I welcome the Minister, Deputy Calleary, to the House.
Nithe i dtosach suíonna - Commencement Matters
Community Development Projects
I thank the Minister for coming to discuss this all-important issue. In 2021, I organised a meeting of women's shed groups with his predecessor, Heather Humphreys, and they came from throughout the country. I did so because I was conscious that men's sheds are very well organised. They have a national forum and regional forums and are in receipt of funding. We gathered together to look at how we could set up a national forum for women's sheds because there are so many shed groups out there. I compliment both the men and the women on all the work they are doing. In some cases, it helps people with loneliness but it is also about collegiality and learning from one another.
I had been thinking about the recent funding of men's sheds before that meeting and asked myself how we could get women's sheds on the same stream to apply for funding. That is why I have put down this Commencement matter. Women's sheds have set up regional forums but they have not got a national forum. I would like to hear the Minister's thoughts about this and where we can go collectively to make sure that women's sheds have equal access to funding as men's sheds.
I thank the Senator for raising this important issue regarding Women's Sheds. I acknowledge the huge work she has put into this issue over many years and join her in acknowledging the fantastic work being done by women's and men's sheds throughout the country. This area of women's sheds is an important issue to many colleagues across government, in particular, the Minister, Deputy Foley, has been working strongly with me regarding women's sheds. As Senator Byrne said, women's sheds provide a space to women of all ages to come together regularly in a safe, comfortable, inclusive and collegiate environment.
Ireland has long been known for its strong sense of community. With one of the highest rates of volunteering in Europe, community groups play a vital role in people's lives, especially in rural areas. Beyond the social benefits, community involvement contributes to mental well-being, social connection and a sense of belonging. Women's sheds have emerged as an important part of the social inclusion landscape by providing a space where women of all ages and all backgrounds can meet regularly to share and learn new skills, work on meaningful projects, take part in activities, connect with their communities or, as Senator Byrne said, meet, have a chat and combat loneliness. Sheds are welcoming and supportive spaces, a place where women feel comfortable expressing their thoughts, sharing their experiences and, most importantly, connecting with each other. It is estimated there are now approximately 120 women's sheds across Ireland. The movement has been accelerating and gaining momentum in recent years. They have the potential to become even more powerful community hubs to promote lifelong learning, a strong support network and reduce isolation.
The programme for Government contains a commitment to continue to fund men's and women's sheds. As Senator Byrne said, I was delighted to announce last week, along with Minister of State, Deputy Buttimer, funding for the Irish Men's Sheds Association, which it will distribute to its member men's sheds throughout the country. Due to the women's sheds being a much newer type of organisation which is still in the early stages of getting structures and procedures in place, I was not able on this occasion to provide funding to women's sheds in a similar way.
I am, however, committed to working with women's sheds to help them on this journey. Last week, a representative from my office met with members of the women's sheds national forum in Athlone to start this progress. I am absolutely committed to supporting women's sheds to ensure they can benefit from having a strong national representative body to advocate on their behalf in order that they have the correct structures and procedures in place to allow my Department to engage with them on funding opportunities. I can confirm to the Senator that officials from my Department along with colleagues from the Department of Health will be meeting with members of the national forum of women's sheds in the coming weeks to discuss how they might be supported to grow the organisation. Both Minister of State, Deputy Buttimer, and I will be focused closely to ensure we have the development of a women's sheds network alongside its men's equivalent to get funding in place for the women's sheds.
I thank the Minister. This is a good news story because only during the week I received a phone call from the Limerick shed because they have a new management team. When they saw the funding, they were asking how they can go about applying for funding because everything costs money. I compliment the Minister on and thank him for being so committed to this. I look forward to working alongside him. I have a lot of contact with many of the sheds because, when we set it up, people contacted us. I have many contact details that I can check to see if it is okay to share with the Minister. It is a good news story. I am aware they have set up regional forums, so it is about creating that overall arching body soon. I look forward to working with the Minister into the future on this good news story.
