Dáil Éireann Debate, Tuesday - 24 June 2025
868. Deputy Emer Currie asked the Minister for Health for an update on the implementation to date of Report of the Review of the Governance Arrangements and the Resources currently in place to support the HSE reimbursement and pricing decision-making process; and if she will make a statement on the matter. [34287/25]
Amharc ar fhreagraThe recently published Programme for Government (Securing Ireland's Future) contains a suite of measures on medicines which my officials will seek to progress over the lifetime of this government.
The Government is committed to providing access to new and innovative medicines for patients. Budgets 2021 to 2024 allocated €128 million in funding towards new drugs while Budget 2025 allocated €30 million in funding for new drugs to be generated by efficiencies identified by the HSE. Up to June 2025 this has allowed the HSE to approve reimbursement for 219 new medicines of which eighty-two (82) of these were for cancer and fifty-five (55) of these were for rare diseases. The OECD reports that Ireland has the second highest rate of state coverage of pharmaceutical expenditure in Europe.
The previous Minister for Health published the Mazars Report in 2023 which found that the HSE Pricing and Reimbursement system was operating as intended and within international norms.
On foot of this review significant funding was allocated by Government for an additional 34 staff across the pricing and reimbursement system. These staff have now been hired. Given the specialised skill set required for these roles, recruitment was a complex endeavour which only reached completion in the second half of 2024. As a result, their full impact on the speed of assessment of new medicine applications will become evident in the coming months.
A further recommendation of the Mazars Review was the introduction of an application tracker by the HSE to support transparency. The initial version of the HSE’s application tracker has now launched. This will allow patients and industry alike to have a substantive overview on the pricing and reimbursement application for a medicine.
For 2025, the HSE National Service Plan will continue the tracker’s development with the introduction of indicative timelines for each step of a medicine’s assessment process.
Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. The timing of company applications for new medicines reimbursement in different countries can vary for several reasons, not least the available market share in each country. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. The reimbursement assessment process cannot begin until an application is received.
Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list once granted marketing authorisation by the European Medicines Agency.
