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Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries

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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.
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RESEARCH ARTICLE
Global landscape analysis of no-fault
compensation programmes for vaccine
injuries: A review and survey of implementing
countries
Randy G. MungwiraID
1¤
*, Christine Guillard
2
, Adiela Saldaña
3
, Nobuhiko Okabe
4
,
Helen Petousis-Harris
5
, Edinam Agbenu
6
, Lance Rodewald
7
, Patrick L. F. Zuber
2
1Department of Molecular Medicine and Development, University of Siena, Siena, Italy, 2Access to
Medicines and Health Products Division, World Health Organization, Geneva, Switzerland, 3Instituto de
Salud Pu
´blica de Chile, Santiago, Chile, 4Kawasaki City Institute for Public Health, Kawasaki-City, Japan,
5University of Auckland, Auckland, New Zealand, 6World Health Organization, Ouagadougou, Burkina
Faso, 7Chinese Center for Disease Control and Prevention, Beijing, China
¤Current address: World Health Organization Malawi Country Office, Lilongwe, Malawi
*rgmungwira@gmail.com
Abstract
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 compen-
sation 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 pro-
grammes. All no-fault compensation programmes reviewed require standard of proof show-
ing 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 com-
pensation 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 compensa-
tion scheme but not both simultaneously. Data from this report provide an empirical basis on
which global guidance for implementing such schemes could be developed.
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PLOS ONE | https://doi.org/10.1371/journal.pone.0233334 May 21, 2020 1 / 15
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OPEN ACCESS
Citation: Mungwira RG, Guillard C, Saldaña A,
Okabe N, Petousis-Harris H, Agbenu E, et al.
(2020) Global landscape analysis of no-fault
compensation programmes for vaccine injuries: A
review and survey of implementing countries.
PLoS ONE 15(5): e0233334. https://doi.org/
10.1371/journal.pone.0233334
Editor: Holly Seale, University of New South Wales,
AUSTRALIA
Received: July 17, 2019
Accepted: April 6, 2020
Published: May 21, 2020
Peer Review History: PLOS recognizes the
benefits of transparency in the peer review
process; therefore, we enable the publication of
all of the content of peer review and author
responses alongside final, published articles. The
editorial history of this article is available here:
https://doi.org/10.1371/journal.pone.0233334
Copyright: ©2020 Mungwira et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which
permits unrestricted use, distribution, and
reproduction in any medium, provided the original
author and source are credited.
Data Availability Statement: All relevant data are
within the manuscript and its Supporting
Information files.
Introduction
No-fault vaccine injury compensation programmes are established to compensate individuals
who experience a rare vaccine-related injury due to the inherent risk of vaccination (e.g. intus-
susception in an infant following vaccination with a well manufactured and administered rota-
virus vaccine, or a life-threatening anaphylactic reaction following any vaccine) [13]. These
programmes do not require the injured party or their legal representative to prove negligence
or fault by the vaccine provider, health care system or the manufacturer prior to compensa-
tion. They serve to waive the need for accessing compensation through litigation processes,
which are often viewed as an adversarial approach requiring establishment of fault by at least
one party prior to compensation [2]. The term ¨no-fault¨ implies a measure put in place by
public health authorities, private insurance companies, manufacturers and other stakeholders
to compensate individuals inadvertently harmed by vaccines [4]. In 1961, Germany was the
first country to implement a no-fault compensation programme that covered vaccine injuries
[2]. This stemmed from the 1953 supreme court ruling to compensate people injured with
compulsory smallpox vaccination [2]. The drive to implement no-fault compensation pro-
grammes in most jurisdictions increased with reports of adverse events following immunisa-
tion with diphtheria-tetanus-whole cell pertussis in the 1970s [2].
However, with continued improvements in reporting and investigation of vaccine safety
events, including in low- and middle-income settings, WHO Member States are identifying
and documenting events that have scientific evidence of causal association to vaccination [5].
This is accompanied by increasing interest for national no-fault compensation policies related
to vaccine injuries [69]. As of 2010, compensation schemes for vaccine-related injuries had
been identified and characterized in nineteen out of WHO’s 194 Member States [2]. At the
time, these programmes were exclusively implemented in high-income countries. Previous
reviews have described the characteristics of existing programmes based on the six common
elements identified by Evans in 1999 including administration and funding, eligibility, process
and decision making, a standard of proof, elements of compensation, and litigation rights [1,
2]. We conducted a global survey of the status of vaccine injury no-fault compensation pro-
grammes (complemented by triangulation of information from multiples sources) with the
aim to update the inventory of such programmes and evaluate and update their characteristics
to forecast the next segment of adopters and guide policy formulation.
Materials and methods
Initially, a landscape analysis and scoping review of published and unpublished literature were
conducted to update the inventory of countries that have implemented vaccine injury no-fault
compensation programmes (scoping review protocol not registered). Published data was sup-
plemented with official documents accessed from government websites (where available).
