Simon Harris (Wicklow, Fine Gael)

When I heard the Deputy would be asking a question today I did not have to ask what topic it was likely to be about. I want to acknowledge that, probably more than any other Member, he raises this issue on a very consistent basis. I acknowledge he is a passionate advocate for those with rare diseases. I thank him for the focus he is keeping on that. I know he has had good engagement with the Minister for Health on this matter and I am very pleased with the work she is doing and her determination to make more progress on the issue of rare diseases and early access to medication for people with rare diseases.

I will say that, at a high level, we have over the past four years delivered access to 194 new medicines, 74 of which were for cancer, but 49 of which were for rare diseases. While accepting we have a lot more to do, we are beginning to make progress in relation to access for rare diseases. The last budget allocation was €30 million for new medicines, to come from within the HSE. We have doubled the capacity of the HSE pricing and reimbursement system. Some of this is about the quantum of funding but, in terms of speeding up the process, it is also about making sure there are enough people working in the system. I am very pleased that we have almost doubled the capacity of those now working on the reimbursement system for new medication. We now have a medicines application tracker to try to increase the transparency because we want this country to do even better in these matters.

The programme for Government commits to an early access scheme. It will be for the Minister to outline how she intends to take that forward, with Government colleagues, in the time ahead, but the points the Deputy made here today are very fair. If it is to be an early access scheme that is to make a difference, that is to be somewhat of a disruptor in terms of making sure people can get access to those medicines much more quickly, it will have to be not just a carbon copy of the existing structures or a parallel process with the same likely outcome. Let us take that away and make sure that is a factor.

Another commitment in the programme for Government that is worth commenting on is the commitment around the heel prick test. We have two population-based newborn screening programmes now and the programme for Government is committing to continually reviewing the number of conditions babies are screened for. Of course, that will help in terms of the early detection of rare diseases as well. Since May 2022, babies have been screened for nine conditions. The previous Minister for Health endorsed the recommendations from the screening advisory committee to add two new conditions. Once implemented, this will bring the number of conditions screened for as part of what is commonly known as the heel prick test in Ireland to 11. Last year, work also began on a complex and detailed process of introducing screening for spinal muscular atrophy, SMA, and for SCID to the national newborn heel prick test.

In terms of the rare disease action plan we have made a number of commitments in the programme for Government and the Minister for Health will bring the new rare diseases strategy to Government for endorsement in the coming weeks. I expect it will be published shortly thereafter. We will look at how we can advance some of the points made through that structure.

In terms of a timeline for the talks on the reimbursement framework beginning, we are eager for that to happen as quickly as possible. We are currently working to identify how quickly that can happen.

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