Joint Committee on Health díospóireacht

Implications for Health Sector of United Kingdom's Withdrawal from the EU: Discussion (Resumed)

Chairman

The purpose of the meeting is to engage with officials from the Department of Health, the HSE and the Health Products Regulatory Authority on the implications for the health sector of the decision of the United Kingdom to withdraw from the European Union. On behalf of the committee, I welcome Mr. Jim Breslin, Secretary General of the Department of Health, and officials from the Department, Mr. Fergal Goodman and Mr. Kieran Smith; Mr. John Hennessy, Mr. John Swords and Ms Paula Keon of the HSE; and from the Health Products Regulatory Authority, Dr. Lorraine Nolan, chief executive, Ms Rita Purcell and Dr. Caitríona Fisher.

By virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of the evidence they give to the joint committee. If, however, they are directed by it to cease giving evidence on a particular matter and continue to do so, they are entitled thereafter only to 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 asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person or an entity by name or in such a way as to make him, her or it identifiable.

I advise witnesses that any opening statements they make to the committee may be published on its 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 ask Mr. Breslin to make his opening statement.

Mr. Jim Breslin

I thank the committee for inviting the Department of Health to engage with it on the preparedness of the health sector for Brexit. The Chairman introduced the witnesses so I will not repeat that. I assure the committee that detailed planning for Brexit has been ongoing in the Department and its agencies for more than two years. As part of the whole-of-Government work on Brexit preparation, the Government is working to secure an orderly and agreed Brexit, but in view of the uncertainty in London and the increased risks of a no-deal Brexit, we will continue to intensify our preparations for any such outcome.

Our number one protection from whatever Brexit brings will be our status as an EU member state, with all the stability, predictability and solidarity that brings. On 19 December, the Government published its contingency action plan, which outlines the approach to no-deal Brexit planning, and the Department of Health and its agencies are contributing in full to this. Brexit of any kind will mean change and will impact on all sectors, including health. It is recognised that managing a no-deal Brexit would be an exercise in damage limitation and it would be impossible in a no-deal scenario to maintain the current seamless arrangements between the EU and UK across a full range of sectors which are currently facilitated by our common EU membership.

It is important to underline that certain measures will allow us to mitigate, as far as possible, the implications of a no-deal Brexit. Both the Irish and British Governments are committed to maintaining the common travel area in all circumstances and have committed to undertaking all the work necessary, including through legislative provision to ensure that common travel area rights and privileges are protected. The Department has focused attention on protecting the common travel area with regard to access to healthcare and allowing the freedom of movement we currently have for Irish and UK citizens. Protecting and maintaining the common travel area and the associated rights and privileges is a key part of our contingency planning and preparations. This is vital in the context of the Good Friday Agreement and the Northern Ireland peace process, as well as broader UK-Ireland relations.

The Department continues to work closely with other Departments and agencies on all aspects of Brexit planning, particularly the Department of the Taoiseach and the Department of Foreign Affairs and Trade. The Department is represented at all cross-sectoral working groups and is co-operating fully with colleagues across Government. The Department has also strengthened its internal capacity to plan for Brexit. I meet the heads of the HSE, the Health Products Regulatory Authority, HPRA, and the Food Safety Authority of Ireland, FSAI, weekly to review progress on Brexit preparedness and to consider any new challenges identified. I have also established a Brexit operations team, chaired by a deputy secretary general in the Department, comprised of senior officials from the Department, the HSE, the HPRA and the FSAI. This group works to resolve issues and to escalate them to the heads of agency group, which I chair, if necessary.

An inter-agency communications group, chaired by my Department, has been established to plan for all aspects of a communications strategy to ensure that the public is fully informed of the health implications of either a central case Brexit or a no-deal Brexit. A further working group is working to identify and monitor medicines that may be vulnerable to supply disruption as a result of Brexit. The Department and its agencies, especially the HPRA, FSAI and HSE, have been in regular contact with stakeholders to assess the level of preparedness for a no-deal Brexit. It is important to state that while the Department continues to monitor and seek assurances in a number of areas, our current analysis is that there are no immediate risks to the health of the population because of Brexit.

Co-operation on healthcare provision and the protection of public health on the island of Ireland and between Ireland and Britain has developed over many years to the mutual benefit of the all parties. Some of these arrangements are underpinned by EU regulations while others are on the basis of bilateral agreements or service-to-service arrangements. Both Governments have repeatedly stressed that they are anxious for these services to continue post Brexit, and the Department of Health continues to be in close contact to facilitate this.

I will update the committee on the progress and the current status of priority issues since the Department's previous appearance on this issue in January 2018. In the event that the United Kingdom leaves the European Union on 29 March 2019 without a withdrawal agreement in place, it will be necessary to put in place legislative provisions to enable necessary healthcare arrangements, including reimbursement arrangements, to be maintained between Ireland and the United Kingdom. The Irish and British Governments have committed to maintaining the common travel area and its associated rights and privileges. These arrangements facilitate access to health services in the UK and Ireland, including access to emergency, routine and planned healthcare. The draft heads of the proposed legislation therefore seek to put in place an appropriate legal framework in Ireland to ensure the continuation of the common travel area arrangements.

The Department, as part of the cross-Government approach to contingency planning, has prepared heads of a Bill which is consistent with our commitment to provide for these rights and privileges. The proposed legislation would allow the Minister for Health and the HSE, as appropriate, to cover the cost of healthcare provided in the UK under the same conditions as currently exist, for example, where treatments are not provided under our own healthcare system or for an Irish person who becomes ill while on a visit to the UK and needs immediate healthcare there. It also makes provision to preserve existing eligibility for healthcare in Ireland for a range of different cohorts of people, including UK pensioners residing in Ireland, frontier workers and for UK residents on a temporary visit here.

As part of our common travel area discussions, key principles have been agreed at official level with the UK to maintain bilateral health co-operation. There has been very good ongoing engagement with the UK on the technical work needed to ensure continuity of arrangements. Proposals are now being examined with a view to ensuring the maintenance of the status quo pending the finalisation of longer-term arrangements. This co-operation will support the objectives of the healthcare legislation proposed in the no-deal Brexit omnibus Bill. This overall framework will build upon many years of very positive co-operation between the two jurisdictions. This is true of our administrative systems but it is also true at a clinical level. There are very strong and well-established relationships at clinician-to-clinician level. Many of our respective clinicians have trained together. 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 Department is working closely with the HPRA and the HSE on the supply of medicine. Since the UK referendum, industry has undertaken very significant work in modifying supply chains and revising regulatory pathways to guard against Brexit. This work is continuous and the Department, the HPRA and the HSE are continuing to work closely with suppliers. As part of a whole-of-Government response to Brexit, the Minister, Deputy Harris, recently outlined a comprehensive set of preparations to ensure continuity of health services and supply of medical products in the event of a no-deal Brexit. This work involves the Department of Health, the HSE, the HPRA and other agencies engaging in intensive Brexit preparedness and contingency planning. Significant work has been undertaken together with the pharmaceutical industry to anticipate, as much as possible, potential vulnerabilities, risk assess these and devise contingencies to minimise and address any risks to continuity of supply of medicines and medical goods. No major supply issues have been identified through the preparedness and contingency planning exercises.

Ireland is unlikely to face serious general medicine supply issues in the period immediately after 29 March. Any emerging supply issues will, in the first instance, be dealt with from existing supplies held within the domestic distribution chain. It is important to reiterate that 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 assurance that they are confident that they will have sufficient stocks to bridge any initial issues at ports, should they occur. 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 to other patients. As an additional safeguard, special consideration is being given to those categories of medicines which are considered most essential to public health. An expert group is examining these categories of medicine and, where the supply chain indicates that Brexit could potentially cause issues, the group is working with suppliers to verify that robust contingencies are in place. Work on this process is ongoing and will continue for the foreseeable future.

Both the HPRA and HSE have requested that companies highlight any issues regarding the availability of specific products associated with Brexit and no major issues have been identified to date. If any potential issue is identified, it will be managed through the existing medicine shortages framework.

Medicine shortages inevitably arise from time to time and are a feature of health systems around the world. The HPRA has an existing medicine shortages framework in place to help prevent shortages from occurring and to reduce the impact of shortages on patients and healthcare professionals by co-ordinating the management of potential or actual shortages as they arise. This framework is already used to manage and address an average of 45 shortage notifications a month. There is no current shortage caused by Brexit.

The mutual recognition of qualifications awarded in the UK and Ireland has been considered in the context of the negotiations on the withdrawal agreement and the framework for the future relationship. Clearly an EU-UK agreement on the mutual recognition of qualifications, were that to be achieved, would address the issue in the best way possible. The recognition of qualifications has been discussed as part of the engagement at official level between the UK and Ireland on the common travel area. Both the UK and Ireland are committed to ensuring measures are in place to allow for the recognition of qualifications within the parameters applying. The UK has recently published draft regulations, which it intends to enact in the case of a no-deal Brexit. This legislation will enable Irish qualifications to be recognised in the UK.

