Brexit Preparations Update: Discussion

On behalf of the committee, I apologise for keeping our guests waiting for an hour. The select committee was discussing legislation and our session took a little longer than planned.

The purpose of this meeting is to receive an update on the preparations for Brexit in respect of the health sector. On behalf of the committee, I welcome from the Department of Health, Mr. Jim Breslin, Secretary General, Mr. Muiris O'Connor, assistant secretary and head of research and development and health analytics, and Mr. Eamonn Quinn, pharmacist; from the HSE, Mr. Dean Sullivan, chief strategy officer, Mr. John Swords, head of procurement, Ms Paula Keon, assistant national director of the EU and North-South unit, and Mr. Shaun Flanagan, head of primary care reimbursement services; and from the Health Products Regulatory Authority, HPRA, Dr. Lorraine Nolan, chief executive, Ms Rita Purcell, deputy chief executive, and Mr. Laurence O'Dwyer, scientific affairs manager.

I draw our guests' attention to the fact that by virtue of section 17(2)(l) of the Defamation Act 2008, witnesses are protected by absolute privilege in respect of their evidence to this committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to do so, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. Any opening statements made to the committee may be published on the committee website after the meeting. Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.

I invite Mr. Breslin to make his opening statement.

Mr. Jim Breslin

I thank the committee for inviting the Department, the HSE and the HPRA to assist it in its examination of issues arising from Brexit. Our discussion will build on previous engagements and the committee's valuable report on the subject. The Department, along with the HSE and the HPRA, last appeared before the committee on 30 January to update it on the preparedness of the health sector for Brexit. Much has happened in the intervening period, including two extensions to the withdrawal date and the election of a new British Prime Minister. The committee's invitation is timely, therefore, as we finalise our preparations for the likely possibility of the withdrawal of the United Kingdom from the European Union on 31 October. No less, I am sure, than committee members, many of us have developed a nightly addiction to the BBC's "Newsnight" and its fascinating dissection of daily Brexit developments in London. I assure the committee, however, that irrespective of such developments, preparations of the Irish health sector for Brexit have been under way for two years and we are working assiduously to undertake as much further preparation as possible in whatever period remains.

Brexit preparation continues to be a priority for the Department and key health agencies, and significant further work has been undertaken since we last met. When we last discussed the subject, I stated that Brexit preparation is an exercise in damage limitation for Ireland, generally, and the health sector, specifically. Had we a choice, all of us would much prefer to devote our intensive efforts to addressing the many positive opportunities that exist to improve the health of our population. Nevertheless, while we all hope negotiations will be successful in resolving the threat of a no-deal Brexit, we must continue to work with industry and other stakeholders to protect public health against every eventuality. This year, we have committed more than €10 million in funding to health sector Brexit preparations. If Brexit proceeds on a no-deal basis on 31 October, it will be necessary to incur further costs this year and on an ongoing basis. We could do much with the money to improve the health service but instead must use the resources to mitigate any potential Brexit impact on population health.

Brexit is not a temporary or once-off adverse event. It represents permanent change to many aspects of daily life, encompassing how we trade, import and regulate goods and services, including health related products. Previously, I outlined to the committee the structures we use for that preparation and they remain in operation. In summary, there is a heads-of-agency group, where I meet the CEOs of the HSE, the HPRA and the Food Safety Authority of Ireland, FSAI, weekly to review progress on Brexit preparedness and to consider any new issues arising.

The Brexit operations team, which is chaired by a deputy secretary general in the Department, is comprised of senior officials from the Department and its agencies, and meets weekly. It works to resolve issues and to escalate them to the heads of agencies group, if necessary. The operations team has a number of groups active in addressing particular issues. Two multi-agency expert groups are working to verify the assurances and contingency planning in place in respect of the supply of medicines and medical devices, respectively. These groups, which include clinical expertise, are working with suppliers to assess the vulnerability of products to supply disruption as a result of Brexit and making further preparations to ensure continuity of care for patients.

A communications group, chaired by the Department, is leading communications with relevant stakeholders and, as part of Government's overall communications strategy, with the public.

As I stated at my last appearance before this committee, our greatest protection against Brexit is our membership of the EU. The Department and the HPRA continue to work very closely with the Commission and with other member states to mitigate the worst effects of Brexit and will continue to do so.

The additional time granted by the extension to a possible Brexit on 31 October has been used to deepen our preparedness. We have reached out to all parts of the health sector, including industry and suppliers, patients and healthcare professionals, to understand the challenges they face and to work together to resolve them. I acknowledge the co-operation we have received across the sector in this work. We will provide detailed information to the committee on this work throughout this session with a particular focus on the areas the committee has requested in terms of the supply of medicines and the movement of health professionals between Ireland and the UK. In this work, our overriding concern is to ensure the protection of public health, the continuity in the provision of health services and the maintenance of existing services.

Our membership of the common travel area, CTA, with the UK also provides certainty to Irish and British citizens resident in the other jurisdiction in relation to access to healthcare. The Irish and British Governments have committed to the shared objective of maintaining the CTA arrangements, which have long facilitated Irish and UK residents in accessing health services in each other's jurisdictions.

Provision has been made to ensure the arrangements necessary to maintain health service co-operation after Brexit. Part 2 of the Withdrawal of the United Kingdom from the European Union (Consequential Provisions) Act 2019 will underpin continuity in the provision of healthcare in the event of a no-deal Brexit. This will see the maintenance of current arrangements for access to routine, planned and emergency health services for UK and Irish residents and visitors in the other jurisdiction. It also includes North-South and east-west health co-operation on access to specialist health services in the other jurisdiction.

In relation to North-South health co-operation, we are committed to protecting the many areas of co-operation in which the health sector has engaged on a cross-Border basis. These well-established and widely supported arrangements make life easier for people living along the Border and allow for the best use of resources for both health systems. Examples include: cancer care at Altnagelvin Hospital, paediatric cardiology services in Crumlin, and cross-Border ambulance services.

The Department has been in regular contact with the Department of Health in Northern Ireland in respect of the commitment of both Governments to ensure the continuation of North-South health service co-operation. These contacts build on many years of positive co-operation. In all of our preparations, we have been able to build upon this very strong spirit of collaboration in the interests of patient care, at clinical, hospital, administrative and political levels. The HSE has been tasked with addressing GDPR and any other issues arising at operational level with its counterparts. In fact, the Northern Ireland Department of Health officials are due to visit the Department for a further meeting in early October. I can say with confidence that all existing North-South health co-operation, including arrangements with Northern Ireland health service providers, will continue.

Safeguarding the supply of medicines and ensuring continuity of care for Irish patients is of utmost importance. The EU has a sophisticated regulatory framework for medicines and medical devices and detailed preparations are in place across industry and regulators as the UK leaves this system. Dr. Lorraine Nolan, from the HPRA, will outline this in more detail. Ireland is at the end of a very sophisticated supply chain when it comes to the importation of medicine and medical devices. My colleagues from the HPRA and the HSE will provide detailed updates on the current position and contingency plans in relation to supply security. We are working closely with the pharmaceutical and medical technology industries to modify supply arrangements and minimise potential disruption.

Ireland is unlikely to face general medicine shortages in the period immediately after 31 October. Any emerging supply issues will, in the first instance, be dealt with from existing supplies held within the domestic distribution chain. This supply chain is different to that of some other markets, including the UK. It is important to reiterate: there are already additional stocks of medicines routinely built into the Irish medicine supply chain; this is different to the wholesaling model which operates in the UK; the pharmaceutical industry and wholesalers have provided direct assurances that they are confident that they will have sufficient stocks to bridge any initial issues at ports, should they occur; and there is no need for hospitals, pharmacists or patients to order extra quantities of medicines, or for doctors to issue additional prescriptions, as doing so could disrupt existing stock levels and hamper the supply of medicines for other patients. Patients should continue to fill their prescriptions in the normal way.

As I have said, strong general assurances have been received from industry but an expert group is also examining categories of medicine where it is deemed especially important to work directly with suppliers to verify that robust contingencies are in place. Unfortunately, medicine shortages arise from time to time and are a feature of health systems around the world. Ireland has an existing multi-stakeholder medicine shortages framework in place, co-ordinated by the HPRA, to help prevent shortages from occurring and to reduce the impact on patients and healthcare professionals by co-ordinating the management of potential or actual shortages as they arise. The health system is, therefore, well placed to deal with any additional shortages as a consequence of Brexit, should they occur.

Brexit is likely to herald changes in our medicines market as we will be less integrated with the larger UK market. Therefore, our focus on this issue will continue well past any Brexit date and into the medium term. Work on the medicines shortages framework and the involvement of clinicians in contingency planning give us an enhanced capacity to respond to any such market developments and, for example, mean that should particular products no longer be available, expert clinicians in the respective medical specialties concerned will have identified equally effective alternatives.

The committee asked about the recognition of healthcare qualifications. The Department of Education and Skills has co-ordinated work across Government to ensure that, as far as possible, arrangements will be in place to maintain recognition of UK professional qualifications. The importance of this work as part of affirming the right to work under the common travel agreement was acknowledged in the memorandum of understanding signed by both Governments.

At the outset, it is important to say that decisions on qualification recognition that have already been made under EU directives will remain valid and existing recognised health professionals will be able to continue to practice in either jurisdiction, subject to compliance with all regulations within that profession. In respect of new recognitions, the recognition of qualifications in the EEA is carried out through the implementation of an EU directive. The directive also provides a mechanism for the exchange of information on professional misconduct as well. It applies to all regulated professions – not only those in the health area.

When the UK leaves the EU, either after the transition period - if it occurs - or on the withdrawal date, UK qualifications and the qualifications of UK nationals will no longer fall within the scope of the directive. Instead, Irish health professional regulators have "third country" recognition routes, which apply to qualifications which are obtained outside the EEA or which are held by non-EEA nationals. The regulators have considered these "third country" recognition routes with the objective of ensuring efficient routes for recognition of UK qualifications, while ensuring that this is done in an objective and non-discriminatory way.

The Irish health professional regulators are satisfied that they can continue to recognise UK qualifications within approximately the same timeframes and the same level of application fee as applies currently, but now under this different legal base. Similarly, the UK has preparations in place in respect of the recognition of health and social care professions, which will enable Irish qualifications to be recognised in the UK in the event of a no-deal Brexit.

Irish regulatory bodies have also been linking with their UK counterparts to develop protocols for transferring personal data in accordance with the general data protection regulation, GDPR. Transfers of personal data by the Irish regulators to their UK counterparts may be required in the processing of recognition applications or in the conveyance of disciplinary information.

