Contraception Prescribing Service

The impending launch of the Contraception Prescribing Service was described as a “seismic” development at the PSI Council’s meeting on 1 October. The regulator expects that the new service will launch in early January.

Dr Denis O’Driscoll, Council President, said he wanted to highlight to Council as a “seminal moment” that they were considering approval of guidelines regarding the Contraception Prescribing Service.

The primary legislation to enable the Service, the Health (Provision of Contraception Prescribing Service in Retail Pharmacy Businesses) Act 2026, has been signed into law.  This Service will enable pharmacists to provide repeat prescriptions for specified forms of contraception to women aged 17 years and over, following an initial prescription from a GP.

Dr O’Driscoll said the pharmacist Contraception Prescribing Service was “an important story” and “seismic in the evolution of pharmacy practise”. He said that there would “probably be a communications campaign led by the Department of Health”.

This service will mirror the regulatory framework that is in place for the Common Conditions Service (CCS). Online training will be completed through the Irish Institute of Pharmacy (IIOP), while enabling legislation and protocols will be finalised by the Department of Health and the HSE respectively. The Implementation Oversight Group is finalising the Operational Guidance document and FAQ supporting resources.

Reform of the Pharmacy Act

Richard Hammond, SC, Chairperson of the Regulatory and Professional Policy Committee told Council about proposals the PSI have for reform of the Pharmacy Act. He said that the regulator, as a stakeholder, can only make suggestions, and that it is up to the Oireachtas and the Department of Health to decide which proposals are adopted. “We cannot reform the Act within our Council,” he said.

Proposed reduction of Council quorum

Amongst proposals to reform the Pharmacy Act was the reduction of the quorum of the Council from eleven people, as required under the Act, to seven, in line with recent developments at the Medical Council and the Nursing and Midwifery Board of Ireland (NMBI) who have reduced their quorums to seven and six people respectively.

The Preliminary Proceedings Committee (PPC) requires a non-pharmacist majority and there was no proposal to change the quorum for the PPC, he added. Dr Anne McGarry, public interest nominee said that she was “surprised” at the proposed change to the quorum as she said that it had not been mentioned before.

Mr Hammond said that there were two factors behind the proposal, namely to allow Council to schedule impromptu meetings and so that the PSI would have a similar quorum to that of other health regulators.

Dr McGarry said that she had “a slight reservation” about the proposal and that she “was looking more at the strategic direction of the organisation”. Mr Hammond said that the Council have met at short notice to discuss, under section 45 of the Act, applications to seek from the High Court the emergency interim suspension of a pharmacist.

Dr McGarry asked, “how many [applications]?”, to which Mr Hammond replied, “You’ll find that there were a few”, and added that the Council needs the ability “to respond to things”. Dr McGarry said that this clarified matters for her, but that she was “not sure that she agreed with it”.

Proposals on FTP reform

Mr Hammond also spoke about the fitness to practise (FTP) policy proposals for a more streamlined and efficient process, including that the Preliminary Proceedings Committee (PPC) would be authorised to accept undertakings. Mr Hammond said that the Executive would continue to monitor undertakings.

Nigel Maloney, pharmacist appointed to the Council, raised the proposed power to enable an authorised officer to ask a complainant to file an affidavit with further information and queried whether this compromised equity of access to justice for both the complainant and the pharmacist.

Mr Hammond said that this was a “verification mechanism” utilised within the PPC’s processing of complaints. Under the Act a committee “may” require the complainant to verify, by affidavit or otherwise, anything contained in the complaint.

Mr Hammond said the affidavit proposal would bring “a significant benefit” in weeding out complaints made which were “not fully honourably” intended, such as those that were made “at 2.00am”.

He said that the requirement for the complainant to file an affidavit, where provided to the PPC, was “not lightly used”, and he did not see equity of access as an issue.

Ms Geraldine Campbell, public interest nominee had concerns with the proposal and said that mechanisms other than an affidavit were required.

Aoife Mellett, Head of Legal Affairs, Governance and Programme Delivery said that an affidavit may be requested where there may be an issue regarding verifying two versions of events put under oath.

Mr Hammond said that it cost €10 to get an affidavit from a solicitor and any exhibit thereto would cost an additional €2.

FTP governance and accountability

Dr Paula Barry Walsh said a discussion was needed on governance and accountability in relation to fitness to practise.

Currently under the Pharmacy Act, on completing an inquiry, a committee of inquiry submits a written report to the Council, which includes the committee’s findings. If the committee finds that the complaint is substantiated, the Council will impose one or more of the disciplinary sanctions, which range from an admonishment or censure to cancellation of registration.

Dr Barry Walsh said, “If you’re accountable you should have the power to change where it [fitness to practise] is steering to”.

Mr Hammond said it would be “worth seeing the finalised legislation, as promulgated by the Oireachtas, to look at how it may impact on things”.

Since 2018, the PSI has been engaging with the Department of Health regarding reform of the Pharmacy Act 2007.

