Written Answers Nos. 1229-1250
1231. Deputy Barry Ward asked the Minister for Health if she will set out the mechanism and timeframe of reference for the HPRA to approve the use of a particular pharmaceutical; and if she will make a statement on the matter. [37707/26]
Amharc ar fhreagraWith respect to marketing authorisations of medicinal products, the HPRA (Health Products Regulatory Authority) operates in accordance with EU pharmaceutical legislation (primarily EU Directive 2001/83/EC) and national legislation (Medicinal Products (Control of placing on the Market) Regulations 2007). While the process mechanism and timelines depend on the authorisation route (national, decentralised, mutual recognition, or centralised), the core assessment steps and timelines are broadly consistent.
Prior to submitting a marketing authorisation application (MAA), the applicant/company determines the appropriate regulatory route, between:
• National procedure, for approval in Ireland only,
• Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP), for approval in multiple EU member states, or
• Centralised Procedure via European Medicines Agency (EMA), for pan-EU approval.
For certain products, applicants are required to apply via the centralised procedure (e.g. innovative, biotechnology-derived, advanced therapy medicinal products, orphan medicinal products, new active substances for specific therapeutic areas).
Assessment timelines can vary depending on the type of procedure and aspects such as the quality and completeness of the dossier, the complexity of the product (e.g. novel biologics versus established generics), and number of review cycles (issues / questions raised). However, typical assessment process and timelines for MAA range from 12 to 24 months, in line with established national and EU protocol. For medicines considered to be of major interest for public health (for example those that target a condition for which there is no treatment option and that have the potential to address an unmet clinical need), the standard assessment timeline via the centralised procedure may be reduced by up to 60 days.
1232. Deputy Niall Collins asked the Minister for Health if there are plans to provide an intense pulsed light (IPL) laser and ocular surface scanner in University Hospital Limerick; and if she will make a statement on the matter. [37718/26]
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.
1233. Deputy Aengus Ó Snodaigh asked the Minister for Health if a scan will be expedited for a person (details supplied). [37740/26]
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.
1234. Deputy Ged Nash asked the Minister for Health the number of cases of multiple system atrophy of which the health authorities are currently aware; the number of people who are living with the condition and who are currently being treated through the HSE system; if the HSE will consider developing a specific clinical programme in respect of the condition; and if she will make a statement on the matter. [37752/26]
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.
1235. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 1268 of 28 April 2026, if the Women's Health Action Plan 2026-2027: Phase 3 will include plans to examine under 17’s access to contraception as outlined in the National Sexual Health Strategy; and if she will make a statement on the matter. [37770/26]
Amharc ar fhreagraThe Women's Health Action Plan 2026-2027: Phase 3 commits to a continued expansion of the eligibility for free contraception to the full reproductive age range, sequentially, in line with commitments in the National Sexual Health Strategy, 2025-2035.
1236. Deputy Pádraig Rice asked the Minister for Health the status of the HIV Action Plan, committed to in the National Sexual Health Strategy 2025-2035; the work carried out to date; the timeline being worked towards for publication; and if she will make a statement on the matter. [37771/26]
Amharc ar fhreagraSexual health is a priority for the Department of Health. The National Sexual Health Strategy, 2025-2035 (NSHS) and National Sexual Health Action Plan, 2025-2038 (NSHAP), commit to developing Models of Care for sexual health and for HIV, to develop an HIV Action Plan and to expand community options for the delivery of PrEP, including widening access through primary care and exploring digital options.
The NSHS and NSHAP (included in one document) can be accessed at the following link: www.gov.ie/en/healthy-ireland/policy-information/national-sexual-health-strategy-2025-2035/
Governance arrangements for the Strategy are laid out in its final chapter; the Implementation Group and various sub-groups and working groups have commenced work. Significant progress has been made in implementing some of its Actions already.
Work on the HIV Action Plan has commenced, following a stakeholder consultation exercise, the outcomes of which are currently being analysed. Further consideration for delivering improved access to HIV prevention, diagnosis, treatment and other supports for people living with HIV will be included in the forthcoming Models of Care for sexual health and for HIV and within the forthcoming HIV Action Plan. It is currently envisaged that the HIV Action Plan and Model of Care for Sexual Health will be published in late 2026 to early 2027.
1237. Deputy Pádraig Rice asked the Minister for Health if Action 1 of the HSE Position Paper on FASD Prevention (details supplied), published in September 2022 and due to be completed within three years of publication, has now been completed; and if she will make a statement on the matter. [37773/26]
Amharc ar fhreagraAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy as soon as possible.
1238. Deputy Pádraig Rice asked the Minister for Health if she will commit to establishing early access schemes for new medicines for the treatment of rare diseases; and if she will make a statement on the matter. [37774/26]
Amharc ar fhreagra1239. Deputy Pádraig Rice asked the Minister for Health the status of the Programme for Government commitment and National Rare Disease Strategy recommendation to consider early access schemes for rare diseases; the status of these considerations; the work carried out to date; the timeline she is working towards in completing this work; and if she will make a statement on the matter. [37775/26]
Amharc ar fhreagraI propose to take Questions Nos. 1238 and 1239 together.
