Our previous article (published in the July/August issue of the IPU Review), discussed the PSI complaints process from the time a complaint is made to the decision of the Council of the PSI (the Council), following advice from the Preliminary Proceedings Committee (PPC), on whether further action should be taken.
Under section 40 of the Pharmacy Act 2007 (the 2007 Act), where the Council decides to take further action, the complaint is referred by the PPC either to mediation or to a Committee of Inquiry. There are two Committees of Inquiry, the Professional Conduct Committee and the Health Committee.
The mediation process is governed by section 37 of the 2007 Act and the PSI’s Mediation Guidelines. It is only complaints which are not viewed by the PPC as particularly serious which might be referred to mediation. Most complaints are deemed not suitable for mediation, and it is only possible with the consent of both the complainant and the registered pharmacist or pharmacy owner. Mediation is a confidential process where a neutral third party (a mediator) sits down with both sides to the complaint to help resolve the matter and to agree an outcome.
If the mediation is successful, the mediator must report the terms of resolution of the complaint to the Council. This may include a disciplinary sanction. Alternatively, if agreement cannot be reached, the PPC refers the complaint to a Committee of Inquiry.
The Health Committee deals with complaints alleging an impairment of a pharmacist’s ability to practise because of a physical or mental ailment, an emotional disturbance or an addiction to alcohol or drugs. Hearings before the Health Committee are normally held in private. A doctor with relevant expertise will be appointed to advise the Health Committee in relation to each complaint referred to it.
The Professional Conduct Committee deals with complaints on all other grounds under section 35 of the 2007 Act, and the default position under section 42 is that its hearings are held in public. However, hearings can be conducted in private if the registered pharmacist or pharmacy owner or the complainant requests a private hearing, and the Committee is satisfied that it would be appropriate to agree to the request.
Solicitors acting for the Registrar of the PSI will investigate the complaint and prepare it for inquiry. This can include gathering medical and pharmacy records, taking witness statements, and asking an expert pharmacist (expert witness) to provide their opinion on whether, if the facts are proven, the conduct would amount to poor professional performance or professional misconduct.
You or your solicitor will receive a Notice of Inquiry setting out the specific allegations that are being made against you, as well as the evidence that will be called in support of those allegations. You will also be informed when a hearing date has been fixed for the inquiry, at least 30 days beforehand.
The Committee of Inquiry may hear preliminary or procedural applications in advance of the inquiry at a ‘callover’: for example, you may wish to make an application for the hearing to be heard in private. You will be notified when callover meetings are taking place and you must give advance notice of any application you intend to make.
A Committee of Inquiry may request you to do one or more of the following:
Such a request is usually only made in respect of complaints which are at the less serious end of the scale. If you refuse to give such an undertaking or consent, the Committee of Inquiry may proceed as if the request had not been made.
In practice, the possibility of undertakings and consents may first be raised by the pharmacists or their lawyers. Sometimes the Registrar of the PSI will be agreeable, or will at least not object, to an undertaking or consent, and this makes it more likely the Committee will find the undertaking/consent acceptable, but ultimately the specific terms of the undertaking are agreed by the pharmacist and accepted by the Committee.
The benefit of an undertaking is that the matter can be resolved without a finding against the pharmacist or a sanction imposed, albeit if the pharmacist breaches the undertaking, that can itself be the subject of a further complaint.
The Committee may also request the pharmacist or the pharmacy owner to consent to an admonishment or a censure. Unlike an undertaking, an admonishment or a censure is a sanction, but it is the lowest level of sanction provided for under the 2007 Act and it does not affect the pharmacist’s right to practise. It amounts to a slap on the wrist and a warning not to repeat the conduct. In a change introduced under the 2020 Act, there is no automatic publication of a sanction of admonishment or censure, unless the Council is satisfied that publication is in the public interest.
A hearing before a Committee of Inquiry may be held in person, or remotely if appropriate. You should attend the hearing with your solicitor and barrister. If you do not attend, the Committee may proceed with the hearing in your absence.
At the hearing, the Registrar bears the burden of proving all allegations against you beyond a reasonable doubt, in relation to (i), the facts alleged against you, and (ii) whether your conduct constitutes professional misconduct or poor professional performance (there are also some other grounds of complaint under the 2007 Act). You or your solicitor are entitled to cross-examine witnesses called on behalf of the Registrar, and to call witnesses and other evidence in your defence, but you are not obliged to do so.
Under section 43 of the 2007 Act, a Committee of Inquiry has all of the powers, rights and duties of a High Court judge and so can compel the attendance of witnesses, examine witnesses on oath and compel the production or inspection of records or other documents.
After hearing all of the evidence, the Committee will decide whether any or all of the allegations have been proven. The Committee sends a written report to the Council detailing its findings, and a copy of this report will also be provided to you. This report may also include a recommendation in relation to sanction, but this is a recommendation only and it up to the Council to decide on sanction.
Following receipt of the Committee’s report, the Council meets to decide on sanction. You have a right to attend this meeting and to make submissions to the Council.
