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No-Fault Compensation Schemes for COVID-19 Vaccines: Best Practice Hallmarks

Authors:
No-Fault Compensation Schemes for
COVID-19 Vaccines: Best Practice
Hallmarks
Duncan Fairgrieve
1
,
2
, Marco Rizzi
3
*, Claas Kirchhelle
4
, Sam Halabi
5
, Geraint Howells
6
and
Normann Witzleb
7
1
British Institute of International and Comparative Law, London, United Kingdom,
2
Centre de Recherche Droit Dauphine,
Université Paris Dauphine, Paris, France,
3
UWA Law School, The University of Western Australia, Perth, WA, Australia,
4
School of
History, University College Dublin, Dublin, Ireland,
5
ONeill Institute for National and Global Health Law, School of Law,
Georgetown University, Washington, DC, United States,
6
School of Law, University of Galway, Galway, Ireland,
7
Faculty of Law,
The Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China
Keywords: vaccine, compensation claims, best practice, COVID-19, injury
The global race for and roll-out of safe and effective COVID-19 vaccines to billions of people is one of
the main ways in which the pandemic will be remembered. However, this overwhelmingly positive
story of international collaboration and successful vaccine design also contains darker chapters of
stark global inequality, vaccine hesitancy, and the way in which (the comparatively few) victims of
adverse effects were often failed by governments and existing compensation schemes.
It is now widely accepted that equity and fairness dictate that a swift and effective legal and
nancial remedy should be available for victims of vaccine injury (1). Vaccination provides both a
direct benet to the person receiving it in terms of personal immunization and an indirect benetto
the broader community as a contribution to wider immunity. Those who suffer serious adverse
effects pay a high price for benets that accrue not only to themselves but to the rest of the
population, especially if they are at low risk of severe disease or long-term effects resulting from a
specic pathogen.
Prior to the pandemic, the unfortunate reality was that gaining a remedy for vaccine injury, if
available at all, was often a Kafkaesque process with a slow and complex route to compensation.
Newly published research by an international group of legal and historical scholars shows that ofcial
vaccine injury compensation schemes existed in only 25 countries in 2020 (2). Although concerns
about rare forms of vaccine adverse effects have led to the near-doubling of international schemes to
43 in 2021, schemesperformance has been highly uneven. While programs in Nordic countries
provide rapid and transparent access to compensation, other schemes erect high hurdles or offer only
inadequate redress.
A concerning example is the UKs Vaccine Damage Payment Scheme (VDPS). Created in 1979,
the scheme provides a one-off payment for those who suffer serious disablement because of
vaccination. Originally designed as a temporary measure, the VDPS remains on the statute
books despite cross-party calls for reform. Criticism has long centred on the fact that the
schemes payment of £120,000 is far too little for cases of serious injury and is well below
comparable damages payments awarded by the courts for such injuries (3). The substantial yet
arbitrary hurdle of showing 60% disablement also means that very few payments have actually been
made in recent times. The stalling of VDPS payments contrasts sharply with the entirely predictable
rise in the number of suspected cases of serious adverse effects reported by patients and medical
professionals to the Medicines and Healthcare products Regulatory Agency since the mass-rollout of
COVID-19 vaccines (4). Although payments may eventually be made, lack of access to timely and
adequate compensation for victims and their families risks leading to legal proceedings, which can
damage vaccines reputationally and provide an unwelcome platform for vaccine sceptics.
Edited by:
Sarah Mantwill,
University of Lucerne, Switzerland
*Correspondence:
Marco Rizzi
marco.rizzi@uwa.edu.au
This Editorial is part of the IJPH Special
Issue COVID-19: Guidance From
Research for Policy and Practice
Received: 09 March 2023
Accepted: 24 April 2023
Published: 03 May 2023
Citation:
Fairgrieve D, Rizzi M, Kirchhelle C,
Halabi S, Howells G and Witzleb N
(2023) No-Fault Compensation
Schemes for COVID-19 Vaccines:
Best Practice Hallmarks.
Public Health Rev 44:1605973.
doi: 10.3389/phrs.2023.1605973
Public Health Reviews | Owned by SSPH+ | Published by Frontiers May 2023 | Volume 44 | Article 16059731
Public Health Reviews
EDITORIAL
published: 03 May 2023
doi: 10.3389/phrs.2023.1605973
The UKs mixed track record with regards to vaccine
compensation is far from unique. Many of the worlds poorer
countries are unable to compensate victims of adverse effects. The
pioneering COVAX No-Fault Compensation Program, which
covers 92 low and middle income countries and economies, is
attempting to redress this (5). However, the problem is
widespread as even high-income countries often provide
inadequate support and publish insufcient data to evaluate
schemesperformance. A particular problem remains the
opacity of the procedures and the difculties claimants
encounter with access and information.
The global communitys mixed track record in providing for
citizens who have behaved altruistically is concerning and contrasts
markedly with the extensive legal indemnities and insurance cover
provided for vaccine producers. COVID-19 is not over and will not
be the last pandemic the world will witness this century. Amidst
recent reports of sharp declines of routine vaccine rates, there is an
urgent need not only to protect and boost public condence in
COVID-19 vaccines, but also in the many other vaccine regimes we
rely on to control diseases. Learning from the past 3 years to create a
common best practice framework for vaccine compensation is one
way of doing so.
