Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): We will now receive a briefing from Department of Health officials on Brexit issues. I welcome Ms Cathy Harrison, the Chief Pharmaceutical Officer. Are you able to hear us, Cathy?

Ms Cathy Harrison (Department of Health): Yes, I can, Chair.

The Chairperson (Mr Gildernew): Thank you. We are hearing you loud and clear. I welcome Ms Eimear Smyth, the senior principal officer in the EU exit transition unit. Are you able to hear us, Eimear?

Ms Eimear Smyth (Department of Health): Yes, thank you, Chair.

The Chairperson (Mr Gildernew): Thanks, Eimear. I welcome Ms Patricia Quinn-Duffy, who is the EU exit lead on reciprocal healthcare and workforce issues. Are you able to hear us, Patricia?

Ms Patricia Quinn-Duffy (Department of Health): I can indeed, Chair.

The Chairperson (Mr Gildernew): You are all very welcome back to the Committee. We appreciate that this has been a long engagement, and we are looking forward to hearing your briefing this morning, after which we will have a question and answer session with members. I invite Cathy to outline how she will manage the briefing, and we will take it from there.

Ms Harrison: Thank you, Chair. We forwarded a paper to the Committee in advance of the meeting, which was a follow-up paper after our meeting in December. I propose to talk through the issues that relate to medical supplies. Then, my colleague Patricia Quinn-Duffy will take you through the areas of the paper that relate to cross-border services and people. We will leave good time for questions. If you are happy with that, I will proceed.

The Chairperson (Mr Gildernew): Yes, go ahead, Cathy. Thank you very much.

Ms Harrison: By way of background, on 30 December 2020, the UK and the EU signed the trade and cooperation agreement (TCA) governing the future UK/EU trading and security relationship. That free trade agreement has applied provisionally since the start of the year, on 1 January 2021. However, it still needs to be ratified formally by the EU Parliament. The Northern Ireland protocol came into effect in Northern Ireland on 1 January 2021. Under the protocol, the key issue for us in relation to medicines and medical devices is that Northern Ireland continues to follow EU laws and regulations on goods, which include medicines and medical devices, whereas GB is no longer obliged to do so.

The trade and cooperation agreement, which is the overall EU exit agreement that applies to the whole of the UK, covers quite a broad range of areas, most of which relate to the information that Patricia will update you on later. Those are matters such as reciprocal healthcare, healthcare security and recognition of professional qualifications. I will talk a little bit about medicines and medical devices and about what we are doing in terms of mitigations to ensure that we minimise disruption to patients and citizens in Northern Ireland.

I will outline what we have been dealing with since the beginning of January. The Committee may be interested to know about the general impact that EU transition has had on our medicines supply chain. From the start of the year, my officials in the Department have been dealing with quite a range of issues that has arisen relating to medicines and medical devices. That has had an effect on supplies going into hospitals, community pharmacies and some direct-to-patient models. The majority of those issues related to trader readiness, which, in a way, was anticipated, given the large-scale changes that the supply chain was expected to introduce. I can assure the Committee that the majority of those issues are resolved now. We are working through them on a case-by-case basis. A few issues remain to be sorted out, but we are working through those as they come up.

We have a surveillance system in place to pick up those issues. We still pick up issues daily, and my team is dealing with those. We have very good connections across the UK — with HMRC, the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA) — and they are helping us to work through solutions. I can assure the Committee that we are dealing with issues very quickly as they arise.

On the Northern Ireland protocol, the pharmaceutical industry currently benefits from a grace period for medicines. That was introduced at the start of January this year to give the industry a further 12 months to prepare for the large changes that will come as a result of the protocol. That is because the protocol has long-term implications for the supply and regulation of medicines.

Historically, our model of supply of all medical products into Northern Ireland has relied on the free movement of supplies from Great Britain. Around 98% of our medicines come from GB. Under the Northern Ireland protocol, however, medicines moving from GB into Northern Ireland will be handled as though they are goods entering the EU from a third country. That means that medicines moving into Northern Ireland from GB will be subject to additional batch testing and other verification. In addition, from 1 January next year, when the grace period ends, all the medicines that we use in Northern Ireland will have to comply with the EU's falsified medicines directive. That affects the packaging of our medicines, and that, again, will not apply in GB from that date.

The pharmaceutical industry has begun to make changes in advance of January next year, and we are working closely with the industry. A lot of work is also going on at national level. We are involved with that so that we can work in partnership with industry and help with its preparations. I can answer questions on that later.

Another area in relation to medicines is licensing. Since 1 January, if a medicine is licensed by both the UK regulator, which, for us, is the MHRA, and the EU regulator, the European Medicines Agency, Northern Ireland complies with the European licence. That is under the terms of the EU acquis. We are now different from the rest of the UK in that regard. If differences arise in the conditions that are detailed in each licence — the European licence or the MHRA licence — that can present difficulties for us. We will have to work through areas of divergence on a case-by-case basis.

Another licensing issue that has arisen, and which is being considered and given a lot of attention by the DHSC working with the EU Commission, is a difference of opinion between the locations of certain functions needed for the licensing of medicines: the MHRA has one interpretation; the EU has another. That is, potentially, quite serious for us. It could slow access to new medicines and delay the introduction of variations in medicines licensing, which happens routinely. That is being given top priority and is, I understand, part of the talks going on between the UK Government and Europe.

We are benefiting from two other grace periods in medicines and the medical supply chain. The grace period for parcels has helped us with some of our direct-to-patient models in particular. Home care supplies and some of our stoma supplies have relied heavily on that grace period and benefited from it. The grace period for the export health certificate (EHC) has helped us with the movement of certain medical feeds, including infant milk and other nutritional supplements. We welcome the fact that the grace periods for those products were extended until 1 October.

The grace periods are welcome. We have the grace period for medicines until 1 January 2022. We have the grace periods for parcels and the EHC until October. Even though they are welcome — they provide some positive short-term mitigations and give us more time to prepare for the big changes from next year — the Department of Health, my colleagues and I are working closely with industry, MHRA and DHSC on longer-term plans, because this is about long-term change and affects all medicines and medical devices. To ensure that we have processes in place that will support industry to be ready by 1 January 2022, a large programme of work is being overseen by the Northern Ireland programme protocol board, of which I am a member. It is looking at a multilayered approach — a wide range of issues and supports that need to be put in place. That said, the significance of the work involved is massive. There is a huge amount of work to be done across a wide range of areas. Almost every aspect of our supply chain needs to be looked at. There is a recognition that the timescales are very tight. In February, a formal request was made by the Chancellor of the Duchy of Lancaster for an extension to our grace period until January 2023. That has not been granted, but industry still says that it needs more time, so I imagine that we will return to that request.

