the HSC organisations undertook studies of their data flows and reviewed all their memorandums of understanding (MOUs) and contracts. This has carried over into the EU exit scenario. We are confident that we have in place appropriate mitigations that will allow data to flow regardless, in a legal manner.

The Chairperson (Mr Gildernew): Are there concerns about the future divergence in data should Britain diverge from the EU? An adequacy decision is in place at the minute, but would any future divergence have an impact, and how can that be addressed?

Mr O'Neill: Chair, that is quite hypothetical at the moment. Transferring data to the UK would be an issue for the EU. The UK has always stated that it would transfer information to the EU because it recognised that it is adequate. Our colleagues across the border would be pushing to ensure that data could freely flow for cross-border services, such as cancer and kidney dialysis, and even for Northern Ireland Fire and Rescue, where there are shared services along border regions.

The Chairperson (Mr Gildernew): Am I to take it that there is some assurance for this island, North to South, because, unilaterally, the British Government have said that they will allow that to flow? What about South to North, Brendan?

Mr O'Neill: That is where the EU may have a problem and, consequently, where the Republic of Ireland may have a problem. However, it is hypothetical at the minute because the situation has not arisen. The UK Government, which lead on the adequacy decisions and discussions, keep assuring us that they are confident that that will be achieved. It is in everybody's interests to make sure that it works.

The Chairperson (Mr Gildernew): Yes, and I am acutely aware that, rather than it being the EU's problem, it could be our population's problem and the health service's problem. As things move on, we could be caught in the middle between these larger discussions and unforeseen consequences.

I will now check back with Paula on the question that she had asked. Paula, will you clarify or repeat your question, please?

Ms Bradshaw: It states in our meeting pack that the Department of Health is considering the policy on the application of the principles of the cross-border healthcare directive after the transition period. I was saying that we are six weeks away from the end of the year. When will a decision or information be forthcoming?

Ms Quinn-Duffy: We hope to get the information to the Minister shortly. We have had to look at some international elements of the agreement with the World Trade Organization, such as paying for care in a country. It was a question of whether we made an agreement with Ireland or with Europe. Some considerations still need to be bottomed out. That is what the issues are. We have provision that anyone who applies before the end of the year will still be able to continue to have their treatment. It also does not stop people who are travelling from having private healthcare in another jurisdiction. However, it means that they will not be able to be reimbursed for their treatment. We should have some guidance and advice on that shortly.

Ms Bradshaw: Thank you.

The Chairperson (Mr Gildernew): It is concerning. I have diverted so many people who have been able to get their treatment only as a result of that scheme. We are 42 days away, and we are hearing "should", "may" and words like that. That is really, honestly, causing anxiety in the community. This is definitely having a massive impact. Again, it is one of these things that we knew was going to happen. It is extremely concerning that we are still trying to catch up at the last minute and, as I said earlier, trying to deal with the COVID pandemic at the same time.

Mr Carroll: Thanks for the presentation. I have a quick comment and a question. In a situation where we need healthcare workers from outside Ireland and the UK, having a points-based system seems pretty regressive, reactionary and racist.

On state aid rules and pharmacy, there was a conversation, maybe last month, about the British Government's plans for changing state aid rules and intervening in the economy after exit. Have there been discussions, research or thought around the benefits of intervening in pharmacy and big pharma? I see that Médecins Sans Frontières has called for more transparency around the vaccine and on how the trials are conducted in regard to patent rules and issues like that. I do not claim to be an expert on any of that, but I know that there is a concern that people get the vaccine as quickly and as safely as possible but without the possibility of big pharma making huge profits from that. Is there any work on that? Are there any possible issues around that? That information would be helpful.

Ms Harrison: Mr Carroll, I think that that is more of a national question — on a UK scale — than a question specific to Northern Ireland. I can tell you that, moving forward, a large part of the work of our medicines regulator, the MHRA, will be promoting life sciences, promoting engagement with the pharmaceutical industry and promoting the UK as a good place to do business. From my point of view, we will encourage Northern Ireland's being well represented in those promotions.

That is more our focus. The state aid questions are probably more UK Government decisions than something that we would seek to influence here directly.

Mr Carroll: I appreciate that, and I appreciate that people have asked urgent questions. People want a vaccine as quickly as possible, and quite rightly, but if there are questions about having a pharmaceutical sector that is not solely for profit, that would benefit people here as well as in the rest of UK.

Can you answer any questions about the consent mechanism, Cathy?

Ms Harrison: Explain a wee bit more what you mean by "consent mechanism".

Mr Carroll: I mean the vote that is going to come four years after the transition period. I do not know if it is your area, but I am looking for clarity on whether that is subject to the petition of concern. Is that known?

Ms Harrison: I do not think that that is strictly our area, to be honest, but I am happy for it to be taken away so that we can pass it on. It might not be for even our Department, Mr Carroll, to be fair.

The Chairperson (Mr Gildernew): Cathy, I want to ask you about the potential vaccines that are being worked on. I think that we all agree that a vaccine that will have an impact on the COVID-19 situation is a source of hope. It appears that the South is getting 1·1% of EU supplies of vaccine, which is 20 million doses. If we were struggling to get supplies — we have seen that for the flu — and we know that we are operating in a global market, is there potential for us to tap into that procurement route?

