Dissenting report from Senator Babet
1.1ThePublic Governance, Performance and Accountability Amendment (Vaccine Indemnity) Bill 2023 amends the Public Governance, Performance and Accountability Act 2013to provide that indemnities cannot be granted to manufacturers of vaccines in relation to the use of a vaccine.
1.2The committee has published[1] 96 public submissions, listed 4 confidential submissions and a sample of 128 further submissions that were classified as survey responses from coordinated campaigns. Members and Senators also received a significant number of calls and emails from various people and professional organisations in support of this bill.
1.3All public submissions received by the committee, including the 128 that have been collated as a single sample submission (number 66) should have been uploaded individually. This lack of transparency is unacceptable and anti-democratic in nature.
1.4My analysis shows that more than 97% of submissions support the passage of this bill. Of the 101 submissions and 127 survey responses, only 5 appeared to oppose the bill.
1.5A public hearing was requested by multiple Senators but was repeatedly denied by the committee. This has prevented subject matter experts appearing as witnesses to present evidence to the committee and answer questions on matters of contention. By refusing to hold a public hearing the committee has failed in its duty to fully consider all aspects of this bill and will leave many questions unanswered.
1.6Although the intention of granting indemnity is to provide faster access to medical products, the reality is that the most recent COVID-19 vaccination program has resulted in significant reported injury and death. Those who profit from the sale of these products have been indemnified.
1.7The final COVID-19 Vaccine Safety Report released by the Therapeutic Goods Administration[2] includes a staggering 139,654 reported adverse events and 1,004 reported deaths following vaccination.
1.8AusVaxSafety is an Australian Government Department of Health and Aged Care funded vaccine safety system. They conducted active vaccine safety surveillance during the COVID-19 vaccine rollout[3]. Surveys of over 6.6 million Australians have been conducted following vaccination. 44.1% of recipients surveyed reported at least one adverse event with 0.9% of recipients requiring a visit to their general practitioner or an emergency department.
1.9On 21 February 2021, Greg Hunt the Minister for Health and Aged Care stated[4]:
The world is engaged in the largest clinical trial, the largest global vaccination trial ever, and we will have enormous amounts of data…But what’s the message for the public? It’s safe, it’s effective, it will help protect you, but it will also help protect your mum and dad, your grandparents, your nonna, all of Australia.
1.10The Western Australian Vaccine Safety Surveillance Annual Report 2021[5] shows that adverse events following immunisation (AEFIs) with the COVID-19 vaccines were reported at 23.8timestherate(per 100, 000 doses) of AEFIs forall other vaccines combined. The report refers to this phenomenon as an “exponential increase” on page 29.
1.11Australian Medical Professional Society stated[6] that “our comprehension of the available COVID-19 vaccine mechanisms of action and their long-term performance, particularly in terms of safety and efficacy, still contains gaps. Yet the government indemnified huge multinational pharmaceutical corporations for all liability from novel therapeutics with minimal short-term data and zero long-term data”.
1.12Australians for Science and Freedom (ASF) raised concern[7] around the indemnities provided to companies for COVID-19 Vaccines, with specific reference to a potential loophole re: the National Health Act’s implicit definition of a vaccine, “a vaccine for the purpose of immunising persons.” ASF mentions that the COVID-19 vaccines, of which hundreds of millions were bought by Australia, have long been recognised not to provide immunisation for any reasonable length of time against COVID-19 infection”. They believe there is a potential loophole in our present legislative framework for the procurement of medical interventions, that could be exploited by companies selling medical interventions for which they would like to remain conveniently excused of liability. This concern appears relevant when you consider that the mRNA vaccine rollout began in early 2021 and the TGA only updated the definition of a vaccine[8] to include mRNA technology on 10 March 2023 and their vaccines overview section to include mRNA technology on 14 November 2023.
1.13There appears to be a lack of clarity around the compliance of the delegate with the Public Governance Performance and Accountability framework when granting indemnity for COVID-19 vaccines. The granting of indemnity has created an unquantifiable, contingent liability and federal budget papers reveal a cost larger than that permitted in the framework.
1.14Sections 60 and 110 of the Public Governance Performance and Accountability Act 2013 enables the Finance Minister, or their delegate, to grant indemnities on behalf of the Commonwealth. Indemnities given by the Commonwealth create contingent liabilities (i.e. they may give rise to a liability on the occurrence of a future event). They are legally enforceable obligations included in contractual arrangements between the Commonwealth and another party whereby the Commonwealth undertakes to accept the risk of loss or damage another party may suffer.
