Australian Immunisation Register Rules 2026

EXPLANATORY STATEMENT

Australian Immunisation Register Act 2015

Australian Immunisation Register Rules 2026

Purpose and operation

The Australian Immunisation Register Rules 2026 (the AIR Rules 2026) revokes and remakes the Australian Immunisation Register Rule 2015 (the AIR Rule 2015), which sunsets on 1 April 2026.

The purpose of the AIR Rules 2026 is to remake the AIR Rule 2015 to ensure the continued operation of the Australian Immunisation Register (AI Register). The AIR Rules 2026 sets out requirements for recognised vaccination providers to report prescribed vaccinations to the AI Register, and defines the prescribed bodies authorised to use and disclose information in the AI Register under the Australian Immunisation Register Act 2015 (AIR Act).

The AIR Rules 2026 is substantially the same as the AIR Rule 2015 and includes minor amendments to improve clarity and consistency. These amendments update or remove obsolete references, refine definitions and renumber provisions. It is important to note that the instrument does not make vaccination mandatory. It only continues the existing requirement for recognised vaccination providers to report the administration of relevant vaccinations to the AI Register.

The remake of the instrument ensures that the AI Register remains a complete and reliable dataset to enable the monitoring of immunisation coverage and administration. Information reported to the AI Register assists the Australian Government to identify the effectiveness of vaccines and vaccination programs, including managing adverse events and identifying any parts of Australia at risk during disease outbreaks. It is also relevant and important for clinical care (to be accessible by other healthcare workers other than the original vaccination provider, as necessary).

Background

The AIR Act establishes the AI Register as a national immunisation register that records vaccines given to all people in Australia. The AIR Act also sets out the contents and purposes of the AI Register, including supporting Australian vaccination programs, and vaccination matters more broadly.

Section 10A of the AIR Act requires recognised vaccination providers to report information to the AI Register that is prescribed by the rules for a relevant vaccination that the vaccination provider administers in Australia, where the vaccination is of a kind prescribed by the rules and is administered in the circumstances prescribed by the rules. The information must be reported within the period and in the manner prescribed by the rules.

Paragraph 10(a) of the AIR Rules 2026 continues to prescribe the following as kinds of relevant vaccinations administered in Australia that a recognised vaccination provider must report information on for inclusion in the AI Register:

Paragraph 10(e) of the AIR Rules 2026 continues to prescribe the information the recognised vaccination provider must report to the AI Register, including patient, provider and vaccine details.

A person who fails to comply with their reporting obligations under subsection 10A(1) of the AIR Act is liable to a civil penalty of 30 penalty units in accordance with subsection 10A(5) of the AIR Act.

Under subsection 10A(4) of the AIR Act, a recognised vaccination provider is not required to comply with the reporting requirement under subsection 10A(1) where the reporting of information is likely to pose a risk to the health or safety of an individual.

Authority

Subsection 31(1) of the AIR Act provides that the Minister may, by legislative instrument, make rules prescribing matters required or permitted by the AIR Act to be prescribed by the rules; or necessary or convenient to be prescribed for carrying out or giving effect to the AIR Act.

Reliance on subsection 33(3) of the Acts Interpretation Act 1901

Subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

Commencement

The AIR Rules 2026 commence on 1 April 2026.  

Consultation

Key stakeholders within the Department of Health, Disability and Ageing were consulted to ensure that the AIR Rules 2026 will operate effectively and efficiently, and no significant issues were raised.

Services Australia and Jurisdictional Immunisation Coordinators (JICs) within each state and territory were also consulted on the remake of the AIR Rule 2015. JICs represent and regularly engage with recognised vaccination providers in each jurisdiction, ensuring provider views were incorporated into the development of the instrument.

All stakeholders agreed that the instrument remains fit for purpose and should be replaced by an instrument that is substantially the same in form.

General

The AIR Rules 2026 is a legislative instrument for the purposes of the Legislation Act 2003.

Details of the AIR Rules 2026 are set out in Attachment A.

The AIR Rules 2026 is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

ATTACHMENT A

Details of the Australian Immunisation Register Rules 2026

Section 1 – Name

Section 1 provides the name of the instrument is the Australian Immunisation Register Rules 2026 (AIR Rules 2026).

