Written Answers Nos. 289-313
289. Deputy Ken O'Flynn asked the Minister for Health the number of retailers of nicotine-inhaling products inspected by the National Environmental Health Service more than once in the same calendar year in 2024, in 2025 and to date in 2026; the number of those retailers referred for summary proceedings as repeat offenders; and if she will make a statement on the matter. [49980/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
290. Deputy Ken O'Flynn asked the Minister for Health the expected court dates for the three prosecution cases currently before the District Court against retailers of nicotine-inhaling products referenced in a reply to the Deputy dated 16 June 2026; the legislative basis applied in determining penalties in such cases; and if she will make a statement on the matter. [49981/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
292. Deputy Erin McGreehan asked the Minister for Health when it was decided by her Department and agreed with the Health Research Consent Declaration Committee (HRCDC) that persons making applications to the Minister for membership of the Committee would be informed that they must instead make their applications through the Committee; if that agreement was formally recorded by the Department and the HRCDC: if the arrangement was requested by the Committee or by her Department; if the HRCDC sends all applications it receives to the Minister for her decision; and if the applications forwarded come with a recommendation (details supplied); and if she will make a statement on the matter. [49987/26]
View answer293. Deputy Erin McGreehan asked the Minister for Health whether her Department considered the data protection implications of the arrangement with the Health Research Consent Declaration Committee (HRCDC) whereby it requires applicants for membership of the Committee to provide their personal data to the Committee without a statutory basis for that requirement. [49988/26]
View answer294. Deputy Erin McGreehan asked the Minister for Health the reason the Health Research Consent Declaration Committee is able to periodically publicly invite expressions of interest for membership of the committee. [49989/26]
View answerI propose to take Questions Nos. 292, 293 and 294 together.
The Health Research Consent Declaration Committee (HRCDC) was established as required by the Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018 (S.I. No. 314/2018). Under these Regulations, the Minister for Health is responsible for the appointment of members.
The HRCDC secretariat provides the required secretarial assistance to support the HRCDC. While the Regulations do not explicitly prescribe the methodology for recruitment to HRCDC vacancies, the HRCDC secretariat uses 'Expression of Interest' (EoI) campaigns as a standard administrative practice. This open approach is grounded in wider government policy, specifically the principles of transparency, diversity, and merit-based selection required by the ‘Guidelines on Appointments to State Boards’. In line with standard procedures, applicants consent to the processing of their data by the HRCDC secretariat when submitting applications. Recruiting members through an ‘expression of interest campaign’ ensures that the HRCDC maintains the highly specialised legal, ethical, clinical, and public-representative competencies necessary to fulfil its statutory mandate effectively. Following the Expression of Interest campaign, the HRCDC secretariat submits the recommended individuals to the Minister for Health for appointment as per the Regulations.
295. Deputy Maurice Quinlivan asked the Minister for Health to examine an appointment referral case (details supplied); and if she will make a statement on the matter. [50001/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly.