1.15On 12 September 2023[9], during Senate Question Time, the Minister for Finance advised that the signing of COVID-19 vaccine contracts would have occurred at the public service level. The Department of Health and Aged care confirmed this detail, they said[10]: “For the purchase of COVID-19 vaccines, after Government agreed, the Advance Purchase Agreements (AstraZeneca, Moderna, Novavax and Pfizer) were all signed by the then Associate Secretary in the Department of Health and Aged Care as that position had the delegation to enter into these arrangements.” This is concerning because there is no accountability for the decision maker as this decision was made 'at the public service level' without the awareness of parliament, nor was it able to be debated in the House or Senate, nor released to the public in any meaningful way.
1.16As stated[11] by the Department of Finance, the written delegation from the Finance Minister requires that an official who is delegated the power to enter indemnities must consider two overarching principles:
(a)that risks should be borne by the party best placed to manage them; and
(b)benefits to the Commonwealth should outweigh the risks involved.[12]
Of specific concern is the requirement that the most probable expenditure if the event occurred is not significant (it would be less than $30 million).
1.17Services Australia Portfolio Budget Statements[13] (page 187) show the compensation paid/to be paid via the COVID-19 vaccine claims scheme far exceeds the $30m threshold. The figures budgeted are $76.9m in 2022/23 and a further $28.8m in 23/24. This substantial cost blowout is a prime example of future risks posed to taxpayers should this bill not pass.
1.18Contracts containing indemnity clauses have not been publicly released in Australia. The exact details of these contracts remain unknown. Contracts have been requested by multiple Senators on 22 November 2023 via an unsuccessful order for production of documents (tied vote). Senator Babet has also asked for release of the contracts in Senate question time[14][15].
1.19Budget paper No. 1[16] shows an ‘unquantifiable contingent liability’ that has been created due to advance purchase agreements for COVID-19 vaccines. The specific details of these contracts are unknown to the public, all that is known is that these contracts have exposed the Commonwealth to a potential liability that is unquantifiable.
1.20Submission 59[17] states that “except in limited circumstances (where the likelihood of the event occurring is less than 5% and the probable expenditure is less than $30M), approval from the Finance Minister, Cabinet, the National Security Committee of Cabinet (NSC) or the Prime Minister is required”. The question that remains unanswered is whether approval was provided by the Finance Minister, Cabinet, NSC, or the Prime Minister for the advance purchase agreements in relation to COVID-19 vaccines.
1.21It is concerning that Minister Gallagher stated during Senate question time[18] on 30 March 2023, regarding the COVID-19 vaccine claims scheme, that:
because the vaccine was developed in a relatively short period compared to others, there were commercial discussions about how to manage schemes and claims like this, but I can’t go into those details. They are commercial-in-confidence.
This is just another example of opacity around negotiations where the deal results in a financial risk to taxpayers that is unquantifiable. Why do corporations have the right to withhold all details from the taxpayers who pay for their products?
1.22Australians for Science and Freedom asked[19]:
why would public transparency about government contracts be detrimental to corporate interests? The only way we can see this being true is if something in the contracts or the contracting process would seem unfair or otherwise inappropriate to the observing public. That sort of secrecy is not a legitimate protection for a company that has invested in a new product, but rather a fig leaf for poor behaviour. The “commercial in confidence” argument does not justify secrecy around contracting. Instead, by using this argument, cover is given to further the corporate interest in saving face while ignoring the interests of the people being represented by the government.
1.23With respect to vaccines, it is well known that “side effects occur after any dose, in both sexes, and with variable latency after vaccination”[20]. Dr Melissa McCann stated in her submission[21] that:
”Given the numbers of adverse events reported to the Therapeutic Goods Administration and the number of claims to the compensation scheme, there is an urgent need to ensure accountability and adequate governance in relation to both the financial and public health and safety obligations of Commonwealth entities such as the Department of Health, with respect to both the purchasing and indemnity arrangements for the COVID-19 vaccination program and the administration of the associated compensation claim scheme."
1.24Dr McCann referred to a statement by the Minister for Health and Aged Care, Greg Hunt on 28th August 2021[22],where he said:
The COVID-19 Vaccine Claims Scheme offers protection to Australians receiving a TGA approved COVID-19 vaccine, irrespective of where that vaccination occurs.
