I welcome the Minister of State to the House. Before I call on the first speaker I wish to welcome to the Visitor's Gallery Mr. Bobby Nealon from Virginia and Scranton. I think that is Scranton, Pennsylvania, the home place of former US President Joe Biden. Mr. Nealon is father to Annie, who is working as an intern with Senator Duffy. The family has strong Ballina and Mayo connections. You are most welcome to Seanad Éireann, Bobby.

I thank the Cathaoirleach for choosing the Commencement matter today and I also thank the Minister of State, Deputy Moran, for coming to the Chamber to deal with it, which I greatly appreciate. Today is such a lovely day. It is dry and the skies are blue and we would be forgiven for forgetting all about the really bad weather we had at the start of the year with all of the rain. There is something in us Irish that we tend to be positive and not to look back. However, it is really important that we set everything up and make plans for the potential risk of floods once again.

I want to talk particularly about Newbridge and what is happening there. During the recent floods we were not very badly affected but we were impacted. Four estates in particular were affected, namely, Raymonds Court, Roseberry Court, College Grove and Riverside Park, as well as the Liffey Linear Park, which nobody could use to walk. That park is a really special place in Newbridge for people who want to exercise and immerse themselves in nature but unfortunately it was closed during the floods. I want to give a shout out to the new area engineer in Newbridge, Mr. Carthac de Brí, who was absolutely excellent. Any time I contacted him on behalf of residents in terms of their fears, their need for sandbags and so on, he was absolutely on the ball. It gives great comfort when residents see that preparations are in place at council level.

In terms of the work that needs to be done by the Department, some work has already started on a number of schemes in Kildare. The scheme in Athy is nearly finished and in north Kildare a number of schemes are under way. While flood mapping published by the OPW confirms fluvial flood risk from the River Liffey, including from the Roseberry stream and the Great Connell stream, the biggest issue is actually the controlled discharge operations at Pollaphuca. These operations are managed by the ESB to regulate water levels. To be fair, I want to thank the ESB and its personnel who were at the end of the phone line any time that I contacted them during the flood period. A number of warnings were issued by the ESB about limited reservoir storage capacity during sustained rainfall, which could lead to increased downstream flood risk to both Newbridge and Clane if water had to be released. Newbridge was formally identified as being at risk of river flooding in national plans going back as far as 2018 so in that context, the planned works should be scheduled in the more immediate term. We have already waited eight years. Given the way climate change trends are going, there is also a need for improved monitoring. A number of councillors, including Councillor Robert Power and the mayor of Newbridge, Councillor Carmel Kelly, have called for electronic water level monitoring stations to be installed in Newbridge and Clane. The flood works are at development stage but are not yet at the construction phase.

When will we get a confirmed date for construction to commence?

I thank Senator O'Loughlin for raising this matter. I assure her that the OPW and Kildare County Council are committed to working in partnership to progress the flood relief measures. Throughout Kildare the OPW has completed four flood relief schemes which protect 110 properties against the risk of flooding. A further two flood relief schemes in Athy and Naas are at development and preliminary design stage. The Morell river flood management scheme is being progressed towards substantial completion. A further scheme in Leixlip to protect 60 properties is being led and progressed by the local authority, with funding provided by the OPW. Upon completion, these four schemes will give protection to 670 properties.

The OPW funds two engineering staff in Kildare County Council to support its delivery of the programme of schemes throughout the county. As it is not feasible to deliver all flood relief schemes concurrently due to constraints in specialised engineer skills in the OPW, local authorities and the consultancy market, the flood relief delivery programme was subdivided into two tranches, focusing initially on tranche one schemes and those already in the delivery pipeline. The prioritisation of the first tranche of the scheme was based on three criteria, including scale of projects, capacity to deliver a national programme and maximising the return on investment with reference to property numbers. Under the national programme, work has yet to commence on the design of 50 tranche two flood relief schemes. The flood relief scheme in Newbridge is part of the second tranche of flood relief schemes. It is anticipated this scheme will provide protection to up to 70 properties. The Government is committed to progressing these schemes under the national development plan.

