Written Answers Nos. 615-635
615. Deputy Ken O'Flynn asked the Minister for Health whether her Department has approved or endorsed any maximum acceptable waiting time threshold for access to primary care occupational therapy services; whether a waiting period of up to 39 weeks is considered clinically appropriate at national level; and if she will outline the evidence, clinical guidance, or policy framework underpinning that position. [16031/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
616. Deputy Ken O'Flynn asked the Minister for Health whether she accepts that operating a service at 75% of funded ceiling constitutes a failure of workforce planning at departmental level; and the specific corrective actions that have been mandated by her Department in response. [16032/26]
Amharc ar fhreagra617. Deputy John McGuinness asked the Minister for Health if the drug sky clarys (omaveloxolone) used for the treatment of Friedreichs ataxia will be made available under licence in Ireland; if she will outline the process to licence the drug; the timeline involved; and if she will make a statement on the matter. [16033/26]
Amharc ar fhreagraUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, I have asked the HSE for an update in 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 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.
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: https://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.
618. Deputy Ken O'Flynn asked the Minister for Health whether her Department has approved a workforce planning model quantifying the additional whole-time-equivalent occupational therapy posts required in Cork South-West primary care services to achieve a maximum waiting time of 12-weeks for adults and children; and if she will provide the number of additional posts identified under that model. [16034/26]
Amharc ar fhreagra“As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.”
619. Deputy Ken O'Flynn asked the Minister for Health whether the Health Service Executive has submitted, in 2024 or 2025, a formal funding request to her Department seeking approval for additional occupational therapy whole-time-equivalent posts in Cork South-West primary care services; if so, the number of posts requested, the estimated annual cost, and the decision taken by her Department on that request. [16035/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
620. Deputy Ken O'Flynn asked the Minister for Health whether her Department has set a policy standard for maximum waiting times in adult and paediatric primary care occupational therapy services; whether 12-weeks remains the intended benchmark; and if not, the revised benchmark now accepted by her Department. [16036/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
621. Deputy Ken O'Flynn asked the Minister for Health the funded whole-time-equivalent ceiling for occupational therapy posts in Cork South-West primary care services for each of the years 2022, 2023, 2024 and 2025; the actual whole-time-equivalent staffing level in each of those years; and the variance between funded ceiling and actual staffing. [16037/26]
Amharc ar fhreagra“As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.”
622. Deputy Ken O'Flynn asked the Minister for Health whether her Department has conducted or commissioned any assessment of the impact of primary care occupational therapy waiting times exceeding 39-weeks on child development outcomes and adult rehabilitation; and if she will provide details of any such assessment. [16038/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
623. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the Health Service Executive maintains data on medical card refusal rates disaggregated by age cohort; if so, whether she will provide the refusal rate for applicants aged 70 years and over in each of the years 2020 to 2025; and if not, the reason such data is not maintained. [16039/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
624. Deputy Ken O'Flynn asked the Minister for Health the gross and net weekly income thresholds applicable to applicants aged 70 years and over for a full medical card in each of the years 2020 to 2025; whether any interim administrative adjustments, circulars, or guidance notes altered the application of those thresholds during that period; and if she will provide copies of any such policy directions. [16040/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
625. Deputy Ken O'Flynn asked the Minister for Health whether her Department currently receives routine, standardised reports from the Health Service Executive on gender identity services for minors, including referral numbers, waiting list numbers, assessment outcomes, numbers progressing to medical intervention, and associated expenditure; if so, the frequency and format of such reporting; and if she will make a statement on the matter. [16053/26]
Amharc ar fhreagraMy Department relies upon the Code of Practice for Governance of State Bodies for governance and safeguarding issues and ensures that all aegis bodies are in compliance with this Code.
Officials in my Department that have oversight of aegis body responsibilities present to the Departmental Corporate Governance Committee on a two-year cycle. This ensures that aegis bodies are reviewed regularly and that my Department holds all aegis bodies accountable to high standards.
As the Deputy will be aware and as set out in the Programme for Government 2025, this Government is committed to ensuring a transgender healthcare service that is based on clinical evidence, respect, inclusiveness and compassion.