The Irish health professional regulation bodies have been examining the mechanisms in place for the recognition of qualifications with the objective of ensuring efficient processes for recognition for those holding UK qualifications while ensuring this is done in an objective and non-discriminatory way. The Irish bodies have been linking with their UK counterparts on this issue.

The maintenance of food safety standards of food imports from the UK and the efficient flow of food through the ports is another issue for which the Department is planning. The withdrawal of the UK from the EU and its new status as a third country will have implications for the official food control system in Ireland. The Food Safety Authority of Ireland is the central competent authority for official food controls, which are carried out by a range of official agencies. Those include the HSE's environmental health service, which is largely responsible for foods of non-animal origin and the Department of Agriculture, Food and the Marine, which is responsible for foods of animal origin and plants. Challenges ahead in this area include import and export issues, as well as potential divergence with EU law over the longer term.

The importation of food is subject to EU legislation. Additional resources have been provided to conduct the appropriate checks where Ireland is the first point of entry to the EU. Preparations are also under way in the event that the UK should decide to require export certificates for certain food products.

To facilitate these preparations the Department is working closely with the relevant agencies and has approved additional resources for environmental health service staff, the public analyst laboratory and the Food Safety Authority of Ireland. It is also working with the environmental health service, the Department of Agriculture, Food and the Marine, the Revenue Commissioners and the Office of Public Works with regard to the infrastructure and traffic management requirements at Dublin Port, Dublin Airport and Rosslare Europort. The aim is to ensure that the appropriate food controls are conducted from a public health perspective, while being cognisant of the implications for trade.

In conclusion, I wish to reiterate that the Department, the Minister for Health, Deputy Harris, and the relevant agencies under the aegis of the Department are fully engaged in Brexit planning to ensure, as far as is possible, that the health sector is prepared for any adverse impacts as a result of Brexit. We recognise the valuable work of the committee and I thank members for the opportunity to be here today. I look forward to the views and questions of members.

Chairman

I thank Mr. Breslin. I now call on Mr. John Hennessy to make his opening statement.

Mr. John Hennessy

I thank the Chairman and members of the committee for the invitation to attend this meeting to discuss HSE Brexit preparedness. I am joined by my colleagues, Mr. John Swords, national director for procurement, and Ms Paula Keon, assistant national director for the HSE North-South unit.

The HSE has been preparing for Brexit for some time on the basis of a central-case scenario and for a potential worst-case scenario, while at all times aware that negotiations are ongoing to help ensure that the necessary transition arrangements are in place to maintain continuity of health services.

A HSE Brexit planning group has been in place since 2017 and has been working closely with our departmental colleagues on a wide range of Brexit contingency planning and mitigating actions. The focus of this work has been on Brexit implications across key work streams, including the continuity of patient and client health services; cross-Border and frontier arrangements, including co-operation and working together, CAWT; emergency healthcare, including the ambulance service; public health matters; environmental health; workforce issues and recognition of qualifications; and continuity of supply of goods and services including procurement.

The focus of the mitigation measures relating to continuity of care is on ensuring that service level agreements and memoranda of understanding are in place where necessary. This applies to specific service areas such as emergency cross-Border arrangements, cardiac and cancer services, treatment abroad placements and CAWT arrangements. The EU North-South unit is working to ensure that services currently available to people living in Border areas continue to be available post Brexit. Examples of those, as I mentioned, include cardiology and radiotherapy services at Altnagelvin and the specialist cardiac services provided on an all-island basis for children at Our Lady's Children's Hospital, Crumlin.

Arrangements in respect of other specific areas of healthcare, such as paediatric organ transplant services, are progressing and agreements are being finalised with the relevant UK hospitals to ensure continuity of service post Brexit. That includes Great Ormond Street Hospital.

The national ambulance services, here and in Northern Ireland, are liaising closely to ensure service continuity and agreement with regard to operating procedures. There are two key memoranda of understanding in place between the respective ambulance services. The first is a memorandum of understanding on the provision of assistance in the management and resourcing of emergency and urgent calls. The second covers mutual aid for declared major incidents. These join the two jurisdictions in their responses to emergency situations.

The environmental health service is engaged in ongoing discussions with the Departments of Health and Agriculture, Food and the Marine about the import and export of foodstuffs and the possible divergence of food regulations and controls over time. As Mr. Breslin mentioned, additional resources have been made available in 2019 to strengthen the environmental health service capacity in this regard, and those additional posts are being recruited at present.

The wider workforce implications of Brexit have been examined in detail by human resources department of the HSE and the key risks such as mutual recognition of qualifications and training for professional staff have been analysed in detail in the context of the movement of healthcare workers. The HSE is liaising closely with the respective professional bodies and the regulators with a view to facilitating the continuation of existing recognition arrangements.

The key risks for the provision of goods and services, such as medical and surgical supplies and medicines, in the short term relate to potential disruption and delay to supply chains. As Mr. Breslin mentioned earlier, a joint working group comprised of staff from the HSE, the Department and the HPRA has been engaged in intensive work that involves the identification of suppliers of critical medicines and detailed follow-up with regard to specific product lines. The key supply chain challenges in the short term are likely to be related to medicines with a short shelf life, those reliant on refrigerated supply chains, compounded products and time-critical logistics. The HSE-HPRA group is liaising closely with hospitals and community pharmacists to identify short, medium and longer-term concerns regarding the continued supply of drugs and any risks to such supply and the proposed mitigation of those risks. This work is being done in close collaboration with the pharmaceutical industry and both hospital and community pharmacy stakeholders.

There is currently a two-month stock of vaccines held in the HSE national cold chain service which, along with the stock held by companies in Ireland, gives approximately a six-month supply on the island to ensure the continuation of service delivery. My colleague, Mr. John Swords, can provide the committee with further details about the continuity of supply of goods and services post Brexit.

In terms of next steps, the HSE is continuing to work closely with service providers, suppliers and patient groups in relation to Brexit preparations. This involves identifying, assessing and addressing the necessary contingency measures and actions required to maintain service continuity in the event of both an orderly and a disorderly Brexit.

The HSE is also continuing to work on awareness of Brexit implications among HSE and health service staff generally along with our colleagues in the HPRA and the FSAI, key suppliers, and with patients and the public in consultation with the Department of Health. This concludes my opening statement. I and my colleagues we will endeavour to answer any questions the committee may have.

Chairman

I thank Mr. Hennessy. I will start proceedings by asking the witnesses to expand on the treatment abroad scheme and the cross-border directive, both of which are very commonly used by Irish patients seeking treatment abroad. They involve reimbursement of payments for those services. How will they continue or will they be affected in any way?

Mr. Jim Breslin

I will ask my colleague, Mr. Goodman, to come in on this. We have previously supplied to the committee data on the activity under those schemes. It is notable that while, as EU citizens, we have entitlement to travel for treatment abroad or to avail of the cross-border directive across the EU, the majority of people are accessing care in the UK or Northern Ireland under both schemes. For the treatment abroad scheme, as I noted in my statement, that is because our specialist links are most developed with the UK. Mr. Hennessy mentioned Great Ormond Street. There is a range of institutions in the UK to which we are very connected. That will continue after Brexit. We are confident about that for two reasons. The level of engagement Mr. Hennessy has described with those institutions indicates that they completely understand the patient rationale here. It is to their advantage that we form part of the catchment area for very highly specialist care and that we are able to feed in our patient to give them a critical mass of treatment within these islands. If they were to lose some of that critical mass it would undermine their services. They want to continue that relationship with us not only for altruistic reasons, which are very important, but also for the reputation of their units. That is the very positive message we have received in our interactions with those facilities.

The heads of the Bill that have been published will give us the legal authority, subject to the drafting and progression of the Bill, to reimburse those facilities for the care they give. At the moment, that is done completely through an EU-wide process where there is low administrative overhead and pretty well-established rules as to how it happens. In a post-Brexit situation, the UK will no longer be part of the EU-defined treatment abroad scheme but we will have an equivalent arrangement with the UK. We will reimburse them, not as we currently do through the EU, but directly, for the care that they give.

In respect of the cross-border directive, the legislation also has an enabling provision which would allow the Minister and the HSE to meet the travel costs of Irish citizens to access treatment on an equivalent basis to the cross-border directive. Currently, if someone goes to an EU member state and pays for their cross-border care, they can come back to the HSE and have that reimbursed. We would seek to put in place a similar scheme. It will not be the EU cross-border scheme but a similar scheme that would allow Irish citizens to continue to travel to Northern Ireland or the UK and be reimbursed by the Irish Government. The UK authorities have indicated to us that they would be interested and prepared to facilitate continuing access under those arrangements.

