6.1 Pharmacy Act 2007 & PSI Governance

6.1 Pharmacy Act 2007 & PSI Governance

Quick Reference: The Pharmacy Act 2007 is the primary legislation governing the practice of pharmacy and the operation of retail pharmacy businesses in Ireland. It repealed the ancient Pharmacy Acts (1875–1962) and established the Pharmaceutical Society of Ireland (PSI) as an independent public interest statutory regulator accountable to the Minister for Health.

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Legislative Context and Primary Intent

Prior to 2007, pharmacy regulation in Ireland was fragmented and largely self-regulatory under 19th-century statutes. The Pharmacy Act 2007 modernized the legal landscape by separating the regulatory function from professional advocacy. The primary intent of the Act is to protect, promote, and maintain the health and safety of the public in relation to the practice of pharmacy and the sale and supply of medicinal products.

Key structural reforms enacted by the 2007 Act include:

1. Establishing the PSI as an independent regulatory authority.
2. Creating a statutory requirement for the registration of pharmacy premises alongside individual practitioners.
3. Establishing a modern Fitness to Practise (FTP) disciplinary framework.
4. Mandating continuing professional development (CPD) for registered pharmacists.
5. Setting strict ownership and operational rules for Retail Pharmacy Businesses.

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Legal Definition of a Retail Pharmacy Business (RPB)

Under Section 2 of the Pharmacy Act 2007, a Retail Pharmacy Business (RPB) is legally defined as a business carrying on the keeping, compounding, or dispensing of medicinal products for sale or supply to the public.

Key Statutory Requirements for RPBs:

• Registration: Every RPB premises must be registered annually with the PSI. Operating an unregistered pharmacy premises is a criminal offence under Section 17.
• Supervision & Control: Under Section 56, an RPB must be conducted under the personal control of a Supervising Pharmacist (who must have at least 3 years of post-registration experience) and managed in every premises by a Superintendent Pharmacist.
• Physical Presence: A registered pharmacist must be in personal attendance at the pharmacy premises at all times when it is open for business to supervise the compounding, dispensing, and supply of medicinal products.

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Structure and Statutory Role of the PSI

The Pharmaceutical Society of Ireland (PSI) is the statutory pharmacy regulator in Ireland. Its principal functions under Section 7 of the Act include:

• Maintaining statutory registers of pharmacists, pharmaceutical assistants, and pharmacy premises.
• Regulating the education, training, and continuous professional development of pharmacists.
• Setting professional standards, codes of conduct, and practice guidelines.
• Conducting inspections and enforcing compliance with pharmacy and medicinal products legislation.
• Investigating complaints against pharmacists and pharmacy owners through Fitness to Practise proceedings.

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Composition of the PSI Council

To prevent regulatory capture and ensure public protection, Section 10 of the Pharmacy Act 2007 specifies that the PSI Council consists of 21 members appointed by the Minister for Health.

A fundamental statutory requirement is that the Council MUST have a lay majority:

• 10 Members: Registered pharmacists selected or elected by the profession.
• 11 Members (Majority): Non-pharmacists (lay members) representing public interest, patient advocacy, educational bodies, health service management, and other non-pharmacy sectors.

The President and Vice-President of the Council are elected by the Council members, provided that at least one of these executive officers is a lay member.

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Statutory Committees of the PSI

The Pharmacy Act 2007 establishes three primary statutory committees to carry out specific regulatory functions:

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Statutory Registers Maintained by the PSI

Under Part 4 of the 2007 Act, the Registrar of the PSI is required to maintain the following official public registers:

1. Register of Pharmacists: Qualified individuals holding a recognized MPharm degree, completed internship, and passed the PSI Registration Examination.
2. Register of Pharmaceutical Assistants: A legacy register created under the Pharmacy Act 1890. No new entries have been permitted since 1987, but existing registered assistants retain specific statutory rights to manage an RPB during temporary absence of a pharmacist (up to specified limits).
3. Register of Retail Pharmacy Businesses: Lists all approved pharmacy premises, their registered owners, Superintendent Pharmacists, and Supervising Pharmacists.
4. Register of Tutors & Training Establishments: Accredits pharmacists and pharmacies authorized to deliver pre-registration master's training.

All registrants must pay an annual retention fee and submit evidence of continuing professional development through the Irish Institute of Pharmacy (IIOP).

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Fitness to Practise (FTP) Framework

Part 6 of the Pharmacy Act 2007 outlines the complaints and disciplinary procedure. Any member of the public, employer, or the PSI Registrar can make a complaint regarding a registered pharmacist or RPB owner.

Grounds for Complaint (Section 38):

• Professional Misconduct: Conduct violating the PSI Code of Conduct or infamous/disgraceful professional behavior.
• Poor Professional Performance: Failure to meet the standard of performance expected of a pharmacist.
• Impairment: Inability to practice safely due to physical or mental illness, addiction, or infirmity.
• Criminal Conviction: Conviction of an indictable offence in Ireland or abroad.
• Contravention: Breach of the Pharmacy Act 2007, Medicinal Products Regulations, or Misuse of Drugs legislation.

Disciplinary Sanctions (Section 48):

If a complaint is substantiated before the Professional Conduct Committee or Health Committee, the Council may impose sanctions ranging in severity:

• Admonishment or censure.
• Attachment of conditions to registration (e.g., remedial training, restricted duties).
• Suspension of registration for a specified period.
• Erasure / Cancellation of Registration: Permanent removal from the register.
• Fines payable to the PSI.

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PSI Authorized Officers and Inspection Powers

Under Section 67 of the Pharmacy Act 2007, the PSI appoints Authorized Officers (pharmacy inspectors) to monitor compliance and investigate suspected offences.

Powers of Authorized Officers Include:

• Right of Entry: Entering any retail pharmacy business, premises, or vehicle suspected of containing medicinal products or records without prior notice.
• Inspection & Audit: Inspecting the premises, equipment, stock of medicinal products, registers, and records (including electronic dispensing databases).
• Seizure & Sampling: Taking samples of any substance or medicinal product, and seizing/detaining records, documents, or computers relevant to an investigation.
• Interrogation: Requiring any person on the premises (pharmacist, technician, owner) to answer questions and provide assistance or documentation.

It is a criminal offence to obstruct, fail to assist, or provide false information to an Authorized Officer exercising statutory powers under Section 67.