John Paul Phelan (Carlow-Kilkenny, Fine Gael)
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1130. To ask the Minister for Health the reason an early/interim access scheme to provide early access to EMA-approved therapies for rare diseases has not been introduced; and if he will make a statement on the matter. [44428/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible.

The HSE robustly assesses applications for pricing and reimbursement to make sure it can stretch available resources as far as possible and to deliver best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). 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.

In February 2023, the Minister announced his intention to progress the development of a successor to the National Rare Disease Plan 2014-2018, in line with the commitment in the Programme for Government.

A National Rare Disease Steering Group was established in December 2023, and it has met eleven times since it first convened. The Steering Group is chaired by Prof. Cecily Kelleher, and has been tasked with developing the new National Rare Disease Strategy and an associated Implementation Plan. As part of Budget 2025, €1.5m was provided for rare diseases to support the provision of care through Ireland’s European Reference Networks (ERNs) for Rare Diseases, bolster the HSE’s National Rare Disease Office, and lay a strong foundation upon which to build following the publication of an updated National Rare Disease Strategy. The Steering Group is expected to have finalised the new National Rare Disease Strategy by end-2024, with implementation commencing in early 2025.

The development of a new Strategy will allow us to consider areas of the previous Plan that need to be further progressed, while also looking to the future and the needs of those patients and families living with a rare disease diagnosis.

A Public Consultation to gather the views of the public, including industry, on the development of the new Strategy closed in Q3 2024, with approximately 600 submissions received. The results of this Public Consultation will be considered by the Steering Group following data analysis.

The Department continues to ensure that our reimbursement system reflects best practices and optimal value-for-money for Irish patients. In Q1 2023, I published the Mazars Review which examined the governance arrangements around the HSE’s Drug Pricing and Reimbursement Process. The Report found that the reimbursement process is operating in line with the legislation and that it is delivering results in line with international norms.