Chairman

On that point, can Ireland enter into bilateral arrangements like that with the UK or would it have to go through the EU?

Mr. Jim Breslin

Part of the rationale here is the common travel area, which provides that we are completely fluid in how people and labour move around. We have such historic links between us in that regard that we have to put an overarching set of entitlements in place. There is no point in telling someone they have a historic right to work in another country if, when they work there and need healthcare, they are not covered for that. The common travel area has always covered not just people's ability to work but also the social security that goes with it. It is through those mechanisms that we will seek to do that. The cross-border directive is probably going to be an extra bit. In the heads of the Bill, we have signalled our intention that we would like to provide for it. We will have to work it through with the Oireachtas as the legislation goes through the Houses.

Mr. Fergal Goodman

I do not have a lot to add, really. The principal distinction between the two schemes is that treatment abroad is very much a service-to-service arrangement, as the Secretary General has said. As Mr. Hennessy has indicated, the HSE is proceeding on the basis that those service-to-service arrangements are essential in many ways and need to be maintained whatever happens. The confirmation of the HSE's legal authority to continue with those arrangements is one of the purposes of the Bill.

As people will be aware, the cross-border directive puts the control in the hands of the patient to elect to source a service elsewhere. That is not something that would otherwise exist in legislation. The omnibus Bill that is being developed will need to pin that down in particular. As the Secretary General has said, what we are seeking is the legal underpinnings that will enable the patients to continue to make those individual choices to access services. That is the policy mandate that the Government has given us in that regard. Both arrangements are essentially dependent on reciprocation from the UK as far as is necessary to enable those systems to operate. At present our understanding is that we expect that reciprocity to be forthcoming, all other things being equal.

Senator Colm Burke

I thank the witnesses for their presentations and am grateful for all the work that has been done by both the Department and the HSE. Everyone very much appreciates it. Both the Department and the HSE played a major part in developing the cross-border directive over a long number of years. As a result, Irish people have benefitted substantially in being able to travel abroad when treatment is not available here.

The presentation suggests that many of the angles have been covered. Is there a particular angle of concern that will now change? The one area I want to find out about is the case of someone who is working in the UK, has private health insurance and ends up receiving healthcare. Have the health insurance companies engaged in the same way as the Department and the HSE as regards making sure the existing arrangements will still be in place after 29 March? Have the witnesses had any feedback from the health insurance companies on that?

Much work has been done as regards joint co-operation between Belfast and Dublin and between Derry and Donegal on providing medical care for people travelling between the North and South to receive care. Will there be any real change in the services that will be available? Will there be a change in how remuneration is resolved between the parties? What kind of changes do we expect in that whole area?

On training in respect of medical care, the working time directive has brought in many changes here. It has been very good for staff as regards working time and the hours they have to put in every week. However, others would claim that there is less training as a result of the reduced working hours. Now that the UK is going to be outside the European Union, the likelihood is that it will change some aspects of the working time directive. How are we going to deal with that?

We have certain qualifying criteria, for example. Has there been any indication that there will be changes to these in terms of the training of nurses, pharmacists, physiotherapists or doctors, including GPs? Has the issue been discussed?

Mr. Jim Breslin

I thank the Senator for his questions. I will ask people to contribute as we go through them. The question on what might change was helpful. People may not have seen it, but I saw a headline in The Times of London. It summarised, albeit inaccurately, the position outlined in my opening statement by saying that medicines would be fine but cross-Border services would be impacted. That is not what I said in my opening statement. I am happy to say that we do not expect the North-South arrangements to be affected by Brexit. That is not the basis on which either jurisdiction is planning. When I referred to the general proposition that Brexit would change our lives and have implications for all sectors, it was not the cross-Border arrangements that we operate that I was thinking about. I can provide examples of what I was thinking about, though.

We have strong North-South relationships. We have provided capital for the opening of the radiotherapy unit in Altnagelvin. We were there at the design stage and the commissioning stage. We pay for the service that we get, as we do for the primary cardiac catheterisation service at Altnagelvin and some other services in the North. Equally, our colleagues in the North are providing for the capital development of Crumlin so that children from the North with congenital heart defects can be treated at that hospital. The North will pay the revenue costs of that. All this is founded on the patient outcomes that can be produced by working together, and we are confident that the arrangements will be sustained through this period of disruption.

The arrangements are largely governed by service level agreements. In some cases, we have contributed to the capital costs. In many cases, we are meeting the revenue costs. Currently, they do not go up to Brussels and back down to the other jurisdiction. Rather, they go directly from the HSE to the facilities in Altnagelvin or elsewhere. We are confident in that regard. Mr. Hennessy can discuss the detailed engagement that has been happening.

The private health insurers have assured us that they are not planning for an impact on those with coverage. I will address an important point that did not come across in the question. I believe I am right in saying that the health insurance policy of an Irish person who is working and resident in the UK will be written in the UK. The VHI or another insurer would write insurance for people who were resident in Ireland, but if they were non-resident in Ireland, they would either get their insurance from the countries they were resident in or would get international health insurance policies. This issue is more likely to arise in respect of someone who is resident in Ireland but who, in the course of his or her business or leisure, is in the UK or US when something happens. That is something with which insurers are familiar. In general, people do not use their private insurance to access healthcare in the UK on a planned basis unless that care is not available in Ireland, in which instance specific arrangements apply. We have heard back from the insurers that there will be no change in this area. They have examined the issue.

Regarding the question on training, a great deal of work has been done by our professional regulators. This is an example of where Brexit changes the situation. If someone trains in the EU, his or her qualification is automatically recognised in other EU member states and no one in their regulators can raise an issue about it. However, the UK will become a third country and there will not be automatic recognition unless an overall deal is done by it and the EU to recognise qualifications. There have been discussions in the context of the future relationship. In the absence of a deal, we will put in place an administratively seamless approach between regulators. The Nursing and Midwifery Board of Ireland, NMBI, is already informing itself on the qualifications in the UK and will not have to go through a long check when it receives an application from a nurse trained in the UK. It will deal with that application within the current timeframes.

The Senator asked a good question about what would happen if the UK diverged over time. That does not relate to the EU's working time directive principally, as the UK could diverge from the directive without it having an implication for the quality of the qualification. Obviously, Ireland would stay with the EU standards. However, if the UK diverged in the period ahead - we have no indication that it will, and I am referring to years from now anyway as opposed to just months - and decided to define the qualifications to be a professional in a different way from the EU, rendering them no longer equivalent, it would raise issues for our regulators and we would have to re-examine the situation. Similarly, if the UK decided to diverge from EU food standards five or ten years after leaving, it would pose a risk for all of our interactions with it and is something that we would have to watch. It would not be an issue for 2019, but it would have to be examined and is likely to be one of the issues addressed in the future relationship between the EU and the UK.

Senator Colm Burke

Many of our training guidelines were developed jointly by Ireland and the UK. I refer in particular to junior doctors. If someone does 48 hours per week in Ireland and the UK diverges from the working time directive as regards training and allows someone to work up to 60 or 65 hours per week, the long-term effect on Irish people who have done two or three years of training in Ireland before going to the UK could be that they would not get the same recognition.

Regarding the exchange between Ireland and the UK of people working in medical services, many junior doctors stay in Ireland for two or three years before going to the UK for another three or four years and then returning. It is important that this co-operation on training continues. Otherwise, both countries will suffer. An eye should be kept on this.

Mr. Jim Breslin

Yes. The Senator's second issue is the focus of attention, and not just as regards doctors, but also nurses.

Senator Colm Burke

And physiotherapists.

Mr. Jim Breslin

There is quite a degree of movement. The Nurses and Midwives Act 2011 provides for the NMBI to enter into agreements with third countries for the purpose of mutual recognition. That will allow the registration bodies in both jurisdictions to say that there is equivalence and that people can seamlessly move back and forth. The same applies in the case of the Medical Council. The bodies involved may need to change their internal rules somewhat, but given the historic linkages and the equivalence that we currently enjoy, the latter is something that all regulators on the two islands wish to continue.

I do not know what the UK's plans on the working time directive are. I do not mean to disagree with the Senator, but the essential point is not the number of hours, but the quality of the training in the course of those hours.

Senator Colm Burke

Yes.

Mr. Jim Breslin

So long as we can maintain that our doctors are getting in that 48-hour period the quality of training that would be expected for someone working for a longer period of time in the UK, it is better that our doctors are working 48 hours instead of 60 hours in terms of the performance of their duties.

Senator Colm Burke

Absolutely.

Mr. Jim Breslin

Where equivalence is concerned, that is where the attention will have to be paid.

Mr. John Hennessy

Our HR department has been doing extensive work with the regulators in respect of this issue and training. The feedback from that process does not reveal significant concerns in the short term but, obviously, there is a need to monitor any divergence in standards over the longer term. That will be a priority.