Structured literature search was done using PubMed, Excerpta Medica dataBASE (EMBASE),
Cumulative index to Nursing and Allied Health Literature (CINAHL) and Global Online
Access to Legal Information (GOALI) using the following predefined keywords: vaccine injury
AND compensation programs; AEFI AND compensation; vaccine AND injury AND no-fault
compensation; vaccine damage payment; and vaccine liability claims (S1 File). Using a lower
cutoff period of 31 Dec 2009 to supplement on previous reviews, 41 articles published in
English with relevant information were reviewed (Fig 1). This descriptive analysis of the char-
acteristics of WHO member states with no-fault compensation programmes implemented is
published elsewhere [10].
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Funding: The author(s) received no specific
funding for this work.
Competing interests: The authors have declared
that no competing interests exist.
Fig 1. PRISMA flow diagram indicating structured literature search to address a descriptive analysis of current policies and practices of no-fault compensation
programmes for vaccine injuries.
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In addition, all WHO Member States were approached, and screening was done using sev-
eral methods to identify those with a no-fault compensation programme for vaccine injuries.
We approached several professional networks including immunization programme focal
points in WHO Regional or Country Offices and local Ministry of Health in Member States.
Screening for programmes was also conducted amongst current and past members of the
Global Advisory Committee on Vaccine Safety (GACVS) [11], and conference attendants
(Global Immunization Meeting [12], Vaccine Safety Net meeting and International Confer-
ence of Drug Regulatory Authorities [13]). During the same period, the WHO Immunization,
Vaccines and Biologicals Department repository and a global survey of national immunization
technical advisory groups collected information on the presence of systematic compensation
programmes for vaccine injuries. This data was used to triangulate the presence or absence of
programmes for compensating vaccine injuries. For each country with a no-fault compensa-
tion programme for vaccine injuries identified through our approach, an expert with in-depth
knowledge of the no-fault scheme was identified through colleagues in WHO country offices
or National Immunization Programme Focal Points within the Member States, and invited to
complete a structured online survey (S4 File). The questionnaire was created using a data col-
lection tool which is based on LimeSurvey (Version 2.06+ Build 151215) to collect data on the
structure, perceived benefits and operational challenges of existing programmes. The survey
was designed by the Global Vaccine Safety team at the WHO Headquarters in Geneva, Swit-
zerland. It was piloted and further refined before being administered. An independent scien-
tific committee consisting of selected members of the GACVS, and additional immunization
experts validated the survey and oversaw the conduct of the study to ensure scientific rigor. An
email was sent out to participants (S2 File) inviting them to complete the online survey and
responses were received from 03 July to 31 September 2018. To ensure data accuracy, survey
respondents were encouraged to submit supporting documents. The survey tool was also
made available in French, an official WHO language (S5 File).
A scientific review of the protocol was conducted in collaboration with the academic and
scientific committee from the University of Siena, Master of Vaccinology and Pharmaceutical
Clinical Development programme. The study was granted exemption from full ethical review
by the WHO Ethics Committee since the study involved human subjects participating in their
professional capacity (as staff or affiliates of WHO regional or country offices or Ministry of
Health) and sharing information available in the public domain. Informed consent was sought
from all participants prior to collecting any study-related data.
Results
All 194 WHO member states were screened for the presence of no-fault compensation pro-
grams for vaccine injuries. We received feedback from 151 countries who responded to an ini-
tial screening step to determine the presence of a no-fault compensation programme. From
these responses, we identified 25 member-states implementing no-fault compensation pro-
grammes (Fig 2) that met the predefined definition [10]. Through the survey and other data
sources (i.e. government documents where available) we evaluated 23 existing programmes
(including two from Japan) based on the six common elements reported in previous reviews
[1,2]. Regional distribution and characteristics of implementing countries are described sepa-
rately [10].
The number of countries implementing no-fault compensation programmes for vaccine
injuries has increased steadily from 19 in 2010 to 25 in 2018. As compared to previous decades
there is, however, no acceleration in the number of countries. In recent years and for the first
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time, a low and a lower-middle-income country, Nepal and Viet Nam respectively, have insti-
tuted such programmes [14,15]. Table 1.
Administration and funding
Administration. Fifteen (65%) of the no-fault compensation programmes for vaccine
injuries are administered at the central government level. Germany, Italy, Republic of China
Fig 2. Member States screened for existence of vaccine injuries no-fault compensation programmes and number of programmes evaluated. 19 countries
responded to survey; Japan provided information for two programmes Latvia, Nepal and Viet Nam.
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Table 1. No-fault compensation programme for vaccine injuries distributed by countries and continents.
Continent Number of
countries
Countries
Africa 0 None
America 2 United States, Canada
Asia 6 China, Japan, South Korea, Viet Nam, Nepal, Thailand
Europe 16 Austria, Denmark, Finland, France, Germany, Hungary, Iceland, Italy,
Luxembourg, Norway, Russia, Latvia, Slovenia, Sweden, Switzerland and United
Kingdom
Oceania 1 New Zealand
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and the Province of Quebec in Canada are the only jurisdictions implementing the compensa-
tion programme at the province level (17%). Finland and Sweden are the only countries where
programmes are administered by the insurance sector [16].