The OPW is piloting a new delivery model of flood relief schemes through tranche two schemes in counties Kilkenny and Donegal. This is referred to as the tranche two pilot. The two tranche two pilot schemes in County Kilkenny are in Freshford and Piltown and in County Donegal they are in Donegal town and Letterkenny. The tranche two pilot is transferring the management of data gathering, as a first step in designing a scheme, from consultant engineers for a single scheme to the local authority for all schemes in the pilot. The pilot means that data gathering, where feasible, may be scaled up from individual communities to all schemes in a county. The pilot will then better inform the prioritisation of future schemes nationally and the scope of service required from consultants to design and facilitate the construction of flood relief schemes. The design of the schemes being delivered through this pilot is at an early stage of data collection to inform the appointment of engineering and environmental consultants.

Localised flooding issues are a matter in the first instance for each local authority to investigate and address. The minor flood mitigation works and coastal protection scheme was introduced by the OPW in 2009. The purpose of the scheme is to provide funding to local authorities to undertake minor flood mitigation works or studies to address localised flooding and coastal erosion problems in their administrative area. This scheme generally applies where a solution can be readily identified and achieved in a short timeframe. Funding of up to 90% of the cost is available subject to criteria. Applications are assessed by the OPW having regard to the economic, technical, social and environmental criteria of the scheme, including a cost-benefit ratio.

Recently I announced an increase in funding supports to be made available to local authorities under the minor flood scheme, including an increase in the upper minor works threshold from €750,000 to €2 million. Details of these revisions to the scheme will be made available to local authorities shortly. Since 2009 the OPW has approved funding under the minor flood mitigation works and coastal protection scheme of approximately €1.8 million to Kildare for seven projects.

Sula dtéim ar aghaidh, cuirim fáilte roimh na cuairteoirí atá sa Ghailearaí inniu, atá istigh leis an OPLA. Gabhaim buíochas leo as ucht teacht isteach.

I acknowledge the OPW is funding two engineering staff in Kildare County Council to support delivery throughout the county. I accept it is not feasible to deliver all flood relief schemes concurrently due to constraints in relation to personnel, etc. However, I was very clear that I was looking for a timeline for Newbridge and the Minister of State did not give me this in his response.

I ask him for that. I acknowledge he is saying the Government is committed to progressing the schemes under the NDP. I also mentioned the monitoring and that is really important in regard to giving real-time river levels and acknowledging that the long-term hydrological data help inform future flood risk management measures.

They are the two questions I am coming back to the Minister of State with. They are around the timeline for Newbridge - particularly for those estates and the walk along the Liffey Linear Park - and on the monitoring, which is hugely important and I know that all Kildare county councillors support me on that.

Sula dtéimid ar aghaidh, tá vóta tar éis a bheith glaoite sa Dáil. A vote has been called in the Dáil. It has just been called if the Minister of State wants to wrap this up for a minute.

We have a pairing arrangement.

The Minister of State has a pairing arrangement.

Yes, okay.

I thank Senator O'Loughlin. She has been on to me a lot in relation to the issues in Kildare and I appreciate the work she is doing to help with what I am trying to do. I did outline to her that the pilot scheme is there but I have also said that the minor works are a way forward. Interim and short-term measures play into the long-term solution. I have been doing this up and down the country. I appeal to the Senator again to go back to the local authorities, where interim works can be carried out to mitigate against flooding, particularly in the context of what we have seen with climate change and the areas the Senator mentioned. I appeal to her to go to the local authorities. I have met, I think, eight local authorities in the past two days and I have been pushing them in that direction. The long-term scheme, particularly the scheme the Senator is talking about, is down the track. It will not happen today or tomorrow. That scheme is made available to the local authorities. The change I have made to that scheme in going from €750,000 to €2 million is significant and that is for the local authorities.

I want to praise, as the Senator rightly said, the engineer and the local authorities. I have been working closely with every local authority, including Kildare. I met some of the team recently. It is not that I have not been aware of the issues there; I am quite clear on them. As regards the measures the Senator talked about, they will be looked at by me and Kildare County Council in the short term.

I thank the Minister of State. I appreciate it.

Cuirim fáilte roimh an Aire Stáit, an Teachta O'Sullivan.

