Chapter 2Key issues and committee view
Introduction
1.1This chapter sets out the views of submitters about key issues arising from the Public Governance, Performance and Accountability Amendment (Vaccine Indemnity) Bill 2023 (the bill).
1.2The chapter begins by outlining the key issues raised by submitters supporting, and opposing, the bill.
1.3The chapter then considers:
the role of indemnities in ensuring timely vaccine supply in pandemic and emergency situations;
the risk-benefit profile of vaccine indemnities;
contested views over the safety and efficacy of indemnified COVID-19 vaccines;
the effects of indemnity on access to compensation for vaccine related injuries through the COVID-19 Vaccine Claims Scheme;
the risk of inadequate compensation schemes exacerbating vaccine hesitancy; and
a National no-fault vaccine injury compensation scheme.
1.4The chapter concludes with the committee view and recommendations.
Support for the bill
1.5The committee received a significant number of submissions supporting the bill, including from individuals who shared their personal accounts of vaccine related injuries, as well as from organisations such as the Australian Medical Professionals’ Society, Australians for Science and Freedom, and COVERSE, a peak body representing individuals who have experienced COVID-19 vaccine related injuries.
1.6Collectively, these submitters raised issues around:
the fiscal, medical, and legal risks resulting from Commonwealth vaccine indemnities;
perceived limitations of the regulatory framework around the safety and quality assurance of vaccines in the face of an indemnified vaccine rollout;
the inaccessibility of the COVID-19 Vaccine Claims Scheme for claimants; and
experiences of discrimination, social exclusion, economic disadvantage, and poor health and wellbeing outcomes for vaccine injured persons.
1.7The committee also received submissions from individuals who were sceptical of the COVID-19 virus, pandemic response, and related vaccines.
Opposition to the bill
1.8The Department of Health and Aged Care, the Australian Medical Association, and Medicines Australia made submissions opposing the bill.
1.9Collectively, these submitters raised issues around:
the need for indemnities to ensure the timely supply of vaccines in pandemic and/or emergency situations;
the rarity of granting indemnities to vaccine manufacturers;
international precedents for indemnities, particularly during the COVID-19 pandemic;
the critical importance of reporting and monitoring all suspected adverse events for all therapeutic goods, including vaccines;
the rigour of the Therapeutic Goods Administration (TGA) vaccine registration, approval, monitoring, and regulatory processes to ensure safety and efficacy; and
vaccine related injury compensation.
The role of indemnities in ensuring timely vaccine supply in pandemic and emergency situations
1.10The policy rationale for providing a vaccine indemnity was explained in Chapter 1, namely that in contrast to the routine supply of vaccines where the vaccine provider may be able to price their upfront investment and risk of liability into the cost per dose of a vaccine, this may not be possible in the exceptional circumstances of a pandemic or public health emergency which may require the urgent development and deployment of vaccines, and where ‘the uncertainty of pandemic and emergency circumstances may make the investment in vaccine development impossible to justify for vaccine providers’.
1.11The Department of Health and Aged Care (the Department) pointed out that where risk sharing in the form of indemnities between the Commonwealth and a vaccine provider is not possible, vaccine providers may:
seek to reflect the risk of loss in the price per dose;
elect to not sell to the Australian Government; or
may otherwise elect not to develop vaccine candidates at all.
1.12The Department noted that where the third option occurs, ‘fewer vaccine candidates may enter the market, decreasing competition and having further impacts on the price and availability of vaccines’.
1.13In this context, the Department argued that ‘risk sharing is either inevitable (that is, through price increases) or otherwise plays an important role in incentivising vaccine development’.
1.14Considering the policy rationale set out above, opposition to the bill largely centred on the argument that without indemnification, the supply of pandemic vaccines (for example, during the COVID-19 pandemic) would likely be delayed and there would be a higher risk of increased rates of morbidity and mortality.
1.15The Department submitted that the ability to grant indemnities to vaccine manufacturers is:
…critical in securing commitments to supply when vaccines are in the early stages of development and there may be global supply shortages and/or extreme global demand.
1.16The Department further submitted that the operation of indemnities in the European Union, the United States, the United Kingdom, New Zealand, and many others states necessitated indemnification in Australia to secure the timely, adequate, and cost competitive supply of COVID-19 vaccines.