My colleague, Ms Keon, has been closely involved in dealing with the North-South relationships. Several joint workshops have been held with representatives of the health services in the North and in the South with a view to ensuring a seamless transition to the post-Brexit situation. They have addressed specific services such as those I mentioned in the opening statement where extensive agreements are in place. The agreements relating to cardiac, radiotherapy, paediatric cardiac and other services have been tested to ensure that they would withstand any kind of Brexit and we are satisfied that they will. We have been working on ensuring a seamless transition on the reimbursement issue and the funding implications in terms of issues such as the cross-border directive such that the current reimbursement arrangements or very similar will be maintained and patients will not be unduly discommoded.

Chairman

Will the Medical Council be responsible for the recognition of qualifications?

Mr. Jim Breslin

Yes. Similarly, other professional bodies such as the NMBI and CORU will be responsible for recognising qualifications relating to their professions.

Chairman

If a university in England introduces a new course such which involves graduate entry rather than standard entry, will that course be assessed under new recognition processes?

Mr. Jim Breslin

Initially, the General Medical Council, GMC, in the United Kingdom would have to recognise the new course. By virtue of its relationship with the GMC, the Irish Medical Council understands where the GMC sets the bar in terms of standards. Once the GMC approved the course, the Medical Council would recognise that as the course meets the GMC test which it considers equivalent to ours, that is sufficient for us to recognise the course.

Deputy Margaret Murphy O'Mahony

The discussion of Brexit nearly always relates to the political or economic consequences. It was late in the day before I started thinking about the impact it may have on our health sector. How can we ensure that the general public understand what is happening or could happen with regard to Brexit? As Mr. Breslin is aware, under the Medical Practitioners Act, Irish qualifications must be recognised in other EU countries. What is Mr. Breslin's view on the potential difficulties in regard to recognising qualifications in England?

He referred to the various groups set up to consider the implications of Brexit. I ask him to expand on the work of the Brexit operations team. What issues does it deal with and what actions does it take?

Mr. Jim Breslin

The Minister briefed the Cabinet on this issue recently. We have issued public statements and it is outlined in the contingency action plan. We have convened stakeholders for discussions, particularly in the area of medicine supply, on which it is very important that there is good clear public information. Later today I will write to stakeholders with whom we had a very good meeting last week, including representatives of the pharmaceutical industry, the Irish Pharmacy Union, which represents community pharmacists, and a range of other stakeholders in order to ensure that we are all aware of the exact situation regarding medicine supplies. As stated earlier, it is very important that people understand that this is a sophisticated industry with well-developed supply chains and some of the largest multinationals in the world delivering medicines to community pharmacists through very well established and resourced wholesalers. The HPRA, the HSE and the Department are working with the industry to pre-empt any issues. As per my opening statement, we are confident that there are no current issues. However, medicine shortage can arise even without Brexit, so we will remain vigilant. If an issue arises, we will put actions in place to resolve it as quickly as possible. We are confident that there is adequate provision and that wholesalers routinely hold sufficient stock to bridge any problems that may arise at the ports. The important message is that there is no need for patients, retail pharmacists or hospitals to increase stock levels or ask for extra prescriptions. To do so would suck product out of the supply chain, which might produce a shortage and mean a person who needs the medicine would not be able to get it. That is a very important public message which we are seeking to promote. We will continue to review this matter with industry representatives. As Mr. Hennessy outlined, we are considering categories of medicines and product lines. In addition to receiving the message from the industry that it has done the preparations - and we are very appreciative of its work in that regard - we are verifying the availability of the most critical medicines and asking the industry to be definitive in regard to how the product will be delivered and that there will be sufficient supply. All of the information to date indicates that the work is proceeding and that there is satisfaction in respect of adequate supply. That is important information which we are promoting to the public. It would be great if something sensible could be done in Westminster to conclude an agreement as that would render all of this damage limitation unnecessary. However, we will continue with it because of the uncertainty. We will continue to make that information publicly available. Obviously, as we get closer to Brexit, we will make further information available.

The potential impact on the flow of patients between Ireland and the UK for specialist services is also a source of public concern. As I stated, we are working to ensure that will continue and are confident that it will. The authorities in the UK are very anxious to facilitate it. As Mr. Hennessy outlined, service agreements have been reached regarding individual circumstances such as cancer or cardiac care in Altnagelvin hospital or other arrangements which we facilitate. We are confident those agreements will withstand any issues that arise out of Brexit. Those are probably the two most important messages I wish to send to the public today.

On the Medical Practitioners Act, as previously outlined, we envisage that the Medical Council will examine its current rule set. Should the UK crash out, an EU-recognised qualification would no longer suffice to practice in the UK. Rather, doctors there would require GMC UK-recognised qualification. We understand the implications of that. Once we are satisfied that a person has such a qualification, we will put him or her through an administrative procedure similar to that in regard to recognition for EU qualifications but which will no longer be automatic.

Deputy Margaret Murphy O'Mahony

There will be two channels.

Mr. Jim Breslin

There will be two channels. A person with a French qualification will automatically be recognised. A person with a UK qualification will not have to undergo the same depth of analysis as a person from a third country with which we have no relationship. There will be a fast-track system but it will differ from the process for holders of EU-recognised qualifications. Our regulators will put back-to-back arrangements in place with their equivalents in the UK to allow that to function.

I refer to the Brexit operation team.

I hope colleagues will have a chance to provide the committee with detail of the importance of that team. The HPRA, the HSE and the Food Safety Authority have been working on this issue for two years and a tremendous amount of work has been done. After Christmas we decided that the cycle of work and the response would speed up considerably to the end of March and beyond. Rather than have meetings every three or four weeks, we need a functional team from across the agencies and the Department which has a leadership and meets every week. In between the weekly meetings, there will be constant bilateral engagement. If the HPRA needs to work with the HSE on a medicine supply issue, it can do so between meetings and report back on the Monday when the operations team convenes again. The Department is providing the leadership for the team to ensure it will all happen in real time. There has been very good collaboration over two years, but we have speeded up its intensity and integrated to a greater extent. It is focusing on the full range of Brexit tasks we will have to undertake under many of the differing headings. It is providing a central point for the agencies to feed into the Department. It is also allowing the Department to feed into central government. When we talk to the Department of the Taoiseach or the Department of Foreign Affairs and Trade, we will do so having freshly left a conversation with the HPRA, the HSE and the Food Safety Authority and with the most up-to-date information possible. It also permits a joined-up stakeholder engagement and communications piece. On Wednesday last Mr. Goodman led a meeting with medicines stakeholders. It was the full range of the industry, regulators and professionals working in the area. He did so with representatives of the HPRA and the HSE in the room. Everybody heard the same thing at the same time. It is important in responding rapidly to an evolving situation that people move at the same speed. That is the purpose of the Brexit operations team.

Chairman

I ask Ms Nolan about medicines. Will HPRA recognition and approval of drugs process change after Brexit? I presume existing drugs will be recognised. As new drugs come from the United Kingdom, however, will there be a different process of recognition and approval?

Dr. Lorraine Nolan

In his opening statement Mr. Breslin mentioned the various regulatory pathways by which medicines come to the market. In the light of Brexit, changes to these regulatory pathways must take place. Where there are activities which are conducted in the United Kingdom such as manufacturing or the batch release or testing of medicines, in the light of Brexit they must be changed to another EU member state. In the case of existing licensed medicines, where there is a dependence on the United Kingdom for the activities to be conducted or where the UK agency was the lead agency in the technical evaluation of the medicines, all of these issues have to be transferred. That is one consequence of Brexit. Preparations have been under way at European level since 2016 and are advancing. The vast majority of the changes have been made, but in fairness to the committee, I note that we are aware of some companies within the United Kingdom which supply both that market and the Irish market which have not as yet made the regulatory changes. The other system is that after the United Kingdom leaves the European Union and becomes a third country, the EU 27 will continue to authorise medicines as it currently does and Ireland will continue to be part of that system. The United Kingdom will separate from that process. We are working on arrangements with the United Kingdom for things like joint packaging. Because we have a common language, for a lot of the medicines supplied here and in the United Kingdom there is joint packaging. Joint packaging with third countries will be an acceptable process. We have worked on solutions to maintain the supply of medicines to the market and ensure we will have sufficient contingency plans in place.

Chairman

Could there be a problem with the companies which have not made their arrangements in accessing the drugs they produce?

Dr. Lorraine Nolan

As Mr. Breslin outlined, an extensive planning process has been in train in the past two years. At this point, we are working with the companies involved. In many cases, we will have sufficient alternatives to those medicines and will not necessarily be reliant on them. This is part of the criticality assessment exercise on which we are working. If it comes down to dependency on a medicine, we are open to looking at pragmatic ways to transition across the period after Brexit to allow supply to continue to the market.