Section 48 of the 2007 Act provides for the range of sanctions that it is open to the Council to impose, as follows:
The sanction must be proportionate, and you should be given as much leniency as possible under the circumstances, while also ensuring that the public interest is protected. The Council will consider any mitigating and aggravating factors that may have an impact on sanction.
One important mitigating factor will be if you have shown insight by accepting that the conduct that gave rise to the complaint was wrong and taken steps to remediate the matter. In order to get the maximum benefit for insight, any admissions should be open and full and should be made at the earliest possible stage in the process. You should always take advice from IPU Professional Services Team and an experienced solicitor about whether it is in your interest to make admissions.
You will be notified of the Council’s decision on sanction. In an amendment introduced by the 2020 Act, if the Council imposes a disciplinary sanction other than an undertaking or consent, then the notification of any sanction must now specify the time within which you may apply to the High Court for cancellation of the decision.
You may apply to the High Court to have the sanction cancelled within thirty days after you receive the notification of the Council’s decision. In an important amendment under the 2020 Act, arising from the Supreme Court judgment in the ‘Corbally’ case in 2015, this includes cases where the sanction imposed is admonishment or censure.
If the sanction is admonishment or censure and you do not apply for cancellation within the thirty-day timeframe, the sanction becomes effective when the thirty days expire. For all other sanctions, the PSI must apply to the High Court to confirm the Council’s decision before the sanctions take effect. This application can only be made after the thirty days during which you can apply for cancellation have expired. Section 52 of the Act provides that the High Court “may but need not confirm the Council’s decision”.
The Council is required to inform you of the High Court’s decision.
The Council is required to notify the HSE and such other persons as it thinks fit of the imposition of a sanction. The 2007 Act previously referred to the Minister of Health but this was amended to the HSE by the 2020 Act.
If the PSI becomes aware of sanctions imposed in another State, the Council notifies the HSE and the pharmacist’s employer if it is in the public interest to do so. In another change under the 2020 Act, if the Council has reason to believe that a pharmacist is registered in another jurisdiction, and that the regulator there may not be aware of the sanction imposed, the Council may give notice in writing to that body.
The Council is required to give public notice of the imposition of any sanction, except for admonishment and censure. As noted above, an amendment introduced by the 2020 Act means that, in the case of admonishment and censure, the sanction will be published only if the Council is satisfied that it is in the public interest to do so. The 2020 Act also provides that the Council can publish the transcript of any part of the proceedings of a Committee of Inquiry or any part of the report of a Committee of Inquiry, if satisfied that it is in the public interest to do so.
“This report may also include a recommendation in relation to sanction, but this is a recommendation only and it up to the Council to decide on sanction.”
As will be clear from the above and from our previous article in relation to the procedures before the PPC, complaints to the PSI can result in lengthy, stressful and complex proceedings. If a complaint is made against you, it is important to get advice as soon as possible from the IPU Professional Services Team and from a solicitor with experience dealing with pharmacy fitness to practise complaints. Depending on the nature of the complaint, it may be possible to avoid its being referred to a full inquiry if, on receiving the PPC’s advice, the Council decides that no further action should be taken. For this reason, it is essential that observations and comments on any complaint are very carefully considered and drafted.
If, however, the Council decides to take further action and the complaint is referred to a Committee of Inquiry, the burden is on the Registrar of the PSI to prove any allegations against you beyond a reasonable doubt.
Depending on the nature of the complaint against you, you may wish to consider making admissions to some or all of the allegations against you, in order to get credit for this when the Council comes to consider the appropriate sanction. You should never take this step without getting advice from legal advice from an experienced solicitor.
If the Committee does make findings against you, you are entitled to make submissions to the Council on the appropriate sanction. If the Council imposes a sanction on you, you may also apply to the High Court for cancellation of the Council’s decision. If you do not do so within 30 days, the Council applies to the High Court for an Order confirming the sanction, except as regards an admonishment or censure.
About the authors: Ruth Cormican is a solicitor and Aidan Healy is Legal Director in DAC Beachcroft Dublin’s Professional, Public and Regulatory Law team, which is led by Gary Rice, Partner. DAC Beachcroft has advised the IPU and its members for many years and specialises in the legal aspects of pharmacy practice. For more information, please contact Ruth Cormican on rcormican@dacbeachcroft.com. For more information on any legal aspect of pharmacy practice, please contact Aidan Healy (ahealy@dacbeachcroft.com) or Gary Rice (grice@dacbeachcroft.com).
The IPU Professional Services Team can be reached via email on pharmacists@ipu.ie or via 01 493 6401.
This is the second of two articles from DAC Beachcroft on the PSI complaints process and what pharmacists should do if a complaint is made against them. Part 1, How to handle a PSI complaint: Complaints and the preliminary proceedings committee was published in the July/August 2024 issue of the IPU Review. It is available to IPU members at ipu.ie/ipu-review > Archive Articles.
DAC Beachcroft
Regulatory, Professional, and Public Law Team
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