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Gnáthamharc

Wednesday, 25 Jun 2025

Written Answers Nos. 207-227

Departmental Data

Ceisteanna (208)

Colm Burke

Ceist:

208. Deputy Colm Burke asked the Minister for Health the total number of people who have travelled abroad under the treatment abroad scheme to receive dental treatment for each of the years ending 31 December 2021, 31 December 2022, 31 December 2023, and 31 December 2024, in tabular form; and if she will make a statement on the matter. [34763/25]

Amharc ar fhreagra

Freagraí scríofa

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

Hospital Facilities

Ceisteanna (209)

John Connolly

Ceist:

209. Deputy John Connolly asked the Minister for Health for a projected date for the opening of the new surgical hub in Merlin Park; the services that will be provided therein; and if she will make a statement on the matter. [34774/25]

Amharc ar fhreagra

Freagraí scríofa

I have asked the HSE, as Sponsoring Agency with day-to-day responsibility for the delivery of the surgical hubs to respond to you directly in relation to the matters raised.

Health Strategies

Ceisteanna (210)

John Connolly

Ceist:

210. Deputy John Connolly asked the Minister for Health the efforts within her Department to develop a new national drugs strategy; and if she will make a statement on the matter. [34777/25]

Amharc ar fhreagra

Freagraí scríofa

The Programme for Government, 'Securing Ireland’s Future' sets out the Government commitment to a health-led approach to drugs use. The Government will assess the outcomes of the existing national drugs strategy and publish a successor strategy.

The successor strategy will be informed by the Citizens Assembly on Drug Use, an evaluation of the existing strategy, consultations with stakeholders, and developments in the EU drugs strategy and action plan.

The Department of Health has commissioned an independent evaluation of the existing national drug strategy. The report of the evaluation will shortly be published.

The Department has convened a number of consultations with stakeholders. Over 300 people attended the consultations that were facilitated and reported upon by independent consultants. The findings from the consultations will inform the development of the new national strategy.

I have established a Steering Group to develop a draft successor national drugs strategy by the end of the year.

It is my ambition that the new national drugs strategy will strengthen the health-led approach to drug use by addressing the health and social needs of people use drugs, reducing the harms associated with drugs, and supporting recovery from drug addiction.

Period Poverty

Ceisteanna (211)

Naoise Ó Cearúil

Ceist:

211. Deputy Naoise Ó Cearúil asked the Minister for Health the steps her Department has taken to develop a plan to make free period products accessible in more locations; and if she will make a statement on the matter. [34780/25]

Amharc ar fhreagra

Freagraí scríofa

Provisions to mitigate period poverty have been included in the Programme for Government, Securing Ireland's Future. Commitments include:

• Developing a plan to make free period products accessible in more locations (Women’s Health).• Provision of free period products in schools to ensure no student is held back due to period poverty (Education).

The Department of Health established an inter-Departmental Period Poverty Implementation Group (“IG”) in 2021 with representation from most Government Departments. The IG meets 2-3 times yearly; its purpose is to implement the recommendations of the Discussion Paper. Its most recent meeting was in early June, 2025. Its purpose is to achieve cross sectoral input and to co-ordinate oversight of implementation measures recommended by the Period Poverty in Ireland Discussion Paper published in February 2021.

These recommendations were supported by Government and include the following priorities:

• Expanding access to free period products in public buildings and publicly funded services.

• Partnering with services and NGOs to provide free period products to those in need.

• Supporting the evidence base through further research.

• Providing procurement supports.

The Implementation Group has been coordinating implementation across Government and enabling wider access to period products; significant developments include:

• The availability of free period products in most public facing bathrooms across the majority of Government Departments.

• The Hygiene Supplies and Period Equality Products Framework has been in place since June, 2023 and can be accessed by Government Departments, State Agencies and other public bodies through the Buyer Zone, Office of Government Procurement website. A wide variety of no-cost dispensers and re-usable and sustainable products are available through the Framework, in addition to traditional tampons and towels.

