EXPLANATORY STATEMENT
Australian Immunisation Register Act 2015
Australian Immunisation Register Amendment (Japanese Encephalitis Virus) Rules 2022
Purpose
The Australian Immunisation Register Amendment (Japanese Encephalitis Virus) Rules 2022 (Amendment Rules) amends the Australian Immunisation Register Rule 2015 (AIR Rule) to require that vaccination providers must, on or after the commencement of the Amendment Rules, report the administration of a relevant vaccine for the Japanese encephalitis virus (JEV) to the Australian Immunisation Register (AIR).
Background
Section 10A of the Australian Immunisation Register Act 2015 (AIR Act) requires recognised vaccination providers to report certain vaccinations administered in Australia to the AIR.
The AIR Rule specifies the reporting requirements for specific vaccines that must be reported under section 10A of the AIR Act, the information that must be reported, the time and the manner the information must be reported in.
Under subsection 10A(5) of the AIR Act, a person who fails to comply with the reporting obligations is liable to a civil penalty of 30 penalty units. However, a vaccination provider is not required to comply with these requirements where the provider reasonably believes that to so is likely to pose a risk to the health or safety of an individual.
On 4 March 2022, Australia’s Acting Chief Medical Officer declared JEV a Communicable Disease Incident of National Significance in recognition of the potential impact on Australia. The JEV can be prevented by vaccination.
The Amendment Rules will add a relevant vaccination for the JEV to the list of vaccinations that must be reported to the AIR. Mandatory reporting of vaccinations for the JEV administered in Australia will improve reporting of vaccinations to the AIR and ensure the AIR contains a complete and accurate dataset of vaccination information to better inform program delivery and respond to disease outbreaks.
At this time, the AIR Act does not mandate the reporting of vaccinations administered outside Australia. Recognised vaccination providers are able (but not required) to report vaccines administered overseas to ensure their patients have a complete AIR record.
Authority
Section 31 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 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 will commence the day after registration on the Federal Register of Legislation.
Consultation
The Department of Health and Aged Care has consulted with Services Australia and Jurisdictional Immunisation Coordinators in each State and Territory on the proposed amendments to the AIR Rule. Stakeholders are supportive of the proposed amendments.
The Department of Health and Aged Care and Services Australia will undertake communication activities to ensure that key stakeholders, including vaccination providers, are aware of the mandatory reporting requirements for vaccinations for the JEV.
General
The Amendment Rules are a legislative instrument for the purposes of the Legislation Act 2003.
Details of this instrument are set out in Attachment A.
This instrument 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 Amendment (Japanese Encephalitis Virus) Rules 2022
Section 1 – Name
Section 1 provides that the name of the instrument is the Australian Immunisation Register Amendment (Japanese Encephalitis Virus) Rules 2022 (Amendment Rules).
Section 2 – Commencement
Section 2 provides that the Amendment Rules commence the day after they are registered on the Federal Register of Legislation.
Section 3 – Authority
Section 3 provides that the Amendment Rules are made under the Australian Immunisation Register Act 2015 (AIR Act).
Section 4 – Repeal
Section 4 provides that each instrument that is specified in a Schedule to the Amendment Rules is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule has effect according to its terms.
Schedule 1 – Amendments
Australian Immunisation Register Rule 2015 (AIR Rule)
Items 1 and 2 – Subparagraph 9(iii) and at the end of paragraph 9(a)
Item 2 amends paragraph 9(a) of the AIR Rule to add an additional category of vaccinations administered in Australia that must be reported to the Australian Immunisation Register (AIR), which is for a relevant vaccination for the Japanese encephalitis virus (JEV).
Item 1 makes a minor consequential amendment to reflect that an additional category of vaccination has been added to paragraph 9(a).
Items 3 and 4 - paragraph 9(b)
Item 4 amends paragraph 9(b) of the AIR Rule to add a new prescribed circumstance for when a relevant vaccination is administered and must be reported to the AIR. That is, for a relevant vaccination for the JEV administered on or after the day after the Amendment Rules are registered on the Federal Register of Legislation.
Item 3 makes a minor consequential amendment to reflect that an additional category of vaccination has been added to paragraph 9(a).
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 (Japanese Encephalitis Virus) Rules 2022
This 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 Amendment (Japanese Encephalitis Virus) Rules 2022 (Amendment Rules) amend the Australian Immunisation Register Rule 2015 (AIR Rule) to require that vaccination providers must, on or after the commencement of the Amendment Rules, report the administration of relevant vaccines for the Japanese encephalitis virus (JEV) to the Australian Immunisation Register (AIR).
Section 31 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 Act.
Section 10A of the AIR Act requires recognised vaccination providers to report certain vaccinations administered in Australia to the AIR.
The AIR Rule prescribes the specific vaccines that must be reported under section 10A of the AIR Act, the information that must be reported, and the time and manner the information must be reported in.
Under section 9(b) of the AIR Rule, vaccinations for the coronavirus known as
COVID-19, influenza, and National Immunisation Program (NIP) vaccines if administered by a recognised vaccination provider in Australia must be reported to the AIR. A relevant vaccination for the JEV will be added to this list of vaccinations under the Amendment Rules.
It is important to note that these proposed amendments do not make vaccination with a vaccination for the JEV mandatory. Instead, they will only make it mandatory to report the administration of a vaccination for the JEV.
In addition, under Section 10A(b) of the AIR Act a vaccination provider is not required to comply with these reporting requirements where the provider reasonably believes that to so is likely to pose a risk to the health or safety of an individual.
A person who fails to comply with their reporting obligations under section 10A may be liable to a civil penalty of 30 penalty units.
Human rights implications
This Legislative Instrument engages the following human rights:
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 introduction of mandatory reporting of the administration of relevant vaccines for the JEV in Australia will 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.
This will standardise the quality of information in the AIR that records the administration of specified vaccinations. 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.
Right to protection or privacy and reputation
The Amendment Rules engage Article 17 of the International Covenant on Civil and Political Rights.
The Amendment Rules require the reporting of personal information of the person being vaccinated, and the person who administered the vaccine, to the AIR.
However, this information is subject to the secrecy provisions in Part 4 of the AIR Act, which concerns the use and disclosure of information stored on the AIR and who can use and disclose this information.
Section 22 of the AIR Act regulates the uploading of personal information or of ‘relevant identifying information’ (and also of commercial-in-confidence information) for the purposes of including such information in the AIR. This provision also regulates the use or disclosure of such information for the purposes of the AIR by setting out particular identified categories of persons who may make a record of, disclose or otherwise, use such information, and setting out the purposes for which they may do so. Further, section 23 of the AIR Act creates an offence where a person makes a record of, discloses or uses protected information contrary to section 22 of the AIR Act.
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 to pose a risk to the health or safety of an individual to do so.
Conclusion
The Legislative Instrument is compatible with human rights. While the Amendment Rules require the mandatory reporting of additional vaccines to the AIR, this is with the aim of protecting the health of the community generally, 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