Since its establishment in 1970, the programme in Switzerland was administered at the can-
tonal level (each of 26 states that compose the confederation). In 2016, the Swiss compensation
policy was amended, and the administration of the programme is done by the central govern-
ment. In Italy, the programme was decentralized in 2001 to be administered at province level
in regions with the ordinary statute but remained run by the central government in regions
with special statute. In 2014, the programme in the People’s Republic of China was amended
requiring all 31 provinces to implement compensation mechanisms for vaccine injuries [4].
Administration of the Chinese programme involves all levels of government: filing of claims
and causality assessment of events is done at district or county level; operational procedures
for compensation are set at province level and general vaccine injury compensation policies
including definitions of what constitutes a vaccine injury are determined at the central govern-
ment level. The programme in Japan is also implemented at all levels of government.
Funding. Fifteen (65%) of the programmes are government funded including those being
implemented in low- (Nepal) [14] and lower-middle-income settings (Viet Nam) [15]. The
programmes in Finland and Sweden are funded by the insurance sector financed by contribu-
tions from pharmaceutical companies marketing their products in these jurisdictions.
Although administered at the government level, the programme in Norway is also funded by a
special insurance organization, the Drug Liability Association. In Latvia, the Treatment Risk
Fund is funded through contributions from medical institutions [17], hence it also acts as pro-
fessional indemnity insurance. In China, Japan and the Republic of Korea, there are two differ-
ent programmes covering injuries arising from vaccines listed in the national immunization
programme (NIP) and non-NIP vaccines [4,18,19]. These programmes are funded differ-
ently, with government funding NIP vaccines, and pharmaceutical companies or market
authorization holders funding non-NIP vaccine injuries. The USA programme is funded by a
flat-rate tax of 0.75 USD on each disease prevented in each vaccine dose (e.g., 2.25 USD for
measles mumps rubella vaccines, and 0.75 USD for Haemophilus influenza type B vaccine) [2,
20]. New Zealand has an Accident Compensation Corporation (ACC) which compensates for
vaccine injuries under a general compensation for accidents and treatment injuries. The ACC
is funded from the contribution of general taxation, and levies collected from employee earn-
ings, businesses, vehicles licensing and fuel [21].
Eligibility
Vaccines. Thirteen programmes (57%) compensate for injuries arising from registered
and recommended vaccines for children, pregnant women or adults (e.g. influenza vaccines)
and for special indication (e.g. travel or occupation) within the jurisdiction. Five (22%) of the
programmes cover injuries arising from mandatory or vaccines pro-actively recommend by
law only including in France, Hungary, Italy, Slovenia and Japan (for injuries arising from NIP
listed vaccines category A which are administered to achieve basic herd immunity). The pro-
grammes in the United Kingdom and Province of Quebec in Canada [22] cover for injuries
arising from vaccines against specific diseases of infections as listed in their legislation.
Timelines of injury and vaccination. Timelines vary considerably from programme to
programme. In the United Kingdom, claims can only be filed when the child is two years old.
For adults, whichever is the latest of the following dates: either on or before their 21st birthday
(or if they have died, the date they would have reached 21 years old), or within 6 years of vacci-
nation. In the USA, the Province of Quebec, Denmark, Italy and Norway, the programmes
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compensate for injuries that occur within three years of vaccination or initial appearance of
symptoms of the vaccine injuries. In case of death, the USA programme compensates if it
occurs within two years of vaccination and not more than four years from the initial date of
symptoms of the vaccine injury that led to death. In Denmark and Norway, the maximum
interval between the occurrence of vaccine injury and filing a claim is 10 and 20 years respec-
tively. In Switzerland, claims can be submitted up to when one is 21 years old for childhood
vaccines or within five years of vaccination. Similarly, the programmes in Japan (for non-NIP
vaccines) and the Republic of Korea have a five years window for filing claims. Finland and
France have a 10 years window for filing a claim, in China, this varies by province. The pro-
grammes in Austria, German, Hungary, Japan (NIP vaccines), Luxembourg, Slovenia, Sweden,
and New Zealand do not have specified timelines between the occurrence of a vaccine injury
and filing a claim.
Injured party. Fifteen programmes (65%) compensate all individuals who experience an
eligible injury arising from a vaccine administered within their jurisdiction. In Denmark, Slo-
venia and China, only citizens are eligible for compensation. Whilst in the Province of Quebec
in Canada, Germany, Italy and Japan (programme for NIP listed vaccines), only province resi-
dents who experience a vaccine injury are eligible for compensation.
Types of injuries covered. All countries implementing no-fault compensation pro-
grammes have a threshold of eligibility for vaccine injury and these include: injuries resulting
in financial loss or permanent or significant injury (i.e. medical disability), serious health dam-
age or death, severe injuries exceeding normal post-vaccination reactions, severe disability sec-
ondary to vaccination against a specified disease in the legislation, serious adverse events
following immunization (AEFI) or disability as per predefined criteria. In the Republic of
Korea, compensation may be considered for any vaccine injury whose treatment cost beyond
USD 260 (300,000 Korean Won). Although the schemes studied are primarily designed to
compensate for inherent risks of vaccination (“no-fault”) Injuries arising from negligence (i.e.
vaccine quality defects or immunization errors) are also covered under the schemes of twelve
of the 23 programmes (52%) studied. In the remaining jurisdictions, injuries arising from neg-
ligence are handled separately either under a medical malpractice indemnity cover or through
civil litigation.