Secondary to that, are you planning for the roll-out of the vaccine to be coordinated on an all-island basis in the sense that we are a single epidemiological unit? I take it, therefore, that, in order to provide population immunity, you would need to have it coordinated North and South.

Ms Harrison: I am sorry, Chair, but the detail of the vaccine roll-out is not my policy area. We do not foresee any issues with EU exit for handling the vaccines and getting them into Northern Ireland. My understanding is that we are dealing with the Northern Ireland population, which is our responsibility, but other colleagues in the Department are best placed to provide the detail on that, which we are happy to relay.

The Chairperson (Mr Gildernew): In your substantial experience as Chief Pharmaceutical Officer, do you agree that a vaccine programme needs to be coherent across the island in order to provide protection for our populations, both sides?

Ms Harrison: We do not work on an all-island basis at this moment in time. We work on the basis of Northern Ireland and Southern Ireland, but we are aligned on principles and objectives for public health. I cannot see that being any different this time around.

The Chairperson (Mr Gildernew): I appreciate that, but I suggest that that be a piece of work that is ongoing to make sure that we are aligned, given that it makes sense. I am just flagging that. Hopefully, that will be an urgent piece of work in the sense that the vaccine will soon be available, and we will want that coordinated roll-out in place.

Mr Buckley: Chair, you mentioned a vaccine, and I appreciate that this may stray into another portfolio. With the EU exit etc, if vaccines that are secured by the UK Government are allocated on a devolved settlement basis, do you anticipate any difficulties with those vaccines being rolled out from GB to Northern Ireland, in particular if difficulties surround the Northern Ireland protocol?

Ms Harrison: Again, I am not here to speak in detail about that.

Mr Buckley: Of course not.

Ms Harrison: It is based on a population-level share of what the UK Government are able to draw down from global supplies. Northern Ireland will receive its share of the vaccine. That will be allocated, and we do not expect any EU issues arising because I know that the vaccine could come over after the end of the transition period.

Mr Buckley: I asked that because I heard your concerns about the supply of other medicines etc in terms of where we are. I suppose the year's extension has removed some of those immediate pressures, but the concern is, rightly, out there about the —.

Ms Harrison: The vaccines will come directly into Northern Ireland.

Mr Buckley: Directly to Northern Ireland? OK. Thanks.

The Chairperson (Mr Gildernew): Cathy, again, from your angle as Chief Pharmaceutical Officer, has consideration been given to how we would deploy a vaccine here? Obviously, there are different ways to use a vaccine. Are we developing a dedicated plan for how we use a vaccine in the context of the North that suits our unique healthcare situation?

Ms Harrison: That work is going on right now, Chair, at the Department and in the HSC. All that planning is under way.

The Chairperson (Mr Gildernew): I have an indication from Pat Sheehan, who is on the phone. Go ahead, Pat, with your question.

Mr Sheehan: Thanks, Chair. I want to ask Brendan about data sharing. Is he aware of data not being shared by the South on travellers coming in, particularly through Dublin Airport, and coming North? There was a problem with that a relatively short time ago.

Mr O'Neill: Thank you, Mr Sheehan. I believe that that relates to the travel locator forms. That is not strictly healthcare data. I believe that it relates to border security, as such, but it is information that people need. It is not within my policy area.

Mr Sheehan: OK, so despite the headline that there are no problems with data sharing, we have a situation here where that particular data relates to a healthcare issue, but there is a problem with sharing it for other reasons.

Mr O'Neill: Maybe I was unclear. I probably should have stated that there are no problems with direct healthcare information being exchanged — direct care being for those treatments and life-threatening cases. There might be issues that are outside our remit.

Mr Sheehan: But there are clearly problems in other areas of data sharing.

Mr O'Neill: Outwith the direct responsibilities of the Department of Health, there may be. We have enough to cover with what we are doing at the moment.

Mr Sheehan: OK. Thanks for that.

The Chairperson (Mr Gildernew): OK. Thank you, members, and thanks to the panel for your presentation, answers and commitment to send further information that was asked for during the session. Thank you, Cathy and the entire team, for your attendance. Good luck in the time ahead. I, honestly, wish you all the best of luck.

Can I ask one final question, Cathy? What is your key concern at the minute about EU exit? What issue is your top priority?

Ms Harrison: The main issue for me, out of all the issues, is healthcare supplies. An enormous amount of work has gone on. Now, it is about providing assurance and drilling down into some particular areas that we still need to focus on. We are moving into a very active phase now given the attention that is on that. I am in contact with wholesalers in the pharmaceutical industry. We have very good relationships. It is important to provide that assurance to the public that a huge amount of work has gone on and that we will keep a very active watch on that in the coming weeks.

The Chairperson (Mr Gildernew): Will you seek additional time for that, similar to the medicines issue, if it is required, and do you think that it would be granted if the situation were serious enough to warrant it?

Ms Harrison: Our understanding is that the additional 12 months that we have secured cannot be extended on the medicines issue. That is a definite redline, if you like, with regard to a new deadline. On other matters, we are waiting on some critical decisions to be made, as we outlined in the briefing. As I say, as a result, it may be a good idea for us to provide a further brief in a few weeks' time. I will take your advice on that, Chair. We would be very happy to do that.

The Chairperson (Mr Gildernew): Yes, that might be a good idea. Thank you for that. Thank you for staying on beyond the scheduled time because of the technical issues. I appreciate your answers, and good luck for the future.