Deputy Bernard J. Durkan

After Brexit the United Kingdom will, effectively, be a third country. I acknowledge the preparatory work already done and congratulate the delegates on the options they have covered. Dipping a little further into the food quality controls that will apply, as a third country the United Kingdom will import from and export to third countries and, presumably, the European Union. If there is no agreement and it is a crash-out, the scenery will be slightly different. Will adequate controls be in place to ensure the quality and standards applicable throughout the European Union will continue to prevail, given, in particular, that we will be in the European Union, while the United Kingdom will not? Is it envisaged that an EU standard will be applicable? I acknowledge the common travel area, but I am a little worried about the extent to which it will prevail if the standards to which we have become accustomed in the European Union continue to apply.

Mr. Jim Breslin

The common travel area does not relate to products but to people. It is a different conversation than for product movement between the United Kingdom and the European Union post-Brexit. Obviously, we have an interest in food safety in that context. Significant preparations are under way. The HSE's environmental health service has responsibility for food safety as it relates to food of non-animal origin, while the Department of Agriculture, Food and the Marine has responsibility for foods of animal origin. Broadly, that is how the division of responsibility works. For example, we have approved 61 additional environmental health officers for the HSE. They will carry out physical checks and checks on documentation in the importation of foods. Currently, arrangements are in place for third country importation. If foods come from outside the European Union and land in Dublin Port as their first port of entry to the European Union, the environmental health service personnel at the port go through the products to ensure they are acceptable for supply to the Irish market. They do this on a risk basis and do not have to go through every product. They look at the nature of the product and decide what to inspect.

In the event that there is a crash-out, products coming from the United Kingdom would have to be subject to the same regime. That means taking a risk-based approach where we would look at the nature of the products, while the environmental health service would make a decision, based on the documentation, on what was worthy of physical inspection. That would involve a logistical operation, in particular at Dublin Port, on the part of the environmental health service of the HSE, officers from the Department of Agriculture, Food and the Marine and Revenue customs officials. While such an operation is already in place, it will have to be beefed up considerably. If a ship arrives from the United Kingdom, officials will have to look at the cargo details, lorries and importers, of which they will have to receive advance notice. They will look at the products involved and a determination that might be made would be for the environmental health service to inspect two lorries off that ship. Revenue will act as the co-ordination mechanism and issue a message to the haulier to the effect that the lorry must be presented for inspection. It would not get to exit the port without that inspection. The lorry and its cargo would be presented for inspection by environmental health officers before it could go on its way.

The Department of Agriculture, Food and the Marine could do the same for meat or similarly the Revenue in the case of a customs issue.

The logistical operation in the port has been carefully planned to ensure that, on a risk basis, we have controls in place but the free flow of traffic continues. It is to ensure that the truck driver who does not have any issues can get off the ship and out of Dublin Port without experiencing traffic jams. Those who are subject to inspection will obviously experience some delay as their products are examined. That is one of the consequences of moving out of the EU. People importing from the UK into Ireland will be subject in some cases to a check of documentation or a physical inspection based on risk. That is not the case now.

Deputy Bernard J. Durkan

During the foot and mouth epidemic in the UK, satisfactory arrangements were put in place to ensure no contamination came from the UK or vice versa. There did not seem to be any great backlogs at ports or airports. It was done efficiently and effectively. I presume cognisance has been taken of that to put something comparable in place now.

I will move on very quickly to the supply of drugs. I have listened to some of our colleagues in the UK predicting a doomsday situation for this country after the UK leaves. To what extent has the Department considered their views? Are there any particular drugs or range of drugs that might be controlled to an extraordinary extent by third countries? That is what the UK will become. What has been our experience in dealing directly with third countries heretofore regarding compliance and availability? How are generic drugs likely to be affected? I presume that has been examined.

On access to healthcare for children, in the run up to the provision of our own new national children's hospital, what arrangements are in place with third countries? I refer to the UK and others. To what degree is remuneration readily available? We can still do that after Brexit. Will Mr. Breslin, however, give us some indication of the other countries besides the UK with which we have such arrangements? My understanding is that any bilateral arrangements require EU approval because we are, and will remain, a part of the EU. I would like some clarification on that issue, just in case we find ourselves in some kind of a cul-de-sac at a later stage.

Mr. Jim Breslin

I might ask the HPRA and the HSE to come in on the drugs supply issue as well. The starting point is that there is a significant routing of medicines from the UK, either originating there and landing in Ireland or being sourced from there. Up to 70% of medicines on the Irish market are manufactured in the UK or transit through the UK. When we talk about the supply chain, and modification of the supply chain, individual manufacturers have looked at that. Some have made arrangements, for example, where the drug is manufactured on the Continent and is moved through the UK landbridge, while some have made arrangements to come directly to Ireland.

Others have decided that where a product was previously contained within a drop for the UK and Ireland, they will now separate out those two loads and send them separately via the landbridge. Significant supply chain modification is under way. Much of that depends on the characteristics of the medicine. If a particular medicine has a long shelf life and little potential for disruption due to a delay at a port, then there is more flexibility on the part of the manufacturer and the distribution chain. Particular areas examined include medicines with a short shelf life, as Mr. Hennessy referenced. A delay could lead to a product expiring. The HSE and the HPRA have reached out to those suppliers in particular to seek reassurance and verification that arrangements in place will not be disrupted.

In general, the arrangements in place in Ireland for the supply of medicines are quite distinct from those in the UK. We are an island and we have a wholesale distribution system very different from that of the UK. We also have significant stocks held domestically within our supply chain. That will be the first port of call if any immediate issues were to arise. We are working with a range of stakeholders in the medicines industry to ensure they have the proper capability to respond to any disruption that might arise. The scale of the thousands of medicines involved requires individual level preparation and planning. In respect of critical medicines, we have an exercise under way to look at alternatives, to look at supply chains and to verify what is under way.

As of today, we have no issue which we are declaring will be a problem or disrupted. We will continue to engage right up to Brexit and beyond to ensure that stays the case. There is a background issue. The Irish market has been very intermingled with the UK market. Potentially, over the medium term rather than in the next weeks, manufacturers or suppliers may look at the Irish market as a smaller market post Brexit. We were part of a huge UK-Ireland market. For some people, we will now be an Irish market of 4.5 million people without a great supply requirement. We may experience a situation relating to our size, as other countries do, where some suppliers decide it is not worth supplying into such a market or they may want to supply on different terms. We will have to watch that in the medium term post Brexit. It is not an immediate issue.

Generic medicines are potentially an issue. Down the road, some suppliers might consider that extra work is required to get into this market, more documentation is needed and not much is sold. They might then question what is the point in continuing. We have to look at all of those situations. In many cases, because we are dealing with generic drugs, the active ingredients are being manufactured by others. One supplier, therefore, making a decision not to supply the Irish market might not be crucial if other generic suppliers provide the same active ingredient or the originator is still on the market. I ask the HPRA to expand on that matter. I ask Mr. Hennessy to speak about the children's services and existing linkages. Regarding our ability to conduct bilateral agreements, the EU-UK withdrawal agreement and the negotiations in Brussels specifically recognise the common travel area as a distinct feature of the Irish-UK relationship and gives us a licence to give that expression post Brexit.

Chairman

I thank Mr. Breslin. I call Dr. Nolan.

Dr. Lorraine Nolan

I will not repeat what Mr Breslin said. I will just add some more information. On Deputy Durkan's question on doomsday scenario predictions in the UK regarding medicines supply, Mr. Breslin outlined very well the logistical preparations the industry is making. We have to remember that, in most cases, the industry has been preparing for almost three years. The industry has great expertise in logistics, knows how to split off supply from Ireland and examine different routing for medicines to come into the country.

In addition, the wholesale distribution model in Ireland is very different from the UK. We hold much larger buffer stocks at the wholesale level than the UK. In general, we hold six to eight weeks of stock. We have, therefore, a mechanism within that system giving us the capacity to maintain supply even if there are delays in getting medicines transported to and from the UK. Our system is more flexible and adaptable because different mechanisms evolved in the UK supply chain compared with the Irish situation.

Mr. Breslin spoke of generic medicines. The generic medicines industry works on smaller margins in respect of supplying medicines to the marketplace. Brexit, as we have said, does mean change. The cost of supply to the market may go up.