The Scheme will be administered by Services Australia and will provide Australians with a single front door to a simple and quick administrative process for compensation. The TGA will provide guidance on recognised adverse reactions as part of their established surveillance program.
The COVID-19 Vaccine Rollout Scheme will be backdated to February 2021 and provide Australians with an alternative, administrative option to seek compensation, rather than a complex and costly court process.
Australians who receive a COVID-19 vaccination and have an adverse event are encouraged to report it to their doctor who can provide the information to the TGA to ensure such events are included in its reporting.
1.25There has been a hesitancy amongst clinicians to link injury to the indemnified, novel COVID-19 vaccines for fear of professional repercussions. For example, a personal injury lawyer stated that[23] “among other hurdles for applicants, clinicians were reluctant to link injury and the vaccine – which the scheme requires for eligibility. “People generally are finding it difficult to gain appropriate expert evidence because medical specialists, generally, are non-accepting of their injuries or are fearful of repercussions professionally,” she said.This fear was irresponsibly perpetuated by Australia’s health regulator AHPRA and the National Boards via a statement made on 9 March 2021 as follows:
“Any promotion of anti-vaccination statements or health advice which contradicts the best available scientific evidence or seeks to actively undermine the national immunisation campaign (including via social media) is not supported by the National Boards and may be in breach of the codes of conduct and subject to investigation and possible regulatory action,”
1.26The COVID-19 vaccine claims scheme has only recognised 10 conditions[24]. Just 4 conditions have been recognised for mRNA products. In terms of adverse events, reference must be made to the serious adverse events of special interest included in[25] the Pfizer 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021 dated 30 April 2021. This is Pfizer’s Adverse Events Report, released in or about November 2021 pursuant to court ordered disclosure expedited under the Freedom of Information Act. It includes 1223 deaths, as seen on page seven. Further, the report outlined nine pages, around 1200+, adverse events of special interest, many of which are identifiable on TGA’s Database of Adverse Event Notifications. These adverse events of special interest were discussed in the Journal Vaccine, in a paper titled “Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.” This study reviewed the available data from both the Pfizer and Moderna phase-3 randomised trials in adults. The findings stated.[26]
In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000 participants). [3] In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants).
“The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.
It is unsurprising that many hospitals around Australia are at or beyond capacity following the rollout of these jabs.
1.27We know from the most recent update regarding the Vaccine Claims Scheme[27] that, as of August 31, 2023, 3,805 claims have been submitted, 199 claims have been approved, 1,252 claims have been deemed not payable, 729 claims have been withdrawn and 1,625 claims are in progress. The average claim is taking a massive 297 days to be paid, deemed not payable or be withdrawn. This is a very long wait for those injured by a novel product that they took in good faith at the recommendation of their government. Some individuals took these vaccines in response to a coercive vaccine mandate. The largest amount paid to a claimant has been $2.21 million and a total of $4.2 million has been paid as compensation for death.[28]
1.28The COVID-19 Vaccine Claims Scheme has been widely criticised since its rollout[29]. For example:[30] “Potential applicants and legal experts have criticised it as overly complex and difficult to access, since a medical professional is required to sign off on documentation linking the reaction to the vaccine, and only a small number of officially recognised side effects such as myocarditis are covered.”
1.29The Vaccine Claims Scheme is too limited in its scope. COVERSE stated in their submission[31] that the claims scheme:
“only provides compensation against a very short list of specified injuries attributed to specific brands of COVID-19 vaccines, as well as other arbitrary qualifying criteria. In other words, the scheme has been designed to exclude the vast majority of Australians who have been injured by a COVID-19 vaccine.”
1.30The end date for the COVID-19 Vaccine Claims Scheme is currently scheduled for 17 April 2024 according to the Department of Health and Aged Care submission[32], but their website states 30 September 2024[33]. It is important to understand why the date has been brought forward or if this is an error.
1.31The Department of Health and Aged Care[34] stated that:
the Commonwealth only grants an indemnity where the benefits to the Commonwealth outweigh the risks.
In the interests of transparency and accountability, the documentation used to justify their decision to grant indemnity should be publicly released for review by independent experts and the public.
1.32The Department of Health and Aged Care states[35] “In this context, indemnities for use of vaccines can be a useful tool to allow the Commonwealth to appropriately share risk with vaccine providers, who incur significant upfront costs in bringing a vaccine candidate to market.”
When one party is indemnified, it does not appear to be a fair risk-sharing arrangement. It appears that the risk has been transferred from the vaccine provider to the Commonwealth.
