Written answer
Clinical Trials
The Minister outlined substantial investment in innovative and rare-disease medicines, while confirming the HSE had received no reimbursement application for sepiapterin.
3569. Deputy Michael Lowry asked the Minister for Health the position regarding a clinical trial (details supplied); and the steps being taken to ensure that Ireland does not fall behind other European countries in providing access to innovative treatments for people living with rare diseases. [56927/26]
Comment on this
3603. Deputy Ryan O'Meara asked the Minister for Health if a pricing and reimbursement application has been received for a medication (details supplied); if so, for an update on the application; and if she will make a statement on the matter. [56999/26]
Comment on this
I propose to take Questions Nos. 3569 and 3603 together.
The Government is committed to investing in new medicines. Supported by €158 million of funding in Budgets 2021-2025, the State delivered access to 250 new medicines. 70 of these were for rare diseases. Budget 2026 allocated €217 million additional investment in medicines, including €30 million in funding for new medicines. This has, as of June 2026, delivered access to 30 new medicines, including 7 for rare diseases.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
Ireland is ‘open for business’ and all pharmaceutical companies are encouraged to submit applications for reimbursement for new medicines that are granted marketing authorisation in Europe.
Further information on the progress of assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at HSE - PCRS www.sspcrs.ie/portal/rdt/pub/application/home.
As of July 2026, no pricing and reimbursement application has been received by the HSE for sepiapterin (Sephience®). The national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission.