Is Pharmacy Fitness to Practice fit for purpose? - DAC Beachcroft

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Is Pharmacy Fitness to Practice fit for purpose?

Published On: 1 January 2016

This is the second in a series of three articles which will examine the process by which the PSI supervises pharmacies, pharmacists and their compliance with the Pharmacy Act 2007 (the "Act"). This article looks at the fitness to
practise processes under the Act. The final article in the series will examine the implications of the Corbally decision one year

Key Points

  • The primary source of fitness to practise complaints is the Registrar of PSI.
  • The fitness to practise process is costly, cumbersome and slow.
  • There can be a lack of clarity and the reasoning around the decisions of a committee of inquiry are not always clear.


Purpose of Fitness to Practise Process

The overarching purpose of the fitness to practise regime is to assure the quality of professional services in the public interest. There should be 3 key outcomes from the fitness to practise process:

  • Dealing with the shortcomings of individual practitioners and where appropriate imposing a sanction.
  • If the process is transparently and consistently run, it will give guidance to other professionals as to what is expected and act a deterrent against conduct unbecoming of the profession.
  • Similarly, a proper process will foster public confidence in the profession.

In this regard, any sanction imposed on a pharmacist should be transparent, consistent and proportionate.

The Complaint

The primary grounds for complaint are professional misconduct and poor professional performance. Professional misconduct includes moral turpitude, fraud and disgraceful conduct. It also includes any breach of the PSI's Code of Conduct.

The use of a code of conduct as a reference point for professional misconduct is troublesome. It is invidious to suggest that any breach of a code of conduct, even an inconsequential one, amounts to professional misconduct. This is particularly troubling where examples cited under the six principles of the code of conduct include such general obligations as to "ensure that he/she is objective in behaviour and decision-making" and to "ensure, in accordance with his/her role, that an optimal practice environment and required resources are evaluated and provided".

Steps in the Fitness to Practise Process

The disciplinary processes of most of the statutory professional regulators in Ireland have a common structure incorporating an investigatory stage, inquiry stage, a decision on sanction and a confirmatory and/or appeal stage. Pharmacy is no different.

Many commentators hold the view that the procedures in the Act are cumbersome, outdated, unnecessarily costly and lead to excessive delay. Having advised on multiple pharmacy fitness to practise cases, we find it hard to disagree.

The process provided under the Act comprises a significant number of steps and can appear unwieldy. A case can be made that some of these steps are unnecessary and add little in terms of ensuring fairness to the pharmacist concerned or to protecting the public. As a result, the process can be quite costly, stressful and time-consuming for the pharmacist. If a complaint is made on foot of an inspection and authorised officers' report, the process will take a number of years, which often means that the subject matter of the complaint has been addressed or rectified by the pharmacist and begs the question as to whether there is a more expedient and effective way of dealing with the shortcomings of a pharmacist.

While there is provision under the Act for mediation, there should be more informal methods of resolving complaints, something which was recognised in the Supreme Court decision in the Corbally case and which we will discuss in our next article.

It would take a very convoluted diagram to explain this fitness to practise process. However if we take the example of a complaint which emanates from a PSI inspection and results in a serious sanction the primary steps include:

  1. The Act provides for the Council to receive and consider reports from its authorised officers. However, this function is delegated to the Registrar. The Registrar will give the pharmacist an opportunity to comment on the report before making a decision on whether it should be considered by the Council. This is effectively a screening mechanism so that the Council does not have to consider all reports.
  2. If the Registrar so decides, the report (and any response to it) is sent to the Council for it to decide whether disciplinary proceedings should be commenced.
  3. If the Council decides disciplinary proceedings should be commenced the Registrar formally makes the 'complaint'.
  4. The complaint' is sent to the pharmacist who has a further chance to respond / make submissions before the complaint is considered by the preliminary proceedings committee ("PPC"). The PPC reviews the complaint and advises the Council whether it "warrants further action". It is required to consider whether the complaint is frivolous, vexatious, made in bad faith or without substance. This can be one of the most important stages in the process. A pharmacist should not reply to a request for observations and comments without the input of someone who is experienced in pharmacy fitness to practise cases.
  5. Having received the advice of the PPC, the Council decides whether to take further action.
  6. The matter is then referred by the PPC to the professional conduct committee ("PCC") or health committee, or to mediation.
  7. The pharmacist receives a Notice of Inquiry and there is a hearing before a committee of inquiry (the PCC or the health committee). A committee of inquiry has all of the powers, rights and duties of a High Court judge in relation to enforcing the attendance of witnesses, examining witnesses on oath and compelling the production or inspection of records or other documents.
  8. Following the hearing, the committee of inquiry sends a report to the Council detailing its findings. The Council meets to decide the sanction. The pharmacist has a further right to attend and make submissions to the Council.
  9. The Council notifies the pharmacist of the sanction and the pharmacist has 30 days to appeal that finding to the High Court (except as regards an admonishment or censure which cannot be appealed).
  10. If the pharmacist does not appeal, the Council applies to the High Court for an order confirming the decision and sanction.

Some of the aspects of the process are curious from a legal perspective. For example, the Council effectively initiates the disciplinary process on foot of an authorised officers' report. It subsequently decides whether the matter warrants further action (following PPC advice) having earlier effectively decided it does warrant further action and instructing the Registrar in this regard. Having not been a party to the hearing, it then decides on sanction having not heard the evidence presented at the hearing. In fairness to the PSI, this is the statutory structure it has been given and it shares this architecture with other regulated professions.

If the Council hands down a disciplinary sanction, this is notified to the pharmacist along with the reasons for imposition of the sanction. However, there is no 'reasoned decision' or written judgement like one would receive from the High Court or in most sporting disciplinary processes.

Hearings are generally in public and sanctions can be published by the PSI where it is in the public interest to do so. Despite this, the complexity of the rules and regulations governing pharmacy, the complexity of the evidence and the lack of a fully reasoned decision often make it difficult to determine whether a finding of poor professional performance and/or professional misconduct (or a finding that there has been neither) and the sanction imposed is consistent with other cases.


Many of the criticisms of the fitness to practise processes under the Act are equally applicable across a range of professions. An independent review commissioned by the PSI and carried out by Felix McEnroy SC recommended that the Council of the PSI should give consideration to (i) whether a less adversarial and more collaborative statutory process of complaint is in the public interest and (ii) whether administrative steps can be taken to ameliorate the burden of distress and delay on both the person making the complaint and the pharmacist the subject of the complaint.

There is limited scope for the PSI to address these issues without there being significant changes to the Act, something which is only likely to happen in tandem with changes to the legislation governing a range of professions. Although the Fine Gael-Labour Government has committed to changing the Act arising from the Corbally decision, it remains to be seen whether a new Government will make anything other than the minimum of change required to ensure the Act is consistent with Corbally, a topic we will explore further in our third article in this series.

Gary Rice , Aidan Healy and Niall Sexton of DAC Beachcroft Solicitors (01 231 9600) are specialists in the commercial and regulatory issues which arise for pharmacies and pharmacists. DAC Beachcroft, a global law firm, is a recognised market leader in healthcare law. This article is for general information purposes only and does not comprise legal advice on any particular matter. You should not rely on any of the material in this article without seeking appropriate legal advice.