No-fault compensation for COVID-19 vaccine injuries in Australia

ON 28 August 2021, the Australian Government formally announced a scheme providing “quick access to compensation” for individuals suffering from serious adverse events “related to the administration of a Therapeutic Goods Administration approved COVID-19 vaccine delivered through a Commonwealth Government approved program”. The scheme is backdated to the start of the national rollout.

Experts have been calling for a no-fault compensation scheme (NFCS) for vaccine injuries well before the start of the pandemic. This announcement is a positive development and could potentially function as a pilot for a broader scheme. NFCSs exist for vaccine injuries in most Organisation for Economic Co-operation and Development (OECD) countries, and are applicable to COVID-19 vaccines. Australia has been a noticeable outlier.

The views expressed in this article are informed by our field expertise as legal, policy and vaccination scholars, and recent data from our ongoing qualitative community study in Western Australia of the public’s attitudes towards COVID-19 vaccination.

We interviewed members of the public between February and July 2021 as part of this broader study, asking questions about an NFCS for vaccine injuries. For the 61 participants whose knowledge and attitudes are presented in this article, 33% (20/61) were aged 18–29 years, 66% (40/61) were female, 38% (23/61) worked in health care and social assistance, 48% (29/61) had a postgraduate degree, and 80% (49/61) resided in the most advantaged postcodes within WA. Participants’ transcripts were thematically analysed in NVivo.

This article identifies four critical areas regarding the set-up of the NFCS.

Should there be a scheme?

Aligning with strong expert support, a majority of our respondents supported an NFCS. Typical justifications invoked mutualism and solidarity, whereby if society pushes its members towards vaccination to protect public health, the few who experience severe adverse events should be cared for.

“I think that if you were one of the unlucky ones that did have a reaction, you should get as much support as you possibly can. The government’s sort of forced us into that position … in terms of saying that we need to get vaccinated and … it’s safe.”

Around a quarter of our participants shared this view, while a slightly larger group did not express any particular reason for their support, likely reflecting a widespread lack of knowledge about the nature and purpose of NFCSs. A much smaller group simply concluded that the benefits outweighed the costs.

The idea of an NFCS was, however, dismissed by about a third of our participants. Some said there should not be special treatment for COVID-19 vaccines compared with other vaccines or pharmaceutical interventions as long as protocol had been followed and all known information had been disclosed.

“I see the COVID-19 vaccination being no different to any other type of drug which has gone through the protocols to be accepted by the authorities to be administered.”

Others rejected recipients’ perceived entitlement from the state.

“We don’t have the taxpayers to keep supporting this level of support. I just object to the fact that for me … we have had this Centrelink mentality for a very long time in Australia. We. Can’t. Afford it.”

Finally, several participants insisted that informed consent should function as a waiver for any compensatory claim – other than based on fault or product defectiveness.

“I don’t think anyone should be held responsible. Yeah. It’s done with good faith. We are given the information when we were immunised. We are told of the side effects and we give consent. So, it’s a bit of a partnership.”

There was a strong sentiment that we get vaccinated for public health, and fatalistically bear the risks. One respondent said:

“… when I get vaccinated tomorrow, I’m blindly trusting a whole team of researchers that I’ve never met from another country. I trust my own government, in good faith, that what they’re saying is true and factual and credible. And I’m doing that for myself, my family and for my country.”

These views possibly correlate with the fact that, owing to the extremely small numbers of serious adverse events in Australia, few people have experienced one or know somebody who has. There is limited awareness of the potentially far-reaching impacts that compensation would help to address, such as the negative impact on household income because of reduced capacity to work, including where the earner needs to provide care to another, or ongoing health or therapy costs that may not fall within the public health system.

Importantly, our participants were not concerned that an NFCS might induce fear and hesitancy in the community. This may be because the risks of COVID-19 vaccines are already widely discussed in public discourse. A minority did suggest that if an NFCS was introduced, it should not be heavily publicised.

“Maybe it’s something that can be mentioned … during a GP visit, or [when] booking or appointment for the vaccine itself.”

Finally, a minority of participants mistakenly believed that an NFCS already exists, or that the National Disability Insurance Scheme (NDIS) performs that function. This perception is understandable, given the centrality of the NDIS in assisting individuals to manage their disabilities. However, the current structure of the NDIS does not offer an adequate solution for individuals experiencing a vaccine adverse event. Many would not acquire a disability at all, or not one of the nature required to meet NDIS eligibility criteria. Importantly, having an NFCS scheme only for COVID-19 vaccines does not solve this problem; it creates inequity between victims of vaccine injury by assisting some but not all.

Overall, our participants’ prevailing appetite validates the government’s establishment of an NFCS. The idea that COVID-19 vaccines should not be subject to “special treatment” could be turned around by policymakers and advocates to argue for the dedicated COVID-19 scheme to cover a broader range of vaccines in the future. This would align Australia with other OECD countries and ensure equity between individuals irrespective of the vaccine dose concerned.

Notably, most vaccine recipients in Australia are children vaccinated as per the National Immunisation Program.