There are also changes in medical devices. The main change is that GB manufacturers who plan to place medical devices on the Northern Ireland market must now appoint an EU or a Northern Ireland-based authorised representative. That is in line with the EU acquis. Non-UK manufacturers are now required to appoint a UK responsible person or a Northern Ireland-authorised representative who, along with the Northern Ireland manufacturers, must register devices with the MHRA before they are placed on the Northern Ireland market. Those changes are taking some time to bed in, and the medical device industry is adapting. Until 30 January 2023, we will benefit from the fact that the UK is recognising all EU-certified devices — those with the Conformité Européenne mark — in GB. That will help to support continuity of supply from GB to Northern Ireland.

In May, the EU medical device regulations will come into force. They are different for Northern Ireland. They are EU directives, so Northern Ireland will comply with them; GB will not. The industry has known for a while that these regulations were coming. They have been planned, and the

guidance on them was first published in 2017, so industry should be preparing for their introduction. A lot of support and advice for the industry has been published by the MHRA on the www.gov.uk website. There is, however, a recognition that the medical devices industry here needs more support and will need more, ongoing advice.

I will hand over to Patricia to pick up on the issues relating to access to healthcare and the workforce.

Ms Quinn-Duffy: Thank you, Chair, and thank you, Cathy. As Cathy said, the trade and cooperation agreement was agreed at the end of last year. Within that, we have been given some comfort around reciprocal healthcare. The social security protocol outlines all of the reciprocal healthcare provisions that will apply between the EU and the UK. In essence, it replicates regulation 883 on the coordination of social security for reciprocal healthcare almost in full, so we will still have access to needs-arising care, which will be similar to a European health insurance card (EHIC). We will have access to planned treatment, which will be similar to an S2. In Northern Ireland, that is generally used for major treatments, such as bone marrow transplants, in the South. Frontier workers will continue to have access to treatment in the jurisdiction in which they work. There will also be provisions for pensioners and posted workers when they move to another country. So, in essence, there is a continuation of the provisions for reciprocal healthcare for most people.

There are some differences, in that the protocol does not apply to the EFTA countries: Norway, Iceland, Liechtenstein and Switzerland. Currently, there are no reciprocal healthcare arrangements with those countries. There has been a re-enactment of an older Norwegian/UK reciprocal healthcare agreement, which allows for needs-arising care for British citizens. There are a lot of difficulties around that, in that it does not support residents of the UK. Hopefully, there will be some movement on those agreements in the next few months.

The memorandum of understanding (MOU) between the UK and Ireland to continue reciprocal arrangements was signed at the end of last year. The trade and cooperation agreement overarches that, and the UK and Ireland are going through both to ensure that, for the post-transition arrangements, there are enough provisions and to determine which provisions apply. In the trade and cooperation agreement, there is a significant element of documentation between the UK and Ireland that, to date, has not been necessary. For example, a pensioner would require an S1, and a frontier worker may also require an S1. Those kinds of documentations were not commonly used in the UK and Ireland. However, because the trade and cooperation agreement is an EU-wide agreement and applies equally to all member states, there will be some new documentation. That is being worked through so that everyone, North and South and in GB, understands what they need to collect from citizens.

Within the reciprocal healthcare element, the withdrawal agreement came into play at the end of the year for all citizens who had used their right of free movement. It applies in full the regulation 883 on the coordination of social security to those people. It also applies to their family members and survivors. So, there is an element of legacy and historical application of the withdrawal agreement.

Whilst the provisions are in the trade and cooperation agreement and the withdrawal agreement are fairly similar, there may be slightly more provision in the withdrawal agreement if people fall under that provision rather than the provision in the trade and cooperation agreement. There are some technical points in the guidance that we need to work through so that we can provide guidance for people on the ground.

The statutory rule (SR) to implement the trade and cooperation agreement is being finalised. We had to work through a number of issues around how it will operate on the ground with the trusts and with the Business Services Organisation (BSO) for registering people with GB. We have worked through that, and we feel that the legislation sits well and understands and applies the provisions. The Committee will get that SR very shortly.

The next point in the trade and cooperation agreement is the element of mutual recognition agreements for professional registration and qualifications. The UK and Europe did not come to an agreement on the continuation of the mutual recognition of professional qualifications (MRPQ) directive. However, they came to agreement on a framework within which regulators can negotiate, on a pan-European basis, to come to an agreement on the recognition of qualifications. In this sphere, in professions that are regulated in legislation to practise or to use the official titles in another jurisdiction, the person needs to be registered within that jurisdiction. The MRPQ directive allowed people to have their professions, in certain circumstances, automatically recognised, which meant that they did not have to demonstrate that their qualification was up to standard. It also allowed for a temporary and occasional application, which meant that, if you were going to be within the jurisdiction only occasionally, there was a slightly simpler way to register, which was not a full registration. The TCA has not come to an agreement on this within the European jurisdictions, so it no longer applies to Northern Ireland or GB-trained professionals. It means that all those professionals will have to follow through the general dual registration route, rather than having their qualification automatically recognised by way of the slightly shorter registration system.

The UK, on the other hand, has provided a two-year bridging grace period, during which it will continue to accept the automatic recognition of professions. Not all healthcare professions are under the automatic recognition system. Social workers, for one, are not automatically recognised for their training, but doctors, nurses, pharmacists etc are. Therefore, within the UK, automatic recognition of European-trained professionals will continue. Also, if there has been an application for a temporary and occasional registration, or if there was a contract prior to the end of transition, that temporary and occasional registration will still apply in the UK, for the year that it applies.

We have looked at other people issues. The settlement scheme is open until 30 June. Under the withdrawal agreement, if anyone wishes to apply their qualification for the withdrawal agreement, they should have their status ratified under the settlement scheme, either with pre-settled status or settled status. There is an opening whereby the Home Office has advised that it will accept late applications in exceptional circumstances, but it has not expanded on what those exceptional circumstances may be. Therefore, we encourage, and we use this forum to encourage, those who have not yet applied to do so. The Home Office and TEO are promoting the settlement scheme to all Northern Ireland citizens.

