Written Answers Nos. 929-950
929. Deputy Michael Cahill asked the Minister for Health if the HSE will meet its target of placement beds as outlined in the HSE Disability Action Plan (2024-2026); and if she will make a statement on the matter. [16977/26]
View answer930. Deputy Thomas Gould asked the Minister for Health the status of a medical card application for a person (details supplied); and if she will make a statement on the matter. [16980/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
931. Deputy James O'Connor asked the Minister for Health if she will outline her Department’s current position on measures to support the availability of new and existing antimicrobials in Ireland; the way in which Ireland’s approach aligns with EU level initiatives on antimicrobial resistance, including provisions under the revised EU pharmaceutical legislation; if any consideration has been given to national or EU level subscription or revenue guarantee models for antimicrobials; and if she will make a statement on the matter. [16982/26]
View answerIreland’s third One Health National Action Plan on Antimicrobial Resistance 2026-2030, known as iNAP3, was jointly published by the Department of Health and the Department of Agriculture, Food and the Marine in November 2025. It is the successor plan to Ireland’s second National Action Plan on Antimicrobial Resistance 2021-2025, known as iNAP2.
Both plans adopt a One Health approach and align to the Strategic Objectives as outlined in the WHO Global Action Plan (2015) and the WHO updated Global Action Plan and the requirements of the European Action Plan on Antimicrobial Resistance (AMR) (2017).
It has been acknowledged globally that a One Health approach is the most effective way to address the global AMR challenge. This is promoted by both the WHO and the European Commission.
Strategic Objective 5 of iNAP3 is to promote research and sustainable investment in new medicines, diagnostic tools, vaccines and other interventions. There are 21 actions across the human health, animal health and environment sectors under this objective. There is also two overarching One Health Action related to research, OH10: Promote research addressing AMR using an Ongoing One Health approach through research partners to fill research gaps and OH-11 ,Support the European joint action on Antimicrobial Resistance and Healthcare Infections ( EU-JARAI2) project.iNAP3 and these actions are available to view online at [www.gov.ie/amr].
In line with iNAP3, the Department of Health will continue to work with partners and stakeholders to encourage and support cross-discipline research on AMR.
At a European level, following over two years of intense negotiations, the EU Pharmaceutical Package is being currently being finalised. Ireland welcomes the finalisation of this important file, as it gives certainty and stability to the regulatory landscape for pharmaceutical manufacturing across Europe. This is the first revision of the legislation in 20 years.
One of the elements of the file is in relation to combatting antimicrobial resistance. The pharma package introduces a new transferrable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics. This voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.
932. Deputy James O'Connor asked the Minister for Health if antimicrobial resistance (AMR) will be a focus under Ireland’s health agenda during its upcoming EU Presidency; if she will outline any planned initiatives, events or policy discussions on AMR at EU level during the presidency; if she will indicate how this agenda will align with Ireland’s national AMR strategy and ongoing EU pharmaceutical reform; and if she will make a statement on the matter. [16983/26]
View answerIreland’s Presidency Health Agenda will aim at positioning health and competitiveness as mutually reinforcing priorities. We will promote population health and wellbeing as a vital foundation for European security and competitiveness and highlight how innovation in health systems delivers better health outcomes for European citizens. We will advance the EU Life Sciences agenda and promote innovative and proactive healthcare that focusses on prevention and the roll out of digital health across the EU.
Ireland's Presidency will drive progress on critical EU legislation that advances our health agenda.
Following over two years of intense negotiations, the EU Pharmaceutical Package is currently being finalised. Ireland welcomes the finalisation of this important file, as it gives certainty and stability to the regulatory landscape for pharmaceutical manufacturing across Europe. This is the first revision of the legislation in 20 years. Following formal approval of the text, work will commence to analyse the implications of the text, to allow for transposition and implementation, in collaboration with relevant stakeholders., political agreement on both the Regulation and the Directive of the Pharmaceutical Package was reached in December 2025. Ireland welcomes the finalisation of this important file, as it gives certainty and stability to the regulatory landscape for pharmaceutical manufacturing across Europe. This is the first revision of the legislation in 20 years. Following formal approval of the text, work will commence to analyse the implications of the text, to allow for transposition and implementation, in collaboration with relevant stakeholders.
