Summary of new regulatory powers
On 1 March 2025, the regulatory powers available to the Health Regulator have become consistent across most regulatory schemes.
This section provides an overview of the meaning and application of these new powers and includes:
- Information or document production notice
- Infringement notice (fine)
- Improvement notice
- Prohibition notice
- Enforceable undertakings
For a table listing amendments to existing legislation, refer to Summary of statutory revisions.
Information or document production notice
An information or document production notice is a notice issued by the Secretary of the department, their delegate or an Authorised Officer to a person which compels a person to provide information or document(s) which will be used to monitor a regulated person’s compliance with regulatory requirements.
Unlike other powers which apply only to regulated persons, an information or document production notice may be issued to any person including those who are not regulated persons.
There are penalties associated with not providing information or documents requested. A natural person does not have to provide information (but must provide documents) if that information may incriminate them.
Infringement notice
An infringement notice (also known as a fine) is a common regulatory tool that enables non-compliance to be dealt with by payment of an infringement penalty in appropriate circumstances.
If an infringement penalty is paid, no further action is taken against the person for the offence that the notice relates to. A person may choose to either pay the infringement penalty, ask the department for an internal review based on prescribed special circumstances or not pay the infringement penalty and instead have the matter heard in court.
How much will the fine for an infringement offence be?
The making of regulations prescribing infringement offences, including the penalty amounts, are subject to the requirements of the Subordinate Legislation Act and the Attorney-General’s Guidelines to the Infringements Act 2006 (the Guidelines).
The Attorney-General’s specify that generally, the infringement penalty will be set at a level that is not more than 25 per cent the maximum penalty for the offence, and in any case should not be more than 12 penalty units for an individual or 60 penalty units for a body corporate.
Improvement notice
An improvement notice is a common regulatory tool that can be issued to a regulated person to require the person to take specified actions to remedy non-compliance with a regulatory requirement.
The purpose of an improvement notice is to bring a regulated person back into compliance with regulatory requirements.
An improvement notice can only be given if the Secretary, their delegate, or an Authorised Officer reasonably believes that a person has, is or is likely to contravene a regulatory requirement, and the notice is necessary to rectify, cease, prevent, or address the causes of a contravention.
Prohibition notice
A prohibition notice can be issued in response to non-compliance to prohibit a regulated person from engaging in an activity that poses a risk of harm to health or safety. The purpose of a prohibition notice is to prevent harm by stopping the activity posing the risk while the non-compliance is being remedied.
A prohibition notice can only be given if the Secretary, their delegate, or an Authorised Officer reasonably believes that a person has, is or is likely to contravene a regulatory requirement, and that, having regard to the immediacy of the risk and the degree of harm that may be caused, the prohibition is necessary to prevent or minimise that risk of harm to health or safety.
A prohibition notice may also require a regulated person to take specified actions to remedy non-compliance with a regulatory requirement. This is to avoid the need to separately issue an improvement notice on the same grounds about which a prohibition notice is being issued.
Enforceable undertakings
An enforceable undertaking is a binding, formal and legally enforceable agreement in which a regulated person promises to take, or not take, specific actions within an agreed timeframe. Unlike most other regulatory tools, an enforceable undertaking is offered voluntarily by the regulated person rather than issued by the regulator. The regulator may sometimes invite the regulated person to offer an enforceable undertaking.
The regulator has discretion to accept an enforceable undertaking and may negotiate with the regulated person on the terms of the undertaking. Once an enforceable undertaking has been accepted, the regulated entity can only withdraw or vary the undertaking with the consent of the regulator.
If an enforceable undertaking has been accepted, the regulated person cannot be prosecuted for the non-compliance that the undertaking relates to while the undertaking is in force or once it has been complied with.
The context of the reforms
Health regulation plays a key role in contributing to the public health and wellbeing vision of a Victoria free of the avoidable burden of diseases and injury, so that all Victorians can enjoy the highest attainable standards of health, wellbeing and participation at every age.
