Written Answers Nos. 533-553
534. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains any central record, oversight mechanism, or reporting framework in respect of reimbursement applications for high-cost or rare disease medicines, including orphan drugs; and if not, how the Department exercises policy oversight of access to such medicines. [33750/26]
View answer535. Deputy Ken O'Flynn asked the Minister for Health whether any formal escalation, prioritisation, or exceptional review mechanism exists within the HSE or under her Department’s policy remit for reimbursement applications relating to rare or progressive neurological conditions, including Friedreich’s ataxia; and if she will detail the criteria and governance of any such mechanism. [33751/26]
View answer537. Deputy Ken O'Flynn asked the Minister for Health whether she considers it appropriate that no prioritisation framework exists within the State’s reimbursement system for life-limiting or progressive rare diseases; and whether any review of this policy position is underway.; and if she will make a statement on the matter. [33753/26]
View answerI propose to take Questions Nos. 534, 535 and 537 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 date72 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.
This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.
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.
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 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. The Minister for Health 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 begin the pricing and reimbursement process for a specific use (indication) of a medicine, the marketing authorisation holder (MAH) must submit an application to the HSE. A medicine must be licensed by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) for an application to be made to the HSE.
The MAH must continue to engage throughout the process with the HSE.
The HSE robustly assesses each application for pricing/reimbursement on objective, scientific, and economic grounds, and on the advice of the National Centre for Pharmacoeconomics to ensure that it can make more medicines available to Irish patients. This ensures that the right medicines are chosen, and approval is at a sustainable price.
536. Deputy Ken O'Flynn asked the Minister for Health the proportion of reimbursement applications for orphan or rare disease medicines that have been completed within the 180-day timeline referenced in policy agreements since 2021; and if she will provide a breakdown by year. [33752/26]
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.
538. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE maintains a national register or consolidated dataset of patients diagnosed with rare neurological conditions, including Friedreich’s ataxia; and if not, whether any plans are in place to establish such a dataset for service planning purposes. [33754/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
539. Deputy Ken O'Flynn asked the Minister for Health whether a nationally defined clinical pathway, model of care, or designated specialist service exists for patients diagnosed with Friedreich’s ataxia; and if not, how care is currently coordinated across the State. [33755/26]
View answerAs the matter raised is a service delivery matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
540. Deputy Ken O'Flynn asked the Minister for Health to clarify the current operational status of any early access or compassionate access schemes for rare disease medicines; and to confirm whether any such schemes are currently available to patients in Ireland. [33756/26]
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 262 new medicines since 2021 including 72 for rare diseases. For 2026, over €217m of additional funding has been made available for medicines including €30 million for new medicines.
The HSE PCRS do not currently operate or fund any early access or compassionate access schemes.
The State has successfully negotiated new Framework Agreements with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
As part of the Agreement talks, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of sandboxed early access programmes 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.
541. Deputy Ken O'Flynn asked the Minister for Health the timeline, governance structure, and eligibility criteria for the proposed “sandboxed early access programme” for rare diseases referenced in the National Rare Disease Strategy 2025–2030. [33757/26]
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 262 new medicines since 2021 including 72 for rare diseases. For 2026, over €217m of additional funding has been made available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements 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, the developers of new medicines 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.
542. Deputy Pádraig Rice asked the Minister for Health to provide clarification on the way in which the Mental Health Bill 2024 will be interpreted and applied in relation to adult transgender people seeking gender-affirming hormone therapy; to confirm whether informed consent through a GP, with appropriate information, will be the default pathway without the requirement for prior psychiatric or psychological assessment; and if she will make a statement on the matter. [33793/26]
View answerAs the Deputy will be aware and as set out in the Programme for Government 2025, this Government is committed to ensuring a transgender healthcare service that is based on clinical evidence, respect, inclusiveness and compassion.
It is in this context that my department has provided funding to the HSE in 2024, 2025 and this year for the establishment and development of the National Clinical Programme for Gender Healthcare. This programme is developing an updated clinical Model of Care with the aim of designing clinical pathways to deliver safe and effective health and social care for those seeking gender affirming healthcare services. This work will also inform an implementation plan for its delivery.
Developing a model of care for Gender Healthcare Services is a complex process and the HSE and my department are working closely together to support the process, ensure transparency and keep the patient at the centre of the process.