I recognise the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. The Government is committed to investing in new medicines for patients, which has facilitated the introduction of 262 new medicines since 2021 including 72 for rare diseases. For 2026, over €217m of additional funding has been made available for medicines including €30 million for new medicines.
The State has successfully negotiated new Framework Agreements with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA), on the pricing and supply of medicines.
These agreements include commitments to reaching pricing and reimbursement decisions within 180 days, excluding stopclocks.
In addition, the developers of new medicines will aim to shorten the timeline to submit medicine reimbursement applications in Ireland to within six months of formal authorisation by the European Commission. Together these measures will enable faster access for patients in Ireland.
The Programme for Government contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this Government. 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. As this work progresses, it will be essential that we take account of the views of patients, of industry, and of clinicians. The mechanisms involved are complex, and the potential impacts must be carefully considered to ensure any future system is fair, effective, and sustainable. In parallel, my officials have commenced work examining reimbursement systems in use across the European Union.
1240. Deputy Seamus Healy asked the Minister for Health the position regarding the charging by pharmacists for blister packs given some pharmacists are now charging €5, €10 or €15 for these packs to medical card holders; and if she will make a statement on the matter. [37778/26]
Amharc ar fhreagraIt is important to reaffirm that blister packs have never been a State-funded service under any of the community drug schemes.
On 31 March 2026, I announced a significant reform of phased dispensing arrangements alongside the introduction of a new patient-centred medicines optimisation support framework. These changes will come into effect on 1 June 2026.
The reforms see rigid phased dispensing fees replaced with a more flexible patient-focused model, which empowers pharmacists to use their professional judgement to support patients most in need.
Vulnerable GMS (medical card) patient groups including those with diagnosed cognitive impairment or dementia, intellectual disability, physical impairment or those patients at risk of medication misuse will be supported (from 1 June 2026) where appropriate with a range of tailored medicines optimisation supports including:
• adjustments to facilitate use of original packaging.
• medication reminder systems.
• administration charts.
• instalment dispensing; and
• blister packs where clinically necessary.
Blister packs should remain a last resort in line with the international evidence due to associated risks including reduced patient autonomy and potential safety concerns. Additionally, it is important to note that not all medicines are suitable for blister-packing.
If, after an assessment, a pharmacist determines, using their professional and clinical judgement, that a GMS patient requires a blister pack for clinical or patient safety reasons, it will be provided free-of-charge, from 1 June 2026.
GMS patients who do not clinically need a blister pack, but who wish to avail of it for convenience reasons, are encouraged to discuss this with their pharmacist, who may charge for this service. Their pharmacist will be able to advise them on the wide range of supports that are available and about risks and benefits of different supports, in order to determine the most appropriate support for the individual patient.
Importantly, all GMS patients who were receiving blister packs free-of-charge prior to the Community Pharmacy Agreement (in August 2025) will continue to do so, under the new reforms.
1242. Deputy Malcolm Byrne asked the Minister for Health the total number of missed appointments across the HSE in 2025; the action she is taking to reduce this number; and if she will make a statement on the matter. [37818/26]
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.
1243. Deputy Sorca Clarke asked the Minister for Health if she is aware that there is currently no occupational therapist covering adult disability services in County Longford; the steps being taken to fill this position; and if she will make a statement on the matter. [37828/26]
Amharc ar fhreagraThis PQ is not for the Department of Health. We respectfully request that this Parliamentary Question be redirected to the Department of Children, Disability and Equality as the matters raised fall under their remit.
1244. Deputy Barry Heneghan asked the Minister for Health the number of emergency department presentations, hospital admissions and addiction treatment episodes where nitrous oxide use was recorded as a contributing factor, in each of the past five years, county or HSE region and age group; the number involving persons under 18 years-of-age, in tabular form; and if she will make a statement on the matter. [37843/26]
Amharc ar fhreagraThis question relates to presentations at HSE services, therefore it has been referred to the HSE for a direct reply.
1245. Deputy Barry Heneghan asked the Minister for Health the actions being taken by her Department, the HSE and relevant public health bodies to address nitrous oxide misuse among young people, including in Dublin; whether any targeted public awareness campaigns, harm reduction initiatives, school-based measures or youth-focused interventions are planned or under way; and if she will make a statement on the matter. [37844/26]
Amharc ar fhreagraNitrous oxide falls under the definition of a psychoactive substance and is already addressed under two pieces of legislation.
Section 3 of the Criminal Justice (Psychoactive Substances Act) 2010 states that a person who sells a psychoactive substance knowing or being reckless as to whether that substance is being acquired or supplied for human consumption shall be guilty of an offence
Section 74 of the Child Care Act 1991 states that it shall be an offence for a person to sell, offer or make available a substance to a person under the age of eighteen years or to a person acting on behalf of that person if he knows or has reasonable cause to believe that the substance is, or its fumes are, likely to be inhaled by the person under the age of eighteen years for the purpose of causing intoxication.