I thank the Senator. I certainly will take her up on that offer. I will ask somebody from my office to engage with her. As I said, we have had meetings and both the Minister of State, Deputy Buttimer, and I will be having further meetings. In our Department, the Minister for Children, Equality, Disability, Integration and Youth, Deputy Foley, the Minister for Health, Deputy Carroll MacNeill, and the Minister of State, Deputy Murnane O'Connor, are focused on assisting. We will take the Senator up on her offer.
It is also worth noting, however, that there are other funding streams. Women's sheds are able to apply to the local enhancement programme, which will be worth €7 million in 2025, for running costs as well as small capital works. The Minister of State, Deputy Buttimer, and I will shortly be announcing the results of the local enhancement programme for 2025. SICAP supports women's sheds, and for major capital, LEADER is also available. I encourage every local shed to engage with its public participation network and its local development company.
I know we ask volunteers to do a lot. I really appreciate all those who take on the mantle of organising sheds. There are so many people who want them but not too many who are willing to take on the mantle of organising them. We are not insisting on the structure for the sake of it, but it is our experience that a national structure is a much more effective way of funding. It is not for the want of funding, but to get the structure in place. I look forward to working with Senator Byrne to do that.
As there is a vote in the Dáil, the Minister has to go. The Minister of State who is due in for the next Commencement matter has to go to vote as well. We will suspend the House for the duration of the vote.
Cuireadh an Seanad ar fionraí ar 2.45 p.m. agus cuireadh tús leis arís ar 2.57 p.m.
Sitting suspended at 2.45 p.m. and resumed at 2.57 p.m.
Medicinal Products
A clear commitment is made in the programme for Government, on page 90, to be specific, to ensure patients in Ireland have access to innovative medicines and treatments as swiftly and effectively as possible. Several steps were promised. We pledged to increased clinical trials and to better support clinicians, researchers and healthcare staff in these efforts. We committed to reviewing the drugs reimbursement process and implementing the Mazars review recommendations so that the entire approval pipeline would be properly resourced. We promised to explore early access schemes, particularly for rare diseases, and to strengthen co-ordination with European partners like the Benelux agreement to enhance our negotiating power and speed of access. We committed to investing in breakthrough treatments, especially for cancer and other major diseases, to improve patient outcomes and to reduce the burdens that delay places on lives and the healthcare system.
The Irish Pharmaceutical Healthcare Association published a position paper in February and I have read its findings. Under the health Act 2013, the HSE is legally obligated to make decisions on new medical reimbursements within 180 days, exclusive of clock stops. A clock stop, as we know, is when the HSE formally requests additional information, but when delays occur without formal written requests due to internal bottlenecks or other inefficiencies, those are not clock stops under the law. They are simply delays and patients pay the price.
Under the 2021 Irish Pharmaceutical Healthcare Association framework agreement, the HSE further committed to implementing reimbursement decisions within 45 days of approval. However, real-world experience shows a different picture. The corporate pharmaceutical unit, CPU, and the National Centre for Pharmacoeconomics, NCPE, play crucial roles in evaluating cost-effectiveness but this process can take up to a year, which is far too long when lives or quality of life are at stake. Families are waiting and in some cases, such as with Duvyzat, the wait is deeply painful. Duvyzat is a promising treatment that can slow the progression of Duchenne muscular dystrophy, a rare and devastating condition. It offers not just a treatment but a glimmer of hope, a chance at a better quality of life for patients and their families. Right now, however, those families in Ireland are receiving a substandard level of care compared with their counterparts in the UK, where Duvyzat is already available.
The European Medicines Agency, EMA, is expected to make a decision on marketing approval by June or July, yet unless our reimbursement scheme significantly accelerates, there is a real and urgent risk that Irish children will continue to suffer and deteriorate while waiting for access. I have seen at first hand the desperation and devastation the unavailability of Duvyzat has caused to little Archie Ennis and his family in Tallaght. I know that when the medicine is approved by the EMA, his family will be watching the clock on it becoming available in Ireland, as will I.
