Medicinal Products

1114. Deputy Ken O'Flynn asked the Minister for Health whether his Department has examined the role of repeat prescribing, automatic renewals, phased dispensing, blister-pack changes, and non-adherence in contributing to medicines waste; and whether any reform proposals are under consideration. [38766/26]

1115. Deputy Ken O'Flynn asked the Minister for Health whether the HSE has a national medicines waste reduction strategy; and if not, whether one will be developed in light of recent research estimating annual medicines waste at over €37.5 million. [38767/26]

1116. Deputy Ken O'Flynn asked the Minister for Health whether the HSE has estimated the environmental impact of unused or expired medicines, including disposal, incineration, contamination risk, and pharmaceutical residues entering water systems. [38768/26]

1117. Deputy Ken O'Flynn asked the Minister for Health when the proposed national scheme for safe disposal of unused medicines will be introduced; what funding has been allocated; whether it will involve community pharmacies; and whether it will operate nationally. [38769/26]

1118. Deputy Ken O'Flynn asked the Minister for Health whether the HSE reimburses medicines which are dispensed but never collected by patients; what safeguards exist to prevent unnecessary reimbursement; and whether data on uncollected medicines is centrally collected. [38770/26]

1119. Deputy Ken O'Flynn asked the Minister for Health whether medication reviews for patients on multiple prescriptions are being used systematically to reduce over-prescribing, duplication, and avoidable waste; and what targets or KPIs apply. [38771/26]

1120. Deputy Ken O'Flynn asked the Minister for Health whether his Department has assessed potential savings from reducing medicines waste by 10%, 20% or 30%; and whether such savings have been modelled for reinvestment in frontline pharmacy or prescribing services. [38772/26]

1127. Deputy Tom Brabazon asked the Minister for Health the timeline for a decision by the HSE drugs group regarding the reimbursement of risdiplam for adults living with spinal muscular atrophy. [38838/26]

1134. Deputy Ken O'Flynn asked the Minister for Health the division of the HSE or Department of Health that holds responsibility for estimating the number of patients clinically eligible for orphan medicinal products approved for reimbursement in the State (details supplied). [38846/26]

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]

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]

1225. Deputy Ken O'Flynn asked the Minister for Health if her Department or HSE has considered establishing an accelerated reimbursement pathway for medicines relating to rare progressive neurological disorders. [39070/26]

1226. Deputy Ken O'Flynn asked the Minister for Health the average duration of the pricing and reimbursement process for orphan medicines since 2020, from initial application to final decision. [39071/26]

1227. Deputy Ken O'Flynn asked the Minister for Health if a review has been undertaken into the patient impact of delays in reimbursement decisions for orphan or rare disease medicines. [39072/26]

1230. Deputy Ken O'Flynn asked the Minister for Health if there is a mechanism permitting interim or conditional reimbursement for medicines treating progressive neurological diseases pending completion of the full reimbursement process. [39075/26]

1338. Deputy Duncan Smith asked the Minister for Health with reference to the framework agreement on the supply and pricing of medicines 2026-2029's commitment to develop an early access scheme for rare diseases; if she will consider the equity of creating a fast-track for patients with rare diseases versus the track for patients whose diseases may not be rare but may have a greater clinical need;…

1353. Deputy Michael Cahill asked the Minister for Health if she will urgently intervene in the case of a person (details supplied) whose application for approval of a prescribed weight-loss medication under the medical card scheme and has been awaiting a decision from the HSE since February 2026, despite supporting documentation from both her GP and consultant orthopaedic surgeon; and if she will…

1451. Deputy Ken O'Flynn asked the Minister for Health whether the HSE formally reviewed reimbursement, managed access, or pricing decisions relating to omaveloxolone (skyclarys) in France, Germany, Italy, Spain, Belgium, the Netherlands or the United Kingdom as part of the Irish reimbursement assessment process; and if she will provide details of any such comparative analysis undertaken. [39831/2…

1452. Deputy Ken O'Flynn asked the Minister for Health whether the National Centre for Pharmacoeconomics considered any international managed access agreements, risk-sharing agreements, conditional reimbursement models or outcomes-based reimbursement arrangements in respect of omaveloxolone (Skyclarys); and if she will provide details of the jurisdictions and models reviewed. [39832/26]