As part of the whole-of-Government preparations, the Department has worked in close partnership with the FSAI, the HSE, and the Department of Agriculture, Food and the Marine on the issue of food safety in the context of the UK's departure. Enhanced staffing and procedures will be in place at the ports to facilitate inspections. In order to avoid unnecessary delays, it will also be vital that industry prepares as fully as possible and significant outreach has been undertaken with industry. Businesses will need to familiarise themselves fully with all relevant customs procedures and ensure that all necessary documentation is properly completed and submitted in advance.

We have engaged extensively with suppliers both in their industry groupings and on an individual company basis on their individual products. We have stressed to them the importance of providing early information on any emerging issue. For our part, we have assured them that we are in problem solving mode. We are focused on pre-empting or solving problems using pragmatic solutions. We will be there to troubleshoot on industry issues that arise in the days and weeks following Brexit.

I am satisfied that the health sector is working well in preparing for Brexit. We are linking with central government to ensure all cross-sectoral issues will be identified and resolved. We are working with industry, including the pharmaceutical, med-tech and food sectors and private health service providers, as appropriate, to ensure the health sector, our employees and citizens will be well prepared and protected as far as possible from the adverse effects of Brexit. I look forward to our discussion.

I thank Mr. Breslin for his opening statement. I call Mr. Sullivan from the HSE to make his opening statement.

Mr. Dean Sullivan

I thank the Chairman and members of the joint committee for the invitation to attend this meeting to discuss our Brexit preparedness. As the committee has been advised, an HSE Brexit planning group has been in place since 2017 and working closely with the Department of Health and other stakeholders on a range of Brexit contingency planning and mitigating actions. The focus of this work has been on the implications of Brexit across the following key work streams: continuity of patient and client health services; cross-border and frontier arrangements; emergency health services, including, as Mr. Breslin mentioned, the National Ambulance Service; public health matters; environmental health services at ports; workforce issues and recognition of qualifications; continuity of supply of goods and services and associated procurement arrangements; GDPR compliance; and communications.

On continuity of patient and client health services, the focus of the mitigation measures is on ensuring updated service level agreements and memorandums of understanding will be in place in specific areas of healthcare such as paediatric organ transplants.

The HSE’s EU and North-South unit is working to ensure services currently available to people living on both sides of the Border will continue to be available post-Brexit. These services include cardiology and radiotherapy services at Altnagelvin hospital, and, as Mr. Breslin mentioned, the specialist cardiac services provided on an all-Island basis for children at Our Lady’s Children's Hospital, Crumlin. A detailed mapping exercise has taken place between the two jurisdictions and produced an agreed list of all services being provided. In addition, the signature of the memorandum of understanding in May on the common travel area has been very helpful in underpinning services in that regard on an ongoing basis.

On emergency services, the national ambulance services here and in Northern Ireland have updated two key memorandums of understanding between the respective services, first, the understanding of understanding on the provision of assistance in the management and resourcing of emergency and urgent calls and, second, the memorandum of understanding on mutual aid in a declared major incident which joins both jurisdictions in response to a major emergency.

The HSE's environmental health service is engaged in ongoing discussions with the Departments of Health and Agriculture, Food and the Marine on the import and export of foodstuffs and the possible divergence of food regulations and controls. Significant additional resources have been put in place to strengthen the capacity of the environmental health officer service in that regard, with nearly 100 additional personnel recruited. At Dublin Port and Rosslare Port work is nearing finalisation with the Office of Public Works on new accommodation facilities for new and existing staff. That accommodation will be completed before the end of October. Training for new and reassigned staff has been brought forward.

The workforce implications of Brexit have been examined by the HSE's human resources department and the regulators have confirmed that no delays or additional costs related to UK qualifications are expected post-Brexit. There is also no significant risk envisaged in the supply of UK qualified health professionals.

On the provision of goods and services such as medical and surgical supplies and medicines, a particular risk for the HSE arises in the supply of medical devices. A number of suppliers have confirmed that the transfer of certification files from UK notified bodies is not yet complete and that, given the lack of capacity within the EU 27, it will not be able to be completed by 31 October or for some time afterwards. The number of medical devices in respect of which there will be regulatory issues is significant and represents a particular risk in maintaining continuity of service from early 2020 in the event of a no-deal Brexit. To address this issue, we are taking in additional stock in these vulnerable product lines and looking for alternatives that do not have certification issues. In addition, we have supplied the Department of Health with examples of particular devices affected in order that the matter can be considered in seeking an appropriate derogation for a transition period.

A joint working group comprising the HSE, the Department of Health and the Health Products Regulatory Authority, HPRA, is engaged in intensive work which involves the identification of suppliers of critical medicines to obtain assurances on their continued intention and capacity to supply the Irish market post-Brexit. Assurances have been received from all relevant companies in that regard. Some 6,500 medicine line items were reviewed by clinicians and pharmacists to identify vulnerable product lines. Assurances have also been sought on existing supply routes. While assurances have been provided, including confirmation that customs requirements have been considered, as appropriate, there remains potential for some delays and disruption to supply routes, for example, owing to delays in transiting the UK land bridge or at UK airports. The key supply chain challenges in the short or immediate term are likely to be related to medicines with a short shelf life, those with refrigerated supply chains, compounded products and time critical logistics. A strong focus has put on mitigating these challenges which include putting in place alternative supply arrangements, working with suppliers to increase stock in certain vulnerable areas and putting arrangements in place with Revenue colleagues to fast-track vulnerable product lines through customs.

On vaccines, a two to three-month stock is held in the HSE's national cold chain service which, with the stock held by companies in Ireland, gives approximately a six-month supply to ensure continuation of service delivery. None of our vaccines is sourced from the United Kingdom.

On GDPR compliance, extensive work is under way to identify organisations which are hosting, accessing or processing HSE personal data within the United Kingdom. This is to ensure completion of EU standard contractual clause agreements which will allow for the continued legal transfer of HSE personal data post-Brexit. The HSE's ICT teams have put in place agreements with all of our main UK suppliers. The HSE continues to notify all suppliers and service providers of their GDPR compliance requirements and expectations in the event of a no-deal Brexit. Appropriate steps are also being taken to address clinical trial compliance issues in co-operation with the HPRA.

We have put in place a detailed communications plan within the HSE and are working closely with the Department of Health's communications team to ensure relevant stakeholders are updated. We have held a number of stakeholder engagements within the organisation and are keeping our website updated on a regular basis. We are engaging with our staff and have a dedicated email address for queries or questions they may have.

In summary, the HSE's preparations are focused on ensuring continuity of all-island patient services, environmental health services at ports, workforce issues related to the free movement of health personnel, maintaining the supply of essential goods and services and ensuring the HSE continues to be GDPR compliant. Notwithstanding these efforts, the risk of a no-deal Brexit on 31 October still has the potential to cause some disruption to health services, despite the mitigation measures in train. Working closely with colleagues within in the Department of Health, the HPRA and wider industry, we are focused on continuing to find positive and practical solutions for patients, stakeholders and staff in that regard.

That concludes my opening statement. Together with my colleagues, I will endeavour to answer questions committee members may have.

I thank Mr. Sullivan for his opening statement. I have to vacate the Chair temporarily. Deputy Louise O'Reilly will step in for me. Dr. Nolan will now make her opening statement. It will complete the opening statements.

Deputy Louise O'Reilly took the Chair.

Dr. Lorraine Nolan

I thank the Chairman and the joint committee for giving me this opportunity to speak to its members about our Brexit preparations. I am the chief executive of the Health Products Regulatory Authority, HPRA. I am joined by my colleagues, Ms Rita Purcell, deputy chief executive, and Mr. Larry O’Dwyer, scientific affairs manager.

The HPRA, as the regulator of medicines and medical devices, has been engaged in preparing for the United Kingdom’s exit from the European Union since Article 50 was invoked. Since the beginning of the year our preparations and engagement with stakeholders have intensified and been based on the worst case scenario associated with a disorderly Brexit.

At a high level, there are three major strands to our work. Since Brexit was announced we have been working with companies to ensure they understand their obligation to be in regulatory compliance by 31 October. We have also been working intensively and proactively with the Department of Health and the HSE on the supply of medicines deemed to be critical to patient care. We have been assisting the HSE in its review of the supply of medical devices.

This has been supported through our work with primary wholesalers, who introduce stock to the market, to review their capacity to hold stock in the event of a disorderly Brexit. I will speak more about those shortly. The HPRA has detailed plans not only to address the immediacy of a hard Brexit, but also to continue with its participation as a key European regulatory agency in the aftermath of Brexit.

The final area of focus has been supporting the Department of Health in engaging with the many relevant stakeholders to ensure a common understanding of the issues and a co-ordinated approach to interaction and communication. In all our work to date, our aim has been to ensure, to the fullest extent possible, that the necessary preparations are completed in time so as to mitigate any potential adverse impacts on patient care.

I will now provide an update on specific elements of our preparations for a no-deal scenario. The committee will be aware from its meeting on 30 January this year that the HPRA has been engaged in an extensive industry engagement exercise with the Department of Health and the HSE, focused on the supply of critical medicines. These are medicines with a short shelf life, refrigerated supply chains, time-critical logistics or compounded for specific patients or patient groups. However, working with the HSE, we have also been able, through this exercise, to review supply arrangements for all prescription medicines regardless of criticality. The review involves liaising directly with hospitals, companies and distributors to identify supply routes and ensure companies have contingency plans in place if their supply routes have been from, or through, the UK. This exercise was first conducted in quarter 1 of this year and work has been ongoing since that time. In advance of the 31 October deadline, we are again repeating this co-ordinated outreach to companies to seek final reassurances of their supply arrangements and contingencies for 31 October in the event of a disorderly Brexit. This work is continuing.

Radiopharmaceuticals, which have a short shelf life and very specialised transport and storage requirements, are one example of this work. While some of these do not transit the UK, the majority are flown from continental Europe to Ireland via East Midlands Airport by one logistics company. Companies which use this route have previously received assurances from their logistics provider that it will continue to operate these supply routes post Brexit. We have been in contact with the companies which supply these products to the Irish market and they confirmed their intention and plans to continue the supply to Ireland post Brexit. We have also requested written assurances from the logistics provider involved. Separately, there is ongoing direct engagement with the logistics provider to ensure that its service can be relied upon and, if necessary, consider alternative solutions that may be required. Currently, all the responses we have received indicate that all parties believe they can continue to supply the Irish market and all parties are actively considering contingency plans. This is a good example of the complexity of the issue and the many players involved in getting product to Ireland. In this case, as the product is intended for both Ireland and the UK, it must stop first at East Midlands Airport. This introduces an element outside the control of all parties. While there is no indication that this will cause a problem, it is indicative of the general position that where there are multiple independent players involved in the supply chain, it is not possible to rule out all risks. However, the HPRA and the HSE plan to actively monitor this situation and manage it as necessary.