1.33The Department of Health and Aged Care also advised[36] that:
the granting of indemnity to vaccine manufacturers is not a practice, which the Department seeks to offer voluntarily, nor are requests for indemnity entertained outside of emergency or pandemic situations.
The Department has clearly stated that indemnity is not offered voluntarily. This implies that indemnity is demanded by vaccine manufacturers and sponsors as a condition of sale.
1.34In their submission to the committee,[37] Moderna attempted to refute any assertion of coercive tactics, they emphasised that “matters of indemnities are solely the responsibility of the Commonwealth government.”
1.35It was noted by the authors of an article in the New England Journal of Medicine[38], ‘Manufacturers won’t agree to procurement contracts or ship vaccine without liability protection’. The authors further stated:
According to an AstraZeneca executive, for example, in the company’s bilateral contracts, it has been granted protection against legal claims arising from the use of its vaccine products, since it “cannot take the risk” of liability. As early as 2006, the International Federation of Pharmaceutical Manufacturers and Associations, the global pharmaceutical-industry lobbying group, publicly demanded that manufacturers be granted protection from lawsuits associated with vaccine-related adverse events if they were going to participate in pandemic responses.
1.36The Independent Review of COVID-19 Vaccine and Treatment Purchasing and Procurement[39], which was released under FOI stated: “Early procurement of vaccines and treatments occurred in the context of uncertainty and a global vaccine shortage – a “sellers' market”. Agreement to conditions not usually included in ordinary procurement contracts was necessary to secure commitments to supply.”
1.37COVERSE states in their submission[40]:
By granting liability protections to vaccine manufacturers (including of mRNA vaccines), the government has created an industrial environment that favours profiteering by pharmaceutical companies over the advancement of new and safe innovative health products for the benefit of Australians.
Innovation in health products demands that manufacturers are acutely concerned with the safety of new products and work hard to improve the safety profile of existing products.
The legal threat of liability provides the necessary financial incentive to work towards those goals, and acts as a natural balance to profit motives that seek to downplay and ignore potential safety issues.
By providing such companies with indemnities, the Australian Government is enabling pharmaceutical corporations to pursue “robber-baron” type behaviour at the expense of Australian citizens.
1.38The Department of Health and Aged Care said:[41]
Where risk sharing 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.
It is important to understand if negotiators discussed other terms of contracts before offering indemnity. E.g. has a higher price been offered in exchange for no indemnity?
1.39Pfizer has been accused of holding Brazil to ransom, over demands to shield itself from COVID-19 vaccine side-effect lawsuits.[42] It is understood that Pfizer asked the South African government to put up sovereign assets guaranteeing an indemnity against the cost of any future legal cases.[43]Latin American countries were asked by Pfizer to put up federal bank reserves, embassy buildings or military bases as a guarantee against the cost of future legal cases stemming from unlikely adverse effects.[44] One needs to ask why they would request such significant collateral? Was Australia required to provide sovereign assets as security?
1.40Alarmingly, an international precedent was set, in accordance with guidance from the COVAX facility, requiring that all 172 member states, including Australia, who received vaccines through the COVAX Facility indemnify manufacturers. [45]The international precedent appears to reinforce the belief that collusion occurred amongst pharmaceutical companies on a global scale. This is concerning and reinforces the need for Australia to thoroughly review the World Health Organisation’s 300+ amendments to International Health Regulations to ensure that sovereignty and autonomy are maintained.[46]
1.41It has been found that [47] “COVID-19 vaccine manufacturers’ indemnification demands constitute state capture in many low to middle income countries (LMICs) though not in high-income countries; this has enhanced global COVID-19 vaccine inequities. Results underscore the need to find alternatives to financial indemnification that do not hinder critical efforts to end the pandemic.”
1.42The Department of Health and Aged Care also stated in their submission that “The Finance Minister has only granted an indemnity to a vaccine manufacturer in preparation for, or in response to, emergency and/or pandemic situations”.
1.43On 20 October 2023, the Chief Medical Officer, Professor Paul Kelly declared that COVID-19 is no longer a Communicable Disease Incident of National Significance (CDINS)[48]. It is important to understand if indemnification of existing COVID-19 vaccines continues beyond that date.
1.44On 20 November 2023, ATAGI provided a statement which announced TGA approval of the Moderna and Pfizer monovalent Omicron XBB.1.5 COVID-19 vaccines[49]. It is important to understand if pharmaceutical companies continue to be indemnified for products which were approved and administered outside of an emergency or pandemic situation.
