Tuesday, 3 Mar 2026

Written Answers Nos. 772-794

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Health Services

Questions (772)

John Brady

Question:

772. Deputy John Brady asked the Minister for Health the status of Section 39 pay restoration for organisations funded by her Department; the reason workers in an organisation (details supplied) funded by her Department have received only one round of restoration while HSE-funded colleagues have received full restoration and scheduled increases; her plans to ensure full parity of pay and eliminate the resulting disparity among staff; and if she will make a statement on the matter. [16619/26]

Written answers

Minister for Health (Deputy Jennifer Carroll MacNeill)

The Department of Health provides in the region of €4.6m in funding annually to approximately 61 projects under the remit of drug task forces under the Drugs Initiative budget. This level of funding was provided in 2023, 2024 and 2025. Additional core funding of €320,000 was allocated in 2024 in the context of the October 2023 Workplace Relations Commission pay agreement. This funding will also be provided in 2026.

The HSE provides a further €22m for the provision of community-based drug services in task force areas.

The Department of Health carried out an internal review of employee pay in the community drug and alcohol services it funds in 2024. The review was undertaken in the context of the October 2023, Workplace Relations Commission (WRC) agreement on pay for workers in Section 39 organisations.

Arising from the review, and informed by the WRC agreement, the Department approved a significant increase in investment grants for community drug and alcohol projects.

This amounts to an 8% increase in employee pay, phased as:

• 3% from 1 April 2023.

• Additional 2% from 1 Nov 2023.

• And a further 3% from 1 March 2024.

The WRC agreement referenced by the Deputy concluded on 10 March 2025 and provides funding for a 9.25% pay increase for organisations funded under Sections 39, 56, 10 and 40, in line with the Public Service Agreement 2024–2026. The agreement represents a significant step in narrowing pay gaps with comparable HSE roles.

These organisations are independent employers, and their pay and conditions are a matter for each employer, provided they comply with employment law. This agreement applies only to grant-funded organisations and does not extend to tendered service providers. Differences between organisations may therefore reflect differing funding arrangements. The Minister has no operational role in relation to staffing or pay decisions within these independent organisations.

The body referenced by the Deputy is funded by the Department of Health and is not formally covered by the 2025 WRC agreement. My Department intends to undertake a review to assess the costs of aligning the WRC increases to community drug and alcohol projects it directly funds including the body referenced by the Deputy.

In addition, the HSE, with ICTU and relevant Departments and agencies, is undertaking a detailed data-gathering exercise on low pay in the sector, which will inform future policy and funding considerations.

Disabilities Assessments

Questions (773)

Michael Healy-Rae

Question:

773. Deputy Michael Healy-Rae asked the Minister for Health if a referral for an autism assessment could take place sooner than the current waiting time (details supplied); and if she will make a statement on the matter. [16675/26]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

HIV Incidence

Questions (774)

Colm Burke

Question:

774. Deputy Colm Burke asked the Minister for Health if Ireland will leverage its upcoming Presidency of the EU to spotlight a collaborative effort across the EU to eradicate HIV as a public health threat by 2030, given previous success by Ireland in this public health area through the Dublin Declaration in 2004; and if she will make a statement on the matter. [17035/26]

Written answers

Minister for Health

Ireland’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.

Departmental Policies

Questions (775)

Barry Ward

Question:

775. Deputy Barry Ward asked the Minister for Health the position regarding the regulation of the advertising and promotion of infant and follow-on formula both in traditional media and online; the actions she will take to address this; and if she will make a statement on the matter. [16469/26]

Written answers

Minister of State at the Department of Health (Deputy Jennifer Murnane O'Connor)

In alignment with international best practice and evidence-based research, national health policy (including the Healthy Ireland Framework, the National Maternity Strategy, the Obesity Policy and Action Plan, and the National Cancer Strategy) emphasises the importance of supporting mothers to breastfeed as well as taking action to increase breastfeeding rates in Ireland.

The Department of Health has engaged with Coimisiún na Meán, as the competent authority to establish a regulatory framework for online safety, update the regulation of television broadcasting and audiovisual on-demand services, and transpose the revised Audiovisual Media Services Directive into Irish law.