• A zero rate of VAT has been applied on newer forms of period products (mooncups, period panties, re-usable towels).

• Menstrual health and period poverty modules have been included in representative Surveys, supporting the evidence base.

• A number of other initiatives have been put in place by other Departments across Government.

In terms of period dignity measures put in place across the health sector and its partnerships, the Department of Health and HSE have been allocated funding for period poverty mitigation, totalling €914,000 in 2025. Annual funding has been in place since 2022 and grant schemes are now well established. The most urgent focus is on reaching those most in need (e.g., the homeless, those living with addiction, minorities including Traveller and Roma women, and those experiencing consistent poverty).

In terms of funding managed directly from the Department of Health, partnerships are in place, renewed annually, with local authorities, the Family Resource Centre National Forum and NGOs. The HSE National Social Inclusion Office is also supporting the 6 Health Regions to provide period dignity supports through their partnerships locally.

In 2025, the Department’s period dignity scheme has supported 24 Local Authorities. 10 NGOs and 46 Family Resource Centres through the FRC National Forum. Initiatives include supply of products through local authority buildings and facilities, family resource centres, community and charity partners, focus groups and local public awareness campaigns, and equipping publicly accessible, national and local government run buildings and facilities (e.g. libraries) with no-cost dispensers and free products in bathrooms.

In terms of expanding the evidence base, the 2022 Healthy Ireland Survey included a module on menstrual health and period poverty. The results indicated that 51% of women currently having periods had missed activities of daily living (e.g. school, college, work, sports, social activities) on occasion because of period symptoms, and that 24% had experienced period poverty.

Similarly, a shorter module on menstrual health and period poverty was included in the Health Behaviour in School-Aged Children Study, 2022, which found that 60% of girls old enough to have periods had missed school on occasion because of period symptoms and that 10% were impacted by period poverty.

The Healthy Ireland Survey reports and questionnaires can be accessed at: www.gov.ie/en/healthy-ireland/collections/healthy-ireland-survey-documents/#:~:text=Below%20are%20all%20the%20relevant%20Healthy%20Ireland%20Survey,2015%20-%202023%20are%20available%20here%20on%20data.cso.ie.

The Health Behaviour in School-Aged Children Study can be accessed at: www.universityofgalway.ie/hbsc/hbscireland/.

The Healthy Ireland and HSE National Social Inclusion Office teams have recently set up linked websites on the topics of menstrual health and period poverty/period dignity. The HSE site links to the HSE’s clinical advice on periods and to information leaflets.

The HSE Period Dignity site can be accessed here: www.hse.ie/eng/about/who/primarycare/socialinclusion/about-social-inclusion/news/hse-period-poverty-pilot.html.

The Women’s Health Fund was established in Budget 2021. This annual fund has supported a range of priority service areas for women, including support for additional period dignity funding in 2024 of approximately €80,000. The Programme for Government and Women's Health Action Plans commit to further developing the transformation in women’s health, which has included free contraception and HRT schemes. Both hormonal contraception and HRT can be used to manage period symptoms such as dysmenorrhoea, menorrhagia or pre-menstrual syndrome.

In collaboration with the Women’s Health Taskforce, I am committed to listening to and working for women in order to improve the health experiences and outcomes for women and girls in Ireland.

Vaccination Programme

Ceisteanna (212)

John Clendennen

Ceist:

212. Deputy John Clendennen asked the Minister for Health if recent evidence from UK studies indicating that the shingrix (recombinant zoster) vaccine may reduce the risk of dementia and provide cognitive benefits has been considered in her Department’s assessment of the vaccine for inclusion in the national immunisation schedule; if these potential wider health benefits will be factored into future evaluations of the vaccine’s cost-effectiveness and public health value; and if she will make a statement on the matter. [34783/25]

Amharc ar fhreagra

Freagraí scríofa

The national immunisation programme in Ireland is based on the advice of the National Immunisation Advisory Committee (NIAC). The committee's recommendations are based on the prevalence of the relevant disease in Ireland and international best practice in relation to immunisation. It makes recommendations on vaccination policy to my Department. NIAC continues to revise recommendations to allow for the introduction of new vaccines in Ireland and to keep abreast of changes in the patterns of disease. It also considers emerging evidence and therefore the immunisation schedule will continue to be amended over time.