I welcome the Minister of State here again and thank him for coming to the House to address my Commencement matter. It asks for the Minister to confirm the nature of the Government's proposed review of legislation that established the electoral mayoralty of Limerick, and to make a statement on same.

To give the Minister of State a bit of background, I say that because there has been a lot of commentary about the Mayor of Limerick. It is also important to make the point at the very outset that on 24 May 2019, voters in Limerick approved a plebiscite supporting the creation of a directly elected mayor with executive functions for Limerick City and County Councils. That was a historic vote and day in local democracy and local government, and for Limerick because Limerick was, after all, the first in Ireland to approve a mayor with executive powers, initiating a process of legislation, reform and implementation.

I salute the Mayor, John Moran, a man of vast expertise and experience. He will say himself, as do the city and county councillors of Limerick, that there were always going to be challenges and difficulties. When you map out and scope out a vision and plan for local government, we cannot compare ourselves with any other local government structure or form across Europe. Of course, the long question always remains around us never having local government if we do not devolve powers from central government. We have, effectively, a local administration and I think, having read, followed and engaged with the city and county councillors of Limerick - which I do extensively - there are challenges but nothing that cannot be overcome. I want to recognise the enormous work that John Moran, as Mayor, has done there. He could have been in many things. He was in the Department of Finance. He brings a vast wealth of experience plus commercial aspects to the job. The various issues that may be challenging are not insurmountable. They can be dealt with.

John Moran went on to become the first directly elected Mayor for the county. Remember, he received 22.9% of the first preference votes and was, therefore, democratically elected Mayor of Limerick City and County Council in 2024.

That is the background.

We are now reading in the newspapers that the Government is going to carry out some sort of review. I welcome a review. I am sure the Mayor and the councillors welcome a review. Everyone welcomes a review. Over the past few days, we read that the Tánaiste was down in Cork and talked about the Minister of State's native city and the Cork city task force. This is great. We are going to see a task force on local government there, which is fantastic. We know Dublin city rejected the proposition of a directly elected mayor when it was put to it. That may be put to it again in another plebiscite or referendum. In the Dublin city task force, we talked about public services; community health; business and unions; arts, culture and tourism; private sector architecture; urban design; planning and all the things that go with local government and local democracy.

It is an exciting time for local government. We know that this week, the national task force on local government already signed off on this report last week and will be delivering it to the Department and the Minister tomorrow - Wednesday. Let us be clear and let us not have any ambiguity. Of course, we look forward to discussing issues around that but that is for another day.

Addressing this issue would be helpful for the people of Limerick and the staff of the city and county council. I acknowledge the director general of the council - he is the only director general of a local authority - and the challenges in his work. Wherever there is change and reform, with regard to the chief executive and the Mayor, there will be tensions and a bulwark for tensions but that is a good thing. It is not a bad thing so I would be interested in hearing what the Minister of State has to say.

Senator Boyhan has given a very level-headed and fair assessment of how the Limerick mayor is working out. Of course, it was never going to be without issues and was never going to go 100% smoothly. I spent 13 years on a local authority and one gripe we always had was that the chief executive was not directly elected and we were the ones who had to face the people and face the music on a five-year term. This was a response to that so I appreciate the Senator's assessment of it.

I will give the substantive response and touch on the review later. The Local Government (Mayor of Limerick) and Miscellaneous Provisions Act 2024 gives effect to the 2019 plebiscite where the people of Limerick voted to have a directly elected mayor. The legislation replaces the previous two-pillar structure with the elected council and the chief executive performing the functions of Limerick City and County Council with a three-pillar structure of the elected council, the Mayor and the director general, who was formerly the chief executive. The legislation makes no change to the primacy of the elected council, which retains all of its reserved functions. Under statute, it continues to govern the work of Limerick City and County Council and oversee the performance of the executive, including the Mayor.

The Príomh Chomhairleoir is a new role established by the 2024 Act and is held by a councillor, who chairs council meetings and is selected by the council each year. The Mayor serves a five-year term and is responsible for the functions outside the council chamber that were previously performed by the cathaoirleach, including the important representative role for Limerick.

