1. Introduction
This regulatory approach sets out how the Queensland Pharmacy Business Ownership Council (Council) carries out regulatory activity to ensure pharmacy businesses comply with the Pharmacy Business Ownership Act 2024 (Qld) (PBO Act) and Pharmacy Business Ownership Regulation 2025 (PBO Regulation).
It provides an overview of who we are and what we do, and the principles that guide us in performing our regulatory functions, including licensing, compliance monitoring and enforcement activities.
In Queensland, pharmacy businesses may only be owned by pharmacists; corporations in which the directors and shareholders are either all pharmacists or a combination of pharmacists and their spouses and adult children; certain friendly societies; and the Mater Misericordiae Limited. Relevant persons to the business must be ‘fit and proper’. The pharmacy business premises must be authorised premises and meet certain minimum standards.
2. Regulatory framework
The Council’s regulatory framework comprises:
- Pharmacy Business Ownership Act 2024: The PBO Act sets out the core regulatory requirements applicable to pharmacy businesses. It also provides for powers and tools to enable the Council to carry out its regulatory functions.
- Pharmacy Business Ownership Regulation 2025: The PBO Regulation provides for minimum standards for authorised premises and set outs the fees applicable to licence applications under the PBO Act.
- Guidance material: The Council will publish guidance material over time on a range of matters, including licensing and premises standards. The Guidance material will assist pharmacy businesses to understand their obligations and supports regulated entities to develop a strong and effective compliance culture.
3. Role and regulatory functions
Pharmacists contribute to the health and safety of individuals and the community by ensuring access to medications, administering vaccinations, supplying medication information, evaluating medication appropriateness, improving medication adherence and medication management.
Government safeguards the public by regulating pharmacy business ownership to promote the professional, safe and competent provision of pharmacy services.
The overall purposes of the PBO Act and PBO Regulation are to promote the professional, safe and competent provision of pharmacy services by pharmacy businesses; and to maintain public confidence in the pharmacy profession.
The Council is a statutory body responsible for regulating pharmacy business ownership and premises standards in Queensland to achieve the main purposes of the PBO Act.
The Council:
- guides and supports pharmacy business owners to comply with the PBO Act;
- licences people to carry on pharmacy businesses at authorised premises;
- maintains a register of information about pharmacy businesses;
- monitors and enforces compliance with the PBO Act, including publishing the results of monitoring and enforcement activities;
- works closely with other pharmacy sector regulators (Appendix 1shows a table of other pharmacy sector regulators);
- leverages stakeholder relationships (e.g. pharmacy associations, consumers and consumer representative groups, pharmacy business owners, professional advisors) to gain insight into business and professional practice and emerging trends, and communicate and engage effectively across the sector; and
- provides information to and advises the Minister on matters relating to its functions.
4. Regulatory powers
The Council has the following key powers under the PBO Act:
- Obtaining further information and documents: the Council may require further information from applicants and licence holder by issuing a notice. A person who does not comply with the notice may have their application withdrawn or be penalised.
- Inspections: Inspections of authorised premises may be carried out by inspectors to ensure that the standards for authorised premises are met.
- Investigations: the Council may investigate matters following a complaint or referral about contravention of the PBO Act or PBO Regulation and may also investigate matters on its own initiative. Inspectors may enter places in certain circumstances and exercise powers to obtain relevant evidence.
- Audits: the Council may audit the operations of pharmacy business licence holders and require full and free access to all documents and property that are relevant to obligations under the PBO Act.
- Appoint a reviewer: the Council may appoint an appropriately qualified person to review documents to determine whether a person is party to a contract which contravenes section 22 of the PBO Act.
- Refusal to grant a licence or other application: the Council may refuse to grant a licence if they are not satisfied that the eligibility criteria are met.
- Conditions: the Council may impose appropriate conditions on a licence.
- Suspension and cancellation: the Council may suspend or cancel a licence on a variety of grounds, including contravention of the Health Practitioner National Law, contravention of the eligibility criteria, or where a person is no longer fit and proper.
- Prosecution: the Council may take enforcement action for a variety of contraventions of the PBO Act, including providing false and misleading information, and persons who are not the owner of the pharmacy business controlling how pharmacy services involving medicines are provided.
5. Regulatory principles
Our regulatory principles guide how we function and meet our objectives.
Our strategic intent is captured in our Strategic Plan 2025-2029. At a high level, our regulatory approach is to:
- provide guidance and support to pharmacy businesses to help them comply with their obligations and we encourage self-regulation;
- use our regulatory tools responsively, based on the level of risk of non-compliance and behaviour of the person; and
- reserve enforcement only for those that demonstrate a persistent disregard for compliance requirements.
We apply the Queensland-Government-Regulator Performance-Framework [PDF] published by the Office of Best Practice Regulation, Queensland Treasury.
Regulatory model practices
Model practice 1
Ensure regulatory activity is proportionate to risk and minimises unnecessary burden
Supporting principles:
- a proportionate approach is applied to compliance activities, engagement and regulatory enforcement actions
- regulators do not unnecessarily impose on regulated entities
- regulatory approaches are updated and informed by intelligence gathering so that effort is focused towards risk.
