Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): I welcome Department of Health officials to our meeting once again. I think that you have all been with us on several occasions. I welcome Ms Cathy Harrison, Chief Pharmaceutical Officer; Ms Eimear Smyth, senior principal officer in the EU exit transition unit; Ms Patricia Quinn-Duffy, EU exit lead in reciprocal healthcare and workforce issues; and Mr David Wilson, senior principal officer for safety, quality and standards.

Tá fáilte romhaibh uilig go dtí an Coiste Sláinte. Welcome to this morning's Health Committee. I will hand over to you, Cathy, to outline how you wish to deal with the briefing, and then we will go into a question and answer session.

Ms Cathy Harrison (Department of Health): Thank you very much. I welcome the opportunity to give an update on EU-related issues as they affect health. In advance of the meeting today, quite a detailed briefing was given to you. It was submitted a couple of weeks ago, so there are some updates today that I will give verbally as we go through.

I will outline some of the medicines issues, and then I will hand over to Patricia to take us through the people and services issues. We will leave a good bit of time for questions at the end. I will just give a run-through to remind members of the key issues on medicines and give an update on the EU negotiations and then hand over to Patricia.

Members will be aware that the Northern Ireland protocol came into effect on 1 January. Under the protocol, Northern Ireland continues to follow EU laws and regulations for goods, including medicines and medical devices. The key point here is that GB is not obliged to do so, so there is a difference.

The protocol has implications for supply and regulation of medicines. I will briefly outline those. Members will be aware that, historically, our model of supply of all our medical products into Northern Ireland has relied upon free movement of supplies from GB into Northern Ireland. We regularly use a figure of about 98% of our medicines flowing from GB into Northern Ireland via that route. However, under the protocol, medicines moving from GB into Northern Ireland will be handled as goods entering the EU from a third country. That means that medicines will be subject to additional testing, specifically batch testing, and some other verification.

In addition, under the protocol, prescription-only medicines that are used in Northern Ireland will have to have packaging that complies with the EU falsified medicines directive. That will not apply in GB. At the moment, the EU Commission and the UK Government have agreed a grace period, which we are currently in, until 31 December, to provide additional time for businesses to prepare for the full implementation of the protocol. However, the full implementation of the protocol as written would have a major impact on medicine supplies if left unmitigated and there were no improvements made to those arrangements. Moreover, industry would have to make significant changes to medicine supply routes in order to handle additional importation arrangements.

We are aware that the pharmaceutical industry has begun to consider the changes that it may need to make to its supply chains and that it has been awaiting further information from the Department of Health and Social Care (DHSC) on the arrangements with which they will have to comply when the grace period ends at the end of this year.

I meet regularly with representatives from the industry, and I have to say that the complexity that the arrangements have introduced is considerable. They are looking at the entire portfolios of medicines that they supply into Northern Ireland. I have met a wide range of companies, and they have all told me the same thing: they are committed to continuing to supply to Northern Ireland, but they are having to consider their options with regard to continuity of supply routes and are considering various options, such as rerouting directly from the EU or directly into Northern Ireland using the Republic of Ireland (ROI). They are also looking at joint packaging with ROI, for example.

They have also advised me that there is a risk of discontinuations. Unless mitigations are introduced, there is a risk that not all their portfolios would transfer over after the grace period. As I have advised previously, the pharmaceutical industry is legally obliged to give the DHSC six months' notice of any discontinuations to any part of the UK, including anything to Northern Ireland, and, because of that, as you know, the end of June was a critical point for us. Industry was stressing to us that it was having to make business decisions. It was a critical time. I have to advise the Committee that, at this stage, a relatively small number of notifications of discontinuations of products has been made to the Department of Health's portal. That information is commercial and sensitive. Numbers are currently low.

In addition to supply issues, I remind members that there are issues relating to the licensing of medicines. Since the start of January 2021, if a medicine is licensed through the centralised authorised procedure, which is handled by the European Medicines Agency (EMA) — that covers innovative medicines, such new medicines, cancer medicines etc — the Medicines and Healthcare products Regulatory Agency (MHRA) can authorise any variations to those central authorisations and licences, as we call them. MHRA can authorise those changes in GB, but, in Northern Ireland, we have to wait for EMA to make the changes. That is an issue that we have to consider, because if there are any differences in the timelines between MHRA and EMA in their decision-making, or if there are any differences at all between the conditions on the licence — for example, with regard to age groups or how the drugs can be used or stored — it can present difficulty.