One of the elements of the file is in relation to combatting antimicrobial resistance. The pharma package introduces a new transferrable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics. This voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.
The Biotech Act I (published in December 2025) is a strategic priority for EU competitiveness and sovereignty. The Act streamlines regulations across clinical trials, advanced therapy medicinal products, and biomanufacturing. It mobilises €10 billion in investment funding (2026–27) via the Biotech EU initiative with the European Investment Bank. Key measures include simplified clinical trial procedures, innovation support mechanisms, and biosecurity safeguards. This flagship legislation will dominate health policy discussions during our Presidency.
The Medical Devices Regulation & In Vitro Diagnostics Regulation (amendments published in December 2025) will simplify and modernise device approval while maintaining patient safety. Expected outcomes include €3–5 billion in annual cost savings for manufacturers, faster patient access to innovative devices, and reduced shortages of critical medical equipment.
The EU Safe Heart Plan aims to reduce premature cardiovascular deaths by 25% by 2035 through improved prevention, screening, and treatment across all Member States. The plan emphasises shifting from treatment to prevention, and among other things calls for stronger action against tobacco and smoking.
Other ongoing files expected to progress during our Presidency include the Critical Medicines Act, the WHO Pandemic Agreement Annex on Pathogen Access and Benefit-Sharing, and the EU Civil Protection Mechanism reform, if not completed during the Cyprus Presidency.
933. Deputy James O'Connor asked the Minister for Health if she will outline the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [16984/26]
View answer938. Deputy Colm Burke asked the Minister for Health the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [17031/26]
View answerI propose to take Questions Nos. 933 and 938 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds. There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
Once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement.
All medicines are considered for pricing of reimbursement in order of application from companies including combination therapies for treating cancer.
While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.
The National Centre for Pharmacoeconomics (NCPE) conducts the Health Technology Assessment (HTA) of drugs for the health service in Ireland in collaboration with the HSE's Corporate Pharmaceutical Unit (CPU). They assess comparative clinical effectiveness and cost-effectiveness of drugs compared to current standard of care. The NCPE engages with stakeholders, including patients and clinicians, throughout the assessment process.
The HSE’s CPU is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
The HSE Drugs Group is a national committee that makes recommendations on the pricing and reimbursement of drugs in Ireland using the criteria set out in the 2013 Act to the HSE Senior Leadership Team.
The decision-making authority in the HSE is the HSE Senior Leadership Team.
935. Deputy Ken O'Flynn asked the Minister for Health in light of Rare Disease Day taking place on 28 February 2026, if she will commit to introducing an early access scheme in Ireland for people living with rare diseases to access EMA-approved orphan medicines; if such an early access scheme will include orphan medicines products licenced for non-oncology conditions; and if she will make a statement on the matter. [16988/26]
View answerI recognise the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. The Government is committed to investing in new medicines for patients, which has facilitated the introduction of 250 new medicines including 69 for rare diseases. For 2026, over €200m is available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements in principle with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stopclocks.
In addition, suppliers will aim to shorten the timeline to submit medicine reimbursement applications in Ireland to within six months of formal authorisation by the European Commission. Together these measures will enable faster access for patients in Ireland.
The Programme for Government contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this Government. As part of the Agreement talks, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases.
This will be a proof of concept initiative, aligned with the commitments in the Programme for Government. As this work progresses, it will be essential that we take account of the views of patients, of industry, and of clinicians. The mechanisms involved are complex, and the potential impacts must be carefully considered to ensure any future system is fair, effective, and sustainable. In parallel, my officials have commenced work examining reimbursement systems in use across the European Union.
936. Deputy Eoghan Kenny asked the Minister for Health if she will review the case of a person (details supplied) who has not received speech and language therapy since 2019; and if she will make a statement on the matter. [17011/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
937. Deputy Mairéad Farrell asked the Minister for Health the reason chaplaincy cover has been reduced at University Hospital Galway to a twelve hour slot; if she will consider reintroducing full chaplaincy cover at UHG; and if she will make a statement on the matter. [17030/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
939. Deputy Colm Burke asked the Minister for Health the plans for a renewed declaration within our upcoming Presidency of the EU to combat the rise in HIV transmission in EU member States to ensure that there is eradication of HIV in the EU by 2030; and if she will make a statement on the matter. [17033/26]
View answerIreland’s Presidency Health Agenda will aim at positioning health and competitiveness as mutually reinforcing priorities.
