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Madden, Bill; Cockburn, Tina --- "COVID-19 Vaccine Claim Scheme: Australia" [2023] PrecedentAULA 53; (2023) 178 Precedent 22

COVID-19 Vaccine Claim Scheme: Australia

By Bill Madden and Professor Tina Cockburn

The Australian COVID-19 Vaccine Claims Scheme (VCS) began on 22 February 2021 but it has an end date, next year. The VCS was introduced to provide no fault compensation to people who suffer specified injuries from specified vaccinations administered to safeguard against the spread of COVID-19. This article provides an overview of the VCS and its underlying policy rationale, describes the experience so far and criticisms of the VCS, alternative compensation pathways and lessons for the future.

Details of the VCS are contained in the COVID-19 Vaccine Claims Scheme – Policy (VCS Policy).^[1] Clause 2 of the VCS Policy defines ‘End Date’ as ‘the date that is two years after the Biosecurity (Human Biosecurity Emergency) (Human Coronavirus with Pandemic Potential) Declaration 2020 made under section 475 of the Biosecurity Act 2015 (Cth) ceases to be in force’. That 2020 Declaration was extended but ultimately ended on 17 April 2022, so the VCS now has less than one year to run before it concludes on 16 or 17 April 2024. Claims received by Services Australia on or before the end date, but not yet processed, will be determined in accordance with the VCS Policy (cl 7, 8 and 9).

There is a small exception for Tier 1 or Tier 2 claims which were made but then suspended when the vaccine recipient died. A Tier 3 claim can then be made after the end date (cl 5(4)).

There is a strong ethical case for no-fault vaccine compensation schemes such as the VCS, especially where vaccination is mandatory, or where sanctions (such as exclusion from workplace participation or attendance at events or venues) are imposed on people who are not vaccinated. Reciprocal justice acknowledges that ‘the community owes a debt of gratitude to an individual who experiences serious injury due to a vaccine offered and accepted in good faith’, and they should therefore be compensated by the State.^[2]

The benefits of no-fault vaccine compensation schemes are obvious. Such schemes may assist in reducing vaccine hesitancy and should assist persons who do suffer the rare adverse reactions from vaccines to obtain speedy, low-cost access to compensation. No-fault vaccine injury compensation schemes have been developed in many countries worldwide.^[3]

In the early stages of the VCS, some hopes were expressed, and lobbying occurred, for extension of the VCS to other vaccines.^[4] The Royal Australian College of General Practitioners’ (RACGP) position statement supported the development and implementation of a no-fault vaccine injury compensation scheme for all vaccines listed on the National Immunisation Program schedule. The RACGP identified the benefits of introducing such a scheme as ‘including:

• protecting the broader community;

• ensuring fair compensation for vaccine injury;

• enhancing confidence in vaccinations; and

• increasing uptake of vaccination programs’.^[5]

However, on present indications, it seems that there will be no extension of the VCS to other vaccines and indeed no extension of the current COVID-19 VCS beyond April 2024.

It is, therefore, important for claims under the VCS to be lodged before the end date, which of course is not consistent with the usual three-year limitation period for personal injury claims. Thereafter the fallback for those suffering vaccine injury would seem to be compensation litigation, Centrelink supports and, in severe cases, the National Disability Insurance Scheme (NDIS).

Reported statistics

An article in The Sydney Morning Herald, published in April 2023, stated that the VCS had paid compensation in the order of $7.2 million since its inception in February 2021, spread over 126 successful claims.^[6] This is, as the article identified, a small ‘fraction of the $76.9 million set aside for possible payments in Services Australia’s portfolio budget statement’. At that time, over 65.6 million vaccine doses had been administered, with 9,300 being ‘associated’ with hospitalisation. The article quoted a spokesperson for Services Australia, who said ‘2,267 claims were in progress or “waiting on further information from applicants” and 562 had been deemed not payable’. The total number of claims lodged up to 12 April 2023 was 3,501. The article included a case study of a successful claim by a 36-year-old man who was placed on life support due to myocarditis (inflammation of the heart muscle) following a Pfizer vaccination in 2021. He lodged his claim in February 2022 and considered himself ‘lucky’ to receive $400,000 compensation relatively quickly, by November 2022.

