Written Answers Nos. 1094-1117
1094. Deputy Ken O'Flynn asked the Minister for Health what governance structures currently oversee laboratory demand management, utilisation monitoring and value-for-money assessment in primary care laboratory services pending full implementation of the Regional Laboratory Networks and MedLIS programme; and if she will make a statement on the matter. [36999/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1095. Deputy Ken O'Flynn asked the Minister for Health the number of private home support providers currently contracted by the HSE under the Home Support Authorisation Scheme, in tabular form by region. [37011/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1096. Deputy Ken O'Flynn asked the Minister for Health the number of audits, inspections, compliance reviews or safeguarding investigations carried out in respect of private home support providers in each year from 2020 to 2026. [37012/26]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
1097. Deputy Ken O'Flynn asked the Minister for Health the number of instances in which a private home support provider was found non-compliant with Garda vetting, qualification verification or training standards in each year since 2020. [37013/26]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
1098. Deputy Ken O'Flynn asked the Minister for Health whether any private home support provider has had a contract suspended, restricted or terminated due to safeguarding, governance or quality concerns since 2020; and if she will provide details. [37014/26]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly as soon as possible.
1099. Deputy Ken O'Flynn asked the Minister for Health whether the HSE centrally records complaints, missed visits, safeguarding incidents or medication-related incidents involving privately contracted home support providers. [37015/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1100. Deputy Ken O'Flynn asked the Minister for Health whether unannounced inspections are carried out in respect of private home support providers operating under HSE contracts. [37016/26]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.
1101. Deputy Ken O'Flynn asked the Minister for Health whether the HSE publishes compliance or performance ratings for private home support providers funded by the State. [37017/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1102. Deputy Michael Cahill asked the Minister for Health to urgently address issues raised in correspondence (details supplied) and ensure that the access to medicines for those with rare diseases will never be an issue for families; and if she will make a statement on the matter. [37032/26]
View answerThe State recognises the importance of timely access to innovative medicines for patients in Ireland.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
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. The Minister has no role in decisions on pricing and reimbursement.
The Department has reached out to the HSE in relation to this matter.
The HSE has advised that it 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.
Regarding pegvaliase (Palynziq®), the HSE have advised that they received communication on the 11th December 2025 from BioMarin (the applicant) notifying the CPU of BioMarin’s intention not to appeal the HSE’s proposed decision not to reimburse pegvaliase (Palynziq®) for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
The HSE advise that the pricing and reimbursement application is now closed based on the correspondence received from BioMarin. The HSE will consider further offers from BioMarin, in line with the Health (Pricing and Supply of Medical Goods) Act 2013, should BioMarin wish to reapply for reimbursement for pegvaliase (Palynziq®).
1103. Deputy Ken O'Flynn asked the Minister for Health whether any independent external audit has been carried out since 2020 on counselling activity data submitted by HSE regions through the Corporate Information Facility; if so, to provide the date, body responsible, scope, findings and recommendations of each audit; and if no such audit has taken place, to confirm the reason [37044/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1104. Deputy Ken O'Flynn asked the Minister for Health whether her Department has received any formal assurance certificate, audit opinion, validation report or compliance statement confirming that counselling activity data reported nationally by the HSE is accurate, complete and comparable across all Health Regions [37045/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1105. Deputy Ken O'Flynn asked the Minister for Health whether a central national dataset exists showing the number of unique individuals accessing Counselling in Primary Care and National Counselling Service supports annually, separate from the number of referrals, appointments or sessions; and if not, whether she will require such data to be collected. [37046/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1106. Deputy Ken O'Flynn asked the Minister for Health whether counselling activity data currently reported to her Department distinguishes between new clients, returning clients, re-referrals, total appointments offered, total appointments attended, cancellations, DNAs and total sessions delivered; and if she will provide the most recent available breakdown by Health Region. [37047/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1107. Deputy Ken O'Flynn asked the Minister for Health whether her Department has assessed the risk that session-based counselling activity figures may overstate service reach where the same individual attends multiple sessions within a reporting period; and, if so, to provide the findings. [37048/26]
View answer1110. Deputy Ken O'Flynn asked the Minister for Health whether the Therapeutic Interventions Service Improvement Programme Board has been given a formal mandate to examine counselling data governance, regional comparability, unmet demand, patient outcomes and workforce capacity; and, if so, to provide its terms of reference. [37051/26]
View answer1111. Deputy Ken O'Flynn asked the Minister for Health whether the planned mapping of HSE and HSE-funded counselling services will include section 39 providers, National Office for Suicide Prevention-funded services, Tusla-funded counselling services, local low-cost counselling charities and community voluntary providers; and when this mapping exercise will be completed. [37052/26]
View answerI propose to take Questions Nos. 1107, 1110 and 1111 together.