We will promote population health and wellbeing as a vital foundation for European security and competitiveness and highlight how innovation in health systems delivers better health outcomes for European citizens. We will advance the EU Life Sciences agenda and promote innovative and proactive healthcare that focusses on prevention and the roll out of digital health across the EU.
Ireland's Presidency will drive progress on critical EU legislation that advances our health agenda.
The Biotech Act I (published in December 2025) is a strategic priority for EU competitiveness and sovereignty. The Act streamlines regulations across clinical trials, advanced therapy medicinal products, and biomanufacturing. It mobilises €10 billion in investment funding (2026–27) via the Biotech EU initiative with the European Investment Bank. Key measures include simplified clinical trial procedures, innovation support mechanisms, and biosecurity safeguards. This flagship legislation will dominate health policy discussions during our Presidency.
The Medical Devices Regulation & In Vitro Diagnostics Regulation (amendments published in December 2025) will simplify and modernise device approval while maintaining patient safety. Expected outcomes include €3–5 billion in annual cost savings for manufacturers, faster patient access to innovative devices, and reduced shortages of critical medical equipment.
The EU Safe Heart Plan aims to reduce premature cardiovascular deaths by 25% by 2035 through improved prevention, screening, and treatment across all Member States. The plan emphasises shifting from treatment to prevention, and among other things calls for stronger action against tobacco and smoking. We will aim to use our Presidency to accelerate work to update the EU tobacco legislation – to include vapes and other nicotine products which have been strongly promoted by the industry over recent years.
Other ongoing files expected to progress during our Presidency include the Critical Medicines Act, the WHO Pandemic Agreement Annex on Pathogen Access and Benefit-Sharing, and the EU Civil Protection Mechanism reform, if not completed during the Cyprus Presidency.
While Ireland’s upcoming EU Presidency will encompass a broad range of priorities, the Government and the Department of Health remain firmly committed to advancing sexual health, including efforts to address HIV transmission and support progress toward the EU’s 2030 objectives.
The Programme for Government, Securing Ireland’s Future, 2025, commits to developing an HIV Action Plan, increasing the availability of Pre-Exposure Prophylaxis (PrEP) and reduce waiting times for access to it, in addition to the publication of a new Sexual Health Strategy, a process that was completed in 2025.
The new National Sexual Health Strategy, 2025-2035 (NSHS) and National Sexual Health Action Plan, 2025-2038 (NSHAP), commit to developing Models of Care for sexual health and for HIV, to develop an HIV Action Plan, as per the Programme for Government commitment, and to expand community options for the delivery of PrEP, including widening access through primary care and exploring digital options.
940. Deputy Colm Burke asked the Minister for Health the progress of eradicating HIV transmission as a public health threat in Ireland; and if she will make a statement on the matter. [17034/26]
View answerSexual health continues to be a priority for this Government, this Department and for the HSE.
The Programme for Government, Securing Ireland’s Future, 2025, commits to developing an HIV Action Plan, increasing the availability of Pre-Exposure Prophylaxis (PrEP) and reducing waiting times for access to it, in addition to the publication of a new Sexual Health Strategy.
The new National Sexual Health Strategy, 2025-2035 (NSHS) and National Sexual Health Action Plan, 2025-2038 (NSHAP), published in June, 2025, commit to developing Models of Care for sexual health and for HIV, to develop an HIV Action Plan, as per the Programme for Government commitment, and to expand community options for the delivery of PrEP, including widening access through primary care and exploring digital options.
The NSHS and NSHAP (included in one document) can be accessed at the following link: [www.gov.ie/en/healthy-ireland/policy-information/national-sexual-health-strategy-2025-2035/] .
Work is commencing on the HIV Action Plan; a subgroup of the NSHS Implementation Group focussing on sexual health services has been convened and will oversee and co-ordinate drafting. A stakeholder consultation request has been shared with clinical, sexual health and public health experts, other relevant divisions of the HSE, community and research partners and representative organisations working with people at risk of and living with HIV.