Calls for provisional payments pending the determination of claims have been resisted (in contrast with, for example, WorkCover claims, where provisional payments are made while the claim is being assessed). The same article cited a spokesperson for the Federal Department of Health and Aged Care who said: ‘Such an approach may result in some claimants having to repay the Commonwealth in the event that their claim is determined by Services Australia to be not payable’.

Basis of the VCS

So, while it exists, how does the VCS work? The VCS Policy was made by Regulation, under the Financial Framework (Supplementary Powers) Regulations 1997 (Cth).

The structure of the VCS Policy is as follows:

1. Preliminary.

2. Submitting a claim.

3. Compensation.

4. Claims – Supporting documentation and other information.

5. Assessment of claims.

6. Offers and acceptance of compensation and settlement deed.

7. Review of decisions.

Determination of claims is made at a public service level. There are no published determinations. There is, however, provision under cl 39 for review should an applicant be dissatisfied with the result, the review being undertaken by a ‘Decision Maker’ who is of a higher level in the public service than the original Decision Maker.

Review of determinations under the Administrative Decisions (Judicial Review) Act 1977 (Cth) does not appear to be available, by reason of the exclusion in sch 1 of that Act, which at paragraph (he) lists decisions under the Financial Framework (Supplementary Powers) Act 1997 (Cth), pt 2.

Coverage

The comments below are a brief overview of the VCS only. Reference should be made to the VCS policy, which is available online: <https://www.health.gov.au/resources/publications/covid-19-vaccine-claims-scheme-policy>.

The VCS applies to COVID-19 vaccines only. Clause 2 of the VCS Policy defines ‘COVID-19 Vaccine’ as ‘a vaccine included in the Australian Register of Therapeutic Goods (ARTG) that is indicated for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.’

It is useful to start with the concept of harm, which cl 2 defines as ‘COVID-19 Vaccine Related Harm or COVID-19 Vaccine Administration Related Harm but excludes the following:

(a) contracting COVID-19;

(b) psychological and psychiatric conditions;

(c) secondary injuries (such as injury suffered when fainting, or a haematoma at the injection site that becomes infected); and

(d) any of the following unless they form part of the symptom complex of COVID-19 Vaccine Related Harm...’

Thereafter follows a list of 24 conditions such as headache, fatigue, dizziness and so on.

Two categories of harm are referred to above. It is probably fair to say that the primary focus is on Vaccine Related Harm but there is also provision for Vaccine Administration Related Harm. Both are carefully defined. It is particularly significant that only physical harm is included; psychological harm is expressly excluded.

As cl 2 specifies, ‘COVID-19 Vaccine Related Harm means a clinical condition developed by the COVID-19 Vaccine Recipient:

(a) that is diagnosed by a Treating Practitioner; and

(b) is included in:

(i) the Product Information in relation to the COVID-19 Vaccine received by the COVID-19 Vaccine Recipient; and

(ii) Table 1 ... but only if the clinical condition referred to in column 1 results from the COVID-19 Vaccine mentioned in the same row in column 2’.

By way of example, in the table that follows, Thrombosis with Thrombocytopenia Syndrome is listed alongside AstraZeneca Pty Limited, and Pericarditis is listed alongside Pfizer Australia Pty Limited, Moderna Australia Pty Limited and Biocelect Pty Ltd (Novavax vaccine).

The VCS was amended from 3 April 2023 to include some additional conditions including major Erythema multiforme (Moderna and Pfizer); Cerebral Venous Sinus Thrombosis (CVST) without thrombocytopenia (AstraZeneca); and Transverse myelitis (AstraZeneca).

There is a causation requirement in the definition of COVID-19 Vaccine Related Harm. The Harm must be ‘most likely caused by the COVID-19 Vaccine and less likely caused by any of the COVID-19 Vaccine Recipient’s other circumstances’. The same causation requirement applies to COVID-19 Vaccine Administration Related Harm.