The cross-border healthcare directive finished at the end of December last year and no longer applies to the UK. It was not part of the trade and cooperation agreement. The UK and the EU agreed that it was not to continue. As members probably know, Ireland has implemented a scheme, which is to apply to Northern Ireland only, to continue a similar provision on an administrative basis for 12 months.

A paper on the options for Northern Ireland is being finalised before it goes to the Minister.

The frameworks for healthcare; blood, organs and tissue; and public health (serious threats to cross-border health) were agreed fully by the Joint Ministerial Council on EU exit matters. Those are some of the very few that have received clearance. The next phase is parliamentary scrutiny, on which I have been liaising with your Committee Clerk. Within the next few months, we will bring those to the Committee for scrutiny. With the elections in Scotland and Wales, there has been a bit of a delay in scrutiny across the UK as each jurisdiction needs to complete that themselves.

Obviously, there will be time for questions, and I am sure that you have plenty on this area. I will hand back to Cathy.

The Chairperson (Mr Gildernew): Thank you, Patricia. Yes, Cathy.

Ms Harrison: Thank you, Chair. I am happy to answer any questions now.

The Chairperson (Mr Gildernew): OK. Thanks. Cathy, you touched on medicines and medical devices, and there has been quite worrying and concerning language around the issue. Just to orientate the Committee to the scale of this, what level of medicines is being or will be impacted financially when the grace period ends?

Ms Harrison: Chair, that affects all medicines that are used in Northern Ireland at the moment — we have about 9,000 lines that we regularly use — and all medical devices. It covers everything that is governed by the EU acquis on the regulation of medicines and medical devices.

The Chairperson (Mr Gildernew): Can you give us an idea of the monetary value of those medicines annually?

Ms Harrison: It is £600 million.

The Chairperson (Mr Gildernew): OK. What about medical devices?

Ms Harrison: I do not have the figure for medical devices. We do not monitor that in the same way, but I can get an estimate from our trusts, based on what they use, and from BSO.

The Chairperson (Mr Gildernew): OK. Thanks, Cathy. You said that there is a difference of opinion — that in itself is worrying — and you then went on to say that that is quite serious. What sort of risk are we talking about? Where have you placed the issue on your risk register?

Ms Harrison: Without mitigation, those are very high risk. Without our taking action, without a very proactive approach being taken and if we did nothing at all until the end of this year, there would be a high level of risk. It is considered a very high risk area. However, an enormous amount of work is going on to avoid that. Ahead of the overall transition of the UK out of the EU, a massive amount of work was done with the medical supply chains. That is standing us in good stead in our understanding of the supply chains. Also, we have built up good relationships. That said, there is a lot of work to be done now on the detail. The movement of our medicines from GB to Northern Ireland is problematic because there are additional checks, such as batch testing. That means that the pharmaceutical industry is looking, where it can, for ways to avoid that route, so the medicine supply chain is being reorientated at the moment. Each part of the pharmaceutical industry is considering what it means for them. We have a lot of engagement with them. I meet a wide range of partners from different parts of the industry, including wholesale, haulage etc. Intense engagement is going on at a national level as well. What I am hearing is that they are all thinking their way into this now. More than that, they are starting to make plans, and changes are coming. In our role in the Department, our priority is to maintain access and equity of access to medicines. That means that our supplies are maintained and that we maintain equity with other UK citizens in accessing new medicines and therapies.

The Chairperson (Mr Gildernew): Many of us, and you and I, have discussed concerns about medicines for several years. We are operating and moving fairly smartly through the first grace period. There is a request to extend that grace period to January 2023. If that extension is not forthcoming — it has not been to date, I think, from what you have told us — what is the potential outcome? What will be the worst-case scenario in January 2022 if there is no extension to the grace period? What could happen?

Ms Harrison: I am already hearing that some parts of the pharmaceutical industry have made decisions and will be ready. In some of the meetings that I have had, I have been getting high levels of assurance that, yes, they are making those changes. It will have an impact on supplies in Northern Ireland, which I will come back to in a minute. I am working with colleagues at DHSC and MHRA on a range of mitigations, so that, if we need them, we will step in to avoid disruption to the supply chain for our patients. That is really the most important message from today: that a lot of the changes that will happen here are within the supply chain. We are working very hard and have so far managed to keep the impact away from the front line — our front-line clinicians and patients. That is what we intend to do.

The Chairperson (Mr Gildernew): That is crucial and, certainly, the first imperative. No one wants a situation in which people's health is impacted by a reduction in supply. Are we facing a potential increase in costs? You mentioned £600 million. We are already facing a difficult budgetary situation generally and in Health in particular. Are we potentially looking at significant cost increases as a result of the issues that you have set out, Cathy?

Ms Harrison: Certainly, the engagement with industry indicates that there are increased costs now in the supply chain relating to Northern Ireland. Essentially, Northern Ireland is now a very small market globally for pharmaceuticals and medical devices. I have had a very high level of commitment from all the parties with which I have been involved in the pharmaceutical industry on working towards a new normal, if you like, for Northern Ireland. However, there is a recognition that, in doing that, our costs are likely to increase. We are doing some work on that in the team. Obviously, we have to put enhanced surveillance arrangements in place. Quite a lot of work needs to be done on the supply chain in Northern Ireland, because, in the past, we have relied on just being part of the UK supply chain. We will now need to have enhanced surveillance on costs and access to medicines and on issues such as discontinuations.

The Chairperson (Mr Gildernew): What is your estimate of the increase in costs?

Ms Harrison: We do not have an indication yet of what that will be. It is very hard to predict at the moment, because companies are just beginning to make business decisions. The pharmaceutical industry is waiting for some critical pieces of guidance from Government, some of which relate to ongoing discussions at EU level. I understand that, within weeks, industry will receive further guidance. At that point, it will start to cement its plans. Our engagement with industry will then shift to the implications of that. We will come back to the Committee with more information as business decisions are made by industry on how it will adapt.

The Chairperson (Mr Gildernew): Thanks, Cathy. My second question is probably more for Patricia. It relates to dual registration of qualifications and staffing issues generally. We are all acutely aware of issues with staff pressures and waiting lists and the impact of workforce vacancies. Anything that creates a chill factor or a barrier to people working here is of major concern. In relation to dual professional registration, Patricia, what services are likely to be impacted as a result of changes to that requirement?

