Federal Register of Legislation - Australian Government

Primary content

Rules/Other as made
This instrument amends relevant vaccines in the Australian Immunisation Register Rule 2015 to be reported to the Australian Immunisation Register to include vaccination of a person with a specified national immunisation program vaccine, on or after 1 July 2021.
Administered by: Health
Registered 30 Jun 2021
Tabling HistoryDate
Tabled HR03-Aug-2021
Tabled Senate03-Aug-2021
Date of repeal 19 Oct 2021
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

 

Australian Immunisation Register Act 2015

 

Australian Immunisation Register Amendment (National Immunisation Program Vaccines) Rules 2021

 

Authority

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

 

Under subsection 33(3) of the Acts Interpretation Act 1901, 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.

 

Purpose

The Australian Immunisation Register Amendment (National Immunisation Program Vaccines) Rules 2021 (the Amendment Rules) amend the Australian Immunisation Register Rule 2015 (the AIR Rules) to mandate that vaccination providers must, from 1 July 2021, report the administration of National Immunisation Program (NIP) vaccines to the Australian Immunisation Register (AIR).

Background


Section 10A of the AIR Act, which took effect 16 February 2021, requires recognised vaccination providers to report certain vaccinations administered in Australia to the AIR. The vaccinations are those prescribed by the rules, when administered in the circumstances prescribed by the rules. Reporting must be done within the timeframe, and in the manner, prescribed by the rules. A vaccination provider is not required to comply with these requirements where the provider reasonably believes that to so would likely to pose a risk to the health or safety of an individual.

 

Vaccination providers must report electronically, or if this is not reasonably practical then in a written form, within 24 hours (and no more than 10 working days after the vaccination). Personal information that needs to be reported includes:

  • the Medicare number (if applicable), name, contact details, date of birth, gender of the individual vaccinated;
  • the provider number, name and contact details of the person who administered the vaccines; and

·         the brand name, dose number and batch number, and date of administration.

 

The capacity to mandate reporting of vaccinations to the AIR arose from the significant investment made and to be made by the Government in the purchase and introduction of COVID-19 vaccines. In order to monitor the safety and efficacy of the vaccines, tracking and tracing of every dose delivered and administered to the Australian population is essential.

The reporting to the AIR of influenza, COVID-19 and NIP vaccines administered in Australia will provide more accurate coverage reporting and assist in a broader understanding of any risks to public health due to vaccine preventable disease outbreaks.

A person who fails to comply with their reporting obligations is liable to a civil penalty of 30 penalty units.

Currently, under Section 9 of the AIR Rules, vaccinations for coronavirus known as COVID-19 and influenza, if administered by a recognised vaccination provider, must be reported to the AIR. NIP vaccines will be added to this list by the Amendment Rules.  

All vaccines listed on the NIP Schedule are free. The most recent NIP Schedule is available at: www.health.gov.au using the search term ‘National Immunisation Program.’ NIP vaccines are also available for individuals in particular circumstances, these are detailed in the National Health (Immunisation Program – Designated Vaccines) Determination 2014 (No. 1).

Details of the Amendment Rules are set out in the Attachment

 

Consultation

 

The Department of Health (the department) undertook a public consultation seeking stakeholder, and the broader public’s, views on the proposed amendment to make it mandatory for vaccination providers to report to the AIR. The scope of consultation included feedback on changes to the AIR Act, including any required changes to the AIR Rules required to support this. The public consultation proposed a suggested staged approach to mandatory reporting, with COVID-19 and influenza vaccines from 1 March 2021, and NIP vaccines from 1 July 2021.

 

In addition, the department consulted directly with the Communicable Diseases Network Australia, Australian Health Protection Principal Committee, and General Practitioner, nursing and midwifery, and pharmacy peak bodies, who are supportive of the measure to make it mandatory for vaccination providers to report all vaccines, including NIP vaccines, to the AIR.

 

Responses to the public consultation paper were received from 5301 respondents, 179 organisation affiliated and 5122 individual submissions. Analysis indicates that key stakeholders, including health peak bodies, are supportive of the move to mandatory reporting. The majority of the 4957 individuals who responded that they do not agree with the proposed legislation amendment provided views regarding mandatory vaccination as opposed to mandatory reporting of vaccination.

 

Key health stakeholder feedback centred primarily on proposed compliance measures for the amendments. Many suggested an ‘escalating approach’, with tougher measures such as civil penalties used as a last resort for repeat offenders. This feedback was considered in the development of the Australian Immunisation Register Amendment (Reporting) Act 2021 (the Amending Act) and specifically the drafting of the Australian Immunisation Register Amendment (Reporting) Bill 2020 to allow a staged approach of which vaccines are required to be reported. Specifically, the approach outlined in 9(1)(b) of the Amending Act.

 

Based on the support for the proposed amendments, the department also proceeded with the staged approach of mandatory reporting, of only COVID-19 and influenza vaccinations initially and then expanding to include NIP vaccines from 1 July 2021.

 

After the amendment to the AIR Rule in February 2021, communication activities were undertaken as part of the COVID-19 vaccination program rollout, and the commencement of the 2021 seasonal influenza program to explain the legislative changes and what is required of vaccination providers. Similarly, communication activities will occur to support the mandatory reporting of NIP vaccines.

 

The Amendment Rules commence the day after registration on the Federal Register of Legislation.