We do not anticipate that there will be a major impact in the aftermath of or at the end of March, but what we may see over time is a rationalisation by the industry of portfolios of medicines that are supplied into the Irish market. We do have systems for dealing with this. Mr. Breslin mentioned that the HPRA has a co-ordinating role in respect of shortages of medicines. We have a framework that has been put in place within the past six months and which is operating very well and has very good capability for managing shortages. The main thing in all our Brexit contingency planning, which has been ongoing for quite some time, is that we have very close engagement with the industry and receive real-time updates from it. The operational meeting to which Mr. Breslin referred gives us a mechanism to be able to react to an evolving situation very carefully. Therefore, with very careful monitoring and with issues occurring over time, the situation has the capability to be very well managed if there is rationalisation of generics. We also have quite an extensive supply of generic medicines in the Irish market. The Deputy may be familiar with the interchangeable lists of medicines published by the HPRA. This is the list of generic medicines that are available in the Irish marketplace. It is an aid used at pharmacy level for changing patients-----

Deputy Bernard J. Durkan

They are available and manufactured here.

Dr. Lorraine Nolan

No, not necessarily manufactured here. These are medicines that are brought into the country. What I am saying is that we have adequate supplies and there is no immediate concern.

There are 1,800 pharmacies which take deliveries 11 times per week on average, through the distribution service. There are numerous pharmacies in different communities. They rely on each other, and it is a very mature and well-stocked system. There is up to four weeks of supply in the individual pharmacies and six to eight weeks in the supply chain. We do not see shortages arising at the moment. There is no difficulty with that; it is well managed. It is encouraging that there is such a large amount of communication going on at the moment. We have written to more than 300 of our main suppliers and have had 70% of them write back. Much of the information in that correspondence states that they have examined their supply chain and that they are looking at six to eight weeks, and in some cases three to six months. Generic medicines were mentioned. Some smaller companies are actually stocking up to six to 12 months worth of product. They are making sure that we will not face an interruption of supply.

It is important to note that we deal extensively with distributors, and because of that we have options within our supply chain. We have been rationalising our logistics operation within health over the last number of years and are bringing efficiencies into it. We are currently extending that process into the Dublin region. We are reducing our inventory in many areas. On average we keep two to three weeks of stock in hospitals across all of our areas, but we rely on each other in the event of any shortage in any given area. We are in control of our information, and we are getting better and better at it. While Brexit poses different problems and questions for us, we are in a position to answer those questions. Our one risk, if it can be called that, is that there may be a delay of product, but there is enough in the system to sustain a shock.

On the question of drugs that might be required on a short-term basis with a quick turnaround time, customs officials have indicated to us that, where paperwork is in place, it will provide a blue light service. That is as good as it gets. We have spoken to suppliers, and instead of just using road, rail and shipping to deliver the products we will also use air freight. Those arrangements are in place with some of the companies at this point in time. We are examining the issues and going out to meet our main supplies to ensure they understand where we are coming from and to make sure that we are working together on this issue.

Chairman

What about vaccines?

Mr. John Hennessy

The level of vaccines in place is fine at the moment. Population health colleagues have tested the supply chains for all the immunisation programmes. Most of them come directly to us from Europe and do not touch the UK at all. All have tested well and we have solid assurances around them.

Senator Keith Swanick

Many of my points have been touched upon, but I welcome what Mr. Hennessy said earlier about the organ transplant programme at Great Ormond Street, and also the collaboration between the ambulance services in case of major incidences and emergencies. My colleague, Senator Burke, mentioned young health professionals going to the UK to gain experience. That is invaluable; I spent some time in south Wales and completed my GP scheme there. Young health professionals gain invaluable experience by working in a different jurisdiction. This is probably an issue for postgraduate organisations, but if a young doctor completed his or her GP scheme in the UK, gained qualification and became a member of the Royal College of General Practitioners, ICGP, perhaps that could be reciprocated with a membership of the Irish College of General Practitioners on returning to Ireland. We hope they will return to Ireland to address some of the shortages we have here.

We had a long discussion about drugs, and I recognise the collaboration between the Department, the Health Products Regulatory Authority, HPRA, and the HSE. I also acknowledge the challenges for refrigerated products and products with short shelf lives. The vaccines were mentioned; are we happy that two months supply is enough? I presume the witnesses were discussing childhood vaccinations. Are travel vaccinations also covered under that grouping? There is also a question about cancer drugs, and immunotherapy and biological agents. Mr. Breslin mentioned critical medicines, but biological agents fall under that critical medicines banner. Often with rheumatological diseases, for example rheumatoid arthritis or inflammatory bowel disease, consultants will go straight in with a biological agent to get a patient's symptoms under control quickly. Previously they might have used a disease modifying agent and built up to using a biological agent. It is nowadays often a first-line treatment. The demand for that product is obviously higher. They are used in such a variety of cases, including gastrointestinal cases or joint cases. Are the witnesses quite happy that we have enough of those types of drugs available? I agree that we have good links with multinational companies and that there are excellent wholesalers in the country. The witnesses correctly said that medicine shortages are an ongoing issue, with or without Brexit, but as a GP on the ground I am beginning to see patients requesting extra drugs because people are seeing the charade and disorganisation in the British Parliament and combining it with the 29 March deadline looming. GPs are once again acting as gatekeepers in a role they did not think they would have. We are trying to reassure people, but would the witnesses consider redoubling the efforts to get the message out to the public on the ground in the form of a media awareness campaign, with radio and TV, for example? People are asking for more inhalers and more blood pressure drugs. People who are using these biological agents are concerned that the consultants will not be sending the high-tech scripts down to their local pharmacy in order that the local pharmacy would dispense them.

As professionals we can be reassured by the comments made here today. However, there is a bit of a disconnect on the ground. People are obviously worried about their conditions, and I believe a public awareness campaign would really help to benefit that cohort of patients.

Mr. Jim Breslin

Coincidentally I signed off on a communication on medicines to go to a range of stakeholders last night. Included in that is the ICGP. It is important that networks of GPs are given the knowledge so that when a patient attends, the GP is able to tell them key things about it. We will look at this issue. We have a communications team in place to do that. At the moment we are getting great free messaging out because people are asking questions, like the members present today, and the newspapers are writing about it. As we come closer to the time we will think about putting our own public messaging out. We have to think about the best way to do that. If we tell people what we do not want them to do, they think that is perhaps what they should do. That is why working through professionals is really important. We must involve the Irish Pharmacy Union, IPU, and the ICGP so that the local community pharmacist is able to discern the real situation and tell clients what it is. We will be doing more and more of that.

The point about medicine shortages already being a feature is absolutely correct. There are 45 medicines on a current list at the moment, but with the HPRA and stakeholders we have put a medicine shortage framework in place to address those. The last thing we want to happen - but which probably will happen in the period ahead - is that shortages in the near future will be blamed on Brexit. There is every chance that the problem will be due to a manufacturing issue or an issue that has arisen for a completely different reason. We must remain clear on what the source of the delays is and to work with stakeholders to explain it, while not allowing erroneous information to make its way into our system.

I will ask Mr. Swords or the HPRA to talk about the critical medicines assessment process, but we are interested in building on the overall message we have received from manufacturers and wholesalers that there is a plan for this and that there is a sufficient amount of medicine.

In the case of medicines where, because of their characteristics there could be a critical issue if they were not available, we want an additional layer of verification. We are doing that by category. It is important that one has a medicine within the category one would be able to prescribe in that situation. There would be some interchangeability. The health professionals are doing this. Doctors, through clinical programmes, and pharmacists are identifying, say, four medicines of which we need a supply. If there was a problem with one, we would still be okay with the other three. That involves more detailed conversations where one is looking for an additional layer of reassurance and verification. We are going through this process. It is not completed and we will keep refreshing it as we go along.

The important point is that just because a medicine is critical, does not mean that it is one about which we are concerned. It could be critical in coming directly to Ireland from the Continent and there could be no disruption. It could have features to it which mean even a short delay of a week or two might not impact our supply. We must not just examine ones that are critical but also examine the current supply chain. That is the level of analysis we are bringing to bear on this.

I am not certain if the travel vaccination is in this process. It is probably in the more general process of checking levels and working with manufacturers.

It is not just about medicines which end up in hospitals but those that the public will need. That includes medicines dispensed through retail pharmacy and prescribed by GPs. We have to take a public health view of this, not just looking at the ones which we order. We have to understand that some medicines will be critical but will be dispensed in the community. They can be just as important as medicines dispensed in hospitals.

Deputy Louise O'Reilly

The reason I was late was I was on the picket line with the nurses this morning showing solidarity in the same way as I would with any public sector worker or civil servant fighting for his or her rights and entitlements. I read through the submissions and I apologise for being late.

The evidence suggests there is a struggle to recruit nurses and other healthcare professionals. Is there any sense within the groups working on this that Brexit will have a negative or positive impact on the health sector workforce? Much work has been done, which is welcome. We had an engagement previously where the same level of work or engagement was not obvious. Is someone examining the implication for workforce planning? There is mutual recognition of qualifications which has been discussed previously. My sense is that the British health service has aggressively recruited staff because it has a fear of the implications of Brexit for its staffing numbers. Is this being countered?

