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2019-2020
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
AUSTRALIAN IMMUNISATION REGISTER AMENDMENT (REPORTING)
BILL 2020
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health, the Hon Greg Hunt MP)
Australian Immunisation Register Amendment (Reporting) Bill 2020
OUTLINE
The amendments to the Australian Immunisation Register Act 2015 (AIR Act) create
a requirement for recognised vaccination providers to report to the Australian
Immunisation Register (AIR) information relating to vaccinations they administer and
vaccines they are notified about that were given outside Australia. The Bill also
creates a power for the Secretary of the Department of Health to require a recognised
vaccination provider to give information if they do not comply with this reporting
requirement.
The AIR is a whole of life, national immunisation register that captures vaccines
administered to those living in Australia. The AIR Act provides that the purposes of
the AIR relate to supporting Australian vaccination programs and vaccination matters
more broadly.
Currently, there is no statutory mechanism by which the Commonwealth can require
vaccination providers to report vaccines administered. Vaccination providers are
encouraged to report all vaccines administered to the AIR however, as reporting is
voluntary, not all vaccines administered are reported.
Reporting to the AIR is maintained at high levels and the data entered is sufficiently
reliable for the administration of childhood immunisations due to a number of existing
policy and program settings which encourage reporting. Reporting of adolescent and
adult other vaccines is lower and less reliable.
Noting the significant investment to be made by the Australian Government in the
purchase and introduction of a COVID-19 vaccine, and the National Immunisation
Program more generally, tracking and tracing of all vaccines administered to the
Australian public will be essential.
Without a legislative change, the Commonwealth cannot enforce the mandatory
reporting of COVID-19 vaccines administered, once the vaccine/s become available
for clinical use.
A staged implementation is proposed, which will be prescribed in the Australian
Immunisation Register Rule 2015, with the mandatory reporting of:
COVID-19 vaccinations (should one or more safe and effective vaccines meet
all necessary regulatory requirements for supply in the Australian market) and
influenza vaccinations from 1 March 2021; and
All National Immunisation Program (NIP) vaccinations from 1 July 2021.
In summary, the key amendments in the AIR Bill:
introduce provisions under which recognised vaccination providers are
required to report certain information in relation to certain vaccinations
administered, both within and outside Australia;
authorise the collection and use of Commonwealth assigned identifiers, known
as a 'provider identification information';
introduce civil penalties should vaccination providers not comply with the
legislated requirements; and
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provide power for the Secretary of the Department of Health to require a
recognised vaccination provider to produce information if they do not comply
with this reporting requirement.
Financial Impact Statement
System enhancements to the Australian Immunisation Register are required to support
increased interactions with AIR, allow for population of specified mandatory and non-
mandatory data fields by vaccination providers, and to provide bulk vaccination
upload functionality. Final costs for the above system enhancements are yet to be
determined.
Regulation Impact Statement
The Office of Best Practice Regulation has confirmed that the Bill would ordinarily
require a Regulation Impact Statement (RIS). Due to truly urgent and unforeseen
events related to the spread of COVID-19, the Prime Minister has granted an
exemption from the need to complete regulatory impact analysis in the form of
Regulation Impact Statements for all urgent and unforeseen Australian Government
measures made in response to COVID-19. The exemption is relied upon for this Bill
due to the urgent response required to manage COVID-19 vaccination reporting to the
AIR. Consistent with the Australian Government's RIS requirements, the Department
of Health (the department) will complete a post-implementation review within two
years of implementation.
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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)
BILL 2020
This Bill 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 Bill
The amendments to the Australian Immunisation Register Act 2015 (AIR Act) create
a requirement to report information relating to certain relevant vaccinations
administered in Australia and outside Australia by recognised vaccination providers to
the Australian Immunisation Register (AIR). The Bill also creates a power for the
Secretary of the Department of Health to require a recognised vaccination provider to
give information if they do not comply with this reporting requirement. Currently,
there is no statutory mechanism by which the Commonwealth could require
vaccination providers to report vaccines administered.
The AIR is a whole of life, national immunisation register, which captures vaccines
administered to those living in Australia. The AIR Act provides that the purposes of
the AIR relate to supporting Australian vaccination programs, and vaccination matters
more broadly.
