Official Report: Minutes of Evidence

The Chairperson (Mr Gildernew): I welcome Ms Cathy Harrison, the Chief Pharmaceutical Officer (CPO), and Ms Patricia Quinn-Duffy, who is the EU exit lead on reciprocal healthcare and workforce issues. We are also joined on video link by Ms Eimear Smyth, who is head of medicines policy and EU exit transition; Ms Fiona Taylor, who is EU exit lead on medicines; and Mr Brendan O'Neill, who is head of information governance in the Department of Health.

I invite the officials to brief the Committee.

Ms Cathy Harrison (Department of Health): Thank you, Chair, and good morning, everyone. On 19 November, we provided an update to the Health Committee, and at that time we agreed to come back and provide some more information. A paper was shared in advance of this meeting, which I hope that the Committee found helpful. This morning, we will focus on updates since the last time we met.

To start, I will remind everybody of the position that we find ourselves in and our current level of readiness across some key areas. The UK left the EU on 31 January 2020 and moved into a transition period, which will end on 31 December and will not be extended. The UK Government and the EU Commission are, as you know, still in negotiation even at this late stage. There is still a possibility that a deal will not be fully confirmed by the end of the transition period. That is the scenario that we commonly refer to as "no deal".

During the transition period, the UK has continued to follow EU law and regulatory processes, but this will change on 1 January when the Northern Ireland protocol to the withdrawal agreement will take effect. In advance of the end of the transition period, the Department is now moving into what we call "response phase", and we are working with all our stakeholders. We continue to actively review our risk analysis and contingency planning, and our goal is to provide the best possible operational response for patients and the public.

The EU exit and the Northern Ireland protocol introduce potential risks to healthcare, which covers a broad range of areas. I will go through a few of those now.

There is a risk to the supply of healthcare products; I am talking specifically about medicines and medical devices. In relation to national contingencies that cover the whole of the UK, there have been no significant changes since our previous update to the Committee, but I will run through what is in place, given that these national contingencies were all designed for the no-deal scenario, which we now may need.

Northern Ireland is part of the UK-wide medical supply contingency programme for EU exit, which is led by the Department of Health and Social Care (DHSC), but with the full involvement of us in Northern Ireland over the last few years and the other devolved Administrations. The UK-wide contingencies seek to address the biggest risk that was identified for healthcare supplies: disruption to supplies that could occur in the short straits in the English Channel. During the last two years, extensive national plans have been established, which has resulted in a multilayered approach being in place and ready for activation. It includes a high focus on trader readiness for people moving goods from the EU into the UK and also enhanced levels of stock of medical goods held within the UK. There is extra ferry capacity and an express ferry service for medicines.

I assure the Committee that our healthcare products and medicines are categorised as category 1 goods, and that could be significant for movement of goods into Northern Ireland in the coming weeks.

In addition to all the work on the supply chain, greatly enhanced arrangements are now in place for surveillance of the medical supply chain in the UK that we are using already. That includes enhanced arrangements relating to the management of shortages, and the Medicines and Healthcare products Regulatory Agency (MHRA) has provided extensive advice on the UK Government website. Regulatory flexibilities have also been agreed and will include a two-year standstill period for medicines and a two-and-a-half-year acceptance of conformité Européenne (CE) marks for medical devices in relation to licensing.

On the Northern Ireland protocol, the UK is currently aligned with the EU acquis for medicines and medical devices, but, as I said at the start, that will change on 1 January when Northern Ireland will remain aligned with the EU acquis and Great Britain will not. That has long-term implications for Northern Ireland in the supply and regulation of medicines and medical devices.

We welcomed the confirmation, on 10 December, when the UK Government published draft unilateral declarations by the EU and UK in the Joint Committee on human and veterinary medicines and also the technical guidance that followed on 11 December. In essence, that confirmed that we have a 12-month phase-in period for certain elements of changes that need to be introduced relating to the Northern Ireland protocol. They relate to the falsified medicines directive and additional regulatory importation controls, such as manufacture and import authorisation, additional batch testing and qualified persons. Those changes will all need to be in place by 31 December 2021. We have a 12-month phase-in period. That was, as I said, very welcome confirmation of a decision that we had understood was made on 5 November, and I previously advised the Committee of that. It is a critical decision for Northern Ireland at this time, because it will allow more time for the pharmaceutical industry and our wholesale industry to adapt to the longer-term changes that we are facing. It is also expected to reduce or largely remove a lot of the risk that we could have been facing if those changes had to be implemented from 1 January next year.

On medical supplies, I have been working very closely with stakeholders in recent weeks to understand some of the issues that are of concern to the pharmaceutical industry, wholesalers, hauliers and everyone involved in the supply chain. There is still a bit of nervousness. They believe that they are very well prepared. They have signed up to the Trader Support Service, which is the advice that is being given, but that is an untested system, and we also have critical category 1 goods that cannot be delayed, so it is important to seek assurance that those category 1 goods will not be delayed at ports. It would not be because of their lack of readiness; it could be because of the lack of readiness of other parties and other complications. We are still working through that.

Chair, with your permission, I will hand over to Patricia. She has some information, and there has been an update since the papers were provided. Things have moved quite quickly this week in some of her areas of work.

Ms Patricia Quinn-Duffy (Department of Health): There has been quite a lot of movement in and around access to healthcare issues this week, so I will give you an update on the various areas. Obviously, the UK and EU are still negotiating. There is no agreement on an EU/UK longer-term reciprocal healthcare arrangement. However, as you know, the EU withdrawal agreement lays out rights for people who have already used their right of free movement, and a lot of things have been confirmed over the past number of weeks. The UK Government and the Department of Health and Social Care have bottomed out some of the issues to allow people to maintain those rights and to understand what they are. We have the cohorts of people who have their right of free movement and the frontier workers. In Northern Ireland, EU, EEA and Swiss nationals who are resident in Northern Ireland before the end of the transition period will be within the scope of the withdrawal agreement. They will be allowed to continue their access to healthcare and will also have their rights maintained for reciprocal healthcare under regulation 883/2004 on the coordination of social security. What it means for them is that, if they are registered with a GP already, they will not have to do anything further. However, if someone arrives before the end of 31 December and has not registered with a GP, they will need to provide evidence that they have been in country before that date.