Once a recommendation from NIAC has been received and considered by the Chief Medical Officer of my Department, a request can be made to HIQA to carry out a Health Technology Assessment. This assessment looks at the evidence of the effectiveness and safety of the vaccine. The assessment also looks at the value for money, cost, organisational, social and ethical issues of providing a new vaccine. The information is collected and presented in a systematic, unbiased and transparent manner.

The recombinant zoster vaccine (RZV, Shingrix) is licensed in Europe for the prevention of shingles and its most common complication, post-herpetic neuralgia.

NIAC recommends the RZV vaccine for adults aged 65 and older, and for adults aged 18-49 who are at increased risk of shingles.

My Department asked the Health Information and Quality Authority (HIQA) to carry out a Health Technology Assessment (HTA) on the herpes zoster vaccine which protects against shingles.

HIQA published this HTA on 19 July 2024. The HTA found that adding the shingles vaccine to the routine immunisation schedule would not be cost effective and would be associated with a substantial budget impact.

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

Legislative Measures

Ceisteanna (213, 214)

John Clendennen

Ceist:

213. Deputy John Clendennen asked the Minister for Health for an update on the implementation of the alcohol labelling provisions under the Public Health (Alcohol) Act 2018; and if she will make a statement on the matter. [34793/25]

Amharc ar fhreagra

John Clendennen

Ceist:

214. Deputy John Clendennen asked the Minister for Health if consideration is being given to delaying the implementation of the alcohol labelling provisions under the Public Health (Alcohol) Act 2018 which is due to come into effect in May 2026; and if she will make a statement on the matter. [34794/25]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 213 and 214 together.

The requirement for health warnings and health information on the labels of alcohol products was enacted at section 12 of the Public Health (Alcohol) Act 2018 on 17 October 2018. The Minister for Health made the Public Health (Alcohol) (Labelling) Regulations 2023 and commenced section 12 of the Act on 18 May 2023. The law will come into operation on 22 May 2026.

Question No. 214 answered with Question No. 213.

Pharmacy Services

Ceisteanna (215)

Michael Cahill

Ceist:

215. Deputy Michael Cahill asked the Minister for Health the strategies that are in place to ensure the continuous supply of prescription drugs to pharmacies throughout the country which have been negatively impacted by Brexit; and if she will make a statement on the matter. [34805/25]

Amharc ar fhreagra

Freagraí scríofa

Medicine shortages are, unfortunately, a feature of modern health systems worldwide and a global health problem. Issues surrounding security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years. The causes of such supply issues are multifaceted, ranging from pandemics, geopolitical events, perennial shortages of raw materials, manufacturing issues, quality issues, unexpected increased demand, commercial reasons, and distribution issues, such as those caused by geopolitical uncertainties. Currently, numerous shortage notifications lack specificity regarding the root cause.

In European legislation, marketing authorisation holders (the companies responsible for placing medicines on the market) are mandated to:

• provide continuous supply to a market that they serve and

• to notify national competent authorities where they expect there to be an interruption in supply.

There are several workstreams ongoing at a national and EU level to minimise the occurrence and mitigate the impact of shortages and to support increased supply chain transparency measures. Nationally, there is;

• Medicines Shortages Framework, operated by our medicines regulator, the Health Products Regulatory Authority (HPRA), on behalf of the Department of Health, which aims to help prevent potential shortages from occurring and to reduce the impact of shortages on patients by coordinating the management of potential or actual shortages across the health service as they arise.

• Medicines Criticality Assessment Group, convened by the Department of Health and chaired by the Health Service Executive (HSE).

• Clinical guidance, where appropriate, issued by the HSE.

