EXPLANATORY STATEMENT
Australian Immunisation Register Act 2015
Australian Immunisation Register Amendment (Reporting) (No. 2) Rules 2024
Purpose and operation
The Australian Immunisation Register Amendment (Reporting) (No. 2) Rules 2024 (Amendment Rules) amends the Australian Immunisation Register Rule 2015 (AIR Rule) to introduce an additional reporting requirement for recognised vaccination providers from 1 March 2025.
This amendment will require a recognised vaccination provider administering a relevant vaccine prescribed by the AIR Rule to report to the Australian Immunisation Register (AI Register) with information about whether the individual was pregnant at the time of vaccination (via the vaccine type or antenatal field).
Maternal immunisation is critical in protecting pregnant women and their babies from serious illness and severe complications from vaccine preventable diseases. The additional information reported under the Amendment Rules is required to ensure that the AI Register contains a complete and reliable dataset that can be used to monitor vaccination uptake and the effectiveness and safety of maternal vaccination programs. The additional reporting information is also relevant for clinical care (to be accessible by other healthcare workers other than the original vaccination provider, as necessary).
Background
Section 10A of the Australian Immunisation Register Act 2015 (AIR Act) requires recognised vaccination providers to report information prescribed by the rules for inclusion in the AI Register for a relevant vaccination that is administered by the recognised vaccination provider in Australia that is of a kind prescribed by the rules and 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 9(a) of the AIR Rule prescribes the following as kinds of relevant vaccinations that a recognised vaccination provider must report information on for inclusion in the AI Register:
- coronavirus (known as COVID-19);
- influenza;
- vaccines specified on the National Immunisation Program (NIP); and
- Japanese encephalitis virus vaccines.
Paragraph 9(e) of the AIR Rule prescribes 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.
It is important to note that the Amendment Rules do not make vaccination mandatory. It is only mandatory to report to the AI Register on the additional information relating to vaccinations.
In addition, under subsection 10A(2) 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 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 Amendment Rules commence on 1 March 2025.
Consultation
The Department of Health and Aged Care (the Department) consulted with Services Australia, Jurisdictional Immunisation Coordinators in each state and territory and software vendors on the Amendment Rules. Stakeholders are supportive of the amendment.
The Department and Services Australia will undertake communication activities to ensure that key stakeholders, including vaccination providers, are aware of the new mandatory reporting requirement under the Amendment Rules.
General
The Amendment Rules are a legislative instrument for the purposes of the Legislation Act 2003.
Details of the Amendment Rules are set out in Attachment A.
The Amendment Rules are 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 Amendment (Reporting) (No. 2) Rules 2024
Section 1 – Name
Section 1 provides the name of the instrument is the Australian Immunisation Register Amendment (Reporting) (No. 2) Rules 2024 (Amendment Rules).
Section 2 – Commencement
Section 2 provides the Amendment Rules commence on 1 March 2025.
Section 3 – Authority
Section 3 provides the Amendment Rules are made under the Australian Immunisation Register Act 2015.
Section 4 –Schedules
Section 4 of the Amendment Rules has the effect that the Australian Immunisation Register Rule 2015 is amended by the terms specified in Schedule 1 of the Amendment Rules.
Schedule 1 – Amendments
Australian Immunisation Register Rule 2015
Item 1 – At the end of paragraph 9(e)(viii)
Item 1 amends paragraph 9(e) of the Australian Immunisation Register Rule 2015
to add a new reporting requirement requiring recognised vaccination providers to report information about whether the individual was pregnant at the time of vaccine administration using either the option of the vaccine type or antenatal field for inclusion in the Australian Immunisation Register.
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 Amendment (Reporting) (No. 2) Rules 2024
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
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.
Section 10A of the AIR Act requires recognised vaccination providers to report information regarding relevant vaccinations administered within a particular period and in the required manner to the Australian Immunisation Register (AI Register) as prescribed by the rules. The current rules are the Australian Immunisation Register Rule 2015 (AIR Rule). Under paragraph 9(a) of the AIR Rule, a recognised vaccination provider must report information for inclusion in the AI Register for the following relevant vaccinations:
- coronavirus (known as COVID-19);
- influenza;
- vaccines specified on the National Immunisation Program (NIP); and
- Japanese encephalitis virus vaccine.
Paragraph 9(e) of the AIR Rule prescribes the required information to be reported by the recognised vaccination provider for inclusion in the AI Register including patient details, provider details and vaccine details.
The Australian Immunisation Register Amendment (Reporting) (No. 2) Rules 2024 (Amendment Rules) amend the AIR Rule to introduce an additional reporting requirement for recognised vaccination providers from 1 March 2025. A recognised vaccination provider administering a relevant vaccine prescribed by the AIR Rule is required to report to the AI Register information about whether the individual was pregnant at the time of vaccination (via the vaccine type or antenatal field).
The Amendment Rules is needed to improve reporting to the AI Register to monitor the effectiveness and safety of maternal vaccines and vaccination programs. It will also ensure that the AI Register is a complete and reliable dataset to enable the monitoring of immunisation coverage and administration. The additional reporting information is also relevant for clinical care (to be accessible by other healthcare workers other than the original vaccination provider, as necessary).
Human Rights implications
The Amendment Rules engage the following human rights.
Article 12 of the Right to Health under International Covenant on Economic, Social and Cultural Rights (ICESCR)
The Amendment Rules engage 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 reporting of information about whether the individual was pregnant at the time of vaccination (via the vaccine type or antenatal field) will improve reporting to the AI Register to monitor the effectiveness and safety of maternal vaccines and vaccination programs. It will also ensure that the AI Register is a complete and reliable dataset to enable the monitoring of immunisation coverage and administration and is relevant for clinical care (to be accessible by other healthcare workers other than the original vaccination provider, as necessary).
Enhancing vaccination reporting will contribute to enriched monitoring and will provide invaluable statistics on health-related issues. This is a positive step towards attaining the highest standard of health for all Australians.
Article 17 of the Right to protection of privacy and reputation under International Covenant on Civil and Political Rights (ICCPR)
The Amendment Rules engage Article 17 of the ICCPR, which is concerned with the right to privacy and reputation. The Amendment Rules require the reporting of personal 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 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 disclosure of protected information in response to a disclosure request where the Minister is satisfied it is in the public interest. 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.
The Amendment Rules do not impact or change the protections afforded to individuals under the above provisions.
Conclusion
The Amendment Rules are compatible with human rights. The Amendment Rules promote the right to health. The reporting of additional information to the AI Register aims to protect the health of the community. The Amendment Rules also limit the right to privacy however, this limitation is reasonable and necessary, and information reported to the AI Register is protected by the secrecy provisions in the AIR Act.
The Hon Mark Butler MP
Minister for Health and Aged Care