Members will be aware of a recent issue that we had with the lung cancer drug Tagrisso. That arose because Tagrisso was already a centrally authorised product, and the new indication for lung cancer was approved. MHRA was able to make those changes quickly for GB, but we had a lag period when we had to wait for EMA. To avoid delay in Northern Ireland, that was all managed. Patients had access to the drug. It was managed by us working with DHSC and MHRA. We need to be aware of that in the future for centrally authorised products.

The other area relating to licensing affects medicines that are licensed through another process called "decentralised" or "mutual recognition" procedures. There is a difference of opinion on the location of specific functions for testing. That was one of the areas, along with some of the supply areas, that have been the subject of the ongoing negotiations with the EU.

Quite a number of issues relate to medicines. For that reason, there has been ongoing discussion with the EU, because we wanted to reach some kind of EU-negotiated solution to say, "Look, a lot of those issues could not have been predicted a number of months ago". Now that we know more, and we know some of the risks, formal negotiations have been going on. The UK Government have been working with the European Commission, and proposals have been put forward by the UK. The whole point and aim is to mitigate any risk to the continuity of our supplies in Northern Ireland as a consequence of the protocol.

I can advise the Committee that, yesterday, 30 June, the EU Commission announced a number of solutions to help the implementation of the protocol. It refers to:

The Commission also indicated in its statement that it will put forward a legislative proposal in early autumn in order to be able to finish the legislative process before the end of the grace period.

The EU proposal is being given careful consideration. It is highly complex and covers a number of areas. Unfortunately, as a result, I cannot comment on any further details of the proposal today, other than to say that it is under consideration and we will know more shortly. Although I welcome the announcement, and it is positive because we always wanted to see a negotiated solution, we need to see further details. When I have seen those and have been able to brief the Minister, I will advise the Committee and come back with more detail. I cannot provide a lot more detail today.

I want to remind members that, in addition to the ongoing negotiations with the EU, considerable work has been going on in the background between me and my team, officials in DHSC and officials in MHRA on other mitigations that might be needed to maintain supplies of medicines. We cannot risk any interruption to our medicine supplies, as you know. That work is still going on. When the fine detail of the EU negotiation is known, we will know which of those mitigations can be stood down and which may need to be taken forward.

Moving on from medicines, a couple of things have happened in relation to medical devices since my previous update. A statutory instrument, the Medical Devices (Northern Ireland Protocol) Regulations 2021, was laid on 16 June. The EU's medical devices regulations came into effect in Northern Ireland on 26 May. On data adequacy, I can update you briefly that, on 28 June, the EU Commission adopted two adequacy decisions for the UK. The EU indicated that that means that personal data can now flow freely from the EU to the UK.

That is the end of my update, Chair. If you are content, we can hand over to Patricia.

The Chairperson (Mr Gildernew): Yes, absolutely. Thank you, Cathy. We will go to you, Patricia.

Ms Patricia Quinn-Duffy (Department of Health): Thank you, Chair. I will give an update on the people and services elements.

There has not been any movement on reciprocal healthcare since the introduction of the Trade and Cooperation Agreement (TCA) and the social security protocol. However, the Irish and UK Governments have been in negotiations on the overlap between the memorandum of understanding (MOU) between Ireland and the UK and the TCA, as to which would apply. They have not issued guidance on it yet, but we expect there to be an exchange of letters shortly, which will be publicised. At that point, I will share those with the Committee so that it can identify which protocol applies in which circumstance. Some of the provisions in the MOU are slightly better than in the TCA for British and Irish citizens in the two jurisdictions in the common travel area (CTA). That guidance should be provided fairly shortly.

On reciprocal healthcare, we have shared guidance with stakeholders in Health and Social Care (HSC): patient payment officers, family practitioner services and the board. We have had discussions on applications of the EU withdrawal agreement and the Trade and Cooperation Agreement. We have sent that out for feedback, because there are always complications on the ground, and people need a bit more information on some applications. That is an ongoing process with operational colleagues.

We had a major announcement this month with the Minister requesting the reinstatement of a temporary scheme, similar to the cross-border healthcare directive. That opens today in the board, and it will accept applications from today. It allows patients ordinarily resident in Northern Ireland to seek treatment in the Republic of Ireland and have the cost reimbursed up to the cost of the treatment to the HSC in Northern Ireland. The proposed scheme is an administrative scheme that has been developed under section 14(a) of the Health and Personal Social Services (Northern Ireland) Order 1972, and we are making arrangements with the board to deliver that service and those arrangements.

Basically, it will work very similarly to the cross-border healthcare directive. The patient must have a diagnostic by a Northern Ireland practitioner; they then decide that they would like to access private treatment in the South. It is up to the patient to source their provider and then apply to the board for authorisation. To ensure that patients are accessing healthcare on a similar basis to that which would be provided in Northern Ireland, and that we are aware of the number of applications and treatments for budgeting purposes, we have introduced the need for prior authorisation of treatments before a patient can go to the Republic for their treatment. That is how the scheme is run in the South, but, in the UK, emergency care and some other treatments would have been available under the directive without prior authorisation. The patient would arrange treatment, pay for treatment and then seek reimbursement from the board.