Another example is insulins, which are critical medicines for diabetic patients and need to be refrigerated during transportation and storage. We have engaged with the three suppliers of insulins to Ireland all of which have provided assurances that they will have a minimum stock of eight to ten weeks of all insulins in Irish wholesalers on 31 October. In addition, all have taken steps to ensure they are in a position to replenish these stocks post Brexit, including by using alternative transport routes which do not involve supply from or via the UK.

A key part of our Brexit planning is to ensure that there is sufficient stock in Ireland in order that temporary delays during transportation will not significantly affect access by patients to medicines. We have contacted all the primary wholesalers which have provided assurances that they will hold between eight to ten weeks of stock for the vast majority of medicines. This level of stockholding will allow Ireland to manage short-term disruptions to the supply of medicines. We have also, as part of our engagement with companies supplying the market, requested that they confirm they will have sufficient stock on 31 October and can maintain these levels in the post-Brexit period by appropriate replenishment procedures. We have also continuously stressed to companies the need to be aware of, and comply with, customs procedures and requirements and have issued individual letters, follow-up calls and a checklist to that effect.

For medicines where stock levels are less than that, we are actively working with the wholesale sector to address potential Brexit impacts and ensure that cases where continuity of patient care could be compromised are addressed insofar as possible. This includes the ability, if possible, to build additional stock levels and the development of contingency arrangements to ensure a sustained process of stock replenishment. Work in this regard is ongoing.

On the supply of medicines post Brexit, it needs to be recognised that some products will still either come from the UK by air or sea or, by necessity, will be transported across the UK. The assurances received from companies are based on the continued operation of these transport routes combined with the maintenance of sufficient stocks levels in Ireland. However, significant and prolonged delays anywhere along these routes could potentially interrupt supply to the Irish market. While our preparations are focused on ensuring that such impacts are prevented or minimised, there are no absolute guarantees.

No major supply concerns for continuity of patient care have been identified to date and we have, through our shortages protocol, plans in place to address issues should they arise. This framework predates Brexit, as medicines shortages can occur for various reasons on an ongoing basis. I emphasise again that there is no need for hospitals, healthcare professionals or patients to order extra quantities of medicines ahead of Brexit. To do so could disrupt existing stock levels and hamper the supply of medicines for other patients.

Marketing authorisations for medicines place a number of regulatory obligations on the holder. These include that the holder must be based in the EU and that each batch of product imported from a non-EU country must be retested and released in an EU member state. Regulatory compliance among companies has been improving steadily as affected operations have moved from the UK to an EU 27 country. In a repeat of the exercise conducted in quarter 1 of this year, we issued a list of questions in August to those companies which potentially may not be in regulatory compliance on 31 October, or 31 December if they availed of a Commission approved temporary waiver of retesting requirements on importation into the EU. A medicine which is non-compliant as of 31 October does not automatically present an immediate risk and we will work to ensure that regulatory issues associated with Brexit will not hinder the supply of medicines in the immediate aftermath. We are continuing to engage with companies to ensure that they address outstanding regulatory actions in a timely manner.

Medical devices, unlike medicines, are not authorised by the HPRA. Each medical device on the market requires a conformité Européenne, CE, mark to demonstrate conformity with the regulatory framework and for medium to high risk devices a CE certificate must be issued by a notified body located in any EU member state. The HSE, as the main procurer of medical devices for the Irish health system, has engaged in an in-depth exercise of analysing medical devices for exposure to the UK - landbridge or manufacturing - and for certification from a UK notified body.

The HPRA is participating in the HSE-led criticality assessment group for medical devices and is sharing information with the HSE to assist in its risk assessment of critical medical devices supplied to and used in the health services. The HPRA has communicated with manufacturers and authorised representatives at national level a number of times to ensure appropriate awareness of the implications of a disorderly Brexit for medical devices. We have also led on EU work with other competent authorities to promote awareness and to prevent adverse impacts on medical devices used in Ireland. From our engagement, we know that larger manufacturers have measures in place to transition their UK medical device certificates to an EU 27 notified body, while many small and medium sized manufacturers have indicated that their main challenge is in securing an EU 27 notified body to issue new certificates. As such, it remains the case that a significant number of UK certificates have not transitioned to an EU member state.

There are a number of factors contributing to this. Historically, there has been a high dependency on UK notified bodies for medical device certification activities. This is due to the broad ranging designation scope which the UK notified bodies have to conduct such activities and to their size. Notified bodies throughout Europe are also preparing for new EU regulations which apply from May 2020, a factor which is impacting on their ability to take on additional certification activities.

The HSE is reviewing the impact of this on medical devices on the Irish market. The situation is not unique to Ireland, although our market is likely to be more impacted. The HPRA and other EU authorities are working together to develop and agree with the European Commission a European approach to manage UK certificates that have not transitioned by the deadline.

If such an approach is not agreed, the HPRA has developed contingencies to manage this. Given that a medical device which becomes non-compliant with regulatory requirements after 31 October does not present an immediate risk, we will work to ensure continuity of care for patients while ensuring that products return to compliance as quickly as possible.

As Government public communications have recognised, any Brexit outcome that does not include regulatory alignment will mean change as the UK and Irish markets adjust over time. Brexit will bring change across all areas and in the dynamics of the supply chain and model in Ireland for both medicines and medical devices. The issues we see in the longer term may be quite different to those in the immediate aftermath.

It is realistic to expect that companies may after a period of time make commercial decisions with respect to the continued viability of supply of certain products to our market. We have stressed to companies that, in advance of making any such decisions, they should let us know of their plans as soon as possible. The earlier we have this information, the better we can plan for change, including working with HSE colleagues. Alternatively, we may be able to help in identifying a course of action to prevent such an outcome.

In closing, I would like to assure the committee of the strenuous efforts being made by HPRA staff in relation to protecting the supply of medicines and health products to Irish patients post Brexit. I also wish to acknowledge the considerable collective efforts of our colleagues in the Department of Health and the HSE and the substantial engagement by industry and healthcare professionals. It is this open and co-operative approach among stakeholders across the health products sector that will help to ensure we effectively and collectively manage the potential impact of Brexit on supply and availability.

We will be happy to address any questions.

I thank Dr. Nolan. I thank everyone for their contributions. Apologies for missing the first few minutes here.

Before I open the debate to members of the committee, I have a number of questions of my own. I might come back on some of them as well, if that is okay.

In her submission, Dr. Nolan stated:

We have contacted all the primary wholesalers who have provided assurances that for the vast majority of medicines they will hold between eight to ten weeks of stock. This level of stockholding will allow Ireland manage short-term disruptions.

I note "the vast majority", but not all. Is there an issue with some? Are there some for which we do not have that necessary buffer? Will we have that issue resolved in advance of a potential no-deal Brexit?

Ms Rita Purcell

I might come in there. We have contacted 44 wholesalers. Nearly 90% of all stock is held by our two primary wholesalers and they are confident. When they say "the vast majority", they are saying, "but for a few product lines". They are, however, giving us details of those product lines and we are working through those. We are able to see whether there are alternatives and whether we need to take contingency action. It is a picture that changes day by day because they have a considerable throughput of stock.

We are also predicting forward as to what the expected picture will be on 31 October. Right now, what we can say is that we are working through any products that have been identified but they have not identified a significant issue of supply to the Irish market. They believe, I would use the word "substantially", all products that are used will have that level of stock. Should there be an issue with a product, our shortages framework would work through it. Does Mr. O'Dwyer want to add anything to that?

Mr. Laurence O'Dwyer

Unfortunately, irrespective of Brexit, at any one time we experience shortages of a number of medicines. Irrespective of Brexit, there will be ongoing shortages of medicines. Some of the products mentioned are products that are already in short supply, in a number of cases, for global reasons such as manufacturing issues and logistics issues. I emphasise that some of those medicines would fall into that category.

With regard to stockpiling, has the HPRA any information that stockpiling is happening? I note the HPRA's advice to people is not to stockpile but people rarely do exactly what they are advised. Anecdotally, I understand that is happening, albeit on a small scale. I wonder has Dr. Nolan information about that. Has the HPRA encountered that at all?

Dr. Lorraine Nolan

From the intelligence we have, we do not have anything to substantiate that such is the case. Consistently, through all our messaging on Brexit reparation, we have engaged with healthcare professionals and we really have cultivated their support in pushing that message out, particularly to patients, to ensure that they do not stockpile. As I mentioned in my statement, it is important. The marketplace operates on a precise dynamic and stockpiling that may occur will upset that balance. In terms of ensuring continuity of supply, it is important that there is messaging to refrain from stockpiling.

Those in County Donegal, for example, will be nearly the worst impacted by it on the basis that a pharmacist in Donegal might well believe that he or she and his colleagues will be the last ones at the end of that supply chain. I suppose the advice to them is not to upset the equilibrium and to ensure that they do not stockpile. Human nature being what it is, however, I can foresee an issue with that.

I have a question on the European health insurance cards, EHICs. A commitment was given by the Government that the EHICs would be made available to people in the North. Can they give us an update on that?

Mr. Jim Breslin

I can update the committee on that. We received approval at Government last week on the approach to that Bill and we will be going back shortly. We have a priority team on it, and drafting is under way with the Office of the Parliamentary Counsel. I would think we will be going back to Government with a full Bill before the end of the month. At that point, we will work with the Whips to schedule time in the Oireachtas. We will obviously make ourselves available as officials to the committee members to talk them through the approach there. It is a priority to have that legislation brought into the Oireachtas in October.

I have a final question before I open the debate. I have a couple more questions but I will hold them over.

Is there a supply line from mainland Europe straight into Irish ports bypassing Britain? Has that been looked at? Is that being sourced? Are we ready to go with that? Can Mr. Breslin give us an update?

Mr. Jim Breslin

There are significant supply routes directly from the Continent into Ireland, with shipping companies coming into Dublin Port and shipping coming into Rosslare. They are well-established routes. There is capacity on those routes.

