Ken O'Flynn

1135. Deputy Ken O'Flynn asked the Minister for Health if any budget impact assessment, cost projection, prevalence estimate, or epidemiological model was prepared in advance of reimbursement consideration for omaveloxolone (skyclarys); and the details of same. [38847/26]

1136. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains a national registry, prevalence estimate or centrally collated dataset for Friedreich's ataxia patients in the State. [38848/26]

1137. Deputy Ken O'Flynn asked the Minister for Health how reimbursement decisions for high-cost orphan medicines are financially planned where the HSE does not centrally retain data regarding the number of clinically eligible patients. [38849/26]

1138. Deputy Ken O'Flynn asked the Minister for Health if the National Centre for Pharmacoeconomics, the HSE medicines management programme, or any external body estimated the likely eligible patient cohort for omaveloxolone (skyclarys) prior to reimbursement consideration. [38850/26]

1139. Deputy Ken O'Flynn asked the Minister for Health if any hospitals, hospital groups, or specialist neurology centres currently facilitate access to omaveloxolone (skyclarys) through named-patient arrangements, manufacturer-supported supply, or exceptional approval mechanisms outside PCRS reimbursement pathways. [38854/26]

1140. Deputy Ken O'Flynn asked the Minister for Health if the HSE maintains any national policy governing interim patient access to medicines awaiting reimbursement decisions for rare diseases. [38855/26]

1141. Deputy Ken O'Flynn asked the Minister for Health if the Department or HSE has examined establishing a formal compassionate or early-access medicines framework for patients with rare progressive conditions pending health technology assistant and reimbursement determinations. [38856/26]

1142. Deputy Ken O'Flynn asked the Minister for Health the number of reimbursement applications for orphan or ultra-orphan medicines remain under assessment by the HSE for more than 12 months as of May 2026. [38857/26]

1143. Deputy Ken O'Flynn asked the Minister for Health if the HSE records the number of patients who seek access to medicines through named-patient or exceptional approval mechanisms outside standard reimbursement arrangements. [38858/26]

1144. Deputy Ken O'Flynn asked the Minister for Health whether any patient safety review, adverse incident review, or clinical governance review has examined the impact of prolonged ambulance dispatch or allocation delays on patient outcomes since 2020; and if so, to provide details. [38862/26]

1145. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service operates under any internally defined escalation thresholds for excessive dispatch delay, delayed resource allocation, or prolonged queue times for emergency incidents; and if so, to provide details. [38863/26]

1146. Deputy Ken O'Flynn asked the Minister for Health whether any review has been conducted regarding whether Ireland's current ambulance dispatch governance framework aligns with international best practice standards in comparable jurisdictions; and if so, to provide details. [38864/26]

1147. Deputy Ken O'Flynn asked the Minister for Health whether any statutory instrument, policy directive, governance framework, operational standard, or national clinical guideline formally defines acceptable maximum ambulance dispatch times in Ireland. [38865/26]

1148. Deputy Ken O'Flynn asked the Minister for Health whether the Department or the HSE maintains any national dataset recording ambulance incidents where dispatch allocation exceeded a specified time threshold; and if not, whether consideration has been given to establishing such reporting mechanisms. [38866/26]

1149. Deputy Ken O'Flynn asked the Minister for Health whether the National Ambulance Service defines any ambulance response delay duration as constituting a potential patient safety incident in and of itself; and if so, the thresholds applied. [38877/26]

1150. Deputy Ken O'Flynn asked the Minister for Health whether any ambulance delays exceeding 60 minutes resulted in incident reviews, serious incident assessments, or patient-safety escalations in 2024, 2025 or to date in 2026. [38878/26]

1151. Deputy Ken O'Flynn asked the Minister for Health whether the HSE Incident Management Framework contains any specific provisions relating to prolonged ambulance response delays. [38879/26]

1152. Deputy Ken O'Flynn asked the Minister for Health whether the Department of Health has assessed whether the absence of national reporting on extreme ambulance delays limits oversight of patient safety risks. [38880/26]

1153. Deputy Ken O'Flynn asked the Minister for Health whether HIQA has ever been requested to examine governance arrangements relating to prolonged ambulance response times. [38881/26]

1154. Deputy Ken O'Flynn asked the Minister for Health whether ambulance delays are incorporated into any corporate, enterprise, or clinical risk registers maintained by the HSE or National Ambulance Service. [38882/26]

1155. Deputy Ken O'Flynn asked the Minister for Health whether the Department receives any routine exception reporting where NAS response performance materially deteriorates below National Service Plan KPI levels. [38883/26]

1156. Deputy Ken O'Flynn asked the Minister for Health whether any internal review has examined whether prolonged ambulance delays should constitute automatically reportable adverse incidents. [38884/26]

1157. Deputy Ken O'Flynn asked the Minister for Health if her Department maintains a central register identifying all statutory, non-statutory, intermediary-funded, and externally governed bodies receiving funding from the Department or the HSE; and if not, whether such a register will be established. [38919/26]

1158. Deputy Ken O'Flynn asked the Minister for Health whether any formal criteria or classification methodology is used by the Department or the HSE to determine whether a publicly funded organisation is categorised as statutory, non-statutory, voluntary, intermediary-funded, or publicly controlled for governance purposes; and if so, to provide details. [38920/26]

1159. Deputy Ken O'Flynn asked the Minister for Health whether her Department or the HSE has conducted any mapping exercise since 2020 identifying which publicly funded health-related bodies are subject to the Code of Practice for the Governance of State Bodies, the Charities Governance Code, service-level agreements, or alternative governance frameworks; and if so, to provide details. [38921/26]