Turning then to COVID-19 Vaccine Administration Related Harm, that is defined to mean

a) either a clinically diagnosed:

(i) shoulder injury; or

(ii) other moderate to significant physical injury giving rise to permanent impairment or the need for an extended period of medical treatment but excluding psychological distress (e.g. shock); and

b) that was sustained during the physical act of performing the administration of a COVID-19 Vaccine; and

c) that was most likely caused by the administration of the COVID-19 Vaccine and less likely caused by any of the COVID-19 Vaccine Recipient’s other circumstances.’

Clauses 4 and 5 of the VCS Policy go on to state that only one claim may be made per person, unless the harm significantly worsens or different harm is suffered.

Eligible claimants and compensation

An eligible claimant (cl 2) is a person who has suffered harm in one of three tiers, usually with a hospitalisation requirement for Tier 1 and Tier 2 vaccine recipients. In broad terms, Tiers 1 and 2 differ by the quantum of the claim. Tier 1 generally relates to claims up to $19,999.99, whereas Tier 2 claims are generally over $20,000. Tier 3 claims can be brought where the vaccine recipient has died.

Reference should be made to the VCS Policy for details, noting that thresholds vary depending on what is being claimed; however, it can be said that the compensation regime is not dissimilar to that provided by the Civil Liability Act 2002 (NSW). For example, recoverable heads of damage include out of pocket expense, lost earnings, paid and gratuitous care, loss of capacity to provide domestic services and pain and suffering. Compensation for pain and suffering is capped at $693,500 by sch 1. There are also caps for lost earnings and for care.

Where the vaccine recipient has died, the dependant lump sum payment is $644,640 with some allowances for additional dependent children and for funeral expenses (cl 2).

Legal costs are not recoverable (cl 13), which is likely to be a barrier to access to justice for more complex claims.

Pursuant to cl 35, ‘the COVID-19 Vaccine Recipient or anyone else who recovers any compensation, damages or similar, or other monetary amounts in respect of the Harm suffered by the COVID-19 Vaccine Recipient’ from a third party payer has an obligation to repay the Commonwealth.

Evidence

Part 4 describes the documentation that the Claimant must provide to Services Australia in support of the claim. For example, they ‘must provide satisfactory information and evidence’ in support of the pain and suffering claimed in accordance with cls 16 and 20. A medical report is required for all claims (cl 14(4)).

Clause 16(3)I(i) states that the medical report ‘must include the Reporting Practitioner’s diagnosis ... of the specific Harm suffered, including:

(A) an explanation as to how that diagnosis was made and any relevant diagnostic criteria, case definitions and tests/investigations undertaken;

(B) if known, the date on which symptoms of the specific Harm were first experienced;

(C) if known, the date on which the diagnosis was first made;

(D) details of the Treating Practitioner (if any) who first made the diagnosis (if different from the Reporting Practitioner), such as name, contact details, provider number and speciality or field; and

(E) the Reporting Practitioner’s opinion as to the circumstances, nature and severity of the Harm’.

In addition, the Report ‘should provide an overview of the nature of the treatment received in relation to the Harm’ and ‘must include the Reporting Practitioner’s opinion as to the extent to which the Harm was most likely caused by the COVID-19 Vaccine (or its administration) and less likely caused by any of the COVID-19 Vaccine Recipient’s other circumstances’ (cl 16(3)(c)(ii)-(iii)).

Settlement documentation

As stated in cl 35 of the VCS Policy, ‘[b]efore any Compensation is paid and as a condition of receiving Compensation, a settlement deed must be executed in a form approved by the Department of Health and Aged Care (and as may be determined by the Decision Maker as necessary or appropriate having regard to the circumstances of a particular Claim)’.

Criticisms of the VCS

Apart from the end date, the VCS has been criticised on the basis of its complexity; delays in finalising claims; the exclusion of recovering the costs of legal, tax, financial and other professional advice (in cl 13) and limited advertising of the VCS. It has also been said that there is a lack of transparency in decision making given that there is no publication of approved claims and discrimination associated with the exclusion of compensation for psychiatric injury.^[7]

Alternative pathways

Even during the continuance of the VCS other compensation options are preserved, and if successful, recovery may be greater than under the VCS scheme. These options include claims under workers’ compensation, Australian Consumer Law, negligence, and other statutory benefits, such as under the NDIS. In relation to claims against manufacturers of COVID-19 vaccines, in October 2020 the federal government announced that it would indemnify the manufacturers of two vaccines (Oxford and University of Queensland), but the details of the cover are not publicly available.^[8]

Of course a key eligibility criterion for NDIS support is that that the person has suffered a permanent and significant disability – those with temporary vaccine related injury will not be eligible.