The proposed amendments to the AIR Act are intended to enable the Government to
track and trace every COVID-19 vaccine administered. Furthermore, the proposed
amendments will provide a strong incentive for providers to ensure that the AIR
contains a complete and reliable dataset of vaccines administered in Australia. This
information can be used to:
monitor the effectiveness of vaccines and vaccination programs, including
adverse events;
identify any parts of Australia at risk during disease outbreaks;
inform immunisation policy and research;
prove vaccination for entry to child care and school, and for employment
purposes;
monitor vaccination coverage across Australia; and
demonstrate eligibility for Family Tax Benefit and Child Care Subsidy
payments.
Human rights implications
The amendments engage the following human rights:
International Covenant on Economic, Social and Cultural Rights (ICESCR)
The Bill 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.
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The Bill 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. It assists the
advancement of this human right by improving the quality of information in the
Australian registry 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 Bill engages Article 17 of the International Covenant on Civil and Political
Rights.
The proposed amendments in this Bill do not change the existing provisions and are
consistent with the secrecy provisions in Part 4 of the AIR Act, which controls the use
and disclosure of information stored on the Register and who can use and disclose this
information.
Existing 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 Register. They also regulate using or disclosing such information for the purposes
of the Register where the person falls within particular identified categories or the
person falls within one of the other paragraphs of the relevant provision.
If any person makes a record of, discloses or otherwise uses such information and it is
not authorised under the AIR Act then the person may have committed a criminal
offence.
For this Bill, the types of information to be collected under the reporting obligation
are the same as those currently collected on a voluntary basis under the AIR Act. The
amendments that expressly authorise or require the collection, use and disclosure of
information will also meet obligations under the Australian Privacy Principles (APPs)
in Schedule 1 to the Privacy Act 1988 (Privacy Act).
Another privacy enhancing feature of the AIR Act is that existing subsections 11(1)
and (2) of the AIR Act provide individuals with control over how their personal
information is used or disclosed. The existing limitations for which the information
can be disclosed are a reasonable and proportionate use of individual's personal
information.
Conclusion
The Bill is compatible with human rights because it advances the protection of human
rights as outlined above and to the extent that it may also limit human rights, those
limitations are reasonable, necessary and proportionate.
The Hon Greg Hunt MP, Minister for Health
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AUSTRALIAN IMMUNISATION REGISTER AMENDMENT (REPORTING)
BILL 2020
NOTES ON CLAUSES
Clause 1 - Short Title
Clause 1 provides that the Bill, once enacted, may be cited as the Australian
Immunisation Register Amendment (Reporting) Act 2020.
Clause 2 - Commencement
This clause provides that the Bill will commence as follows:
Sections 1 to 3 - The day of Royal Assent
Schedule 1, Part 1 - The day after Royal Assent
Schedule 1, Part 2 - the later of:
o Immediately after commencement of Schedule1, Part 1; and
o Immediately after commencement of the Federal Circuit and Family
Court of Australia Act 2020.
However, Schedule 1, Part 2 does not commence at all if the Federal Circuit and
Family Court of Australia Act 2020 does not commence.
Clause 3 - Schedule(s)
This clause provides that each Act that is specified in a Schedule to this Bill is
amended or repealed as set out in the applicable items in the Schedule concerned, and
any other item has effect according to its terms. This is a technical provision which
gives operational effect to the amendments contained in the Schedules. Schedule 1
amends the Australian Immunisation Register Act 2015 (AIR Act).
SCHEDULE 1 -- AMENDMENTS
Part 1 - Main amendments
Australian Immunisation Register Act 2015
Item 1 - Section 4
This amendment inserts definitions applicable to the Australian Immunisation
Register Amendment (Reporting) Bill 2020.
This amendment will clarify the definitions of:
a 'civil penalty provision' has the same meaning as the definition used in the
Regulatory Powers (Standard Provisions) Act 2014
'provider identification information' as per Section 5A
These changes define a framework for the use of civil penalties to enforce civil
penalty provisions.
Item 2 - After section 5
The amendment to insert subclause 5A(1)(a)(b)(c) clarify the provider identification
information that will be required when a recognised vaccination provider administers
a vaccine and reports it to the AIR.
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The AIR Act does not currently explicitly provide that a recognised vaccination
provider must provide their provider number to identify themselves. This amendment
will explicitly state that this information is required to be reported to the AIR to
ensure the provider reporting is a recognised vaccination provider.
This amendment does not change the requirement of who is able to report information
to the AIR.
Item 3 - Section 6
This amendment will insert additional words into section 6 of the AIR Act to clarify
that the Crown cannot be prosecuted or be held liable for monetary fines under the
Act.
Item 4 - Section 7
This amendment will insert additional words into the simplified outline of Part 2 of
the AIR Act to explicitly state that vaccination reporting is mandatory and penalties
may apply for non-compliance, as set out in the Bill amendments.