In 2023, the Department set up an inter-departmental group with Coimisiún na Meán and other agencies to ensure online safety codes relating to the marketing of foods high in fat, salt and sugar and also follow on formula, where there is a public health concern with regard to the health of children remains a priority for an Coimisiún. Officials in the Department of Health have engaged with the Coimisiún na Meán to discuss developments in relation to such codes. The Department has also made two submissions to the public consultations held by Coimisiún na Meán in January and December 2024. Coimisiún na Meán have indicated that the restriction of advertisement of infant formula and breastmilk substitutes is included in their work plan for the future and the Department expects to be involved in further discussions around this area in due course.

The World Health Organisation (WHO) established the WHO International Code of Marketing Breastmilk Substitutes to promote safe and adequate nutrition for infants, by the protection and promotion of breastfeeding and by ensuring the proper use of breast-milk substitutes. The Code applies to breast milk substitutes (infant formula) when marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breast milk.

Under EU legislation, the requirements for promotional and commercial practices for infant formula are set out in Commission Delegated Regulation (EU) 2016/127. These measures are designed so that the marketing and distribution of infant formula does not interfere with the protection and promotion of breastfeeding. The Health Service Executive (HSE) Breastfeeding Action Plan Progress Report action 3.13 regarding strengthening compliance with the international Code of Marketing of Breastmilk Substitutes noted that provisions in relation to the marketing of commercial milk formula have been included in clinical infant feeding polices for maternity and primary care services and within the National Standards for Infant feeding in Maternity Services. In 2021, the HSE launched a national policy on the marketing of breast milk substitutes to protect parents and staff along with a guidance document for working within the code.

In 2025 the Department of Health formed a breastfeeding steering group to research and design the development of a new whole of government breastfeeding policy. While there has been a significant amount of implementation of the actions under the HSE Breastfeeding Action Plan, further implementation of these actions is required under the development of a new whole of government breastfeeding policy, including implementation of the WHO Code.

The Department has engaged independent strategy company MCCP to oversee the consultation process to assist the development of a new national breastfeeding strategy. In November 2025, the Department hosted a large multistakeholder event which included members from academic, advocacy and interdepartmental groups alongside colleagues from Northern Ireland. These groups included a member from Baby Law Feeding Group Ireland (BLFGI). The outcomes of this consultation will inform the development of a national breastfeeding strategy. In addition to this consultation, the department will further engage with BLFGI in future consultations that will be conducted through the All-Island Breastfeeding Network.

In addition to stakeholder engagement, consultation with Coimisiún na Meán is ongoing in the development of the new Obesity Policy and Action Plan and the new Breastfeeding Strategy in respect to regulation of marketing of High fat salt and sugar foods and for breastmilk substitutes.

The Deputy will be aware of the recommendations from the seventy-eight World Health Assembly Resolution entitled: “Regulating the digital marketing of breast-milk substitutes” published on the 27th of May 2025. The recommendations include engaging all government agencies responsible for implementation of the International Code of Marketing of Breastmilk Substitutes, the Guidance on ending the inappropriate promotion of foods for infants and young children and the Guidance on regulatory measures aimed at restricting digital marketing of breast-milk substitutes. The recommendations made in the WHA resolution are being addressed in the ongoing consultation with Coimisiún na Meán and will be considered by the Breastfeeding Steering group in the development of a national breastfeeding strategy.

The Department intends to build on the work of the HSE Breastfeeding Plan through the development of this new Breastfeeding Strategy and remains committed to increasing breastfeeding supports to all mothers and families in Ireland. A new national Breastfeeding Strategy is expected to be published this year.

Medical Cards

Questions (776)

Cathal Crowe

Question:

776. Deputy Cathal Crowe asked the Minister for Health if there is scope for discretionary medical cards to be granted more consistently in cases of chronic illness, or for broader reform of the medical card system; the specific criteria used in assessing eligibility for discretionary medical cards; and if she will make a statement on the matter. [16214/26]

Written answers

Minister for Health

Medical Card provision is primarily based on financial assessment. In accordance with the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE, which assesses each application on a qualifying financial threshold. This is the amount of money that an individual can earn a week and still qualify for a card. It is specific to the individual’s own financial circumstances.

People under 70 are assessed under the general means tested medical card thresholds which are based on an applicant’s household income after deduction of tax, PRSI and Universal Social Charge. Certain expenses are also taken into account. Detailed guidelines are available at: www2.hse.ie/services/schemes-allowances/medical-cards/applying/assessment/. People aged 70 or older are assessed under medical card income thresholds which are based on gross income. However, those aged over 70 can also be assessed under the general means tested scheme where there are particularly high medical costs. Details are available at:www2.hse.ie/services/schemes-allowances/medical-cards/other-types-of-medical-card/over-70s/.