The reforms are necessary to ensure that health regulation in Victoria is modern and evolves in line with contemporary best practice regulation, and with changes in risks, technology, knowledge and practice, and community expectations.
Previously a range of health portfolio regulatory frameworks did not include a full set of ‘mid-range’ compliance and enforcement tools. This has limited the regulator from responding to non-compliance in a targeted and effective way.
The use of the new powers
The use of the new powers is guided by the Health Regulator's Compliance and Enforcement Policy. To determine whether it needs to take regulatory action and, if so, what action to take, the Health Regulator considers factors including the level of risk posed, the nature of any non-compliance, the tools available under relevant legislation and the compliance posture and of the regulated person.
The Health Regulator continues to maintain internal policies, procedures, and training to support the appropriate, effective, and consistent implementation of compliance and enforcement powers in line with the regulator’s updated compliance and enforcement policy.
The Health Regulator continues to develop and refine engagement and communication strategies to provide compliance guidance and support to regulated entities and improve understanding of regulatory requirements and the Health Regulator’s role and powers.
Regulatory burden management
The improvements to compliance and enforcement powers do not create new regulatory requirements. Rather, the new powers increase the options for addressing non-compliance with existing requirements in a graduated, proportionate and risk-based way.
The new powers as a prevention tool
The main purpose of the new powers is to better prevent and minimise risk of harm to the health or safety of Victorians. The new powers will support the regulator’s ability to ensure compliance with the law.
Provision of guidance to regulated entities to improve understanding of regulatory requirements and how to achieve compliance will continue to be foundational to the Health Regulator’s operational approach.
The Health Regulator's skills and expertise
The Health Regulator has centralised regulatory expertise within the department, delivering agile, flexible, and efficient regulatory processes and resourcing. The consolidation of regulatory functions is intended to bring together regulatory expertise and enable the department to adopt a more consistent, risk-based regulatory approach. The Health Regulator continues to maintain internal policies, procedures, and training, to support the Health Regulator to have appropriately trained and qualified staff.
Summary of statutory revisions
Some powers introduced for specific sectors, already exist within legislation. This varies between sectors. This table lists new powers which have been introduced or amended for the regulation of each statutory scheme.
| Act | Amendments |
|---|---|
Assisted Reproductive Treatment Act 2008 (regulation of reproductive technologies) |
|
Drugs, Poisons and Controlled Substances Act 1981 (regulation of medicines and poisons) |
|
Health Services Act 1988 (regulation of private hospitals and day procedure centres) |
|
Non-Emergency Patient Transport and First Aid Services Act 2003 (regulation of Non-Emergency Patient Transport Services and First Aid Services) |
|
Public Health and Wellbeing Act 2008 (legionella risk management and regulation of pest control operators) |
|
Radiation Act 2005 (regulation of radiation use) |
|
Safe Drinking Water Act 2003 (regulation of water providers) |
|
Human Tissue Act 1982 (regulation of human tissue users, including schools of anatomy) |
|
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Term Definition Health Regulator The branch of the Victorian Department of Health responsible for administering licensing and permits, analysing regulatory compliance, enforcing the law, undertaking regulatory reform and policy, for various parts of the health system. Person A legal person – a natural person or entity with separate legal personality Regulated person A legal person holding a licence, permit, registration or other form of permission issued by the department. For a sector-specific legal definition of this term, please refer to the definitions of “regulated person” as found in the Health Legislation Amendment (Regulatory Reform) Act 2024. Secretary of the Department of Health Means the head of the Department of Health (within the meaning of the Public Administration Act 2004). Certain functions relating to compliance and enforcement powers may be delegated to suitable Officers Authorised Officer Means a person appointed by the Secretary for the purposes contained within an Act. Generally, this is to detect, analyse, and investigate compliance with regulatory requirements. Officer Means an Authorised Officer or Delegate of the Secretary of the Department of Health able to exercise regulatory powers.
Reviewed 17 March 2025