The recent international review of existing vaccine
compensation schemes identied four hallmarks signifying
best practice across all analysed countries (1): accessibility:
compensation funds should be accessible, with low legal and
nancial barriers, good sign-posting, and facilitate the evaluation
of harm (2); transparency: decision-making processes and
compensation frameworks should be transparent with clear
funding responsibilities (3); timeliness: each scheme should
include clear and short time-frames for compensation
decision-making (4). Finally, adequacy of compensation: the
potential signicance of vaccine injuries, no matter how rare,
should be reected in compensation that is materially
proportionate to the harm suffered.
Legislators around the world would do well to check if their
own scheme hits these best practice hallmarks.
AUTHOR CONTRIBUTIONS
DF was lead author and contributed to the concept, draft and
revisions ahead of submission; CK and MR contributed to the
concept, draft and revisions ahead of submission; SH, GH, and
NW contributed to revisions ahead of submission.
CONFLICT OF INTEREST
The authors declare that they do not have any conicts of interest.
REFERENCES
1. Halabi S, Omer S. A Global Vaccine Injury Compensation System. JAmMed
Assoc (2017) 317:4712. doi:10.1001/jama.2016.19492
2. Fairgrieve D, Borghetti JS, Dahan S, Goldberg R, Halabi S, Holm S, et al.
Comparing No-Fault Compensation Systems for Vaccine Injury. Tulane J Int
Comp L (2023) 35 (1):75118.
3. Judicial College. Guidelines for the Assessment of General Damages in Personal Injury
Cases.16thed.Oxford,UnitedKingdom:OxfordUniversityPress(2022).
4. UK Government. Coronavirus Vaccine - Summary of Yellow Card Reporting
(2023). Retrieved from: https://www.gov.uk/government/publications/
coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-
summary-of-yellow-card-reporting (Accessed on February 16, 2023).
5. COVAX. COVAX No-Fa ult Compensation Program for AMC Eligible Economies
(2023). Retrieved from: covaxclaims.com (Accessed on April 28, 2023).
Copyright © 2023 Fairgrieve, Rizzi, Kirchhelle, Halabi, Howells and Witzleb. T his is
an open-access article distributed under the terms of the Creative Commons
Attribution License (CC BY). The use, distribution or reproduction in other
forums is permitted, provided the original author(s) and the
copyright owner(s) are credited and that the original publication in this
journal is cited, in accordance with accepted academic practice. No use,
distribution or reproduction is permitted which does not comply with these
terms.
PHR is edited by the Swiss School of Public Health (SSPH+) in a partnership with
the Association of Schools of Public Health of the European Region (ASPHER)+
Public Health Reviews | Owned by SSPH+ | Published by Frontiers May 2023 | Volume 44 | Article 16059732
Fairgrieve et al. No-Fault Compensation for COVID-19 Vaccines
... Additionally, establishing causation is useful for legal settings, including compensation for injured recipients as well as prosecution of any wrongdoing. The extent of liability is important, as those seeking treatment often have few options, and little resources, owing to the often debilitating nature of their illness, and its lack of acknowledgement and subsequent compensation by health systems [24]. Vaccine injury compensation schemes are uncommon [25,26]. ...
... The experience of the vaccine injured has largely been one of gaslighting and being ignored, and only now are their concerns being heard [24]. Still, treatment is limited, and limited resources exit for injury compensation [27]. ...
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Full-text available
Delineating the epidemic of vaccine injury from the coterminous condition long covid is a challenging prospect, but one with many implications not just for treatment, but also has important legal considerations for settlements of vaccine injury. The shared etiological factor of the spike protein in both vaccine injury and long covid make differentiation difficult, and while treatment is largely similar between vaccine injury and long covid, there are important distinctions. Furthermore, diagnostics are important for monitoring treatment progress and assessing the extent of subclinical vaccine injury in population having received a covid-19 vaccine. The development of rigorous diagnostics is an important step towards the recognition of both long covid and vaccine injury, as those suffering these conditions have faced immense challenges in having their conditions recognized, treated, and compensated by insurance companies or national health services.
Article
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.
Article
Vaccines are extremely safe and harm is rare. Worldwide, more than 30 000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually.¹ The occurrence of serious adverse events, such as those that result in death, threaten life, require inpatient hospitalization, or result in significant disability, are rare (eg, <1 adverse event occurs per 10 million doses for tetanus toxoid vaccines, 1-2 adverse events per 1 million doses for inactivated influenza vaccine, and none for hepatitis A).
Comparing No-Fault Compensation Systems for Vaccine Injury
  • Fairgrieve
Comparing No-Fault Compensation Systems for Vaccine Injury
  • D Fairgrieve
  • JS Borghetti
  • S Dahan
  • R Goldberg
  • S Halabi
  • S Holm
Fairgrieve D, Borghetti JS, Dahan S, Goldberg R, Halabi S, Holm S, et al. Comparing No-Fault Compensation Systems for Vaccine Injury. Tulane J Int Comp L (2023) 35 (1):75-118.
Guidelines for the Assessment of General Damages in Personal Injury Cases
  • Judicial College
Judicial College. Guidelines for the Assessment of General Damages in Personal Injury Cases. 16th ed. Oxford, United Kingdom: Oxford University Press (2022).
Coronavirus Vaccine -Summary of Yellow Card Reporting
  • Uk Government
UK Government. Coronavirus Vaccine -Summary of Yellow Card Reporting (2023). Retrieved from: https://www.gov.uk/government/publications/ coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccinesummary-of-yellow-card-reporting (Accessed on February 16, 2023).