The HPRA hosts a list of current and resolved shortages on its website: www.hpra.ie/find-a-medicine/for-human-use/medicine-shortages?data=eyJpZCI6bnVsbCwic2tpcCI6MCwidGFrZSI6MTAsInF1ZXJ5IjpudWxsLCJvcmRlciI6Imxhc3R1cGRhdGVkIERFU0MiLCJmaWx0ZXIiOiJBbGwifQ%3D%3D. The webpage is updated daily as the HPRA receives new information. In the event that patients or their carers are unable to source a medicine, they are advised to discuss possible alternatives with their doctor pending the resumption of normal supply.

The HPRA is not currently aware of any supply issues with Somatuline products. The HPRA have reached out to the marketing authorisation holder for Somatuline products to confirm the supply situation. Once an update has been received, my Officials will advise the Deputy directly via email.

Creatinine is not a medicinal product, it is a by-product of muscle breakdown. If the Deputy was intending to refer to Creatine, that would be a supplement and not a medicinal product. If it was intended to refer to a different medicinal product, I would invite Deputy Cahill to revert to my Office.

Hospital Facilities

Ceisteanna (216)

Michael Cahill

Ceist:

216. Deputy Michael Cahill asked the Minister for Health if funding will be provided to upgrade University Hospital Kerry to Model 4 Hospital status, thus enabling staff to administer radiotherapy treatment to patients who currently have to make the long daily round trips to Cork city hospitals; and if she will make a statement on the matter. [34806/25]

Amharc ar fhreagra

Freagraí scríofa

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

Medical Cards

Ceisteanna (217)

Michael Cahill

Ceist:

217. Deputy Michael Cahill asked the Minister for Health if she will consider providing medical cards in Budget 2026 to all those qualifying for an old age pension; and if she will make a statement on the matter. [34807/25]

Amharc ar fhreagra

Freagraí scríofa

Eligibility for a Medical Card is primarily based on a financial assessment which is conducted by the HSE in accordance with the Health Act 1970 (as amended). The HSE assesses each medical card 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.

Persons aged 69 and under are assessed under the general means tested medical card thresholds which are based on an applicant’s household income after tax and the deduction of PRSI and the Universal Social Charge. Certain expenses are also taken into account. Examples of allowable expenses include rent, mortgage, certain insurance costs, childcare, maintenance, nursing home net costs which help to increase the amount a person can earn and still qualify for a medical card. Detailed guidelines are available at: www2.hse.ie/services/schemes-allowances/medical-cards/applying/assessment/.

Persons aged 70 or older are assessed under medical card income thresholds which are based on gross income. The weekly gross medical card income thresholds for people aged 70 and over are currently €550 per week for a single person and €1050 for a couple. However, it should be noted that those aged over 70 can also be assessed under the general means tested scheme where there are particularly high costs, e.g., medication, nursing home fees. Furthermore, the Deputy may be aware that, since 2015, every individual aged 70 and over has automatic eligibility for a GP visit card.

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.

Where a person's sole income is derived from a social protection payment, he/she will be awarded a medical card.

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.

Healthcare Policy

Ceisteanna (218)

Michael Cahill

Ceist:

218. Deputy Michael Cahill asked the Minister for Health if an initiative will be considered whereby a subsidisation of fees for medical students in return for a set period practising in rural Ireland; and if she will make a statement on the matter. [34828/25]

Amharc ar fhreagra

Freagraí scríofa

Significant progress has been made by my department working in collaboration with the Department of Further and Higher Education, Research, Innovation and Science and the Higher Education Sector to increase the number of student training places across health-related disciplines to meet future demand for health services.

The Programme for Government 2025 includes commitments to provide more graduate entry medicine programmes focused on preparing students for careers in rural and remote medicine, ensuring those in under-served areas have access to skilled healthcare professionals.

In October 2022, the Higher Education Authority (HEA) ran an expression of interest (EOI) process seeking responses from Higher Education Institutions (HEIs) interested in building capacity in Dentistry, Pharmacy, Medicine, Nursing, and Veterinary Medicine. EOIs were sought from institutions with the capability to expand existing courses or create new courses in these areas.

