Colm Burke (Cork North-Central, Fine Gael)
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592. To ask the Minister for Health her views on whether the Programme for Government commitment to review the reimbursement process is entirely separate from the previous review carried out by a company (details supplied); if new terms of reference will need to be created for this new review; and if she will make a statement on the matter. [49731/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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, further 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.

An external review of the pricing and reimbursement process, the Mazars Review, was published in 2023. This determined that the pricing and reimbursement process operated in line with international norms.

The State values its productive partnership with the pharmaceutical industry and this is evidenced by the ongoing collaboration and the investment in new capacity in the pricing and reimbursement system last year which was a key recommendation on foot of the outcome of the Mazars Review.

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.