Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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It will not come as a surprise to the Tánaiste that I am going to use this question to again raise the issue of the rare disease drug reimbursement process we have. I have lost count of the number of times I have been in here with the Tánaiste and the Taoiseach over the last five or six years since I became a TD. I can quote league tables until the cows come home showing how we languish as laggards in a European context. The most recent report ranks us 28th out of 36 European countries with regard to providing drugs, for example, for patients who suffer from a rare condition.

I am not going to waste my time on that today. I would like to focus on what the programme for Government is going to allow for us going forward. There are two specific references in the programme for Government that give me some bit of hope and optimism for the future and I would like the Tánaiste to provide some clarity on that. First, there is a provision in the programme for Government on the devising of an early access scheme. I met with the Minister for Health in the last weeks and, to be fair, since she was appointed she has been very proactive.

I must give her credit for that. Specifically in respect of early access schemes as a focus in the programme for Government, I need to emphasise how important it is that any early access scheme needs to be decoupled from the existing reimbursement process. If we are going to put drugs through a process that essentially has to run through the same hoops as the system that is currently in place, it will be doomed to failure. That is my concern. Typically you are looking at 600, 700 or 800 days for reimbursement for a rare drug. As I said, any system that provides for early access will have to radically overhaul that.

The second point in the programme for Government is a commitment to a review of the reimbursement system as a whole. Again, that is something I have sought for a number of years. Any review we undertake cannot be a carbon copy of the Mazars report. The Mazars report, from inception to its actual publication, took the best part of four or five years. We have committed to this in the programme for Government as a provision. We need to actually start the process of reviewing the current reimbursement system now. If we wait a further two years, we are not going to see the full published review by the end of this Government's term.

Today I ask for two things. Will the Tánaiste give me the direction of any thinking in respect of an early access scheme? How quickly can that come on stream? With regard to the overall review of the reimbursement system, will the Tánaiste give a commitment that it will start urgently so that we can at least have it published in the next couple of years?

Simon Harris (Wicklow, Fine Gael)
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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.

Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
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The Tánaiste referenced the number of staff that the State has put in, as one example. Despite the number of staff increasing from four to 30-odd at this stage, the length of time it takes to assess a drug is actually lengthening, not shortening, despite the additional staff. That is one point of clarity.

The Tánaiste also referenced the heel prick test. The decision to add those two extra conditions was made in 2022, as he said. That was largely down to Les Martin in Wicklow, a constituent of the Tánaiste's, who was right behind that campaign. That decision was made in 2022. Fast forward to 2025 and the two conditions referenced are still not being tested for despite them being recommended in 2022. It has not been implemented.

Within the health Act there are specific deadlines for the National Centre for Pharmacoeconomics, NCPE, to make decisions. It is supposed to make a decision within 180 days. A recent report by the Irish Pharmaceutical Healthcare Association, IPHA, stated that 86% of all applications are not being dealt with within the legislative times provided for in the health Act 2013. Some 86% of all applications are going overdue.

The NCPE administers all this. The NCPE makes the decisions. I am not casting aspersions on anybody in that organisation. It has handled hundreds of millions of euro in taxpayers' money over the past decade but there is no oversight, no governance, no independent chair, no SLA, nothing. That was a recommendation in the Mazars report a number of years ago. That needs to be done. As I said, I am not casting aspersions on anybody, but a lot of taxpayers' money has been handed over.

Simon Harris (Wicklow, Fine Gael)
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I thank the Deputy for referencing Les Martin, a person I know well from County Wicklow and somebody who has done incredible advocacy work in relation to this based on the lived experience of his two sons. I thank Les for that work too.

The points Deputy O'Sullivan makes are fair. The Minister has rightly reminded me that she is committed to a root-and-branch reform and examination of all the various processes in place in relation to rare diseases. The opportunity to bring forward the new rare diseases plan will be a chance to turbocharge our focus on some of these issues. However, we are already beginning to look at how we can do this in new ways. For example, the Minister, Deputy Carroll MacNeill, had engagement with her Italian counterpart in recent days on how we can co-operate and collaborate more across the European Union. Deputy O'Sullivan raised the issue of DMD in the House last week and we went to the North-South Ministerial Council. In fairness, it was also raised by Deputy Crowe. At the North-South Ministerial Council we immediately started a conversation about how our two departments of health can work together. On part of the island you might have the medication, while on another part of the island you might have the professionals. Particularly given that we live in a small country, collaboration at European level, across the island of Ireland and across Ireland and the UK are going to be important steps. The Minister is committed to continuing close engagement with the Deputy on it.

On the reimbursement piece, we have significantly increased the staff to try to speed up the timelines. We will keep in close contact.