It was stated in the submissions that the HSE is continuing to work on awareness of Brexit among HSE and health service staff generally, key suppliers, patients and with the public. I appreciate the dilemma because we do not want to panic people. We have been focused on Brexit for a long time. However, more people are beginning to focus their attention on it and they are concerned. I have spoken to people who are nervous and asking whether they should get a six months supply with their next prescription. There will be an issue if everybody starts stockpiling. I respect it can be tricky but has any consideration been given to a media campaign? It should be more than just talking to the professionals and somewhere along the lines of radio, television or newspaper advertisements.

The Department stated it would be impossible in a no-deal scenario to maintain the current seamless arrangements between the EU and the UK across a range of sectors that are currently facilitated by our common EU membership. There is no such thing as a good Brexit. We said this repeatedly and nobody majority on the island voted for it. However, we are where we are. In the event of a no-deal scenario, where will the first implications hit? Will there be a requirement at that stage for legislative change or will it have to come in advance of that?

Last weekend, I attended a conference in Belfast and was also at the Border Communities against Brexit protest, where people asked me about cross-Border health services. For example, GP out-of-hours services operate between Keady and Castleblayney, and Altnagelvin and Inishowen. They work well because they are geographically close. In the event of a no-deal Brexit, will these services continue? Is it anticipated that there will be a break in some services while alternative arrangements are made? I recognise it is not the fault of any person in this room that we find ourselves where we are. However, is it anticipated that there will be a break and then it will be necessary to restore those services or is it anticipated that services will continue seamlessly?

I asked if service level agreements had been Brexit-proofed at a previous committee meeting. It was a year ago and the answer was, "We did not know". I appreciate that at that stage nobody could have predicted how this would go. The level of unpreparedness in Britain and its impact on us is a concerns. It is clear that while we could do all the work to prepare ourselves, we are geographically close to people who may undo any good work that might be done.

Mr. Jim Breslin

It is not anticipated that there will be any break in services. We have confidence in that. Mr. John Hennessy has spoken about the Brexit-proofing of service level agreements, which has been completed. He spoke about co-operation and working together, CAWT, because some of those arrangements are under a co-operation mechanism which we have. We are not anticipating anything in that regard.

I noted early in the meeting that The Times Ireland edition jumped from a general statement about Brexit at large to Secretary General says medicines will be okay but cross-Border services are going to be impacted. I did not say that.

Deputy Louise O'Reilly

That clarification is welcome but it underlines the need for a media awareness campaign. I also read that article and it was not correct.

Mr. Jim Breslin

When I talked about the impact across sectors – some of the discussion has highlighted some of the areas - there are things which are currently automatic but will not be when the UK becomes a third country.

We have had two examples so far. One is in the area of food safety. When product is moving east-west at the moment, it is moving within the EU. If the UK crashes out, when product moves east-west, it will be coming from a third country and there will have to be a risk-based decision as to whether the documentation is pulled and there is a physical inspection. We are putting 61 staff into the HSE to do that. We are spending €6 million on staff. If we could have that €6 million to spend on patient care, I would much prefer it, but because Brexit is happening, that is what we are doing. Going from a situation that was seamless to one in which we have administrative overhead is an example of the impact Brexit has on this country and on the UK.

The Deputy referred to professional qualifications that are currently automatic. We will have a procedure that makes it smooth and seamless but it will require an extra procedure. It will not delay things, but while recognition of EU qualifications is automatic, we will have to have a means of saying we understand the standard of a UK qualification and will have to apply our system to recognise it here. It is an extra layer that will have to be built in.

On the question of awareness, we are actively considering our communications strategy. We are working through intermediaries, particularly health professionals, general practitioners and pharmacists, as well as patient groups. Mr. Hennessy can speak on that. There are particular patient groups that would have particular anxiety. If we can give them information, they will be able to talk to their membership as well. The Deputy asked about the content and timing. We are actively considering pushing messaging out in a more visible, public way.

Deputy Louise O'Reilly

Yes. I do appreciate that it has to be balanced but it is something that cannot be ruled out at this stage. Anecdotally, I have spoken to people who are planning to get a few extra just in case. It is a question of putting people's minds at rest and assuring them there is no need to do that, and that if they do it, they will contribute to the problem rather than it being any solution.

Mr. Jim Breslin

Mr. Goodman has reminded me about the question of legislation. The Bill whose heads were published is to be introduced before a no-deal crash out, which we hope will not happen. That is subject to drafting and bringing the Bill through the Oireachtas. The intention is that the legislation, which would sit above what we have talked about and would allow for the HSE to reimburse services in the UK that are treating Irish patients, for example, would go through before 29 March.

On workforce, there is a degree of speculation and it is not going to impact us immediately in April. However, it will potentially change the global attractiveness of the UK. One of the things that may happen is that professionals who are trained elsewhere in the EU may no longer find it attractive to go to the UK. The UK is seized of that. They may then find themselves running into shortages in the UK. They are just as worried about non-professionally qualified healthcare staff such as cleaners, porters and other staff. There may well be shortages in those areas because traditionally a lot of those posts have been filled by foreign nationals in the UK. They may respond to that by looking for English-speaking health professionals and targeting us. Equally, we would be more attractive in that situation because EU-qualified professionals who want to come to an English-speaking country will no longer have the UK to go to and may be interested in Ireland. It is push and pull and it is hard to speculate. We are working on getting the professional recognitions in place that would allow us to be able to move in the event of any patterns that develop.

Mr. John Hennessy

I have just a couple of points to add. I will ask Ms Keon to speak on the North-South dimension because she has been very close to Brexit-proofing the agreements between the various providers. We mentioned some of them but the Deputy is right that the GP out of hours service is an important part of that programme as well. We have been very conscious of the need for clear, reliable information for the public and for patients. The committee is going to see evidence of a lot more proactive communication from this end over the next four to six weeks. It has already kicked off with some stakeholders in respect of suppliers. We are meeting the National Patients Forum, which has representation from most of the patient advocacy groups, especially those representing people with chronic conditions. We are meeting it next week to provide information and assurance where necessary on particular issues like medicines and supplies. We understand fully how people would be concerned about those things, and with the benefit of good, reliable information, we may be able to prevent the kind of stockpiling tendencies to which the Deputy referred. We are watching closely at the supplier end as well to see if there are any unusual patterns of ordering from any particular sources. Included in that programme of communication, as Senator Swanick mentioned, would be general practitioners, pharmacists and prescribers generally to help assure people about supply chains and to try to manage it.

The Secretary General has covered most of the workforce issues. The HSE HR department has analysed in great detail the Brexit details across the spectrum of qualifications, training, education and recruitment. We have a good handle on the implications there.

Ms Paula Keon

The Deputy is correct about the GP out of hours service. It is a very important part and I will get to it in a minute. In fact, there have been 30 years of intensive cross-Border work between North and South. For those of us who live on the Border, it is very much the norm to get a service in the other jurisdiction. Since 1992 there has been a formal arrangement, the Ballyconnell agreement, whereby services North and South set up the cross-Border organisation, Co-operation and Working Together, CAWT. That was done largely using European INTERREG funding to seed projects North and South to use economies of scale and find solutions that we could not otherwise find because of our geographic distance from the urban centres. To Brexit-proof our current range of work, which is an INTERREG 5A €30 million project, we have it underpinned by Her Majesty's Treasury. With the Department of Health, we went to the UK to seek assurance that the current round of funding will be secured until the end of the programme of funding in 2020. The future of European funding is obviously uncertain and probably part of the future arrangements. We will have to see what happens there. The current round of funding that seeds these projects is underpinned.

Outside the INTERREG funding there is a lot of North-South work going on. The radiotherapy centre is very innovative and the only capital build in health on the island of Ireland with a ratio of two thirds to one third built and the same in respect of patients. A second one is the primary percutaneous coronary intervention, PCI, which is clinically absolutely the solution for the patients of Donegal. They only have a 90 minute window for their stents. It is absolutely the solution for our patients. We did a mapping exercise to look at all these service-level agreements and memorandums of understanding, including the ambulance service and GP out of hours service, which was the solution for 243 patients in 2018, as was noted earlier. We have all of those mapped and they are underpinned by the common travel area. As Mr. Breslin said, it is not anticipated that there would be any break in service on day one.

Deputy Louise O'Reilly

Ms Keon mentioned the INTERREG funding for CAWT. I am very familiar with that organisation and its work. How long is the current round of funding to last?

Ms Paula Keon

That funding covers up to 2021.

Mr. Jim Breslin

From the publications released by the Commission in December 2018, we know that there is recognition of the importance of those funds in Brussels. As has just been said, there is a commitment to continue with the current programme but the importance of building upon it is also being looked at. Even in the context of no deal, I do not believe that Brussels will say that it is over with. The UK authorities and ourselves are certainly committed to trying to continue with co-operation.