296. Deputy Grace Boland asked the Minister for Health the number of WTE consultant paediatric cardiologists based at CHI Temple Street Hospital; and if she will make a statement on the matter. [50004/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
297. Deputy Grace Boland asked the Minister for Health the number of WTE environmental health officers employed by HSE in Dublin north county formerly CH09 in 2024, 2025 and to-date in 2026, in tabular form; and if she will make a statement on the matter. [50005/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
298. Deputy Grace Boland asked the Minister for Health the number of WTE specialist registrars in vascular surgery based at Beaumont Hospital as of 22 June 2026; if she will provide the same figure as of 30 June 2023, in tabular form; and if she will make a statement on the matter. [50006/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
299. Deputy Grace Boland asked the Minister for Health whether GPs can currently refer directly for gynaecological pelvic MRI under the GP access to community diagnostics scheme; and if she will make a statement on the matter. [50007/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
300. Deputy Grace Boland asked the Minister for Health the reason gynaecological pelvic MRI is not available through GP referral where other MRI indications, including orthopaedic pelvic indications, are available; and if she will make a statement on the matter. [50008/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
301. Deputy Grace Boland asked the Minister for Health whether her Department or HSE intends to review GP access to gynaecological pelvic MRI as part of the national endometriosis framework and wider women’s health policy; and if she will make a statement on the matter. [50009/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
302. Deputy Grace Boland asked the Minister for Health whether gynaecological pelvic MRI will be added to GP access pathways under appropriate clinical criteria; and if she will make a statement on the matter. [50010/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
303. Deputy Grace Boland asked the Minister for Health whether the HSE will create a direct GP referral pathway to specialist gynaecological imaging for suspected endometriosis or complex pelvic disease if direct GP access is not proposed; and if she will make a statement on the matter. [50011/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
304. Deputy Grace Boland asked the Minister for Health whether her Department has reviewed the cost and patient impact of funding endometriosis-related care abroad compared with investing in improved diagnostic and treatment pathways in Ireland; and if she will make a statement on the matter. [50012/26]
View answerThe HSE Endometriosis Surgery Abroad Interim Scheme (ESAIS) was established by the HSE as a temporary measure to support patients requiring surgery for endometriosis who are on a waiting list for the surgery in Ireland but do not have a date for surgery. It aims to allow these patients to access the surgery they need, by facilitating their attendance at a specialist centre abroad, with costs covered by the HSE. This is planned to be operational over a limited period of time while improved diagnostic and treatment pathways in Irish services for endometriosis are being scaled up in accordance with the National Endometriosis Framework.
On 18 October 2025, I launched the National Framework for the Management of Endometriosis. The Framework sets out for the first time in Ireland a defined clinical pathway for women with endometriosis, which spans primary to secondary care to specialist complex care in tertiary settings.
Funding of over €5 million was invested in endometriosis services between 2021 and 2025.
Two supra-regional specialist centres, in Tallaght University Hospital and Cork University Maternity Hospital, have been established for the management of complex endometriosis cases.
Regional Specialist Centres for moderate cases have been established in the Rotunda, the Coombe, and Limerick, with clinics under further development in Galway and the National Maternity Hospital. All endometriosis sites are operational and taking referrals.
In addition to the implementation of the Framework, I also mandated several actions to expedite access to care for women impacted by endometriosis. Significant progress has already been made, including:
• The HSE carried out over 140 additional surgeries in Q4 2025 for women waiting for surgery.
• An additional colorectal surgeon has been successfully recruited by the HSE in Cork and Tallaght, strengthening our complex care capacity.
• Q1 2026 showed substantial increases in referrals, clinics and new patient throughput across the network of specialist endometriosis services.
• An additional 65 whole-time-equivalent healthcare professionals have been prioritised through the HSE National Service Plan 2026 to expand and fully implement the framework.
• ESAIS was opened on 18 October 2025. ESAIS has facilitated women to access surgery abroad in five different countries across Europe to date.
• €2 million in funding has been ringfenced for research into all aspects of women’s health, including endometriosis. This is the first time Irish research funding has been dedicated specifically to women’s health.
• Two education officers are working across the country to deliver the comprehensive Menstrual Information Specialising in Endometriosis (MISE) programme which aims to educate people, particularly in schools, sports clubs and workplaces, on menstrual health, with a focus on endometriosis.
• Two permanent two-year endometriosis fellowships have been funded, with the first two candidates due to complete their fellowship in July of this year. Both fellowship positions will be recruited for on a recurring basis, ensuring a pipeline of expertise into public endometriosis services.
I am committed to expanding specialist endometriosis services, improving support services for women with endometriosis and promoting awareness of endometriosis, both among the public and crucially within our own health services.
305. Deputy Robert Troy asked the Minister for Health when a person (details supplied) will receive a hospital appointment. [50013/26]
View answerUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. The Minister for Health is prohibited from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly, as soon as possible.
306. Deputy Michael Healy-Rae asked the Minister for Health if the S1 form requested by persons will be expedited (details supplied); and if she will make a statement on the matter. [50023/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
307. Deputy John Paul O'Shea asked the Minister for Health for an update on the delivery of the implementation plan in response to the report entitled 'The Use of Uro-gynaecological Mesh in Surgical Procedures'; and if she will make a statement on the matter. [50054/26]
View answerIn July 2018, the Chief Medical Officer (CMO) asked the HSE to pause all vaginal mesh surgical procedures where clinically safe to do so, pending implementation of recommendations as set out in his report on The Use of Uro-Gynaecological Mesh in Surgical Procedures.
