Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

631. To ask the Minister for Health if she intends on expediting the review of the drug reimbursement process as committed to in the Programme for Government; and if she will make a statement on the matter. [4291/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context | Oireachtas source

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.

Amongst its observations, the report recommended the introduction of a Medicines Reimbursement Application Tracker to demonstrate how a medicine is progressing through the process. This will enhance transparency for patients and provide applicant companies real time visibility on a new medicine application. The tracker was launched in December 2024.

As recommended in the Mazars Report, the Government allocated significant funding for an additional 34 WTE for the agencies involved in the HSE’s medicines pricing and reimbursement system. These additional staff will allow each agency to operate to its full potential, ensuring timely and efficient assessment of applications.

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.