1.17Medicines Australia, the peak body for the research-based pharmaceutical industry of Australia, submitted that indemnities are important for the entire supply chain from the doctors, nurses and pharmacists who administer and prescribe vaccines, to the researchers, distributers and manufacturers who make them. Medicines Australia emphasised that a fit-for-purpose legal liability framework, by way of indemnification, is essential to ensure Australia is in the best position to protect its citizens ahead of any future pandemic.
1.18The Australian Medical Association, the peak professional body for doctors in Australia, submitted that indemnities were essential to securing contracts with vaccine suppliers in response to the COVID-19 pandemic and were a significant factor driving ‘one of the most successful COVID-19 vaccine rollouts globally’.
Risk-benefit profile of vaccine indemnities
1.19The committee received differing views on the risk-benefit profile of vaccine indemnities.
1.20The Department submitted that indemnities are only granted when the benefit of securing the timely supply of vaccines outweighs the risk of loss or damage another party may suffer.
1.21The Department explained that these benefits include achieving population level immunity, saving lives, and managing the health and economic effects of pandemics and other public health emergencies
1.22The Department also rejected as incorrect the assertion in the explanatory memorandum to the bill that ‘indemnities provided to vaccine manufacturers and sponsors have become commonplace during and post the COVID-19 pandemic’. The Department noted that:
contractual indemnities to vaccine providers have only been granted in a limited number of occasions since 2013; and
the COVID-19 pandemic necessitated an approach to contracting for vaccines which reflected the urgency and scale of the health emergency.
1.23The Australian Medical Association submitted that risk is inherent to all medicines, including vaccines, and the provision of medical care more generally. Therefore, healthcare providers and the health policy infrastructure cannot reasonably be expected to remove risk altogether, but rather can be expected to make the greatest efforts possible to minimise and mitigate risks.
1.24By contrast, Australians for Science and Freedom (ASF), a network of clinicians, academics, and lawyers ‘united in growing disquiet at federal and state responses to the COVID-19 pandemic’, submitted that the notion of vaccines ‘saving lives’ by preventing or delaying deaths resulting from infectious diseases, does not fully capture the cost-benefit trade-off of the COVID-19 vaccine rollout. ASF proposed considering the WELLBY (wellbeing year) measure, in effect an economic proxy for life-satisfaction, as an alternative metric to assess the costs and benefits of granting indemnities to vaccine manufacturers.
1.25Drawing on the WELLBY, ASF posited that by contrasting the human health and wellbeing costs caused by COVID-19 vaccine related injuries and harms with the human health benefits of preventing infection, illness, disease, and death, an approximate ‘$2 billion worth of human thriving would be taken from Australians and directed into company pockets via the granting of product indemnity’.
Differing views on indemnified COVID-19 vaccines
1.26As stated in Chapter 1, the process for registering vaccines for use in Australia is entirely separate to the process for granting indemnities to vaccine manufacturers.
1.27All TGA approved vaccines are required to meet high safety and efficacy standards and are subject to robust domestic and international pharmacovigilance mechanisms.
1.28Despite this, there are always expected to be a small number of adverse events following immunisation (AEFI) with all TGA approved vaccines, including COVID-19 vaccines. The occurrence of AEFI does not undermine the safety and efficacy of vaccines or the robust pharmacovigilance of the TGA.
1.29During the COVID-19 pandemic response, the Commonwealth Government was advised by a range of expert groups populated by epidemiologists, medical practitioners, economists, and senior public servants, including the:
Australian Health Protection Principal Committee (AHPPC);
Australian Technical Advisory Group on Immunisation (ATAGI);
Communicable Diseases Network Australia (CDNA);
Infection Control Expert Group (ICEG);
Public Health Laboratory Network (PHLN);
Pharmaceutical Benefits Advisory Committee (PBAC); and
COVID-19 Vaccines and Treatments for Australia – Science and Industry Technical Advisory Group (SITAG).
1.30The membership of each of these committees is publicly available and can be accessed via the Department of Health and Aged Care website.
1.31With respect to the prevention of transmission of the virus in the community, the TGA has previously advised the Senate that the approved indication of effectiveness for any COVID-19 vaccine is not the prevention of transmission, but rather the prevention of severe coronavirus disease and death resulting from the SARS-CoV-2 virus.
