Medicinal Products

2146. Deputy Erin McGreehan asked the Minister for Health the specific positions Ireland will advocate during negotiations on the EU pharma package regarding incentives for the development and commercialisation of orphan medicines and advanced therapy medicinal products; and if she will make a statement on the matter. [42963/26]

2147. Deputy Erin McGreehan asked the Minister for Health the engagement her Department has had with Irish-based advanced therapy and rare disease stakeholders regarding the proposed changes to regulatory data protection and market exclusivity provisions under the EU pharma package; the concerns identified through this engagement; and if she will make a statement on the matter. [42964/26]

2148. Deputy Erin McGreehan asked the Minister for Health the role Ireland intends to play during its EU presidency in shaping the implementation of the Critical Medicines Act with regard to securing the supply chains for orphan medicines, advanced therapies and biologic medicines; and if she will make a statement on the matter. [42966/26]

2149. Deputy Erin McGreehan asked the Minister for Health the discussions taking place at EU level regarding the inclusion of advanced therapy medicinal products and orphan drugs within strategic stockpiling, procurement or supply resilience mechanisms under the Critical Medicines Act; and if she will make a statement on the matter. [42968/26]

2150. Deputy Erin McGreehan asked the Minister for Health the discussions taking place at EU level, in the context of the EU pharma package and Ireland’s forthcoming EU presidency, regarding greater cooperation between member states on access, pricing, reimbursement and procurement pathways for orphan medicines and advanced therapy medicinal products; and if she will make a statement on the matter…

2232. Deputy Barry Ward asked the Minister for Health the position regarding the decision process behind the review by the HSE Drugs Group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy (SMA); and if she will make a statement on the matter. [43302/26]

2247. Deputy John Paul O'Shea asked the Minister for Health the criteria used by the HSE to approve cholesterol-lowering injections for patients who are unable to tolerate statins; whether the cost of such treatment is covered by the HSE where a patient is deemed clinically eligible; and if she will make a statement on the matter. [43355/26]

2255. Deputy Pádraig O'Sullivan asked the Minister for Health if she is aware that according to a survey published by an organisation (details supplied) in May 2026, only 27% of orphan medicines for rare diseases approved between 2021 and 2024 were available to patients in Ireland as of January 2026, compared to an EU average of 43%; the steps being taken to improve access to orphan medicines for …

2256. Deputy Pádraig O'Sullivan asked the Minister for Health if she is aware that according to a survey published by an organisation (details supplied) in May 2026, patients in Ireland wait on average approximately 801 days for access to orphan medicines for rare diseases, compared to an EU average of 614 days; the measures being taken to reduce this waiting time; and if she will make a statement…

2257. Deputy Pádraig O'Sullivan asked the Minister for Health the specific provisions of the Framework Agreement on the Supply and Pricing of Medicines agreed in March 2026 that will address the finding in a survey (details supplied) that Ireland has an orphan medicine availability rate of 27% against an EU average of 43%; and if she will make a statement on the matter. [43429/26]

2265. Deputy Mairéad Farrell asked the Minister for Health the position in relation to the reimbursement of internationalised normalised ratio test strips and machines for persons who require long-term oral anticoagulant therapy with warfarin; and if she will make a statement on the matter. [43499/26]

2266. Deputy Pádraig O'Sullivan asked the Minister for Health the number of patients receiving standard oral nutritional supplements reimbursed under the community drug schemes, broken down by those receiving first-line products on List A and those receiving non first-line products on List B, in tabular form; and if she will make a statement on the matter. [43512/26]

2267. Deputy Pádraig O'Sullivan asked the Minister for Health if she is satisfied that the categorisation of standard oral nutritional supplements into List A first-line products and List B non first-line products under the Standard Oral Nutritional Supplements First-line Prescribing List for Adults Living in the Community 2019 remains clinically appropriate; whether that list has been reviewed si…

2268. Deputy Pádraig O'Sullivan asked the Minister for Health the total expenditure by the Health Service Executive on standard oral nutritional supplements reimbursed under the community drug schemes in each year since 2021, in tabular form; and if she will make a statement on the matter. [43514/26]

2269. Deputy Pádraig O'Sullivan asked the Minister for Health the process by which standard oral nutritional supplements are assessed and assigned to List A or List B for reimbursement under the community drug schemes; the criteria applied; the body responsible for making these determinations; and if she will make a statement on the matter. [43515/26]

2270. Deputy Pádraig O'Sullivan asked the Minister for Health the number of prior reimbursement approval applications for List B standard oral nutritional supplements received by the Primary Care Reimbursement Service in each year since 2021; the number approved and refused respectively; the average processing time for such applications; and if she will make a statement on the matter. [43516/26]

2271. Deputy Pádraig O'Sullivan asked the Minister for Health whether she will review the requirement for six-monthly renewal of reimbursement approval for List B standard oral nutritional supplements, given the administrative burden this places on general practitioners, dietitians and hospital clinicians; and if she will make a statement on the matter. [43517/26]

2327. Deputy Ken O'Flynn asked the Minister for Health whether any review, analysis, assessment, briefing, report, business case, internal examination or other evaluation has been undertaken since 1 January 2024 regarding the drivers of variation in reimbursement costs for salbutamol nebule products under the General Medical Services Scheme; if so, to provide the date, author, purpose and principa…

2351. Deputy Naoise Ó Muirí asked the Minister for Health the position regarding the availability of the omnipod 5 automated insulin delivery system in Ireland; the status of its approval and reimbursement process; and the timeframe for its expected roll out, in view of its availability in other European countries and the growing demand among Irish diabetes patients for access to advanced insulin …

2359. Deputy Pádraig O'Sullivan asked the Minister for Health the number of applications for new drugs that have been approved for reimbursement in each of the years 2021 to 2025, in tabular form; and if she will make a statement on the matter. [43769/26]

2360. Deputy Pádraig O'Sullivan asked the Minister for Health the number of applications for new drugs that have been refused for reimbursement in each of the years 2021 to 2025, in tabular form; and if she will make a statement on the matter. [43770/26]

2361. Deputy Pádraig O'Sullivan asked the Minister for Health the number of applications for new drugs that are currently under consideration for reimbursement; and if she will make a statement on the matter. [43771/26]

2362. Deputy Pádraig O'Sullivan asked the Minister for Health the drugs that will be considered for reimbursement at the June 2026 meeting of the NCPE drugs group; and if she will make a statement on the matter. [43772/26]

2364. Deputy Pádraig O'Sullivan asked the Minister for Health the status of the progress of givinostat through the drug reimbursement process; and if she will make a statement on the matter. [43774/26]

2365. Deputy Pádraig O'Sullivan asked the Minister for Health if she is satisfied with the NCPEs role within the drug reimbursement process and that appropriate governance and best practice is in situ in its activities; and if she will make a statement on the matter. [43775/26]