Process and decision making
Process. In all the compensation programmes, the process is initiated by the injured party
or their legal representative filing a claim with a special administrative unit handling vaccine
injury compensation. In New Zealand, this process is initiated by the healthcare worker
reviewing the injury, who then notifies the ACC. Eighteen of the programmes (78%) are purely
administrative in nature with a unit consisting of health officials or an insurance organization
that processes claims operating under a pre-set legislation. Five of the programmes (22%) in
Austria, Finland, Hungary, and the USA have an approach that either combines both adminis-
trative and civil litigation processes or are considered a judicial review in Denmark. The
national vaccine injury compensation programme in the USA involves a special court that
deliberates on claims and makes the final decision on compensation for injuries pre-listed, or
upon examination of an expert witness for non-listed injuries, an approach like civil litigation.
Decision making. In the purely administrative programmes, a group of medical experts
reviews individual cases of vaccine injuries filed for compensation and make the decision
based on available evidence. Once a decision to compensate or refuse compensation is made,
the recommendations of the expert group are forwarded to the programme for action. In juris-
dictions with both administrative and legal approaches, the final decision on compensation is
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made by legal experts (e.g. Austria, Denmark, Hungary, USA). In Finland and Sweden, com-
pensation decisions are based on civil (tort) liability laws. Decisions making process varies
amongst programmes ranging between 10 days to five years depending on the nature and
complexity of the claim.
Standard of proof
All programmes reviewed require standard of proof showing a causal link between vaccination
and injury. As described by Looker et al, most compensation programmes adopt the “balance
of probabilities” approach which assumes that it is “more likely than not” that the vaccine
caused the injury considering its nature, the consistency of time interval from vaccination, the
existing medical evidence establishing an association between the injury and the vaccine
including other supporting information available [2,23]. In sixteen of the programmes (69%),
the standard of proof is based on a causal association to vaccination based on standard causal-
ity assessment. In the rest of the programmes, the standard of proof is as determined by a
selected group of experts. The USA compensates injuries that are listed on the vaccine injury
table occurring within pre-defined timelines [24]. Claimants with injuries not listed on the
vaccine injury table are required to prove that vaccine caused the injury by presenting neces-
sary medical records or opinions which may include testimonies from expert witnesses. In
China, the standard of proof is based on epidemiological causation and the regulation excludes
from compensation injuries that are deemed coincidental to vaccination [4]. In Switzerland,
the causality assessment of vaccine injuries is subjected to methodological approval by a group
of experts. This group of experts is equivalent to a national immunization technical advisory
group (NITAG), a group of experts that provides scientific recommendations for evidence-
based immunization policy and programme decisions [22,25]. In the Canadian Province of
Quebec, the standard of proof is based on the existence or lack thereof of a probable causal
link between the injury and the vaccine as determined by three independent medical experts
appointed by the province, injured party and a third nominated by the initial two medical
experts.
Elements of compensation
In all programmes, once a final decision has been reached, claimants are compensated with
either (or a combination of): a lump-sum of money; monetary compensation calculated based
on medical care costs and expenses, loss of earnings or earning capacity; or monetary compen-
sation calculated based on non-monetary criteria e.g. pain and suffering, emotional distress,
permanent impairment or loss of function. Other benefits include disability pension, survival
pension, or death benefits. In the province of Quebec, the amount of compensation is deter-
mined based on rules and regulations as prescribed in the Automobile Insurance Act and is
identical to the compensation offered to victims of automobile accidents. In Viet Nam, com-
pensation for disability arising from a vaccine injury is equivalent to 30 months base salary or
calculated based on lost or reduced income with a standardized formula [15]. The programme
in Switzerland offers compensation equivalent up to USD 70,000 aimed at covering costs
related to vaccine injuries that are not covered by other third-party benefits [25].
In twelve of the programmes (52%), the amount of compensation is calculated on a case by
case basis and the final amount paid out depends on the extent of the injury. In ten of the pro-
grammes (44%), the compensation amount is standardized. Compensation amounts also vary
across existing compensation programmes, and across provinces in countries implementing
decentralized compensation programs e.g. China [5].
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Litigation rights
In fifteen (65%) jurisdictions, claimants are required to file a vaccine injury claim with the
compensation programme, but still maintain the right to pursue civil litigation against the vac-
cine manufacturer or health care professionals if they can prove there was a fault (i.e. vaccine
quality defect). In Canadian Province of Quebec, Denmark, Hungary, New Zealand, Slovenia
and Sweden, vaccine injury claims can only be filed with the compensation programme (26%).