1.32This is clearly stated in the Product Information document for each TGA approved COVID-19 vaccine which are made available to healthcare professionals and the public and can be accessed via the TGA's website.
1.33With respect to the incidence of AEFI and vaccine related harms and injuries, the TGA has previously advised the Senate that while there is no predetermined rate of AEFI, there are always expected to be a small number of adverse reactions to all TGA approved vaccines, including COVID-19 vaccines.
1.34The Department of Health and Aged Care highlighted the systems in place to monitor the incidence of AEFI including:
TGA registration, approval, monitoring and regulation;
monitoring and certification of manufacturing practices;
batch release assessment;
consultation with expert advisory groups, including ATAGI and SITAG; and
robust domestic and international pharmacovigilance mechanisms (or the detection, assessment, understanding and prevention activities around AEFI).
1.35The overwhelming majority of AEFI are expected to have minor and short-lived symptoms, such as:
nausea;
fatigue;
muscle pain;
chills;
low-level fever; and
pain or redness at the injection site.
1.36More severe AEFI are less common but do occur. Severe side effects linked to COVID-19 vaccines include:
myocarditis;
pericarditis;
thrombosis with thrombocytopenia syndrome;
Guillain-Barre syndrome; and
immune thrombocytopenia.
1.37Monitoring of AEFI is ongoing and informs the TGA’s analysis and regulation and can change the registration status of a vaccine, or other therapeutic goods. For example, because of analysis by the TGA of reports of AEFI in people who had received the Vaxzevria (AstraZeneca) vaccine, this vaccine is no longer available in Australia from 21 March 2023 onwards.
1.38In Australia, there have been 14 adult deaths recognised by the TGA as linked to COVID-19 vaccination. There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination.
1.39A significant number of submissions raised concerns around the use of the language of ‘safe and effective’ in relation to TGA approved COVID-19 vaccines, referring to the high number of adverse event reports submitted to the TGA (139654 as at 29 October 2023).
1.40The TGA monitors the safety of therapeutic goods in Australia by encouraging the reporting of suspected adverse events to the TGA. Medical practitioners and individuals are strongly encouraged to report all suspected adverse events to the TGA for all therapeutic goods, including vaccines, regardless of whether causality can be proven.
1.41The TGA states that this approach increases the size of its open access Database of Adverse Event Notifications (DAEN) and in doing so strengthens the veracity of analysis and findings around patterns of adverse events in the Australian population.
1.42However, the TGA notes that reporting an adverse event does not necessarily mean there is something wrong with the therapeutic good, or that the therapeutic good is the cause of the adverse event.
1.43The TGA states that its monitoring of AEFI is aligned with international best practice pharmacovigilance as set out in the World Health Organisation’s (WHO) causality assessment process for individual serious adverse events following immunisation. The process for reporting and investigating adverse events associated with therapeutic goods, including vaccines, can be accessed via the TGA's website.
1.44The TGA also argues that referring to the broad rate of AEFI reports decontextualised from the TGA analysis of AEFI, as released via the monthly COVID-19 vaccine safety reports, does not provide data-driven evidence that undermines the safety and efficacy of the COVID-19 vaccines. This is because reporting rates alone do not accurately capture the distinction between a suspected AEFI and causally verified severe side effects linked to COVID-19 vaccines.
1.45The committee also received markedly differing views on the safety and efficacy of indemnified vaccines, with a significant focus on COVID-19 vaccines.
1.46Several submitters who supported the bill raised concerns around the safety and efficacy of indemnified COVID-19 vaccines, arguing that in both the Australian and the global context, COVID-19 vaccines had:
failed to prevent transmission of the virus in the community; and
resulted in a range of adverse side-effects, harms, and injuries.
1.47These concerns were encapsulated in the submission from Australians for Science and Freedom, which stated:
Gifting product indemnity to vaccine manufacturers strengthens the incentives to produce shoddy vaccines, pushes the costs of that shoddiness onto the shoulders of Australians, and reinforces the social norm that vaccines are uniquely desirable health interventions, ingratiating them to the public and thereby hindering independent scientific evaluative efforts and lowering the minimum acceptable levels of safety and efficacy still further.
1.48The committee received a significant number of submissions which echoed similar concerns to those articulated above, centred on the logic that granting indemnities compromises the quality and safety of vaccines by incentivising risk-taking, removing the legal, fiscal, and social responsibilities of manufacturers, and short-cutting quality assurance and regulation.