The EU settlement scheme will be the main route for EU, EEA and Swiss nationals to register their residency in the UK. It is open until 30 June 2021 and, after that point, one of the items that will be sought for registering with a GP is that the individual has settled status under the settlement scheme.

Irish nationals who are resident in Northern Ireland at the end of the transition period who have used their right of free movement do not have to do anything further if they are currently registered with a GP. If they register with a GP after 1 January and have been in country before 31 December, they will need to identify that they have been in country before that date in order to ensure their withdrawal agreement rights. They will be able to register with a GP in any case if they are living in Northern Ireland. However, in order to ensure their withdrawal agreement rights, they have to have been in country before 31 December. They also will not have to register with the EU settlement scheme, although I understand that, if Irish citizens have partners who are non-EEA or EU nationals, it may be simpler and in their interest to register with the EU settlement scheme.

The Chairperson (Mr Gildernew): Before you go on, Patricia, is this a reciprocal deal between the British and Irish Governments or is it part of the EU —?

Ms Quinn-Duffy: No; this is part of the EU withdrawal agreement. There is a cohort of people under the agreement whose rights are maintained through social security coordination. Under regulation 883/2004, anybody who has used their right of free movement, either to the UK or to Europe, will have their rights maintained until they stop being in the other country. They will maintain rights under the scheme, predominantly for life. In healthcare, that means that you have the right to a European health insurance card (EHIC) and an S2, which is planned care treatment. Most citizens who are EEA nationals in Northern Ireland would use that to go home to give birth. There is also a right to an S1, which allows you to retire to your home state or another European country and have your healthcare paid for by your competent state, which for EEA citizens in Northern Ireland is the UK.

The Chairperson (Mr Gildernew): Just for clarification before you continue your presentation, do the common travel area rights remain intact?

Ms Quinn-Duffy: I will come on to that later in the discussion.

The Chairperson (Mr Gildernew): There is one other key thing. You mentioned people who are resident prior to 31 December. What about people who are not born?

Ms Quinn-Duffy: Children who are born to citizens who are already in state fall under the scope of the withdrawal agreement. The withdrawal agreement applies to the citizen who is in scope, their family and their survivors. Quite a significant number of people are involved in that. The withdrawal agreement is very complicated but this is part of the work that we have been doing with the Department of Health and Social Care, DWP and HMRC to look at how we identify people who are in scope and what they need to do to prove it. It means that family members can join at a later date, as long as the relationship was there before the end of December. Children or adopted children born afterwards fall under the scope of their parents.

The Chairperson (Mr Gildernew): OK, sorry. Go ahead.

Ms Quinn-Duffy: I will move on to frontier workers who fall under the agreement. This is for those who are frontier workers prior to 31 December. It covers those who live in the Republic of Ireland but work in the North of Ireland. For those citizens, frontier working is a particular type of cross-border working in that you have to return home daily or at least once a week to be included under the social security regulations.

To maintain citizens' rights under the withdrawal agreement, EEA, EU and Swiss citizens who live in the Republic and work in Northern Ireland will have to apply for a frontier worker permit to prove that they have a withdrawal agreement right to continue working. That is now open on www.gov.uk for those citizens to apply.

The Chairperson (Mr Gildernew): How many people will that involve?

Ms Quinn-Duffy: There are not huge numbers. In health and social care, there are maybe 50 or 60 people, and they will need to have a permit. It is open for applications until 30 June 2021.

Irish or British citizens or Northern Ireland people who live in the Republic and work in Northern Ireland do not need to apply for a permit to continue working in Northern Ireland. To demonstrate their right to healthcare, they may need to keep documentation to prove that they were working in Northern Ireland before 31 December. That will mostly maintain in being registered with a GP in Northern Ireland. Around 2,000 frontier workers are registered with GPs in Northern Ireland, and they will not need to do anything to continue their rights to access a GP.

The withdrawal agreement people will have a right to a European health insurance card. If they travel within the rest of Europe, they will have a UK-issued EHIC. Under the withdrawal agreement, the system is now open for applications for a new card to use from January of next year. Unfortunately, this may not be the case unless the UK comes to a full agreement with the EU on future reciprocal healthcare rights for everyone else in Northern Ireland. The EHIC may not be available for them from 1 January. However, anyone who is travelling or a student who is studying abroad will fall under the withdrawal agreement and will be able to use their EHIC for the continuation of their journey or study until they return home.

People who have moved from Northern Ireland and the UK to live in the EU will maintain their EHIC rights. That could be people who have moved or retired to the EU. Those who have retired to the EU will have UK EHICs. Those who have moved to live and work in the EU will have their resident country's EHICs, which they can use when they return to Northern Ireland to access healthcare if the need arises.

On the common travel area, the UK and the Irish Government have been working very closely to get an agreement in place. It is at a very advanced stage, and both sides are committed to ensuring that it is in place before the end of the year. Those arrangements will ensure that, when visiting the other country, citizens will continue to be able to access the necessary healthcare and to benefit from cooperation between UK and Irish healthcare providers, regardless of the outcome of the negotiations with the EU.

The arrangements build on commitments that UK and Irish citizens living in the other country will be able to continue to access healthcare on the same terms as locals. There will be a commitment that new frontier workers will be able to continue to have access to healthcare on the same terms as now. We expect that to be in place by the end of the year.