It is in this context that my Department has provided funding to the HSE in 2024, 2025 and this year for the establishment and development of the National Clinical Programme for Gender Healthcare. This programme is developing an updated clinical Model of Care with the aim of designing clinical pathways to deliver safe and effective health and social care for those seeking gender affirming healthcare services. This work will also inform an implementation plan for its delivery.
626. Deputy Ken O'Flynn asked the Minister for Health the specific safeguarding and clinical governance standards that currently apply to gender identity services for minors pending the completion of the new Model of Care; whether these standards require full psychiatric assessment, comprehensive developmental history, screening for autism spectrum conditions, and documented differential diagnosis prior to consideration of any medical intervention; and if she will make a statement on the matter. [16054/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
627. Deputy Ken O'Flynn asked the Minister for Health whether any internal audit, clinical audit, external review, or governance assessment has been conducted since 2020 in respect of gender identity services provided to minors, including referrals abroad where applicable; if so, to provide the date and high-level findings of such reviews; and if she will make a statement on the matter. [16055/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
628. Deputy Ken O'Flynn asked the Minister for Health what national dataset currently exists for the purposes of planning, oversight and evaluation of gender identity services for minors; whether this dataset captures referral source,diagnostic profile, co-morbidities, intervention pathway, outcomes, and costs; whether any data gaps have been formally identified by her Department; and if she will make a statement on the matter. [16056/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
629. Deputy Ken O'Flynn asked the Minister for Health the total annual expenditure incurred by the Health Service Executive in respect of gender identity services for minors in each year since 2020, including domestic services, overseas referrals, and ancillary supports; whether expenditure is subject to specific budget ceilings or value-for-money review; and if she will make a statement on the matter. [16057/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
630. Deputy Peter 'Chap' Cleere asked the Minister for Health if there are plans to return oncology services to Saint Luke’s Hospital, Kilkenny from UPMC; and if she will make a statement on the matter. [16073/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
631. Deputy Eoin Ó Broin asked the Minister for Health to provide an update on the development of a model for a vaccine damage scheme; the timeframe for the commencement of a scheme; and if she will make a statement on the matter. [16075/26]
Amharc ar fhreagraSignificant 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.
632. Deputy Pádraig Rice asked the Minister for Health the reason a HSE webpage is currently unavailable (details supplied); the length of time that it has been down; the timeline for it going live again; and if she will make a statement on the matter. [16085/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
634. Deputy Gillian Toole asked the Minister for Health the contingency plan in place for the provision of general practitioner services in Ratoath and Dunboyne County Meath, pending the retirement of general practitioners from the provision of medical services in these towns, during the first quarter of 2026; and if she will make a statement on the matter. [16104/26]
Amharc ar fhreagraGPs are self-employed practitioners and therefore may establish practices at a place of their own choosing. There is no prescribed ratio of GPs to patients, and the State does not regulate the number of GPs that can set up in a town or community.
Under the GMS scheme, the HSE contracts GPs to provide medical services without charge to medical card and GP visit card holders. Currently there are 2,600 GPs contracted to provide services under the GMS Scheme. A further 637 GPs do not hold a GMS contract but hold some other contract(s) with the HSE for the delivery of health services.
Where a vacancy arises in a practice with a GMS contract, the HSE becomes actively involved in the recruitment process to find a replacement GP for the panel concerned. While recruitment is ongoing, the HSE put a locum or other suitable arrangement in place to provide continuity of care. As of January, there were 19 GMS vacancies across the country, less than 1 percent of the total number of GMS panels.
In relation to GMS vacancies in Ratoath and Dunboyne specifically, as this is a service matter, have asked the HSE to respond to the Deputy directly as soon as possible.
635. Deputy David Cullinane asked the Minister for Health the number of capital projects submitted to the HSE estates for Waterford city and county from acute, primary, community, mental health and other services over the past ten years; the status of each project; whether they are at appraisal, design, planning or construction or any other phase codified by HSE estates; the current status of each project, by year; and if she will make a statement on the matter. [16111/26]
Amharc ar fhreagraAs the Health Service Executive is responsible for the delivery of public healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.