1.49Several submitters articulated these concerns:
Giving indemnity has allowed them (vaccine manufacturers) to make profits at the expense of people like myself getting injured, with no responsibility whatsoever.
Vaccine indemnity can create a situation where the profits of pharmaceutical companies are prioritized over the well-being of those who receive their vaccines.
1.50The Department rejected this assertion, submitting that there is a critical distinction between the reallocation of legal risk by way of indemnification and the robust regulatory and clinical environment in which vaccines are approved for use, tested, and monitored post-administration.
1.51The Department, in both their initial and supplementary submissions, reiterated that the indemnification of vaccine manufacturers did not compromise the rigour and independence of TGA vaccine registration, approval, monitoring and regulation. The Department’s initial submission stated:
The granting of indemnity in no way reduces the high safety and efficacy standards required by the TGA when approving a vaccine for provisional or full registration, and has no impact on the approval process itself.
Effects of indemnification on access to compensation for vaccine related injuries through the COVID-19 Vaccine Claims Scheme
1.52Several submitters shared personal accounts of the difficulties they had experienced accessing compensation for vaccine related injuries through the COVID-19 Vaccine Claims Scheme. For many of these submitters, these effects have been further compounded by the discrimination and social exclusion they experienced post-injury, leaving many, in their own words, devastated, stressed, and broke.
1.53The committee also received a significant number of submissions from individuals who shared their personal accounts of vaccine related injuries and the effects of these injuries on their physical, mental, and economic health, and wellbeing.
1.54Many of these submitters reported loss of income and employment, out of pocket medical and legal expenses, alleged gaslighting by medical professionals and government officials, and general disappointment with what they experienced as a restrictive, complex, and onerous claims scheme.
1.55Many of these submitters were unsuccessful in accessing the scheme altogether and received no compensation for vaccine related injuries, despite having the support of at least one medical professional. This experience was not uncommon among those submitters:
I have received a clinical diagnosis of, and treatment for, myopericarditis due to mRNA vaccine from both a cardiologist and a GP… (however) due to the ridiculously restrictive nature of the government compensation scheme, I do not qualify to apply for any compensation.
1.56Some of these submitters were successful in accessing the scheme but noted that the compensation received was below their initial request and inadequate for the economic, physical, and mental costs incurred.
1.57The Department of Health and Aged Care submitted that the COVID-19 Vaccine Claims Scheme was designed to simplify compensation claims for individuals who suffer moderate to severe impact following an adverse reaction to a TGA approved COVID-19 vaccine and to support public confidence in the COVID-19 vaccination roll-out.
1.58To be eligible under the Scheme, the claimant must meet the following requirements:
suffered a clinical condition or administration related injury most likely as a result of receiving the COVID-19 vaccine;
received inpatient hospital treatment (with limited exceptions); and
met the threshold for accessing the Scheme of at least $1000 in losses (such as out of pocket medical costs and lost income); and
submit a medical report from their treating doctor or hospital physician with the treating doctor’s opinion on the diagnosed condition or injury and likely link to vaccination.
1.59Several submitters felt the eligibility requirements for the scheme were restrictive, complex, and onerous. Some submitters suggested the eligibility requirements misplaced the responsibility to establish causal links to prove the relationship between the vaccine and the related injuries suffered onto claimants, rather than vaccine manufacturers and regulators. To that effect, MsStephanie Eaton pointed to the:
…irony of seriously vaccine injured (people) having to prove causality when there was no longitudinal data for the novel vaccines.
1.60COVERSE, a peak body advocating for individuals who have experienced COVID-19 vaccine related injuries, submitted that meeting the eligibility criteria of the scheme required a significant investment of time and money, as well as above average levels of scientific literacy, which prohibited many vaccine injured persons from submitting a claim in the first instance, let alone a successful claim.
1.61Freedom of Information (FOI) documents from Services Australia revealed that, as at 30 August 2023, fewer than 200 of the 3803 claims made through the COVID-19 Vaccine Claims Scheme had received a compensation payment and fewer than 40 per cent of claims were finalised.
1.62While the provisions of the bill itself do not speak directly to, or seek to address, the adequacy and/or accessibility of the COVID-19 Vaccine Claims Scheme, there was a shared perception among many vaccine injured submitters that indemnification has inhibited their ability to seek compensation for vaccine related injuries.
