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No-fault compensation schemes for COVID-19 vaccine injury: a mixed bag for claimants and citizens
Abstract
The development of vaccines against SARS-CoV-2 (COVID-19) presented a unique set of challenges. There was a global need for safe, effective vaccines against a new virus. In response to the development of vaccines for COVID-19 (some of which used novel technologies), there was a proliferation of no-fault compensation schemes (NFCS) for COVID-19 vaccine injuries. We identified 28 national vaccine injury NFCS operating in December 2019. Just 2 years later, over 130 countries had some NFCS coverage for COVID-19 vaccines. This rapid expansion was primarily driven by the creation of three multinational schemes. The COVID-19 Vaccines Global Access (COVAX) scheme covers vaccines given under the COVAX framework in 92 low and middle-income countries across the globe. The African Vaccines Acquisition Trust (AVAT) scheme covers vaccines administered under the AVAT framework in 36 African and Caribbean countries. The UNICEF scheme covers vaccines administered by UNICEF in 18 Asian countries.
Because of the sudden expansion of no-fault compensation for vaccine injury, especially in developing economies, more research on the foundations, procedures and outcomes of NFCS is needed. In this article, we examine how these NFCS meet the needs of individual claimants and society more widely. To do so, we first review the rationales offered to support the creation of vaccine injury NFCS. We then argue that, in order to achieve their function as compensation mechanisms, NFCS should be accessible and offer substantive and procedural justice to claimants. Finally, we focus on transparency and accountability as necessary requirements to allow scrutiny over existing NFCS and their wider impacts.
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As of Aug. 2, 2021, 1693 injury claims associated with COVID-19 medical countermeasures have been filed in the Countermeasures Injury Compensation Program (CICP), of which 686 claims were related to COVID-19 vaccines and urgently needed compensation decisions. However, from an economic and public policy perspective, we find that the CICP design has unintended consequences: locating CICP in the executive agency DHHS potentially creates a conflict of interest, and not permitting judicial review generates a lack of checks and balances, both of which could jeopardize justice. These fundamental problems would subsequently weaken four key performance indicators of CICP compared with its judicial counterpart in the Court of Federal Claims. CICP lacks accountability, transparency, and cost-effectiveness efficiency, with 94% of its total costs spent on administration rather than compensation. CICP's ability to compensate is also questionable. If COVID-19 claims were compensated at its historical rate, CICP would face around 317.94 million in total outlays, 72.1 times its current balance. To ensure just compensation for injured petitioners during COVID-19 and future public health emergencies, we recommend Congress (1) initiate a major reform by relocating CICP from DHHS to the Claims Court or (2) keep CICP within DHHS and make incremental changes by permitting judicial review of DHHS administrative adjudication of CICP claims. We further recommend Congress audit and adjust budgets for CICP and DHHS promptly propose an injury table for COVID-19 claims. This is the first study that contributes an economic perspective to the limited literature on CICP and also provides unique and rich economic data.
To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.
The so-called vaccine court is a small special court in the United States Court of Federal Claims that handles controversial claims that a vaccine has harmed someone. While vaccines in general are extremely safe and effective, some people still suffer severe vaccine reactions and bring their claims to vaccine court. In this court, lawyers, activists, judges, doctors, and scientists come together, sometimes arguing bitterly, trying to figure out whether a vaccine really caused a person’s medical problem.
In Vaccine Court, Anna Kirkland draws on the trials of the vaccine court to explore how legal institutions resolve complex scientific questions. What are vaccine injuries, and how do we come to recognize them? What does it mean to transform these questions into a legal problem and funnel them through a special national vaccine court, as we do in the U.S.? What does justice require for vaccine injury claims, and how can we deliver it? These are highly contested questions, and the terms in which they have been debated over the last forty years are highly revealing of deeper fissures in our society over motherhood, community, health, harm, and trust in authority. While many scholars argue that it’s foolish to let judges and lawyers decide medical claims about vaccines, Kirkland argues that our political and legal response to vaccine injury claims shows how well legal institutions can handle specialized scientific matters. Vaccine Court is an accessible and thorough account of what the vaccine court is, why we have it, and what it does.
