Written Answers Nos. 528-551
528. Deputy Paul Lawless asked the Minister for Health if registrants of the Pharmaceutical Society of Ireland were formally consulted on the proposed 42% fee increase; if so, the outcome of that consultation; and if she will make a statement on the matter. [35844/26]
Amharc ar fhreagraI would like to thank the Deputy for raising the question.
The PSI is operating within a constrained financial environment, with ongoing operational deficits placing sustained pressure on its reserves.
A public consultation exercise was carried out from 30 October to 27 November 2025. The survey was published on the PSI website, and an email was sent to all registrants and wider stakeholders, highlighting that a public consultation was ongoing in relation to the PSI’s Fees Rules.
As part of the public consultation exercise, registrants and wider stakeholders were provided with a copy of the revised Fees Rules, the Core Funding Review Report, which provided the rationale for the proposed increase in fees, and a survey to provide comments in relation to the proposed changes to the PSI Fees Rules.
The PSI received 682 responses to the public consultation.
The PSI also met with key representative bodies, the Irish Pharmacy Union (IPU), Hospital Pharmacists of Ireland (HPAI) and Pharmacists in Industry, Education, and Regulation (PIER).
Overall, the consultation feedback reflected a range of concerns among respondents regarding the affordability and perceived fairness of a uniform fee increase, including calls for consideration of tiered or segmented fees, greater transparency and clarity on value for money (including more detailed cost information and benchmarking).
The PSI considered this feedback and proposed phasing the increase over three years to reduce the immediate burden, noting that some flexibilities (for example, differentiated categories) would require legislative change.
529. Deputy Aidan Farrelly asked the Minister for Health if her Department or any bodies and agencies under its aegis use, or have in the past used, software and or products from a company (details supplied); the duration and cost of the contract; and the services they avail of from the company. [35868/26]
Amharc ar fhreagraMy Department has not procured any services from the company detailed.
I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
Details for other bodies under the aegis of my Department are operational matters for the bodies concerned and the Deputy should contact the relevant Director/CEO/Registrar directly.
530. Deputy Grace Boland asked the Minister for Health the number of WTE dietitians, by grade posts filled, at each primary care centre within the Dublin North County healthcare area, in tabular form; and if she will make a statement on the matter. [35888/26]
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.
531. Deputy Grace Boland asked the Minister for Health the number of WTE registrars in nephrology based at Beaumont Hospital; and if she will make a statement on the matter. [35889/26]
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.
532. Deputy Grace Boland asked the Minister for Health the number of WTE speech and language therapists, by grade posts filled, at each primary care centre within the Dublin North County healthcare, in tabular form; and if she will make a statement on the matter. [35890/26]
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.
533. Deputy Cathy Bennett asked the Minister for Health if her Department could review Nursing and Midwifery Board of Ireland processing timelines and introduce enforceable service standards; and if she will make a statement on the matter. [35899/26]
Amharc ar fhreagraResponsibility for the regulation and registration of nurses and midwives in Ireland rests with the Nursing and Midwifery Board of Ireland (NMBI).
As the recognition of applications for nurses and midwives sits with the Nursing and Midwifery Board of Ireland (NMBI), I have referred the question to the NMBI for its attention and direct response to the Deputy.
534. Deputy Cathy Bennett asked the Minister for Health if she could establish a streamlined pathway for nursing and midwifery applicants trained in Ireland and the North of Ireland, improve transparency and communication obligations to applicants; and if she will make a statement on the matter. [35900/26]
Amharc ar fhreagraResponsibility for the regulation and registration of nurses and midwives in Ireland rests with the Nursing and Midwifery Board of Ireland (NMBI).
As the recognition of applications for nurses and midwives sits with the Nursing and Midwifery Board of Ireland (NMBI), I have referred the question to the NMBI for its attention and direct response to the Deputy.
535. Deputy Cathy Bennett asked the Minister for Health if her Department could assess the impact of current delays on national workforce planning and service delivery within the nursing and midwifery sector; and if she will make a statement on the matter. [35901/26]
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.
536. Deputy Robert O'Donoghue asked the Minister for Health if she will outline the pathway available for access to the medication Miglustat for a child diagnosed with Juvenile Batten Disease (CLN3), where the medication is already approved and reimbursed in Ireland for other rare conditions, including Gaucher Disease and Niemann-Pick Type C; and if she will make a statement on the matter. [35902/26]
Amharc ar fhreagra538. Deputy Robert O'Donoghue asked the Minister for Health if she will review the case for access to Miglustat for children diagnosed with Juvenile Batten Disease, particularly where there is significant unmet clinical need and no alternative treatment currently available; and if she will make a statement on the matter. [35904/26]
Amharc ar fhreagraI propose to take Questions Nos. 536 and 538 together.