Section 2 – Commencement

Section 2 provides that the AIR Rules 2026 commences on 1 April 2026.

Section 3 – Authority

Section 3 provides that the AIR Rules 2026 is made under the Australian Immunisation Register Act 2015 (AIR Act).

Section 4 – Schedules

Section 4 provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Section 5 – Definitions

Section 5 defines key terms used in the instrument and adopts definitions from the AIR Act where appropriate, including definitions such as ‘AI register’ (defined in section 4 of the Act as ‘the Australian Immunisation Register’).

Section 6 – Primary health networks

Section 6 prescribes Primary Health Networks as prescribed bodies for the purposes of the AIR Act. This ensures that Primary Health Networks are authorised to use and disclose information in the Australian Immunisation Register (AI Register) under subsection 22(2) of the AIR Act, for the purposes permitted under the AIR Act. This supports their role in improving immunisation coverage and public health outcomes.

Section 7 – Bodies facilitating research relating to vaccines

Section 7 prescribes bodies facilitating research relating to vaccines as prescribed bodies for the purposes of the AIR Act. This ensures that bodies facilitating research relating to vaccines are authorised to use and disclose information in the AI Register under subsection 22(2) of the AIR Act, for the purposes permitted under the AIR Act.

Section 8 – Other prescribed bodies

Section 8 prescribes other prescribed bodies for the purposes of the AIR Act. This ensures that other prescribed bodies are authorised to use and disclose information in the AI Register under subsection 22(2) of the AIR Act, for the purposes permitted under the AIR Act. It also updates outdated references to relevant state bodies, ensuring the correct entity is prescribed as an ‘other prescribed body’.

Section 9 – Officers, employees or contractors of prescribed bodies

Section 9 prescribes officers, employees, or contractors of prescribed bodies as prescribed bodies for the purposes of the AIR Act. This ensures that officers, employees, or contractors of prescribed bodies are authorised to use and disclose information in the AI Register under subsection 22(2) of the AIR Act, for the purposes permitted under the AIR Act.

Section 10 – Reporting requirement relating to certain relevant vaccinations administered in Australia

Section 10 provides the reporting requirements relating to vaccinations by prescribing which vaccines must be reported, the required data elements, and the timeframe and method for reporting this information to the AI Register. In terms of the prescribed circumstances for reporting, the AIR Rules 2026 updates the dates the relevant vaccinations are administered to 1 April 2026 (the date the instrument is to commence). This is to avoid the AIR Rules 2026 imposing reporting obligations on recognised vaccination providers retrospectively (noting that the AIR Rule 2015 imposes reporting obligations for vaccines administered up to and including 31 March 2026).

This section ensures the AI Register contains a complete and reliable dataset to enable the monitoring of immunisation coverage and administration. It also assists the Australian Government to identify the effectiveness of vaccines and vaccination programs, including managing adverse events and identifying any parts of Australia at risk during disease outbreaks.

Schedule 1 – Repeals

Schedule 1 repeals the whole of the Australian Immunisation Register Rule 2015, as it is due to sunset on 1 April 2026.

ATTACHMENT B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Australian Immunisation Register Rules 2026

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Disallowable Legislative Instrument

The Australian Immunisation Register Rule 2026 (AIR Rules 2026) revokes and remakes the Australian Immunisation Register Rule 2015 (AIR Rule 2015), which sunsets on 1 April 2026.

Subsection 31(1) of the Australian Immunisation Register Act 2015 (AIR Act) provides that the Minister may, by legislative instrument, make rules prescribing matters required or permitted by the AIR Act to be prescribed by the rules, or necessary or convenient to be prescribed for carrying out or giving effect to the AIR Act.

The purpose of the AIR Rules 2026 is to remake the AIR Rule 2015 to ensure the continued operation of the Australian Immunisation Register (AI Register). The AIR Rules 2026 is substantially the same as the AIR Rule 2015, with minor amendments to improve clarity and consistency, and to remove obsolete references.

The AIR Rules 2026 continues to prescribe:

• the specific vaccines that must be reported to the AI Register under section 10A of the AIR Act, including the information that recognised vaccination providers must report, and the time and manner the information must be reported in, and
• the bodies authorised to use or disclose protected information in the AI Register for the purposes of the AI Register, consistent with section 22 of the AIR Act.