Ms Quinn-Duffy: The requirement for dual registration has not changed; it is the method of registration that has changed. There was always a requirement to be registered. That needs to be made clear. Anyone who is already registered continues to be registered and recognised under the withdrawal agreement, so, if any professionals have already registered, that registration continues. Therefore, that is not impacted. New registrants who are working in the Republic as part of their role will need to be registered.

We have estimated that the services that go into the South are the Northern Ireland specialist transport and retrieval (NISTAR) in particular to children's paediatric in Dublin with the hospital transport of a child. The other impacted services will be paramedics, because there is an MOU between the two ambulance services to support each other around the border regions. The other occasion on which people may go into the Republic concerns social workers who deal with at-risk children who are being placed with family members or in care in either jurisdiction. Those are cross-border services that go both ways. There have been discussions on all those professions and services, and we do not expect that there will be an impact on those services. Once nurses and doctors are registered, particularly around the NISTAR, there will be no further impact on services. Most of the other services come north: it is patients from the South coming to the North to have treatment. Professionals in the North give advice — for example, the North West Cancer Centre gives advice over the phone to patients — and all those things will continue to be covered by the registration in Northern Ireland alone.

There is a slight mixed bag of registrations, and because the UK has a two-year grace period for European qualifications — the two-year period is specifically for healthcare professions — anyone coming into the UK can still have their professions automatically recognised, so there are fewer barriers for people coming into Northern Ireland than there are for UK-trained professionals going to EU jurisdictions and, in particular, into the Republic.

I do not know whether that answers your question. There are negotiations and ongoing work between the regulators to look at the framework in the TCA. That will be a slightly longer-term process because it is a pan-European agreement on the recognition of training, so that will have to be agreed by all the member states. That will not happen in the short term. We then have agreements within the common travel area (CTA). It has been agreed that the regulators will work together in the overarching MOU on the CTA. Again, because that was part of the overarching UK-EU negotiations, no work was really done on the subject before the end of last year, so the regulators are now talking to one another and starting that process for coming to agreements within the CTA and within the EU, but, as I say, those things will not happen in the short term.

The Chairperson (Mr Gildernew): As a result of Brexit, have you noticed any further difficulties with, or tailing off in, the process for recruitment from European countries other than the South and countries outside Europe?

Ms Quinn-Duffy: Any difficulties or tailing off are probably more to do with COVID and its impact on the movement of people, but I do not have any figures to hand on that. The immigration requirements will probably impact more on Europeans than the recognition of qualifications, because there is a continuation of the recognition of qualifications for those who come to the UK. The new immigration requirements mean that someone who is coming to work needs to have a work visa, so there is an expense for Europeans who are coming into the UK to work. The healthcare visa reduces the price and cost to the incoming potential workforce in the sector, so there is less of an impact on healthcare workers than there is on those in other professions. The waiver on the immigration health surcharge for healthcare professionals also reduces the cost. If those two mitigations changed, there would probably be slightly more impact on Europeans. However, those provisions provide access to rest-of-world professionals and reduces the cost to them of coming here to work. Also, there is no limit on the number of people who can be recruited, so it opens things up to the rest of the world compared with Europe. The Government intend to review the impact of the points-based system on recruitment into the UK. At this time, it is very difficult to say what that impact has been.

The Chairperson (Mr Gildernew): Very briefly, Patricia, can you tell me what engagement you have had with your counterparts in the South on cross-border flexibilities and workforce issues?

Ms Quinn-Duffy: We have had a number of meetings with our counterparts on the provisions and what we can do to find solutions and come to a common agreement, because it is in everyone's interests that cross-border services continue and develop and that other services can be put in place. In Europe, there are, obviously, restrictions on what Ireland can do as it has to comply with the European acquis, whereas we do not. However, we are working with them on that issue and have regular conversations.

The Chairperson (Mr Gildernew): My final question is on reciprocal healthcare and the cross-border directive. I am starting to see large numbers of people being impacted by that, and I am sure that other MLAs are too. I understand that the legacy cases are still being dealt with and that there are some short-term reciprocal arrangements between here and the Twenty-six Counties. However, other parts of Europe were a significant outlet, and, given our waiting list situation, is the current situation not a disaster and should it not be a priority to get an urgent replacement for the cross-border directive?

Ms Quinn-Duffy: The options are going to the Minister. Once he has looked at them and taken advice, we can come back with further detail.

The Chairperson (Mr Gildernew): There is nothing that you can tell the Committee today on what is being done to address the situation. Before Brexit, people were able to avail themselves of treatments in Europe. What can you tell the people affected to offer some hope or light?

Ms Quinn-Duffy: Waiting list initiatives are under way to address waiting lists and waiting times, particularly because of COVID. Those waiting list initiatives are being taken forward as a priority in the Department to address waiting times, so that is where the focus is on addressing waiting lists and waiting times. The cross-border healthcare directive was an additional provision, which was available when we were part of the European Union. Options are being given to the Minister as to whether those provisions can be continued. I have to wait for his decision on the options that he has been given.

The Chairperson (Mr Gildernew): When would you expect a decision from the Minister?

Ms Quinn-Duffy: Very shortly. I was waiting for legal advice, which I received this morning. That will go to the Minister this week.

The Chairperson (Mr Gildernew): OK. Thank you. Before I go to members, I want to go back to Cathy about the risk register. I am not sure whether I picked up exactly on your response around medicines. I take it that you will have a risk register. What level of risk have you attributed to medicine supply in your risk register?

Ms Harrison: Medicines are considered high risk in the overall risk register. They are on red at the moment.

The Chairperson (Mr Gildernew): OK. Thank you.

Mr Buckley: Thank you, Cathy and Patricia. I appreciate your presentation. You will know that I have deep concerns about the implications and implementation of the protocol. The issue of medicine supplies and medical devices has not been given the political scrutiny that it deserves at present because it has been pushed down the line somewhat with the 12-month derogation. That was welcome in the first instance, but, as has been mentioned, the time is ticking on that clock. Cathy, you mentioned the engagement that is going on. I would like you to give us a broad outline of what the Minister and the Department are doing at a UK level to promote a mutual recognition agreement between the UK and the EU for medicines and whether there is any realistic prospect of that being progressed at pace before the end of the year. That will be crucial as to whether there is a cliff edge after the derogation period ends. That is my first question for Cathy.

