Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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576. To ask the Minister for Health he will engage with an organisation (details supplied) to find out the number of complaints made in the years 2021, 2022 and to date in 2023; the number of complaints the PPC advised of no further action; the number of complaints referred to mediation or inquiry, in tabular form; and if he will make a statement on the matter. [51961/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Deputy, to help inform the answer to the question, my officials have reached out the the Pharmaceutical Society of Ireland (PSI) for clarity.

As the statutory regulator charged with protecting public health and safety by regulating pharmacists and pharmacies, the PSI takes action to address poor professional performance, professional misconduct and failings in legislative compliance. One of the ways they do this is by considering formal complaints made against pharmacists and pharmacies under the Pharmacy Act 2007.

Complaints are heard by the PSI's statutory Disciplinary Committees. The PSI share information and learnings from complaints and the outcomes of inquiries in the interest of maintaining and upholding professional standards, raising awareness around patient and public safety matters from a public safety perspective, and promoting compliance with pharmacy and medicines legislation. Dealing effectively with complaints is at the heart of the PSI's commitment to protecting patients and the public and maintaining public confidence in pharmacists and pharmacies.

Formal complaints

Formal complaints about pharmacists and pharmacies are generally made to the PSI in writing. They can relate to the conduct, practice, behaviour, health of a pharmacist or how a service is provided by a pharmacy. Formal complaints must be processed strictly in line with the provisions of the Pharmacy Act 2007.

Preliminary Proceedings Committee

Once the PSI has received and processed a complaint, it is referred to the Preliminary Proceedings Committee (PPC) for consideration in accordance with the process as set out in the Pharmacy Act 2007. The PPC, upon reviewing the complaint, advises the PSI Council whether there is sufficient cause to warrant further disciplinary action being taken in relation to either the pharmacist and/or pharmacy the subject of the complaint. The PPC can then refer the complaint to either mediation or for hearing before a statutory Committee of Inquiry.

Mediation

Mediation can only take place where the PPC has decided that further action is required and refers the matter to mediation. If mediation is unsuccessful, the complaint will then be referred to a committee of inquiry. The person making the complaint and the pharmacist or pharmacy owner must agree to the complaint being resolved using mediation. If either side does not agree to mediation, the PPC will refer the complaint to a Committee of Inquiry instead.

Withdrawal of complaints

It is possible that once a complaint process has started, a complainant may later choose to withdraw that complaint. This can happen at any time during the process. Once a complaint has been withdrawn, the relevant Committee will update the Council and may advise the Council to:

- take no further action or

- proceed as if the complaint had not been withdrawn.

The table below details the complaints received in 2021, 2022 and 2023 (to date), the complaints considered by the PPC, referred to inquiry or mediation, the complaints withdrawn and those where the PPC advised no further action was required.

As of 23/11/2023, thirty complaints have yet to be considered by the PPC. Eleven will be heard at an upcoming PPC meeting. Observations and information are being collated for the remaining nineteen.

I am satisfied with the complaints and procedures process as outlined above.

Pádraig O'Sullivan (Cork North Central, Fianna Fail)
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577. To ask the Minister for Health the last time his Department engaged with an organisation (details supplied); to whom the organisation reports, as an agency of his Department; and if he will make a statement on the matter. [51962/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The PSI is accountable to the Minister for Health and the Oireachtas in carrying out their role as the Pharmacy Regulator of Ireland.

The PSI have a Corporate Governance Framework, Codes of Conduct for their Council, Committees and staff, and related governance policies and procedures to support their compliance with the Code of Practice for the Governance of State Bodies. The PSI meet their statutory governance obligations as set out in the Pharmacy Act 2007, the Ethics in Public Office Act 1995, and the Standards in Public Office Act 2001.

The Code of Practice for the Governance of State Bodies aims to ensure commercial and non-commercial State bodies meet the highest standards of corporate governance. It provides a framework for the application of best practice and is intended to take account of developments in respect of oversight, reporting requirements and the appointment of Board members. The Code is based on the underlying principles of good governance: accountability, transparency, probity and a focus on the sustainable success of the organisation over the longer term.

For public accountability and reporting purposes, the PSI is an aegis body of the Department of Health. In keeping with this obligation, three governance meetings were/will be held with Department of Health officials in 2023. The Department met with PSI in March and September of this year and are due to meet again in December.

Within the Department of Health, Medicines, Controlled Drugs and Pharmacy Legislation Unit (MCDPLU) is the main point of contact for the PSI, though other units may engage with the PSI as required, dependent on business needs. MCDPLU also liaises with the PSI on a variety of issues relating to the Pharmacy sector; the PSI Registrar is a member of the Expert Taskforce to support the expansion of the role of pharmacists in Ireland, as established in July 2023.