Cathal N. Young, O’Reilly & Co. Solicitors recently represented Emily Felix in a significant legal challenge concerning access to Skyclarys (omaveloxolone), a treatment for Friedreich’s ataxia, a rare and progressive neuromuscular condition.

The case brought important questions about access to treatment for patients with rare diseases and the need for timely decision-making where a condition is progressive and irreversible.

Emily Felix and Friedreich’s ataxia

Emily Felix, from Co. Kilkenny, was diagnosed with Friedreich’s ataxia at the age of 12. Friedreich’s ataxia is a rare inherited condition which progressively affects the nervous system and can impact mobility, coordination, speech and other aspects of daily life.

By 2026, Emily was reliant on a wheelchair and had experienced significant deterioration in her mobility and speech. She was also continuing to work and study while living with the effects of the condition.

Skyclarys, whose active ingredient is omaveloxolone, is a treatment authorised in the European Union for patients aged 16 and over with Friedreich’s ataxia. While it is not a cure and cannot reverse damage already caused by the condition, clinical evidence indicates that it may slow the progression of the disease.

For patients with a progressive condition, the timing of access to treatment can therefore be particularly important.

The legal challenge

An application for pricing and reimbursement of Skyclarys had been made to the HSE in August 2024. The application remained under consideration while various assessments and discussions took place.

In July 2026, Emily Felix brought proceedings before the High Court seeking judicial review in relation to the delay in determining access to Skyclarys.

The legal challenge sought, among other reliefs, an order requiring the HSE to determine the application for approval, reimbursement, funding and/or access to the medication. It also sought interim arrangements to allow access to the treatment while the reimbursement process remained unresolved.

On 28 July 2026, the High Court granted permission for the judicial review challenge to proceed. Mr Justice Cian Ferriter acknowledged the urgency of the situation and allowed the matter to be returned to court in September.

The proceedings highlighted the particular difficulties that can arise where a patient is living with a progressive condition and is awaiting a decision concerning a treatment which may slow further deterioration.

A wider issue for patients with rare diseases

Emily’s case also took place against the backdrop of a wider campaign by people living with Friedreich’s ataxia and their families for access to Skyclarys in Ireland.

The HSE’s decision-making process involved consideration of clinical evidence, cost-effectiveness, the impact on the medicines budget and commercial negotiations concerning the price of the treatment. In August 2026, the HSE Drugs Group initially recommended that Skyclarys should not be reimbursed at that time.

However, following further discussions and a substantially improved financial proposal from the manufacturer, Biogen, the HSE subsequently approved reimbursement of Skyclarys for people with Friedreich’s ataxia on 25 August 2026.

The decision represented an important development for people living with the condition in Ireland, who had been seeking access to the treatment for a considerable period.

The importance of timely decision-making

The proceedings brought by Emily Felix demonstrate the role that judicial review can play where a person seeks to challenge the lawfulness of decisions or processes involving public bodies.

For patients living with rare and progressive conditions, delays in decision-making can have consequences that cannot necessarily be remedied at a later date. Emily’s case brought that issue into sharp focus and contributed to a wider public discussion about access to medicines for rare diseases in Ireland.

At Cathal N. Young, O’Reilly & Co. Solicitors, we were proud to represent Emily Felix in this important legal challenge. The case demonstrates the importance of ensuring that individuals have access to appropriate legal remedies where decisions affecting their fundamental interests are subject to delay or require review.

The subsequent decision by the HSE to approve reimbursement of Skyclarys means that eligible patients living with Friedreich’s ataxia in Ireland can now access this treatment through the public health system.

Cathal N. Young, O’Reilly & Co. Solicitors provides legal advice and representation in judicial review and public law matters. If you require advice regarding a decision or process involving a public body, our team can advise you on the legal options available.