Pádraig Rice (Cork South-Central, Social Democrats)
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2579. To ask the Minister for Health the status of the Programme for Government commitment to review the drugs reimbursement process; if work has commenced on advancing this commitment; the timeline she is working towards; and if she will make a statement on the matter. [46800/25]

Colm Burke (Cork North-Central, Fine Gael)
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2634. To ask the Minister for Health when her Department intends entering into negotiations with the pharmaceutical industry regarding the medicine pricing agreement, given that the existing agreement expires on 30 September 2025; and if she will make a statement on the matter. [47050/25]

Colm Burke (Cork North-Central, Fine Gael)
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2635. To ask the Minister for Health if her Department is prepared to engage with the pharmaceutical industry with a view to putting in place a process which will enable new medicines to be assessed within the 180-day time frame set out in legislation under the Health (Pricing and Supply of Medical Goods) Act 2013; and if she will make a statement on the matter. [47051/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 2579, 2634 and 2635 together.

The Programme for Government (Securing Ireland's Future) contains a suite of measures on medicines which my officials seek to progress over the lifetime of this government.

In line with the commitments in the Programme for Government, consideration is being given to various measures to address access to medicines. The Department is reviewing reimbursement systems across the EU to explore options for recommendation to Government and this work is ongoing.

The State invested in new capacity in the pricing and reimbursement system last year.

This investment encompassed additional significant resourcing which was allocated for 34 additional staff across the pricing and reimbursement system. Given the specialised skillset required for these roles, recruitment was a complex endeavour which only reached completion in the second half of 2024. As a result, the full impact on the speed of the assessment of new medicine applications will soon become evident. This is in addition to the development and launch of a HSE medicines pricing and reimbursement tracker to enhance transparency in the pricing and reimbursement system.

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.

Multi-annual Framework Agreements on the Supply and Pricing of Medicines (FASPM) have been negotiated between the HSE, the Irish State, and the pharmaceutical industry since the 1970s. These Agreements provide certainty and stability to the pricing and supply of medicines in Ireland, benefitting both the industry and patients.

It is expected that formal engagements will commence this month with the pharmaceutical industry on the next iteration of FASPMs. The State looks forward to further productive engagement with the industry to reach an outcome that ultimately benefits patients in Ireland.