In 2024 the HEA recommended the progression of several projects, including two new Medicine programmes: A Graduate Entry Rural and Remote Medicine Programme in the University of Galway, and a direct entry Medicine programme in the University of Limerick. At full roll out it is anticipated this will provide a further 78 student places per annum between both Universities, 48 of which will be available in the University of Galway Programme.

The Department of Further and Higher Education, Research, Innovation and Science currently provides a subsidy, via the HEA, to HEIs towards the cost of Graduate Entry Medicine (GEM) provision for EU student places. The subsidy provides support for broadening access to GEM programmes by assisting HEIs in providing the courses at lower fee rates for EU students than would otherwise be required for the HEIs to offer the courses on a sustainable basis.

Mental Health Services

Ceisteanna (219)

Conor D McGuinness

Ceist:

219. Deputy Conor D. McGuinness asked the Minister for Health if she will provide a list of all approved mental health centres currently registered with the Mental Health Commission; to indicate for each whether it is designated as an acute facility; the number of in-patient psychiatric beds available at each centre; and the number of instances in which a child was admitted to an adult psychiatric unit at each location, for each of the past ten years, in tabular form. [34843/25]

Amharc ar fhreagra

Freagraí scríofa

The Mental Health Commission's (MHC) 2024 Annual Report, which will be published this Friday, June 27, 2025, notes that the frequency and duration of the admission of children to adult approved centres continued to decrease last year.

Information on registered centres, bed numbers and child admissions to adult inpatient mental health units (approved centres) is available on the website of the MHC and can be found at the following link: www.mhcirl.ie/. 2024 figures for child admissions to adult units will be included in the Commission's 2024 Annual Report.

Hospital Services

Ceisteanna (220)

Barry Heneghan

Ceist:

220. Deputy Barry Heneghan asked the Minister for Health the current procedures in place to facilitate emergency marriages in hospital settings, particularly for patients who are terminally ill; if she will consider introducing a more compassionate and streamlined process, similar to best practices in other jurisdictions, to ensure that such marriages can take place quickly and with minimal administrative burden; and if she will make a statement on the matter. [34853/25]

Amharc ar fhreagra

Freagraí scríofa

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

Covid-19 Pandemic Supports

Ceisteanna (221)

Barry Heneghan

Ceist:

221. Deputy Barry Heneghan asked the Minister for Health the supports currently in place for healthcare workers suffering from long Covid, particularly those who contracted the virus in high-risk front-line settings; and if she will consider introducing a long-term, pensionable support scheme following the conclusion of the special leave with pay scheme; and if she will make a statement on the matter. [34854/25]

Amharc ar fhreagra

Freagraí scríofa

It is important to recognise the role that our healthcare workers played during the pandemic. They went beyond the call of duty, working in front-line environments, treating COVID-19 positive patients, particularly in the early days when the control measures that we now take for granted were not yet in place.

In response to this, a Temporary Special Scheme was put in place for 12 months in July 2022 to support eligible staff who were impacted by Long-COVID in the public health sector.

The intention of this scheme was to support those employees working in COVID-19 environments in the time before PPE and vaccinations were readily available.

It is my understanding that there are approximately 159 employees currently on the Special Scheme, the majority of whom have been supported on full pay for almost 5 years now.

My Department has always worked hard to ensure supports have been in place for those workers impacted by long-COVID, and at our request, the Department of Public Expenditure, Infrastructure, Public Service Reform and Digitalisation (DPER), have agreed to extend the scheme on four occasions already, most recently at the end of June 2024 when it was extended for a further 12 months for the existing cohort of employees already being supported by it.

However, I understand DPER have been clear that this is the final extension that would be granted, and as such, the Special Scheme will conclude on 30th June 2025.

I would like to re-assure those 159 employees who have been supported by the scheme for up to 5 years now, that they will continue to be supported, and the full provisions of the Public Service Sick Leave Scheme will apply for anyone who remains unable to return to work.

The sick leave scheme provides:

- Full pay for three months.

