Shane Moynihan (Dublin Mid West, Fianna Fail)
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7. To ask the Minister for Health if the Belgian model is being examined in the context of the programme for Government commitment to investigate early access schemes for rare disease treatments; and if she will make a statement on the matter. [34617/25]

Shane Moynihan (Dublin Mid West, Fianna Fail)
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The Minister is no doubt aware of the cases of those who suffer with Duchenne muscular dystrophy, a matter which has been raised in the Dáil a number of times, as well as with the Minister directly, not least because of the Thompson boys in my own constituency. This has brought into focus the need for an early access scheme for rare disease drugs. I know there is a commitment to this in the programme for Government that has been discussed before. What considerations is the Department is taking into account? Is it looking at other models internationally of how such a scheme might be applied?

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I recognise the importance of timely access for patients to medicines, including new medicines. Supported by €128 million of funding, in the past four years the State has delivered access to 194 new medicines. Of these, 74 were for cancer and 49 were for rare diseases. Budget 2025 allocated €30 million for new medicines, to come from efficiencies to be identified by the HSE.

The Government has introduced a suite of new measures to enhance capacity in the HSE’s pricing and reimbursement system, including 34 additional staff, which is a 100% increase, and a medicines application tracker to increase the transparency and efficiency of the process. Access to medicines requires industry and the State to work together, through timely assessment, reasonable pricing and fully completed health technology assessments. This partnership has already directly benefited patients, for example those with cystic fibrosis and other rare diseases. In this spirit of co-operation, I continue to encourage pharmaceutical companies to submit timely applications for their products so as to increase access for patients with unmet needs. It is also the responsibility of the HSE to improve its efficiency and it has been enabled to do that with the provision of a 100% increasing in staffing in that area.

All medicines are assessed from a clinical, economic and ethical standpoint, with no hierarchy of disease. Upon approval by the European Medicines Agency, applications for reimbursement are assessed by the HSE in the order in which they are received from applicant companies.

As outlined in the programme for Government, as the Deputy correctly identified, consideration will be given to various measures to address access to medicines. As part of this, my Department is looking at reimbursement systems across the European Union, including Belgium. We are working closely with our Benelux partners on access to medicines where we have had some previous success.

Shane Moynihan (Dublin Mid West, Fianna Fail)
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It is great to hear about the progress that has been made in implementing the recommendations of the Mazars report on this subject that was published some years ago. That goes to the heart of the extra resourcing that the Minister spoke about. She is right; there needs to be a partnership between industry and the State to make sure that these applications are put through immediately and that the HSE can adjudicate on them accordingly. I am very encouraged to hear that the Department is considering other systems internationally, like the Belgian model. This model is particularly interesting because it shows a way in which timely access to these drugs that is not necessarily contingent on EMA approval can be provided. That is based on EU Regulation No. 726/2004. Article 83 of the regulation provides access to medications that are in late stage clinical development, expected to receive EU marketing authorisation and targeting patients with serious conditions. If we had those sorts of parameters for a scheme focused on early access to rare disease drugs, it would be a game-changer for many families that are afflicted with these conditions.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I want to put a little bit of context on this. The State spent more than €3 billion in 2023 providing medicines to patients. We sometimes forget that €3 billion of the health spend goes to providing medicines. That is appropriate but it is a major budgetary consideration as well. With the early access programmes, we have to get the balance right between being able to get access to the drugs and also being able to work out how that programme intersects with the State's ability to negotiate the right price for the drugs.

Regarding Duchenne muscular dystrophy, which the Deputy mentioned, I do not see how the State could be more proactive in trying to support this. On approval from the European Medicines Agency, I asked the CEO of the HSE and the Secretary General of my Department to find ways to support this. The HSE has proactively reached out to the company to ask it to submit an application. I made it my business to speak with the Italian Minister of Health at the EPSCO Council in Luxembourg to ask him to encourage the company to submit an application to Ireland. We will do everything we can because we recognise the life-changing implications of some of these drugs. However, as Minister, I must also point out that we have to get an early access programme right in a way that enables the State to get the best negotiating price for the delivery of drugs for everybody.

Shane Moynihan (Dublin Mid West, Fianna Fail)
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I appreciate the efforts of the Minister in this regard and I have conveyed that to the families involved. I am very grateful for the Minister's proactive approach. The beauty of getting an early access scheme right is that it does not necessarily rely on the proactivity of the State to be involved in that process but, rather, the partnership is hardwired into every piece of the system and the State is empowered to get value for money but also to ensure timely access to these drugs. In many cases of patients with rare diseases, time is the issue when it comes to stopping the deterioration of their conditions. I ask the Minister to keep us updated on the Department's progress in looking at these international models and to ensure that the best practice we learn from those is applied in any such Irish case.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I will do so, Deputy.