It is envisaged that the Action Plan will encompass all areas of HIV prevention, testing, diagnosis, surveillance, and care and supports for people living with HIV, also supporting the international goals and commitments to which Ireland is a signatory.
It is vital that those at risk of HIV infection are encouraged to access regular testing and preventive programmes such as Pre-Exposure Prophylaxis (PrEP) and post-exposure prophylaxis (PEP). These measures are key elements towards achieving UN and WHO aims of ending the HIV/AIDS epidemic in Europe by 2030 and supporting wider national and international commitments, including the Sustainable Development Goals.
The free home STI testing service, which includes HIV, was launched nationally in 2022 following a successful Sláintecare Integration Fund pilot, and has been expanded in line with increasing demand. The service is credited with increasing testing capacity by circa 33%, and may have played a part in the decrease in STI rates seen to date from 2024 onwards. Early detection means lower onward transmission and the home testing service is anecdotally reaching many who might have been reluctant to attend an STI clinic in person.
A national HIV pre-exposure prophylaxis (PrEP) programme commenced in November 2019. Free PrEP medication is available to individuals who meet clinical eligibility criteria, attending HSE approved PrEP services. Public PrEP services are delivered through the public network of STI clinics and through some approved private providers. There are currently 13 approved public PrEP services, located in public STI clinics, and 42 private or general practitioner (GP) PrEP providers. Appointments at the 13 public PrEP services are free of charge, however, the private providers charge for consultations.
The population has grown significantly in recent years, and clinical criteria for PrEP eligibility have been widened, increasing the number of people eligible. The number of people eligible to access PrEP has been expanding since inception, with the number of individuals re-imbursed for PrEP at least once expanding from 1763 in 2020 to 7,037 users by the end of 2025. An additional 2,196 new PrEP users were added in 2025.
While the PrEP service continues to grow, many PrEP services had reached capacity and service users were reporting challenges accessing appointments. In order to expand PrEP services and provide additional supports to our rapidly growing population, we were allocated additional funding of €550,000, through Budget 2025, and an additional €100,000 in 2026, to further support delivery of the PrEP scheme. The total allocation to €6.55m in 2025.
The 2025 allocation included funding for 7WTE to increase capacity for in-person appointments within the PrEP clinics, with all staff in place by October, 2025. In order to increase the number of providers, a PrEP competency framework and eLearning platform has been developed; these can be accessed by GPs with an interest in providing PrEP; numbers have increased substantially in 2025.
Current research, funded under the HRB's Evidence for Policy programme, is ongoing to establish an online PrEP pathway, as a digital solution to address PrEP capacity challenges, which will be comprehensively evaluated in regards to efficiency, capacity, value for money, feasibility and acceptability. However, despite additional staffing, support for medications, increases in the numbers of private providers, and streamlining treatment pathways, we are aware that additional capacity for PrEP may be needed.
The National Condom Distribution Service, another key aspect of prevention, continues to distribute condoms through the national STI clinic network, on campus and in partnership with community organisations working to support key groups at higher risk of HIV and STI infection. Over 1.2m free condoms were distributed in 2025
The HSE also continues to run campaigns with regard to both prevention and to tackle stigma related to HIV infection. Late diagnosis can be related to fear of stigma related to HIV; the "You, Me and HIV" campaign was launched by the HSE in 2025, in partnership with Poz Vibes, a community group representing and supporting people living with HIV. The campaign highlights the importance of early diagnosis and viral suppression, highlighting that one can live a normal life with HIV treatment and that undetectable = untransmissible. More information on the campaign can be found here: [www.about.hse.ie/news/hse-launches-new-campaign-to-address-hiv-stigma-in-ireland/]
The Health Protection Surveillance Centre (HPSC) publish weekly and annual reports on HIV incidence. These can be accessed at [www.hpsc.ie/a-z/hivandaids/hivdataandreports/]
941. Deputy Claire Kerrane asked the Minister for Health to provide an update on a HSE-owned building (details supplied) and its use by a local organisation, which has sought it from HSE estates; and if she will make a statement on the matter. [17043/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
942. Deputy Mark Ward asked the Minister for Health the number of vacancies in CH07 for the role of support coordinator who works together with the HSE and local authorities; and if she will make a statement on the matter. [17046/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
944. Deputy Mairéad Farrell asked the Minister for Health if she is aware of the difficulties facing small nursing homes and the widespread closures of nursing homes who are struggling to cope with rising costs; and if she will make a statement on the matter. [17051/26]
View answer945. Deputy Joe Cooney asked the Minister for Health the reasons the drug acarizax is not included in either the medical card scheme or the drugs payment scheme; if she will consider the inclusion of the drug; and if she will make a statement on the matter. [17057/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
946. Deputy Paul Nicholas Gogarty asked the Minister for Health the reason for the significant delays in advancing the assisted human reproduction legislation; and if she will make a statement on the matter. [17061/26]
View answer947. Deputy Paul Nicholas Gogarty asked the Minister for Health the measures in place to protect the rights of children in ‘legal limbo’ whilst the assisted human reproduction legislation remains stalled; and if she will make a statement on the matter. [17062/26]
View answer967. Deputy John Brady asked the Minister for Health when it is intended to fully implement the Health (Assisted Human Reproduction) Act 2024; the steps her Department is taking to address the gaps in the framework that continue to affect LGBTQ+ families; and if she will make a statement on the matter. [17187/26]
View answerI propose to take Questions Nos. 946, 947 and 967 together.
The Health (Assisted Human Reproduction) Act 2024 was signed into law by the President in July 2024, having passed all stages in both Houses of the Oireachtas.
The primary purpose of this complex and far-reaching legislation is to regulate fertility clinics providing treatment and ensure that assisted human reproduction (AHR) practices and related areas of research are conducted in a more consistent and standardised way and with the necessary oversight. The 2024 Act encompasses the regulation for the first time of a wide range of practices undertaken in Ireland, including: the use and donation of gametes and embryos for AHR and research; pre-implantation genetic testing of embryos; and embryo and stem cell research. The establishment of the Assisted Human Reproduction Regulatory Authority (AHRRA), as provided for in the legislation, is a vital component in the effective regulation of this sector.
Prior to this, the Children and Family Relationships Act 2015 introduced a regulatory framework for the legal parentage for children born in Ireland as a result of a donor-assisted human reproduction (DAHR) procedure which takes place in an authorised Irish DAHR facility. This allows for the birth of a donor-conceived child to be registered as such by an tArd-Chláraitheoir (the Chief Registrar). This applies equally to single women, same-sex female couples and opposite-sex couples, when they have undertaken a DAHR procedure in full accordance with the 2015 Act.
The AHR Bill as initially published also included provisions in respect of domestic altruistic surrogacy. However, the final 2024 Act also includes substantive new provisions in respect of the regulation of future surrogacy arrangements undertaken by Irish residents in other jurisdictions and the recognition of parentage arising from certain past domestic and international surrogacy arrangements.
While the 2024 Act was progressing through the Houses of Oireachtas, issues were identified which required further consideration and consultation with the Office of the Attorney General. Formal drafting of the Health (Assisted Human Reproduction) (Amendment) Bill – which is largely concerned with outstanding issues of parentage and citizenship, but also seeks to make other necessary amendments to various other sections of the 2024 Act – is at an advanced stage, led by the Office of Parliamentary Counsel, along with officials from my Department, the Department of Justice, Home Affairs and Migration (DoJHAM), and the Department of Children, Disability and Equality.
The major remaining outstanding matters to be finalised relate to issues regarding citizenship and the recognition of parentage arising from children born as a result of DAHR procedures or surrogacy undertaken by Irish citizens abroad. The completion of the drafting of provisions in this regard, which is being led by the DoJHAM, is being progressed having regard to the complex legal and policy issues involved. It is a legally intricate area which impinges on very important aspects of private international law, must take into account Court judgments on a number of relevant ongoing legal cases and requires significant levels of engagement with the Office of the Attorney General.
In that context, the Departments note both the difficulty internationally in securing bilateral or multilateral arrangements for mutual recognition of parental status and the absence of comparable comprehensive legislative frameworks in other jurisdictions. The Departments are therefore proceeding on the basis that a cautious and legally robust approach is required and will continue to progress the remaining issues as a priority with the Office of the Attorney General.
The importance of ensuring that parentage can be recognised in a wide set of circumstances is acknowledged.