The Mayor has new functions assigned under the Act, including preparing a mayoral programme as well as responsibility for strategic and policy functions previously carried out by the chief executive. These functions include proposing the annual budget and the corporate plan to the council, which has the final decision-making role by accepting them with or without amendments; strategic development, including proposing the development plan, which is a matter for the plenary council to agree; housing and building strategy, including proposing the housing strategy for approval as part of the development plan; road transport and safety; and environmental services.

Under the Act, the Mayor is an ex officio member of the council with similar rights, responsibilities and duties to other members. The director general is responsible for supporting the Mayor and the council in their roles, the day-to-day operations of the council and specific executive functions. These functions include staffing and human resources, the role of Accounting Officer and administering schemes, grants and enforcement.

The legislation is clear in its design of the roles of Mayor, Príomh Chomhairleoir and director general while preserving the democratic role of the elected members of the council. It mirrors the intention of the detailed policy proposals put before the people of Limerick in the 2019 plebiscite and reflects the recommendations of the independent implementation advisory group on the design of the mayoral office. Importantly, the legislation provides that the Minister will conduct a review of its operation and effectiveness not later than three years after the establishment of the mayoral office, that is, by mid-2027. This timeframe was viewed as an appropriate balance between assessing the new office in a timely way while also allowing time for the new arrangements to bed down.

As part of the review, the Minister shall consult with the Mayor, Limerick City and County Council, the consultative forum and other appropriate people. On the completion of the review, the Minister shall make a report to each House of the Oireachtas on its findings.

The review will commence in mid-2027, and there will be full consultation. I thank the Senator for his fair and level-headed assessment of this new ground of having a directly elected mayor and allowing that person to represent, in the best possible way, the people of Limerick and to take the appropriate steps to ensure that the city and county drive forward. I appreciate the Senator raising the matter. I hope I have given him enough detail on how the review will work.

The Minister of State has given more than enough detail. He said the review will take place in 2027 and that it will engage with the councils, which is important, various stakeholders, which is also important - I am glad it was confirmed - the consultative forum and other appropriate people. On completion of the review, the Minister will consider the report and make it available to both Houses of the Oireachtas. What more could you ask for? I thank the Minister of State. This will provide greater clarity and certainty to the elected members about what will actually be happening as opposed to what they are reading.

I will finish by wishing the Department, the Minister and the two other Ministers of State in the Department continued success with their work. The local democracy task force will be with them tomorrow. Ultimately, it will be a matter for the Minister to consider. The report will be submitted to the Minister and he will bring it to the Government. I hope there will not be a long delay. There is no point in just having a report. I understand that there is a suite of recommendations attached to this report. We need to see those implemented. The faster that happens, the better.

The Senator referred to the local democracy task force. I absolutely agree that its findings and recommendations have to be taken seriously. Local government is important, but it is not perfect. The Senator represents councillors and talks to them on a daily basis. He will know that there is often frustration about reserved functions and that councillors sometimes feel helpless. I felt I could get more done in the council than I can get done here, but that is a different matter.

Up here is the problem, not Cork.

We will have a review of the Oireachtas as well while we are at it. The Senator is 100% right. It will be interesting to see those findings. I assume that the findings and learnings about how the position of democratically elected Mayor of Limerick is working out will be worked in. It will be interesting to see what direction is taken.

With the permission of the House, I will give a minute of my time to Senator Gallagher.

Is that agreed? Agreed.

I congratulate the local volunteers involved in Croílar na nDrumlíní and thank them for their work. They are involved in trying to get a resource house for Cootehill. Notable among them are Dr. Fiona O Hé and Ms Kerry Mullen. I thank them for their work. I also thank my colleague Councillor Carmel Brady for her advocacy in this area. She contacted me about the matter as late as yesterday. I grew up in the Cootehill area. I spent a lot of my youth there and I went to school there. As a result, I have a passionate interest in this matter. I welcome the Minister of State.

When the group to which I refer got together to do this, it developed a target area or an operational area for the resource house to serve - basically, a natural community area. The group carried out research and found a number of things. It found that there was a deprivation score as low as 29.54 in the area.