Model practice 2
Consult and engage meaningfully with stakeholders
Supporting principles:
- formal and informal consultation and engagement mechanisms are in place to allow for the full range of stakeholder input and Government decision making circumstances
- engagement is undertaken in ways that help regulators develop a genuine understanding of the operating environment of regulated entities
- cooperative and collaborative relationships are established with stakeholders, including other regulators, to promote trust and improve the efficiency and effectiveness of the regulatory framework.
Model practice 3
Provide appropriate information and support to assist compliance
Supporting principles:
- clear and timely guidance and support is accessible to stakeholders and tailored to meet the needs of the target audience
- advice is consistent and, where appropriate, decisions are communicated in a manner that clearly articulates what is required to achieve compliance
- where appropriate, regulatory approaches are tailored to ensure compliance activities do not disproportionately burden particular stakeholders (e.g. small business) or require specialist advice.
Model practice 4
Commit to continuous improvement
Supporting principles:
- regular review of the approach to regulatory activities, collaboration with stakeholders and other regulators to ensure it is appropriately risk based, leverages technological innovation and remains the best approach to achieving policy outcomes
- to the extent possible, reform of regulatory activities is prioritised on the basis of impact on stakeholders and the community
- staff have the necessary training and support to effectively, efficiently and consistently perform their duties.
Model practice 5
Be transparent and accountable in actions
Supporting principles:
- where appropriate, regulatory frameworks and timeframes for making regulatory decisions are published to provide certainty to stakeholders
- decisions are provided in a timely manner, clearly articulating expectations and the underlying reasons for decisions
- indicators of regulator performance are publicly available.
Our primary aim is to ensure that pharmacy businesses are owned by pharmacists, with limited exceptions, recognising their medicines expertise, public trust and professional obligations to prioritise the safe and competent provision of pharmacy services over commercial interests.
As part of our approach, we will also:
- act independently, impartially and in the public interest;
- apply learnings from other regulators to establish best practice systems and processes;
- collaborate and share information with other regulators to ensure consistent and risk-based compliance interventions; and
- know the pharmacy industry well, including business and professional practices and how risk is evidenced and use that information to inform our regulatory interventions.
6. Risk based approach
There is a range of compliance obligations imposed on licence holders under the PBO Act and PBO Regulation. While all compliance obligations are important, there can be differences in the level of risk associated with any given instance of non-compliance. Different entities and business models may also pose a higher risk of non-compliance than others.
The Council will apply a risk-based approach to regulation to ensure the objectives of the regulatory scheme are met, whilst avoiding undue regulatory burden where appropriate.
This means that the Council will focus its regulatory activities and resources on compliance areas and entities where the relative risks of non-compliance are greatest. This also helps Council to identify the appropriate regulatory response.
The Council will consider:
- Nature of non-compliance: the context of the non-compliance, including the number of instances of non-compliance (limited, significant or widespread);
- Consequences of non-compliance: relative impact of non-compliance on achieving the objectives of the PBO Act and PBO Regulation; and
- Risk profile of the regulated entity: the profile of the entity, particularly its compliance history with the Council and with other regulators in the pharmacy sector and its general attitude towards compliance.
The Council will apply this approach to licensing, compliance monitoring, audit, investigation and inspection activities.
Initial focus areas for Council will include:
- Arrangements that may meet the new definition of ‘material interest’ under the PBO Act.
- Fitness and propriety, including any adverse information relating to a person’s legislative compliance, health practitioner registration or criminal history.
- Complex business structures or complex and/or vertically integrated supply chains which may require consideration of whether section 22 of the PBO Act may be engaged.
- Novel or emerging business models, including pharmacy businesses which provide pharmacy services largely online without premises open to the public.
As it progresses in its operations, Council will develop risk profiles and programs of work designed to more comprehensively guide its regulatory approach. These will be progressively incorporated into this document.
7. Appendix 1 – Pharmacy regulators
Body | Main responsibility |
|---|---|
Pharmacy Board of Australia (PBA) | Registration of pharmacists and complaints about health, conduct or performance of pharmacists. The Pharmacy Board is supported by AHPRA |
Australian Health Practitioner Regulation Agency (AHPRA) | Supports the National Boards including the Pharmacy Board, protecting the public and setting standards for all registered health practitioners. AHPRA and the National Boards work together to register and renew registration of health practitioners and, where required, investigate complaints or concerns regarding health practitioners |
Department of Health (QLD) | Regulation of medicines and poisons under the Medicines and Poisons Act 2019 Administration of pharmacy administered vaccination programs. Pharmacists must provide immunisation services in accordance with the applicable regulatory requirements. |
Office of the Health Ombudsman (OHO) | Independent Queensland body which resolves complaints about the provision of health services by registered health service providers, including pharmacists |
Department of Health and Aged Care (Cth) | Administers the Pharmaceutical Benefits Scheme (PBS), which regulates pharmacy operations regarding the supply of items listed in the PBS. The Therapeutic Goods Administration (TGA) regulates therapeutic goods, including medicines and medical devices that may be supplied by pharmacists. |
Other state and territory regulators of pharmacy ownership |
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