Irish Deputies Warn Drug Reimbursement System «Fundamentally Broken» Amid Skyclarys Delays

On April 29, Irish deputies in the Dáil warned that the country’s drug reimbursement system is «fundamentally broken» and needs urgent reform. This comes as approximately 200 Irish patients await Skyclarys (omaveloxolone), a treatment for Friedreich’s ataxia, despite its availability in other EU states.

Deputies Pádraig O’Sullivan (Fianna Fáil) and Louis O’Hara (Sinn Féin) pressed Health Minister Mary Butler on delays. O’Sullivan noted Ireland ranks 23rd out of 27 EU states for rare disease treatment reimbursement, calling it a «laggard.» He criticized the system where common medications and specialist therapies costing hundreds of thousands of euros follow the same approval pathway.

O’Hara highlighted the case of Aoife Quinn, diagnosed with Friedreich’s ataxia in 2021, who faces becoming wheelchair-bound without Skyclarys. Minister Butler outlined the Skyclarys application timeline: Biogen Idec (Ireland) Limited submitted a formal application in August 2024, but the full pharmacoeconomic dossier wasn't submitted until July 2025. The National Centre for Pharmacoeconomics completed its assessment in December 2025. An initial meeting occurred in February 2026, but as of April, a «commercial proposal from the company remains outstanding.»

Butler mentioned €188 million in dedicated funding for new medicines from 2021-2026, enabling 263 new treatment approvals, including 72 for rare diseases. She also confirmed a «sandbox» early-access program for rare diseases is agreed upon. O’Sullivan, unconvinced, suggested Biogen provide early local access while state negotiations continue. Both deputies urged Biogen to engage in good faith with the HSE.