1.45The Department of Health Annual Report[50] for 2021-22 states regarding vaccines that:
under certain conditions the Australian Government has provided an indemnity for the supply of certain vaccines to the suppliers of the vaccines. The contracts under which contingent liability is recognised will expire across a range of dates to 2036.
This is another clear example of obscure statement being made regarding indemnity with no real detail or clarity.If contract terms remain out of sight, there will be a lack of clarity and a lingering cynicism amongst the Australian people.
1.46Australians for Science and Freedom stated in their submission[51]:
Because the free gift of product indemnity will be handed over in the future as negative side effects develop, its size cannot be estimated in advance unless rigorous, independently validated, long-run, high-sample-size studies are conducted in advance of product rollout. Even then, the estimate of the size of the gift is just that: an estimate. Product indemnity is an unfunded contingent liability of unknown size that falls on the shoulders of Australians to finance.
1.47Federal budget paper number 1[52] refers to indemnities for specialised external advisers during the COVID-19 pandemic. It states that:
“The Government has provided indemnities for certain specialised external advisers engaged to provide advice on emerging markets issues related to COVID-19. Indemnities were provided to mitigate personal risk and provide coverage for costs related to any legal proceedings that may arise in relation to the provision of that advice. The indemnities apply for the period of engagement as advisers and for claims that are notified within 12 years after cessation of the adviser’s engagement. Until the indemnity agreements are varied or expire, they will remain as contingent and unquantifiable liabilities”.
It is unknown how many external advisers were indemnified and for what purpose. We do not know what role they had in vaccine procurement. This should be disclosed publicly along with any conflicts of interest.
1.48There have been multiple attempts via the courts by victims who are seeking compensation for injuries caused by indemnified vaccines. One example of current litigation is a class action filed by NR Barbi Solicitor P/L[53]. The potential cost to the Commonwealth if the claimant is successful cannot be quantified.
1.49Australians for Science and Freedom aptly stated that[54]
“medical innovation is implicitly suppressed in any areas not privileged by government regulation. For this reason, handing vaccine manufacturers product indemnity should be seen as equivalent to throwing cold water on the developers of future simple supplements, behavioural protocols, pharmaceutical medicines, architectural designs, or other prevention and treatment options that may hold far more potential to fight infection and symptoms of disease than vaccines.”
1.50We know that not all countries gave in to indemnification requests by pharmaceutical companies for COVID-19 vaccines.
1.51According to media reports, India has not provided any contractual indemnities to COVID-19 vaccine manufacturers, which appear to have stalled negotiations with Moderna and Pfizer:
The "indemnity clause" is reportedly one of the main reasons whythe two vaccine manufacturershave stayed out of India.[55]
1.52It appears that India has continued to maintain its position and has not provided indemnities to COVID-19 vaccine manufacturers.[56] Union minister Rajeev Chandrashekhar shared on his Twitter account a video of Pfizer CEO Albert Bourla. Sharing the video, the minister said, "Just to remind all Indians, that Pfizer tried to bully Govt of India into accepting conditions of indemnity”.
1.53India turned its back on the vaccine and decided to use other safe and effective early treatments, using inexpensive repurposed medication. The State of Uttar Pradesh in Northern India introduced Ivermectin as prophylaxis for close contacts of Covid patients, health workers as well as for the treatment of the patients themselves through a government order on 6 August 2020.
1.54Following a High Court ruling[57], the Republic of South Africa’s COVID-19 vaccine contracts have been released publicly. There are many concerning details within the Pfizer Laboratories P/L contract which include:
5.5: Purchaser Acknowledgement:
“Purchaser acknowledges that the Vaccine and materials related to the vaccine, and their components are constituent materials are being rapidly developed due to the emergency circumstances of the COVID-19 pandemic and will continue to be studied after provision of the Vaccine to the Purchaser under this Agreement. Purchaser further acknowledges that the long-term effects and efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known. Further, to the extent applicable, Purchaser acknowledges that the Product shall not be serialized”.
6.5 (b): Effect of Termination:
“The termination or expiration of this Agreement shall not affect the survival and continuing validity of Sections 1, 2.1(b)-(d), 2.6, 2.7 (b-e), 2.8, 3.1, 3.3, 3.4, 4.4, 4.5, 4.6, 4.7, 5.4, 5.5, 6.2 (final sentence), 6.5, 7, 8, 9.2, 9.3, 9.4, 9.5, 9.6, 10, 11, 12 or any other provision which is expressly or by implication intended to continue in force after such termination or expiration.