The issue of granting medical cards on the basis of illness or a disability was previously examined in 2014 by the HSE Expert Panel on Medical Need and Medical Card Eligibility. The Group concluded that it was not feasible, desirable, nor ethically justifiable to list medical conditions in priority order for medical card eligibility. In following the Expert Group’s advice, a person’s means remains the main qualifier for a medical card.

However, every effort is made by the HSE, within the framework of the legislation, to support applicants in applying for a medical card - in particular, to take full account of difficult circumstances in the case of applicants who may be in excess of the income guidelines. In such circumstances, the HSE may exercise discretion and grant a medical card, for example:

• Discretionary medical cards issued to patients with significant medical expenses but who do not satisfy the means test.

• Emergency medical cards are issued to patients that are terminally ill, or are seriously ill, and in urgent need of medical care that they cannot afford.

I can assure the Deputy that, to ensure the medical card system is responsive and sensitive to people's needs, my Department keeps medical card issues under review and any changes are considered in the context of any potential broader implications for Government policy, the annual budgetary estimates process and legislative requirements arising.

Regarding the specific criteria used in assessing eligibility for discretionary medical cards, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Healthcare Policy

Questions (777)

Cathal Crowe

Question:

777. Deputy Cathal Crowe asked the Minister for Health if the monthly threshold under the drug payment scheme limit will be reviewed again in the near future (details supplied); if not, if additional flexibility will be applied on a case-by-case basis; and if she will make a statement on the matter. [16215/26]

Written answers

Minister for Health

The Drugs Payment Scheme (DPS) ensures that expenditure on approved prescribed medicines or medical appliances does not exceed a named threshold in any calendar month. The DPS is not means tested and is available to anyone ordinarily resident in Ireland. Currently, the DPS threshold is €80, so no individual or family pays more than that a month on approved prescribed medicines or medical appliances. The DPS significantly reduces the cost burden for people with ongoing expenditure on medicines. Considerations of further changes to the DPS threshold will be made in the context of current healthcare priorities and the budget available.

However, people who cannot, without undue hardship, arrange for the provision of medical services may be eligible for a medical card. In accordance with the provisions of the Health Act 1970 (as amended), eligibility for a medical card is determined by the HSE. In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness.

In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge. As you are aware, changes to the eligibility thresholds for GP visit cards will come into effect in April 2023 which will ensure that more people have access to this care free of charge.

The DPS is deliberately designed as a simple universal non-means tested scheme which is in place to protect those who do not qualify for a medical card. There is a process around means testing for medical cards which requires that the HSE consider hardship and inability to pay for required health care when making determinations around eligibility for healthcare services. The introduction of diverse DPS thresholds would introduce a level of complexity into the operation of the scheme that is not justified when there is another scheme in place to assist in cases of hardship.

Further information regarding these schemes is available at www2.hse.ie/costs-schemes-allowances/.

Finally, individuals may also be entitled to claim tax relief on the cost of their medical expenses. This includes medicines prescribed by a doctor, dentist, or consultant. Relief is at the standard tax rate of 20%.

Healthcare Policy

Questions (778)

Cathal Crowe

Question:

778. Deputy Cathal Crowe asked the Minister for Health to address matters concerning IBD care (details supplied) which extends beyond gastroenterologists and specialist nurses; and if she will make a statement on the matter. [16216/26]

Written answers

Minister of State at the Department of Health

As this is a service matter, I have asked the Health Service Executive to respond to the deputy as soon as possible.

Healthcare Policy

Questions (779)

Barry Ward

Question:

779. Deputy Barry Ward asked the Minister for Health the position regarding treatment for people suffering from a condition called Fragile X Syndrome; if this is under review within her Department; and if she will make a statement on the matter. [16227/26]

Written answers

Minister for Health

As 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.

Primary Care Services

Questions (780)

Eamon Scanlon

Question:

780. Deputy Eamon Scanlon asked the Minister for Health if she will examine the provision of basic minor-injury treatment services in primary care and out-of-hours services such as Caredoc, rather than directing such cases to emergency departments; if she accepts that patients presenting with minor injuries to emergency departments contributes to overcrowding; and if she will make a statement on the matter. [16231/26]

Written answers

Minister for Health

Minor Injury units provide safe and convenient care to recent minor injuries that do not require emergency department care. They can handle a variety of conditions, including broken bones (non-complex fractures), dislocations, minor burns and scalds, cuts and wounds. These units are designed to provide the same level of care for specific conditions as an Emergency Department (ED), but more locally and with significantly shorter waiting times.