- Half pay for three months, followed by:

- Temporary Rehabilitative Remuneration (TRR) can provide up to a further 547 days of paid leave.

- The Critical Illness Protocol that forms part of the sick leave scheme may also provide additional supports for up to 3 years.

I am aware that concerns have been raised by a number of unions about the scheme ending, and I know that the matter was before the Labour Court again on the 11th of June 2025. The findings from this Court hearing are currently awaited.

I am also aware that the Minister for Social Protection has reviewed the EU recommendation in respect of the recognition of COVID-19 (not long-COVID) as an occupational illness, and I understand that following this review it was determined that COVID-19 did not meet the requirements to be recognised as an occupational illness in the context of the Occupational Injuries Benefit Scheme and the Social Welfare Consolidation Act.

Covid-19 Pandemic

Ceisteanna (222)

Barry Heneghan

Ceist:

222. Deputy Barry Heneghan asked the Minister for Health if she will clarify the Government’s position on formally recognising long Covid as an occupational illness, particularly in light of recent recommendations from the European Union; and if she will make a statement on the matter. [34855/25]

Amharc ar fhreagra

Freagraí scríofa

The Government recognises the risk that public health sector staff faced in management of the pandemic and in July 2022 introduced a Temporary Scheme of Paid Leave for Public Health Service Employees with Long-COVID that no other sector had.

While the EU Advisory Committee on Health and Safety recommended the recognition of COVID-19 (not long-COVID) as an occupational illness in health and social care settings, recognition of COVID-19 nationally as an occupational illness falls under the remit of the Minister for Social Protection.

After reviewing the EU recommendation, the Minister for Social Protection found that COVID-19 did not meet the requirements to be recognised as an occupational illness in the context of the Occupational Injuries Benefit Scheme and the Social Welfare Consolidation Act.

Healthcare Policy

Ceisteanna (223)

Barry Heneghan

Ceist:

223. Deputy Barry Heneghan asked the Minister for Health if she will review the current HSE criteria for access to approved treatments for spinal muscular atrophy, particularly in relation to the exclusion of approximately 20 adult patients who were over 18 at the time of initial approval; if she will engage with stakeholders, including two organisations (details supplied), to explore a fairer, needs-based approach; and if she will make a statement on the matter. [34856/25]

Amharc ar fhreagra

Freagraí scríofa

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Therefore, I have asked the HSE to provide an update in relation to treatments for SMA patients over 18 years of age.

The HSE has advised that once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement. All medicines are considered for pricing of reimbursement in order of application.

While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.

The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds. There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

In terms of the specific details of the application for pricing and reimbursement of risdiplam (Evrysdi®):

Reimbursement approval is in place for risdiplam (Evrysdi®) for the treatment of 5q spinal muscular atrophy (SMA) under the High Tech arrangements from the 1st September 2023. Reimbursement support is for a subgroup of the licensed indication.

As a condition of reimbursement, an individual patient approval system has been put in place by the HSE, to enable reimbursement for patients who meet the predefined criteria as per a HSE devised managed access protocol.

If the manufacturer of Risdiplam(Evrysdi® (Roche) submits a de novo application for adult patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3, that application will be duly progressed through the formal processes governing the pricing and reimbursement of medicines.

In terms of the specific details of the application for pricing and reimbursement of onasemnogene abeparvovec (Zolgensma®):

In October 2021, onasemnogene abeparvovec (Zolgensma®) was approved for reimbursement in Ireland following joint assessment and negotiations under the Beneluxa initiative for the treatment of patients with spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA type 1, or pre-symptomatic patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.

As a condition of reimbursement, an individual patient approval system has been put in place by the HSE, to enable reimbursement for patients who meet the pre-defined criteria as per a HSE devised managed access protocol.

www.hse.ie/eng/about/who/cspd/medicines-management/managed-access-protocols/onasemnogene-abeparvovec-zolgensma/managed-access-protocol-onasemnogene-abeparvovec-zolgensma.pdf

In terms of the specific details of the application for pricing and reimbursement of nusinersen (Spinraza®) for adult patients (>18 years):

The HSE approved funding of nusinersen (Spinraza®) effective 1st July 2019 for the treatment of 5q Spinal Muscular Atrophy (SMA) Type I, Type II and Type III in children under 18 years.

