368. Deputy Máire Devine asked the Minister for Health how the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement, particularly the 180-day decision timeline, are being applied to the case of patients with Friedrich's Ataxia to prevent further delay in addressing a clear unmet need for treatment and reimbursement. [22736/26]

Two new Framework Agreements with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) on the supply and pricing of medicines (FASPM) have been successfully concluded following extensive engagement and negotiation with the pharmaceutical sector.

The Agreements will enable faster access to new innovative medicines for patients. They also reflect the Government’s commitment to ensuring security of supply for essential medicines, reducing the risk of medicine shortages for patients while safeguarding the sustainability of the health services.

The Agreements benefit patients by ensuring a commitment and a structured process towards achieving a 180-day timeline for completing pricing and reimbursement decisions for medicines, accelerating patient access to new treatments. This will mean that, by Q1 2029, the HSE will make decisions on medicine reimbursement applications within 180 days net.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE), through its Senior Leadership Team has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices. HSE decisions on which medicines are reimbursed are made on objective, scientific, and economic grounds. There are formal processes that govern pricing and reimbursement applications for medicines and new uses of existing medicines. The HSE considers all criteria outlined in the Health (Pricing and Supply of Medical Goods) Act 2013 before making any decision on pricing/reimbursement.

In respect of Friedreich’s ataxia specifically, the HSE has received an application for Skyclarys (omaveloxolone). The National Centre for Pharmacoeconomics Ireland (NCPE) has completed a Health Technology Assessment (HTA), following which the HSE Corporate Pharmaceutical Unit (CPU) has commenced commercial engagements with the applicant.

The HTA and the output of commercial negotiations along with patient group submissions received will be considered by the HSE in line with the 2013 Act.

The National Rare Diseases Strategy 2025-2030 was published by the Minister for Health in August 2025.

An Implementation Oversight Group has been launched to progress the recommendations of the National Rare Diseases Strategy. It began meeting in February 2026 to commence work-planning for the Strategy’s 11 recommendations.

Under the new FASPM, the State and the pharmaceutical sector have also agreed to develop a future strategic partnership which will support the development of a piloted early access programme for new medicines for rare diseases in line with Programme for Government commitments. Research and scoping work is underway in the Department to support the development of a pilot programme in this regard.