Some Minor Injury units are located in, or within close proximity to, hospitals which allows for the clinic and its staff to access other hospital services. Patients may need to be referred if the required treatment cannot be provided at the Minor Injury unit, such as for orthopaedic or plastic surgery.

A range of community healthcare services are provided in primary care settings, such as public health nurse, physiotherapy and GP services. Out-of-hours GP cooperatives provide for urgent GP care outside of normal GP practice hours. GPs do not provide the same range of services that are provided at Minor Injury units. Patients who contact their GP or local out-of-hours GP service provider may be referred to a Minor Injury unit or their local ED, although a referral is not required to attend either service. Decisions to refer patients to further/other services are based on the clinical need of the patient.

The HSE website provides advice on when, depending on the patient’s condition, a patient should visit a Minor Injury clinic or attend their nearest ED. In addition, ahead of periods of expected increased healthcare demand, such as Bank Holiday weekends, the HSE publicly request persons who require treatment to consider the appropriate care service.

Last year, there were 222,697 attendances at Injury Units, representing a 5% increase compared to 2024. Crucially, the median Patient Experience Time (PET) in an Injury Unit remains exceptionally low at just 1.3 hours, ensuring that patients with non-life-threatening injuries can access the care they need much more quickly than in a traditional emergency department setting.

In 2023, the HSE undertook a National Injury Unit (IU) Review to examine the existing level of service and put forward recommendations to improve coverage, including:

• To standardise and expand the opening hours of all existing IUs to operate from 8am to 8pm, 7 days a week;

• To increase the number of IUs nationally to meet growing demand and improve geographical coverage.

The objective of the IU expansion programme is to provide more equitable access to IUs, to avoid longer waiting times in Emergency Departments (EDs), and to reduce unnecessary ED attendances of lower acuity patients.

As part of the HSE’s 2023 review, the geospatial and population implications of site options under consideration were assessed. The 2026 National Service Plan includes provision for the opening of additional IUs in Tallaght, Athlone, Carlow and Ballina.

Departmental Data

Questions (781)

Paul Lawless

Question:

781. Deputy Paul Lawless asked the Minister for Health the number of doctors who qualified in each of the years 2024 and 2025; the number of those graduates who subsequently entered employment within the Irish Health Service; and if she will make a statement on the matter. [16236/26]

Written answers

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Primary Care Centres

Questions (782)

Paul Lawless

Question:

782. Deputy Paul Lawless asked the Minister for Health if her attention has been drawn to the ongoing delays for patients seeking GP appointments at a particular primary care centre, where waiting times of up to two weeks are common; if she is further aware that elderly patients with scheduled appointments are often waiting over an hour beyond their allotted time with no prior notice; the measures being taken to address GP capacity pressures in the area; and if she will make a statement on the matter. [16243/26]

Written answers

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Health Services Staff

Questions (783)

Claire Kerrane

Question:

783. Deputy Claire Kerrane asked the Minister for Health if there is only one MS nurse for the whole of Connacht, if it is acknowledged that this is not enough; and if she will make a statement on the matter. [16252/26]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Civil Registration Service

Questions (784)

Pa Daly

Question:

784. Deputy Pa Daly asked the Minister for Health whether there is currently a registrar in post in the Tralee Civil Registration Office; if not, the reason an interim or deputy registrar has not been appointed; and if she will make a statement on the matter. [16256/26]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

Civil Registration Service

Questions (785)

Pa Daly

Question:

785. Deputy Pa Daly asked the Minister for Health the arrangements that are currently in place in County Kerry to ensure the timely registration of deaths; whether the Civil Registration Office in Killarney is now operating as the principal office for the county; whether its current opening hours are sufficient to meet demand; and if she will make a statement on the matter. [16257/26]

Written answers

Minister for Health

As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.