There are eligibility criteria to ensure that those accessing the scheme are ordinarily resident in Northern Ireland, that they have been diagnosed with a clinical need for the treatment, and that the treatment is one that is commissioned by the board, meaning that they are not getting access to care that would not otherwise be provided in Northern Ireland. The patient will receive repayment up to the value of the treatment in the HSC. That will be discussed with the patient during their application, and the healthcare resource group costs will be available to patients, although they are very complicated, and a discussion with the board at that point is probably very important for the patient.

There are exemptions

long-term care, such as social care elements, will not be paid for out of the scheme. That is similar to the cross-border healthcare directive. Organs and organ transplants will not be available, nor will public vaccination programmes. That is exactly the same as the cross-border healthcare directive.

As with the prior scheme, no costs will be reimbursed for travel or accommodation through the scheme. As the patient is stepping outside the HSC in Northern Ireland, it is their responsibility to be as assured as they can that the practitioners that they see in the Republic provide quality treatment. To help with that, we have been in touch with our counterparts in the Republic, and we are working together to allow patients to continue to access the national contact point that was available under the cross-border healthcare directive, which gives a bit more assurance for the treatments in the South.

We recommend that any patients using the scheme have a valid global health insurance card (GHIC) or European health insurance card (EHIC), so that they do not have difficulties accessing any emergency treatment in the public sector. We also recommend that they have comprehensive medical insurance, because, if they are in a private healthcare setting, they may need additional treatments that are not part of the authorised treatment. In that case, they may have to pay additional costs, which might not be recoupable from the board, and the medical insurance really should cover that element. It is more a safety net because EHIC and GHIC can only be used in a public setting.

During this period, the Minister has requested that we do a full policy review and consultation on the scheme to see how we will look it in the future, as it has been capped at 12 months to start with.

The next urgent issue is the EU settlement scheme, which closed yesterday. To ratify their rights under the EU withdrawal agreement, EEA and Swiss citizens should have applied to the scheme by yesterday. To date, as far as I am aware, the UK has not extended the scheme to allow late applications or an extension to application times. Rights under the EU withdrawal agreement include rights to access healthcare. The settled status is an immigration status to continue to live and work in the UK. Those applying to the scheme will receive either settled status or pre-settled status. Anyone applying will get a certificate of application once their application has started to be considered.

We are aware that some people have not applied, and the Home Office has made it clear that late applications will be accepted under a range of conditions, which, to be honest, will be taken on a case-by-case basis because it is not very clear what those conditions will be. It has said "exceptional circumstances", but we do not know what those exceptional circumstances are. However, the Home Office has made it clear that there should be no discrimination against those who have settled status, as it is up to the individual to apply. It has also advised that there should be no retrospective checking of settlement status by employers. However, right-to-work checks for new employees will include slightly more evidence for EU citizens. A settled status will be looked for at that point for working purposes.

In the run-up to the closure, in the final weeks of the applications, we advised our stakeholders to tell those of their employees who had not applied to get their applications in by yesterday. We also shared employers' duties with stakeholders across the HSC.

Healthcare is a residency-based system in Northern Ireland, and the test to determine eligibility is known as ordinary residence. For EU citizens who were in Northern Ireland before 31 December, that would be an EU settlement status. We understand that some people might not have applied and that the applications will be considered, but those who have already registered with a GP are considered to be ordinarily resident. They will have had an ordinary residence check made, and there will be no retrospective checks on GP registrations. However, if a person were to move to a new GP or to apply initially to a GP, and they have not done so before, they would go through an ordinary residence check. If, at that point, a person is discovered not to be registered, we would encourage them to get EU settlement status and to apply to the settlement scheme, and we would direct them to how they can get help to do that.

All emergency treatment is free at the point of delivery in an emergency department, and necessary healthcare will not be denied to anyone. However, some people may be eligible for a charge unless an exemption applies under the Provision of Health Services to Persons Not Ordinarily Resident Regulations (Northern Ireland) 2015.

As far as the Home Office is concerned, once they apply to the EU settlement scheme, their application is accepted and they have a certificate of application, people's rights are maintained until their application's completion, however long that may take. That may include any review of what their status has come out as. I have been told that that process could take up to a year. As long as people have a certificate of application, however, they will still be able to access healthcare on the current grounds.

