Written Answers Nos. 322-342
322. Deputy Duncan Smith asked the Minister for Health the position regarding the planned delivery of seven postnatal hubs in Donegal; to provide a timeline for the delivery of the hubs; the details of the staffing requirements; and if she will make a statement on the matter. [38445/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
323. Deputy Mark Ward asked the Minister for Health if she will consider running a pilot orphan drug early-access programme in order that children with Duchenne muscular dystrophy can access givinostat; if a pricing and reimbursement application is being progressed by the HSE for givinostat; and if she will make a statement on the matter. [38448/26]
Amharc ar fhreagra324. Deputy Mark Ward asked the Minister for Health if givinostat will be made available for children with Duchenne muscular dystrophy; and if she will make a statement on the matter. [38449/26]
Amharc ar fhreagraI propose to take Questions Nos. 323 and 324 together.
The State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly patients with rare diseases.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date,72 of these new medicines were for rare diseases. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
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.
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. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
With respect to Givinostat, the HSE received a commercial proposal from Italfarmaco, the marketing authorisation holder for Givinostat on 08 May 2026.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
The Programme for Government contains a commitment to examine the development of early access schemes for rare diseases.
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 and recommendations in the National Rare Disease Strategy 2025–2030.
325. Deputy Niamh Smyth asked the Minister for Health if she will review the case of a person (details supplied); if she will provide an update on the supports recommended for the person in question; if she will address the adequacy of the supports offered given the professional recommendations made; and if she will make a statement on the matter. [38456/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
326. Deputy Michael Cahill asked the Minister for Health to significantly increase home help hours across County Kerry (details supplied); and if she will make a statement on the matter. [38467/26]
Amharc ar fhreagraAs this is an operational matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
327. Deputy William Aird asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy; and if she will make a statement on the matter. [38468/26]
Amharc ar fhreagraUnder 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.
328. Deputy Michael Murphy asked the Minister for Health her attention has been drawn to the fact that the memory clinic in south Tipperary remains closed due to resourcing and administrative process issues; the length of time the clinic has been closed; the number of patients currently awaiting assessment and reassessment; the measures being taken to restore the service; and if she will make a statement on the matter. [38483/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
329. Deputy Michael Murphy asked the Minister for Health the reason patients referred to the south Tipperary memory clinic are being advised to seek private assessment services due to the continued closure of the public clinic; the steps being taken to ensure equitable access to dementia and memory assessment services in Tipperary; and if she will make a statement on the matter. [38484/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
330. Deputy Michael Murphy asked the Minister for Health the timeline for the reopening of the south Tipperary memory clinic; whether additional staffing or resources have been sanctioned to address the stated resourcing and administrative issues; and if she will make a statement on the matter. [38485/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
331. Deputy Michael Cahill asked the Minister for Health the details of new residential respite services being provided in County Kerry, in relation to both children and adults (details supplied); and if she will make a statement on the matter. [38486/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
332. Deputy Erin McGreehan asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy. [38500/26]
Amharc ar fhreagraUnder 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.
333. Deputy Joe Neville asked the Minister for Health the timeline for when Part 12 of the Health (Assisted Human Reproduction) Act 2024 will be commenced; and if she will make a statement on the matter. [38512/26]
Amharc ar fhreagraThe Deputy will be aware that the Health (Assisted Human Reproduction) Act 2024-including Part 12, which has the heading “Past Domestic and International Surrogacy”–was signed into law by the President in July 2024, having passed all stages in both Houses of the Oireachtas.
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.
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. The formal drafting process for the Health (Assisted Human Reproduction) (Amendment) Bill is in its final stages, led by the Office of Parliamentary Counsel, along with officials from my Department, the Department of Justice, Home Affairs and Migration, and the Department of Children, Disability and Equality. I expect to be in a position to introduce the published Bill to the Dáil this term.
The AHR Amendment Bill is a very substantive piece of legislation. It is largely concerned with outstanding issues of parentage and citizenship, particularly in respect of children born as a result of a DAHR procedure or surrogacy arrangement undertaken abroad by Irish resident parents or undertaken by Irish citizen parents living abroad. It also seeks to make other necessary amendments to various other sections of the 2024 Act, including in respect of the “past” surrogacy provisions in Part 12.
As the Deputy may be aware, it was necessary to commence some sections of the 2024 Act which relate to basic administrative functions of the AHRRA in order to be able to formally establish the body. I also signed an Order last month to commence three subsections of section 232 of the 2024 Act. This allows for the parentage of some donor-conceived children not covered by the Children and Family Relationships Act 2015 to be recognised.
However, practically the entire remaining provisions in the 2024 Act are inter-connected, are largely contingent on the AHRRA being suitably operational and are subject to further amendment through the AHR Amendment Bill.
For instance, it was decided that the “prospective” and “past” international surrogacy provisions in the complete AHR legislation (as amended by the new Bill) must be commenced concurrently to ensure their proper operation.
A further concern is that a legal “lacuna” would be created in respect of surrogacy arrangements undertaken in any “interim” period between the time of the commencement of the “prospective” provisions and that of the “past” provisions, if the latter were to be commenced at an earlier point.
At a broad level, 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 this regard, it is also worth noting that where the child has a genetic father from 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 it is probable that if the intending parent(s) who have undertaken a surrogacy arrangement abroad were 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, 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.
Finally, I want to reassure you that further progressing the entire AHR legislation and making the AHRRA fully operational are Government priorities and key commitments in the Programme for Government. Every effort will continue to be exerted to ensure that all outstanding work in this regard is concluded as soon as practicable.