1.63This perception was challenged by the Department who submitted that, unlike in other jurisdictions which have legislated no-fault-compensation schemes such as the United States of America and New Zealand, Commonwealth indemnification does not preclude vaccine injured citizens from taking direct legal action against vaccine manufacturers.
1.64The details of individual indemnity agreements are unknown. However, the Department noted:
a customer (party A) could agree in the contract to pay for court awarded damages that a vaccine provider (party B) would otherwise need to pay to a patient who suffered a vaccine injury, and associated court and solicitor costs;
the precise scope, or limits of the indemnity, are generally heavily negotiated, and must be agreed by the parties and documented in the contract; and
the granting of a contractual indemnity generally does not grant party B immunity from legal action, nor cap the liability of the indemnified party to a third party claimant.
1.65The COVID-19 Vaccine Claims Scheme is currently scheduled to end on 30September 2024.
Concerns regarding the COVID-19 Vaccine Claims Scheme
1.66Robust compensation schemes providing support for the small, but expected number of people who experience severe AEFI are vital to maintaining public trust and participation in pandemic response vaccination efforts.
1.67As noted in several submissions, many Australians with personal experience navigating the COVID-19 Vaccine Claims Scheme have found it to be restrictive, complex, onerous, and ultimately unhelpful.
1.68Further, several submitters indicated that the inaccessibility and/or inadequacy of the COVID-19 Vaccine Claims Scheme has not only been a source of personal disappointment for claimants, but also a driver of future vaccine hesitancy.
1.69These sentiments were a recurrent theme throughout the inquiry and are exemplified in the below excerpts:
I was never an anti vaxer. I have had all my vaccinations and used to get my flu shot. I am so scarred by my injuries and experience from the Covid vaccine that I will never touch another vaccine.
I genuinely believed that rolling up my sleeve for the vaccine was the responsible and patriotic thing to do… (however, following vaccine related injury) I have endured significant financial losses …. (and) harbour no illusions about the possibility of ever receiving substantial compensation through the government's woefully inadequate vaccine claims scheme.
1.70In addition, submissions from the Western Australian Department of Health and the Immunisation Foundation of Australia (a health promotion charity and patient advocacy organisation that supports the National Immunisation Program) spoke to the risk that inadequate support and compensation for vaccine related injuries may exacerbate vaccine hesitancy in the community and negatively impact public trust in future immunisation and pandemic response efforts.
A National no-fault vaccine injury compensation scheme
1.71Both the Western Australian Department of Health and the Immunisation Foundation of Australia supported the bill on the stipulation that the bill be amended to prohibit the indemnification of vaccine manufacturers ‘other than when provided as part of a National no-fault vaccine injury compensation scheme’.
1.72The Western Australian Department of Health acknowledged that the bill in its present form:
…would likely limit the Australian Government’s ability to establish a national no-fault vaccine injury compensation scheme, since the majority of similar schemes in other countries involve granting manufacturers indemnities in return for legally-mandated financial support of a publicly-managed compensation program.
1.73The Immunisation Foundation of Australia argued that a national no-fault vaccine injury compensation scheme is ‘the best way to ensure that individuals who suffer vaccine injuries have access to compensation’ and noted that:
Such a scheme would provide compensation to victims of vaccine injuries without requiring them to prove fault on the part of the vaccine manufacturer. This would make it easier and faster for victims to receive compensation, and it would remove the financial burden of vaccine injuries from individuals and their families.
1.74Both the Western Australian Department of Health and the Immunisation Foundation of Australia argued that a National no-fault vaccine injury compensation scheme would help enhance public trust in Australia’s National Immunisation Program.
1.75The Western Australian Department of Health noted that National no-fault vaccine injury compensation schemes operated in 25 countries prior to the COVID-19 pandemic including the United States of America, the United Kingdom, Canada, and New Zealand. However, the accessibility, adequacy and transparency of these schemes vary considerably.
1.76Although advocacy for a National no-fault vaccine injury compensation scheme does not neatly align with the core objectives of the bill, there are several shared concerns and objectives between the submissions from the Western Australian Department of Health and the Immunisation Foundation of Australia and many of the submissions received in support of the bill, namely:
streamlining access to timely and adequate compensation for vaccine related injuries;
alleviating the proof burden on claimants to vaccine compensation schemes; and
enhancing public confidence in the safety and efficacy of vaccines.
