Written Answers Nos. 841-861
841. Deputy Michael Cahill asked the Minister for Health the steps being taken to address the lack of support and information on alternatives to abortion being offered to women facing unplanned and difficult pregnancies (details supplied); and if she will make a statement on the matter. [32332/25]
View answerTo support an individual in making an informed decision, the My Options service offers non-directive listening support, counselling and information for people experiencing an unplanned pregnancy. Information is available about all options, including continued pregnancy supports and abortion services. The ethos of the service is client centred and counsellors take their lead from the person contacting them for information and support.
Those experiencing an unplanned pregnancy who contact MyOptions are provided with a service staffed by experienced accredited counsellors. All counselling is provided in a non-judgemental, non-directive manner, which allows the individual experiencing the pregnancy (and their partner) the time and space to make the best decision for them. The individual is supported by the counsellor in whatever decision is made and counselling can continue throughout a pregnancy.
842. Deputy Barry Heneghan asked the Minister for Health the clinics that are held at a location Darndale health centre, Dublin 17; and the frequency in which each of these clinics are held, in tabular form. [32339/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
843. Deputy Barry Heneghan asked the Minister for Health the locations within CHO9 area where HSE substance misuse teams are based; the number of WTE staff, by job title working in each of these teams, by location, in tabular form. [32340/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
844. Deputy Barry Heneghan asked the Minister for Health the number of WTE consultant ENT surgeries are based at Beaumont Hospital in 2023, 2024 and to-date in 2025, in tabular form. [32341/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
845. Deputy Barry Heneghan asked the Minister for Health the number of WTE administrative staff, by grade working at Tonlegee Road primary care centre in 2024 and to-date in 2025, in tabular form. [32342/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
846. Deputy Aisling Dempsey asked the Minister for Health if there are plans to review all age-based exclusion criteria regarding spinal muscular atrophy treatments, given that adults were excluded from treatments as they were over 18 at the time of the original HSE approval. [32354/25]
View answer847. Deputy Aisling Dempsey asked the Minister for Health if there are plans to extend reimbursement for spinal muscular atrophy treatments to adults. [32355/25]
View answerI propose to take Questions Nos. 846 and 847 together.
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 pre-defined 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 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 (>18 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.
849. Deputy Peter 'Chap' Cleere asked the Minister for Health her views in relation to a matter (details supplied); and if she will make a statement on the matter. [32361/25]
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 devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.
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.
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.
Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.
In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):
On 25th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.On the 6th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).
A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).
As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.
850. Deputy Pádraig Rice asked the Minister for Health to provide further details in respect of the audit into governance and equity in patient access and waiting-list management at Children's Health Ireland, commissioned by her Department and the HSE; the reason this audit will review the methods of payments by private patients to consultants; the timeline she is working towards in completing this audit; and if she will make a statement on the matter. [32365/25]
View answerThe HSE CEO is commissioning an audit of governance and equity in patient access and waiting list management at Children's Health Ireland (CHI).
This audit will aim to assess governance and equity in access to care within CHI, and in particular the balance between public and private patient management. This will include a range of factors including methodologies of payments by private patients to consultants undertaking any private consultations on site.
As this is an operational matter, I have asked the HSE to respond to the Deputy directly, as soon as possible.
851. Deputy Marie Sherlock asked the Minister for Health the number of inspectors in HIQA in 2019 to 2024 and to date 2025; and if she will make a statement on the matter. [32368/25]
View answer853. Deputy Marie Sherlock asked the Minister for Health the rate of recruitment turnover of staff at the rank of inspector in HIQA for each of the years 2019 to 2025; and if she will make a statement on the matter. [32370/25]
View answerThe information requested by the Deputy is set out in the attached table, which provides a breakdown of HIQA inspectors on 1 January each year between 2019 & 2025, and the latest figure for June 2025. The inspectors are provided by division between designated centres for children, older persons, disability, Regulatory Practice Development Unit, healthcare (including permanent International Protection Accommodation Services inspectors), and HIQA’s Information Handling Centre.
|
Division |
1st Jan 2019 |
1st Jan 2020 |
1st Jan 2021 |
1st Jan 2022 |
1st Jan 2023 |
1st Jan 2024 |
1st Jan 2025 |
1st Jun 2025 |
|
Children’s |
12 |
14 |
15 |
14 |
13 |
14 |
14 |
15 |
|
Older Persons |
21 |
22 |
27 |
34 |
34 |
35 |
35 |
37 |
|
Disability |
33 |
37 |
35 |
40 |
40 |
40 |
40 |
39 |
|
Regulatory Practice Development Unit |
4 |
4 |
3 |
2 |
2 |
2 |
2 |
2 |
|
Healthcare |
12 |
14 |
13 |
12 |
16 |
20 |
28 |
27 |
|
Information Handling Centre |
1 |
1 |
1 |
1 |
1 |
0 |
||
|
Total |
82 |
91 |
94 |
103 |
106 |
112 |
120 |
120 |
In relation to the rate of recruitment turnover of staff at the rank of inspector in HIQA for each of the years 2019 to 2025, HIQA have provided the following number of leavers per year for the time period specified: 2019 – 8; 2020 – 2; 2021 – 3; 2022 – 11; 2023 – 10; 2024 – 2; 2025 (to date) – 1.