8: Indemnification
8.1. Indemnification by Purchaser. Purchaser hereby agrees to indemnify, defend and hold harmless Pfizer, BioNTech, each of their Affiliates, contractors, sub-contractors, licensors, licensees, sub-licensees, distributors, contract manufacturers, services providers, clinical trial researchers, third parties to whom Pfizer or BioNTech or any of their respective Affiliates may directly or indirectly owe an indemnity based on the research, development, manufacture, distribution, commercialization or use of the Vaccine, and each of the officers, directors, employees and other agents or representatives, and the respective predecessors, successors and assigns of any of the foregoing (“Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including, without limitation, reasonable attorneys’ and other counsels’ fees and other expenses of an investigation or litigation), whether sounding in contract, tort (delict), intellectual property, or any other theory, and whether legal, statutory, equitable or otherwise by any natural or legal person (collectively, “Losses”) caused by, arising out of, relating to, or resulting from the Vaccine, including but not limited to any stage of design, development, investigation, formulation, testing, clinical testing, manufacture, labelling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation,dispensing, prescribing, administration, provision or use of the Vaccine, any information, instructions, advice or guidance provided by Pfizer, or BioNTech or any of their respective Affiliates and relating to use of the Vaccine, or any processing or transfer of anyone’s personal information processed and transferred by Purchaser to the Indemnitees (“Covered Activities”).
9.3 Excluded liability
Nothing in this Agreement excludes or limits the liability of either Party for:
(i)Fraud or fraudulent misrepresentation
(ii)Any breach of section 10 (Confidential Information)
(iii)In the case of Purchaser, the indemnity given it under Section 8 (indemnification); or
(iv)In the case of the Purchaser, failure to pay the Price for the Product or any other sums properly owing to Pfizer under this agreement.
1.55If contract terms similar to the South African agreement were included in the Australian contracts, they should never have been entered into.
1.56COVERSE[58] referred to two countries that are worth mentioning for their approaches towards recognising and compensating COVID-19 vaccine injuries: Thailand and South Korea. They said:
In both countries, the number of people who have been compensated demonstrates a level of acceptance and compassion not found in many other jurisdictions (including Australia and the USA). There are fewer limitations on the types of reactions eligible for compensation (as it is widely acknowledged that vaccines can precipitate a large and diverse range of serious reactions, though each type of reaction might only occur in a very small number of people).
Recently, South Korea even extended its scheme to provide a commiseration payment to families of citizens who had died within 90 days of having a COVID-19 vaccine, regardless of proven causality.
While such schemes may end up delivering payments to people who have suffered health conditions unrelated to their vaccinations, the approaches taken ensure that the number of genuine cases who slip through the cracks will be minimised, and the government conveys a very strong message to the public that they will be taken care of if their vaccinations cause harms. Despite compensating significantly more people than many other programs, it is worth noting that both of these programs maintain capped compensation payments, meaning that a number of people with extremely serious and ongoing medical conditions will not be adequately provided for, which again demonstrates the limitation of government programs.
1.57Submission 59 by the Department of Health and Aged Care challenges the assertion that indemnities have become commonplace. The very same submission[59] by the Department provides two pages (page 14 and 15) of products and manufacturers which have been indemnified over the past 10 years. The definition of ‘commonplace’ is open to interpretation, but what can be confirmed is that indemnity has been granted multiple times.
1.58The Department of Health and Aged Care’s original submission[60] refers to Moderna’s onshore mRNA Manufacturing Agreement.It states that:
The Commonwealth has entered into a strategic partnership with Moderna to establish domestic mRNA vaccine manufacturing capacity and capability in Australia. Under the agreement between the Commonwealth and Moderna, the Commonwealth may enter into a pandemic vaccine advance purchase agreement (PVAPA) with Moderna for locally manufactured mRNA vaccines in certain circumstances where an infectious disease pandemic is declared. Moderna will also have the capacity to supply the Commonwealth with non-pandemic vaccines through a non-pandemic vaccine supply agreement (NPSA).
The submission confirms that the Commonwealth has provided indemnities to Moderna under the arrangements to cover ‘certain liabilities’.It is important to understand if the indemnity granted to Moderna will only apply in case of emergency, considering their capacity to supply the Commonwealth with non-pandemic vaccines via a NPSA.