Item 5 and Item 6 Subparagraphs 9(b)(iii) and (iv) and Paragraph 9(d)
This amendment broadens the inclusion of provider identifying information to include
a provider number as defined in 5A.
Item 7 - Division 2 of Part 2
This amendment requires recognised vaccination providers to report relevant
information to the AIR vaccines that they administer and/or and vaccines they are
given information about given outside Australia. Such disclosure of personal
information is authorised by the AIR Act and therefore "authorised by law" for the
purposes of the Privacy Act.
The relevant information will be prescribed under the Australian Immunisation
Register Rule 2015. The reliance on rules for the new reporting obligation in Division
2A is due to the staged approach for the reporting obligation. The Department is
seeking to require mandatory reporting in relation to any COVID-19 vaccinations
(should a safe and effective vaccine/s meet all necessary regulatory requirements for
supply in the Australian market) and flu vaccinations from 1 March 2021, whereas
mandatory reporting in relation to other National Immunisation Program vaccinations
will not be required until 1 July 2021.
This amendment also makes it a requirement for recognised vaccination providers to
report within the period prescribed by the rules and in the manner prescribed by the
rules, the information prescribed by the rules for that vaccination.
Collection of information prescribed by the rules, rather than in the AIR Act is
considered reasonable, necessary and proportionate. The rules will allow for
flexibility in relation to a number of matters including, for example, what vaccines
need to be reported.
The relevant information set out in the rules will include information that is currently
collected by the AIR, this process seeks to formalise through an instrument what
information vaccination providers are required to report.
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This amendment also provides an exception to mandatory reporting to the AIR where
vaccination providers believe it would put an individual's health or safety at risk. This
clause has been included based upon feedback received during the consultation
process for this Bill.
This amendment sets out the action that the Secretary may take if a recognised
vaccination provider fails to comply with the 'requirement to report' under 10A or a
'notice to produce' under 10B. Non-compliance may result in imposition of a civil
penalty of up to 30 penalty units.
This penalty unit does not accumulate, however this penalty will have a deterrent
effect for vaccination providers who fail to report as it is likely that as the majority of
vaccination providers administer vaccines or a daily, weekly or monthly basis there
will be multiple contraventions.
For example, if a vaccination provider failed to report 500 influenza vaccines the
maximum civil penalty would be 500 x 30 penalty units. If the provider is a corporate
entity the 'corporate multiplier' is likely to be applicable. The corporate multiplier
would also apply for corporate entities that do not comply, with the notice to produce
power.
Compliance action by the Secretary or their delegate will include a degree of
discretion in what actions should be taken for non-compliance. It is conceivable
evidence that vaccination providers who have failed to report a single vaccination
event and are otherwise compliant with legislation are likely to have experienced
isolated software issues. In such circumstances education and support would be
provided in the first instance.
If a vaccination provider is not reporting any vaccines to the AIR and does not
undertake behavioural change even after education and support is provided, more
serious compliance action would be considered. This could include the Secretary
issuing a written notice under section 10C to provide a formal warning to a
vaccination provider.
Item 8 and Item 9 Paragraph 12 (1)(a) and Subparagraph 12(1)(b)(iii)
This amendment aligns the existing wording of 'providing' information to the AIR
with the new text of 'reporting' used in section 10A and 10B.
Item 10 and Item 11 Section 28
This amendment to the AIR Act expands section 28 of the AIR Act to also deal with
civil penalties. This amendment also inserts new sub clauses relating to the civil
penalties applicable in 10A and 10B including clarifying what is an enforceable civil
penalty, authorised applicant and the relevant court/s.
Item 12 Subsection 30(1)
This amendment clarifies that the functions or powers the Minister may delegate. This
clarification is required due to the new Secretary delegations to be introduced in
subsections 30 (4) and (5).
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Item 13 Section 30
This inclusion allows the Secretary of the Department to delegate functions relating to
the compliance measures outlined in 10B and 10C to an SES employee of the
Department. Delegates are confined to members of the Senior Executive Service,
which aligns with the guidance published by the Senate Standing Committee for the
Scrutiny of Bills.
Part 2--Contingent amendments
Australian Immunisation Register Act 2015
Item 14 Paragraph 28A(3)(b)
This addition allows for the scenario where the Federal Circuit and Family Court of
Australia Act 2020 commences between the introduction and passage of the
Australian Immunisation Register Amendment (Reporting) Bill.
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