There was an announcement in Parliament this morning of a unilateral offer, in the event of no deal, for citizens with long-term conditions that need ongoing treatment. That will be a time-limited healthcare scheme that supports UK residents visiting the EEA or Switzerland from 1 January. Such treatment was covered under the European health insurance card (EHIC) scheme. The scheme will be introduced with the intention that individuals with certain requirements to treatment abroad, such as regular oxygen treatment, chemotherapy or dialysis, will be able to get that treatment if they travel abroad.

The scheme will support travel from 1 January 2021 to 31 December 2021. People applying to the scheme must be ordinarily resident in the UK and entitled to the treatment where they reside. Full guidance will be published. Essentially, the scheme will allow a person to pay for treatments. It is estimated that oxygen therapy, for example, can cost €500 for a tank of oxygen. Dialysis can be in the thousands.

The scheme is to allow those people to continue to go on holiday. They will be encouraged to secure travel insurance because the scheme will not cover them for care needs arising from other issues that they may have while on holiday.

We are working on the cross-border healthcare directive. Unfortunately, given the considerable number of things that have come into play over the past few weeks, we have had to reprioritise looking at the policy around that until the new year. We are at an advanced stage and hope that it will not take too much time to have the policy advice in place.

We are working on a statutory rule to ensure that access to healthcare is accounted for for all the cohorts. We are still in the very late negotiation stages. We were expecting a common travel area (CTA) agreement to have been signed and/or a deal with the EU, so it has been delayed until we get clarification on those issues.

I would like to talk to you about the healthcare common frameworks programme. Three common frameworks are in place for healthcare: public health protection and health security; blood safety and quality; and organs, tissues and cells, apart from embryos and gametes, safety and quality. There was a fourth framework reciprocal on cross-border healthcare, but it is being set aside as "no further action at this point", but it will be reviewed in the spring.

We expect the frameworks to go to the Joint Ministerial Committee (EU Negotiations) on Monday. The summary frameworks are on their way to the Committee because we expect your scrutiny of the frameworks to be in 2021.

The Chairperson (Mr Gildernew): Thank you for bringing us that interesting information. There do appear to be areas of progress, and there are probably areas of concern. I am sure that the Committee will get more of the detail, and the devil is in the detail. However, I welcome the substantial information that you have presented us. We will consider it further.

Ms Harrison: Thank you, Chair. On the wider legislative programme, we advised the Committee previously that 11 statutory instruments had to be considered. Six of those have now been laid, and four will be laid by the end of the year. One has been postponed until January of next year.
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We understand that you have direct briefings from the Food Standards Agency (FSA), so I do not go into a lot of detail here, but we can relay any issues back to it, as we have done in the past, if that is OK, Chair.

There are no updates on data since the last meeting.

On residual risks and where our focus is, for the last couple of months we have been actively reviewing the state of readiness in Northern Ireland and exploring residual risks in detail and with stakeholders. For example, we identified specific issues relating to home care, so we worked with the National Clinical Homecare Association (NCHA) and our trusts to secure assurances on the supply of medicines and treatments to our patients, as well as on other issues, such as the movement of controlled drugs, and we now have an assurance that there are no issues with the movement of those.

We have worked very closely with the pharmaceutical industry and with wholesalers. I would like to put record my thanks for the support that they given to the Department and my colleagues and for the work and the contingencies that they have put in place, often without much detail and with a great deal of uncertainty. I wish to express my deep gratitude for all the work that they have done.

Last week, the Department hosted three very successful stakeholder events for community pharmacies, general practices, optometrists, dentists, care homes and independent hospitals. Those events were about providing advice on the operational readiness guidance, answering questions and advising them to, where necessary, register with the Trader Support Service, if they purchase goods directly from GB.

We will move into an active response period in the next few weeks, during which we will address issues as they arise. In that regard, I am working very closely with all the arm's-length bodies, and we meet them regularly. We have another meeting next week, just before Christmas. They have guidance to work on. We are also collecting issues on a regular basis through our sitreps (situation reports), and those are being escalated to two dedicated strategic cells that I chair in the Department so that we can address any issues of concern. My colleagues and the team are available for specific queries, and we have a dedicated, monitored mailbox for that. That is the end of my update. We are happy to answer questions.

The Chairperson (Mr Gildernew): OK. To facilitate the question-and-answer session, I ask that one member of your team, or you, give the principal answer to a question. We will only include someone else if they have additional information to share. Given that you are with us today, Cathy, perhaps you can identify who is best placed to do that. As usual, I ask members to be as succinct and focused as possible. I ask members who are on the phone to stay on mute when they are not speaking, and if they have access to headphones, it is best to use them. I will start off with a couple of questions. I will then go to the Deputy Chair, Pam Cameron, on the phone and then to other members.

You talked about the 12-month derogation period that was agreed. Is it realistic to expect agreement between the two sides in that 12-month period? Are there sticking points? If so, are they political or technical in nature?

Ms Harrison: The issues that we are dealing with are technical. The pharmaceutical industry will have to adapt how it supplies medicines to Northern Ireland. Those changes require quite a lot of thought on the part of individual businesses about how best to maintain their supplies. It is for each business to make up its own mind about how best to maintain, from the point of view of profit, access to supplies in Northern Ireland. I understand that different companies are taking different approaches. There is a role for Government in supporting that. In the new year, we will be working with the Department of Health and Social Care in England and the Medicines and Healthcare products Regulatory Agency. We will start that work in January and ensure that we use the time wisely, as 12 months is not very long for some of the changes that may be needed here.

The Chairperson (Mr Gildernew): You said that different Governments are taking different approaches; do you mean European ones?

Ms Harrison: Different companies. Some companies may choose to fly medicines and medical goods directly into Northern Ireland from an EU country. They may choose to move them up through the Republic of Ireland, or they may choose to use a common transit convention, which, essentially, moves them through GB — they have 90 days to move through — without being mixed with the rest of the GB supply chain. There are significant changes.

The Chairperson (Mr Gildernew): Like a bonded warehouse?