Something Dr. Nolan referred to was the modification of supply chains that has already taken place by pharmaceutical companies. Some of them will, depending on the nature of the product, find it just as realistic to come directly into Ireland and will have modified their supply chain and be doing that now. Others will be keeping it under review. There are particular products that are not relevant to that, particularly products that are sourced from and originate in the UK.

There is substantial shipping capacity to come direct from the Continent. It adds approximately 20 hours to the journey and it is an issue in terms of the product. If one hears the discussion being held on a wider basis, there are certain perishable products - I am not talking about medicines or medical devices - where those 20 hours are a challenge. In general, once one adds 20 hours, one is adding cost because one will need a driver for longer. For pharmaceuticals and medical devices, which often are reasonably high-value products, that route exists. Companies have already made the change or will consider the change in the event of Brexit fallout.

Given the timeframe, I note, "will consider the change". Has Mr. Breslin been engaging with his counterparts in the North in terms of the maintenance of that supply on the basis that there is a logic that, as a small island, we would do our best to withstand Brexit as a unit?

Mr. Jim Breslin

Yes. There is also the fact that much of the trade that ends up in Northern Ireland comes through Dublin Port. We are conscious of that. We would be working collaboratively - as we would work with authorities throughout the UK including on east-west trade - to ensure that there is smooth flow at all stages of that supply chain.

Has Mr. Breslin had ongoing engagement in that regard? Would that include meetings, phone calls and a plan worked up together?

Mr. Jim Breslin

We have overall engagement with the department in Northern Ireland. This is intensive engagement on all elements of Brexit. Mr. O'Connor has led this interaction. I will not say we have daily engagement but we certainly have weekly engagement with counterparts, as we do with Whitehall and the department in London. In all of this engagement everyone is focused on health, which is the important issue, and everybody is seeking to ensure exactly what we are trying to achieve here, which is no disruption.

I thank the witnesses for their time and all of their work. I was very taken when I heard that two companies bring in 90% of the drugs. What are the names of those two companies?

Mr. Jim Breslin

They are the two wholesalers. United Drug and Uniphar are our biggest wholesalers. This does not mean they import all of the drugs. They are part of the supply chain for those drugs and those drugs could be delivered to their warehouses by the manufacturers. It is not that the two companies do all of the logistics. They do the wholesaling, particularly out to community pharmacies.

The Department is in communication with the two companies.

Mr. Jim Breslin

All of the agencies represented here are in very close communication with them. It is probably worth saying that on 10 September, every stakeholder, including wholesalers, the Irish Pharmacy Union, the Irish Pharmaceutical Healthcare Association, IPHA, representing the major manufacturers, and Medicines for Ireland representing the generic manufacturers, were at the same table and the Minister was present. We received updates on everybody's preparations and we gave updates on ours. We are all on the same page on this. We are all working together on it. Our assessment is shared.

The Minister has met both companies.

Mr. Jim Breslin

Yes; I am not certain the two companies were represented at the meeting I mentioned. We sought representatives from the wholesalers' association, and the representative who attended was from one of the companies. Dr. Nolan and a representative of HSE can speak about their daily outreach to those companies.

That is okay. I want to check that the Minister has, presumably, met both of these companies.

Mr. Jim Breslin

The bit I want to correct is with regard to attendance at the meeting on 10 September. Perhaps Mr. Quinn can tell me whether the two companies were represented. I know United Drug was represented.

Mr. Eamonn Quinn

United Drug and Unipharm form part of Pharmaceutical Distributors Federation Ireland and representatives from both companies attended on behalf of that body the meeting attended by the Minister and a previous meeting in April or May.

I thank Mr Quinn. There is a lot of public concern about the impact on drugs and devices and the messages are mixed. In preparation for this meeting I had a quick look back. On 20 August, the British Medical Journal reported a no-deal Brexit may worsen drug shortages. On 6 September, a headline in The Irish Times read, "Varadkar rules out food, medicine shortages under no-deal Brexit". Unfortunately for us, on 19 September the British Brexit secretary, Steven Barclay, pointed out that two thirds of our drugs come across the UK by land and that there could be shortages in Ireland. The next day the Government dismissed those warnings. The British Medical Journal is warning, as is the Brexit secretary, but in Ireland these warnings are being dismissed as they relate to us.

We have also had statements made this morning and reported on RTÉ last night that there are risks. Specifically what was picked up was the risk to medical devices. Casual observers and those relying on these drugs and devices hear very conflicting things from very senior sources. Is it the case that two thirds of the drugs come across the UK land bridge? There is a very serious risk to multiple days of disruption to that land bridge and we have no idea how long these delays could go on for. Is it the case that two thirds of the drugs come across the land bridge? If so, which drugs are the highest risks? I accept the witnesses are all trying to do everything they can to mitigate the risks but, understandably, their language is hedging, which it has to and this is not a criticism. Mr. Breslin said Ireland is unlikely to face medicine shortages in the period immediately after but it may face them. The language is couched. Do two thirds of the drugs come across the land bridge? What are the risks? Which drugs are at risk for which type of patients? This morning, we have heard some quite stark warnings about medical devices. Will Mr. Breslin speak to us about which medical devices these are? Are they pacemakers? Are they life-saving medical devices? Are we speaking about more day to day devices such as disposable syringes? What devices are we speaking about? For the drugs and devices that are high risk what type of risks or impact does Mr. Breslin foresee and hope to mitigate against for patients?

Mr. Jim Breslin

I will come back to the devices in a moment. With devices it is not primarily a supply issue, it is a regulatory issue so it is quite distinct. Of course we are listening to what UK sources say but it is clear the UK sources are not working from the same information basis as us. The figure of 60% originated in Ireland. It is the figure we looked at two years ago when we started Brexit planning. It is not just what is coming over the land bridge as it also includes what originates in the UK. It is product with UK touch points. They are the products we sought to protect when we set about making our preparations two years ago . As Deputy Donnelly has heard, we have done a significant amount of work and number of exercises to guard and protect those products. This is a figure we originated. It is not a figure the British have come up with. It is the universe of products on which we have been working with the industry for two years to protect them in the event of a no-deal Brexit.

The engagement with industry on this has been at two levels. It has been with suppliers, whereby we have sought, as regulator and the HSE as customer, reassurances that companies have undertaken the Brexit preparations they need. I have spoken about some of the options they face in this situation, including drugs coming directly to Ireland. All them have reassured the regulator and the HSE on their Brexit preparedness. We heard this when we brought everybody together in a full discussion on this. People are confident about the preparations.

At the start of this year we went at this from another direction. Rather than going from top down with companies we put in place a criticality assessment exercise, whereby we looked at particular therapies-----

I am sorry to cut across Mr. Breslin but we are veering back into the statements. My question is on which drugs and devices are at risk.

Mr. Jim Breslin

This is the process by which we determine the vulnerability and impact. The criticality assessment exercise looked at therapeutic areas where there would be high impact if we did not have the drug. It also looked at the vulnerability of the drug, including its relationship to the UK. It then interrogated with the manufacturers those products to verify, and not simply be assured on, the extent of the preparations in place. Resulting from this we have very much whittled down the type of risk we face. Without being categoric, our biggest risk in the initial period is with regard to short shelf life drugs. If we have disruption of a drug where we have eight to ten weeks of supply already buffered in Ireland we can replenish over that period as we go along but if we have a short shelf life drug and there is disruption in the UK it is of concern to us. Most of the very short shelf life drugs do not come over the land bridge but some come directly from the UK to Ireland. They are manufactured in the UK and come across the Irish Sea. We have worked with the suppliers of these particular drugs to assess the capacity we have in the country in the first instance. If we had no ability to-----

I am sorry to cut across Mr. Breslin. He is answering a very broad question that I am not really asking. He is answering a question on the safety concerns. I am specifically asking which drugs and devices would be affected. If he would prefer not to say because of public fear that is fine and we can move on but he is answering a much broader question that I am not really asking. Is he in a position to identify the drugs and devices?

If he is not, that is okay. We will move on.

Mr. Jim Breslin

As was indicated in our statement and that of the HPRA, we do not have products about which, at this point, we have such a concern. We are not closing the book on the matter, however, and will stay with those potentially impactful products in order to ensure that everything we have been told and have verified remains the same throughout the period. That is why we need to be ready for any eventuality.

To be clear, the answer to the question is "No". The Department has identified specific drugs or devices.

Mr. Jim Breslin

There are currently no specific drugs or devices that we consider an immediate Brexit problem for us. We will build, and have built, contingencies for areas of risk.

The answer is "No".

Mr. Jim Breslin

Yes.

I turn to the issue of food, about which there was much talk of regulation. Let us imagine that the British Prime Minister and the US President do a wonderful trade deal, which the latter astonishingly stated will quadruple trade with the UK, and let us say American beef starts landing in Belfast. In order to protect Irish beef and impose EU standards in respect of it and on the broad assumption that beef from the US will almost certainly not meet EU standards in a variety of ways, what will happen? Will the State have to take action to prevent beef from crossing the Border from the Six Counties?

Mr. Jim Breslin

There will not be regulatory divergence on day one and, therefore, there will be periods within which to put in place strategies. On that day, however, there will be inspections for east-west trade through the ports. The UK will be a third country and there will be an inspection process with environmental health inspectors in ports to spot-check food products that are imported, while the Department of Agriculture, Food and the Marine will have the same in respect of meat. That will be in place irrespective of the fact that, on day on , the UK's regulatory standards will be equivalent.

Am I correct in stating that in the case of beef coming into Belfast, State officials in Northern Irish ports will be watching?

Mr. Jim Breslin

No, I refer to Dublin Port and Rosslare Europort, and goods from third countries.

My question is about the Northern Irish ports.

Mr. Jim Breslin

The answer to that question is the overall answer the Government has given, namely, that there is intensive engagement with the European Commission on North-South flows. The issue is being worked through and everybody is agreed we need to manage it while balancing the Single Market requirements with the need to protect the North-South co-operation and agreements that are in place.

I appreciate that and I do not ask Mr. Breslin to make policy calls, which are a matter for the Minister. Nevertheless, we are 26 working days from a de facto no-deal Brexit. Foodstuffs that fall outside any recognised regulatory regime will come into Northern Ireland. We are all agreed that nothing will be stopped at the Border and that the only place goods can be checked is when they land in Northern Ireland. In the case of foodstuffs and drugs, both of which will no longer be under any safety or regulatory regimes we recognise, will the State have any officials present when the goods land in Northern Ireland, whether at the airports or ports? Is there a plan for Irish officials to be present on the basis that once the goods leave the ports, nobody will check anything in the short term, particularly as there will be no checks at the Border?