In the PSI’s 2022 position paper on reform of the Act the regulator said that the FTP system is overly complex and lengthy and presents challenges for Council in carrying out its functions.

Mr Hammond continued: “If there is a surge in complaints, the Council will fulfil its statutory function”.

Mr Hammond said that he had no concerns regarding accountability and governance and that FTP was not being delegated. He said that where a Professional Conduct Committee makes a mistake then their decision is open to judicial review. “No regulator can avoid judicial review,” he said.

He added that the regulator should not take judicial review “personally” as it involves getting someone’s decisions opened up to judicial scrutiny. “If you succeed, fine, if you lose that’s ok too as we will know what to do in the future,” he said.

He said the objective should be to “ensure that the [FTP] process is properly equipped to succeed, and not to second guess the mind of a judge”.

Mr Hammond also said it was a good thing that a FTP committee had the power to make findings.

He said that if Council were to become an appeal or review body regarding FTP inquiries “every outcome” would be open to being appealed to Council which would lead to a “significant” increase in workload and cost.

Mr Hammond said that about one in 200 FTP inquiries were appealed to the High Court under judicial review.

Ms Nestor said that a clearer picture would emerge “further down the road” regarding what the legislation will look like, but that what was proposed was to follow the Medical Council, the NMBI and CORU “to make our FTP processes as efficient as theirs”.

Dr McGarry said that she thought it was important that an assessment be carried out as to the practical impact of the proposals. She said that there should be a long discussion so that Council would be better informed regarding the implications.

Ms Nestor said that she would give updates at Council meetings as to what stages the proposals are at, that the issue would remain on the agenda for Council meetings and that it would be up to Council as to when to have conversations.

Ms Barry Walsh asked whether a training day could be used to discuss the impact of such proposals and advocated for early engagement with the Minister for Health and the Department of Health.

Ms Joanne Kissane, Registrar said that Council could discuss the proposals again in March.

Mr Hammond said that the Heads of Bill was the first stage and Ms Nestor said that it would not be a case of simply furnishing the Act to Council.

Mr Peter Dennehy, public interest nominee, said that Council should be careful as to what it may expect from the process of the drafting of the legislation, that although the PSI would not be ignored, its impact would be limited.

Council approved the Reform of the Pharmacy Act and the updated policy proposals on Reform of the FTP Processes.

Approvals and reports

Vice-President, Emily Kelly, presented for discussion the Report from the Audit and Risk Committee (ARC), which was prepared by Crowleys DFK.

Ms Kissane, as Registrar, in providing her report to Council also gave an update on progress on the recommendations of the 2023 Workforce Intelligence Report.

Amongst activities concluded was the establishment of a dedicated forum for pharmacist employers and employees. The forum has proposed best practice working conditions including rest periods, employee benefits and appropriate delegation of non-pharmacist tasks.

One activity completed under the stewardship of IIOP is the promotion of workplace health and wellbeing resources and professional supports available to pharmacists experiencing burnout and stress.

A further completed initiative is the publication of guidance that sets out the distinct responsibilities associated with each governance role in Retail Pharmacy Businesses. One task outstanding was the commission of a feasibility study tasked with proposing a suitable and viable approach to addressing the need for professional leadership for pharmacy.

Ms Kissane also referenced the Workforce Working Group, a multiagency group established in April 2024 which includes pharmacists in leadership roles and representatives from the Department of Health.

The Group was established to address workforce planning and recruitment and retention challenges and is a joint initiative by the PSI and the Department of Health.

The establishment of the Group was also one of the recommendations of the Workforce Intelligence Report.

Ms Kissane said that the Report had six key recommendation headings including Strategic Workforce Planning, Leadership, Innovation and Technology, Attracting and Recruiting Pharmacists, Career Sustainability and Progression, and Working Conditions.

Ms Kissane also informed the meeting that Cora O’Connell was appointed the Chief Pharmaceutical Officer at the Department of Health at the end of September and congratulated her on her appointment.

Ms Kissane also referenced the Business Transformation Programme (BTP) of the PSI which aims to allow pharmacists to provide their services digitally and also includes digital complaints functionality.

The BTP was established to modernise PSI regulatory systems to support effective delivery of statutory functions. The overall aim is to bring together registration systems, complaints, investigations and risk-based oversight. The benefits of this project are better quality data, more streamlined processes and greater effectiveness of regulatory processes.

Ms Kissane said that the procurement process for phase three of the BTP, which will enhance the PSI’s inspection, investigation and regulatory capabilities, has now been completed. An approved increase of €129,031, including VAT, was sought to enable the award and delivery of Phase 3, subject to completion of the procurement process and satisfactory contractual arrangements.

Ms Kissane said that all projects in the Service Plan 2026 were “progressing as expected”.

Dr McGarry, who is also chairperson of the Performance and Resources Committee introduced the committee’s Report to Council, which Council approved along with the Management Accounts to 30 June, plus high-level forecast and the Annual Review of Environmental Policy.

The Council is due to meet in public again on 8 December.