The establishment of a national talk therapy programme board to enhance access to talk therapies and ensure greater consistency in delivery and standards of service provision is a priority action for HSE Mental Health Services in the National Service Plan for 2026.
Included in the scope of the Talk Therapies Programme Board (TTPB) will be the provision of therapeutic interventions, supports and services across the lifespan, i.e. for adults and for children and young people, and at every levels of service provision i.e. from universal supports to specialist mental health services and acute level services.
The HSE TTPB will provide consolidated leadership and governance for relevant therapeutic interventions, with the aim to increase capacity, and facilitate access to, high quality integrated supports and services for all who require them.
Specifically the TTPB will provide:
• The means to mobilise and align efforts towards universally accessible talk therapies
• Greater consistency of approach and standards in service provision
• Stronger oversight and leadership
• Delivery models that are better integrated and coordinated from the outset, and can remove obstacles associated with levels of care if required and clinically appropriatePotential to further assess and develop partnership and multi-agency working, and shared-care arrangements
• A focus for proposals for further resource in this area
The Programme Board will commence its work this year, and service mapping will include HSE funded counselling services, which will include some section 39 providers, and National Office for Suicide Prevention-funded services. As part of its work, the Programme Board will also be considering the use of routine outcome measurement across HSE talk therapies.
As Minister I am satisfied with the effectiveness of the CiPC service, and with the administration of the service, including data collection and validation and how this informs my Department’s policy making and decisions on investment in the annual Estimates process. I continue to invest in CiPC and other State funded counselling supports, including €2 million in funding announced in 2025 to provide access to a suite of new talk therapies and counselling supports specifically tailored for men. Access to the services began from September 2025 and to date over 1,400 men have been supported.
1108. Deputy Ken O'Flynn asked the Minister for Health whether any formal reconciliation report is produced comparing counselling activity data across Health Regions to identify anomalies, outliers, inconsistent definitions or unusual month-on-month movements; and if so, whether such reports will be published. [37049/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1109. Deputy Ken O'Flynn asked the Minister for Health whether the HSE Mental Health Services Key Performance Indicator Metadata document includes standard national definitions for referral, re-referral, assessment, attendance, discharge, completed case, DNA, cancellation and unique client; and if she will provide those definitions. [37050/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1112. Deputy Ken O'Flynn asked the Minister for Health whether she will commit to publishing a national counselling services dashboard showing, by Health Region, referrals, re-referrals, unique clients, waiting times, sessions delivered, average sessions per client, outcomes and unmet demand. [37053/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1113. Deputy Paul Murphy asked the Minister for Health further to Parliamentary Question No. 465 of 19 March 2026, to provide an update on the commercial negotiations with the pharmaceutical company to provide givinostat by the HSE. [37054/26]
View answerThe State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly patients with rare diseases.
Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date,72 of these new medicines were for rare diseases. Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
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. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
With respect to Givinostat, the HSE received a commercial proposal from Italfarmaco, the marketing authorisation holder for Givinostat on 08 May 2026.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
1114. Deputy Barry Heneghan asked the Minister for Health if she is aware of concerns regarding access to the specialist functional seizure service in St. James's Hospital; if she will clarify whether the ward is intended to operate as a national referral service or only for patients within the hospital catchment area; the steps being taken to improve access for patients experiencing severe and frequent seizures; and if she will make a statement on the matter. [37071/26]
View answerI am assuming the deputy is referring to the Functional Neurology Disorder (FND) clinic in St. James's Hospital and as this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.
1115. Deputy Barry Heneghan asked the Minister for Health whether she is aware of concerns regarding products commonly referred to as "CALI pens", marketed as CBD vapes, including reports that some may contain synthetic cannabinoids; whether the HSE or emergency departments have identified adverse health incidents linked to their use; the oversight or testing arrangements in place for such products; the measures being taken to protect children and adolescents and raise awareness of the associated risks; and if she will make a statement on the matter. [37072/26]
View answer1116. Deputy Ken O'Flynn asked the Minister for Health further to Parliamentary Question No. 2663 of 14 April 2026, whether the expenditure figures provided relate solely to psychological services abroad or whether they also include associated travel, accommodation, administration, translation, assessment, or ancillary clinical costs. [37074/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
1117. Deputy Ken O'Flynn asked the Minister for Health whether the HSE maintains a centralised database recording referrals abroad for gender-related care under the Treatment Abroad Scheme; and if so, which HSE division is responsible for governance and oversight of that database. [37075/26]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