Ms Harrison: Thank you, Jonathan. There is ongoing engagement on matters such as mutual recognition, which goes right to the heart of some of the regulatory challenges with which the industry is dealing. Those issues are handled at a national level through the Specialised Committee on the Protocol on Ireland/Northern Ireland. Those meetings are ongoing, and, in February, our Minister specifically asked for attention to medicines and medical devices issues to be escalated by the EU, and that was successful. Medicines are now being considered at those high-level meetings. That is where key decisions are made on the interpretation of the Northern Ireland protocol.

The Department is engaged with a wide range of groups. I am a member of a high-level Northern Ireland protocol programme board that reports to Steve Oldfield, who is the chief commercial officer in DHSC, and he reports to the Cabinet Office. A very high level of attention is being given to that matter. We are fully connected to it and have regular meetings each week. We are very engaged on that agenda. We are able to feed into those critical decisions through our engagement via the programme board and our engagement with TEO and its contacts. TEO is fully briefed and up to date on all those issues and can provide support through its engagement. The critical decisions are made at EU and UK Government level.

Mr Buckley: OK. Given your extensive engagement, which is important, what is your professional assessment of a realistic prospect of a mutual recognition agreement progressing before the end of the year, when the derogation period ends?

Ms Harrison: We have a very ambitious work programme that we are working on. Work has started and is ongoing. The timeline is extremely challenging. Twelve months was challenging, and now that we are well into the year, it is challenging. That is what I am hearing from the industry. It is not a uniform picture, however. The pharmaceutical industry is a very broad church. Multibillion-pound global companies are used to dealing with highly complex supply chains all around the world, and they have already made decisions about what they are going to do. However, there are also much smaller players, and the Department, and those working on this in the UK, recognises that those smaller players have a lot of issues to deal with in the time frame.

Mr Buckley: Given the huge difficulties that the protocol will present for GB companies accessing NI, can you give us a headline figure, percentage-wise, of medical goods and devices that come from GB mainland into Northern Ireland? You might not have that figure to hand, but it would be interesting to know. Given the multitude of legal cases taken around the Northern Ireland protocol, are you aware of any legal action forthcoming from the Minister or the Department on the Northern Ireland protocol and the disadvantage that it places on Northern Ireland citizens?

Ms Harrison: The percentage of medical goods that moves from GB to Northern Ireland is very high; we estimate it at about 98%. That is because we have always been part of the UK supply chain. There has not been a separate Northern Ireland supply chain until now. Almost 100% of our goods come from GB. I am not aware of any legal action being taken by the Department at the moment.

Mr Buckley: That figure should scare anybody: 98% of medical supplies and devices coming from GB are being affected by the madness of the Northern Ireland protocol. It is a serious issue. I am glad that the Department is engaging proactively to find solutions, including an extension period, to sort these issues out. I ask that Cathy come back to me or to the Committee on whether any legal options are being explored. Have there been any cases of category 1 goods being delayed at ports when arriving in Northern Ireland, and when will the six-month ferry operator contracts end?

Ms Harrison: At the start of the year, we anticipated some disruption, with delays at ports, but it never materialised. We have been dealing with issues successfully so that most patients and the health service have been unaware of any impact at all. Most of the issues have been about trader readiness and business decisions that companies have had to make for changes that have arisen because of EU exit and the Northern Ireland protocol. I am not aware of any significant delays with goods coming from GB into Northern Ireland that have had an impact.

Mr Buckley: I have two final questions.

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

Mr Buckley: Yes, I know, Chair, but it is a very detailed presentation and requires a thorough examination. Which seasonal vaccines could be most affected, and how could the supply problems be mitigated after 31 December? What is the state of play on the EU-related SRs still to be agreed and legislated for at this stage? Will it be necessary to bring forward further legislation in advance of the 12-month derogation period?

Ms Harrison: With regard to vaccines, we are working to continue with the involvement of Northern Ireland in national vaccination programmes. That work is well advanced. Patricia may have information on the EU-related SRs. Patricia, can you answer that?

Ms Quinn-Duffy: Yes. During the year, some technical amendments may have appeared due to scrutiny of the legislation that was laid before the end of the transition period. One on healthcare security will come to the Committee shortly. It is part of the applications around the frameworks for healthcare security. We may also have a few technical amendments to MRPQ and the legislation that was laid, but those are not particularly significant. They are to amend deficiencies in the legislation.

As agreements emerge between the UK and Europe and/or other jurisdictions, there may be amendments made to apply those, whether it is a trade agreement or a reciprocal healthcare agreement. Those may need to be applied through legislation, but, at the moment, we are not expecting a particularly heavy volume of work to come through.

Ms Ní Chuilín: Thank you, Cathy and Patricia. Your paper states that there is a cross-border healthcare directive and that Britain and Ireland are reviewing the terms of the MOU to clarify the interaction with the TCA. Where does that sit? It seems to me that the Minister has taken his direction from the British Government. What circumstances and implications are being fed through to that process?

Finally, on the drugs bill, the Minister made a statement in the Assembly this week about waiting times, and I think Patricia alluded to that, but I do not know because the statement was vague, as were Patricia's comments. Perhaps we could find out about that.

On the use of generic drugs, you said that there will be a financial increase. What is that increase? Are cheaper generic drugs being explored, since you correctly described the pharmaceutical industry as an "industry"?

Ms Quinn-Duffy: I will take the first few questions. You asked about the MOU and the TCA and the interaction. Basically, pre-exit, there were two different strands of healthcare that could be attained. There was that which was under the social security coordination regulations, which included your European health insurance card, which was your needs-arising care when you went abroad; and your S2, which was the planned care route to public hospitals. The other related to people who moved around, such as pensioners who retired to another EU state from wherever they worked. They were still responsible for paying for their healthcare.

Under the TCA, most of those provisions continue. In anticipation, Ireland and the UK were negotiating a continuation of that kind of reciprocal healthcare under the auspices of the common travel area. So, at the end of the year, we ended up with two similar documents. The UK Government and the Irish Government are working through the provisions in both the trade and cooperation agreement and the Ireland/UK MOU to identify which one applies and which one gives the most provision to patients moving around.

