The State is committed to providing timely access to new and innovative medicines to all patients and has made considerable investments in new medicines in recent years.
Supported by €158 million of funding, since 2021, the State has delivered access to 250 new medicines or new uses for existing medicines, including 101 for treating cancer and 69 for treating rare diseases.
Budget 2026 allocated €217 million of investment in medicines, including €30 million for new medicines.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices.
The HSE advise that the application for Omaveloxolone [sold under the brand name Skyclarys] remains under consideration with the HSE.
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. The criteria the HSE considers in making any decision on pricing and reimbursement is set out in Section 21 of the Health (Pricing and Supply of Medical Goods) Act 2013.