As I understand, the current position in respect of the parentage of a child born as a result of a surrogacy arrangement, for example, is that most commonly an intending male parent who is genetically related to the child applies to the Courts for a Declaration of Parentage based on being the biological father of that child. In relation to DAHR procedures, on the other hand, the gestational mother is automatically considered to be the child’s parent.
In this regard, it is also worth noting that where the child has either a gestational mother or genetic father from AHR or surrogacy, that parent’s partner or spouse, if parentage has not been formally assigned to him or her, can apply for guardianship of the child, which affords many of the responsibilities of a parent and the protections that come with it.
Furthermore, my officials inform me that it is probable that the intending parent(s) who have undertaken a surrogacy arrangement or a DAHR procedure abroad will have been issued with a birth certificate by the jurisdiction in which the child was born which names the intending parent(s) as the parents of that child. In such a scenario, my officials inform me that the parental status of those so named on such a foreign birth certificate may in effect be accepted by public or State bodies in a number of instances currently, prior to the commencement of the relevant provisions related to such ‘historic’ surrogacy arrangements or DAHR procedures.
I welcome the opportunity to hear all perspectives on issues relevant to the work of my Department. I was happy to meet with Equality for Children / the LGBTQ+ Parenting Alliance and, indeed, other advocacy groups, and to listen to their views. At the meetings, the groups shared their experience and were given time to make their views known. So, I can assure the Deputy that I am fully up to speed on the issues of interest to the groups.
I would also refer to the fact that many of the issues raised in relation to what they wish to see included in the forthcoming AHR Amendment Bill are reflected in the Oireachtas Joint Committee on Health’s pre-legislative scrutiny (PLS) report, which was published in October 2025. The PLS report and recommendations have been and are being considered as part of the formal drafting process.
Much progress has been made on the path to providing the necessary oversight and regulation of the AHR sector. Some administrative sections of the 2024 Act have been commenced, specifically to formally establish the AHRRA. In addition, work is underway with a view to commencing section 232 of the 2024 Act. This will result in the parentage of some donor-conceived children not covered by the 2015 Act being recognised.
In conclusion, this is a very complex area and we need to get it right. For practical and legal reasons, the 2024 Act can only be fully commenced when an operational Regulatory Authority is in place and the Amendment Bill is enacted. However, please be assured that further progressing the AHR legislation and making the AHRRA fully operational are Government priorities and represent key commitments in the Programme for Government.
948. Deputy Noel McCarthy asked the Minister for Health the current methods of payment for the tobacco and nicotine inhaling products licence; if the introduction of any additional payment methods for retailers are currently being considered; and if she will make a statement on the matter. [17074/26]
View answerAs this matter relates to implementation, it has been referred to the HSE for direct referral.
949. Deputy John Lahart asked the Minister for Health the approval process for bempedoic acid (nilemdo) under the drugs payment scheme; the reason for delays in processing individual applications for this medication; if she will ensure that applicants who have exceeded the monthly DPS threshold while awaiting approval will be reimbursed in full; and if she will make a statement on the matter. [17075/26]
View answerAs this is a service matter and under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices, this question has been referred to the HSE for attention and direct reply to the Deputy.
950. Deputy Holly Cairns asked the Minister for Health if her attention has been drawn to women with hormone positive breast cancer being excluded from free menopause care due to being unable to use HRT; and whether she would consider adding non-hormone based medication to reduce the symptoms of menopause to the drug payment scheme and medical card scheme (details supplied). [17077/26]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the Department of Health, the Minister for Health and the HSE. The national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE by the pharmaceutical company. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and
(9) The resources available to the HSE
The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Pharmacoeconomic reports are reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
The decision-making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
In terms of the specific details of the application for pricing and reimbursement of fezolinetant (Veoza®):
• The HSE received an application for pricing / reimbursement on the 8th February 2024 from Astellas (the applicant) for fezolinetant (Veoza®) indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
• The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 9th February 2024.
• The NCPE Rapid Review assessment report was received by the HSE on the 12th March 2024. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of fezolinetant (Veoza®) compared with the current standard of care.
• The HSE commissioned a full HTA on the 8th April 2024 as per agreed processes.
• The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and / or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement recommendations for each individual medicine and indication listed. Details of the assessment(s) of fezolinetant (Veoza®) are available at [www.ncpe.ie/fezolinetant-veoza-hta-id-24005/] .
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