In the USA, claimants forego their right to file for a civil claim once they have accepted
compensation from the national Vaccine Injury Compensation Programme (VICP) [2]. The
characteristics of the existing programmes are summarised in Table 2 below.
Benefits of vaccine injury compensation programmes
The benefits most referred to in existing no-fault compensation programmes were: fair com-
pensation for individuals inadvertently injured by a vaccine meant for public good and
increasing confidence in public vaccination programmes. Most respondents did not consider
sustenance of vaccine supply, protecting manufacturers from liability and stabilization of vac-
cine prices as benefits of their programmes (Fig 3). Compensation programmes were seen by
respondents to enhance the legal basis of mandatory vaccination systems (in member states
where such laws existed) and a sign of the government‘s commitment towards immunization
programmes.
Challenges of vaccine injury compensation programmes
The most notable operational challenge of the existing programmes noted by respondents was
lack of public awareness of programme existence, strict requirements for standard of proof
that vaccine caused injury, and long timelines for filing claims and receiving compensation
(Fig 4). Despite the lack of awareness ranking as a high challenge for most programmes, few
participants indicated programme accessibility as an operational challenge. Most participants
did not consider their programmes to be overwhelmed by the number of claims filed. One
jurisdiction cited challenges with having a non-standardized calculation of compensation
amount and inadequate programme funding.
Discussion
As countries expand vaccine use and strengthen their safety surveillance and investigative
capacity, occasional severe vaccine reactions are identified [5,26]. Subsequently, the question
of fair and equitable compensation of identified vaccine injuries is more frequently raised. Pre-
vious reviews have shown that compensation programmes were perceived as interventions to
offer equitable access to benefit for the injured party and lessen the financial burden for vac-
cine manufacturers [1,2]. For the injured party, usually, those with adequate resources would
afford to access litigation procedures creating inequity to accessing compensation [27,28]. For
vaccine manufacturers, an increase in litigation cases and substantial amounts paid out in
compensation led to most players exiting the market and a subsequent significant decline in
vaccine supply [29].
Proponents of this administrative approach argue it is less adversarial, more economical,
and reduces the need to allot blame whilst maximizing opportunity for those with genuine vac-
cine injuries to access fair compensation [2,30]. Therefore, according to such proponents,
since vaccinations are usually recommended and sometimes required and enforced by global
and local authorities to control infectious diseases [31], no-fault compensation programmes
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are warranted and should be considered a social responsibility of each government, and global
or national health authorities towards those injured by vaccines.
This evaluation has identified no-fault compensation programmes being implemented in
Nepal and Viet Nam, a low and lower-middle-income country respectively. The general prin-
ciples guiding the implementation of no-fault compensation programmes in these settings
remains the same as identified in programmes implemented in high-income countries [1,2].
The implementation of these programmes based on six common elements (administration
and funding, eligibility, process and decision making, standard of proof, elements of compen-
sation, and litigation rights) indicates the feasibility of developing policy guide for countries to
adopt. However, the diversity of actual programme implementation across Member States
supports the need for developing compensation policies adjusted to local requirements, eco-
nomic capacity and legal structures. A potential limitation of our study is that, as the focus was
Table 2. Characteristics of existing no-fault compensation programmes for vaccine injuries.
VICP element Programme attribute Number of countries (N = 23 programmes)
Admin Central Government only 15 (65%)
Provincial Government 3 (13%)
Insurance sector 2 (9%)
Combination of the above 3 (13%)
Funding source Government only 15 (65%)
Other sources�� 8 (35%)
Eligibility: vaccines Registered/recommended vaccines 13 (57%)
Mandatory vaccines 5 (22%)
Based on diseases listed in legislation 2 (9%)
Non-NIP vaccines��1 (4%)
No information 2 (9%)
Eligibility: injured party All injured by a vaccine administered within jurisdiction 15 (65%)
Country citizens only 3 (13%)
Province residents only 4 (17%)
No information 1 (4%)
Process and decision making Purely administrative process 18 (78%)
Combination of administrative and civil litigation processes 5 (22%)
Standard of proof Causal association to vaccination 16 (69%)
As determined by a group of experts 5 (22%)
No information 2 (9%)
Compensation Standardized compensation 10 (44%)
Case by case basis 12 (52%)
No information 1 (4%)
litigation rights Vaccine injury compensation scheme alone 6 (26%)
Both vaccine compensation schemes and tort law or civil claims are allowed
^
15 (65%)
No information 2 (9%)
22 jurisdictions evaluated with 2 programmes from Japan resulting in 23 programmes evaluated.
�� Other sources include: Pharmaceutical company contribution i.e. the USA, China for non-NIP vaccine injuries, Japan for non-NIP injuries; Insurance: Finland,
Norway, and Sweden have special insurance funds where all pharmaceutical companies in their jurisdiction contribute towards. France complements Gov. funding with
national health insurance, Latvia has treatment risk fund.
��China, Republic of Korea, Japan—separate system for non-NIP vaccines (detailed information available only for Japan).
^
Limited in some jurisdiction i.e. USA
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on programmes dedicated to vaccine injuries, other broader compensation mechanisms that
could include vaccines–such as that from New Zealand–could have been missed.
