Oireachtas Joint and Select Committees

Wednesday, 15 October 2025

Joint Oireachtas Committee on Health

Treatment of Rare Diseases: Discussion

2:00 am

Professor Michael Barry:

Yes. I suppose there are a number of aspects there. The timelines are impacted significantly by the industry in two ways. One is that it does not submit an application here. I cannot do anything about that if it does not. The other is that when it is asked to submit the evidence for a technology assessment, there are delays in that. The Deputy will see in table 2 that there is a delay with price negotiation. That is an important fact, when 27% of the timeframe for orphan drugs is lost in negotiations. You can make all those things better. To come back to the Deputy's point on whether we can do things better, I mentioned earlier that we are looking at early access and what an early access scheme would look like. In other words, you would allow a drug onto the market, continue to do the assessment, and put a timeframe on it of maybe a year and a half or two years, when you would know what the value for money is, and then negotiate on price again. That can be done. The Deputy is right. It is a fair point and it is being looked at right now.

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