Mr. Jim Breslin

The first issue is the standards. There is a presumption in what the Deputy stated that the standards will be different in the North.

I did not mean that they will be different but that they will be in a framework which is no longer recognised.

Mr. Jim Breslin

The UK will still have its own food safety and medicine standards, and it will implement them to protect its own citizens.

On the second question, we will await for the agreement to be reached between Ireland and the European Commission to activate anything for food safety we need to activate. We have not activated that at this stage.

On the money issue, a no-deal Brexit will leave Ireland with less cash. Is there a fiscal plan with the HSE for that eventuality? Does the Department have a plan for next year that outlines the money we assume we will have but that notes there is a good chance we will have, say, €500 million or €1 billion less? Is there contingency planning for running the healthcare system in the event of having less money than we would like because of a no-deal Brexit?

Mr. Jim Breslin

The first category of issues is the Brexit-related costs we are likely to incur. We have made provision in that regard this year and will make further provision, which is important and will include the environmental health staff who will be required at the ports.

The second issue falls within the overall fiscal budgetary strategy the Minister for Public Expenditure and Reform has outlined. We are all operating to a no-deal Brexit budget at this stage. In finalising the budget for next year, it will not be done on the basis of hoping that nothing happens. Rather, it will be finalised on a no-deal Brexit basis, and the Department and the HSE will develop their plans for next year on that basis. We do not envisage they will require to be adjusted in the event of no deal.

My final question relates to the GDPR. If there is a no-deal Brexit, the UK will not be governed by the GDPR. There is quite an active exchange of patient information, whether for the treatment abroad scheme or various others, particularly between the North and South. Given that the UK will be outside the GDPR regime and that we have a statutory responsibility to protect the data of our citizens here, what are the implications of that? For example, if somebody travels to Northern Ireland for a cataract operation, as happens frequently enough, are there any GDPR implications?

Mr. Jim Breslin

Specific arrangements will be put in place for such cases. Mr. O'Connor might update members in that regard.

Mr. Muiris O'Connor

Much work is being done to ensure that the GDPR will be honoured in the context of continuing the arrangements with the UK when it is a third country. All our regulators have been in contact with UK regulators, while all service providers have been in contact with their counterparts North, South, east and west to inform them of their obligations to interface with the EU where the GDPR applies. We have supported in practical ways our agencies and service providers to do what I outlined. Standard contractual clauses will need to be put in place to ensure that the information in respect of a patient in Altnagelvin Area Hospital, for example, will be treated with the safety, security and confidentiality that is expected in the EU. The matter has constituted an awful lot of the work in recent years. When one compares our preparedness now with that in March, we are now much more comprehensively ready.

Before I call Deputy O'Connell, I would like to ask a brief follow-up question on the matter of the GDPR. Mr. O'Connor stated that all the stakeholders are engaging with their counterparts in Britain on the sharing of information. Is it his expectation that such people will have local level agreements between themselves in respect of how the data are managed? For example, if the headquarters of a 32-county organisation are in Dublin, it may hold information on people North and South. Will the Department rely on such an organisation to make a local agreement? Such an organisation would be based in both the Thirty-two Counties and the Six Counties. Is the Department giving such organisations direction with regard to how the data will be managed? On 1 November, potentially, some of the information such organisations hold will be governed by the GDPR while some will be governed by whatever the new rule will be. Will such organisations be expected to devise rules and has the Department given them guidance or instructions?

Mr. Muiris O'Connor

It is a matter for each agency and service provider to ensure its compliance with EU regulations. It is the organisations' responsibility in the first instance but we have been proactive in supporting the agencies and service providers to understand how to secure the agreements. Much like in the case of other issues, the EU has total equivalence and the exact same standards now and for the immediate future, but there is a large programme of work to ensure that the local-to-local interaction will continue.

In maintaining treatment abroad and cross-border directive services there are a lot of data exchanged to ensure reciprocation and reimbursement. Provision is being made to develop GDPR agreements at national level.

I am talking about information on British citizens in Dublin which will no longer be covered by the GDPR.

Mr. Jim Breslin

The reverse is actually the problem. The transmission of data outside the European Union needs to be governed by agreement and a convention between the person transmitting them and the person receiving them. There are model agreements to do this. It might be helpful for the HSE to explain how it put them in place.

Is it going to be at the level of the organisation? Will a template be issued?

Mr. John Swords

There are contracts in place with all of the ICT suppliers. It is mandatory and they have been given the new documentation to which to sign up. It is put in place to protect information both ways.

Is it in place?

Mr. John Swords

All of our suppliers have been requested to do it in any communication which will occur after Brexit.

Ms Paula Keon

The European Commission has given us direction in the form of a model agreement which we have used. Two years ago we started a mapping exercise of all of the services operating on a North-South, east-west and all-island basis. We have worked our way down with the services. We have a data protection officer in the HSE with deputies. We have drafted the standard contractual clauses, SCCs, from the ten-page model we received from the European Commission which cannot be altered. We have mapped the data they will share in the list of service level agreements and memorandums of understanding in place. They will all be completed. There is no resistance from our Northern colleagues. They will all be signed as a matter of process as we work through them.

Mr. O'Connor has said we are much better prepared now than we were in March. It is good that we had an extension or we would be goosed.

I am assuming from the opening statements that everything will stay the same and that we will have ten to 12 weeks’ headroom in the case of medical supplies. For perishable, short-life products, insulin is not one of them. It can be used after six months out of the fridge. I assume the delegations are referring to feeds and chemotherapies. This is a vulnerable patient cohort. I imagine it concerns feeds for premature babies in, say, the Coombe hospital and bespoke chemotherapy bags. It is from the west coast of the United Kingdom that we are getting much of our stuff. Will Mr. Breslin expand on the products in question?

Mr. Jim Breslin

They are not exclusive to the one supply route. Mr. Quinn will explain the plans we have put in place.

Mr. Eamonn Quinn

In the first instance, we were talking about risk. Just because there is a risk does not necessarily mean that there could be a serious case of disruption of supply. We are recognising the risk and there is specific engagement with the suppliers of those products. The products in question provide total parenteral nutrition such as feeds for baby bags and adults, compounded and oncology products.

I know from experience that if the bespoke bag of feed for a premature baby goes missing, the baby will have to be maintained on basic fluids. It is essentially a case of keeping them alive, rather than fixing them. I am not trying to create panic, but this is serious in this part of the medicine supply chain.

Mr. Eamonn Quinn

That is why they were included in group one in our criticality assessment exercise. They were top of the pyramid and we engaged directly with the companies. We have identified the suppliers to the Irish market and hospitals. It involved going to the hospitals involved in the clinical space and understanding from where they were sourcing. It then involved going back to the suppliers to understand on several levels if they were committed to continuing supplying to the Irish market. Given that the United Kingdom is an island, the companies had to be asked if they had the materials to continue manufacturing the products. The assurances we received up to the first phase in April were positive. We repeated the exercise recently and the responses we received were extremely positive. There has been a high level of assurances in terms of commitment and the ability to supply the Irish market. There is a risk in moving the products from point A to point B. The companies have been asked to consider and are putting in place contingency measures also.

If the bag of feed is delayed, it is gone.

Mr. Eamonn Quinn

The shelf life of these products is not that narrow. We have engaged with clinicians in that space.

Perhaps the expert, Dr. Lorraine Nolan, could speak about this issue.

The delegates are doing their best to answer questions.

Dr. Lorraine Nolan

I concur with everything Mr. Quinn said. We need to clarify it on the basis of paediatric total parenteral nutrition products manufactured in Ireland. Mr. Quinn is correct. These are high risk products and vulnerable patient groups. Everything we have done has the highest priority. There is complexity and there are multiple suppliers.

What is coming from the west coast of the United Kingdom?

Mr. Laurence O’Dwyer

We are sourcing some adult hospital total parenteral nutrition products from the United Kingdom. We recently experienced a shortage of these products linked with manufacturing issues at the facility. The medicines shortage framework kicked in at that stage. We worked with clinicians on the ground through the hospitals network and the company involved to minimise and avoid any clinical impact on patients. This was done through using authorised total parenteral nutrition products through the normal channels and the available compounded product capacity for patients with bespoke clinical needs.

Has there been any move towards Irish production of these perishable medicinal products?

Mr. Jim Breslin

That forms part of our contingency planning. That is why we can talk about no immediate issues. Up to 15% of our volumes of cancer compounded products come from the United Kingdom. That means that 85% originate here. We will seek to boost that figure. We have facilities, including in public hospitals, where over time and with other strategies we can seek to boost it. We will also seek to husband the product to ensure it is managed as efficiently as possible. It is all built on the interrogation of suppliers coming across the Irish Sea and the resilience of their supply chains, as well as their contingency planning. These are our contingency plans. They just do not operate on the basis that we hope everything will go well. We scenario-plan them such that if three or four issues go against us, we will have a further back-up plan.

If there is a hard Brexit and no agreement, will all bets be off? Are we expecting a tariff to be placed on the 15% of products coming into the country?

Are we expecting anything like that to happen? As for the portion we cannot make ourselves, or for which we do not have a ready-made equivalent, what can be done? Can we be held to ransom as a state in being charged exorbitant amounts for the few per cent of product we get in from the United Kingdom?

Mr. Jim Breslin

No. The tariff issue does not arise. On other issues, we have contractual relationships and are a customer in that situation. It is more a question of where a problem will arise that will not be of anybody's intentional making. For example, there has been a lot of discussion about the fact that products may not be able to get through the Dover Strait, certainly within current timelines. However, the products about which we are talking which are coming from England are not subject to being brought through the Dover Strait. They will come via the Irish Sea. They may be coming from Holyhead or Liverpool. There will be other ports available too such as Pembroke, Fishguard and so on. There is more than one route into Ireland and products that originate in the United Kingdom will not have to come through the Dover Strait. If the issue of the Dover Strait were to persist for a significant period, supply through that route would become an issue. The Chair has made reference to this matter. In that situation people would look to divert and not come through the Dover Strait but instead come directly into the country. The short shelf-life products, the particular products on which we are touching, are not subject to that risk. While there is a risk related to the Dover Strait, it concerns other categories of product.

To be comprehensive, in her opening statement Dr. Nolan talked about radiopharmaceuticals. They are a category 1 product in our critical assessment exercise. We have investigated fully the supply chain, which is by air freight into East Midlands Airport where the UK stock of radiopharmaceuticals is taken off and from where the Irish stock transits to Ireland, again by air freight. The detailed discussions with the logistics and supply companies on the continued resilience of that route are really important, but it is not a Dover Strait issue. That issue does not affect that product, but, as set out in the opening statement, we have to be alive to it.