No-fault compensation programmes are considered by some to increase adequacy and fair-
ness of compensation as they provide clear legal guidance on how to access compensation for
vaccine injuries [28]. However, implementation of such a compensation system should be con-
sidered simultaneously with the implementation of a well-established, comprehensive national
social welfare system [4]. This has been thought to increase the efficiency of compensation
programmes.
Advocacy for the implementation of no-fault compensation programmes should be
approached cautiously to avoid distorting the public perception of vaccine safety and under-
mining confidence in immunization programmes. Sufficient country capacity for adverse
event investigation and causality assessment should also be considered before considering a
compensation programme. Most of the implementing countries surveyed in this article have
not assessed the positive impact of no-fault compensation programmes on their vaccination
programmes. However, there is no published data that suggests a negative impact of vaccine
injury compensation programmes on immunization programmes. Unlike previous publica-
tions that have placed emphasis on the protection of vaccine manufacturers from liability, sus-
taining vaccine supply and stabilizing vaccine prices as benefits of compensation programmes
[1,2,6], our findings suggest that these programmes are increasingly being considered for fair
compensation of injured party and maintain confidence in immunization programmes. This
perception has the potential to encourage countries to implement compensation programmes
Fig 3. Perceived benefits of no-fault compensation programmes for vaccine injuries.
https://doi.org/10.1371/journal.pone.0233334.g003
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Global landscape analysis of no-fault compensation programmes for vaccine injuries
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for the benefit of the population and not perceived as merely protecting the interests of vaccine
manufacturers.
From the identified operational challenges for compensation programmes, policy formula-
tion should include clear and appropriate communication strategies to ensure public aware-
ness of compensation procedures, while not raising undue concerns and confidence issues in
vaccination. Efficient systems should focus on developing policies that would allow pro-
grammes to process claims within an acceptable turnaround time, reduce bureaucratic chal-
lenges, have standardized procedures to ensure equity and fairness, and have dedicated
funding mechanism to ensure programme sustainability.
Despite not having data from all main survey respondents, our approach of triangulating
information from multiple sources allowed us to have a general picture of 88% of the existing
programmes. This study did ask national respondents to state how they implement their pro-
gramme in a structured way. This enriches our findings as it provides first-hand information
from reliable sources which may be missed by literature review and grey literature searches
alone. Data on policies and practices of no-fault compensation programmes from Iceland,
Russia, and Thailand was not available at the time of documenting the results. This resulted in
some incompleteness of the current evaluation. However, as each of the programmes is imple-
mented uniquely in the context of country economic capacity and legal systems, the available
Fig 4. Operational challenges of no-fault compensation programmes for vaccine injuries.
https://doi.org/10.1371/journal.pone.0233334.g004
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Global landscape analysis of no-fault compensation programmes for vaccine injuries
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information will be useful in guiding policy reviews and formulation for the next set of adopt-
ers. An important aspect to implementing VICP is understanding the main drivers for coun-
tries implementing compensation policies. Despite knowing motivations for implementing
countries to adopt VICP policies, drivers for new implementers especially in less resourced set-
tings remain undocumented. Our findings did not elaborate on this aspect and this remains an
important area to explore as motivation for implementing VICP are likely to be different in
varying socio-economic settings.
Conclusion
As countries expand their use of vaccine and strengthen their vaccine safety surveillance and
investigative capacity, occasional severe vaccine reactions are identified. Subsequently, the
question of fair and equitable compensation of identified vaccine injuries is more frequently
raised. Findings from this study demonstrate that interest in this issue is no longer limited to
high-income countries. They also demonstrate the diversity of approaches that have been
selected so far, thereby justifying the development of global guidance documents. The current
absence of evidence related to the impact of such programmes on vaccine confidence and clar-
ification on the purpose (justice, ethical requirement in case of mandatory vaccination,
reduced litigations among others) will have to be clarified in elaborating such guidance.
Disclaimer
The authors alone are responsible for the views expressed in this article and they do not neces-
sarily represent the views, decisions or policies of the World Health Organization or of the
other institutions with which they are affiliated.
Supporting information
S1 File. Search strategy_landscape-analysis.
(DOCX)
S2 File. Profile of survey respondents.
(DOCX)
S3 File. PRISMA-ScR checklist.
(DOCX)
S4 File. English questionnaire.
(PDF)
S5 File. French questionnaire.
(PDF)
Acknowledgments
We sincerely thank all the survey respondents of the study who took the time to provide us
with useful information on how no-fault compensation programmes are implemented in their
jurisdictions. Special thanks to the following colleagues who assisted in identifying experts to
take part in our study; Oleg Benes, Dr Kari Johansen, Dr Eugene Lam, Dr Houda Langar, and
Dr Shuyan Zuo. We sincerely acknowledge Professor Sue Ann Clemens, Dr Ralf Clemens, Dr
Bernadette Hendrickx and the management team of the Master in Vaccinology and Pharma-
ceutical Clinical Development at the University of Siena for the support provided during this
work.