Departmental Schemes

Questions (786)

Mark Ward

Question:

786. Deputy Mark Ward asked the Minister for Health if her Department is developing a vaccine injury scheme; if so, the details of this scheme; the way in which a person can apply; and if she will make a statement on the matter. [16286/26]

Written answers

Minister for Health

Significant work has been completed by my Department to develop a model for a vaccine damage scheme and officials are continuing to refine the proposed model. It is my intention to bring the model to Cabinet for discussion and consideration in due course. Until the model has been considered and approved by Government, it is not possible to provide any further information in relation to the scheme's implementation.

Air Corps

Questions (787)

Aengus Ó Snodaigh

Question:

787. Deputy Aengus Ó Snodaigh asked the Minister for Health if she is aware of findings by public health expert (details supplied) two years ago which pointed to the need for a full occupational cohort study of mortality in the Air Corps; whether they have been asked to carry out such a study by the Defence Forces or the Department of Defence; and if she will make a statement on the matter. [16292/26]

Written answers

Minister for Health (Deputy Jennifer Carroll MacNeill)

This Question should be directed to my colleague, the Minister for Public expenditure, infrastructure, Public service reform and Digitalisation as the Civil Service occupational health service and the Office of the Civil Service Chief Medical Officer fall under his remit. Monitoring of occupational health risk is conducted by that Department.

Healthcare Policy

Questions (788, 791)

Barry Ward

Question:

788. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to the concerns of families of people suffering from Friedrichs ataxia in relation to the difficulty in obtaining treatment in Ireland; and if she will make a statement on the matter. [16311/26]

Barry Ward

Question:

791. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with families or support groups for people suffering from Friedrichs ataxia in Ireland; and if she will make a statement on the matter. [16314/26]

Written answers

Minister for Health

I propose to take Questions Nos. 788 and 791 together.

Friedreich’s ataxia (FRDA) is a rare genetic neurological condition characterized by slowly progressive ataxia and neuropathy with onset usually in the teenage years.

The Minister for Health regularly meets with patient advocacy and representative groups, including those suffering from rare diseases. In addition officials in the Department, the HSE and CHI have regular engagement with patient advocacy and representative groups.

The Minister for Health attended a briefing in Leinster House on Friedreich’s Ataxia on 24th February 2026. The briefing was led by a group of people who have been diagnosed with Friedreich’s Ataxia and their family members.

The briefing event showed the many challenges and obstacles that currently exist for those diagnosed with the illness, and the Department will resolve to ensure implementation of the National Rare Disease Strategy 2025 – 2030 and its vision, to ensure that all people living with a rare disease have access to equitable, inclusive, safe and cross-sectoral care throughout their life journey that will enable them to reach their full potential and to live their best lives.

Since the launch of the Strategy, an Implementation Oversight Group has been launched and met in February to begin work planning for the 11 recommendations. As implementation of the Strategy progresses, it is intended that patient representation is a key feature and will be embedded in all structures.

Healthcare Policy

Questions (789, 790)

Barry Ward

Question:

789. Deputy Barry Ward asked the Minister for Health the position regarding any research into the cost of annual treatment for a patient suffering from Friedrichs ataxia; and if she will make a statement on the matter. [16312/26]

Barry Ward

Question:

790. Deputy Barry Ward asked the Minister for Health the position regarding any research being carried out into the viability of providing treatment for people suffering from Friedrichs ataxia in Ireland; and if she will make a statement on the matter. [16313/26]

Written answers

Minister for Health

I propose to take Questions Nos. 789 and 790 together.

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, therefore, I have asked the HSE for an update on this matter.

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 robustly assesses 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.

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.

In terms of the specific details of the application for pricing and reimbursement of omaveloxolone (Skyclarys®):

The HSE received an application for pricing and reimbursement of omaveloxolone (Skyclarys®) on the 1st August 2024 from Biogen Idec (Ireland) Limited (the applicant) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.

• 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 2nd August 2024.

• The NCPE Rapid Review assessment report was received by the HSE on the 29th August 2024. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of omaveloxolone compared with the current standard of care.

• The HSE commissioned a full HTA on the 25th September 2024 as per agreed processes.

• The NCPE HTA Report was received by the HSE on the 16th December 2025. The NCPE recommends that omaveloxolone not be considered for reimbursement: www.ncpe.ie/omaveloxolone-skyclarys-hta-id-24033/.

• 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.

This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.

Question No. 790 answered with Question No. 789.

Question No. 791 answered with Question No. 788.