In 2023 the HSE established a National Vaginal Mesh Implant Oversight Group. The focus of this group was to review and assess implementation of the CMO’s recommendations and assess the appropriateness of resuming uro-gynaecological mesh procedures. The Department received an updated report from the group in February 2025.
Officials in my Department are currently liaising with the HSE and other stakeholders as part of an evidence-based process to determine whether to re-introduce the procedure. As this is an extremely complex issue it is not possible to give a timeline for decision at present.
Women’s health is a key priority for the Department of Health. I understand the impact the pause on the use of uro-gynaecological mesh has on women who wish to avail of this surgery, however my Department must take a safety-first approach to this issue.
308. Deputy Paul Lawless asked the Minister for Health the reason the HSE does not fully reimburse patients who avail of the cross border directive through providers such as Kingsbridge in northern Ireland, in circumstances where those patients were on Irish public waiting lists and had been informed that their procedure would not be available within six months; and if she will make a statement on the matter. [50061/26]
View answerThe Northern Ireland Planned Healthcare Scheme (NIPHS) has been in effective operation since 1 January 2021. This Scheme was introduced to mitigate the loss of access to care from private providers in Northern Ireland under the EU Cross Border Directive (CBD), which ceased to apply as a result of Brexit.
The current administrative scheme enables persons ordinarily resident in the State to access and be reimbursed for private healthcare in Northern Ireland by the HSE, provided such healthcare is publicly available within Ireland. Such healthcare will be reimbursed at the cost of providing that treatment in the State or the cost of same in Northern Ireland, whichever is the lesser. The HSE provides further information for patients on the HSE NIPHS website: www2.hse.ie/services/schemes-allowances/niphs/
It is important to note that reimbursement, under the provisions of the CBD and NIPHS, is confined to the costs of the care itself and does not include any additional costs, such as travel or accommodation costs, incurred by the patient. Reimbursement rates are set by the HSE. And are those applicable to the cost of treatment in the Public Health Service in Ireland.
309. Deputy Erin McGreehan asked the Minister for Health the current status of the health technology assessment and reimbursement decision for pluvicto (lutetium-177 PSMA therapy) for the treatment of metastatic castration-resistant prostate cancer; the timeline for a final determination; and if she will make a statement on the matter. [50111/26]
View answerThe Government recognises the importance of timely access for patients to new medicines. Budgets 2021 to 2025 have included dedicated funding for new medicines of 158 million euros. Budget 2026 allocated an additional 30 million euros of funding for new drugs out of 217 million euros in additional funding for drugs. This has enabled the HSE to approve reimbursement for 276 new medicines or new uses for existing medicines, including 110 for treating cancer and 75 for treating rare diseases.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the Act a company must submit an application to the HSE to have a new medicine added to the formal Reimbursement list.
Pluvicto® (lutetium (¹77Lu) vipivotide tetraxetan) is a medicine used to treat prostate cancer. It is indicated, in combination with androgen deprivation therapy (ADT), with or without androgen receptor (AR) pathway inhibition, for adult patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with AR pathway inhibition and taxane-based chemotherapy. The medicine was granted marketing authorisation by the European Medicines Agency (EMA) in September 2022.
On the 9th January 2023, the HSE received an application from Advanced Accelerator Applications, a Novartis Company, for pricing and reimbursement of Pluvicto®.
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 clinical experts and public interest members.
The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team. The totality of clinical and economic evidence for this treatment was comprehensively and extensively reviewed by the Drugs Group at the April 2025 meeting.
Evidence considered included a HTA report from the NCPE, a patient interest group submission, two additional clinical representations, and advice from the National Cancer Control Programme Technology Review Committee, an expert group whose membership includes clinicians specialising in oncology.
The decision-making authority in the HSE is the HSE Senior Management Team (SMT). The HSE SMT decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine. The SMT supported the Drugs Group recommendation not to reimburse this treatment.
The HSE Corporate Pharmaceutical Unit (CPU) issued a formal written Notice of Proposal to the applicant on Tuesday 5th May 2026.
