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; therefore, the matter of enhertu, zongertinib and sevabertinib has been referred to the HSE for attention and direct reply to you.
For a medicine to be reimbursed by the HSE it must undergo HSE’s pricing and reimbursement process for medicines.
• Budgets 2021-2025 allocated €158 million for new drugs. This has facilitated the introduction of 250 new medicines / new uses for existing medicines, including 101 for oncology and 70 for rare diseases. As you will be aware, this €158 million investment largely reflects the initial in year expenditure associated with a drug approved in any given year - the actual budget implications for each drug approval are considerably higher over a number of years, particularly the first five following its introduction.
• Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding provided this for the medicines budget. This has enabled the funding of 40 new medicines/ new uses for existing medicines, including 17 for oncology and 9 for rare diseases, for the period from January 2026 to September 2026.
There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.
These measures include:
• Funding by the Government to an almost doubling of capacity in the HSE’s pricing and reimbursement system with 34 additional staff
• New Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments and towards achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions following application by the Marketing Authorisation Holder.
• A commitment from Irish Pharmaceutical Healthcare Association (IPHA) member companies to aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of formal authorisation of medicines by the European Commission.
A key priority and area of focus is to reduce the timeline for reimbursement decisions to consistently meet 180 days. The recently commissioned end-to-end process review of the reimbursement system is primarily targeted at supporting this objective.
The Programme for Government contains a commitment to examine the development of early access schemes for rare diseases. The State and the pharmaceutical sector have agreed to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases. This will be a proof-of-concept initiative, aligned with the commitments in the Programme for Government and recommendations in the National Rare Disease Strategy 2025–2030. Scoping and research work is underway by the Department, including examining models in other jurisdictions.
We are now finalising the appointment of the Clinical Trials Advisory Council (CTAC) to oversee the implementation of the NCTOG’s Final Recommendations. The CTAC will include expert membership drawn from across the sector, and will commence activities in the coming weeks. These activities will have a forward-facing, long-term, and sustainable focus, and include the establishment of a National Clinical Trials Body to oversee our clinical trials sector. The NCTOG's 20 key recommendations, across six priority areas, will create a more agile and streamlined regulatory system for clinical trials whilst maintaining the highest standards of data and patient protection, in addition to supporting the expert workforce needed to administer growing numbers of clinical trials. The resulting reduction in start-up times for clinical trials, and standardisation of the regulatory processes, will enable greater numbers of clinical trials to be conducted in Ireland, also helping strengthen Irish participation in multinational trials and increasing Irish patients' access to innovative life-changing treatments.
