Medicinal Products

2366. Deputy Pádraig O'Sullivan asked the Minister for Health her views on whether it is appropriate for members of the NCPE to be engaging in public commentary while deliberations on certain drugs are currently being undertaken; and if she will make a statement on the matter. [43776/26]

2368. Deputy Pádraig O'Sullivan asked the Minister for Health if the State remains on course to achieve the 180-day review timeline for new medicines and new uses of existing medicines committed to under schedule four of the Framework agreement on the supply and pricing of medicines, given that according to the EFPIA patients W.A.I.T. indicator 2025 survey the average time to access new medicines …

2385. Deputy Sean Fleming asked the Minister for Health when a medication will be available for people with medical cards (details supplied); and if she will make a statement on the matter. [43870/26]

2390. Deputy Aengus Ó Snodaigh asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations, given that it is the only available treatment for this progressive disease, which currently can be classed as having an ‘unmet need’ as outlined in the National Rare Disease Strategy 2025-2030. [43946/26]

2391. Deputy Aengus Ó Snodaigh asked the Minister for Health her views on whether the current delay aligns with the "equitable access" promised in the newly launched National Rare Disease Strategy 2025-2030, given that persons in the Friedreich’s ataxia community in Ireland are being left behind waiting for a decision regarding the skyclarys reimbursement, while patients across Europe gain access …

2398. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 566 of 21 April 2026, to provide an update on an application for pricing and reimbursement (details supplied); if the company has submitted a proposal to the HSE’s corporate pharmaceutical unit; if the company has met with the HSE since making an offer; the steps being taken to urgently progress a decisio…

2414. Deputy Ken O'Flynn asked the Minister for Health to outline the governance arrangements governing reimbursement rule changes, claim validation criteria, claim rejection criteria and reference pricing decisions within the Primary Care Reimbursement Service, including the decision-making authorities involved, review mechanisms and oversight structures. [44052/26]

2415. Deputy Ken O'Flynn asked the Minister for Health the number of pharmacy reimbursement claims submitted, approved, adjusted, rejected and successfully appealed in each year from 2020 to date, together with the most common reasons recorded for claim rejection or adjustment. [44053/26]

2416. Deputy Ken O'Flynn asked the Minister for Health whether any internal audit, external audit, assurance review, risk assessment or value-for-money review of PCRS reimbursement decision-making processes, claim validation controls, claim rejection procedures or reference pricing arrangements has been completed since 2020 and to provide the dates and findings of such reviews. [44054/26]

57. Deputy Seán Crowe asked the Tánaiste and Minister for Finance his views on the distinction in the VAT rate between oral and injectable medications; if there are plans to include injectable medicines under annex III of the EU VAT Directive in order that the VAT rate can be equalised at 0%; and if he will make a statement on the matter. [40430/26]

212. Deputy Paul Murphy asked the Minister for Health if her attention has been drawn to the case (details supplied); the scrutiny HPRA applied to the necessity and proportionality of the numbers; the alternatives or reductions that were considered; where the animals will come from; how many have already been used; when they will be reflected in official animal-use statistics; and the information …

229. Deputy John Connolly asked the Minister for Health the steps being taken to ensure compliance by the HSE with the statutory requirement (details supplied) under the Health (Pricing and Supply of Medical Goods) Act 2013 to make reimbursement decisions within 180 days of receiving an application; and if she will make a statement on the matter. [40477/26]

235. Deputy Marian Harkin asked the Minister for Health to provide an update on the provision of treatment to adults with SMA, Spinal Muscular Atrophy, that is available to under-18s; and if she will make a statement on the matter. [40525/26]

280. Deputy Pádraig O'Sullivan asked the Minister for Health the proportion of innovative oncology medicines approved at European level that are currently available and reimbursed in Ireland; the reason this proportion remains at approximately 25% given that the 180-day reimbursement timeline has been a legislative requirement under the Health Act 2013 for over a decade; the accountability measure…

281. Deputy Pádraig O'Sullivan asked the Minister for Health the current status of the proposed expansion of the drugs group to include patient and public interest members as committed to under the new framework agreement on medicines published in March 2026; whether an expression of interest process has been initiated to identify suitable patient representatives; given that no such process has be…

282. Deputy Pádraig O'Sullivan asked the Minister for Health if she will provide a specific update on the design and implementation of an early access scheme for medicines in Ireland, as referenced in the new framework agreement on medicines published in March 2026; whether a pilot has been announced or a design process initiated that includes patients and clinicians; the timeline within which a f…

290. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 1239 of 19 May 2026, to provide further details regarding the strategic partnership established with the pharmaceutical sector to develop an early access programme for rare diseases; the status of this work; the timeline she is working towards for operationalising this programme; and if she will make a sta…

291. Deputy Pádraig O'Sullivan asked the Minister for Health the current state of Ireland’s preparedness for utilising the EU’s Joint Clinical Assessments, JCA, on clinical trial data in evaluations by the HSE and the National Centre for Pharmacoeconomics (NCPE); when she expects such JCA’s to be applied to such evaluations; and if she will make a statement on the matter. [40695/26]

292. Deputy Pádraig O'Sullivan asked the Minister for Health the guidance that has been issued to Irish marketing authorisation holders regarding the process, timelines, and expectations for considering the EU’s Joint Clinical Assessment (JCA) by the HSE and the National Centre for Pharmacoeconomics (NCPE); the way JCA reports will be factored into the reimbursement recommendations for treatments;…

1099. Deputy Pádraig O'Sullivan asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy; and if she will make a statement on the matter. [38709/26]

1103. Deputy Sorca Clarke asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy. [38725/26]

1110. Deputy Ryan O'Meara asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy, given the Rare Diseases Technology Review Committee recently met regarding same and is now expected to make its recommendation to the HSE drugs group (details supplied; and if she will make a statement on…

1111. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE has carried out any national assessment since 2020 of the annual cost to the Exchequer of unused, expired, uncollected, or otherwise wasted medicines under State-funded medicine schemes; and if she will publish any such assessment. [38763/26]

1112. Deputy Ken O'Flynn asked the Minister for Health whether the HSE records the quantity and estimated value of unused or expired medicines returned to community pharmacies under State-funded medicine schemes; and if not, whether she intends to establish such a reporting mechanism. [38764/26]

1113. Deputy Ken O'Flynn asked the Minister for Health what policy measures are currently in place to reduce avoidable medicines waste under the GMS, DPS, LTI and other community drug schemes. [38765/26]