The 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.
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 is the statutory decision maker for the pricing and reimbursement of new medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE considers the criteria set out in the Act. The Minister for Health 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.
The HSE must comply with the relevant legislation when considering investment decisions around new medicines. Pharmaceutical companies are required to submit formal applications to the HSE if they wish their medicines to be added to the list of reimbursable items / funded via hospitals and must continue to engage with the HSE throughout the process. In order to submit a formal application the medicine must hold a marketing authorisation.
The European Medicines Agency (EMA) is a centralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA plays an integral role in the authorisation of medicines in the EU.
To date, the EMA has not granted a marketing authorisation for Miglustat for the treatment of Juvenile Batten Disease. As outlined above, the national assessment and decision process cannot commence in the absence of a marketing authorisation.
The State has successfully negotiated new Framework Agreements on the Supply and Pricing of Medicines with the Irish Pharmaceutical Healthcare Association and Medicines for Ireland. These Agreements include commitments that will enable faster medicines access for patients in Ireland.
As part of the Agreement talks, the State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases.
This will be a proof of concept initiative, aligned with the commitments in the Programme for Government. The mechanisms involved are complex, and the potential impacts must be carefully considered to ensure any future system is fair, effective, and sustainable.
537. Deputy Robert O'Donoghue asked the Minister for Health whether the HSE has considered the use of compassionate access, exceptional reimbursement mechanisms, or off-label prescribing supports in cases involving ultra-rare conditions such as Juvenile Batten Disease; and if she will make a statement on the matter. [35903/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
539. Deputy John Connolly asked the Minister for Health the steps her Department is taking to address the need for increased ambulance services in County Galway; whether her Department currently has proposals to expand or enhance ambulance capacity in the county; and if so, to provide the details of any such proposals, including timelines, resource allocations, and planned service improvements; and if she will make a statement on the matter. [35905/26]
Amharc ar fhreagraAs this is a operational matter, I have asked the Health Service Executive (HSE) to respond to the Deputy directly, as soon as possible.
540. Deputy Mark Wall asked the Minister for Health if she will consider including fibromyalgia in the long-term illness scheme; and if she will make a statement on the matter. [35908/26]
Amharc ar fhreagraThe Long-Term Illness (LTI) Scheme was established under Section 59(3) of the Health Act 1970 (as amended). Regulations were made in 1971, 1973 and 1975, prescribing 16 conditions to be covered by the Scheme. Further information, including the list of conditions, can be found at:
[https://www2.hse.ie/services/schemes-allowances/lti/about/]
Under the LTI Scheme, patients receive drugs, medicines, and medical and surgical appliances directly related to the treatment of their illness, free of charge. While there are currently no plans to extend the list of conditions, it is important to remember that the LTI Scheme exists within a wider eligibility framework.
Individuals and families in Ireland may be entitled to the following schemes:
• General Medical Services (GMS) Scheme (medical card). Eligibility for a medical card is determined by the HSE, in accordance with the provisions of the Health Act 1970 (as amended). In certain circumstances the HSE may exercise discretion and grant a medical card, even though an applicant exceeds the income guidelines, where he or she faces difficult financial circumstances, such as extra costs arising from illness.
• In circumstances where an applicant is still over the income limit for a medical card, they are then assessed for a GP visit card, which entitles the applicant to GP visits without charge.
• Under the Drugs Payment Scheme (DPS), no individual or family pays more than €80 a month towards the cost of approved prescribed medicines. The DPS is not means tested and is available to anyone ordinarily resident in Ireland.
The issue of granting medical card eligibility based on having a particular disability or illness was previously examined in 2014 by the HSE Expert Panel on Medical Need and Medical Card Eligibility. The Group concluded that it was not feasible, desirable, nor ethically justifiable to list medical conditions in priority order for medical card eligibility. In following the Expert Group’s advice, a person’s means remains the main qualifier for a medical card.
541. Deputy Niamh Smyth asked the Minister for Health if she will urgently review the case of a person (details supplied); if she will provide an update on the matter; if the appointment will be expedited given the circumstances; and if she will make a statement on the matter. [35910/26]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. The Minister for Health is prohibited from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
542. Deputy Michael Cahill asked the Minister for Health her views on a submission (details supplied); and if she will make a statement on the matter. [35924/26]
Amharc ar fhreagra543. Deputy Michael Cahill asked the Minister for Health her views on a submission (details supplied); and if she will make a statement on the matter. [35925/26]
Amharc ar fhreagraI propose to take Questions Nos. 542 and 543 together.