They are the radioisotopes for use in radiology. I do not know much about that area. What will happen if we do not sort out the East Midlands issue?

Mr. Jim Breslin

It is not a question of sorting it out because it is working. Everybody has said it will work and that it will need to work for the UK supply. It is actually difficult to envisage how or why something would arise in that situation. There is full agreement between the European Union and the United Kongdom on the issue of air transit. It is not that somebody would do something intentionally, nor is it enough for us to say “job done, move on.” Because of its impact, we have to have specific contingency arrangements in place. We are talking to the suppliers and monitoring the position for any rapid response we would have to introduce or a fall-back position that we would have to have. By far the most resilient and preferable route is the one being used. Sustaining it is our key strategy.

What headroom do we have? Would we have a ten to 12 week supply of product or how is it brought in?

Mr. Jim Breslin

It is a product with a very short shelf-life. Mr. Quinn may speak about it. It is a half-life that it loses.

If things were to go pear-shaped, something we do not expect to happen, how long would we have?

Mr. Eamonn Quinn

Let us be honest. There is no headroom for radiopharmaceuticals in that respect because they cannot be stored. There are other contingencies we would explore with the companies, but there are inherent risks associated with them also. The supply chain is necessarily “just in time”. There is a very specific timeline for getting to the airport on the Continent, flying in and flying out again. That is the situation. It should be noted that the companies involved have contingency measures in place to deal with those issues now and that they can be employed in the shorter term. We are looking to engage and have engaged with the suppliers, distributors and logistics companies involved in providing for higher levels of assurance. We want to provide the utmost assurance we can in this space. The Deputy, rightly, points out that there is a risk, but a risk does not necessarily translate to there being a problem. It is a matter of what steps we can take to mitigate it.

On counterfeit medicines, are people being opportunistic when everybody else is concerned about maintaining the integrity of the supply chain? Has the criminal element been considered in possible breakdowns in regulation or the status quo? Could there be opportunistic individuals who would release large batches of counterfeit medicines onto the market? Has this element been considered in terms of the integrity of the supply chain?

Mr. Jim Breslin

We will ask the HPRA to respond to that question.

Dr. Lorraine Nolan

Within the European network for the regulation of medicines there is a very extensive protocol and procedure in place for the exchange of information on counterfeit medicines. These European systems will keep going after Brexit. We have a very close working relationship bilaterally with our counterpart agency in the United Kingdom, the Medicines and Healthcare Products Regulatory Agency, MHRA. We have set up a process for engagement at frequent interval. The sharing of information on supply chain integrity will be included in that protocol. Radiopharmaceuticals is an issue on which have had extensive discussions with our colleagues in the UK agency also. We have also agreed to work bilaterally to support each other. As colleagues from the Department of Health have indicated, these are products with a very short shelf-life. The maximum they possibly have is 24 hours or less. They have a discrete usage and are only intended for particular patient groups. Therefore, there is no competition between two markets for them. It is a matter of working to ensure we can keep the flow moving. We have a commitment from their side that they will work with us to ensure this happens.

It is in everybody’s interests.

Dr. Lorraine Nolan

Yes.

On medical devices, it is true to say everybody is piggy-backing on the United Kingdom’s regulation, but if there is a hard Brexit, we will be in a position where we will no longer be able to do that. There has historically been a high dependene on the United Kingdom. In May 2020 things are due to change. Therefore, we really have only a nine-month period in which something could go wrong. Is there a concern about new medical devices coming onto the market? Is there anything in particular that we think we will really need that will come on-stream in the next few months? I am asking the delegates to predict the future. Do they see anything coming out that patients may have to do without if there is a fallow period?

Dr. Lorraine Nolan

I will take the first part of that question about the regulatory processes. I will then pass over to colleagues from the HSE to talk about their ongoing review and evaluation of medical devices.

The Deputy is right that historically there has been a high dependence on the United Kingdom's regulatory activities, specifically certification of activities for medical devices in Europe. That being said, there is an issue of scale and numbers that may be impacted on. We are working very hard and have close dialogue with the European Commission on this issue and are hopeful a European solution can be achieved to have an ordered regulatory transition. If that is not achieved, at the end of the day, from the point of view of the safety of these devices and their quality and performance, just because regulatory compliance may fall as and from 31 October, it does not necessarily present any immediate risk to patients. In fact, from a regulatory viewpoint, given that the United Kingdom will be totally aligned up to 31 October, we have a full alliance. We will manage that situation on a national basis in terms of regulatory compliance because we will not allow it to compromise continuity of care for patients. To give reassurance on the regulatory process, it can be managed. Obviously, we will have to work with the industry to ensure it is working towards achieving that compliance and to making devices compliant as soon as possible. The position is changing as regards the regulatory basis in Europe. That is excellent in terms of the protection of public health because the framework coming into place is to raise the standards of patient protection. The notified body system in Europe is working through a process. Therefore, there is a timing issue with it which will sort itself out over time. It is unfortunate that Brexit and the introduction of the new regulatory changes have coincided, but I am confident that a European solution can be found.

I will pass over to colleagues in the HSE who will speak about the assessment work that has been taking place.

Mr. Dean Sullivan

This has been an area of particular focus for us in our preparations. Mr. Swords will talk through some of the detail.

Mr. John Swords

As we said last time, we were carrying out extensive work on investigating the supply chain of our medical devices. We spoke of risk earlier. We examined areas of risk and what might cause problems. We looked at what was manufactured in the UK, what is distributed through the landbridge and whether there are alternatives. There was also the matter of notifying bodies, which was the critical area that was highlighted as a red risk. If it fell under that, we were very concerned. We have worked with the Department and the HPRA on mitigating against those risks and seeing as we go.

The medical devices question is enormous. Worldwide, there are 600,000 categories of products. One can imagine the amount of items which fall under that. Our area covers approximately 2 million items in 39 categories across 274 companies. We are working quite a lot on communications. There have been many communications with companies in conjunction with the HPRA and the Department and we also meet them face to face. We are now at our third iteration of meetings. Yesterday, we were with 70 companies in Galway and had a good engagement around products which we consider to be at risk because of notifying issues. As we went through the risks, we honed down on areas. We received assurances that the companies were aware that this was coming and that Brexit was very serious. It took a little while for them to understand the depth and extent of the work that has to be gone through. We pestered them with communications and we compliment them on staying with us and remaining patient with us in respect of all the questions we asked of them. It should be noted that the response from industry and from distributors has been fantastic. When one considers the effort made by the Department, the HPRA and ourselves in the HSE in our work every day, it can be mapped with the co-operation we have received from the manufacturers and distributors. It has shown a great unity to ensure there will not be risks that affect patient care.

Considering the need to keep their products selling, it is in their interest to co-operate.

Mr. John Swords

Of course. One advantage that we have in Ireland is our reliance on distributors but less so on manufacturing, which is different to Europe. We have transport issues across the seas, as has been outlined, but it is an advantage in that we have many irons in the fire and there are more areas of supply. Nonetheless, we all rely on the transportation across the seas and how that is dealt with. We are seeing many companies and manufacturers diverting from the UK and going around the landbridge. We are getting strong information on how the supply chain operates. Another distinct advantage of Brexit coming, if one wishes to call it an advantage, is that one learns a great deal about the supply chain. We have found that the supply chain has learned a lot about itself, in that many of the distributors did not understand where their products came from but they have had to learn because of how we have probed them and how we have worked with them on this.

We are at the stage where we are satisfied that the distributors and manufacturers are looking at this in a very serious way and that they have found assurance on notifying bodies. They are willing to transfer the notifying body from the UK to an EU 27 notifying body but the capacity within that is taking time, because of the pressures on it. Deputy Donnelly asked what are the areas of risk. Whether one wishes to call it risk or contingency planning, we are forward planning on this. We are taking all the areas that have not confirmed that they have transferred the notifying body and we are looking at those areas in particular to see if we need additional stocks, which is a very concentrated effort, rather than saying that we should take stock and stockpile. The Vice Chairman asked if there was evidence of stockpiling. There absolutely is not. We took a policy decision with the Department at an early stage not to stockpile, which is the correct thing to do. As members are aware, stockpiling creates its own issues. There are peaks and valleys in manufacturing, jobs can be lost and then when one returns to it, the capacity is not there. The best supply chain is a straight line and continuity of supply, which is what we have worked on all along.

There is evidence of stockpiling in the UK, which is causing problems and concerns in some of the areas we are examining where the notifying bodies have not transferred or have not been confirmed to have transferred over. Approximately 30 companies are affected by this now across 6,500 line items. We are meeting with the companies on an ongoing basis to put the mitigating action in place. We have taken an additional 50,000 sq. ft of storage space in Ballycoolin, purposely for the event of ring-fencing stock that will be required or that we deem to be at risk. We are not saying that we are putting it into hospitals or into the NDC or that we are asking the companies to take extra; this is a contingency on top of the contingency. We have approximately three weeks' stock in the hospitals - some will have four weeks and others two and a half - and seven weeks' worth of stock used across 6,000 lines in the NDC. On top of that, the HPRA has mentioned how in the distribution of drugs in particular, there is eight to ten weeks of stock. On average, it is about six weeks. We are looking at buying some time for any issue that may arise because of notifying bodies and examining each of those areas. They are across cardiology. In the case of one particular company, we have taken in an additional four months of stock to ensure that we do not have an issue around paediatric cardiology. I refer to ophthalmics and areas like that. We are taking in surgical packs, which are very bulky. We are in discussions with the 12 suppliers we have on that and in detailed discussions with the manufacturers here. We are confident that we will be able to allay any issues which may arise in that area. Those are the types of contingencies that we are putting in place. We are at the final stages of going through scenarios. We are confident that there is supply in the system, that the distributors and manufacturers are working with us and that with the Department and the support of the HPRA, we are confident that we will overcome any issues that may arise.

Mr. Jim Breslin

Lest there be any confusion, to clarify for the general audience, we are discussing medical devices. Returning to the point made in the opening statement, this is a Europe-wide issue. There are medical devices that are manufactured across Europe that have a CE mark from a UK notified body. The solution will not only be what we have discussed here but will also be found at the table in Brussels, where we look at what the risk is. We will have to make a decision around -----

I am conscious that we are under a little time pressure. Deputy Durkan has not come in yet and Deputy Donnelly has a supplementary question. I have one brief question before we go further. We have discussed stakeholder engagement and the level of meetings. The committee has been told that we are in better shape than we were in March. What is the extent of the Minister's involvement in these meetings? Does he chair them? Does he attend? To what extent is the Minister's approach hands on?