Committee view
1.77The committee rejects the assertion by proponents of the bill that granting indemnities to vaccine manufacturers in any way compromises the quality and safety of TGA approved vaccines in Australia.
1.78The committee acknowledges that without indemnification, the supply of pandemic vaccines, as seen during the COVID-19 pandemic, would likely be delayed and there would be a higher risk of increased rates of morbidity and mortality.
1.79The committee considers three issues raised by the bill below.
Indemnification is vital for pandemic and/or emergency response capability
1.80The committee was persuaded by arguments presented by the Department of Health and Aged Care, the Australian Medical Association, and Medicines Australia that the ability of the Minister for Finance, or their delegate, to grant indemnities on behalf of the Commonwealth to vaccine manufacturers, though rarely exercised, is a vital pandemic and/or emergency response capability that should not be removed.
1.81There is no question that timely access to vaccines was, and continues to be, integral to an effective COVID-19 pandemic response in Australia and internationally. Removing the ability to indemnify vaccine manufacturers would almost certainly hinder the Commonwealth Government’s ability to respond to any future pandemic or emergency situations.
1.82The committee concurs with Medicines Australia that indemnities also provide critical protections for the doctors, nurses and pharmacists who administer and prescribe vaccines.
1.83The committee also rejects the assertion in the explanatory memorandum to the bill that the indemnification of vaccine manufacturers is, or risks becoming, commonplace in Australia.
1.84The committee understands that the Australian Government does not regularly or voluntarily offer indemnities to vaccine manufacturers. Indemnities are only considered in anticipation of, or in response to, emergency or pandemic situations where the public health benefits outweigh the risks. This is apparent in the limited number of indemnities granted to vaccine manufacturers, compared with the number of vaccines procured for the National Immunisation Program without indemnification.
Indemnities do not incentivise risk taking by vaccine manufacturers nor compromise the rigour of TGA vaccine registration
1.85The committee accepts the view put by the Department of Health and Aged Care that the benefits of providing indemnities include achieving population level immunity, saving lives, and managing the health and economic effects of pandemics and other public health emergencies.
1.86The committee also accepts the view of organisations such as the Australian Medical Association that risk is inherent to all medicines, including vaccines, and that Australia’s health policy infrastructure cannot reasonably be expected to remove risk altogether, but rather make the greatest efforts possible to minimise and mitigate risks.
1.87Nevertheless, the committee recognises many submitters were concerned about the perceived relationship between indemnification and the incentivisation of risk taking by vaccine manufacturers.
1.88The committee also recognises many submitters were concerned about the perceived relationship between indemnification and the expedited and/or reduced quality assurance of vaccines by the Therapeutic Goods Administration (TGA).
1.89That being acknowledged, the committee was convinced by arguments presented by the Department of Health and Aged Care that there is a critical distinction between the allocation of legal risk, by way of indemnification, and the robust regulatory and clinical environment in which vaccines are registered, approved, monitored, and regulated by the TGA.
1.90The COVID-19 pandemic saw an unprecedented global prioritisation by governments, scientific and medical researchers, experts, and pharmaceutical companies to develop effective vaccines against the SARS-CoV-2 virus. Although this process was expedited, the committee is considers it inaccurate to conflate expedition with short-cutting, or an increased risk appetite.
1.91The committee understands that the expedited vaccine development and registration process was enabled in large part by a combination of international collaboration, organisational prioritisation, surge resourcing efforts and considerable overtime, both rostered and unpaid, by those working to develop and register vaccines and support the pandemic response more broadly. These efforts are deserving of our gratitude and ultimately supported one of the most successful COVID-19 vaccine rollouts globally.
1.92The committee rejects the assertion in the explanatory memorandum to the bill that the indemnification of vaccine manufacturers has created an incentive for risk-taking in the pharmaceutical industry which is not aligned with the fundamental principles of medicine.
1.93There is no evidence to suggest that indemnification, or the expedited timeframes in which COVID-19 vaccines were developed, reduced the safety and efficacy of vaccines. These vaccines were registered for use and administered in Australia because they met the TGA’s high standards for safety and efficacy.