Technical people will know what that means. One third of the population has primary education only. At the time of research, less than 9% had third level education. It has the oldest age profile of any settlement larger than 500 in the country. That is a very specific issue. I am saddened to say that child welfare referrals and substance abuse are at the highest level in Cavan and Monaghan in the area of Cootehill. Suicide rates are double those in other areas. The housing assistance payment, HAP, in the private rental sector is very strong. That is the need that is there for our family resource house. There is Hub Muinchille on a site there. It is a little group doing volunteer family support work and social inclusion work inasmuch as it can.

In 2019, the group in question got a survey done with LEADER funding. In that survey, five things were established. First, there was a lack of investment in community resources in Cootehill. Second, there was a lack of feeling accepted and respected in their own community. People felt that they were not getting their fair share of things. Third, not being able to access needed services was a real issue for people. This is empirical research. Fourth, there was a lack of support networks to help them with their problems and difficulties. Fifth, there was an absence of ability to feel safe in the community. All of that is quite distressing.

A number of other things are important. There is an available and suitable premises in the Hub Muinchille in what was the Bank of Ireland building there. It is a suitable legal entity. There is support from all the relevant agencies, including the children and young people’s services committee, CYPSC, Cavan County Council and Cavan County Local Development, CCLD. There is cross-community support. A drop-in centre that supported people in getting what they needed is very necessary in Cootehill and would serve a great purpose.

The Minister of State is very welcome to the House. I thank my learned colleague, Senator Joe O'Reilly, for sharing his time on this very important issue for the people of Cootehill. I thank Dr. Fiona O'Hanlon, Claire and Ms Kerry Mullen for their great work in Croílár na Drumlíní in Cootehill. They do an awful lot of volunteer work. They do excellent work for people of Cootehill and, indeed, the wider area. The one thing they are missing is a family resource centre base. They were disappointed the last time out when they were not successful. We are hopeful again that a new stream of funding will be made available in the budget later on in the year when they will have an opportunity to go again.

We are fortunate to have a very successful family resource in Monaghan in Teach na nDaoine, one in Clones, one in Cavan town and one in Killashandra. I gladly report that one is on its way to Carrickmacross.

As outlined by my colleague, the need is very much there. We sincerely hope that they will be successful next time around. We had a very successful meeting today with the Minister, Deputy Foley, where we outlined the case. They did an excellent job of doing so. I am delighted to hear the Minister of State's response this afternoon.

I thank Senator O'Reilly for raising this issue, which I know is very close to his heart as a man from Cootehill. This is something that he sees on the ground day in and day out and he fully understands the need here. It is great to see such cross-party co-operation in the interests of local democracy and shared local community. I thank Senator Gallagher for his comments on the matter.

I am taking this matter on behalf of the Minister, Norma Foley. She informed me earlier today that she had met both Senators and the fantastic volunteers involved in this fantastic local initiative. It is great to hear that Councillor Carmel Brady is involved in the campaign.

Senator O'Reilly put it very well when he spoke about the deprivation index of the area and how great a need there was. The survey results that have been gone through are backing up what the Senator said. It is encouraging to hear about a suitable venue and support on the ground from local agencies.

In terms of the expansion of the family resource centre programme, this is the latest in a number of very positive developments for the programme over the last few years. There is a programme for Government commitment to increase funding and to expand the capacity and network of family resource centres. This year's budget honours that commitment, with funding secured for a further ten family resource centres. This will bring the family resource centre membership up to 136 this year. That expansion follows the increase in the programme by five members last year, when funding was secured as part of the 2025 budget. This was the first such expansion since 2018. The programme expanded by five last year and 15 this year.

The commissioning of new family resource centres is an operational matter for Tusla, the Child and Family Agency. It is responsible for the day-to-day administration of the family resource centre programme. To be clear, neither the Minister nor the Department have had any involvement in the assessment process for new members of the family resource centre programme or in selecting new programme members, and therefore cannot comment on any particular application.