Other areas include the mutual recognition of professional qualifications and the registration of professionals. Dual registration of professionals is ongoing between the North and the South to ensure that professionals can continue to provide North/South services adequately. We are working with the Department of Health and Social Care and the Department for Business, Energy and Industrial Strategy (BEIS) in London on continuing arrangements after the standstill point, which is the two years during which the UK is still offering automatic recognition for the automatically recognised professions. Work is probably going to get under way on that in the autumn and will go on into 2022. We are working very closely with BEIS on updates on the common travel area, and we have regular meetings with it on the compatibility of regulations and on the regulators working together, as the overarching MOU on the CTA directed. There has been very little movement on that to date. There have been lots of discussions held, research done and enquiries made, and I suspect that we will have more to tell the Committee come the autumn about the regulators working together under the CTA and on the direction of travel for professional qualifications.

We have three healthcare frameworks: blood, tissue and organs and health protection. There has been very little movement to date on their getting any scrutiny. There are negotiations under way to include more on the Northern Ireland protocol and the UK internal market in the frameworks, and because of that, no further scrutiny has been done. We hope that, over the summer, the frameworks will be updated further to include those elements, because it is very important to Northern Ireland that they be in there and that the frameworks contain those agreements, which we would then be able to scrutinise in the autumn. The four jurisdictions will have separate scrutiny processes, and we want ours to include details of all the things that will impact on Northern Ireland, as we will be complying with the EU regulations, while the rest of the UK will not.

The Committee asked for feedback on the reciprocal healthcare framework and for that to be taken forward. I have taken that back to the Department of Health and Social Care, but there has been no further movement on or review of that. There has been minor movement on the agreement of the MOU under the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019, which is the underpinning legislation of the agreement that replaces the reciprocal healthcare framework. We have had very little movement on that to date, but the four UK jurisdictions give regular updates. Along with Scotland and Wales, we are pushing to have some amendments made to the MOU that will be in place instead of the reciprocal healthcare framework. We said that we would like a review of that as well, but, again, the Cabinet Office has not asked for an update on that. I just want to advise the Committee that there has been very little movement on that since our previous update to the Committee.

Those are all the updates that I have on people and services. There has been some movement on some things, and not an awful lot of movement on others, but we expect other areas to start apace in the second half of the year, and we will keep the Committee up to date with that.

The Chairperson (Mr Gildernew): Thank you, Patricia. There is a lot in both those presentations, and I thank you for them. I will be as brief as possible, because we are very conscious of time.

Cathy, I will go to you first. My first point arises out of what you flagged up about six months' notice of any discontinuations being needed. Will you outline the impact of the discontinuations and tell us whether those are being mitigated or you are confident that they can be mitigated? Will you give us some idea of the types of areas that we are talking about and the significance of mitigation?

Ms Harrison: There are a small number of lines at the moment. Those are commercial and sensitive, so I cannot provide any details on them. I can, however, advise that a process will be taken forward whereby each one of the medicines and the implications of their withdrawal from the Northern Ireland market will be considered. That work is to be undertaken in the coming weeks. For example, we could have a situation in which a range of alternatives to a particular drug is already on the market. If so, no further action may be needed. We really need to go through them case by case. We have not been in this position before specifically for Northern Ireland. Some drugs are discontinued in the UK, and a risk assessment would be done for the whole population, but we have not been in this position before, so we will go through them on a case-by-case basis in the coming weeks.

The Chairperson (Mr Gildernew): I am very conscious that you and I discussed those issues at length way before Brexit even came around, but this is where the rubber meets the road.

I will ask you a more general question. Brexit has led to a lot of things having to be rearranged. There are new distribution lines and new channels. Labelling and licensing have changed. There are so many issues with medicines.

I tentatively welcome some of the very recent indications that there are some areas of movement that could be quite significant, and I welcome the fact that you flagged up some of those areas today. In general, however, regarding the ongoing negotiations and the arrangements that are being made, it has always been my view that we need to address whatever the issues are positively, but that requires goodwill and negotiating in good faith. Are you of the view that those negotiations are taking place in a climate of goodwill and good faith? Are you confident that that will be maintained in order to ensure that the negotiations being carried out by London take cognisance of the fact that we have a particular vulnerability here in the North and a very specific set of requirements and that we need to ensure that we have medicines and medical devices?

I am struck by the fact that I have heard some English politicians in recent days say that the EU takes a legally purist approach to this. That sounds to me as though the EU insists that laws and agreements are upheld. I am therefore concerned that there could be some sort of poisoning of that negotiation. Is there a positive framework, and are issues being worked through effectively?

Ms Harrison: I believe that they are. The seriousness of the issues with medicines is now well understood by all parties, and a huge effort has been made by both sides really to understand the issues. I have no reason to believe that there is anything other than a positive tone to the discussions.

