Ceisteanna ó Cheannairí - Leaders' Questions
Dail Éireann — 2026-07-15
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Micheál Martin (FF), Cork South-Central

As this is my last Leaders' Questions of this term, I thank the Ceann Comhairle and all Deputies in the House for their co-operation throughout the year. I thank the entire team that works here, the ushers, the staff in catering and so on, for the manner in which they look after all of us on an ongoing basis. We deeply appreciate that. To the Deputies, while we disagree on many issues, this is parliamentary democracy in action and long may it continue. I just wanted to say that.
I thank Deputy Cullinane for raising this issue. I accept this is a matter of urgency for those with the condition of Friedreich's ataxia. I have met with Craig Coady and with others who have the condition. It is extremely worrying for them to say the least. The experiences they and their families are going through while awaiting the assessment of this drug are extremely traumatic. I appreciate the Deputy saying there has to be a process or a scientific input into whether medicines are effective or not, or suitable for reimbursement. It took a length of time. I think the company was slow over the past two years in responding to the HSE. The timeline is there. I know the Deputy has kept in close contact with the Minister on that. The commercial proposal was ultimately received from Biogen on 27 May. It went through a lot of interactions before that, which, in my view, could have been quicker on the part of the company.
That said, there is a process where first a health technology assessment was published in December 2025. That is public and was not that strong in terms of its assessment of Skyclarys at the time. There was a clear recommendation from that. That was then moved on to the HSE drugs group. I accept there are issues in terms of how this gets communicated. However, up to now since the 2013 Act, there has not been a practice whereby there is a parallel political operation while this group is meeting monthly. I think 70 rare disease drugs were approved in the four years between 2021 and 2025. It was not the case that people were waiting every month. That is something we have to be conscious of. I understand it but we need to work on the communication of all that. These are scientists and people with expert knowledge who meet to assess drugs. They are not politicians. We have to protect that process too in terms of their assessment of the efficacy of drugs and so forth with regard to conditions. This year alone, 26 drugs for rare diseases have been approved and many more drugs outside of that.
It is a serious and urgent situation for the families. Our hearts go out to them. It is a disease that progresses and has severe impacts on those with the condition. It has now been referred to the rare diseases technology review committee and the Minister is taking steps to get that established as quickly as possible to assess this. It is my understanding that some of the national expertise and practising consultants in this field would be on that group, and I hope we can get an outcome as quickly as possible.

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Record URI: https://data.oireachtas.ie/akn/ie/debateRecord/dail/2026-07-15/debate/main
Retrieved: 2026-09-14T01:01:08+00:00
Sitting date: 2026-07-15