 

The Amendment Rules are a legislative instrument for the purposes of the Legislation Act 2003.

 


ATTACHMENT

 

Details of the Australian Immunisation Register Amendment (National Immunisation Program Vaccines) Rules 2021

 

1                    Name

Section 1 provides that the name of the instrument is the Australian Immunisation Register Amendment (National Immunisation Program Vaccines) Rules 2021 (the Amendment Rules).

 

2                    Commencement

Section 2 provides that the Amendment Rules commence on the day after they are registered.

 

3                    Authority

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

4                    Schedule

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 Rules)

 

Item 1 - Section 4

This item amends section 4 of the AIR Rules to provide new definitions of the following terms:

·         national immunisation program vaccination; and

·         specified national immunisation program vaccine.

A national immunisation program vaccine is a vaccine provided under section 9B of the National Health Act 1953, in other words a vaccine provided for the National Immunisation Program. This item also provides a note after the definition to inform the reader that in 2021, the vaccines that are authorised to be provided, and the circumstances in which those vaccines are authorised to be provided, under section 9B of the National Health Act 1953 are specified in the National Health (Immunisation Program—Designated Vaccines) Determination 2014 (No. 1).

A specified immunisation program vaccine is defined as meaning a national immunisation program vaccine other than a vaccine for influenza or Q fever. Influenza is already subject to mandatory reporting under the AIR Rules. Prior to Q fever vaccination, additional pre-vaccination screening is required. The AIR does not currently have the functionality to record Q fever pre-vaccination screening or vaccines. As such Q fever vaccines are not included in the definition of a ‘specified immunisation program vaccine.’

Item 2 - subparagraph 9(a)(ii)

This item amends subparagraph 9(a)(ii) of the AIR Rules to remove the phrasing ‘influenza and’, and replace with ‘influenza,’. This is a technical amendment to assist with the inclusion of the amendments at item 3 of the Amendment Rules.

Item 3 - at the end of paragraph 9(a)

This item amends paragraph 9(a) of the AIR Rules to add an additional category of vaccinations administered in Australia that must be reported to the Australian Immunisation Register (AIR). This additional category is relevant vaccination (i.e. a vaccination administered inside Australia, or outside Australia if information about the vaccination is given to a recognised vaccination provider) with a specified national program vaccine.

 

At this time, no Rules are prescribed mandating 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.

 

Item 4 - subparagraph 9(b)(ii)

 

This item amends subparagraph 9(b)(ii) of the AIR Rules by replacing ‘2021; and’ with ‘2021;’. This is a technical amendment to assist with the inclusion of the amendments at item 5 of the Amendment Rules.

 

Item 5 - at the end of paragraph 9(b)

 

This item amends paragraph 9(b) of the AIR Rules to add a new prescribed circumstance for when a relevant vaccination is administered and must be reported to the AIR. This is, for a relevant vaccination of a person with a specific national program vaccine, the vaccine was administered on or after 1 July 2021.

 

 

 


Statement of Compatibility with Human Rights

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

 

Australian Immunisation Register Amendment (National Immunisation Program Vaccines) Rules 2021

 

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 (National Immunisation Program Vaccines) Rules 2021 (the Amendment Rules) amend the Australian Immunisation Register Rule 2015 (the AIR Rules) to mandate that recognised vaccination providers must, from 1 July 2021, report National Immunisation Program (NIP) vaccines administered in Australia 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 AIR Act.

 

Section 10A of the AIR Act, which took effect 16 February 2021, requires recognised vaccination providers to report certain vaccinations administered in Australia to the AIR.

 

The vaccinations are those prescribed by the rules, when administered in the circumstances prescribed by the rules. Reporting must be done within the timeframe, and in the manner, prescribed by the rules. A vaccination provider is not required to comply with these requirements where the provider reasonably believes that to so would likely to pose a risk to the health or safety of an individual.

Currently, under section 9 of the AIR Rules, vaccinations for coronavirus known as COVID-19 and influenza, if administered by a recognised vaccination provider in Australia, must be reported to the AIR. NIP vaccines will be added to this list by the Amendment Rules.

Vaccination providers must report electronically, or this is not reasonably practical then in a written form, within 24 hours (and no more than working days after the vaccination). Personal information that needs to be reported includes:

  • the Medicare number (if applicable), name, contact details, date of birth, gender of the individual vaccinated;
  • the provider number, name and contact details of the person who administered the vaccines; and

·         the brand name, dose number and batch number, and date of administration.

The information to be collected under the Rule are the same as those previously collected on a voluntary basis under the AIR Act.

A person who fails to comply with their reporting obligations under section 10A is 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 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 introduction of mandatory reporting of the administration of NIP vaccines 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.

It assists the advancement of this human right by standardising the quality of information in the AIR that records vaccines administered. 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 protection or privacy and reputation

The Amendment Rules engages 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 controls the use and disclosure of information stored on the AIR and who can use and disclose this information.

 

Further, existing privacy provisions in the AIR Act regulate the uploading of personal information or of ‘relevant identifying information’ for the purposes of including such information in the AIR. They also regulate using or disclosing 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.

 

Additionally, vaccination providers have the capacity to decline to report 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 community more generally and information reported to the AIR is protected by the secrecy arrangements in the AIR Act.  

 

The Hon Greg Hunt MP, Minister for Health and Aged Care