Deputy Kate O'Connell

I thank the witnesses. It is nice to see Mr. Breslin again. I want to take up a few issues regarding the reality of the situation. Deputy O'Reilly mentioned the anecdotal evidence. My understanding is that people on the ground, and older people in particular, are stockpiling drugs, especially drugs with narrow therapeutic indexes and so on. In the event that a GP has run off a six-month GMS prescription form and it is legally presented to a pharmacy which has stock on the shelf, Mr. Breslin will understand the conundrum of a pharmacist who is faced with a person who is concerned about the future. Perhaps the person gets his or her news from Sky rather than the BBC or something else might feed his or her fears. My understanding is that people on the ground are stockpiling and I am concerned about that. I am sorry for being late, but I have heard various reports that we have approximately ten to 12 weeks of headroom in the supply chain for medication. If people are getting six months' worth of prescriptions, that headroom will be depleted.

Often when a product is in short supply or is controlled, there is a limit to the number of packs a retail pharmacy can acquire in a month. I assume somebody puts something into a computer and once a business has its 20 packs, it gets no more. Has the Department imposed or considered imposing anything like that? Has it considered limiting the monthly orders of retail pharmacies dealing with one of the big suppliers to 1.2 or 1.1 times what they ordered in the previous month?

There has been talk of a media campaign. I urge caution in that regard because when one tells people not to stockpile, the first thing they do is get a truck and fill it full of tablets. That is the nature of people and the survival instinct. When it comes to supply issues, some of the products we get in through the UK include bespoke feed bags, total parenteral nutrition, TPN, and specials. In this committee and within my own party I have heard conversations about how the Department has engaged with the manufacturers. My understanding is that approximately 80% of some types of TPN comes from one place in the UK. Are we sure that, if there is no deal and the UK crashes out on 29 March, we will be able to feed those people in April? Do we have the capacity to supply ourselves as a stop-gap? Does the Department have something in place so that somebody waiting for their nutrition in one of our acute hospitals will not be left hungry?

Regarding the marketing authorisations and dual labelling arrangements we have with the UK - and Dr. Nolan might be the expert on this - my understanding is that we have piggybacked on the UK for a long time in respect of packaging. Most marketing authorisations are authorised through the UK where the qualified person, QP, is domiciled in the UK. If there is a hard Brexit and the UK is not in the EU any more, the QPs who are authorising medications and who are responsible for pharmacovigilance will no longer be allowed to sign off because they will not be domiciled within the EU. This leads to a conundrum where we speak English and nobody else does. Are there provisions in this regard in the event of a no-deal Brexit? Have we spoken to the Dutch or other friendly countries which might print the other side of their information leaflets in English? Is there something in place to deal with the fact that we are piggybacking on the QPs in the UK, which may no longer be possible?

As a UK graduate, I am interested in professional qualifications. The witnesses have said there will be an additional layer, but that assumes that the standards will stay the same. With respect, that is only a short-term solution. With regard to people who have graduated recently, it is unlikely that the UK will have allowed standards to fall too far by summer, but theoretically we can only add in that layer if there is alignment of standards. Is there any plan for what happens thereafter? I know we are talking about things that could happen based on whatever happens across the water.

Mr. Jim Breslin

I will start with the Deputy's final question. We touched on the recognition of qualifications earlier, but there is a risk of divergence. We have different scenarios. We have a regulator-to-regulator arrangement that will be in place in the context of no deal, which is based on the fact that we know the standards are currently equivalent. The most ideal scenario is an agreement to avoid no deal. The next most ideal is that, in the future relationship between the UK and EU, something is concluded on recognising qualifications between the EU and UK. That would be great. We would then be fairly close to where we started. In the event that the UK and Ireland have a bilateral arrangement, it will not be a bilateral arrangement so much as the two regulators understanding the qualifications in both jurisdictions and recognising them because they are equivalent. If UK standards were no longer equivalent, it would be an issue for both regulators. That will not happen by accident. The UK would have to decide that it wants its professionals to be different from those of the EU. That would be a big decision to be made in the UK. Our regulator would have to make the implications of such a move very clear and plan for it were it to happen. That is the same for the whole EU rule book. It is not just about professional qualifications. If the UK diverges from the EU in any element of standards, it will have implications for trade, movement and so on. It is a big policy question for people in Westminster who have a lot on their minds at the moment. If they got that freedom, how would they use it?

Moving on to the other areas, Dr. Nolan will certainly be able to talk on dual-labelling and marketing authorisation holders, MAHs. She may also be able to talk on the TPN. On shortages, it would helpful if the HPRA representatives talked about the medicines shortage framework. From the contact the HPRA and the HSE are having with wholesalers, we know that they are looking at ordering to ensure that there are no artificial reasons for products being taken down. They will continue to do that up to and beyond Brexit.

Dr. Lorraine Nolan

I will start where Mr. Breslin ended, which was on ordering, and work through questions in that way. Wholesalers have a process for putting stock in allocation when there is a concern in respect of supply and availability. As we work through and identify products that could be impacted - and we are not at that stage yet because we have not identified these products - those processes can be activated. That system of controlling what is supplied to pharmacies exists and can be activated and put in place.

I will start with the TPN and compounded products. The Deputy is right in that regard. We have identified these as a category of products in respect of which particular risks will arise from Brexit because many of them have short shelf lives and some have particular storage requirements that it may not be possible to fulfil if there are delays in getting imports in through the ports. We work with three TPN compounders and suppliers in the UK. We have engaged with these and with compounding companies based in Ireland. In all cases, the companies have told us that their Brexit planning is well developed. They have increased their stocks of component parts and are looking at the logistics of getting products into Ireland. Some of this is routed through the UK but the companies are looking at flying it into Ireland directly. We are engaging with them almost weekly to get updates in real time. It is an evolving situation. If we become aware of any concerns, we will take appropriate measures to address them.

We have not been informed of any concerns relating to those supplies.

The Deputy mentioned the conduct of regulatory activities, of which there are many because of the United Kingdom's history in pharmaceutical manufacturing, etc. These include specifically mentioned activities such as QP batch release and pharmacovigilance QP residing in the United Kingdom. Over the past two years, the regulatory system across the European network has been preparing widely for this and we have also been working with the companies. It is the case that the vast majority of companies have worked to transfer those activities into the other EU 27 member states. Some of that work, specifically in the area of quality control testing, for example, has been transferred to Ireland. Similar transfers have happened with the batch release activities and the QPV. We do not necessarily have any concerns about that.

Joint labelling has been an issue that we have been working extensively on, especially as 60% of the medicines supplied in Ireland have joint labels with the UK. Ms Purcell will speak a little on that. We have been exploring the possibilities of coming up with joint labelling with other EU member states and we have had quite extensive discussions with Scandinavian countries in that regard. There are associated challenges because the look and feel of products will change very much for both healthcare professionals and patients but it is something we are developing as a contingency.

Ms Rita Purcell

Deputy Kate O'Connell

I thank the witnesses.

Chairman

That concludes our hearing this morning. I thank from the HSE, Ms Paula Keon, Mr. John Hennessy and Mr. John Swords, from the Department of Health, Mr. Jim Breslin, Mr. Kieran Smyth and Mr. Fergal Goodman, and from the HPRA, Dr. Lorraine Nolan, Ms Rita Purcell and Dr. Caitríona Fisher. The meeting stands adjourned until next Wednesday morning when we will engage again with the Department of Health and the HSE on general matters. Is that agreed? Agreed.

The joint committee adjourned at 11.40 a.m. until 9 a.m. on Wednesday, 6 February 2019.

Joint Committee on Health díospóireacht - Wednesday, 30 Jan 2019

Implications for Health Sector of United Kingdom's Withdrawal from the EU: Discussion (Resumed)

Mr. Jim Breslin

Mr. John Hennessy

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Fergal Goodman

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. John Hennessy

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Dr. Lorraine Nolan

Dr. Lorraine Nolan

Mr. Jim Breslin

Mr. Jim Breslin

Dr. Lorraine Nolan

Dr. Lorraine Nolan

Mr. John Hennessy

Mr. John Hennessy

Mr. John Hennessy

Mr. John Swords

Mr. John Hennessy

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. Jim Breslin

Mr. John Hennessy

Ms Paula Keon

Ms Paula Keon

Mr. Jim Breslin

Mr. Jim Breslin

Dr. Lorraine Nolan

Ms Rita Purcell

Dr. Lorraine Nolan

Dr. Lorraine Nolan

Dr. Lorraine Nolan

Mr. Jim Breslin

Dr. Caitríona Fisher

Dr. Lorraine Nolan

Dr. Lorraine Nolan

Ms Rita Purcell

Joint Committee on Health díospóireacht -
Wednesday, 30 Jan 2019