The Chairperson (Mr Gildernew): OK. Thank you. I have a couple of questions for you, Patricia.

First, I note that you said that you have to have a diagnosis here to access cross-border reciprocal healthcare. I also note that there are 137,235 people waiting for a diagnosis. That is a 4·7% increase on last year. A significant part of the population is therefore precluded and excluded from the scheme as a result of not having received a diagnosis. Is that not a concern? Should you not have been looking at the potential for people to access a diagnosis in the South as part of how we address waiting lists here? Is that not a fundamental and first building block of health treatment?

Ms Quinn-Duffy: Sorry, Chair, but "diagnosis" is probably not the right word to use.

The Chairperson (Mr Gildernew): It was "diagnostic". We have a particular problem with diagnostics.

Ms Quinn-Duffy: Yes. If people have a letter from their GP to say that they need a diagnostic, they can seek that diagnostic under the cross-border healthcare directive. The original way in which the cross-border healthcare directive worked was that people did not need authorisation from the board. They now need to have a letter from their GP to go to the board to get authorisation to seek a diagnostic, however. They can apply for that. I am sorry if I misled the Committee, Chair.

The Chairperson (Mr Gildernew): OK. That is an important clarification, which I welcome. It is key that we explore every avenue to try to deal with waiting lists. I am conscious that that is only one small element of the wider cross-border directive. I have personal experience as an MLA of assisting and supporting people to travel across Europe, often for hip treatment and other things that cause so much pain and distress. None of that is currently available, as we are outside the system. Is there any progress to report on further access to wider European healthcare?

Ms Quinn-Duffy: That will be taken forward within 12 months in the review of the scheme. The difficulty with accessing cross-border European healthcare is that we do not have reciprocity with the other nations. The other nations' national contact points do not have to provide patients with any information or background on the clinicians whom they would be attending, so there is potentially more risk involved in travelling further afield. We have some arrangements with the South to be able to access the national contact point. We are working together on that, so that will be considered.

You are right to say that very different costs apply around Europe. Lithuania, Latvia and Hungary are places to which people went to get osteo-related treatment for hips, knees and shoulders, for example, and it is sometimes more cost-effective to go to those places than to the Republic. At the moment, we have to balance that against patient safety and travelling in the current conditions. All of that will be taken forward in the review this year as to whether we can extend the scheme further afield to the rest of Europe. That having been said, most patients who used the cross-border healthcare directive would have gone to the South.

The Chairperson (Mr Gildernew): Thank you. We will keep an eye on that. My question comes more from the point of view of availability than of cost. It is about eating into those waiting lists and not allowing them to grow. The cost element is very important, but accessibility and availability are issues as well.

My final question before I go to members is on the EU settlement scheme. I raised the subject in Chairperson's business. In my constituency this week, I had an engagement with a group of young children from East Timor who had put together a container of aid for their compatriots back home. I picked up significant concern and anxiety among that group of people in my community in Dungannon about their status and general situation. I understand that people can access emergency medical care and that that does and will happen, because people need it. My concern, however, is that people will be afraid to come forward for the booster vaccine. It is not something that they absolutely have to get, but they have been encouraged to do so. Given that we are dealing with a pandemic, it is important to extend the EU settlement scheme in order to reassure those people.

From running a business in the area and years of working in the health system, I know that the other thing to consider is that we are totally reliant on those people in key front-line businesses, such as food production and engineering, and in healthcare, domiciliary care and all of that. They are important to our community, yet they are particularly vulnerable in those settings. There is therefore a huge need to address the fact that the end of the settlement scheme could add to people's hesitancy to come forward for a vaccine. They may be afraid that doing so will trigger a look into their status. That is a significant issue. What are your thoughts on that, please?

Ms Quinn-Duffy: We have been in contact with the Executive Office about communications around the settlement scheme. I will just clarify that people from East Timor are generally Portuguese citizens.

The Chairperson (Mr Gildernew): Some are, while some are not. I am just using that as one example. There are all the other communities as well.

Ms Quinn-Duffy: Yes. Settlement status applies to anyone who is a European. It will not apply to anyone who has another immigration status. There is an issue around access to vaccines. We have been participating in some discussions around there being no recourse to public funds. Some people may end up not being able to access treatments or may feel vulnerable that they are not able to do so. You are correct about the vaccines. That is something that we should probably take away and look at to see whether we need to issue communications. I can also speak to the COVID vaccine teams about whether they have had any difficulties to date with getting vulnerable and marginalised groups to accept taking the vaccine and then address the settlement status question in that mix.