This is not solely a procedural issue. The impact of delays is significant. Disease progression leads to higher treatment costs, increased hospitalisations and avoidable suffering. Delayed access reduces health gains and can lead to lost quality-adjusted life years. It places a greater burden on the healthcare systems, requiring more long-term care and more intensive interventions, and ultimately, it creates an economic and emotional burden on patients and their families. The numbers tell the story. For orphan treatments, Ireland made nine medicines available in an average of 597 days, compared with 401 days in Scotland and a weighted European average of 403 days. This puts our system behind those of our European peers. Just 20% of all orphan drugs approved by the EMA are available in Ireland, as opposed to other countries such as the UK, which has access to more than 60% of all medicines approved by the EMA.
The Mazars review identified what patients of the industry already know, namely, that the reimbursement process in Ireland lacks transparency. Months can pass with no communication, visibility on timelines or clarity on the next steps. To address this, have the following reforms been considered: transparent indicative timelines for each stage of the reimbursement process, from rapid review to final HSE decision; structured accountability to ensure compliance with the 180-day statutory timeline; and clinician-led horizon scanning to prioritise high-impact new therapies and expedite submissions? Timely access to medications is not a luxury. It is a necessity.
I thank Senator Costello for raising this issue. I will be answering on behalf of the Minister for Health, Deputy Carroll MacNeill.
The State acknowledges the importance of faster access to new medicines for patients. The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement is for licensed indications that have been granted marketing authorisation by the EMA or the Health Products Regulatory Authority, HPRA. In making a reimbursement decision, the HSE is required under the Act to have regard to a number of criteria, including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact.
HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds and having regard to the advice of the NCPE. Formal processes govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded or reimbursed.
The Senator mentioned the external review of the pricing and reimbursement process, the Mazars review, which was published in 2023. While this determined that the pricing and reimbursement process operated in line with international norms, a number of recommendations were made on foot of its findings.
In the same year, 50% of applications for reimbursement progressed following a rapid review without the need for a full health technology assessment. Furthermore, 90% of generic and biosimilar medicines were approved for reimbursement within 90 days.
A number of these recommendations have now been implemented. One of the key recommendations of this review was enhancing the capacity across the pricing and reimbursement system, with significant funding allocated for 34 additional staff within the system. These 34 new staff have now been hired, of which 16 additional new staff were recruited and are now in place within the NCPE. This is a significant investment by the State and reflects the Government's commitment to providing access to new and innovative medicines to patients faster. The full impact of additional staffing within the NCPE on the speed of assessment of new medicine applications will become evident in the coming months. This additional capacity will significantly enhance and support the ability to appraise the increased volume and complexity of submissions from pharmaceutical companies for new drugs that are coming through the application process.
Another recommendation from this review was greater transparency for all stakeholders. A key focus was the implementation of a pricing and reimbursement medicines tracker to be developed by the HSE. The tracker has now been launched, with the initial iteration available since December 2024. In real time, this will show the status of a reimbursement application for a new medicine, from rapid review to a final decision by the HSE. Senator Costello asked about this. The HSE national service plan will continue the trackers' development with the introduction of indicative timelines for each step of a medicine's assessment process. That was the question the Senator specifically asked.
I thank the Minister of State for her reply. I welcome the recruitment of 34 new staff because time is of the essence when it comes to getting the necessary medication to people. As I said, time is something patients with certain rare illnesses do not have. I fully welcome the 34 new staff and I will be keeping a close eye on the progression and real life impact the additional staff will have in terms of a reduction in timelines.
I am pleased to hear the Senator welcomes the 34 new staff who have been put in place and the efforts made to enhance and improve the pricing and reimbursement system, including the significant additional staffing to which we have referred. To fully benefit patients, the pharmaceutical industry must also play its part. Ireland is open for business and encourages timely applications for reimbursement with reasonable pricing offers - that is really important. We are confident that timely engagements and applications from industry for new and innovative medicines to be reimbursed will support faster and improved access to medicines for patients in Ireland.
