There were two PSI Council meetings in recent weeks, the first on 12 December, which encompassed a wide range of issues, while a shorter meeting was held on 16 January to discuss a report on feedback received following public consultation on the proposed Draft Pharmaceutical Society of Ireland (Fees) (Amendment) Rules 2024. Over the following pages, Danielle Barron provides an account of both meetings.
Registrar Joanne Kissane opened the December meeting by offering some brief highlights of her Registrar’s report. The PSI continues its active membership of the Community Pharmacy Expansion Implementation Oversight Group (IOG) to oversee the introduction of a Common Conditions Service in community pharmacies, including contraceptive prescribing by pharmacists to extend or continue a prescription for contraception. The PSI is leading the second workstream, “education and training for pharmacists and regulatory matters”, and has carried out initial research into potential approaches to training for each of the eight common conditions named, a draft specification for which has been shared with the oversight group, Ms Kissane noted.
Reform of the Pharmacy Act remains a priority activity for the Regulator, and Ms Kissane explained that the PSI had submitted an action plan to the Department of Health in November 2024 that identifies a subset of high priority proposed legislative changes that are at a “relatively low level of complexity”. The proposed changes that are being sought in the short-term relate to the Fitness to Practise process, including the role of the PSI Council in the process, along with a request to provide powers to the PSI to introduce outcomes-focussed regulatory standards. “We believe these could be actioned within a short timeframe,” Ms Kissane said.
The PSI is seeking powers similar to those enjoyed by the Medical Council, the Nursing and Midwifery Board of Ireland and other regulatory bodies, Ms Kissane explained. “The imperative for change is very much supported by the planned expansion of our scope of practice and recommendations of the Expert Taskforce,” she commented. “The suite of tools we have available to us at the moment will not be sufficient when we have a Common Conditions Service and it will be more challenging for us to regulate against those,” she said, adding that this includes the removal of roles from the PSI Council. “For Council’s knowledge, we wrote to the Professional Regulation Unit in the Department. They are very supportive of the amendments.” The Registrar also noted these changes are already in train for the Medical Practitioners Act as the Medical Council is seeking similar amendments. “As a result of the Medical Council moving forward, other regulators have sought similar amendments,” Ms Kissane added.
Ms Kissane also delivered an update on progress within the PSI in growing patient public involvement in its work. On 1 December 2024, the PSI joined the HPRA Patient forum in discussion at their last meeting held for the year. For 2025, the PSI intends to work collaboratively with the HPRA and will be leading a session with the forum to gain ‘valuable insights’ on its work, which Ms Kissane said they are “quite excited” by. “It’s very much a partnership approach . . . it is important we start hearing the patient and public voice consistently in our work,” she commented. Ms Kissane also informed Council that the PSI has recently applied for funding from the Health Research Board for a research project, which will focus on how the PSI can involve patients and the public in its work. The application was submitted in December and if it is successful, the PSI will be informed in June 2025.
Proposed changes to the PSI registration process and PSI CPD rules were also outlined by Ms Kissane. These had been drafted by a barrister-at-law and are currently in the process of discussion and redrafting. These rule changes seek to operationalise the proposed changes to the CPD model for pharmacists and also pharmaceutical assistants, and include the flexibility for Council to operate the CPD system via an outsourced mechanism, she explained. The draft will be presented to the Regulatory and Professional Policy Committee (RPP) in February and will hopefully be put before the Council at its meeting in March for approval. Ms Kissane thanked her colleagues in the Practitioner Assurance Team for their ongoing work over recent years, noting it had been a long process to get to this point.
Council member Martin Higgins noted that the composition of patient boards is important, in order to ensure they are “truly representative”. In response, Ms Kissane noted that the HPRA Patient Forum is an “experienced group of patient representatives” who offer “very insightful input”.
Pharmacist and Council member Sean Reilly noted the changes in the Fitness to Practise rules and queried whether that would mean private sessions of the PSI Council would no longer take place. Ms Kissane said it would be a long time before this happened but “yes, potentially”. Mr Reilly expressed his concern at this, saying “someone has to sit above the PCC (Professional Conduct Committee) . . . there has to be a review of sanctions”. Ms Kissane assured him and the rest of Council members present that she would keep them updated on any movement on this, stressing that this change would only happen if it is legislated for.