We are involved in those discussions because, with the border, we have the most daily use of those kinds of provisions, so we are at the table with those. However, it is between the UK and Irish Governments to come to an arrangement.

The cross-border healthcare directive is a slightly different provision. It was in Europe and was based on free access to services. As the trade and cooperation agreement did not come to any agreement on the provision of services, the directive no longer applies to the UK. The Minister asked us to look at what the options may be for that kind of provision for Northern Ireland patients, so we are looking at how that may be able to apply, whether it is possible to apply it, and whether it would be legal within the UK framework because the overarching frameworks in the European Union no longer apply to the UK. There are quite a lot of technical legal issues that we needed to bottom out first. As I said to the Chair, I got my final legal advice this morning, so we should be able to get that to the Minister today or tomorrow for his consideration.

The cross-border healthcare directive was a provision by which a patient could opt out of the national system, attend a private or public clinic or hospital in another European jurisdiction, pay up front for their healthcare, and have the equivalent value of what that treatment would have cost in their home jurisdiction repaid. It is a very different type of provision from the reciprocal healthcare arrangements.

The other thing that you talked about was the waiting list initiative. I do not have the detail on what that programme would be; we would need to come back to the Committee on that. It is part of the COVID recovery phase rather than the EU strand. We can get officials to come back with some more detail on that, but a waiting list initiative programme is under way to address our very long waiting lists. That is probably the only way to describe them.

The Chairperson (Mr Gildernew): OK. Thank you, Carál. I am going to move on to —.

Ms Ní Chuilín: Sorry, Colm. I did not have any feedback on the drugs bill.

The Chairperson (Mr Gildernew): OK.

Ms Harrison: You asked about generic medicines in Northern Ireland. The medicines that we use fall into two broad categories: branded medicines and generic medicines: Branded medicines are still under patent and tend to be newer medicines that are introduced to Northern Ireland at the same time as the rest of the UK and would be covered by the National Institute for Health and Care Excellence (NICE), for example. We would be waiting for new innovative medicines, they come out and are covered by patent for a number of years. The other category is generic medicines. Those are medicines that have come off patent and there is, basically, an open market across the world in which many, many generic medicines companies provide generic medicines at a much lower cost.

In Northern Ireland, in the region of 80% of prescribing is generic. That is among the highest in Europe and is certainly on a par with the rest of the UK. We would be very keen to continue that split, and one of our areas of focus will be to continue to work with the generic manufacturers, They have a particular challenge with the new way of working, as Northern Ireland is a smaller market. The generic companies work to very tight profit margins and there is a lot of them, so some specific work is going on to work on generics. We are also looking at other weak points in our supply chain where we might have very small manufacturers of drugs who, although their drugs might still be covered by patent and are branded, might supply such a small volume into Northern Ireland that we become an unattractive market.

There is quite a complex number of issues to deal with in Northern Ireland. On generics, you are right: they are critical to managing cost-effective prescribing in Northern Ireland, and that is something that we have done successfully for many years. We are hearing that there is a risk of cost increases. Of course, as we get into new ways of working, we will have to get to a new normal, where our prescribing is still cost-effective. We definitely do not want to move backwards.

Ms Bradshaw: Thank you, panel, for the presentations this morning. They lay bare, again, the folly of Brexit. The sound is not great this morning, so apologies if you have already answered some of these questions. Paragraph 39 relates to the "new Northern Ireland Planned Healthcare Scheme" from the Irish Government. It is being operated on an "admin" basis. Can you explain what you mean by admin? You have said also that it is in place for 12 months. When did that start, and when does it finish? Will there be any extension of the admin-basis period, given the impact of COVID and the shutdown of services? That is my first question.

Ms Quinn-Duffy: The cross-border healthcare Ireland scheme is being run by the Irish Government, for Irish citizens to come into Northern Ireland. That is what that scheme is; it is nothing that we in the Department have done. Those patients will predominantly be going into the private sector. The scheme started on 28 December and will run for a year, on an administrative basis. My understanding is that they are looking at the provisions and whether it can continue post December. However, it is really a matter for the Irish Government as to how they manage the scheme.

Ms Bradshaw: OK. Thank you. My second question picks up on what Cathy spoke to the Chair about: the registration of healthcare staff who operate on both sides of the border. One category of staff who are in contact with me are those who work in the air ambulance service. Cathy will be aware that there have been very few incidents when staff have had to cross the border to perform an operation. They are concerned that, even though the Department of Health has agreed to cover the cost of it, the actual administrative burden on them to find all their qualifications and submit for registration to the Irish Medical Council, for example, in the midst of a pandemic, is an awful lot of work. They wonder why the memorandum of understanding could not, on this occasion, have been extended to cover those very infrequent cross-border operations. It just seems like a lot of work at this time.

Ms Quinn-Duffy: I will take that one, too. We appreciate that there is an awful lot of work and that the administrative burden lies with the applicant. We are talking to the Irish Government and are working with the regulators to provide some support on this. Unfortunately, these are regulators in a different jurisdiction, and they have to comply with their own legislation and their own requirements. We can try to negotiate, but, because this was part of the overarching UK/EU negotiations, we were not able to do anything prior to the end of transition. It is something that we are keenly aware of; we know what it means for North/South healthcare cooperation. We emphasise that position, both in the UK and in the Republic, and we are working with regulators as best we can to come to some arrangement.

As I said before, there are frameworks in the European Union under the trade and cooperation agreement, but that is going to be a slightly longer-term process. Under the MOU between the UK and Ireland, the regulators can work together under the common travel area, but, again, it is not going to happen in a short time period.

Unfortunately, need to have something in place, and it really is that people need to be dual-registered. We try to support applicants as far as we can, but it is a matter for operational colleagues. As I have said, we try to do as much as we can to mitigate this and have these things in place to ensure the continuation of services.

Ms Bradshaw: Thank you. I want to pick up on that, Chair. Given the very small number of times that the air ambulance has to go into the South to support people, is there any way that you can possibly halt that while the pandemic is happening? There are massive burdens on our hospitals at the minute, and it seems that, considering the amount of work that the people who are on the air ambulance will have to put in compared with how frequently it is used, it is probably more prudent to halt it.