Section 10A of the AIR Act requires recognised vaccination providers to report information regarding relevant vaccinations administered in Australia to the AI Register as prescribed by the rules. The instrument remakes the existing AIR Rule 2015 and continues these reporting requirements.

Importantly, the AIR Rules 2026 does not make vaccination mandatory. It only continues the existing requirement for recognised vaccination providers to report the administration of relevant vaccinations to the AI Register.

Section 22 of the AIR Act permits a prescribed body to use or disclose protected information in the AI Register, where the use or disclosure is for the purposes of the AI Register. Section 4 of the AIR Act defines a prescribed body as a person prescribed by the rules for the purposes of this definition. The AIR Rules 2026 continues the list of prescribed bodies as set out in the AIR Rule 2015.

The remake of the instrument ensures that the AI Register remains a complete and reliable dataset to enable the monitoring of immunisation coverage and administration. Information reported to the AI Register assists the Australian Government to identify the effectiveness of vaccines and vaccination programs, including managing adverse events and identifying any parts of Australia at risk during disease outbreaks. It is also relevant and important for clinical care (to be accessible by other healthcare workers other than the original vaccination provider, as necessary).

Human Rights implications

The AIR Rules 2026 engage the following rights:

Right to health in article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR)

The AIR Rules 2026 engages article 12 of the ICESCR by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The AIR Rules 2026 provides legislative infrastructure to assist in the Australian Government’s policy objective of protecting the health of individuals and the community more generally by enhanced monitoring of vaccine preventable disease and vaccine coverage.  

It assists the advancement of this human right by standardising the quality of information in the AI Register that records the administration of specified vaccinations. Enhancing vaccination reporting will contribute to enriched monitoring and provides invaluable statistics on health-related issues. This is a positive step towards attaining the highest standard of health for all Australians.

Right to privacy and protection from attacks on reputation in article 17 of the International Covenant on Civil and Political Rights (ICCPR)
 

The AIR Rules 2026 engages article 17 of the ICCPR, which is concerned with the right to privacy and reputation. The instrument requires the reporting of personal and protected information of the person being vaccinated, and the person who administered the vaccine, for inclusion in the AI Register.

However, this information is subject to the secrecy provisions in Part 4 of the AIR Act. Section 23 of the AIR Act creates an offence where a person makes a record of, discloses, or otherwise uses protected information in a way that is not authorised by section 22 of the AIR Act. Relevantly, protected information includes personal information and relevant identifying information obtained under the AIR Act (section 4 of the AIR Act). Section 22 authorises a person to collect, make a record of, disclose, or otherwise use protected information for the purposes of including such information in the AI Register. This provision also authorises the recording, disclosure, and use of protected information in other circumstances, including disclosure to specified recipients and for specified purposes.

One of these circumstances is where the Minister authorises handling protected information for a specified purpose. The Minister may only authorise the use or disclosure of protected information in response to a disclosure request where the Minister is satisfied it is in the public interest (see subsection 22(3) of the AIR Act). All disclosure requests are considered in line with the secrecy provisions in Part 4 of the AIR Act and other relevant legislation, such as the Privacy Act 1988, specifically balancing the purpose of the disclosure against the privacy impact of disclosure on the affected individual.

Additionally, vaccination providers have the capacity under subsection 10A(4) of the AIR Act to decline to report the administration of a vaccination where they consider it would likely pose a risk to the health or safety of an individual to do so, thereby promoting the right to privacy.

The AIR Rules 2026 do not impact or change the protections afforded to individuals under the AIR Rule 2015, as it mainly updates obsolete references.

Conclusion

The AIR Rules 2026 is compatible with human rights. The instrument promotes the right to health (article 12 of the ICESCR) and the right to privacy and protection from attacks on reputation (article 17 of the ICCPR). While the AIR Rules 2026 requires the reporting of prescribed vaccines to the AIR, this requirement aims to protect the health of the community. Any resulting limitation on the right to privacy is reasonable and necessary, and information reported to the AIR is protected by the secrecy provisions in the AIR Act.

The Hon Mark Butler MP

Minister for Health and Aged Care