There was a query from Council member Geraldine Campbell on the current timeline for decisions of the Preliminary Proceedings Committee (PPC), noting that this was the second report where none of the complaints for PPC reached the KPI requirement. It was noted that the 2025 service plan involved carrying out a review of the PPC and the improvements required in meeting those timelines. Mr Reilly acknowledged that the backlog has reduced significantly in recent times but Ms Kissane admitted there is “still a long way to go” and said it is an area for significant improvement.
Pharmacist Council member Emily Kelly queried if there would be a change to governance of the IIOP if CPD rule changes went ahead. She noted that the “trust” that comes from it being a separate organisation has “helped it flourish” and said she personally would not like to see a change in this.
Ms Kissane then continued with a Service Plan update, this being the final Service Plan of this current corporate strategy. A request for approval from Council of the PSI’s 2025 Service Plan and budget by Ann McGarry of the Performance and Resources Committee was granted after she said she was happy to recommend it for approval.
The Registrar noted that the new Service Plan includes a new range of strategic activities, while also continuing some that were commenced under the current Corporate Strategy.
Naturally, a significant focus for 2025 will be supporting the expanded scope of practice of pharmacy, while the rollout of digital health initiatives will also be a priority; Ms Kissane noted that the PSI had recently been invited to become a member of the Board of the National e-Prescribing Project.
In relation to the Budget, this largely echoed previous years in that the financial position of the PSI remains “challenging”. A key priority for the PSI will be the delivery of a core funding review, explained Ms Kissane, to ensure a sustainable financial position and appropriate funding model for PSI. “Ongoing and prudent management of finances is required and will be delivered.” A proposed expenditure of €11.887 million for 2025 will be matched by an income of just €8.856 million. It was explained that €1.128 million will be funded from reserves, which leaves a €1.903 million deficit.
Council member Cyril Sullivan noted an extra €1 million approximately on registrant and customer relations and also pay costs. This is linked to recent recruitment and involves full-year costs of posts filled during 2024 and also public sector pay increases. The budget was approved by Council. A request for approval from Council of the draft Corporate Strategy 2025-2028 following review by the Minister for Health was also sought and granted. A request for approval from Council of the appointment of a Returning Officer and Alternate Returning Officer for the Election of Council pharmacist members in 2025 was then approved.
The report to Council from the Business Transformation Project Programme Board was delivered by Grainne Power, who noted the project is progressing well, with assessments for phase four about to commence. Sean Reilly queried why the project was lasting this long — he believed it was a one-year project and suggested a target date for completion. Ms Power said phase four piece already has a “solid foundation” and she is confident that organisation is in good place to assess how phase four could be delivered “in short order”.
Ms Kissane noted they are building on the business intelligence gained from phase three and building a regulatory risk model based on information they already have. While Mr Reilly expressed his concern that vendors “might string this out as long as there is money there”, Ms Power clarified that phase four has no vendor committed to it as yet. It was clarified that the steering group and oversight board has a budget approved by Council — if more budget is required, then they will return to council with a business case for same.
Ann McGarry then delivered her report to Council from the Performance and Resources Committee. She emphasised the importance of the strategic financing review, saying it is crucial in terms of the ongoing viability and financing of PSI. “We are not in dire straits yet . . . the crunch years will be 2026 on,” she commented. A request for approval from Council of management accounts to 30 September 2024 was granted, as was a request for approval from Council of an Updated Reserves Policy, which will see dedicated reserves for FTP hearings become part of overall reserves. Approval was also granted for the updated Treasury Management Policy.
A request for approval from Council of the winding up of a pension scheme established prior to the Pharmacy Act 2007 was sought and granted; it was noted that there is just one person currently in that scheme — arranging payment to that one former employee need not be formally approved by Council.
The report to Council from the Regulatory and Professional Policy Committee was given by Rory O’Donnell, who had requests for approval from Council of the updated TCQR route policy approved, as well as a request for the revised PSI fees Rules to be submitted for public consultation. A request for approval from Council of the Accreditation Panel for MPharm visits was granted.