852. Deputy Marie Sherlock asked the Minister for Health the number of private nursing homes that the HSE have taken control of; to set out the reason, clinical or financial, for 2019 to 2024 and to date in 2025; and if she will make a statement on the matter. [32369/25]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
854. Deputy Marie Sherlock asked the Minister for Health for breakdown of agency spend, per job rank/type, in HIQA, for each of the years 2019 to 2025; and if she will make a statement on the matter. [32371/25]
View answerThe information requested by the Deputy, which has been provided to me by HIQA, is set out in the attached table.
HIQA - Breakdown of Agency Staff Expenditure by Area of the Organisation - 2019 to 2025
|
2019 |
|
|
Information Technology |
512,189 |
|
Regulation Support |
233,258 |
|
Health Technology Assessment |
152,935 |
|
Health Information and Standards |
296,051 |
|
Corporate Services |
174,313 |
|
Total |
1,368,746 |
|
2020 |
|
|
Information Technology |
420,258 |
|
Regulation Support |
67,436 |
|
Health Technology Assessment |
89,710 |
|
Health Information and Standards |
263,559 |
|
Communications |
29,816 |
|
Corporate Services |
354,449 |
|
Total |
1,225,228 |
|
2021 |
|
|
Information Technology |
601,395 |
|
Regulation Support |
192,371 |
|
Health Technology Assessment |
85,808 |
|
Health Information and Standards |
154,440 |
|
Communications |
73,138 |
|
Corporate Services |
375,841 |
|
Total |
1,482,993 |
|
2022 |
|
|
Information Technology |
120,486 |
|
Regulation Support |
68,452 |
|
Health Technology Assessment |
161,282 |
|
Health Information and Standards |
117,533 |
|
Communications |
9,167 |
|
Corporate Services |
276,942 |
|
Human Resources |
89,228 |
|
Total |
843,090 |
|
2023 |
|
|
Information Technology |
244,892 |
|
Regulation Support |
98,505 |
|
Health Technology Assessment |
56,684 |
|
Health Information and Standards |
76,518 |
|
Corporate Services |
348,283 |
|
Human Resources |
411,535 |
|
Total |
1,236,417 |
|
2024 |
|
|
Information Technology |
283,894 |
|
Regulation Support |
482,997 |
|
Health Technology Assessment |
118,800 |
|
Health Information and Standards |
37,222 |
|
Communications |
91,834 |
|
Corporate Services |
432,495 |
|
Total |
1,447,242 |
|
Year to April 2025 |
|
|
Information Technology |
153,358 |
|
Regulation Support |
133,567 |
|
Health Technology Assessment |
55,847 |
|
Communications |
31,108 |
|
Corporate Services |
124,351 |
|
Human Resources |
122,876 |
|
Total |
621,107 |
855. Deputy Cathal Crowe asked the Minister for Health why nurses are currently not entitled to bereavement leave (details supplied) that is comparable to other public servants; if she proposes to rectify this; and if she will make a statement on the matter. [32378/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
856. Deputy Peadar Tóibín asked the Minister for Health further to Parliamentary Question No. 1165 of 13 May 2025, to outline the same relevant statistics for all individual hospitals which may have specific local arrangements in place with private entities for service provision. [32383/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
857. Deputy Peadar Tóibín asked the Minister for Health in relation to treatments paid for under the national treatment purchase fund where an individual received care in a private setting, if an agreed hourly rate is paid to clinicians agreed centrally, or agreed regionally or by provider; and to outline these for different types of treatment - surgical, exploratory and so on - since its inception. [32384/25]
View answerThis Government remains committed to increasing capacity in the public system and until that capacity is in place to meet the increased levels of demand, it’s appropriate that we make use of additional capacity in the public and private systems to ensure that patients have access to the care they need.
Accordingly, the Waiting List Action Plan approach includes targeting the delivery of additional capacity for patients in both public and private hospitals, through a coordinated approach by the HSE and the National Treatment Purchase Fund (NTPF).
NTPF Insourcing initiatives are governed by a Memorandum of Understanding (MOU) between the NTPF and the relevant public hospital. Under the MOU, the public hospital confirms that any such work is additional work over and above core hospital activity and is specifically carried out to reduce waiting lists. All governance for insourcing remains with the public hospital, based on specific treatment plans where a need is identified and a solution available. All work is approved at the appropriate senior level.
The NTPF also sources treatment and appointments for patients through outsourcing arrangements with Private Hospitals. This is done through a Panel Agreement established following a competitive tender competition. As with insourcing initiatives, while the NTPF identifies patients eligible for treatment, the clinical suitability is determined by the public hospital. The payment to the private hospital is based on a tendered price for the relevant procedure, and all payments to Consultants are a matter for the Private Hospitals.
The NTPF does not engage directly with, employ, or make payments to individual consultants.
858. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to the concerns of pharmacists regarding the prohibitive cost of the shingles vaccine, despite it being recommended by the National Immunisation Advisory Committee; if her Department has engaged with the manufacturer in any way to seek a reduction in price per unit; and if she will make a statement on the matter. [32385/25]
View answerThe 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.
859. Deputy Michael Healy-Rae asked the Minister for Health to examine the case for grant approval for a person (details supplied); and if she will make a statement on the matter. [32391/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