The HSE received a further application for pricing and reimbursement of nusinersen (Spinraza®) on the 17th September 2020 from Biogen (the applicant) indicated for the treatment of 5q Spinal Muscular Atrophy (SMA) in adult patients (greater than18 years).

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 28th September 2020.

The NCPE Rapid Review assessment report was received by the HSE on the 29th October 2020. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended for nusinersen (Spinraza®) to assess the clinical and cost-effectiveness compared to the current standard of care for adult patients (greater than18 years).

www.ncpe.ie/nusinersen-spinraza-hta-id-20044/

The HSE commissioned a full Health Technology Assessment on the 9th November 2020 as per agreed processes.

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 CPU met with Biogen regarding their application for Nusinersen (Spinraza®).

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. The pharmacoeconomic report will be reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group will consider all of the evidence and make 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.

A completed HTA is required from the applicant (Biogen) to progress this application, as per the formal processes governing the pricing and reimbursement of medicines. In the absence of a completed HTA the pricing and reimbursement application cannot progress.

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

Assisted Decision-Making

Ceisteanna (224)

Barry Heneghan

Ceist:

224. Deputy Barry Heneghan asked the Minister for Health if, in light of the major increase in the workload of an organisation (details supplied) arising from the Assisted Decision Making ( Capacity ) Act 2015 and the Assisted Decision Making (Capacity) ( Amendment) Act 2022, she will provide additional funding to this organisation to enable it to provide staff contracts of greater than one year; and if she will make a statement on the matter. [34857/25]

Amharc ar fhreagra

Freagraí scríofa

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

Hospital Services

Ceisteanna (225)

Barry Heneghan

Ceist:

225. Deputy Barry Heneghan asked the Minister for Health to provide details on the services currently provided for paediatric patients with epilepsy at a hospital (details supplied); the number and grade of staff that are currently attached to this service at this site; the number of current staff vacancies within this service; the number of epilepsy patients currently registered with this service; the number of patients currently awaiting first consultations; and if she will make a statement on the matter. [34858/25]

Amharc ar fhreagra

Freagraí scríofa

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

Regulatory Bodies

Ceisteanna (226)

Pádraig Rice

Ceist:

226. Deputy Pádraig Rice asked the Minister for Health to identify the legislation or statutory instrument that will provide the Health Information and Quality Authority with the power to investigate specific individual complaints; if the necessary provision has been commenced; the timeline for implementation of these powers; and if she will make a statement on the matter. [34874/25]

Amharc ar fhreagra

Freagraí scríofa

The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 contains provisions to give HIQA a discretionary power to carry out an independent review of a defined type of a serious patient safety incident, where some or all of the care of a patient was carried out in a nursing home. A minor technical amendment to the Patient Safety Act is required so that it can be commenced at the earliest possible date.

This provision will not replace the responsibility of nursing homes’ services to address concerns. However, it will support patients and their families when something goes seriously wrong with the care they received in a nursing home and will ensure that appropriate external processes are in place to review serious patient safety incidents.

My Department is actively working towards making this amendment to the Patient Safety Act so that the provision can be commenced at the earliest possible date. When commenced, this provision will further support HIQA in their important work to drive ongoing improvements for the many patients and families who rely on our health and social care services.

Emergency Departments

Ceisteanna (227)

Ruairí Ó Murchú

Ceist:

227. Deputy Ruairí Ó Murchú asked the Minister for Health the number of persons presenting at the emergency department of Our Lady of Lourdes Hospital, Drogheda, in the years 2023, 2024 and to date in 2025; and if she will make a statement on the matter. [34880/25]

Amharc ar fhreagra

Freagraí scríofa

As this is a service matter, I have asked the HSE to respond to the deputy directly.

Roinn