The previously discussed PSI (Registration) Rules Amendments were agreed by Council to be sent for public consultation, as were the PSI (CPD) Rules Amendments. In response to a request for approval from Council of the draft IIOP Annual Work Plan 2025, Emily Kelly noted the importance of mentoring and asked there be continued focus on mentoring and mental health supports for pharmacists. The draft Plan was duly approved. A request for approval from Council for suspension of practice reviews for 2025 was granted in light of a clarification that legislative changes would be required to allow full removal.
The report to Council from the Audit and Risk Committee was offered by Geraldine Campbell, who had requests for approval from Council of Anti-Fraud and Corruption Policy and an updated Safety Statement granted. Finally, the report of the Special Purpose Committee saw a number of appointments approved to the Board of the Business Transformation Programme (BTP), the PSI Disciplinary Committees and PSI Advisory Committees. The public Council meeting adjourned until January 30 2025, when its first meeting of the new year will take place.
On 16 January a brief public PSI Council meeting took place to discuss the report on feedback received following public consultation on the proposed Draft Pharmaceutical Society of Ireland (Fees) (Amendment) Rules 2024. These rules are in relation to the fees for the Third Country Qualification Recognition (TCQR) process.
The report was outlined by Damhnait Gaughan, who noted that feedback had suggested the proposed fees were too high, yet the current fees do not cover the cost of the TCQR process; “These were set in 2008 and haven’t kept pace with what is needed to deliver the route,” she commented. The new fees would support a more streamlined fairer TCQR process where the hidden costs are removed and are estimations based on extrapolation of current costs associated with this TCQR process and requirements going forward for the new process, she said. “The cost needs to be borne by applicants and not subsidised by the organisation, the registrants or the State, that is the cost recovery model,” Ms Gaughan said.
During the meeting it was clarified that the proposed fees are largely in line with those of other jurisdictions. Council member Sean Reilly and others raised the issue of the negative feedback to the consultation. It was agreed that the PSI may have to further clarify that the proposed fees are based on a “cost recovery model” and perhaps be more explicit about their justification for the fee increase. It should also be clarified that registrants are not subsidising applicant fees. “The response needs to incorporate some of the very valid reasons why PSI considered it proportionate,” said council member Ann McGarry.
Registrar Joanne Kissane again emphasised that while, “there is an overwhelming sentiment that the fees are disproportionate . . . the fee in place doesn’t cover the cost of the route”. “The revised fee is very transparent for applicants and where an applicant doesn’t have to do an examination the cost is quite reasonable.” Richard Hammond agreed, saying perhaps more public or professional awareness is needed of the costs involved in this TCQR process; “This is economically reasoned rather than anecdotal or feelings-based.”
Paula Barry Walsh also commented that she is “fully in favour” but suggested that “more of the rationale [for the increase] could be reflected in the document, in terms of the justification for the decision that is ultimately made”.
Ms Kissane also noted the number of applicants had grown significantly in recent years from 40 pre-COVID to 50 or 60 consistently in recent years. Ms Gaughan also noted that the new criteria makes it more open than the previous TCQR process and will allow for pent up demand to come into the system.
Council member John Given expressed his belief that the numbers coming through the TCQR route will “grow significantly” in the coming years, with evidence already that external parties are trying to recruit pharmacists to Ireland via social media etc. This could have a huge financial impact if the costs of fulfilling the route aren’t being met. “If there were to be 2,000 additional registrants that would make a significant difference, but that remains to be seen,” said Ms Kissane.
Ms Gaughan and Ms Kissane agreed that the final report would be amended to reflect more of the reasoning behind the fee increases: “It is clear that the PSI response has to be fleshed out in this particular document for publication,” said Ms Gaughan.
Pharmacist Council member Emily Kelly stressed that there are still a number of “unknowns” with the new TCQR process: “The key is that this would be reviewed regularly rather than it being another 20 years,” she said, suggesting that this review process should be formalised.
Danielle Barron
PSI
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