The Public Health (Tobacco Products and Nicotine Inhaling Products) (Amendment) Bill is currently before the Dáil.
Ireland is a Party to the WHO Framework Convention on Tobacco Control (FCTC). At the 6th Conference of Parties to the FCTC, a decision was adopted inviting Parties to consider measures to protect tobacco control activities from all commercial and other vested interests related to e-cigarettes. In the spirit of that decision, it would not be appropriate for me to engage further on these topics.
544. Deputy Paul Donnelly asked the Minister for Health if consideration has been given to a change in the law regarding prescription collection after hours; and whether patients can provide evidence that they have that medicine, a prescription and valid ID. [35926/26]
Amharc ar fhreagraI have interpreted the Deputy’s question to be in relation to an emergency supply of a prescription-only medicine by a pharmacist, at the request of a patient.
The ‘emergency supply’ provisions of Regulation 8 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended) permit pharmacists, in emergency circumstances, to supply certain prescription only medicines without a prescription.
According to guidance from the Pharmaceutical Society of Ireland (PSI, the pharmacy regulator), where a patient requests an emergency supply, the pharmacist must interview the patient and satisfy themselves that:
• There is an immediate need for the medicine
• It is not practicable to obtain the prescription without undue delay
• The treatment has been prescribed ((by a medical practitioner, registered dentist, or registered nurse) for the patient on a previous occasion
• They can safely specify the dose of the medicine for the patient.
Pharmacists who dispense an "emergency supply" of a prescription only medicine, without a prescription, must meet certain legal requirements including:
• No more than a 5 day supply of the medicine may be made, or the nearest equivalent minimum dosage pack unit size with the exception of:
• - aerosols for the relief of asthma, creams or ointments, where the smallest available size may be supplied,
• - the oral contraceptive pill, where a full cycle may be supplied or
• - liquid antibiotics, where the smallest quantity that will provide a complete course may be supplied.
• The words ‘Emergency Supply’ must be included on the label of the dispensed medicine
• The reason for the emergency supply must be documented in the prescription register (daily audit report) and in the Patient Medication Record (PMR) of the pharmacy
• The name and address of the previous pharmacy which dispensed the medicine (where different to the pharmacy making the supply) must also be documented in the prescription register (daily audit report) and PMR.
Also in the PSI guidance to pharmacists is that it is in the best interests of the patient that the emergency supply provisions are reserved for genuine emergency circumstances only. The importance of regular attendance and consultation with the prescriber should be communicated to patients. Also, it is important to bear in mind that doctor-on-call services are available nationwide and patients may be referred to these services, if appropriate.
545. Deputy Cathy Bennett asked the Minister for Health the timeframe in which they intend to have an MRI scanner operational within Monaghan Hospital. [35934/26]
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.
546. Deputy Pearse Doherty asked the Minister for Health if she will intervene to make the drug Givinostat available to children who need it, given that parents of a child that suffers from Duchenne muscular dystrophy has recently made a public plea for the drug to be made available urgently; and if she will make a statement on the matter. [35938/26]
Amharc ar fhreagraThe 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.
547. Deputy Robert Troy asked the Minister for Health if she will urgently examine the processing times for cross border/Northern Ireland planned healthcare re-imbursement applications; if she is aware that applications are currently taking six months to approve; if she believes it is acceptable that such patients are awaiting re-imbursement for six months, as the same patients have, in most cases, been awaiting surgery through the HSE for extended periods of time; and if she will urgently commit to putting additional resources in place to ensure that applications are dealt with in a more timely manner. [35940/26]
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.
548. Deputy Robert Troy asked the Minister for Health if she will ensure a cross border reimbursement application for a person (details supplied) is processed without further delay. [35941/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
549. Deputy Pádraig Rice asked the Minister for Health if she will respond to correspondence (details supplied); and if she will make a statement on the matter. [35966/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond direct to the Deputy as soon as possible
550. Deputy Donna McGettigan asked the Minister for Health the measures she will take to ensure a person (details supplied) receives the medical treatment she urgently requires; and if she will make a statement on the matter. [35987/26]
Amharc ar fhreagraUnder the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. The Minister for Health is prohibited from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.
In relation to the particular query raised, as this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
551. Deputy Donna McGettigan asked the Minister for Health if she is aware of a serious complaint concerning the treatment of a child (details supplied) within CAMHS-ID, involving the discontinuation and withholding of clinically appropriate medication without clear justification; whether she will confirm if an investigation has been initiated; and if she will make a statement on the matter. [35988/26]
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.