Funding options

The main options for funding an NFCS include governments, manufacturers, or both. The majority of our participants believed that governments should pay, since they strongly encouraged or even mandated vaccination. As one participant put it when asked where compensation should come from:

“The government, because they’re the ones wanting us to get the vaccine.”

This aligns with concepts of social responsibility and social contract associated with vaccination contributing to the greater good of the community. As a government-funded scheme would essentially be resourced from taxpayer contributions, the public would be repaying a “debt of gratitude” to individuals who suffer a harm.

Although only a small minority of our respondents supported a joint funding model, this strategy could overcome the “Centrelink mentality” critique mentioned above by drawing on manufacturers’ contributions. Moreover, existing NFCSs are at times criticised because they can end up creating a de facto liability shield for manufacturers. Only a handful of cases are filed when the easier NFCS option is available (here and here).

Presently, manufacturers of COVID-19 vaccines already benefit from ad hoc liability indemnities under their contracts with the Australian Government. Should a consumer win a legal action against a manufacturer it would already be government that “foots the bill”. Designing an NFCS co-funded by government and the private sector could therefore strike a fair balance in a policy field fraught with competing values and interests. One respondent commented:

“… perhaps the government set money aside and then potentially the manufacturer put in as well. So, it’s like a 50/50 and then it is only sent out on when you have those reactions.”

A scheme such as this can be set up without imposing costs on manufacturers that are so great they are dissuaded from supplying the market. In the US, a levy attached to each dose directly contributes to the national compensation scheme.

Causal requirements

Causation is a critical element of an NFCS and poses a particularly thorny issue in the context of a pandemic. The consensus among our participants was that compensation should be awarded where there is certainty that the adverse event complained of is indeed due to the vaccine and is sufficiently serious.

A particular effort is needed to manage expectations that only adverse reactions certainly caused by COVID-19 vaccines will be compensated. The highest degree of certainty is only required in criminal cases in our legal system (“beyond reasonable doubt”). The standard of proof in civil cases is the less demanding “balance of probabilities”, which would apply for an NFCS.

Proof of causation can be linked to a closed list of recognised adverse reactions, as in the US. This seems to be the option adopted by the Australian government for the announced NFCS. However, an alternative option leaves the test open, as in the recent Canadian COVID-19-specific NFCS, or the COVAX scheme, where the possibility of compensation for adverse events later proved not be linked to the vaccine is preferred to the risk of excluding worthy claims. In the context of novel pandemic vaccines, the latter seems more appropriate as knowledge about these products evolves and consolidates.

Categorising the degree or impact of the reaction as a criteria for redress could employ existing definitions of serious versus non-serious events used in Australia, which are based on the same criteria from the World Health Organisation.

Systemic issues

Any NFCS must sit coherently within the broader legal system. The Australian COVID-19 vaccine NFCS is set to leave the option of litigation open. Our participants supported this.

Given the peculiar nature of COVID-19 vaccine injury, it is important that the compensation system is a dedicated one. A specific design to assess vaccine injury claims, rather than “tacking it on” to an existing structure, such as the NDIS, facilitates efficient and tailored decision making. This is of vital importance to claimants whose capacity to earn, even temporarily, is affected by the event.

A broader issue is whether compensation should be linked to “assigning blame” or accountability. Most of our participants considered an NFCS as providing a safety net to injured parties, not assigning blame.

“These things can happen, people can have adverse reactions, and I think it would be for the government potentially to support them if there’s [sic] ongoing health requirements after that point. But to say who’s to blame is not the right question.”

Some participants referred to a highly publicised adverse reaction following influenza vaccination of a child in 2010 in WA; they supported compensating the family and recalled their navigation of the legal system. Since litigation is a costly exercise with no guarantee of success, it is not an easily accessible route. This is what makes NFCSs so important.

There is also the issue of governments and employers mandating COVID-19 vaccinations for workers (here and here). Those responsible for imposing such requirements may be legally liable for adverse events following vaccination, and the Australian Industry Group has called for a similar form of protection for businesses to reduce the risk for employers who may face workplace claims. An NFCS for individuals may be just the beginning.

Conclusion

Despite heavy media coverage in the early stages of the rollout, the number of individuals with serious adverse reactions to a COVID-19 vaccine will remain very small. For those who are affected, however, the impact is real and significant.

We ought to ensure that our new NFCS is appropriately designed to discharge our civic duty of providing easily navigable pathways and offering meaningful financial support to those rare individuals who are harmed.

Dr Marco Rizzi is Senior Lecturer at the University of Western Australia Law School. He specialises in torts, risk regulation and health law and policy.

Shevaun Drislane is a PhD candidate at the University of Western Australia School of Social Sciences.

Dr Samantha Carlson is a Post Doctoral Research Officer at the Telethon Kids Institute, and an Honorary Research Fellow at the University of Western Australia.

Leah Roberts is a Research Assistant at the University of Western Australia School of Social Sciences.

Dr Katie Attwell is a vaccination policy researcher and vaccination social scientist. She leads VaxPolLab at the University of Western Australia.

The statements or opinions expressed in this article reflect the views of the authors and do not represent the official policy of the AMA, the MJA or InSight+ unless so stated.