Peadar Tóibín (Meath West, Aontú)
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1040. To ask the Minister for Health how the HPRA is funded. [2196/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Health Products Regulatory Authority (HPRA) is largely self-funded by fee income. These fees are laid out in an annual Statutory Instrument, made under Section 13 of the Irish Medicines Board Act 1995 (IMB Act).

A policy of annual fee reviews following consultation, was introduced in 2004. The HPRA may additionally charge for services, under Section 14 of the IMB Act following consultation with the Minister for Health.

Since its establishment in 1996, The Health Products Regulatory Authority (HPRA), has consistently run its regulation of human medicines authorisation, manufacturer and wholesaler operations without recourse to exchequer funding.

Sufficient reserves have been established to allow the HPRA to fund capital and IT expenditure and deal with unexpected costs as these arise. This is both a requirement under the IMB Act and a stated objective of the Authority of the HPRA.

For medical devices, cosmetics, blood, tissues and cells, the HPRA receives a partial subvention from the Department of Health but also commits to ensure that the income received matches the costs of those functions.

The total HPRA income for 2023 was €39.629 million of which €5.560 million in funding was provided by the Department of Health.