The applicant has since met with the CPU and they have submitted a commercial offer which remains under consideration.
310. Deputy Erin McGreehan asked the Minister for Health the steps being taken to ensure Irish patients have timely and equitable access to innovative oncology treatments, including radioligand therapies such as pluvicto; and the way Ireland compares with other EU Member States in access to such treatments. [50112/26]
View answerThe Government recognises the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. Budgets 2021-2025 allocated €158 million for new drugs, and Budget 2026 allocated an additional €30 million. Since 2021, this funding has facilitated the introduction of 276 new medicines, including 75 medicines for rare diseases and 110 for treating cancer.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
The HSE is the statutory decision maker for the pricing and reimbursement of new medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE considers the criteria set out in the Act.
Once a company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product.
Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list until an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration.
In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure, and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients.
There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.
These measures include:
• Funding by the Government to an almost doubling of capacity in the HSE’s pricing and reimbursement system with 34 additional staff.
• New Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments and a structured process towards achieving a 180-day timeline for reimbursement decisions by Q1 2029.
• A commitment from IPHA member companies to aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of marketing authorisation of medicines by the European Commission.
311. Deputy Erin McGreehan asked the Minister for Health the current capacity within the public health system to deliver radioligand therapies, including the availability of nuclear medicine facilities, trained personnel, and radiopharmacy supports; and the plans in place to expand this capacity. [50113/26]
View answer312. Deputy Erin McGreehan asked the Minister for Health whether her Department has undertaken or commissioned any strategic review of Ireland's nuclear medicine and radiopharmacy infrastructure; and the actions planned to develop a sustainable, indigenous capability in this area. [50114/26]
View answer313. Deputy Erin McGreehan asked the Minister for Health if consideration is being given to developing a national strategy for radiopharmaceutical production and usage, in light of increasing global demand and supply constraints; and if she will outline any engagement with industry, academia, or international partners on this issue. [50115/26]
View answer314. Deputy Erin McGreehan asked the Minister for Health the level of capital and operational investment allocated to nuclear medicine and advanced cancer therapies over the past five years; and the projected investment over the next five years to support emerging treatments such as radioligand therapies. [50116/26]
View answer318. Deputy Erin McGreehan asked the Minister for Health if she will support a dedicated session of the relevant Oireachtas Committee to examine the case for investment in nuclear medicine and radiopharmacy infrastructure, including emerging cancer therapies; and if officials from her Department would be available to attend. [50120/26]
View answerI propose to take Questions Nos. 311, 312, 313, 314 and 318 together.
The Government is committed to providing timely access to new and innovative medicines to all patients, including those with cancer, alongside the planned development of the infrastructure required to safely deliver these therapies.
Budgets 2021–2026 provided almost €190 million in dedicated funding for new medicines supporting access to a wide range of treatments, including cancer therapies. Radioligand therapies are regulated at EU level and are considered for reimbursement by the HSE. 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, having regard to clinical and cost-effectiveness and competing demands across the health service.
The HSE has advised that there are challenges associated with the delivery of radioligand therapy in Ireland in terms of infrastructure and resources, and that investment will be required to provide capacity. Radioligand therapy often has a dependency on PET/CT imaging, and related work is progressing through the development of a National Strategy for Radiology Services.
There is no standalone national strategy for radiopharmaceutical production at this time. Work in this area is being progressed through national service planning arrangements.
The National Cancer Control Programme has engaged with cancer centres and nuclear medicine specialists and has established a Radioligand Therapy Advisory Group to support consideration of service requirements. This Group has recommended the commissioning of a report to inform a national plan for these services, including consideration of infrastructure such as radiopharmacy capacity and cyclotron facilities.
More generally, the Strategic Medicines Access and Availability Group, established by the Department of Health in November 2025, is considering measures to support the availability of medicines in Ireland. This includes work to address medicines shortages and gaps in availability and to reduce reliance on exempt medicinal products, with input from relevant stakeholders including the HSE, HPRA and NCPE.
Future investment will be considered in the context of these processes and in line with broader Government priorities, including the National Development Plan.
The Minister engages with the Oireachtas on matters relating to health policy. The scheduling of Committee sessions is a matter for the relevant Committee.