Responsibility for these Acts rests with the Department of Justice, Home Affairs and Migration and the Department of Children, Disability and Equality respectively.
The HSE and various community groups are monitoring the situation regarding nitrous oxide and are responding appropriately to the rise in its use. Through public awareness campaigns, harm reduction advice, and engagement with at-risk groups, they are working to mitigate the very real health risks, including nerve damage.
As a key part of this approach, the HSE has disseminated a harm reduction factsheet, detailing risks, effects, and advice, to Drug and Alcohol Task Forces, student unions, and at festivals. Additionally, parents are also supported with information through various formats, including the drugs.ie website, dedicated factsheets, and a series of webinars.
Significant support is being provided for drug prevention. In 2023, a first of its kind funding programme to support evidence-based drug prevention initiatives was launched, providing €1.5 million to date. This funding has supported five projects and represents a significant step in developing our approach to drug prevention in Ireland.
I am committed to strengthening the prevention of drug use among children and young people in the forthcoming national drugs strategy.
1246. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service maintains any internal target timeframe between receipt of a 999 call and allocation of an ambulance resource, even where such targets are not publicly reported. [37848/26]
Amharc ar fhreagra1250. Deputy Ken O'Flynn asked the Minister for Health whether any incidents involving delayed ambulance allocation have been escalated to the HSE Enterprise Risk Register, Serious Incident Management Team, or National Incident Management System since 2020. [37852/26]
Amharc ar fhreagra1251. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service maintains a central dataset recording the elapsed time between emergency call receipt and ambulance resource allocation for every 999 incident nationally. [37853/26]
Amharc ar fhreagra1280. Deputy Ken O'Flynn asked the Minister for Health whether any ambulance allocation delays exceeding 30 minutes, 60 minutes, 90 minutes or longer are centrally recorded, categorised, monitored or escalated within the National Ambulance Service. [37886/26]
Amharc ar fhreagra1283. Deputy Ken O'Flynn asked the Minister for Health whether any mortality, morbidity or patient-outcome analysis has been conducted examining the impact of delayed ambulance allocation or dispatch since 2020.; and if she will make a statement on the matter. [37889/26]
Amharc ar fhreagra1286. Deputy Ken O'Flynn asked the Minister for Health whether any regional variance data exists comparing ambulance allocation times between urban and rural regions. [37892/26]
Amharc ar fhreagra1287. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service maintains any internally recorded median or average ambulance allocation times from 999 call receipt to dispatch decision; and whether those figures are publicly reported. [37894/26]
Amharc ar fhreagra1292. Deputy Ken O'Flynn asked the Minister for Health whether any internal analysis has been conducted regarding regional disparities in ambulance allocation times between urban and rural areas since 2020. [37899/26]
Amharc ar fhreagra1296. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service records the number of incidents in which ambulance allocation exceeds internally accepted dispatch timelines; and if so, to provide annual figures from 2020 to date. [37903/26]
Amharc ar fhreagra1300. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service maintains a dataset recording the longest ambulance dispatch allocation delays nationally and by region; and if so, to provide details. [37907/26]
Amharc ar fhreagra1301. Deputy Ken O'Flynn asked the Minister for Health whether any category of ambulance call is currently operating outside intended dispatch allocation standards on a recurring basis. [37908/26]
Amharc ar fhreagra1302. Deputy Ken O'Flynn asked the Minister for Health whether any formal escalation thresholds exist within the National Emergency Operations Centre for excessive ambulance allocation delays. [37909/26]
Amharc ar fhreagraI propose to take Questions Nos. 1246, 1250, 1251, 1280, 1283, 1286, 1287, 1292, 1296 and 1300 to 1302, inclusive, together.
As outlined in earlier answers to the Deputy, National Ambulance Service (NAS) key performance indicators (KPIs) relating to emergency resource allocation, as published in the Health Service Executive's National Service Plan and based on the HIQA standard, align to the Priority Dispatch Standard as published by the regulator for the profession, the Prehospital Emergency Care Council.
NAS performance against KPI targets included in the NSP is reported on a monthly basis in line with the HSE's Performance Management Framework. The HSE Framework is designed to ensure that delivery of all its healthcare services, including those provided by the NAS, are of the highest quality.
Regarding the Deputy's specific questions, as these relate to NAS day-to-day service and operational matters, I have asked the HSE to respond to him directly with any further pertinent information it may have, as soon as possible.
1247. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service records the number of incidents in which ambulance allocation exceeds specified time thresholds including 10, 20, 30 and 60 minutes. [37849/26]
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.
1248. Deputy Ken O'Flynn asked the Minister for Health whether any patient harm reviews, mortality reviews, or clinical governance assessments have identified ambulance allocation or dispatch delays as a contributory factor since 2020. [37850/26]
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.
1249. Deputy Ken O'Flynn asked the Minister for Health whether any correlation analysis has been conducted between ambulance dispatch timelines and patient outcomes, including cardiac arrest, stroke, trauma or sepsis cases. [37851/26]
Amharc ar fhreagra