It is important that the HSE is given time to develop a model of care that is based on the best clinical evidence and that will deliver the best outcomes for persons with gender incongruence or dysphoria.
The Mental Health Bill 2024 completed all stages in the Oireachtas on 29 April 2026 and is with the President for her consideration. Should the Bill be enacted and commenced, it will, among other things, put in place statutory regulations that will apply to community-based mental health residences and services for the first time.
Department officials have begun preliminary work with the HSE and the Mental Health Commission to look at how best to operationalise the new legislation, including the regulation of community mental health services.
543. Deputy Pádraig Rice asked the Minister for Health the steps she is taking to address the gaps in neurological services identified in the recent report by an organisation (details supplied); the actions planned to improve equitable and timely access to specialist neurological services across the country; the timeline for implementation of these measures; and if she will make a statement on the matter. [33794/26]
View answerThe HSE Neurology Model of Care (2016) provides the framework for how neurology services should be developed and organised across the country based on international best practice and the HSE National Clinical Programme for Neurology is responsible for implementing this. It recognises that neurological care should be integrated and equitably distributed across the country and in that regard, it recommends that neurology services be developed in all model 3 and 4 hospitals. The National Clinical Programme for Neurology is actively working on a Hub and Spoke model to guide equitable neurology services around the country to align with the new health regions and to tackle the gaps in neurology services nationally. Budget 2025 allocated €4m for 30 WTEs for neurology services.
My Department is committed to working with all key stakeholders including the HSE, advocacy groups such as the Neurological Alliance of Ireland and patient partners to deliver on the investments made in neurology services in 2025 and commitments to improving neurology services in the Programme for Government.
As of 2026, decisions on the utilisation, prioritisation and reprioritisation of resources are at the discretion of the HSE Regional Executive Officers in alignment with the priorities set out in the HSE 2026 National Service Plan. This is within an overarching framework to remain within both budget and WTE limit. In that regard I have referred your question to the HSE for consideration and direct response to you.
544. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 958 of 3 March 2026, if the Alcohol Act Technical Evaluation Group submitted an interim report; if so, the date; if not, the timeline now being worked towards; and if she will make a statement on the matter. [33795/26]
View answerThe Alcohol Act Technical Evaluation Group (AATEG) was established in November 2024 to evaluate the provisions of the Public Heath (Alcohol) Act 2018. An interim report on the progress of the Group was submitted on 11 March 2026.
The Group will submit its final report on the evaluation of the provisions of the Act in 2027.
545. Deputy Barry Heneghan asked the Minister for Health the expected timeframe for the publication of the general scheme of the health (assisted human reproduction) (amendment) Bill; whether a timeline with target milestones has been set for the completion of drafting and Government approval; the current stage of work being undertaken by her Department, the Office of the Attorney General and the Office of Parliamentary Counsel; and if she will make a statement on the matter. [33806/26]
View answerThe Deputy will be aware 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.
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.
There has been intensive work between the three relevant Departments (the Department of Health, the Department of Justice, Home Affairs and Migration, and the Department of Children, Disability and Equality) in progressing the drafting of a General Scheme and policy paper, culminating with Government approval being secured for the drafting of the Health (Assisted Human Reproduction) (Amendment) Bill. The Joint Committee on Health completed its pre-legislative scrutiny of the Bill, based primarily on a policy paper provided by the three Departments, and published its report in October 2025.
As previously advised, the drafting of the Amendment Bill is at a well-advanced stage, led by the Office of Parliamentary Counsel, along with officials from the three relevant Departments. It will be a substantive piece of legislation, largely concerned with outstanding issues of parentage and citizenship, but will also make other necessary amendments to various other sections of the 2024 Act. I expect to be in a position to introduce the published Bill to the Dáil this term.
