CTH Parliament Passes Bill to Introduce Mandatory Reporting for Vaccination Providers
Tuesday 9 February 2021 @ 1.55 p.m. | Legal Research
On 3 December 2020, the Australian Immunisation Register Amendment (Reporting) Bill 2020 (Cth) (‘the Bill’) was introduced to the House of Representatives. The Bill was passed by the House of Representatives on 3 February 2021. Subsequently, on 4 February, the Bill was introduced and passed through the Senate and is currently awaiting assent.
Purpose of the Bill
The primary purpose of the Bill is to make an amendment to the Australian Immunisation Register Act 2015 (Cth) (‘AIR Act’) requiring recognised vaccination providers to report certain information regarding certain vaccinations administered within and outside of Australia. If the Bill receives assent, the specifics of the proposed mandatory reporting requirements will be outlined in a separate statutory instrument. These rules will cover reporting time periods, the manner of reporting and the information required for reporting.
The Bill intends to authorise the collection and use of Commonwealth assigned identifiers which will be known as ‘provider identification information’. Currently, the AIR Act does not require recognised vaccination providers to provide their provider number when reporting to the AIR. This amendment will require providers to provide their name, contact details, provider number (if applicable) and AIR provider number (if applicable) for reporting purposes.
In his Second Reading Speech, the Minister for Health, Mr Gregory Hunt stated that AIR data will be used:
- to monitor the effectiveness of vaccines and vaccination programs, including adverse events;
- to identify any parts of Australia at risk during disease outbreaks;
- to inform immunisation policy and research;
- as proof of vaccination for entry to child care and school, and for employment purposes;
- to monitor vaccination coverage across Australia; and
- to demonstrate eligibility for family tax benefit and childcare subsidy payments.
The Minister further stated that:
"The amendments in the bill will support Australians' health and wellbeing by improving reporting to the AIR to better inform vaccine projections, purchasing, delivery and program performance, and analyses of vaccine effectiveness and safety, which will be particularly important for the COVID-19 vaccines."
The Bill also considers various non-compliance measures. Firstly, the Bill proposes that a penalty of up to 30 penalty units will be imposed for a failure to comply with the ‘requirement to report’ or a ‘notice to produce’ under the AIR Act by a recognised vaccination provider. The Explanatory Memorandum states that if the provider is a corporate entity, the ‘corporate multiplier’ is likely to apply. The intent of the civil penalty is to produce a deterrent effect for non-compliance, especially considering that the penalty applies to each instance of an unreported vaccination and vaccination providers may provide several vaccinations in a single day. However, the Minister noted in his Second Reading Speech that some discretion will be granted to accommodate for the reasonable possibility of isolated issues and technical failure.
Secondly, the Bill proposes more stringent measures where a provider continually fails to comply with mandatory reporting requirements despite provided education and support. In these circumstances, the Bill will allow the Secretary of Health to issue a written notice or provide a formal warning to the provider.
Significance to COVID-19 vaccinations
The Bill only requires mandatory reporting for relevant vaccinations “of a kind prescribed by the rules”. These rules will be prescribed under the Australian Immunisation Register Rule 2015 (Cth). The Explanatory Memorandum explains that the reason for relying on rules is to grant sufficient flexibility for the staged approach for introducing mandatory reporting obligations. Most notably, the Department of Health has expressed its intent to prioritise the enforcement of mandatory reporting for COVID-19 vaccinations and flu vaccinations from 1 March 2021. In contrast, the Department does not intend to enforce mandatory reporting for other National Immunisation Program vaccinations until 1 July 2021.
In particular, the Minister noted in his Second Reading Speech the following 4 COVID-19 vaccines which are anticipated to be rolled out to the public through a free, voluntary vaccinations scheme:
- 33.8 million doses of the University of Oxford/AstraZeneca vaccine, available from early 2021;
- 51 million doses of the University of Queensland/CSL vaccine, available from mid-2021;
- 40 million doses of the Novavax protein subunit vaccine, available from the first half of 2021, with the option to purchase an additional 10 million doses in 2022; and
- 10 million doses of the Pfizer/BioNTech mRNA vaccine, available in the first half of 2021.
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Australian Immunisation Register Amendment (Reporting) Bill 2020 (Cth) and supporting documents available on TimeBase’s LawOne service