Oireachtas Joint and Select Committees

Wednesday, 15 October 2025

Joint Oireachtas Committee on Health

Treatment of Rare Diseases: Discussion

2:00 am

Photo of Pádraig O'SullivanPádraig O'Sullivan (Cork North-Central, Fianna Fail)
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I welcome all the witnesses. I appreciate the debate up until now. I know Professor Barry has a very difficult job. I have no doubt he has seen a lot of parliamentary questions from the likes of Deputy Burke and me over the years. We understand he has a difficult role and it is a role he tries his best to perform diligently. It has been interesting listening to the past half hour of the debate and the discussion of question of ethics versus economics. As I said, I understand tough decisions have to be made.

In table 2 of the NCPE’s submission, it shows a timeline of 1,165 days from European Medicines Agency, EMA, marketing authorisation to the HSE drugs group review. Delays with the manufacturer account for 52.7% of that timeline. The NCPE’s own time of 222 days, combined with the 18 days at the Health Service Executive’s corporate pharmaceutical unit, CPU, total 240 days, or approximately eight months. Under the health Act, as I understand it, there is a requirement for this process to be completed within 180 days. To state the obvious, we are acknowledging that requirement is not being met, albeit it is not a massive disparity with what is required. It is still not being met at the same time.