The State has made considerable investments in new medicines in recent years. In 2023, more than €3.2 billion was spent on medicines by the State. That represents nearly one in every eight euro of public money that is spent on health. I think the Senator can see the level of commitment from the Department on this.
Assisted Human Reproduction
I am here to speak of a heartbreaking and unjust case. It is the case of Melanie, a woman whose husband died from cancer. Despite doing everything right, she has been locked out of accessing IVF through the public system.
Before her husband, Dylan, died or even began chemotherapy, they froze his samples, following medical advice, to preserve a chance of starting a family. Dylan gave full written consent that Melanie could use those samples in the event of his death. Tragically, Dylan passed away earlier this year and now Melanie, who continues to pay monthly to store the samples, is being told she cannot use them through the public system. There is no protocol, policy or pathway for someone in her position. Melanie has gone through so much, losing her beautiful husband to cancer so young, at just 32 years old, and in the midst of her grief the State has forced her to open herself up to scrutiny and to relive her trauma just to be heard, to fight for a small piece of happiness and to fulfil her husband's dying wish that she might have their child, even if he could not be here to see it. Now she is being told she does not fit the system.
Her story raises a wider issue, which is who gets access to fertility treatment in Ireland and who does not. As someone who is in a relationship, I have access to the public system. It is still not fully or fairly implemented and it is under-resourced and overly restrictive, but the point is that, because my partner is alive, I have access to it. Melanie is not asking for the world; she is asking for one chance, a chance that I and other Members have. The public model is built on an outdated definition of family: a heterosexual couple coming together and living together. If, however, you are single, are in a same-sex relationship or, like Melanie, are a widow who has legally consented to samples, you are locked out. Ten years ago we celebrated the marriage equality referendum result, a proud day that changed so many people's lives, but the reality is you can now marry who you love but our fertility system tells us not to expect to start a family with them. The message is that love is equal but family is not.
What kind of health system denies someone the chance because their partner has died, even where their partner gave clear consent? What does the Minister of State say to Melanie as she witnesses this debate, as she listens not just as a grieving wife but as someone who is holding on to a last piece of the future she planned with the man she loved? This is not just about one woman; it is about whether our healthcare system reflects the real Ireland we live in today and the families we actually have, not just the ones the system has decided to serve. We need clear, compassionate protocols for reproduction, we need fertility policies that include all families and we need to stop forcing people in pain to navigate policy gaps and silence when what they really need is support. No one should have to go through what Melanie is going through, and certainly not alone.
I look forward to the Minister of State's reply and to hearing what she has to say about this.
I thank the Senator for raising this very sensitive matter and for giving me, on behalf of the Minister, Deputy Carroll MacNeill, the opportunity to inform the House of the up-to-date position on the provision of publicly funded fertility services. The Senator and I will both appreciate the fact the Minister cannot comment on individual cases.
As part of the final phase of the roll-out of the model of care for fertility, referrals for publicly funded, privately provided IVF or other assisted human reproduction, AHR, treatment commenced in September 2023. The criteria that prospective patients should meet to access fully funded AHR services were agreed by the Department and the HSE and subsequently approved by the Government in July 2023. The criteria were agreed following consultation with experts in the field of reproductive medicine and include limits in respect of the age of the intending birth mother, body mass index and the number of children a couple already have. These are very much in keeping with those applied in other jurisdictions, even though in most European countries, for instance, such treatments are only partially funded and require often significant out-of-pocket payments by patients.
Decisions in respect of any proposed changes to the access criteria and-or the range of services provided through the publicly funded AHR treatment initiative require further extensive consultation between Department of Health officials and colleagues in the HSE and also with relevant specialists in the field of reproductive medicine. This process is under way.