Covid-19 Pandemic Supports

Questions (792)

Pat Buckley

Question:

792. Deputy Pat Buckley asked the Minister for Health the current waiting times for each of the six long-Covid clinics; the funding that has been allocated annually to long-Covid services and research since 2021; the interim supports that exist for patients who are unable to access specialist clinics; the oversight mechanisms in place to ensure hospitals such as St. Vincent’s University Hospital and St. James’s Hospital are implementing the long-Covid Model of Care consistently; the national data being collected on the prevalence and severity of long-Covid; and when will this be publicly available. [16316/26]

Written answers

Minister for Health

As this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.

Vaccination Programme

Questions (793)

Mark Wall

Question:

793. Deputy Mark Wall asked the Minister for Health if she plans reduce the cost of the shingles vaccine for State pensioners and those who cannot afford the cost of the vaccine at the moment; and if she will make a statement on the matter. [16326/26]

Written answers

Minister for Health

The immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). NIAC considers the prevalence of the relevant disease in Ireland as well as international best practice in relation to immunisation when developing its advice.

The current NIAC guidelines state that the shingles vaccine may be considered for those aged 65 years and older, due to the greater burden and severity of disease in this age group and in those aged 18 years and older at increased risk of shingles.

The Health Information and Quality Authority (HIQA) has carried out a Health Technology Assessment (HTA) on the herpes zoster vaccine which protects against shingles. A HTA is a multidisciplinary research process that collects and summarises information about a health technology. HIQA’s HTA examined the evidence on the clinical effectiveness and safety of shingles vaccines. The cost effectiveness and budget impact were also reviewed, along with the ethical, social and organisational implications of including the vaccine in the adult immunisation schedule.

HIQA published this HTA on 19 July 2024. The HTA found that adding the shingles vaccine to the routine immunisation schedule, at the vaccine price at the time, for all adults aged 65 years and over would not be cost effective and would be associated with a substantial budget impact.

While the vaccine is considered safe and effective, its protective effect diminishes over time. HIQA also noted the substantial budget impact associated with vaccination. If made available to everyone aged 65 and older, vaccination would cost €218 million over five years.

Whilst the HTA found that the introduction of the shingles vaccine was not cost effective based on the cost of the vaccine, it found that it could be cost effective for vaccination of those at 75 years and 80 years if the cost of the vaccine was reduced by 80%.

Given that the healthcare budget is finite and decisions regarding increased spending relating to a change in one area could impact the provision of other health technologies and treatments within the healthcare system, the cost-effectiveness must be considered in any decision-making process.

My Department considered the findings of this HTA in 2024 and determined that the introduction of the vaccine could be reconsidered when the cost effectiveness of the vaccine is confirmed as being more favourable.

I can confirm that the introduction of the shingles vaccine to the immunisation schedule in Ireland is again being actively considered for a cohort of immunocompromised individuals, in line with NIAC advice and cognisant of the cost effectiveness of market pricing and available funding.

Health Screening Programmes

Questions (794)

Tom Brabazon

Question:

794. Deputy Tom Brabazon asked the Minister for Health to provide an update and timeline on the introduction of spinal muscular atrophy screening into Ireland’s newborn screening programme. [16335/26]

Written answers

Minister for Health

As Minister for Health, I am determined to support our screening programmes, which are a valuable part of our health service, enabling early treatment and care for many people, and improving the overall health of our population.

Currently, all babies (between 3 and 5 days old) are offered newborn bloodspot screening (generally known as the ‘heel prick’ test), which tests for nine rare but serious conditions that are treatable if detected early in life. The Programme for Government commits to continually reviewing the number of conditions babies are screened for.

Incremental progress continues to be made on the expansion of the National Newborn Bloodspot Screening Programme (NNBSP). In 2023, two recommendations from the National Screening Advisory Committee (NSAC) on the addition of Severe Combined Immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) to the NNBSP were approved.

In Budget 2024, an additional €1.4 million of new development funding was provided to support the SMA/SCID implementation process. Once both conditions have been fully implemented, the number of conditions screened for in Ireland will increase to 11.

In terms of the current implementation status, I am pleased to confirm that this process is in its final stages, with screening for both SCID and SMA expected to commence in April this year.

I am acutely aware of how difficult it is for parents, families and children who have received a diagnosis of a rare disease, and how challenging daily life can be for them. This is why I remain committed to the further expansion of screening in Ireland in accordance with internationally accepted criteria and best practice.

• Written Answers Nos. 758-771
• Written Answers Nos. 795-814