Medicinal Products

746. Deputy Ken O'Flynn asked the Minister for Health the total number of salbutamol nebule items dispensed under the general medical services scheme in each month from January 2024 to date in 2026; and if she will provide the corresponding average reimbursement cost per item for each month. [28033/26]

747. Deputy Ken O'Flynn asked the Minister for Health the reimbursement price per unit applicable to salbutamol nebules under the Primary Care Reimbursement Service in each month from January 2024 to date in 2026; whether any changes to pricing arrangements, reference pricing, or reimbursement rules occurred during this period; and if she will detail same. [28034/26]

748. Deputy Ken O'Flynn asked the Minister for Health the clinical guidelines, prescribing controls, and audit mechanisms in place governing the prescribing of salbutamol nebules under the general medical services scheme; and whether any review has been conducted in light of increased expenditure in 2025. [28035/26]

749. Deputy Ken O'Flynn asked the Minister for Health the reason the Primary Care Reimbursement Service does not capture or retain data on the clinical indication associated with medicines reimbursed under the general medical services scheme, including salbutamol nebules; and whether there are plans to introduce such data capture to support expenditure oversight and value-for-money assessment. [28…

750. Deputy Ken O'Flynn asked the Minister for Health whether analysis has been undertaken by her Department or the Health Service Executive into the change in seasonal expenditure patterns for salbutamol nebules between 2024 and 2025; and if she will provide the findings of any such analysis. [28037/26]

751. Deputy Ken O'Flynn asked the Minister for Health whether any internal audit, external audit, or value-for-money review has been conducted in respect of expenditure by the Primary Care Reimbursement Service on salbutamol nebules under the general medical services scheme since January 2024; if so, to provide the dates and findings of such reviews; and if not, the reason none has been undertaken…

752. Deputy Ken O'Flynn asked the Minister for Health whether any expenditure thresholds, alerts, or variance triggers exist within the Primary Care Reimbursement Service to identify significant increases in spend on specific medicines, including salbutamol nebules; and if she will outline the governance arrangements in place when such increases occur. [28039/26]

754. Deputy Ken O'Flynn asked the Minister for Health whether benchmarking has been carried out comparing expenditure and utilisation of salbutamol nebules in Ireland with other EU member states; and if so, to provide the findings of such benchmarking. [28041/26]

755. Deputy Ken O'Flynn asked the Minister for Health whether the Primary Care Reimbursement Service or the Health Service Executive has identified any risks relating to over-prescribing, inappropriate prescribing, or dependency in respect of salbutamol nebules; and if she will outline any mitigation measures in place. [28042/26]

756. Deputy Ken O'Flynn asked the Minister for Health whether any changes to prescribing guidance, reimbursement criteria, or clinical pathways for respiratory care were introduced between January 2024 and February 2026 which may have influenced the level of prescribing of salbutamol nebules; and if she will detail same. [28043/26]

777. Deputy Seán Canney asked the Minister for Health if she will consider making versatis patches available to a wider cohort of patients as some patients, including a person (details supplied) are unable to sleep for prolonged periods, and are forced to sleep in a sitting position, due to nerve pain; if she will recognise that for some patients this is the only relief available for them and they…

853. Deputy James Geoghegan asked the Minister for Health if the drug skyclarys (omaveloxolone) used for the treatment of Friedreich's ataxia will be made available under licence in Ireland; and if she will make a statement on the matter. [28209/26]

872. Deputy Aindrias Moynihan asked the Minister for Health the measures being taken in digital interventions by HPRA to shut down websites, social media and e-commerce listings promoting illegal medicines in Ireland; and if she will make a statement on the matter. [28386/26]

886. Deputy Pádraig Rice asked the Minister for Health further to Parliamentary Question No. 423 of 5 February 2026, the status of an application for pricing and reimbursement (details supplied); if the HSE is still considering this application; the projected timeline for a decision; and if she will make a statement on the matter. [28668/26]

282. Deputy Natasha Newsome Drennan asked the Minister for Health to ensure that the HSE urgently 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; and if she will make a statement on th…

332. Deputy Emer Currie asked the Minister for Health the latest update on the accessibility of skyclarys for the treatment of Friedreich’s ataxia; the timeline as to when the HSE senior leadership team will make a decision; and if she will make a statement on the matter. [27367/26]

339. Deputy Peter 'Chap' Cleere asked the Minister for Health if she will intervene to ensure that the HSE urgently 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. [27404/26]

340. Deputy Peter 'Chap' Cleere asked the Minister for Health her views on way in which the current delay with the skyclarys reimbursement negotiations aligns with the equitable access promised in the newly launched National Rare Disease Strategy 2025-2030. [27405/26]

360. Deputy Ken O'Flynn asked the Minister for Health whether her Department has established a formal, national definition of “clinically critical medicines”; and if so, the criteria used to determine such classification; and if she will provide the current list of medicines designated under this definition. [27514/26]

361. Deputy Ken O'Flynn asked the Minister for Health whether a formal risk-assessment or stratification model is in place to categorise medicines by clinical criticality and patient safety risk; and the methodology used within such a model; and if she will outline how it is applied in practice across the health service. [27515/26]

362. Deputy Ken O'Flynn asked the Minister for Health whether respiratory emergency medicines, including salbutamol nebules, are classified as clinically critical within any national prioritisation system; and if she will detail the specific safeguards applied to ensure continuity of supply for such medicines. [27516/26]

363. Deputy Ken O'Flynn asked the Minister for Health the governance structure underpinning the Medicines Criticality Assessment Group; the decision-making authority within that structure; and the level at which final determinations are made in relation to supply risk mitigation actions. [27517/26]

364. Deputy Ken O'Flynn asked the Minister for Health whether formal escalation thresholds exist within the medicines shortages framework based on clinical risk levels; and if so, the criteria for escalation; and the actions triggered at each level. [27518/26]

365. Deputy Ken O'Flynn asked the Minister for Health whether minimum stockholding requirements or buffer stock policies are in place for medicines deemed clinically critical; and the basis on which such levels are determined; and the mechanisms used to monitor compliance. [27519/26]

366. Deputy Ken O'Flynn asked the Minister for Health whether national early warning or predictive monitoring systems are in place to identify potential shortages of clinically critical medicines in advance; and if she will outline the data sources and indicators used within such systems. [27520/26]