I would like to thank the Deputy for raising this question.
The Pharmaceutical Society of Ireland (PSI) is a statutory regulator established under the Pharmacy Act 2007 and funded primarily through registrant fees. Any amendment to PSI fee rules requires the approval of the Minister for Health.
Under the PSI Corporate Strategy 2025-2028 the PSI Council committed to undertaking a Core Funding Review. The purpose of the Core Funding Review was to enable the Council of the PSI to safeguard the long-term financial stability and sustainability to support the ongoing operation of the organisation and to assess the strategic financial direction of the PSI. A key objective was to confirm that PSI’s fee model operates on a cost-recovery basis, in line with best practice for regulatory bodies, to support the delivery of its statutory functions and ensure public confidence in the standard of services received in pharmacies and by pharmacists.
The review was carried out by Mazars and the associated Core Funding Review Report highlighted that PSI is currently operating at a deficit and that, without corrective action, its capacity to deliver statutory functions—including inspections, complaints handling and other regulatory activity—would be at risk. The review recommends a baseline fee increase of 41.75% across all fee categories (except TCQR related fees as they were recently increased) to restore financial sustainability.
The review also recognised the scale of the proposed increase and recommended that, subject to legislative constraints, options to reduce the first-year impact should be examined, including phasing implementation over a 2–3 year period, and that this should be considered in consultation with the Department of Health, noting that phasing would increase pressure on PSI reserves.
The phased implementation of the 41.75% increase over 3 years was recommended by the Council of the PSI to address some of the feedback that came from the public consultation process. There has been no increase in registration fees since the establishment of the Fees Model in 2008; however, there were two fee reductions in 2010 and 2014. As part of the Core Funding Review, CPI was applied to the original fees set in 2008 and showed that CPI increased by 24.1% over that period (2008-2025), with no upward revision to PSI fee levels. It also concludes that if fees had risen in line with CPI over that period, then the proposed fee would be €558, which is higher than the proposed fee of €539, which is being introduced on a phased basis over 3 years.
The Department considered the proposed fees increase from the PSI in that context, having regard to the evidence in the Core Funding Review, the results from the public consultation, PSI’s ability to discharge its statutory functions, governance and value-for-money considerations, and the impact on registrants and agreed the approach to phase the implementation of the increase over 3 years.