Ms Quinn-Duffy: Paula, I will probably come back with a bit more detail, but my understanding is that there is an emergency provision where there is a threat to life. So, there is, potentially, a provision where that might be used. I can come back to you with more detail. The temporary and occasional provision was probably the more appropriate way, but there is still an application process for the temporary and occasional registration. Because those forays can be quite infrequent, it is to try to come to some arrangement where it works more appropriately. I will come back with a bit more detail on the emergency provision.

Ms Bradshaw: I appreciate that, and I appreciate all your work in this regard. Thank you.

Ms Flynn: Thanks, Cathy and Patricia. Your briefings are always really detailed, and I find them really useful. Patricia, a couple of members have touched on this a few times, but I want to come back to it quickly for a point of clarification. You mentioned that the healthcare common frameworks are in place. At the previous briefing, there was talk about the first three common frameworks and that the fourth framework was on cross-border healthcare. Is that fourth framework already in place or is it still under review? I know that it was to be reviewed in the spring.

Ms Quinn-Duffy: The process for the frameworks that have been paused or were agreed for no further action is just under way, so it is being looked at. There will be another round to consider whether it is appropriate that that framework is required. It covered both reciprocal healthcare and the cross-border healthcare directive.

Ms Flynn: Is it contained or included in your options paper to the Minister?

Ms Quinn-Duffy: No, the framework is for how the internal market in the UK will work and how jurisdictions in the UK will work together if there are divergences. Moreover, there is an agreement in the UK as to how the external negotiations for international agreements are taken forward. As healthcare is a devolved matter, the devolved regions have a say in how their healthcare works. International agreements are a reserved matter, so the UK Government are negotiating those with other countries, and the UK needs to agree how that negotiation works. That was what the framework set out to do. The reason that it was agreed that no further action should be taken was that, under the Healthcare (European Economic Area and Switzerland Arrangements) Act, there is a memorandum of understanding between the jurisdictions of the UK as to how any regulations or agreements would be taken forward by the UK Government. It was felt that that was a more legislative and more practical way of doing it. We will all, as separate jurisdictions, look at this again to make sure that we have the appropriate mechanisms in place.

Ms Flynn: That is great, Patricia. It would be really useful if you were to take another look at that in your review. If you could update the Committee, that would be really useful. Thanks very much, Patricia.

I have a couple of questions for you, Cathy. When you briefed us in December, you spoke of nervousness among stakeholders. Clearly, that nervousness is still there and is in the Department of Health by the sounds of it. When we talk about medical supply chains, do we know how many of our local stakeholders have, or have not, signed up to the Trader Support Service? Could that be affecting the transition with medical supplies?

Ms Harrison: At the start of the year, there was evidence that it was not so much our local traders. I think that, in Northern Ireland, people were very tuned in.

All our stakeholders in the pharmaceutical and wholesale industries were fully ready. Problems arose with trader readiness more with the wide range of multiple suppliers that supply into Northern Ireland, so issues arose early on.

I would not say that they have all gone away but there is a much higher awareness now of the Trader Support Service, so that is not a residual concern that we have at the moment and moving forward. Companies are registered now, and, largely, there is a much better understanding across the UK.

Ms Flynn: Ok. Thank you. Jonathan touched on the fact that 98% of medicine supplies into the North come from Britain. Has that figure changed with the new structures and arrangements that were put in place with the transition? At the last briefing, you spoke about companies taking different approaches to maintain supplies, whether flying them from the EU into the North, from South to North or, indeed, from Britain into the North. Can you see that 98% fluctuating? Have you monitored any change?

You referenced a range of issues regarding the supply chain to hospitals and pharmacies. Could you elaborate a wee bit on specific issues? Are we already starting to see delays or shortages? Hopefully, the surveillance system that you mentioned can be strengthened to help to mitigate that.

Ms Harrison: We have no evidence yet of any change to the 98%. That figure represents our historical supply chain. Basically, we are a part of the UK.

What we do know now is that companies are starting to make some decisions about Republic of Ireland and direct-to-Northern Ireland models. Over the coming months, we will get more information about that, and will have to consider new ways of monitoring. There are no ways of monitoring these things at the moment. We have never had to, and I would like the Committee to recognise that.

This is going to be long-term change. It is going to take quite a lot of time and, probably, investment for us to get new surveillance of the market and for monitoring that and cost impacts. We are starting that work this year, but I can see that a lot more will need to be done.

We are across a range of issues relating to hospitals and everything. The common pattern was a misunderstanding among companies around who was responsible for making import declarations. I cannot give you any examples because they are commercial and in confidence but we dealt with a wide range of issues. We also dealt with quite a range of issues where third parties were involved in the supply chain. The medical supply chain is so complex. We did know that anyway, but now we really know. For example, a third-party logistics company, such as a parcels provider, plays an important role in getting medicines directly to the homes of patients who want privacy, particularly for some home-care medicines and stoma and incontinence products. Third-party logistics was an active category for issues. Other than that, it was down to mainly individual readiness among businesses.

Ms Flynn: OK. Did it translate into delays or shortages for hospitals and pharmacies? That was the important part of the question.

Ms Harrison: In most cases, we intervened to avoid any impact on patients. Sometimes, we had patients contact us directly, and we were able to intervene and turn things around very quickly. I would not say that there was no impact but there was a very minimal impact on patient care across most issues.

Ms Flynn: Thanks very much, Cathy.

Mr Chambers: Cathy, at the outset, I thank and commend your Department for the work that it is doing on these issues. They are not of your making or, indeed, the Minister's. My family businesses are involved in selling tobacco products. Recently, tobacco companies announced that they were having to change packaging on the products that were coming into Northern Ireland because different packaging, with different health messages, was required from that on products that are on sale in GB. As a result, they dropped a lot of their brands, because it was not cost-effective to create new production lines to meet the demands of selling a product to Northern Ireland.

Pharmaceutical companies are not charities. Is there a danger that they will do something similar to what the tobacco companies have done and simply reduce the availability of products if it is not cost-effective to produce them to get them into Northern Ireland? You alluded to the fact that there will be cost implications, probably substantial, albeit, you do not yet know what they will be, that will take away valuable budget from other aspects of NHS work. Will the choice of over-the-counter (OTC) products, which are a big part of a pharmacist's sales, be impacted on? More importantly, do you envisage price increases on those products? Finally, are we going to be totally dependent on the EU for our ongoing supply of medicines? Given its failures around the procurement of the COVID vaccine, such a situation does not fill me with any great confidence.