The last twenty years has seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically-tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence for injuries that might have been the result of vaccinations under the National Childhood Vaccine Injury Act compensation program. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of certainty on causation that would be required under the program in the initial legislation, assuming that better science would be developed on vaccine causation. The Department of Health & Human Services, intimately involved in the program, takes the position that causal proof must be backed by “hard science” under the program. The Federal Circuit, the federal court charged with overseeing the program, has gradually been relaxing the sufficiency standard for causal proof. This article argues that the Federal Circuit, while implementing a program with different policy goals and not constrained by toxic tort law, has gone too far under the Act as written, but that the logic of their decisions should cause Congress to amend the Act. Resolving the appropriate level of proof of causation is critically important. Requiring too high a standard would leave worthy victims uncompensated and potentially threaten vaccine supplies as manufacturers, concerned about liability exposure, withdraw from the market. But too low a standard could open the floodgates to unworthy claims and suggest to the public that vaccines present risks that outweigh their benefits, damaging their integrity.
Programmes that provide no-fault compensation for an adverse event following vaccination have been implemented in 19 countries worldwide, the first in Germany in 1961 and the most recent in Hungary in 2005. We performed a review of these programmes and determined elements that were common to all of them: administration and funding, eligibility, process and decision-making, standard of proof, elements of compensation and litigation rights. Most programmes were administered by state or national governments except in Finland and Sweden where they are coordinated by pharmaceutical manufacturers. Although funding is usually from Treasury, Taiwan (China) and the United States of America impose a tax on vaccine doses distributed. Decisions on compensation are made using established criteria or assessed on a case-by-case basis, while the standard of proof required is usually less than that required for court cases. Benefits provided by programmes include medical costs, disability pensions and benefits for noneconomic loss and death. Most countries allow claimants to seek legal damages through the courts or a compensation scheme payout but not both. We conclude that a variety of programmes, based on ethical principles, have been successful and financially viable in developed countries throughout the world. We believe there is a strong argument for widespread implementation of these programmes in other developed countries.
I contend that virtue ethics provides the best ethical justification for vaccination programmes, and associated payment schemes for vaccine damaged individuals (which have been adopted in twenty-four countries and one province). Virtue ethics justifies vaccination programmes, as they contribute to the common good, and associated payment schemes, as they demonstrate compassion, justice and prudence in response to virtuous vaccination decisions by citizens. I also argue that the virtues of maturity and prudence justify voluntary vaccinations. I utilise several virtues to analyse, and suggest reforms to, the United Kingdom’s (UK) Vaccine Damage Payment Scheme (VDPS). I also compare the UK VDPS with the schemes that have been adopted in other states, in particular the Vaccine Injury Compensation Programme (VICP) which has been adopted within the United States (US).
A expressão ente descentralizado não e unívoca. Mesmo tendo em mira apenas o fenômeno jurídico da descentralização administrativa — portanto, excluída a descentralização política operada nos Estados federais — pode-se toma-la em mais de um sentido. As próprias sistematizações dos vários direitos positivos influirão no conceito de ente descentralizado.
From science advocate and March on Science National Co-Chair Jonathan M. Berman, an essential takedown of the anti-vaccination movement, from its nineteenth-century antecedents to today's Facebook activists, offering strategies for refuting false claims of friends and family.
Vaccines are a documented success story, one of the most successful public health interventions in history. Yet there is a vocal anti-vaccination movement, featuring celebrity activists (including Kennedy scion Robert F. Kennedy Jr. and actress Jenny McCarthy) and the propagation of anti-vax claims through books, documentaries, and social media. In Anti-Vaxxers, Jonathan Berman explores the phenomenon of the anti-vaccination movement, recounting its history from its nineteenth-century antecedents to today's activism, examining its claims, and suggesting a strategy for countering them.
Despite its being deliberated since at least the 1980s, a national vaccine injury compensation program still does not exist in Canada. The omission of such a program stands as a gap in Canadian immunization policy in comparison to many other equivalently developed countries. This article outlines the arguments for a compensation program and the design elements that would be best suited to a program in the Canadian context.
Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near-total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine-injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of principles. This article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less-severe injuries whenever the vaccination was required by law or professional duty.
Comparing no-fault compensation systems for vaccine injury
- Fairgrieve
At 40-41 Mello discusses two additional NFCS rationales, reasonableness and failure of informed consent. These arguably encounter the same difficulties as other non-consequentialist rationales when
- M M Mello
Access to Justice: Interim Report to the Lord Chancellor on the Civil Justice System in England and Wales
- S H Woolf