Mr. Jim Breslin

There are different levels of involvement. We have clinical groupings, which are meeting on this where I am not present. I outlined the operations group, which meets weekly and is attended by the deputy secretary general. Next Friday, I will meet the key agencies. Then we will sit down and brief the Minister. He has met stakeholders. He has come to weekly meetings but not all, as we are working through a level of detail. As a group and as officials in the Department, we have briefed him. He has also met the wide group of stakeholders that we bring around the table. We have had several of those meetings. He has been able to hear our reports at first hand.

The Minister does not attend every one of the weekly meetings but he receives a briefing afterwards.

Mr. Jim Breslin

He receives a regular briefing for himself and on Brexit issues for the Government for meetings he attends every Tuesday.

That is more than just a weekly briefing then.

Mr. Jim Breslin

Yes. Last Thursday he was briefed on issues at Government. We had the Minister and the management board sit down with Brexit as a specific agenda item and we went through that. He is as up to speed on Brexit issues as is anyone in the Department.

I call Deputy Durkan. I am conscious of the time and although I do not wish to limit the Deputy, if he goes over time he will be eating into Deputy Donnelly's time.

I will bear that in mind. I thank our witnesses for appearing and for giving such detailed replies. Has provision been made for sensitive and short-life products in the event of stockpiling happening elsewhere which may impact on us? Is there sufficient refrigerated space to deal with such products to ensure continuity of supply for the Irish market?

Mr. Jim Breslin

Yes, absolutely. One important factor in the Irish distribution chain is that it holds quite an amount of stock even on a normal basis. Wholesalers, pharmacists and the HSE have an existing buffer and for product that needs to be refrigerated, there is a large amount of refrigeration space. This is the norm for us. Other markets that are just-in-time and that run with much lower levels of stock would not be able to hold at the level that we do. Particular features of our wholesaling and distribution system mean that we have that built in. It will be one of the things that we will call on if we run into temporary problems.

Presumably the Department has identified the extent to which the State can replicate the supply chains outside of the UK in all situations because one may have a knock-on effect on the other. Those who are in the business of distribution must look at where products are coming from. If they are sourced in the UK, that is likely to cause a problem. To what extent has provision made for alternative sourcing from the Continent? With regard to fluctuations in the money markets in the context of sourcing products in the UK, presumably the Department has factored in the value of sterling and the buying power of the euro, which is likely to go lower as we go deeper into the uncertainty.

Mr. Jim Breslin

Context for this industry is important. For much of the product, we are talking about some of the largest multinational enterprises that exist. Some of them have a manufacturing presence here but all of them have a multinational reach. Many of them have logistics operations that would far outweigh anything that the Department of Health, the HSE or HPRA has. Our biggest defence in this situation is the sophistication and expertise of the industry with which we are dealing. When we engage with them, it is clear that a considerable amount of logistical thought has gone into this issue and into the quality control systems that need to be operated. This is not pick and lift. This is product that has to go from manufacturer to patient under certain conditions and there is a rigour in the industry in quality control and logistics. The industry has been solving this problem and tell us of its progress over the course of our Brexit preparations. It has been giving us good reassurance throughout the process.

On sterling, it might help Deputy Donnelly's point around how far a euro or dollar will get next year-----

I am always happy to help a colleague.

Mr. Jim Breslin

I have not yet seen the scenario where there is an appreciation in sterling in the event of a no-deal crash out. One would expect the purchasing power of the Euro to be stronger in that situation. While it is not something we are hoping for, in that situation, sterling is not a currency that would be moving against us.

It is something we should keep in mind because it will have a bearing on the sourcing of supplies eventually.

Are EU standards lower than British standards in any case?

Mr. Jim Breslin

No. British standards today are the EU standards.

That is good and there will be no change in that. Ideally the island of Ireland would apply the Single Market and customs union rules. This is particularly important with regard to food supplies. Has the Department been in contact with distributors, including importers and exporters? Northern Ireland suppliers and distributors have a vested interest in ensuring the highest possible standards are applicable on the island of Ireland. That is in their interests. If one talks to Ulster farmers in Northern Ireland, for example, they will very quickly tell one that they are inextricably linked with the South and with the EU in the context of standards.

This leads me to a question on ports and airports. To what extent has the Department been in touch with port and airport authorities and their customs units with a view to ensuring that the dumping of products from lower standard economies does not happen via the North of Ireland? The standards that apply here must also apply in the North. Has the Department been in touch with them?

Mr. Jim Breslin

Yes, absolutely. The Northern Ireland relationship is between the FSAI and its counterpart in Northern Ireland. A strong mission is shared between them in respect of food safety standards.

On the question of ports and airports, and particularly the ports, an inter-agency approach is being taken. The Departments of Health and Agriculture, Food and the Marine, the HSE, the FSAI and the customs division of the Revenue Commissioners are working together. The logistical planning of the operation of the ports is being led by the Revenue Commissioners. We have built into our operations the staffing capacity to scale up our existing inspection processes in the ports. It is important to say that third-country products, including product coming into Dublin Port from all over the world, are currently subject to food controls and inspection on a risk rated basis. That would apply to east-west trade if the UK leaves and we will have the personnel in place to upscale the inspection capacity without impacting the flow through the port, as and from the date that the UK leaves if it does so without an agreement.

Has the Department also provided for the necessity to increase the number of inspections of products? I have tabled numerous questions on that issue from time to time.

Mr. Jim Breslin

Yes, very much so. The methodology for Dublin Port, for example, is that the documentation will be lodged by the importer in advance of the product getting onto the ferry in Holyhead, let us say. The importer will have lodged the documentation and it will be assessed, including in respect of food items, as to whether the cargo is risk rated for inspection. The Revenue Commissioners will send a message to the haulier on the ferry that he or she will have to go to an inspection point to be inspected. The inspection might be conducted by the Department of Agriculture, Food and the Marine staff if the product is meat, for example, or by customs officers if they have an interest in the cargo or by HSE environmental health staff in respect of certain food items.

Is Mr. Breslin happy that sufficient resources are in place to ensure there is adequate cover? Is he happy that in respect of product coming directly from the EU that does not travel through a third country, the inspections at EU level are adequate to provide assurance?

Mr. Jim Breslin

We are working on the basis of adequacy. Currently, product from third countries is risk rated and we will be doing the same in this situation. Depending on the category of food involved, we will determine the risk attaching to it and will inspect on that basis. Much of the €10 million to which I referred has been invested in the environmental health service so that it has additional staffing. We will have inspections in place from day one. We will have to review that and build on it over the period ahead.

To what degree has the Department made alternative arrangements for sensitive and urgently required supplies? The quantities involved my be small but such supplies are important nonetheless. I refer to products coming from a number of sources, including through the UK.

Is it possible to alter the source of supply in all cases, particularly where a serious health risk might arise? In other words, is it possible to fly the product here very quickly, or within an hour or two, from another location?

Mr. Jim Breslin

Yes. We have worked with the Revenue Commissioners. Where we are trying to fast-track products through a port because of their sensitive nature, we have an advance-notice arrangement with the Revenue Commissioners so their inspections or delays on their end will not apply. More generally, as we have explored, in many situations we do not have single-supplier products. In many circumstances, as in the context of therapeutics, different types of products can be used, depending on availability. We currently manage this. Where a shortage arises in respect of a particular proprietary product, we consider alternatives or different sourcing mechanisms. We also have the ability within our system to make sure that whatever product we do hold in Ireland is used in the most effective way possible. The HPRA will have experience of our running into a supply shortage for a period, although not of circumstances in which we do not have any product. The important point is that all the product be available, and available for the most effective use. It is important not to have products not being used.

In the event of there being a shortage of sensitive supplies in Northern Ireland, does the Department have any arrangement to co-operate with the Northern authorities? I refer to co-operation in the opposite direction?

Mr. Jim Breslin

Mr. Swords might answer that.

Mr. John Swords

Yes, we do, we work very closely with our colleagues in the North and across the rest of the United Kingdom. Particularly in light of Brexit, we have made logistics arrangements with our counterparts so that if there are difficulties in either direction, we can assist each other.

Assurances were mentioned in the opening statement. I refer to assurances in regard to supplies sourced in the UK or sourced outside the UK but arriving here via the UK. In all cases, have alternative arrangements been made for where these assurances cannot be delivered upon?

Mr. Jim Breslin

The risk arising has to be rated. If we have eight to ten weeks of stock, it is important that the industry not wait until the final week to replenish it but instead do so on an ongoing basis. We have discussed this with the industry. Even where there are delays of a number of days – for example, on the route between Dover and Calais – we would still get product through over the period of eight to ten weeks. The important point is that everybody work to the worst-case scenario, anticipate any issues that arise and replenish as they go rather than wait until a problem arises.

The treatment purchase scheme was mentioned at the outset. Provision is made for the continuation of a reciprocal arrangement with Northern Ireland. Does it apply to the rest of the United Kingdom still?

Mr. Jim Breslin

Yes. I can ask my colleagues to talk about the detail. On foot of the legislation passed earlier this year, we have an agreement in train with the United Kingdom to facilitate using the common travel area to ensure the kind of reciprocation we currently enjoy.

On the treatment abroad scheme, we sent 590 patients to the United Kingdom in 2018. We sent just 73 to European locations outside the United Kingdom. The patients were predominantly sent to England. Of the 590, only 37 went to Northern Ireland. The patients generally go for specialist treatment. We have an understanding at the highest levels that both countries are committed to continuing with the arrangement. The HSE has individual relationships with the particular service providers that are delivering the services. They have reinforced that in the run-up to Brexit as part of our preparations for it.

The Deputy will also be interested in cross-border treatment. In 2018, 6,308 patients went to the United Kingdom on a provisional basis under the cross-border directive. Just 420 went to locations in Europe outside the United Kingdom, with approximately half going to Poland. Of the 6,308 patients, the majority went to Northern Ireland, for ophthalmic and orthopaedic treatment and so on. As part of our arrangements with the United Kingdom authorities, we have signalled that we wish to continue with that, and we have provided for it in the legislation. The authorities are happy to facilitate us in that regard.