The Chairperson (Mr Gildernew): OK. Thank you, Patricia. That is an important issue, so I appreciate your commitment to having a look at it.

I will now go to members. In the light of time pressures, I remind members and the panel to be as brief as possible with questions and answers.

Mr Chambers: I welcome any movement that guarantees the unfettered supply of medicines and medical devices into Northern Ireland after 1 January 2022. I note that Cathy said that there was a good tone to the negotiations at the moment. I will refer back to the presentation that European Commission vice president Mr Šefcovic made to a Stormont Committee earlier this week. When he was asked about the supply of medicines into Northern Ireland, he was reported as saying:

That comes across to me as some sort of blackmail. It is quite disgraceful that an EU negotiator would try to use the health and welfare of the citizens of Northern Ireland as some sort of political football. Does Cathy feel that a statement of that kind, coming from a senior EU figure, compromises or undermines her negotiating position on new arrangements?

Ms Harrison: What I will say, on the positive side, is that we have now received a written proposal from the EU that outlines the details on medicines. That is being given consideration, and I cannot provide any detail on it, but that is potentially the more important focus at the moment for me. We really need to understand the scope of that and how comprehensive the proposals and solutions are that have been put forward.

Certainly the statement yesterday suggests, in the Commission's words, that it is a "creative solution" that:

We need to see a little bit more detail on that, and I will come back to the Committee, Mr Chambers, when I have that detail. My focus is on seeing what is on the table and how far it goes, and we will take it from there.

Mr Chambers: It seems as though Mr Šefcovic was on a solo run on Monday when he spoke to the Committee. Thanks, Cathy.

Mr Carroll: I have a couple of questions. I will run through them quickly together, because I know that we are tight for time. The first one is on the discontinuation of products. Cathy said that it was commercial and sensitive, but, to be frank, and with respect, we need a better answer than that. We need to find out how many products we are talking about: is it four, five, 15 or 20? What is the number? It is not good enough that "commercial and sensitive" is the argument. You indicated that they may be easily replaceable. Is that the case, just for clarity on that?

Why is the period for the new cross-border treatment scheme only 12 months? Is there an appeals process to challenge that? I have two other questions. The healthcare scheme is important, North and South, in terms of lack of services and considering the fact that, to this day, hundreds of women, North and South, still travel for terminations. Have there been any discussions about improving access to those services for women on the island?

Finally, on the EU settlement scheme, as you indicated, even though the scheme has ended, there is some flexibility. The problem is that the flexibility lies with the Home Office, which is not always great, to put it diplomatically, when it comes to people's precarious immigration status. What consideration has it given, or will it give, to people's late applications being down to inability to get access to documents from their doctors, or from whomever, because of COVID? If there is a period when their settlement status is being considered or appealed, will they still have access to public funds if there is a period when they are unsure or their status is uncertain?

Sorry about all the questions, but we are short on time, so I thought that I would throw them all in together.

Ms Harrison: Discontinuation numbers are quite low at the moment. There is a formal notification process, and, when companies notify DHSC, it is on the understanding that the information will be handled sensitively. I cannot provide more information about that. On the question of whether they are easily replaceable, what I said was that we need to go through it on a case-by-case basis and see exactly what we are dealing with. I am sure that there will be a range of issues. Replacements may be available for some products but not others, and we will have to look at other mitigations. The six-month notice period gives us a bit of time to work through that.

The Chairperson (Mr Gildernew): OK. Were there questions for Patricia in that?

Ms Quinn-Duffy: I will try to take you through them. The purpose of the 12-month period is to get a scheme up and running and allow us to do a full review of the policy and how it would go forward. The cross-border healthcare directive leaves a gap in relation to how we work with other countries on this. It is important that we get the best outcome for the people of Northern Ireland and that considerations are made appropriately. We obviously want to have a full public consultation on it to seek information, particularly from those who have travelled, in order to get the best policy and scheme for Northern Ireland if we go ahead.

Agreements on terminations are not my area; my advice is that that question is potentially one to ask the Department.

The Home Office has been lacking when it comes giving details of when or how it will accept late applications to the settlement scheme or of what it will accept as an exceptional circumstance. We have tried to get clarity on that, but it is still quite vague. We are not in a position to advise people anyway. We can advise them to go to the support services, particularly Advice NI and STEP, to get advice on how to apply. If someone has applied and has a certificate of application, their status basically remains as it was. They will be able to get access to healthcare and social services etc until the end of the process as if they had settled status. That could be through appeals and reviews and, as I said earlier, it could take up to a year. For those that may go through, they expect it to take the full length of the application process.

