3317. Deputy Sean Fleming asked the Minister for Health to review correspondence regarding a clinical trial (details supplied); and if she will make a statement on the matter. [59934/26]

3781. Deputy Paul McAuliffe asked the Minister for Health the pathway that will be available to eligible Irish patients of phenylketonuria while the reimbursement process for sepiapterin is ongoing. [62888/26]

3782. Deputy Paul McAuliffe asked the Minister for Health the measures being taken to ensure that Ireland’s commitments under the National Rare Disease Strategy translate into timely access to innovative medicines for people living with rare diseases. [62887/26]

3783. Deputy Paul McAuliffe asked the Minister for Health her engagement in relation to pre-reimbursement taking place between PTC and the relevant HSE bodies. [62886/26]

3784. Deputy Paul McAuliffe asked the Minister for Health the current status of sepiapterin in Ireland; and if she will make a statement on the matter. [62885/26]

3789. Deputy Seán Crowe asked the Minister for Health to report on the way in which the National Rare Disease Strategy is being implemented to ensure timely access to innovative treatments for rare disease patients, including those with Phenylketonuria (PKU). [62911/26]

3790. Deputy Seán Crowe asked the Minister for Health the status of sepiapterin for the treatment of phenylketonuria (PKU) in Ireland; whether a formal pricing and reimbursement application has been submitted to the HSE by an organisation (details supplied); if not, the engagement that has taken place between the HSE and the company on the matter; the steps being taken to expedite access to this treatment; the indicative timeline for assessment and reimbursement once an application is received; the interim or early access arrangements available to eligible patients in the absence of reimbursement; and if she will make a statement on the matter. [62910/26]

3870. Deputy Ciarán Ahern asked the Minister for Health the status of a treatment (details supplied); whether a formal pricing and reimbursement application has been submitted to the Health Service Executive by PTC Therapeutics (details supplied); the steps being taken by her Department or the HSE to progress or expedite access to this treatment; the timeline for assessment and potential reimbursement once an application is received; the interim or early access arrangements available to eligible patients in the absence of reimbursement; and if she will make a statement on the matter. [63236/26]

I propose to take Questions Nos. 3317, 3781 to 3784, inclusive, 3789, 3790 and 3870 together.

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.

To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.

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: www.sspcrs.ie/portal/rdt/pub/application/home

As of the 28th August 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.