A comprehensive national application and assessment process was undertaken in 2025, which was led by Tusla and independently chaired by a representative of the University of Limerick. All applications were reviewed and scored against clearly defined and published criteria, including population need, level of deprivation, child population data, existing service provision and existing service gaps. Decisions on the successful services were made by the assessment panel. This process was outlined in the Tusla outcome letters that issued to all applicants. A total of 49 organisations applied for membership of the family resource centre programme, following an open call from Tusla for applications to join the programme. This shows a strong level of interest in communities around the country in having family resource centres as part of their community infrastructure.

I understand that Tusla was very impressed with the level of interest in joining the programme, and with the quality of the applications received. Regrettably, funding only allowed for 15 new members to be selected from the 49 organisations that applied, leaving 34 applications unsuccessful. I thank those organisations for their interest in joining the programme and for the important work they continue to do day in and day out.

The benefits of community-based services such as family resource centres cannot be overstated. Many of us will have witnessed first-hand the impacts that family resource centres have on the communities they operate in and the communities and families they support. They engage with vulnerable families, offer services to individuals across the whole life cycle from early years to senior citizens and, crucially, foster a positive and inclusive community spirit. The range of services they provide can be extensive, determined by the needs of the relevant communities. It is particularly important to note that many services are delivered at no cost or low cost to families, who otherwise might not be able to access them. Also, by availing of funding schemes operated by other Government Departments and agencies, there is great potential for family resource centres to grow their scope and reach, and further embed themselves in their communities, and that is what we wish to do in government.

I thank the Minister of State for acknowledging that I have been discussing this issue with her personally and writing to her on this subject over some time. I also appreciate her acknowledgement of the need in this regard. In the minute I have, I want to say to the Minister of State that I would like to hear a concluding remark from her to say that the real need that is in Cootehill will be brought to the decision-making table on the next occasion.

Let us assume the funding will be there, because if it is not, then the Minister of State cannot do it. I cannot see that this real, crying need in Cootehill could be rivalled elsewhere. The need for a family resource centre is there. It would be a place where people could drop in, get a form filled, get counselling, chat and find companionship. It will be just what it is called: a resource house for the community, and a home-from-home where people can pop in. The proposed site is very well situated in the centre of the town. It is a very fine building. This would be exciting for Cootehill, and I would be delighted to invite the Minister of State and the Minister, Deputy Foley, down for the day, if the Minister of State can give me the commitment.

I thank Senator O'Reilly for his fantastic advocacy on this issue, which I know is so important to him and his constituents. The next step is to make sure we can secure funding for the continued expansion of this scheme. The step after that would be for Cootehill, and others in this boat, to apply for any such new scheme that may come in. I suppose the exact same requirements will be looked at.

I reiterate that it is a comprehensive national application and assessment process.

It is led by Tusla and is independently verified and independently chaired. Applications are reviewed and scored against clearly defined and already published criteria. Population need, level of deprivation, child population data, existing service provision and existing service gaps are all part of that picture. The Senator clearly outlined that he feels Cootehill absolutely fits those criteria. Unfortunately, there may be plenty of other places that fit those criteria, so it is important the next application deals in particular with those-----

I do not think Cootehill will be rivalled.

I hope the Senator is right.

While no additional funding is available for this year, the Minister intends to continue to pursue the expansion of the programme through the budgetary process in line with the programme for Government. If successful in securing funds for future expansion of the family resource centre programme, a new call for applications will be launched to ensure all existing and newly interested locations can apply. I understand that Tusla, over the coming months, will be in contact with organisations whose applications were unsuccessful as part of this call, and that Tusla intends to engage with any parties interested in applying for potential future open calls for applications. I encourage both Senators to ask people to engage with Tusla on this matter.

Gabhaim buíochas leis an Aire as teacht chuig an Seanad inniu. I welcome her to Seanad Éireann. As she may be aware - I know she is because she put up a video on social media - last Saturday, 28 February marked rare disease day. It was very welcome to see Leinster House lit up in the colours of blue, pink and green in acknowledgement of this important day. While we mark and acknowledge rare disease day, it must not be lost on us that such diseases are not in fact so rare. That is something the Minister has pointed out as well. When we look at them in their totality, it is estimated that approximately 300,000 people, or one in 17 of all people living in Ireland, are living with a rare disease, with a significant, long-lasting and all too often life-limiting impact on their lives and the lives of their families.

People living with such rare diseases are being subjected to unacceptable waiting times for access to European Medicines Agency, EMA, approved orphan medicines designed for rare diseases affecting fewer than one in 2,000 people, with the average delay between EMA approval and availability in Ireland being 710 days. This is time that people living with rare diseases, unfortunately, just do not have to spare. That is why I am requesting an update on the programme for Government commitment to a review of the drugs reimbursement process in line with the 2018 Oireachtas health committee report on evaluating orphan drugs and calling for this review to begin as soon as possible in order that we can deliver on improving access to these life-saving medicines within the lifetime of this Government.

The 2018 Oireachtas health committee report on evaluating orphan drugs specifically called for a review of the national drugs reimbursement process highlighting the need for legislative reform to improve the accessibility and timeliness of drug reimbursement decisions. Between 2020 and 2023, Ireland only reimbursed ten of 46 EMA-approved orphan medicines. The barriers these medicines face in getting approval include limited data availability and small sample sizes, among other technical challenges. However, these medicines are approved by the EMA and our European colleagues in Germany, North Macedonia, Cyprus, Austria and Switzerland. They are approving and funding such treatments in under 300 days on average, while Irish patients are waiting an average of 710 days for access to life-changing and often life-saving treatments, that is, of course, if they are approved for reimbursement at all.

I welcome the commitment from the Minister to supporting the new rare disease strategy, which is a welcome development that will support early intervention for many rare diseases, particularly expanding the use of the heel-prick test to screen for more diseases and maintaining a national rare disease register. However, while early identification is important, this must be coupled with additional support for reimbursing orphan medicine treatments. This is why I am calling for the Department of Health to begin the review, committed to in the programme for Government, of the national drugs reimbursement process. It should begin soon to ensure it can be front-loaded in the lifetime of this Government and that changes can be implemented in the Government's lifetime. While it is welcome that the new rare disease strategy has been published, I also ask the Minister to give an update on when the implementation oversight group for the rare disease strategy will be constituted.

This will show real commitment from the Department to the implementation of the rare disease strategy, reassuring people living with rare diseases that the Government is committed to supporting them in accessing the life-saving treatments they need. I hope the Minister will work to ensure this review of the drugs reimbursement process is commenced as soon as possible. Delaying the review any further will only add unnecessarily to the delays that people living with rare diseases already face when compared with our European neighbours. There is an opportunity for us to develop a new pathway for access to orphan medicines with this review so that people living with rare diseases can access treatments and in order that the reimbursement process is clearer, more predictable and in line with the guidance of the European Medicines Agency and our European colleagues.

Sula mbogaim ar aghaidh go dtí an Aire, cuirim fáilte roimh na cuairteoirí san Áiléar inniu ó Irish Countrywomen's Association, Marlay Guild. Tá míle fáilte rompu.

I thank Senator Ní Chuilinn for raising this important matter. Supporting those living with rare diseases is a priority for me as Minister and for the Oireachtas. It is important to remember that 300,000 people, as the Senator said, are living with a rare disease. While the disease may be rare, the fact of living with a rare disease is not. On foot of that, the national rare disease strategy was launched in August 2025. The Department of Health will now ensure its implementation and its vision to ensure that all people living with a rare disease have fair, equitable, inclusive, safe and cross-sectoral care throughout their journey. An implementation oversight group has been launched. It met in February and that implementation work is under way. Work has begun on planning for the 11 recommendations. As implementation of the strategy progresses, it is of course intended that patient representation will be a key feature and will be embedded in all structures.

I have a couple of updates on the pricing and reimbursement system. There has been dramatically increased resourcing across the pricing and reimbursement system, with 34 new people hired to work in it. That is essentially a doubling of that team, which is very important. There is also the development of a tracker to increase transparency. Since the negotiation of the agreements in principle on the supply and pricing of medicines with the Irish Pharmaceutical Healthcare Association and Medicines for Ireland, those agreements will commence this year and last until the end of 2029. Those agreements work alongside and indeed supersede some of the other work because they provide the commitment and structured process towards achieving a 180-day timeline for completing the health technology assessment and the reimbursement decisions. That is a significant change from the current waiting period.