Mr Carroll: Thanks. I know that you said that the advice from the Home Office is pretty vague, but can you share that, as well as any clarity around access to benefits and healthcare? It would be useful to have that in writing. Thanks.

Ms Ní Chuilín: Gerry asked a question about information being commercial and sensitive. I wanted to ask about that as well. Is it really just a criterion for commercial sensitivity? You said that negotiations are going on and that you hope that they will be clarified in the future. Can we have a bit more detail about that?

My other question has already been covered. It is about the EU settlement status and the MOU on cross-border travel. What I want clarification on, if you do not mind, is, if the cost for a procedure or diagnostic is higher in the South than it is with the HSC here, where is the negotiating, and are the patients expected to make up the shortfall? Those are my questions.

Ms Harrison: I can provide a written explanation about the details of commercial and sensitive.

The negotiations that you referred to have resulted in the UK Government providing a proposal to the EU, and the EU is now coming back with a range of formal solutions. That is what we are considering at the moment. The negotiations have yielded some outputs. We just need to go through the detail of those to see how far they go.

Ms Ní Chuilín: Very briefly, Cathy, if those drugs are sourced within Britain, which jurisdiction is the commercial sensitivity with?

Ms Harrison: There is an issue with the release of information. Your question was about who it is held by. That information is held by DHSC. That is the easiest answer. The companies notify DHSC under certain conditions, and they understand how their information will be handled. DHSC shares certain information with us so that we are kept aware and so that I can update you and the Minister, but we do not get into a lot of detail. I am not at liberty to disclose that, because the information is held by DHSC. It is owned by DHSC.

Ms Ní Chuilín: OK, so you will not have to follow Official Journal of the European Union notices around that commercial sensitivity. I would appreciate it if you could get that in writing. I will leave it there, as I know that we are pressed for time.

Ms Bradshaw: Thank you, panel, for this morning. First, what is the situation with the approval of new drugs after December 2021 by EMA or MHRA? My second question is on cross-border healthcare provision. The way that I read it is that you source the provider, you pay up front and you cover any shortfall. Why is the same process not accessible to independent hospitals in Northern Ireland? I have a second part to that. Can you go privately to an independent hospital and get a diagnosis that allows you to go to the Health and Social Care Board to go to the South? It is really just around the logistics. Thank you.

Ms Harrison: We anticipate continuing to follow our existing arrangements on medicines and approval. Broadly, there are two stages here. First, there is the marketing authorisation being given to the drug, and that is centrally authorised medicines, which cover most of our innovative medicines, Paula, such as our new cancer medicines and other medicines that we are waiting for. Marketing authorisation is stage 1, and those will all go through the centrally authorised route for GB and us. Once you have the marketing authorisation, the process starts with how the National Institute for Health and Care Excellence (NICE) will consider them for use in the health service. You know that we follow NICE, so our aim is that we will maintain those arrangements. Some issues may arise that we will need to consider. We will be work through those in the coming weeks and months to determine whether there are any differences between us and any divergence.

Ms Quinn-Duffy: I will answer your other questions. Cross-border healthcare provision is not currently available to the Northern Ireland independent sector because it is based on the cross-border healthcare directive, which was not available to the independent sector in Northern Ireland prior to Brexit. That is why it is a 12-month scheme, as I explained earlier. It is to look at all the different options, and, if it is the independent sector, we will need to consider that. Should we be allowing this to the independent sector in Northern Ireland and should we be allowing it to the independent sector in GB? Those things need to be considered, which is why the scheme is a 12-month scheme, with a review of the full policy. Yes, we are aware that that is an issue, but, as I said, it is based on the cross-border healthcare directive, which did not allow for access in your home territory.

On getting an independent sector diagnosis, yes, it is quite appropriate to take that to the board to ask for authorisation to travel.

On Carál's question, the patient meets the shortfall between what it would cost the board or Health and Social Care in Northern Ireland and the private healthcare cost in the South, so there is a patient element and there is a board element to the cost of treatment.

Ms Bradshaw: Can I come back on that very quickly, Chair?

The Chairperson (Mr Gildernew): Yes.

Ms Bradshaw: Obviously, this is something that is desirable, and I am not knocking it down. However, because it is no longer an EU requirement to have this, is there not the potential that this scheme could be legally challenged by independent sector providers in Northern Ireland or in GB? It does seem like unfair competition.