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Global landscape analysis of no-fault compensation programmes for vaccine injuries
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Author Contributions
Conceptualization: Randy G. Mungwira, Christine Guillard, Patrick L. F. Zuber.
Data curation: Randy G. Mungwira.
Formal analysis: Randy G. Mungwira, Patrick L. F. Zuber.
Investigation: Randy G. Mungwira, Patrick L. F. Zuber.
Methodology: Randy G. Mungwira, Christine Guillard, Adiela Saldaña, Nobuhiko Okabe,
Helen Petousis-Harris, Edinam Agbenu, Lance Rodewald, Patrick L. F. Zuber.
Project administration: Randy G. Mungwira, Patrick L. F. Zuber.
Supervision: Christine Guillard, Adiela Saldaña, Nobuhiko Okabe, Helen Petousis-Harris,
Edinam Agbenu, Lance Rodewald, Patrick L. F. Zuber.
Validation: Randy G. Mungwira, Christine Guillard, Patrick L. F. Zuber.
Writing – original draft: Randy G. Mungwira, Christine Guillard, Patrick L. F. Zuber.
Writing – review & editing: Randy G. Mungwira, Christine Guillard, Adiela Saldaña, Nobu-
hiko Okabe, Helen Petousis-Harris, Edinam Agbenu, Lance Rodewald, Patrick L. F. Zuber.
References
1. Evans G. Vaccine injury compensation programs worldwide. Vaccine. 1999; 17 Suppl 3:S25–35.
2. Looker C, Kelly H. No-fault compensation following adverse events attributed to vaccination: a review of
international programmes. Bull World Health Organ. 2011; 89(5):371–8. https://doi.org/10.2471/BLT.
10.081901 PMID: 21556305
3. Cook KM, Evans G. The National Vaccine Injury Compensation Program. Pediatrics. 2011; 127 Suppl
1:S74–7.
4. Fei L, Peng Z. No-Fault Compensation for Adverse Events Following Immunization: A Review of Chi-
nese Law And Practice. Medical law review. 2017; 25(1):99–114. https://doi.org/10.1093/medlaw/
fwx001 PMID: 28177508
5. Lei J, Balakrishnan MR, Gidudu JF, Zuber PLF. Use of a new global indicator for vaccine safety surveil-
lance and trends in adverse events following immunization reporting 2000–2015. Vaccine. 2018; 36
(12):1577–82. https://doi.org/10.1016/j.vaccine.2018.02.012 PMID: 29454518
6. Halabi SF, Omer SB. A Global Vaccine Injury Compensation System. JAMA. 2017; 317(5):471–2.
https://doi.org/10.1001/jama.2016.19492 PMID: 28114657
7. Tuells J. [Reasons for an injury compensation programme for adverse vaccine-related events in Spain].
Med Clin (Barc). 2013; 140(12):554–7.
8. Keelan JE, Wilson K. Designing a No-fault Vaccine-injury Compensation Programme for Canada: Les-
sons Learned from an International Analysis of Programmes: Munk School of Global Affairs, University
of Toronto; 2011.
9. Isaacs D. Should Australia introduce a vaccine injury compensation scheme? J Paediatr Child Health.
2004; 40(5–6):247–9. https://doi.org/10.1111/j.1440-1754.2004.00357.x PMID: 15151575
10. Mungwira RG, Maure CG, Zuber PLF. Economic and immunisation safety surveillance characteristics
of countries implementing no-fault compensation programmes for vaccine injuries. Vaccine. 2019.
11. Organization WH. Global Advisory Committee on Vaccine Safety—members [updated July 2018; cited
2018 26 October 2018]. Available from: http://www.who.int/vaccine_safety/committee/members/en/.
12. Organization WH. The Global Immunization Meeting: Successfully Navigating Transitions. 2018.
13. 18th International Conference of Drug Regulatoru Authorities (ICDRA) 2018 [cited 2018 18 Oct 2018].
18th ICDRA Conference official website]. Available from: http://www.icdra2018.ie/.
14. Nepal WCO-. Vaccine injury compenstion in the immunization rules of Nepal. 2018.
15. Nam GoV. Special Decree on Vaccination. In: Health Mo, editor. Viet Nam2016. p. 9–12.
16. Finnish Patient Accident Law 1986 [Available from: http://www.finlex.fi/fi/laki/ajantasa/1986/19860585.
17. Latvia NHS. Treatment Risk Fund [updated 22 January 2018. Available from: http://www.vmnvd.gov.lv/
en/cross-border-healthcare-contact-point/treatment-risk-fund.