It is important to remember that there has been an additional €158 million in funding in the past four years. We have delivered access to 250 new medicines in that time, about 110 of which were for cancer and 69 were for rare diseases. While we have allocated another €30 million in funding specifically for new medicines, at the moment we spend close to €4 billion every year on drugs. The pressure of that on our budget is significant. That is nearly €4 billion, which is more than twice the complete spend on the Department of Defence. The Department of justice spends €6 billion in the whole year for all the salaries of An Garda Síochána and the justice system in its entirety. That is to put the €4 billion in context. It is a very significant amount of money. What are we spending . that on? We are spending it on medication people get in hospital, that people get through their pharmacist that is paid for by the State. Even where a person pays €80 in the pharmacy, it is not that the drugs cost €80, it is that the State pays for the rest of it. Those are benefits to the taxpayer and to people living in Ireland in the healthcare system. The pricing is an important part of the reimbursement decisions that will ultimately have to be made in respect of rare disease drugs, as every other drug, and the State has to try to get the best value for money to continue to support as many people as possible within the budget, even though that budget is expanding.

It is also important to say that, as part of the framework agreements to which I referred, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of sandboxed early access for rare diseases. That is a proof of concept initiative. It aligns with the commitments in the programme for Government. In parallel, my officials have examined reimbursement systems throughout the European Union. They will bring forward further proposals in the coming months. Those mechanisms are quite complex and the potential impacts have to be considered carefully. I thank the Senator for giving me the opportunity to discuss the matter.

I know how busy the Minister is and I appreciate her coming to the Seanad today with that update.

The 180-day target is obviously a huge improvement on the 710 days, and even an improvement on European best practice. When does the Minister expect that to be met?

It is very easy for us to forget, when we are talking about these figures and price agreements, that a lot of the time we are talking about children, because a lot of rare diseases will present in childhood. The unpredictable nature of these reimbursement processes at times leads to conditions worsening in children and to unsettled times for families. It is important to remember that.

The Minister mentioned the rare diseases strategy. It is brilliant that the committee met in February, which is very recent. I thank the Minister for the update. There was disappointment to see very vague comments within the strategy in relation to access to orphan drugs. There was no mention of the reimbursement review, which is needed to identify the problems with the current criteria as they relate to orphan medicines.

With regard to the pricing agreement, the Minister mentioned the IPHA. I would point out that there are other industry stakeholders outside of the IPHA that have intimate knowledge of the reimbursement process given that their respective companies specifically and only manufacture and develop rare disease treatments. These stakeholders are very happy to discuss access to orphan medicines with Department stakeholders and the Minister. It is something to bear in mind.

Certainly, if it is a 180-day target, that is very positive. Does the Minister have any information on when that might be met?

The Department would always be happy to speak with any other parties in the pharmaceutical sector. It is important to point out that the 180-day period is for the decision from the application through the HTA process to reimbursement. I know there is a bit of a disconnect here. Because something has been EMA-approved, there is an assumption that that consideration is happening in the HSE. That only happens if the drug company makes an application in Ireland and that is not always the case for a lot of different reasons. For example, in addition to the commitment on pricing and reimbursement decisions within 180 days, the IPHA member companies will aim to shorten their timeline to submit reimbursement applications in Ireland to within six months of formal authorisation by the EMA. That is another important part of the timeline.

Again, the State will always have to be acutely conscious of the pricing decision and that pricing decision is going to come at an earlier stage. The State has to have the opportunity to negotiate on behalf of the State and the taxpayer to get the best value. We want to make sure we have access to many medications for all forms of disease, but especially rare diseases, as part of the rare disease strategy.

It is very important that I set those pieces out. It is for the company to make the application. It is for us to respond to that in an appropriate and timely way. There is a price calculation at the end of that. I have set out the broad budgetary parameters around what we are spending on drugs at the moment. Of course, there is not a single person in the Oireachtas who does not want to support every person in the State. I am simply setting out some of the realities around some of the decisions that will ultimately have to be made at a later stage.