Ms Harrison: Thank you for your questions. It is too early to provide categorical advice on what the impact will be on product availability and price, but there is definitely a risk of both: companies could reduce their product range, and the prices could increase. They are risks that exist without any mitigation, and we are working actively with industry to work through it and, as I said earlier, to go back to the principles of maintaining access to supplies and equitable access for our citizens. There is a huge amount of work going on there, but, yes, those are the sorts of issues that companies will be considering around product ranges and costs. OTC medicines will also be impacted on. A lot of the issues that we have discussed will have an impact on them, to some extent.

You asked whether we will be fully reliant on EU supplies. Again, it is too early to say, because the industry is just beginning to make changes and its own decisions. I cannot say, for definite, to what extent we will be reliant on EU- or GB-based supplies, or others.

Mrs Cameron: I apologise for my lateness and for missing almost the entire presentation, but I got caught behind an accident on the way in. Thank you, Cathy, Patricia and team for your ongoing work on this subject. It is a complex issue, and I appreciate the work that you are doing on it. My questions are generic. Cathy, what is your early read-out of the protocol in respect of the flow of medicines, medical devices, blood and tissue, and clinical trials? Is the one-year derogation working as envisaged? Have there been teething problems? Is the agreement preventing customs controls from kicking in on the GB to NI movements of medicines and vaccines?

Ms Harrison: The main thing, in an early read-out of the Northern Ireland protocol, is that there is now a much greater awareness that there are long-term implications for medical goods supply chains. That awareness is still growing, to be fair, and there will probably be more focus on it in the near future. There is much more awareness that longer-term change is needed. I can see that a lot of decisions are starting to be made in the industry and that there is a great will to make changes and move into whatever new way of working there needs to be. I can see that people are working towards solutions. At government level, we are working very closely with all stakeholders to try to understand how best to intervene and what mitigations will have the most impact. That is still a very active piece of work; it is a work in progress.

I think that it feels early. This is a massive change, and we are only a few months into it. The monumental scale of the change is beginning to hit home across the board, and I hope that that message is getting across. We have indicated at EU level that more time may be needed, and I think that that is highly realistic at this stage. I can see the amount of work needed and how seriously the issues are being taken. It is not a matter of people avoiding this for 12 months or waiting until December to make a start on it. There is a lot of thinking going on here. There is a lot of legal advice among companies and logistics advice.

The one-year derogation is really helping us. It means that there is minimal impact on our supply chain. We have some issues that I referred to in previous answers. One issue relates to radiopharmaceuticals, for example, the supply chain for which has been diverted up through the Republic of Ireland, and that has caused some issues for patients in the north-west and Belfast since January. Other than in those cases, the one-year derogation has been very beneficial.

Mrs Cameron: Cathy, has the derogation prevented customs controls from kicking in on the movement of medicines and vaccines?

Ms Harrison: There are customs controls in place for medicines at the moment. The 12-month grace period has, however, given us more time, specifically relating to batch testing, which needs to happen at product level for medicines now moving from GB into Northern Ireland. There is no facility for that at the moment. It just does not exist, because we are all part of the same market. Without the derogation, that would have come into place in January, but we simply would not have been ready. I do not think that it has delayed it, as such. It has, however, given us more time to think through the best way to handle those issues. For some of those things, we are relying on the advice of our regulator and the interpretation of the EU.

Mrs Cameron: Are there potentially more problems and issues to come? That is what I was getting at in my last point.

Ms Harrison: On the movement between GB and Northern Ireland, there are batch tests and verification checks that are on hold at the moment. That is one of the major challenges that the pharmaceutical industry is flagging up about its ability to maintain the GB to Northern Ireland routes, and it is one of the reasons why many companies are considering alternative routes through the Republic of Ireland and direct to Northern Ireland.

Mrs Cameron: Thank you. Finally, Cathy, have there been any problems with reciprocal healthcare since 1 January, or is it not possible to get a fuller picture because of the COVID travel restrictions that have been in place?

Ms Quinn-Duffy: We are not aware of any difficulties at the moment around reciprocal healthcare. Obviously, there has not been a lot of people movement to see whether or not there is agreement on the ability to use EHICs and global health insurance cards in the rest of Europe.

We are not expecting any difficulties with people coming into Northern Ireland. The BSO for GP registration and the trusts, when it comes to secondary care, are well aware of the provisions. We have been working with them to make sure that they are aware of what is happening and how they apply those provisions. When people go abroad, there may be some instances where there is confusion in other jurisdictions. The NHS Business Services Authority manages those reciprocal healthcare provisions on behalf of the UK as a whole. It is for that body to bottom out the operational issues that occur for patients when they are in another EU country.

Mrs Cameron: OK, thank you, Patricia.

The Chairperson (Mr Gildernew): Thank you, Cathy and Patricia. Eimear did not come in, but I thank her for being here this morning as well.

There are a number of outstanding issues of grave concern which are, I have to say, a result of Brexit. The protocol was, largely, put in place because mitigations were needed. We have asked for grace periods in order to facilitate some of the transfers. However, we are seeing increased difficulties for professionals who are working across the North, and for recruitment, as a result of Brexit — not as a result of the protocol. We have been removed from the cross-border directive as a result of Brexit. We need to be honest in the Committee about that, and we need to deal with it realistically. Those issues have not arisen as a result of the protocol: the protocol has provided some protections. The supply of medicines is clearly under threat as a result of Brexit. We have been saying for quite some time that there is no good Brexit. Costs will, potentially, go up as a result of Brexit, not as the result of any protocol.

Finally, reciprocal healthcare and the European health card are issues of huge concern for people. Those are being removed because of Brexit. That will create significant difficulties for the Department, for our society and, most importantly, for people at the receiving end of all of that. We will need to have considerable further engagement with you. I appreciate your attendance at the Committee this morning, once again, and your very fulsome answers where possible in most cases, in relation to many of the issues that we are dealing with. However, the uncertainty remains a real concern and we will need to address that. I anticipate that we will be looking for an updated briefing from you at some point.

For now, Cathy, Patricia and Eimear, thank you for attending this morning and we appreciate you being here. Go raibh maith agaibh, agus bígí slán.

Ms Harrison: Thank you, Chairperson.