Ms Harrison: Exactly. There are a number of options, and different companies are making their own decisions.

The Chairperson (Mr Gildernew): Is 12 months sufficient time to get to the solution?

Ms Harrison: The indications that I am getting are that, for most companies, it is, but they are all telling me that it is not a very long time. They are all working on that now. Some have said that it may take them longer, but the clarity given in the past week was really necessary. Those businesses are experts in logistics; they can now work at pace, and we will be working closely with them, where needed.

The Chairperson (Mr Gildernew): We have been discussing this for some time, even prior to the restart of the Assembly. When we discussed it in August, September and October 2019, the short straits issue was prevalent. This issue seemed to appear significant towards the end. Are there other issues on the horizon that have not been considered or that you are now starting to become aware of as a result of everything coming so close to a conclusion?

Ms Harrison: The issues that have arisen in relation to the additional checks that are needed and FMD compliance are a consequence of the Northern Ireland protocol, which, of course, was not with us when we met in August 2019. They are a consequence of the agreement on 31 January 2020 and the Northern Ireland protocol.

Sorry, what was your second point?

The Chairperson (Mr Gildernew): Your response addressed it, so I move on to the issue of stockpiling. Has the contingency programme on stockpiling medicines and medical devices been successful? If so, to what extent? How much time do we have stockpiles for? Is it enough for a worst-case scenario?

Ms Harrison: The ask from Government was that a minimum of six weeks of additional stock be held in the supply chain for medicines in the UK. That is on top of business-as-usual stocks. Assurances have been provided on that basis. We are holding a lot more stock than that in Northern Ireland; some of our wholesalers, for example, are telling me that they have in excess of three months' stock in place whereas they would normally have perhaps seven or eight weeks'. There is a significant uplift in stock in GB and, importantly, Northern Ireland. Our hospitals are holding more stock. You will know — I have advised you before — that the emphasis in our contingencies has always been the supply chain in order to prevent and avoid the need for community pharmacies and front-line services to stockpile. We have assurances that we have more stock in the system.

The Chairperson (Mr Gildernew): Contracts with ferry operators are in place to transport category 1 goods. You said that medicines are in category 1 and that those contracts are in place for six months. What is anticipated to happen after that six months?

Ms Harrison: Those contracts are in place between the EU and GB. They are managed by DHSC. I understand that six months is the agreement. The assessment of risk was that disruption would occur over a period, but that, before six months had passed, a new way of working would have been established. I do not have any more detail than that, but common sense suggests that, if they need to be extended beyond that period, they will be. The six-month period was based on evidence and an analysis of the risk.

The Chairperson (Mr Gildernew): OK. Patricia, you mentioned in your presentation that access to the EU settlement scheme will end on 30 June. Does that mean that, from 30 June onwards, a person will enter the new points-based immigration system? What impact is that likely to have on healthcare staff and vacancies? We see that playing out before our eyes with the COVID-19 situation, but we know that recruitment is a more general problem. We are very conscious of the potential income limit of £30,000, which is not appropriate for here. What is your assessment of the impact that that is likely to have on the provision of healthcare staff that we need?

Ms Quinn-Duffy: The immigration system will be in place from 1 January. Any new EU citizens wanting to live and work in the UK will need to have a skilled worker visa at that point. The system has been extended. At the moment, it is set at the qualification level of degree and above. It will expand down to A-level and above, and that will allow some further qualifications and roles to be included in the skilled worker route. It will not include social-care staff in particular, and there is an issue with the continuation of non-national social-care staff.

In the new year, the system will include the NHS visa or the health and care visa, as it is called. The health and care visa fast-tracks the application process for people using a skilled worker route visa. It also removes the need for them to pay the immigration health surcharge, which at the moment is £625 per person per year. The UK Government have realised that there need to be incentives for workers to come to work in the health and care sector.

The shortage occupation list includes all nurse and doctor categories. The Migration Advisory Committee (MAC) made recommendations in its last review. However, the Government have decided not to implement those recommendations until there has been a review of the worker profiles and the impact of the new immigration system in January. It means that roles on the shortage occupation list in Northern Ireland will have a different salary threshold. The threshold has been moved down to £26,400, and for those on the shortage occupation list or trainee roles, it has been reduced to £20,400. That gives us a bigger scope for roles to be included in the skilled worked route.

The Chairperson (Mr Gildernew): Will it still take in domiciliary care workers?

Ms Quinn-Duffy: No.

The Chairperson (Mr Gildernew): Is that a concern?

Ms Quinn-Duffy: It is a concern, yes. We have engaged significantly on this issue, as it is not just a problem for Northern Ireland; it is a problem right across the UK for domiciliary and social-care staff. The Government's position is that, because of the rise in unemployment, they expect the home market to provide the staff.

The Chairperson (Mr Gildernew): That is a bit speculative. It is not very planned, and I am concerned, given the pressures. The Committee is already hearing about the lack of domiciliary care packages and the pressure that that is putting on the care-home sector and hospital discharges. It is a very complex system, and that is an important and worrying element. How does the Department of Health tell the British Government what it needs for its population and systems?

Ms Quinn-Duffy: That has been included in correspondence between the Minister and the Government here. It is part of a programme. Not only are health and social care workers part of it, but it also includes agricultural workers. It is something that everyone is very aware of. The Department for the Economy has the lead on immigration, and we have been working very closely with it. Social-care work has always been on the agenda as a problem. It has been very clearly identified, at every point, that the position is not satisfactory.

Mrs Cameron: I thank the witnesses for their attendance at the Committee. It is obviously a very complex subject. I have a couple of questions.

First, do the officials agree with the Minister that the UK Internal Market Bill will protect NI from potential divergence on bloods, organs and tissue that might affect the supply of those products to NI? Does EU law not trump everything else?