1.59Australian Medical Professional Society proposed[61] that any indemnified provisional vaccine should be part of the Black Triangle scheme. The scheme is designed to improve the rate of reporting by reminding health professionals and consumers to report suspected adverse events related to new medicines, or those being used in new ways.
Recommendation 1
1.60The Senate should pass this bill.
1.61There is strong public support, with more than 97% of submissions supporting the passage of the bill. As evidenced in the small number of negative submissions the government and bureaucracy are clearly out of touch with the public and many subject matter experts.
1.62The denial of public hearings has impacted the committee’s findings and has silenced many witnesses who have personally and professionally been impacted by indemnification.
Recommendation 2
1.63The public release of all contracts containing indemnity clauses is necessary to retain and rebuild the trust of the Australian people.
1.64Communication between the minister and the delegate should be publicly disclosed to ensure there is no political pressure applied in cases of indemnity.
1.65Existing contracts that contain indemnity clauses should be audited to ensure compliance with the act.
Recommendation 3
1.66The COVID-19 vaccine claims scheme is not fit for purpose and has left many injured Australians without sufficient compensation. The government must extend and amend the compensation program to make it easier for victims of vaccine injuries to be compensated. The re-design should be led by feedback from those who have been personally impacted.
Recommendation 4
1.67Vaccine mandates must be prohibited, especially when enforced in conjunction with a novel product that has been indemnified.
Senator Ralph Babet
United Australia Party
Senator for Victoria
Footnotes
[1]Finance and Public Administration Legislation Committee, Public Governance, Performance and Accountability Amendment (Vaccine Indemnity) Bill 2023, https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Finance_and_Public_Administration/VaccineIndemnity47.
[2]Covid-19 Vaccine Safety Report 2nd November 2023 COVID-19 vaccine safety report - 02-11-23 | Therapeutic Goods Administration (TGA) (accessed 8March 2024).
[3]AusVaxSafety, Covid-19 Vaccine Safety Data COVID-19 vaccines | AusVaxSafety (accessed 8March 2024).
[4]https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/interview-with-david-speers-on-abc-insiders-on-the-covid-19-vaccine-rollout.
[5]The Western Australian Vaccine Safety Surveillance Annual Report 2021, page 28 Western Australian Vaccine Safety Surveillance – Annual Report 2021 (health.wa.gov.au) (accessed 6March 2024).
[6]Australian Medical Professionals' Society, Submission 62, pp. 7-8.
[7]Australians for Science and Freedom, Submission 65.
[8]Supplementary Budget Estimates 2023-2024 Outcome: 1 - Health Policy, Access and Support PDR Number: SQ23-002123
[9]Question time, Australian Senate, 12September 2023, Hansard - Senate 12/09/2023 Parliament of Australia (aph.gov.au)
[10]Department of Health and Aged Care, Submission 59 - Supplementary Submission, p. 5.
[11]Department of Finance, RMG414, https://www.finance.gov.au/publications/resource-management-guides/indemnities-guarantees-and-warranties-commonwealth-rmg-414#-what-is-a-commonwealth-indemnity-
[12]Public Governance, Performance and Accountability (Finance Minister to Accountable Authorities of Non-Corporate Commonwealth Entities) Delegation 2022, Public Governance, Performance and Accountability (Finance Minister to Accountable Authorities of Non-Corporate Commonwealth Entities) Delegation 2014, p. 13.
[13]Department of Social Services, Portfolio Budget Statements, 2023/24, Portfolio Budget Statements 2023-24 Budget Related Paper | Department of Social Services, Australian Government (dss.gov.au)
[14]Senate Official Hansard, 22 November 2022.
[15]Hansard - Senate 12/09/2023 Parliament of Australia (aph.gov.au)(page 4274)
[16]Budget Paper No. 1 2023/24, Budget Paper No. 1 | Budget 2023–24
[17]Department of Health and Aged Care, Submission 59.1 - Supplementary Submission, p. 4.
[18]Senate question time, 30th March 2023, Hansard, page 1690, Hansard - Senate 30/03/2023 Parliament of Australia (aph.gov.au)
[19]Australians for Science and Freedom, Submission 65, p. 7.
[20]Neurological Adverse Reactions to SARS-CoV-2 Vaccines - PMC (nih.gov)
[21]Dr Melissa McCann, Submission 46.