I do not want Mr. Breslin to answer this question in a way that might come back to trip him again. In the course of his negotiations and deliberations with the various bodies he liaised with in the past 12 months or so, there would have been one or several issues about which he had some concerns and was not happy. I am not asking him to tell me what they might be, for obvious reasons, but I am wondering whether he has put in place an alternative to deal with these issues in any given circumstances. I can think of several scenarios and I am sure Mr. Breslin can too. This is a very important issue from the point of view of the medical, health and food sectors in this country.

Mr. Jim Breslin

I shall ask a representative of the HPRA, the regulator, to talk about that but I will give a general overview because we have been at this a long time. The original concern was that people did not believe Brexit would happen and that, while there was a lot of talk about it, something would come to the rescue. Without being facetious, I believe some of the developments in recent months have taken from the complacency. People have been very exercised this year in seeing Brexit as a real threat, not only to the public health sector but also to their businesses. They have also been exercised by the need to get that sorted.

In the final preparations, particularly where there will be significant costs, people have done a lot of work up to the final trigger and have been operating on the basis that a deal might be arrived at. The important point is that they be ready to make any changes they need to make and do so on a timely basis. We have been stressing the importance of planning and doing so as speedily as possible, rather than working on the basis that something will come to the rescue and that it will all go away. The latter presumption is not a safe one in any contingency planning. I ask Dr. Nolan to talk about the detailed engagement.

Dr. Lorraine Nolan

Even from my opening statement, it is clear we have had a very extensive period of engagement with all the stakeholders involved. To put it in context, 7,000 medicines are authorised for supply in our market. We have contacted the marketing authorisation holders for all those products, not just once but on many occasions. We also engaged with all the wholesalers. They have reassured us that they are considering everything they need to put in place and that they are planning for Brexit. They are also examining their contingency plans, including for identifying alternative transport routes. The companies are very sophisticated and since logistics are key to their viability, they have high levels of expertise in respect of anticipation and planning in this regard.

We are doing everything we can do and anticipating everything we can. We will continue in this regard until the deadline, or until the United Kingdom exits. That said, things can happen. The co-operation arrangement developed between the HPRA, the Department and the HSE and the mechanisms we have in place through the operations group and the criticality assessment are such that, coming into the existing systems and from a regulatory viewpoint in terms of our shortages framework, we have really strengthened our intelligence capability. I am confident that we can anticipate and that we have systems in place to manage what may happen.

However, there are many unknowns with Brexit. I must be honest about that. As stated earlier, there are no guarantees, but I believe we have anticipated insofar as it is possible to do so. I also believe we have developed a good methodology to be able to manage the situations that may arise over the coming period.

I wish to return to the cross-border directive. It is in place and we are 26 working days away from God knows what. My understanding of what Mr. Breslin is saying is that there is an active agreement in place such that on the 27th day, people will be able to continue to go to Belfast, Derry or wherever, they will pay for their treatment as they currently do and the HSE will reimburse them when they return. Can Mr. Breslin confirm that is the case and that there is an agreement, in writing, between the two Governments to the effect that it will continue?

Mr. Jim Breslin

Yes. There is the legislation, the overarching memorandum of understanding that was signed between the Tánaiste and Minister for Foreign Affairs and Trade, Deputy Coveney, and his counterpart and we have a drafted agreement between ourselves and the UK which will be signed on the last day before the UK leaves. All that is in place.

I have a question about some of the work that is taking place. Mr. Breslin said in his statement that "strong general assurances have been received from industry but an expert group is also examining categories of medicine where it is deemed especially important to work directly with suppliers to verify that robust contingencies are in place". Various people here are still using the present tense - examining categories and looking at supply chains. Again, we are 26 working days away from it. When will the Department be moving from a position of examining to one where it has examined. When will this work be completed to his satisfaction?

Mr. Jim Breslin

We will continue to examine. For example, for the end of March we had to examine it in the preceding period before that. We are now going back and refreshing that. Even in the event of a Brexit we would continue to monitor the market. It will not be a final, one-off exercise where we will say, "They were compliant in May or they were compliant in June". We will ensure and verify compliance up to the point of departure and, in fact, beyond for the most risky areas.

My final question is a follow-up. We have been here for hours and it sounds as if an enormous amount of work continues to be done. It also sounds as if it is good, multi-agency work, which we do not always have conversations about in the committee when it comes to healthcare. I wish to ask a question I asked previously again. Mr. Sullivan stated, "The number of medical devices that will have regulatory issues is significant and represents a particular risk to maintaining service continuity from early 2020". He also stated, with regard to medicines, that there remains a potential for delay and disruption to supply routes and that a no-deal Brexit still has the potential to cause disruption to health services. That is fine, but my understanding of what we have been told today is that there are no specific risks at present, the breadth of the work that has been done has looked at all the medicines, the devices and regulation of qualifications and so forth and that the witnesses' position is that, of course, things might happen and we are in a world of unintended consequences and unknown unknowns but they have, therefore, reasonable caveats in their statements. Is it the case, however, that they do not have a shortlist of specific risks where they think things are more likely to go wrong? Essentially, the sense I am getting is that on 1 November things will carry on. They may not, but our guests have nothing left on their plates which says, "However, we think the following two or three disruptions are likely to occur". To ask again a final time, are there specific risks about which they are still concerned, such as specific devices?

Mr. Jim Breslin

I am not being pedantic but I wish to unpick the word "risk". Once one risk rates, one will risk rate in terms of impact, such as if we did not have it, and based on vulnerability. If I could use a different terminology, we do not have a current concern that a product will not be available to us on day one or week one. There are products that, due to their nature, we will be monitoring very intensively over the period and we require, and have put in place, a number of contingencies to guard against any issues. There is risk, therefore, but it is not a risk that we are saying is of current concern, that says we have a shortage that we must deal with at this point in time.

Does that apply across the health service?

Mr. Jim Breslin

Regarding what Mr. Sullivan said in his opening statement on medical devices and the notified bodies, which is the fact that not all the products that have UK notified bodies have got a new EU notified body behind them, we need to link that up with what the HPRA and the Department are saying, which is that the engagement of all of us is with those suppliers to become compliant. That is at the fore of the European Commission's position in saying that they must become compliant. However, in a situation where, Europe-wide, there are products that are required for healthcare and have public health implications and which up to the last day have a full CE mark signed off by a European member state, but on day one there is an issue over that, then we, the Minister and the HPRA have stated in Brussels that we need to solve that problem as part of a European system. It is not a supply issue but a regulatory one. We will be making our voice very clear. I understand why that decision will not be made until the end of this process. To make it six months out, one gives people no incentive to comply. However, we will have to examine it in that situation and look at the implications. Ireland and other member states will have a view on that and will be seeking to come up with a solution.

This country is not stockpiling medicines because it has the headroom of normal supply. The headroom is up to 12 weeks and that can be replenished in the intervening period. The only issue is devices and that is a historical issue because of the piggybacking on the UK regulations. We are stockpiling surgical packs and so forth to some extent, but that is because of the device element and not the drug element. Is that correct? I only have three minutes.

Mr. Jim Breslin

To avoid terminology taking flight-----

I do not want the wrong message to emerge from this meeting.

Mr. Jim Breslin

There is a question in any distribution system regarding the buffer that is held. We have a very significant buffer with medicines and we have always had that. We also have a significant buffer with medical devices. At national level, the HSE, on a specific product basis, might make a decision to increase the buffer for medical devices. That is where the HSE is, but that is quite different from individuals or even service providers such as hospitals, pharmacists and so forth making a decision on that.

In terms of devices, for insulin patients the needles for testing blood and the lancet are classed as devices. Are we okay for them for diabetes testing?

Mr. Jim Breslin

Yes.

Regarding the 2020 May regulations for devices - this has nothing to do with Brexit - is it envisaged that the HPRA and the EMA will take on the 39 categories? It is not really an authorised product and I am aware the HPRA is helping out in this regard now, but I assume it will not be subsumed into the HPRA's work.

Dr. Lorraine Nolan

To be honest, we would need another session to go into this in detail. First, the EMA has no role in respect of the regulation of medical devices. It is a notified body system. It is a decentralised approach. Our organisation does not issue certificates for devices. They are issued by certification organisations throughout Europe.

We are transitioning to a new regulatory regime, which enhances the standard those notified bodies have to comply with. From the notified body viewpoint, one can imagine that their quality systems and resourcing are all being elevated in standard. That takes time and is the complexity for them when they are being asked to accept certification activities that were previously conducted by the UK in order to bring them in. They are struggling with capacity issues in this. It can be managed, which is the one thing to say about the regulatory system. Mr. Breslin has outlined that we are confident that a European solution can be found. If it cannot be found at a national level we can make decisions as a regulator to work with those companies to bring them into compliance. I have spoken about the fact of the risk that these present. It is the same regulatory system on 31 October as on 1 November. We will do whatever it takes to keep continuity of care going and will work with the companies. There is a risk over time that, commercially because of uncertainty, that may change in terms of whether manufacturers will supply the marketplace or not. That is a problem we have with Brexit in general.

Finally, if there is a hard Brexit and there is a particular drug, not a device but a drug, that is produced in the UK, it can no longer come seamlessly into our country. The batch will have to be tested for release onto the European market. Have we the qualified persons in place here? I believe we discussed that to some extent on the last occasion.

Dr. Lorraine Nolan

We have. The Deputy is correct. The European Commission has given a derogation until the end of this year, so the testing that is currently performed in the UK continues to be performed there. This is a transition agreement. The industry has made very good progress on transferring regulatory activities that were conducted in the UK, which would have been the location of the marketing authorisation, the holder of the testing, and the batch released activities to the EU 27. Ireland has received many of those transfers. We have not received them all as they have also gone to other European countries. That work has been very much in train over the last number of months. There are still levels of non-compliance but the industry is continuing to work towards these and as the deadline approaches will see a big push in that direction.

There may be issues with the testing, to be honest with the committee on this point. For some complex biological medicines that are proteins etc., the relocation and the finding of a facility in Europe may not be as easy and then there is competition for contract laboratory space. It will depend on where we end up across the European system on this. A European solution will probably be determined, if necessary. If not, it can be managed on a national basis and we can work with companies towards compliance on that as well.

I wish to clarify the Deputy was given three minutes because this was the time she asked for.

On behalf of the committee I thank all of our witnesses. I will not name everybody but our thanks go to every single one of them for coming in today, for their open engagement and indeed for the work they are doing and continue to do in this area. None of us looks for this but we really appreciate the efforts made to mitigate the potential damage. As there is no other business the committee is now adjourned until next Wednesday, 2 October.

The joint committee adjourned at 2.30 p.m. until 9 a.m. on Wednesday, 2 October 2019.