1.94The committee also accepts the argument put forward by the TGA that the approved indication of effectiveness for any COVID-19 vaccine is not the prevention of transmission, but rather the prevention of severe coronavirus disease and death resulting from the SARS-CoV-2 virus.
1.95In the committee’s view, gesturing towards community transmission rates to question the safety and efficacy of the COVID-19 vaccines is an argument that misunderstands, and potentially obfuscates, the core purpose of COVID-19 vaccines.
1.96That is not to suggest the vaccine rollout has been a positive experience for all involved. The committee acknowledges the people who experienced severe adverse events following immunisation. The committee also extends its condolences to the families and loved ones of the 14 Australians whose deaths have been linked to COVID-19 vaccination.
The COVID-19 Vaccine Claims Scheme
1.97As noted earlier, opponents of the bill argued that the vaccine rollout and pandemic response more broadly has greatly benefitted the medical, social, and economic health of the Australian population.
1.98Nevertheless, it is clear from many submissions to this inquiry that the distribution of these costs within Australian society has not always been counterbalanced by accessible, timely and adequate support and compensation for those who have suffered severe vaccine related injuries.
1.99Over the course of the inquiry a significant number of submitters focussed the committee’s attention on issues surrounding the adequacy of the COVID-19 Vaccine Claims Scheme, with many sharing their personal experiences of disappointment navigating the scheme.
1.100The committee understands that the scheme was designed to simplify compensation claims for the small number of people expected to suffer moderate to severe adverse reactions to TGA approved COVID-19 vaccines and to support public confidence in the COVID-19 vaccination roll-out. The scheme is an optional alternative to potentially costly and time-intensive litigation.
1.101The committee acknowledges the view that the eligibility requirements currently in place for the scheme appear to have been, on several occasions, prohibitively restrictive for many Australians and failed to meet the central stated aims of the scheme.
1.102Further, with most claims made to the scheme yet to be finalised, the committee is concerned with the resourcing levels of the team tasked with managing the scheme within Services Australia. While acknowledging that the assessment of claims is complex and spans the work of multiple agencies, greater efforts must be made to finalise claims within reasonable timeframes.
1.103The committee also recognises the risk that inadequate support and compensation schemes for vaccine injury may become a significant driver of vaccine hesitancy. This poses a threat to public trust and participation in future immunisation and pandemic response efforts, including the National Immunisation Program and maintaining ongoing COVID-19 vaccination.
Concluding remarks
1.104The benefits of immunisation are vital in protecting the health of the Australian population. The committee is unanimous in its view that passage of this bill would have a severely detrimental effect on Australia’s future capacity to manage any future pandemic, and consequently on the health of the population. This is because Australia’s pandemic response would be inhibited by an inability to source and secure the timely provision of life-saving vaccines in an emergency by a prohibition on the granting of indemnities.
1.105Further, it is clear to the committee that the granting of an indemnity for legal risk in an emergency does not compromise the efficacy and robustness of the vaccine assurance, monitoring, and regulatory processes undertaken by the Therapeutic Goods Association.
1.106That said, the committee acknowledges the risk of vaccine injury cannot be eliminated and there will be a small, but expected, number of people who may suffer vaccine injury. The committee accepts the principle, based on equity and fairness, that any person who is injured while helping to protect the community—in this case, by contributing to herd immunity—should not bear the consequences of the injury alone.
1.107Accordingly, the committee considers it incumbent on government to ensure that any vaccine injury claims scheme offers timely, easily accessed, and adequate compensation to persons suffering vaccine injury. Further, the committee considers it prudent to take seriously any risk of increased vaccine hesitancy associated with the view that the COVID-19 Vaccine Claims Scheme, or indeed any vaccine compensation scheme, is overly onerous. With new strains of COVID-19 continuing to emerge and the COVID-19 Vaccine Claims Scheme scheduled to end on 30 September 2024, the committee considers it appropriate to review the COVID-19 Vaccine Claims Scheme and consider the merits of a National no-fault vaccine injury compensation scheme as part of the National Immunisation Strategy.
1.108The committee recommends that the Australian government review the COVID-19 Vaccine Claims Scheme and consider the merits of a National no‑fault vaccine injury compensation scheme as part of the NationalImmunisationStrategy.
1.109The committee recommends that the Senate not pass the bill.
Senator Louise Pratt
Chair