Posthumous assisted human reproduction, PAHR, is defined in the Health (Assisted Human Reproduction) Act 2024 as AHR treatment involving the use of the gametes of a person, or of an embryo created by the use of such gametes, subsequent to the death of such person. The Health (Assisted Human Reproduction) Act 2024 includes provisions which will introduce regulation of PAHR but this legislation has not been commenced to date. A key condition in the legislation for PAHR to be permitted is that the relevant AHR treatment should not begin prior to 12 months having passed from the death of the relevant deceased intending parent. This is to allow for an appropriate period of reflection and mourning for the surviving partner and space for her to be certain that she wishes to proceed with PAHR in the new circumstances of her life. The Department of Health understands that, in the few countries which specifically provide for PAHR, there is such a required post-death period. There is also a requirement in the 2024 Act that the deceased person and the surviving partner would have received appropriate counselling and advice on issues in respect of succession rights, for instance, before providing their fully informed consent to PAHR, parentage of an as-yet-unborn child and the implications of same. The provision of treatment related to PAHR is not part of the services currently funded through the publicly funded AHR treatment initiative. I will finish following the Senator's response.
It is good to hear that consultations are ongoing. The IVF system currently, even the public one, is not up to where it needs to be. Equally, Melanie is under no illusion that she has to wait 12 months. She knows all of this stuff. The problem is that the consultation has not started. There is no legislation around this. As someone who has a low egg count, she does not have the time to be waiting until the Government decides to start this process. Women's reproductive health, and all reproductive health, should be a priority for the Government. I am really asking to for a timeline as to when this will be proposed. We cannot just leave people waiting in limbo. It is ridiculous to have people sitting there, praying and hoping that legislation will change. She has engaged with consultants and hospitals. They have all said they cannot do anything until legislation changes. They are pushing for it equally.
I thank the Senator. As I said, there are potentially highly sensitive and complex factors which arise here and these would need to be fully teased out, resolved and a firm decision agreed upon before it is decided whether, notwithstanding what is permitted in the relevant legislation, the State should fund this very distinct form of AHR treatment. However, I want to reassure the Senator that the Minister, Deputy Carroll MacNeill, is focused, through the full implementation of the model of care for fertility, on ensuring that patients receive care at the appropriate level of clinical intervention and then those requiring, and eligible for, advanced AHR treatment such as IVF will be able to access same through the public health system. The Minister, Deputy Carroll MacNeill, is eager to see how we can most effectively grow the scheme further, in line with the programme for Government commitment, whether through broadening certain criteria or increasing the range of services available. The Minister hopes to be in a position to announce a clear plan of action in this regard in the coming weeks.
Health Services
I thank the Minister of State for taking this Commencement matter on behalf of the Minister for Health. I wish to comment on public service community radio. We have a great radio station in Kildare, Kfm. It provides an important public service. That was how I first heard of this particular situation. Some of the women impacted contacted me afterwards. There is a new modern primary day healthcare centre in Athy which provides a great service, including a postpartum service for new mothers. This is important to facilitate checkups for baby and mother, to begin the vaccination programme and to deal with things like breastfeeding support and postnatal depression support. It is a vulnerable time for mams and children. People quite suddenly received texts cancelling their appointments in Athy, in some cases with less than 24 hours' notice. They were told they had to travel to Portlaoise hospital instead. This also impacted women in Monasterevin because they were attending a clinic in Portarlington that was also cancelled. Many mums may need someone else to drive them or may have to organise babysitting for their other children. During a vulnerable time, it is a real shock to get a text cancelling a service like this out of the blue. The response we are getting is that it is because of staff shortages. Children and postpartum women should be a priority. There is no timeline for when the service will recommence in Athy and in Portarlington. It supports new mums in Portarlington and Monasterevin. When can we expect this vital and important service to recommence? Is there anything available to support them in the meantime, such as transport for those who do not have access to private transport? Public transport between Athy and Portlaoise is practically non-existent. If this will continue for a time, I propose that transport arrangements be put in place. It should not have happened, especially with such little notice to mums. Getting a text when you are prepared and have put arrangements in place to say that you have to go to another place is not acceptable. Portlaoise is a large town and the hospital is dealing with its own patients. There is a concern that there will be long delays for mams and their babies. It is not good enough. The women I represent in Athy and Monasterevin deserve better. I look forward to hearing the response from the Minister's office and the Department.