546. Deputy Barry Heneghan asked the Minister for Health the measures being taken by her Department and the HSE to improve access to multidisciplinary neurological services, including physiotherapy, speech and language therapy, neuropsychology, dietetics and inpatient neurorehabilitation; and if she will provide an indicative timeline for the implementation of these measures; and if she will make a statement on the matter. [33807/26]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
547. Deputy Barry Heneghan asked the Minister for Health whether a national plan is in place to ensure equitable access to specialist neurological services across all regions, having regard to reported disparities between centres; if she will outline any planned service expansions or workforce increases in this area; and if she will make a statement on the matter. [33808/26]
View answerThe HSE Neurology Model of Care (2016) provides the framework for how neurology services should be developed and organised across the country based on international best practice and the HSE National Clinical Programme for Neurology is responsible for implementing this. It recognises that neurological care should be integrated and equitably distributed across the country and in that regard, it recommends that neurology services be developed in all model 3 and 4 hospitals. The National Clinical Programme for Neurology is actively working on a Hub and Spoke model to guide equitable neurology services around the country to align with the new health regions and to tackle the gaps in neurology services nationally. Budget 2025 allocated €4m for 30 WTEs for neurology services.
My Department is committed to working with all key stakeholders including the HSE, advocacy groups such as the Neurological Alliance of Ireland and patient partners to deliver on the investments made in neurology services in 2025 and commitments to improving neurology services in the Programme for Government.
As of 2026, decisions on the utilisation, prioritisation and reprioritisation of resources are at the discretion of the HSE Regional Executive Officers in alignment with the priorities set out in the HSE 2026 National Service Plan. This is within an overarching framework to remain within both budget and WTE limit. In that regard I have referred your question to the HSE for consideration and direct response to you.
548. Deputy Barry Heneghan asked the Minister for Health for an update on current waiting times for neurology services; the current number of persons on neurology outpatient waiting lists by hospital group; the actions being taken to address these waiting lists; and if she will make a statement on the matter. [33809/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
549. Deputy Barry Heneghan asked the Minister for Health the number of persons on neurology outpatient waiting lists; the average waiting time for an appointment; the actions being taken to reduce these waiting lists, by hospital, for each of the years 2020 to 2026, in tabular form; and if she will make a statement on the matter. [33810/26]
View answerIt is acknowledged that many patients are still waiting too long for hospital appointments and treatments. I am conscious of the burden that this places on patients and their families.
I published the Waiting Time Action Plan (WTAP) for 2026 on January 30th, as part of this Government’s ongoing commitment to improving access to hospital care and reducing waiting times for patients.
The multi-annual Action Plan approach was implemented in September 2021 to sustainably reduce and reform hospital waiting lists and waiting times. Significant progress has been made under this approach in reducing the length of time patients are waiting.
With the 2026 plan, we will continue to build upon the progress delivered to date under the multi annual action plan approach, moving towards the ultimate vision of a public healthcare service in which everyone has timely access to high-quality scheduled care, where and when they need it.
National waiting list information by hospital, specialty, and time band is published monthly by the NTPF on its website: www.ntpf.ie/home/nwld.htm.
The information is now being made available through an interactive visual tool which provides users with a much-improved way of accessing and analysing waiting list information.
The specific information requested by the Deputy that is not readily available on the NTPF website in respect of average waiting times is set out in the attached spreadsheet.
The health system does not collect the data necessary to calculate the time to treatment of patients who have already received their care, which would be necessary to calculate the average waiting time for patients. The mean and median average waiting times provided to my Department by the NTPF and set out in the attached, are in respect of how long patients on lists have been waiting.
550. Deputy Barry Ward asked the Minister for Health the position regarding the funding and delivery of residential places for adults with intellectual disability; and if she will make a statement on the matter. [33812/26]
View answerThis PQ is not for the Department of Health. We respectfully request that this Parliamentary Question be redirected to the Department of Children, Disability and Equality, as the matters raised fall under their remit.
551. Deputy Barry Ward asked the Minister for Health her views on the merits of the provision of emergency funding for housing and full-time care for the adult children of aging parents; if this is under consideration within her Department; and if she will make a statement on the matter. [33813/26]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
552. Deputy Barry Ward asked the Minister for Health if she will provide a list of all capital projects, including hospitals, primary care centres and other health infrastructure works delivered by her Department or the HSE, which have been completed on time and within budget in Dublin in each of the past five years, in tabular form; and if she will make a statement on the matter. [33829/26]
View answerAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
553. Deputy Shane Moynihan asked the Minister for Health the number of Acts for which her Department has responsibility; the number of these that have official texts available in both English and Irish; the number that are available in English only; the number that are available in Irish only; and if she will make a statement on the matter. [33853/26]
View answerMy Department is currently collating the information requested and a reply will issue directly to the Deputy as soon as possible.