334. Deputy Peadar Tóibín asked the Minister for Health if the Food Safety Authority has carried out any testing on beef that has been imported from South America in each of the past five years; if so, to publish the result of that testing; and if not, the reason, given the EU is about to ban Brazilian beef. [38520/26]
Amharc ar fhreagraAs this question relates to operational matters within the remit of the Food Safety Authority of Ireland (FSAI), I have requested that the FSAI respond directly to the Deputy.
335. Deputy Peadar Tóibín asked the Minister for Health whether she will provide details of the original and revised floor allocation plans for ICT operations within the new National Children's Hospital; whether earlier plans provided for a substantially larger dedicated ICT operational floor and accommodation for approximately 100 ICT staff. [38529/26]
Amharc ar fhreagra336. Deputy Peadar Tóibín asked the Minister for Health whether she will provide details of any changes made to ICT operational accommodation and staffing models during the redesign and development phases of the project, including any transition towards outsourced ICT operational support arrangements. [38530/26]
Amharc ar fhreagra338. Deputy Peadar Tóibín asked the Minister for Health whether any ICT-related works or preparatory works commenced prior to the completion of formal tendering or procurement processes; if so, the circumstances under which this occurred; whether she has assessed the operational implications of ICT support personnel being required to operate from off-site locations rather than from dedicated on-site ICT operational facilities, including implications for operational resilience, emergency response times, cybersecurity co-ordination, logistics and staff safety. [38532/26]
Amharc ar fhreagra344. Deputy Peadar Tóibín asked the Minister for Health the current operational model for ICT services at the National Children's Hospital; the extent to which ICT support will be delivered onsite versus offsite; the number of ICT staff planned for onsite deployment; the rationale for any reduction from earlier plans for a dedicated ICT operations floor; and the assessment undertaken of risks to operational resilience, emergency response times, and patient safety arising from this model. [38540/26]
Amharc ar fhreagraI propose to take Questions Nos. 335, 336, 338 and 344 together.
As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
337. Deputy Peadar Tóibín asked the Minister for Health whether she will provide a breakdown of all contracts, tenders and expenditure associated with ICT integration, commissioning, infrastructure, electronic health record systems and operational ICT services connected with the National Children's Hospital project, including all contracts awarded to a company (details supplied) or associated entities. [38531/26]
Amharc ar fhreagra345. Deputy Peadar Tóibín asked the Minister for Health the total expenditure to date and projected final cost associated with ICT systems at the National Children's Hospital, including contracts awarded for infrastructure, integration, commissioning and electronic health records; the details of any contracts awarded to a company (details supplied); the procurement process followed; and whether an independent review has been conducted to assess value for money and operational effectiveness. [38541/26]
Amharc ar fhreagraI propose to take Questions Nos. 337 and 345 together.
As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
339. Deputy Peadar Tóibín asked the Minister for Health if she will provide details of the final catering and restaurant facilities planned for the new National Children's Hospital, including the seating capacity, operating hours and facilities available for parents, overnight families, visitors and staff. [38533/26]
Amharc ar fhreagra340. Deputy Peadar Tóibín asked the Minister for Health whether she has carried out any assessment regarding the adequacy of restaurant and welfare facilities for lower-paid staff, long-stay families and clinical personnel working extended shifts within the new hospital. [38534/26]
Amharc ar fhreagra346. Deputy Peadar Tóibín asked the Minister for Health the rationale for the scale and design of catering and restaurant facilities at the National Children's Hospital; whether a full-service staff and family restaurant was included in earlier design phases; the reasons for any changes made; and the assessment undertaken of the impact of current catering arrangements on staff wellbeing, patients, and families requiring long-term stays. [38542/26]
Amharc ar fhreagraI propose to take Questions Nos. 339, 340 and 346 together.
As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
341. Deputy Peadar Tóibín asked the Minister for Health the total number of parking spaces to be provided at the new National Children's Hospital campus; the projected staffing levels for the campus; the number of parking spaces that are reserved or allocated for senior management, consultants, or administrative personnel; whether any assessment has been carried out regarding the adequacy and allocation of parking provision for staff, families, shift workers, on-call personnel, technical support staff, and emergency operational requirements; and if she will make a statement on the matter. [38535/26]
Amharc ar fhreagra347. Deputy Peadar Tóibín asked the Minister for Health the number of car parking spaces to be provided at the National Children's Hospital for staff, patients and visitors; the basis on which this level of provision was determined; whether it aligns with projected staffing levels and patient volumes; and the plans to address identified shortfalls, particularly for shift workers, on-call staff and families travelling long distances. [38543/26]
Amharc ar fhreagraI propose to take Questions Nos. 341 and 347 together.
As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
342. Deputy Peadar Tóibín asked the Minister for Health whether comparisons have been undertaken between the original planning layouts and revised floor plans for the hospital to determine whether operational infrastructure, including ICT facilities, staff welfare accommodation, restaurant facilities or parking provision, was reduced during later redesign phases of the project. [38536/26]
Amharc ar fhreagra343. Deputy Peadar Tóibín asked the Minister for Health whether any review has been undertaken into the way in which office and administrative space within the new National Children's Hospital was allocated, including whether increases in office accommodation for management, consultants or administrative functions reduced space available for operational infrastructure such as ICT facilities, staff welfare areas, restaurant facilities, or other support services; and if she will make a statement on the matter. [38537/26]
Amharc ar fhreagraI propose to take Questions Nos. 342 and 343 together.
As this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