My second question is: why is there particular concern in respect of the continuity of supply of category 1 critical goods through GB ports to NI? Why is that not covered by the 12-month derogation agreed by the EU and UK? How many of the weekly HGV consignment secured by Her Majesty's Government will benefit Northern Ireland?

Ms Quinn-Duffy: I will answer your question on the divergence on blood, tissue and organs. The common frameworks that are being organised are really the framework that officials and administrators will use on divergence. Blood, tissue and organ safety and quality are a devolved matter, so each nation can technically diverge if it wishes to or if it sees a need to. However, under the NI protocol, Northern Ireland has to comply with EU regulations, which means that we have to keep pace with them. Therefore there is potential for divergence for us, as we to have to comply with any new EU regulations. Equally, GB nations may decide they wish to diverge.

The framework sets out the process by which the nations would work together to ensure that, if there was divergence, it would not impact on the internal market and to ensure that all the devolved nations are aware of any processes that would come into place in a certain area to deal with a certain issue. As organs are dealt with on a national basis, we have a very close working relationship on them, as well as on tissue and blood. Northern Ireland is predominantly self-sufficient in blood, although we bring in some blood from GB. This is to ensure that that supply can continue. The framework is, basically, how we manage divergence to minimise the impact.

I hope that that answers your question.

The Chairperson (Mr Gildernew): Have you a follow-up or another question, Pam?

Mrs Cameron: I also asked about critical goods.

Ms Harrison: You asked about ports. The issue here is trader readiness. In my update, I indicated that we have high levels of assurance about the readiness of the pharmaceutical supply chain. Moreover, our goods are category 1. The anticipation is that there will be no delays at ports in the flow of those goods from GB to Northern Ireland and back. Those lorries have to return empty.

The residual concern that we have is about everyone else who will be at the ports. Will they have the same readiness that we do? It is important for all businesses that trade between Northern Ireland and Great Britain to sign up immediately with the Trader Support Service and make sure that they are prepared.

That will avoid some of the risks that could occur if people turn up but are not prepared and do not, for example, have their customs declarations completed. We are seeking assurances that flow will be prioritised. That will be important. Those are the main issues around ports. We have received assurances that there are no concerns around ferries and ferry capacity, for example. It is mainly about the logistics at the ports and the handling of the new trader-readiness arrangements.

Your third question related to the £400 million and Northern Ireland's share of it for Health. Is that correct?

Mrs Cameron: No. It was this: how will the weekly HGV consignment secured by Her Majesty's Government benefit NI?

Ms Harrison: At this time, the consignments that are guaranteed to come in from the EU will benefit Northern Ireland, because our goods will still flow through the UK system for the next 12 months. Our needs are included in those at the moment.

The Chairperson (Mr Gildernew): I am aware that Brendan needs to leave around noon. He has the information relating to data. Do any members have a data issue that they want to ask Brendan about? I will rejig things to take account of that. Jonathan may have a question. Órlaithí has one, so I will go to her first, because she is on my list, and then I will check with Jonathan.

Ms Flynn: Cathy's brief for your previous appearance here mentioned some of the data-sharing issues. Will you elaborate on what the problem is with data-sharing? Who is it between? We know that there have been issues, even on an all-island basis — North and South — in the context of COVID. I know that the data-sharing issues that you have at present have not been resolved. Could the delay in resolving those issues be putting any patients at risk of not receiving their medicines and medical devices?

Mr Brendan O'Neill (Department of Health): There are no issues or hold-ups with patient data exchange. You may be talking about the passenger locator forms. The Minister gave an update on that to the Assembly on Monday, in his update on the North/South Ministerial Council. It was in response to Mr O'Dowd. It is outside matters relating to EU exit, however.

Ms Flynn: Sorry, Brendan, but I am still not clear about the data-sharing issues that you are talking about. What are those issues? What is the problem?

Mr O'Neill: There is no problem with the exchange for patients receiving treatment either North/South or South/North. That has been underpinned with contractual agreements. There are firm contracts in place to cover all of that. There should therefore be no issue.

Ms Harrison: The outstanding issue is the lack of the adequacy agreement with the EU. Do you want to say something about that, Brendan?

Mr O'Neill: Certainly. A conversation is still going on about achieving data adequacy. That simplifies the exchange of patient information. The arrangements that are currently in place, however, will ensure that data flows, regardless.

Ms Flynn: Thank you, Brendan. That is clear.

The Chairperson (Mr Gildernew): We will move on to Paula Bradshaw. You are on mute, Paula.

Ms Bradshaw: Sorry. Thank you, Cathy and Patricia. I have two questions, but, before I get to them, I want to place on record my thanks to you both. I have always found your briefings to be excellent, not just those to the Health Committee but those that you gave prior to the Assembly's being restored. I know that you have had a lot of work over the past few years.

Patricia, my first question is to you. It is on some of the changes that you mentioned that will come in around reciprocal healthcare for Irish nationals. What consideration has been given to the fact that a lot of the GP practices are under a lot of pressure? They are going into the Christmas season with some closures and stuff. I appreciate that it is not your fault, but how do some of the people who receive this information at this late stage get registered in such quick time to avoid any complications at the far side? How are you going to communicate with people to encourage them to register with a GP?

Ms Quinn-Duffy: Registration with GPs has been streamlined in the past year in any respect. To register with a GP, the GP need only check that the person is legally in the UK. The rest of the assessment is done at the Business Services Organisation (BSO). A streamlined process is already in place. People will be registered with a GP for three months, and, during that time, there will be an assessment check done to ensure that they are in the country, as they say they are, and that there is evidence of them living and working there. They may be asked to provide some documentation to prove that, but that will be done via BSO, and they will be registered when the form is completed and has been sent to BSO. There should therefore not be any delays for any reason at that point.

How we are communicating that to patients is by updating nidirect to ensure that the information is clear there to advise people of their citizens' rights and what they need to do. We have also had some communications with other organisations, including some of the organisations that work with EEA nationals, to advise them and to ensure that they are aware of the arrangements as well. We also have an update tomorrow with some other stakeholder advice groups, which we will be able to update to ensure that they are aware of those issues and of where to get the information from.

