240. Deputy Ken O'Flynn asked the Minister for Health the average and median time taken for reimbursement decisions for orphan or rare disease medicines over the past five years; the specific timelines applicable in the case of treatments for Friedreich’s ataxia; and whether any delays have arisen in the assessment process for this category of medicines. [29079/26]
Parliamentary questions
Questions
TDs ask ministers questions to get answers on the record, most of them in writing. Here is every one asked in the 34th Dáil, by the department it went to and the subject heading it was filed under. How questions work
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Showing questions asked by Ken O'Flynn under the heading Medicinal Products.
196 questions match, newest first.
244. Deputy Ken O'Flynn asked the Minister for Health whether skyclarys has been approved or reimbursed in other EU Member States or comparable jurisdictions; and whether such decisions are considered in Ireland’s reimbursement process. [29083/26]
745. Deputy Ken O'Flynn asked the Minister for Health the factors underlying the increase in expenditure by the Primary Care Reimbursement Service on salbutamol nebules dispensed under the general medical services scheme between 2024 and 2025; and if she will provide a breakdown of the extent to which this increase is attributable to volume of items dispensed, reimbursement price per item, and any changes to dispensi…
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. [28036/26]
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. [28038/26]
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]
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]
368. Deputy Ken O'Flynn asked the Minister for Health which body holds ultimate accountability for ensuring continuity of supply of clinically critical medicines at national level; and the oversight mechanisms in place to monitor performance against this responsibility. [27522/26]
369. Deputy Ken O'Flynn asked the Minister for Health the preparatory steps that have been taken to align national policy with the forthcoming European Union list of critical medicines; and whether an interim national list is in operation pending the introduction of EU measures. [27523/26]
2109. Deputy Ken O'Flynn asked the Minister for Health the total expenditure incurred by the Primary Care Reimbursement Service on salbutamol nebules dispensed under the General Medical Services Scheme in each month from January 2024 to date in 2026. [20299/26]
2110. Deputy Ken O'Flynn asked the Minister for Health the number of claims submitted for salbutamol nebules or equivalent short-acting bronchodilator nebules under the General Medical Services Scheme, the Drugs Payment Scheme, and the Long-Term Illness Scheme, in each of the years 2024 and 2025. [20300/26]
2111. Deputy Ken O'Flynn asked the Minister for Health the number of claims for salbutamol nebules rejected or unpaid by the Primary Care Reimbursement Service in 2024 and 2025, and the reasons for rejection. [20301/26]