A vaccine injury class action was filed in the Federal Court on 26 April 2023. In Rose v The Secretary of the Department of Health & Aged Care, the allegations include that the defendants made misleading vaccine statements, that there were reckless failures with regard to approvals and continuing approvals for vaccines and that the public had a reasonable expectation of skill. The lead plaintiff is a 46-year-old man who allegedly suffered severe cognitive impairment, altered cardiac function and severe chronic fatigue from a single dose of the Moderna Vaccine in October 2021. The first case management hearing is not until November 2023.

Other potential avenues for financial support include income protection insurance claims, claims under superannuation policies, including for total and permanent disablement, Centrelink payments, and Commonwealth mental health supports.

As noted at the outset, the VCS now has less than one year to run before it concludes in April 2024. The VCS has the promise of providing accessible, fair, just, economical, informal and quick compensation to those who have suffered harm as a result of being vaccinated against COVID-19. Yet given the criticisms outlined above it remains to be seen whether these goals have been met. Accordingly, there is a pressing need for a register or some other form of publication of approved claims to improve transparency and to allow for an evaluation of the scheme to create an evidence base to provide lessons for the future. In the meantime, public education is needed to not only inform potential claimants about the scheme, but also to educate doctors asked to provide medical reports to support claims.

Bill Madden is special counsel at Carroll & O’Dea Lawyers. EMAIL bmadden@codea.com.au.

Professor Tina Cockburn is director of the Australian Centre for Health Law Research and professor of law in the School of Law at the Queensland University of Technology. EMAIL t.cockburn@qut.edu.au.

^[1] Australian Government Department of Health and Aged Care, COVID-19 Vaccine Claims Scheme – Policy (3 April 2023) <https://www.health.gov.au/resources/publications/covid-19-vaccine-claims-scheme-policy?language=en>.

^[2] N Wood et al, ‘Australia needs a vaccine injury compensation scheme: Upcoming COVID-19 vaccines make its introduction urgent’, Australian Journal of General Practice 49 (Suppl 36) 2020.

^[3] For a discussion, see K Watts and T Popa, ‘Injecting fairness into COVID-19 vaccine compensation: No fault solutions’ Journal of European Tort Law 12(1), 2021, 1–39.

<https://doi.org/10.1515/jetl-2021-0005>.

^[4] See for example Royal Australian College of General Practitioners, ‘No-fault compensation scheme for immunisations' (Position statement, August 2021) <https://www.racgp.org.au/FSDEDEV/media/documents/RACGP/Position%20statements/No-fault-compensation-Scheme-for-Immunisations.pdf>.

^[5] Ibid.

^[6] M Ward, ‘Thousands left waiting for compensation after claims of COVID-19 vaccine injury’, The Sydney Morning Herald, 16 April 2023.

^[7] For a discussion, see T Popa, ‘Establishing a Regime for COVID-19 Injury Compensation’ (Paper delivered at Legalwise Seminar: COVID-19 Vaccine Injury, Cosmetic Surgery Update and Subpoenas for the Health Sector, 30 May 2023). See generally J Evans, ‘The major problem with Covid-19 vaccine compensation claims’, news.com.au (23 October 2022) <https://www.news.com.au/national/the-major-problem-with-covid19-vaccine-compensation-claims/news-story/39b052c5ec6abd11ff933659d309a20f>.

^[8] N Wood, ‘Who pays compensation if a COVID-19 vaccine has rare side-effects? Here’s the little we know about Australia’s new deal’ The Conversation (15 October 2020) <https://theconversation.com/who-pays-compensation-if-a-covid-19-vaccine-has-rare-side-effects-heres-the-little-we-know-about-australias-new-deal-147846>.