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.