Ms Bradshaw: I really appreciate that. I am conscious that, as a Health Committee, we know how difficult it is to get through to a GP practice at the minute because of the pressure of COVID. You cannot just call in. I know that that is outside your control, but I appreciate the information on how you are trying to communicate.

My second question is for you, Cathy, and it follows on from what you said to Colm about stockpiling. You will recall that, earlier this year when the pandemic first hit, there was a problem as a result of a shortage of salbutamol nebulisers. A lot of the planning is probably looking at normal times. Are you factoring in another pandemic or another big issue that will come out of left field and will throw a spanner in the works for a lot of your preparations?

Ms Harrison: The issue that occurred with salbutamol arose because of a general upsurge in demand for prescriptions for people who had had an inhaler at some point and had concerns around respiratory health. That did cause some short-term issues. It was not really a shortage issue. Rather, it was caused by a peak in demand. It was the case in the short term and is now resolved. The contingencies that are in place cover every single part of the medicines supply chain. We have looked at everything and at all products, and there is a high level of intelligence around what is going on in the supply chain right now, and that allows us to monitor at a national level and to take action in Northern Ireland, if needed, on specific issues that we know may be coming up. The amount of stock in the UK at the moment means that we are dealing with a very small number of issues at this time. Should issues arise, we have arrangements in place to deal with them. COVID has been factored in. The business-as-usual stock levels have been adjusted over the past few months for certain product lines.

All of the stockpiling and contingencies are on top of those. At this time, we have fairly robust arrangements in place for our medicine supplies.

The Chairperson (Mr Gildernew): Paula, you are on mute. We cannot hear your contribution.

Ms Bradshaw: Sorry. Part of the issue with the inhalers, and possibly other medicines, is that, as soon as people within a health community think that there is a shortage, they rush to their GP to try to get their stock up to date. It was not necessarily about the big stockpile. It was really about trying to get through the supply chain to the GPs and the community pharmacists. Thank you very much again.

Ms Harrison: There is no need for anyone to order additional prescriptions at the moment. Our advice is that people should continue to do what they always do and order their repeat prescriptions. Our doctors have been advised not to authorise longer prescriptions or anything like that because of all the work that has gone on in the supply chain, in order to try to keep things as normal as possible. There is currently no shortage of inhalers. I know that people are very worried about a lot of things at the moment, so I just want to give that assurance.

Mr Buckley: Thanks to the panel for their contributions. It is always helpful to hear from both of you. I have consistently raised issues about the impact of the protocol arrangements on not only other sectors but, principally as it relates to this Committee, the supply of medicines and devices. The 12-month derogation from the effects of the protocol is, without doubt, welcome, and, indeed, I know that industry welcomes it for preparedness. Unless officials and Governments put in the hard yards now, however, it is simply a case of kicking the can down the road. Local businesses and patients deserve better than this limbo and stay of execution. It states in your briefing:

Let us be clear: those costly requirements have not gone away. They are simply delayed. We need a vibrant set of mutual recognition agreements in areas between the UK and EU. With that in mind — this is probably to Cathy — do the officials acknowledge that the 12-month derogation from the protocol does not remove the inevitable delay and cost envisaged through batch testing and qualified person controls this time next year? Would a comprehensive mutual recognition agreement remove those challenges?

Ms Harrison: The 12-month derogation does not remove the need for compliance. All that it gives us is more time. Critically, it gives industry more time to think through how it will deal with those logistical challenges. From my engagement with the industry, that is how it is approaching this. Industry is looking at the logistics. It is looking at ways in which it can manage the changes and comply with the legal requirements of the protocol without incurring prohibitive cost increases. That is why that time is so critical. I do not believe that it will be wasted. I know that the industry is already making decisions. Some in the industry are stepping forward to tell me what those are for specific product lines, and that is very reassuring. Others have more complex business portfolios, where they are dealing with a lot of different manufacturers, and will need to work through the challenges in the next 12 months.

Costs are an issue. This is certainly not the last briefing that we will give to the Committee on these subjects. We will be paying particular attention to costs in the new year. Again, through my engagement with industry, I can tell you that, because of the volume of stock that is in the UK at the moment and our assurances on flow through the 12-month phase-in period, the impact of costs may not be immediate, but we will have to bear it in mind. Given the implications for our small population, we will also bear in mind whether those costs should all be borne by Northern Ireland. After all, it was a UK decision to leave the EU.

The EU has not reached a decision on the issue of mutual recognition. I understand that it is an issue that industry is very keen to support.

Mr Buckley: OK. In your opinion, would a comprehensive mutual recognition agreement remove the current challenges?

Ms Harrison: Obviously, it will depend on the scope of the agreement. It may not remove the risks outlined that are specific to our compliance with the Northern Ireland protocol. We would need to explore in more detail the words in the agreement, should one be agreed, and understand what the implications are. I could not give any assurance at this time. My understanding is that it may not.

Mr Buckley: OK. Secondly, you mentioned home-care products. Can you give more detail on which home-care products have been identified as having the potential to see supply shortages? How have those barriers come about?

Ms Harrison: First, the home-care sector is where we have treatments for patients delivered directly to the patient. It may be where a nurse is involved in the administration of a medicine or treatment — generally specialist treatments — to patients at home. A number of different companies are involved in that. The majority of them move their treatments directly in from GB. We have been working with them in the past few weeks in particular. We have also been working with our trusts. What I needed to know was that they understood the requirement to register with the Trader Support Service, for example, to make sure that their goods would not suffer from any delay. I have those assurances. I also asked our trusts to look in detail at what support they may need to give to the home-care organisations and to make sure that there are good lines of communication in place, and I have had that assurance. I also asked that we have contingencies in Northern Ireland if anything unforeseen should happen. The assurance that I have had on that is that there are already tried and tested systems in place in Northern Ireland for home-care patients should there be a disruption to their supplies. That was one of our residual risks. My team and I did a very worthwhile deep dive into home care with the providers and the health service.

