Medicinal Products

549. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE has prepared or received any gross and net budget impact analysis in respect of the proposed reimbursement of tirzepatide and semaglutide for diabetes and weight management indications; the estimated annual gross cost to the Exchequer in each of the first five years of potential reimbursement; any estimated dow…

550. Deputy Ken O'Flynn asked the Minister for Health the estimated number of adults nationally who meet the clinical eligibility thresholds outlined in the completed HTAs for tirzepatide for diabetes and weight management indications; the estimated number of adolescents who would meet the subpopulation criteria proposed for semaglutide reimbursement; whether her Department has been advised of pro…

551. Deputy Ken O'Flynn asked the Minister for Health whether her Department has undertaken any comparative assessment of the timeframe from marketing authorisation to reimbursement decision for GLP-1 receptor agonists in Ireland relative to other EU Member States; whether she considers the current pharmacoeconomic assessment and negotiation timeline proportionate to the scale of the public health…

552. Deputy Ken O'Flynn asked the Minister for Health whether formal commercial negotiations between the HSE Corporate Pharmaceutical Unit and the relevant marketing authorisation holders in respect of tirzepatide and semaglutide are currently active; whether any price proposal has been received following completion of the HTA processes; whether any budget ceiling or access cap has been set as a m…

617. Deputy John McGuinness asked the Minister for Health if the drug sky clarys (omaveloxolone) used for the treatment of Friedreichs ataxia will be made available under licence in Ireland; if she will outline the process to licence the drug; the timeline involved; and if she will make a statement on the matter. [16033/26]

1109. Deputy Michael Cahill asked the Minister for Health to urgently examine and allow for a continuous glucose monitors on the long term illness scheme for a person (details supplied); and if she will make a statement on the matter. [15157/26]

560. Deputy Ken O'Flynn asked the Minister for Health whether the Primary Care Reimbursement Service holds reimbursement claims data for salbutamol nebules dispensed under the general medical services scheme from 1 January 2025 to date; and if so, to provide the total number of claims and the monthly breakdown [13447/26]

561. Deputy Ken O'Flynn asked the Minister for Health whether the Primary Care Reimbursement Service holds reimbursement claims data for alternative nebulised bronchodilator products dispensed under the general medical services scheme from 1 January 2025 to date; and if so, to provide the total number of claims and the monthly breakdown, including identification of the relevant product categories …

562. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE conducted any national analysis of prescribing substitution patterns arising from reported shortages of salbutamol nebules since 1 January 2025; and if so, to provide details of the methodology used and any conclusions reached [13449/26]

563. Deputy Ken O'Flynn asked the Minister for Health the national monitoring framework which is in place within her Department or the HSE to assess the patient impact of essential medicine shortages under the general medical services scheme; and whether this framework includes tracking of clinical substitution, cost impact, or regional variation [13450/26]

564. Deputy Ken O'Flynn asked the Minister for Health whether any additional expenditure has arisen under the general medical services scheme as a result of prescribing alternative products due to salbutamol nebule shortages since 1 January 2025; and if so, to provide the estimated amount and the basis of calculation [13451/26]

588. Deputy Ken O'Flynn asked the Minister for Health the number of claims submitted under the General Medical Services Scheme, Drugs Payment Scheme and Long-Term Illness Scheme for salbutamol nebules or equivalent short-acting bronchodilator nebule products in (a) 2024 and (b) 2025; the number and value of such claims paid; the number and value rejected or unpaid; and whether she will provide the…

589. Deputy Ken O'Flynn asked the Minister for Health whether the Department or the Health Service Executive maintains centralised data on the number of patients whose access to reimbursable salbutamol nebules or equivalent substitute products was impacted during registered shortage periods in 2024 and 2025; if so, the number recorded; and if not, whether she intends to introduce a monitoring mech…

590. Deputy Ken O'Flynn asked the Minister for Health whether any formal risk assessment, clinical safety review, or value-for-money analysis was conducted in relation to the ongoing shortages of salbutamol nebules during 2024 and 2025; whether contingency procurement arrangements were activated; and what governance structures are in place to ensure uninterrupted reimbursement access for essential…

591. Deputy Ken O'Flynn asked the Minister for Health the total expenditure incurred in 2024 and 2025 on salbutamol nebules and equivalent substitute products under the Community Drug Schemes; the additional expenditure, if any, arising from the use of Exempt Medicinal Products during shortage periods; and the budgetary provisions in place to manage future supply disruptions. [13632/26]

604. Deputy Ken O'Flynn asked the Minister for Health whether there is a formal departmental policy providing for automatic reimbursement of clinically equivalent substitute medicines once the Health Products Regulatory Authority has listed a reimbursable product as being in shortage; if not, whether she will outline the policy rationale for the absence of such an automatic trigger mechanism; and …

605. Deputy Ken O'Flynn asked the Minister for Health to set out the statutory, regulatory, or administrative basis under which Exempt Medicinal Products are supported under Discretionary Hardship Arrangements during medicine shortages; whether these arrangements are governed by published criteria; and whether her Department intends to place such arrangements on a formalised national footing. [136…

607. Deputy Ken O'Flynn asked the Minister for Health whether national clinical governance guidance has been issued by her Department or by the HSE in respect of reimbursement decision-making during shortages of time-sensitive respiratory medicines, including salbutamol nebules; whether such guidance addresses continuity of care, risk mitigation, and equity of access; and if she will make a statem…

608. Deputy Ken O'Flynn asked the Minister for Health the number of occasions in the past three years on which medicines listed on the Community Drug Schemes Reimbursement List were formally declared in shortage by the Health Products Regulatory Authority; in how many such cases substitute reimbursement required discretionary approval; and whether her Department maintains a central register of suc…

611. Deputy Ken O'Flynn asked the Minister for Health whether her Department has engaged with representative bodies for community pharmacists, respiratory clinicians, or patient advocacy groups in relation to reimbursement continuity during medicine shortages; whether any formal consultation process has been undertaken since 2020; and if she will provide details of the outcome of any such engageme…

612. Deputy Ken O'Flynn asked the Minister for Health whether she will commit to publishing a formal contingency reimbursement protocol setting out clear, automatic procedures for substitute medicine reimbursement where a reimbursable product is listed in shortage by the Health Products Regulatory Authority; and if she will indicate a timeframe for the development and publication of such a protoco…

636. Deputy Ken O'Flynn asked the Minister for Health the current number of medicines listed as being in short supply on the national medicines shortage list maintained by the Health Products Regulatory Authority; the number of these classified as critical or without a clinically equivalent alternative; the average duration of shortages recorded in each of the past three years; and the steps being…

637. Deputy Ken O'Flynn asked the Minister for Health whether her Department maintains a formal medicines supply resilience strategy addressing strategic stockholding, diversification of supply chains, early warning mechanisms and substitution protocols; if so, when it was last reviewed; and if she will outline the key policy measures currently in force [13763/26]

638. Deputy Ken O'Flynn asked the Minister for Health whether her Department receives routine structured reports from the Health Products Regulatory Authority and the HSE regarding medicines shortages affecting chronic disease management, including respiratory conditions; the frequency and format of such reports; and how this information informs policy and budgetary planning [13764/26]

639. Deputy Ken O'Flynn asked the Minister for Health whether automatic reimbursement mechanisms are in place under community drug schemes to ensure that where a reimbursable medicine is unavailable due to shortage, clinically appropriate substitute medicines are reimbursed without additional administrative burden on patients or prescribers; and if not, whether she will introduce such a mechanism …