Ms Quinn-Duffy: To be honest, yes, we have considered that that is a possibility with this scheme. It is an arrangement under the 1972 order, and we have looked at that and have considered that. Again, that is why the scheme is a 12-month scheme to allow us to consider, rather than the cross-border healthcare directive as such, the full application of this policy of allowing people to seek treatment in an independent sector, to have part of the funds of the cost of healthcare paid back and reimbursed to them, and whether or not that should apply to Northern Ireland, the UK, the Republic of Ireland, Europe and/or wider. We have also had correspondence and considerations from people who are going to Turkey for treatment, which would not have fallen under the cross-border healthcare directive. We need to consider a lot of things to give a scheme under elements that would apply, which is why it is to the Republic only. It is based mostly on the cross-border healthcare directive, and we will consider all those other options and considerations in the 12-month period.

Ms Bradshaw: OK. Thank you very much.

The Chairperson (Mr Gildernew): I have another couple of indications from Cara and Órlaithí. I ask everybody to be as brief as possible with questions and replies, please. Go ahead, Cara.

Ms Hunter: Thank you, Chair, and thank you, panel. I am mindful of time, so I have just one question. When you were before us in December 2020, I asked about radioactive isotopes. As we know, they are a crucial part of cancer treatment. Now that we are six months post-transition, do you have an update or any concerns on that subject?

Ms Harrison: Not at the moment. Our arrangements for radioactive isotopes were affected by the protocol's introduction in January, and the supplies that we relied on, which were previously flown into East Midlands Airport and then to Belfast, were diverted via Dublin. That caused some issues for our trusts, which we worked through. As you know, my team deals with a lot of day-to-day issues in relation to working with the trusts and the companies involved. I am pleased to say that those issues are now resolved, and we are back to having deliveries direct to Belfast. We keep a very close eye on that because of the time-critical nature of the drugs. At the moment, we have reverted to our Belfast deliveries.

Ms Hunter: Thank you, Cathy.

Ms Flynn: It is good to see you again, Cathy and Patricia. Cathy, you mentioned that some of the stakeholders in the supply chain are awaiting confirmation from the Department of Health regarding future arrangements. Apologies if I missed some of the context of what you were talking about, but will you elaborate on what the Department still has to confirm with the stakeholders? You also mentioned — we have spoken about this over the past couple of months — that a lot of companies and suppliers are reconsidering their options, and some have rerouted to go through the South as opposed to Britain. There is also the issue of joint packaging with the South. Do you have any figures on how many companies, in that process, are starting to go via that route? Have there been any issues with that? That process seems to be progressing straightforwardly. It would be a positive and not all doom and gloom, and obviously solutions can be worked out.

I am conscious that this is a public meeting and that the public watch a lot of Committee meetings. Some of the issues have been debated in the Chamber as well. When we talk about issues around shortages and discontinuations of drugs and medicines, it can worry people who are watching. Cathy, you mentioned a lag period for that lung cancer drug, but the important thing for me was that patients had access to that treatment and that drug. It was managed and worked through, so fair play to you for all the work that you did to oversee that.

On the discontinuations, you are dealing with small numbers of people who have gone into the portal when medicines have been discontinued. We have said before that there are supply disruption alerts that are constantly in the system. Cathy, you said before that it is quite normal to get those disruption alerts —.

The Chairperson (Mr Gildernew): Briefly, please, Órlaithí.

Ms Flynn: Sorry. Are the levels that you are dealing with for disruption and discontinuation normal?

Can it be down to a global supply chain issue, or is it more as a result of Brexit?

Ms Harrison: Industry is specifically waiting for guidance on what is expected of it when the grace period ends. That will be informed by the offer from the EU, and the analysis of that will then inform what advice can be given to industry. That will then allow industry to start to make firm decisions. The companies that have been speaking to me have been advising that one of the consequences of the protocol is that they will, potentially, have to reroute. I have no evidence that they are doing that on any kind of large scale. We do not monitor that at the moment. I do not think that it is active currently, but it is on the cards from January. There is no need for them to do anything at the moment because we are in the grace period. They are really still in the planning process.

You make an important point about reassuring the public about shortages and discontinuation. First of all, issues always arise across the world with the global market in medicines, and we are constantly dealing with issues. There is a high level of surveillance across the UK, and, when issues arise, we provide advice, such as supply disruption alerts and other advice. At the moment, there is no significant increase in those. The thing that could start to change in the future is that, depending on the outcome of the negotiations and the proposal that is on the table, we may have more Northern Ireland-specific issues to deal with that do not affect the rest of the UK. In all cases, our aim will be to maintain continuity of treatment. We do not want anyone who is listening to be worried about their treatment or medicines.

Ms Flynn: Thank you, Cathy.

The Chairperson (Mr Gildernew): I thank the panel very much for the detail and for your commitment to provide further information in writing to the Committee. I wish you all the very best of luck as you continue to work through extremely difficult issues that are of concern to the Committee. We appreciate the engagement on that basis. All the very best, and take care in the time ahead. Thank you very much.