Mr Carroll: Thanks for the presentation. I have two questions. Patricia, you said that work is to be finalised in the year on the cross-border healthcare directive. I may be slightly paraphrasing you there. Your paper states that, as it stands, treatments will be protected for "up to one year". The concern is that people may be waiting for two years, three years or longer for treatment. How does that work? The current arrangement ends in a year. Is the new scheme then developed by both Departments to ensure that people get treatment?

Ms Quinn-Duffy: The cross-border healthcare directive allows patients to get treatment in the private or public sector. Most people go to the private sector in another country to have treatment and then reclaim the funds up to the cost of the local tariff rate for that treatment. The directive itself will no longer apply to the UK, so there will not be the support around patient advice in the other countries and there will not be the same reciprocity under the directive once we get to the end of the year. Anyone who has applied for, has had or is seeking treatment by the end of this year will be able to complete that process. Anyone who has already got authorisation, applied for authorisation or started treatment will be able to finish that off, have the treatment and get their reimbursement. From 1 January, the directive will no longer apply, and patients will not be able to access that kind of treatment. We will be looking at the policy principles around the cross-border healthcare directive, because we can no longer participate in it, to see whether it is appropriate to offer a similar or some other policy to patients in Northern Ireland going forward.

Mr Carroll: OK. I do not claim to be an expert — you obviously are — but my understanding of it is that there are memorandums of understanding (MOUs) on different issues. If a policy or scheme could be developed between the two Departments to ensure that people get that treatment over the next couple of years, most people would support that.

January is when that will hopefully be finalised —

Ms Quinn-Duffy: Yes, we will need to pick that up.

Mr Carroll: — and we will get a briefing on it. Thanks.

Cathy, I know that you cannot give us a detailed list, but do we have a general sense of what is stockpiled here and what is stockpiled in Britain?

Ms Harrison: I should have mentioned that our BSO has a 10-week stockpile of over 1,700 commonly used lines that it is responsible for and has access to further stocks that are available in the UK. As a minimum, there will be six weeks' stock available of all medicines.

Mr Carroll: Here?

Ms Harrison: In Northern Ireland, we did not ask for additional stock on top of that, but I am getting assurances that there is significantly more stock in place. I am hearing that there is more than three months' stock in our supply chain, which is a lot more than we normally have for just-in-time.

In addition to stockpiling, one of the other big changes that we are seeing is that a number of our wholesalers are changing their business models. They have traditionally been short-line wholesalers that held fast-moving lines in Northern Ireland and then have drawn in slower-moving lines from bases in GB, but they have advised me that they are moving to what they call "main line", which means that they are holding a full inventory of stock in Northern Ireland. We have much more volume and range of stock in Northern Ireland currently.

Mr Carroll: To clarify, Cathy, do we have all medicines for six weeks stocked here? Is that correct?

Ms Harrison: The other thing to say is that, when you talk about stockpiles, people think of a big warehouse full of medicines. That stock is in the supply chain, so we have access to six weeks' stockpile, but I can tell you that we also have physically increased the stock that is being held in our wholesaler supply chain in Northern Ireland for our commonly used lines, and some of our pharmaceutical companies are holding much more stock in Northern Ireland. In addition, we have an assurance that, for all medicines, there is at least six weeks' stock within the supply chain across the UK, to which we also have access.

Mr Carroll: Sorry, perhaps I am not getting it. Do we have six weeks' medicine stockpiled in the North?

Ms Harrison: We have at least six weeks is what I would say, but it is not necessarily a stockpile. It is within the supply chain. We have those stocks and access to them, so I think that the answer is yes. We have significantly increased volumes of stock in Northern Ireland. It is different for different product lines. Some have a lot more than six weeks' worth, and some of the businesses are telling me that they have in excess of three months' stock.

The Chairperson (Mr Gildernew): It is not all in the North, however. The concern is that, for example, with PPE, it took six weeks from our first case until we got a drawdown on that stockpile. As Chief Pharmaceutical Officer, would you not prefer that we had a physical stockpile? I get what you are saying about the supply chain, but, as Chief Pharmaceutical Officer for the North, are you satisfied? I am also conscious of issues with ferries, including COVID issues. Someone mentioned earlier that other contingencies may kick in and that you may get a couple of factors coming together at the same time. Is that not a concern?

Ms Harrison: A decision was made very early on about national contingencies and also for here that stockpiles are problematic, because you end up having warehouses full of stock that needs managed. The preferable way in which to manage risk in the supply chain is to have more stock in the supply chain that can flow into Northern Ireland. As a consequence of our arrangements, we have much more stock in Northern Ireland than we ever would have had before.

I assure the Committee that we have a high volume and range of stock in Northern Ireland. It is much higher than normal.

In addition to that, the ask of government overall has been a minimum of six weeks on top of business as usual in supply chains. That is the minimum that I am hearing, and not only that but there is much more in Northern Ireland. There are thousands of lines. Decisions were made on medicines. From our experience of stockpiles, we know that it is an imperfect situation to hold government stockpiles. The more sustainable situation here, considering that we could have disruption over a number of weeks, is for stock to be held within the supply chain.

The Chairperson (Mr Gildernew): I take that point that there is lots of stock of lots of things, but if the item that you need is not in stock or runs low, you will be 100% out regardless of what is in the overall stock. I suppose that is the complexity of it.

Ms Flynn: It is good to know that we have the stocks prepared for three months, but have you looked at any contingency plans on an all-island basis with the South? Say you end up in a doomsday scenario where there are blockages at the ports in the North or at the English Channel, have you had any conversations to put in contingency plans? I am just thinking of the likes of category 1 products. You mentioned that you cannot afford to have shortages of category 1 products because they are so vital to helping people. Have there been any conversations with the South on that?