[22]https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/no-fault-covid-19-indemnity-scheme
[23]https://www.news.com.au/national/the-major-problem-with-covid19-vaccine-compensation-claims/news-story/39b052c5ec6abd11ff933659d309a20f
[24]https://www.health.gov.au/sites/default/files/2023-12/covid-19-vaccine-claims-scheme-policy_0.pdf
[25]COVID-19 Vaccination Status (Prevention of Discrimination) Bill 2022 and the Fair Work Amendment (Prohibiting COVID-19 Vaccine Discrimination) Bill 2023 Submission 4 (page 17)
[26]Fraiman et. al., Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults.
[27]Supplementary Budget Estimates – 25 October 2023 Answer to question on notice, SQ23-001034
[28]Supplementary Budget Estimates – 25 October 2023 Answer to question on notice, SQ23-001035
[29]https://www.smh.com.au/national/thousands-left-waiting-for-compensation-after-claims-of-covid-19-vaccine-injury-20230413-p5d03y.html; https://www.news.com.au/finance/economy/federal-budget/covid-vaccine-injury-payouts-explode-to-77-million-budget-reveals/news-story/df39fcf430c6cadb487a9914df7a3422
[30]https://www.news.com.au/national/the-major-problem-with-covid19-vaccine-compensation-claims/news-story/39b052c5ec6abd11ff933659d309a20f
[31]COVERSE, Submission 60, p. 4.
[32]Department of Health and Aged Care, Submission 59, p. 7.
[33]https://www.health.gov.au/our-work/covid-19-vaccine-claims-scheme#:~:text=Claims%20for%20compensation%20under%20the,lodged%20until%2030%20September%202024.
[34]Department of Health and Aged Care, Submission 59 - Supplementary Submission, p. 13.
[35]Department of Health and Aged Care, Submission 59 – Supplementary Submission, p. 6.
[36]Department of Health and Aged Care, Submission 59, p. 9.
[37]Mr Stephen Kolano, Submission 5.
[38]NEJM, December 3, 2020, No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines | NEJM
[39]FOI 4049 – 4062 Review of COVID-19 Vaccine and Treatment Purchasing and Procurement (health.gov.au) (page 6)
[40]COVERSE, Submission 60, p. 3.
[41]Department of Health and Aged Care, Submission 59.1 - Supplementary Submission, p. 6.
[42]https://www.theguardian.com/global-development/2021/sep/10/pfizer-accused-of-holding-brazil-to-ransom-over-vaccine-contract-demands
[43]https://www.thebureauinvestigates.com/stories/2021-04-19/pfizer-backs-down-over-asset-seizing-clause-in-south-africa-vaccine-deal/
[44]https://www.aljazeera.com/news/2021/3/11/investigation-pfizer-bullied-latin-american-nations
[45]https://www.gavi.org/covax-facility
[46]Proposed amendments to the International Health Regulations (2005) submitted in accordance with decision WHA75(9) (2022) https://apps.who.int/gb/wgihr/pdf_files/wgihr2/A_WGIHR2_6-en.pdf
[47]Gorodensky, A., Kohler, J.C. State capture through indemnification demands? Effects on equity in the global distribution of COVID-19 vaccines.J of Pharm Policy and Pract15, 50 (2022). https://doi.org/10.1186/s40545-022-00442-y
[48]Professor Paul Kelly, 20 October 2023, End of COVID-19 emergency response | Australian Government Department of Health and Aged Care
[49]ATAGI, Monovalent announcement, 20th November 2023, ATAGI recommendations on use of the Moderna and Pfizer monovalent Omicron XBB.1.5 COVID-19 vaccines | Australian Government Department of Health and Aged Care
[50]Department of Health Annual Report 2021–22 | Australian Government Department of Health and Aged Care
[51]Australians for Science and Freedom, Submission 65, p. 4.
[52]Budget Paper No. 1 | Budget 2023–24
[53]https://www.covidvaxclassaction.com.au/
[54]Australians for Science and Freedom, Submission 65, p. 8.
[55]. FP Staff, ‘What the indemnity clause is and how its waiver will accelerate arrival of COVID-19 vaccines in India’, Firstpost, 20 July 2021.
[56]Raajnandini Mukherjee, ‘BJP minister attacks Congress for backing vaccines, Jairam Ramesh says ‘bullshit’’, India Today, 20 January 2023.
[57]Pandemic Transparency - Health Justice Initiative (HJI)
[58]COVERSE, Submission 60, p. 5.
[59]Department of Health and Aged Care, Submission 59.1 - Supplementary Submission.
[60]Department of Health and Aged Care, Submission 59.
[61]Australian Medical Professionals' Society, Submission 62, p, 6.
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