I thank Senator O’Loughlin for this opportunity to address the House today on behalf of the Minister for Health regarding the provision of community midwifery services in Athy by the maternity unit at Midlands Regional Hospital Portlaoise. I endorse what the Senator said about Kfm. I had the privilege of representing Kildare in the European Parliament for five years. I am well aware of the huge value of the community service provided by Kfm.
Coming back to the Senator's question, the Government recognises the critical role midwives play in the delivery of safe, nationally consistent and woman-centred maternity care. The Minister for Health understands the disruption and distress that the interruption of this service may have caused to women in the area. I think all of us here today do as well. The Minister would like to reassure the Deputy and the women attending this service that measures have been put in place to resume it.
The midwifery service provided in Athy Primary Care Centre is a midwifery-led, antenatal satellite service from Midland Regional Hospital Portlaoise for women with normal-risk pregnancies. The service was temporarily paused last week to facilitate unplanned staff leave. The HSE has confirmed that the midwifery-led antenatal clinics will be operating as normal from this week in Athy Primary Care Centre and Portarlington Primary Care Centre. Midland Regional Hospital Portlaoise has been contacting affected women directly about this matter. The HSE has provided assurances that all efforts will be made to continue with the midwifery-led community clinics without interruption, including enhancing recruitment of the midwifery workforce.
This Government recognises the importance of midwifery and community care. This has been underpinned by significant investment in services, both in Portlaoise and nationally. The national maternity strategy is moving into its final years. A total of €28 million in new development funding has been invested through the strategy since 2016. This has enabled the total recruitment of more than 530 full-time staff across the country. These staff and this investment improve women's lives every day. Midland Regional Hospital Portlaoise has directly benefited from investment through the national maternity strategy. Since 2018, 12.5 additional whole-time equivalent staff have been funded at the unit through the strategy, including nine whole-time equivalent midwives and midwife specialists. The unit has benefited from over €150,000 in capital investment through the strategy since 2020, including funding for a home away from home birthing room, scanning equipment and neonatal support equipment. I have a little more to say but will wait for the Senator's response.
I thank the Minister of State. Like her, I acknowledge the critical role that midwives across the country play in the delivery of excellent services for mums and their new babies. I acknowledge that the Minister for Health has said that she understands the disruption and distress that has been caused. I appreciate that in the Minister of State's answer, she said measures had been put in place to resume the service and that they have confirmed that the antenatal clinics will be operating as normal from this week. That is important news in Athy Primary Care Centre and Portarlington Primary Care Centre. The Minister of State talked about the issue with recruitment, which is obviously important, because every new mum deserves to have the very best. I wish the Minister of State well with the task force that is being established. I stress that it is important to make sure contingency plans are in place so that something like this does not happen again in south Kildare or indeed anywhere else in the country.
I thank the Senator. To finish the reply, Midland Regional Hospital Portlaoise is funded for 76.5 whole-time equivalent midwives, which falls comfortably within the recommended staffing levels for the number of births at the unit. In response to challenges with vacancies in permanent midwifery positions nationwide, a national midwifery task force was established in October 2023. It is bringing together midwives, HSE professionals and academic expertise to enhance practices around midwifery workforce planning. In budget 2025, an additional €2 million in new development funding has been provided for the continued implementation of this national maternity strategy. All 19 maternity services now offer a midwife-led supported care pathway.
Cuireadh an Seanad ar fionraí ar 3.30 p.m. agus cuireadh tús leis arís ar 3.33 p.m.
Sitting suspended at 3.30 p.m. and resumed at 3.33 p.m.