Ms Harrison: We have ongoing dialogue with the South. I am in regular contact with an official there, and I have a request for a call from him this afternoon or tomorrow before the Christmas holidays. We are in regular communication, and if it were required, we could draw on our good relationships. There are complexities because there are differences in licensing, for example, so it is not just as simple as it could be, but, in an emergency, we would have an agreement that we would call one another if we needed to.

Mr Chambers: I do not see any problem in the supply of the COVID vaccine, given that it is coming in through central government, but can you reassure us that Brexit will not create or present any obstacles to the free flow of the vaccine coming through to Northern Ireland?

Whenever we talk about the stockpile of drugs and the six-week supply, I assume that we are talking about purely prescription drugs. A lot of us self-medicate when we have a cold or whatever, and we just buy off-the-shelf products from the pharmacy. I am very conscious that paracetamol just disappeared off the shelves in the early days of the pandemic, along with children's paracetamol, which was quite concerning, because things like Calpol are standard products in any parent's medical chest, and they just disappeared off the shelves for a considerable number of weeks. Can you assure me about the vaccine and that there will be no problems with the non-prescription drugs that we use to self-medicate?

Ms Harrison: First, there are no issues with the flow and delivery of the vaccine into Northern Ireland. Secondly, the scope of the arrangements on stockpiling includes prescription-only medicines and pharmacy medicines, which can be sold only under the supervision of a pharmacist, so that means stronger painkillers, some cough medicines and other treatments as well as general sales list medicines, which are the ones that you can buy in pharmacies and in supermarkets and other shops. It covers everything.

Ms Hunter: Thank you, Cathy and Patricia, for being here today. Your contributions have been extremely helpful. My question comes off the back of Órlaithí's comment on the Western Trust and medicine on a cross-border basis. I believe that the North West Cancer Centre based in Altnagelvin gets its radioactive isotopes from the South. Do you have any concerns about any difficulties with that as a result of Brexit?

Ms Harrison: Medical radio isotopes are one of the areas that we looked at. You will remember, Chair, that that is a subject that we have talked about at length throughout the last couple of years. It was one of the first areas that we pinpointed as being in need of a high level of assurance, and I can give that. Those products have a very short life, and they are transported into Northern Ireland for treatment and diagnostic purposes for patients. They are used at two sites, one of which is in the Western Trust area and the other in Belfast. They are flown from the EU to East Midlands Airport and then directly to Aldergrove, from where they are moved to the sites in the Western Trust and in Belfast. We have revisited our contingency arrangements for those products on a number of occasions, including very recently, and we have had assurances that we should not anticipate any issues with the medical radio isotopes.

Ms Hunter: Have you had regular conversations with the Western Trust?

Ms Harrison: I had a meeting with the senior team specifically on EU transition and the particular needs of the trust's services on the border. I think that the meeting might have been only last week or maybe the week before; I cannot remember because the days go in so quickly.

The Chairperson (Mr Gildernew): I was wondering about the isotopes as well, so I am glad that that has been raised.

I wanted to ask you about medical devices. Previously, a decision was taken very quickly to create a facility in Belgium to provide stents. Are the issues with one-off, custom-made medical devices part of the reason for the 12-month delay or are they a separate area of concern? Have those concerns been addressed at this point?

Ms Harrison: When you say one-off medical devices, are you thinking about bespoke, custom-made items?

The Chairperson (Mr Gildernew): Yes, custom-made; things that you cannot stockpile.

Ms Harrison: I will have to find that out for you. I do not have an answer on that. I will come straight back to the Committee on that.

The Chairperson (Mr Gildernew): I appreciate that.

I will take you up on your offer to talk about frameworks generally. We will be talking more about some of the frameworks later. The paper says:

First, what is the point of us being in a framework with Scotland, England and Wales in an area where we are bound to the EU? Secondly, building on that, it is mentioned that officials from Scotland, England and Wales will cooperate on mechanisms that should be built "where possible". Would it not make sense for officials from the Dublin Departments to also be involved, given that our frameworks are going to need to include North/South as well as east-west work?

Ms Quinn-Duffy: The frameworks are designed by the UK Government for areas that are, more or less, in the UK internal market. Where an EU competence has returned to a devolved competence, meaning that there is an ability to diverge, particularly on blood and tissues, and where Northern Ireland has to comply with EU regulations, it keeps the rest of GB and the whole of the UK in line as far as possible to make sure that the transfer on those issues can continue. As organ donation and transplant is a UK-wide mechanism, it is necessary for us all to work together on that. There is an imperative for us to work on it.

For the purpose of the framework, that is not a UK or common travel area (CTA) arrangement. However, I understand that there is a bilateral element in the CTA for the UK and Ireland for organs. It may be that, in some areas, there will be little divergence in those areas in order to maintain cohesion.

The Chairperson (Mr Gildernew): OK. I suppose that we will have to keep a sharp eye on that in the time ahead.

Thank you for your presentations today. I agree; they have been very interesting, and this has been a very useful engagement. Thank you for your responses, insofar as it was possible to give them, to most of the questions and for your commitment to provide us with any additional information that you were not able to give to us today.

I thank all of your officials online, and you, Cathy and Patricia. Thank you very much. I wish you all a very happy and peaceful Christmas. I hope that everybody gets some sort of a break over Christmas because I know that you have all been working extremely hard in very challenging times. Hopefully, everyone will stay safe and will be able to enjoy Christmas within the limits of what is sensible, if not of what is allowed.

Ms Harrison: Thank you, Chair. If I could just thank the Committee for the support that it has given us in the last few months and particularly for the scrutiny that it was able to apply to the high volume and complexity of legislation that we put in front of it. Thank you all.

The Chairperson (Mr Gildernew): Thank you. Ádh mór oraibh. Slán libh.