PLOS ONE
Global landscape analysis of no-fault compensation programmes for vaccine injuries
PLOS ONE | https://doi.org/10.1371/journal.pone.0233334 May 21, 2020 14 / 15
18. Ihara T. [The National Vaccine Injury Compensation Program in Japan]. Nihon Rinsho. 2011; 69
(9):1645–50. PMID: 21922768
19. Kim MK, Lee YK, Kim TE, Kong I, Yang HJ, Suh ES. Surveillance and compensation claims for adverse
events following immunization from 2011 to 2016 in the Republic of Korea. Clin Exp Vaccine Res. 2017;
6(2):146–55. https://doi.org/10.7774/cevr.2017.6.2.146 PMID: 28775979
20. Health UDo, Services H. National vaccine injury compensation program. Statistics Reports found at:
http://www.hrsa gov/vaccinecompensation/statistics_report.htm, and http://www.hrsa gov/
vaccinecompensation/statistics_report.htm#.claims_filed. 2016.
21. Farrell A-M, Devaney S, Dar A. No-fault compensation schemes for medical injury: a review. 2010.
22. Quebec Vaccine Injury Compensation Programme 1985 [updated May 2018. Available from: https://
www.quebec.ca/en/health/advice-and-prevention/vaccination/vaccine-injury-compensation-program/.
23. Kelly HA, Looker C, Isaacs D. A no-fault compensation scheme for serious adverse events attributed to
vaccination. Med J Aust. 2011; 195(1):4–5. PMID: 21728930
24. Health Resources and Services Administration H, H. H. S. National Vaccine Injury Compensation Pro-
gram: Revisions to the Vaccine Injury Table. Final rule. Fed Regist. 2017; 82(12):6294–305. PMID:
28106358
25. OFSP Ofdlsp. Indemnite
´et re
´paration morale pour dommages conse
´cutifs àune vaccination [updated
28 Jun 2018. Available from: https://www.bag.admin.ch/dommages-vaccination.
26. Maure CG, Dodoo AN, Bonhoeffer J, Zuber PL. The Global Vaccine Safety Initiative: enhancing vaccine
pharmacovigilance capacity at country level. Bulletin of the World Health Organization. 2014; 92:695–6.
https://doi.org/10.2471/BLT.14.138875 PMID: 25378762
27. Mello MM. Rationalizing vaccine injury compensation. Bioethics. 2008; 22(1):32–42. https://doi.org/10.
1111/j.1467-8519.2007.00590.x PMID: 18154587
28. Barringer PJ, Studdert DM, Kachalia AB, Mello MM. Administrative compensation of medical injuries: a
hardy perennial blooms again. J Health Polit Policy Law. 2008; 33(4):725–60. https://doi.org/10.1215/
03616878-2008-014 PMID: 18617673
29. Franklin D. Litigation a threat to vaccine supply? Sci News. 1984; 126(11):167. PMID: 11653600
30. Wilson K, Keelan J. The case for a vaccine injury compensation program for Canada. Can J Public
Health. 2012; 103(2):122–4. https://doi.org/10.1007/BF03404215 PMID: 22530534
31. World Health O. Global Vaccine Action Plan 2011–2020. Global Vaccine Action Plan 2011–2020. 2013.
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... Thus, the burden of vaccine-related injury, which is not evenly distributed among vaccine recipients and a fortiori among the entire population, should entitle vaccine recipients who had suffered injuries to compensation. The principle of solidarity also obligates the community to provide support for individuals, so that no one person should individually bear the burden of injury [20,22,23].With regard to the utilitarian considerations of promoting vaccine compliance, it has not been empirically proven that compensating injured individuals through legislation improves vaccine compliance [20]. However, legislation to compensate vaccine recipients who had suffered injuries attributed to the vaccine (assuming it does in fact aid the injured individuals) has the potential to bolster trust between vaccine recipients and the healthcare system [24]. ...
... The majority of no-fault vaccine injury compensation programs legislated in the World Health Organization Member States stipulate that the discussion of vaccine injuries will be conducted in an administrative procedure. Proponents of administrative procedure claim that it allows fairer access to compensation for vaccine recipients who suffered injuries [22]. In the USA for example, with a combination of an administrative and legal approach [32], the percentages of vaccine-related claims awarded monetary compensation (for petitions filed through 10/01/1988 through 09/01/2020) were as follows: 36% due to the hepatitis B vaccine; 32% due to the DTP vaccine; 38% due to the Hemophilus Influenza B vaccine; 38% due to the MMR vaccine; and 46% due to the hepatitis A vaccine [33]. ...
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Background Following other countries, Israel passed the Vaccine Injury Compensation Law in 1989, which provides for compensation to vaccine recipients who had suffered injuries without proving negligence. In 2021, after deliberations between the ministries of health and of finance Covid-19 vaccines (administered from the beginning of the campaign on December 20, 2020 and up to December 21, 2022) were included within the compensation law. The current study aims to examine the objectives of Israel’s Vaccine Injury Compensation Law, at the time of its enactment, and to explore barriers to their fulfillment. These issues are especially relevant in light of the discussions held on the option for liability exemption which excludes the possibility of redress from the Covid-19 vaccine manufacturers in case of injury attributed to the vaccine, and considering the heavy burden of proof required in standard tort law. Methods The study employed a qualitative methodology which made use of both content analysis of relevant documents and in-depth interviews. Results In passing the Vaccine Injury Compensation Law, legislators sought to assist vaccine recipients who had suffered injuries by both lowering their burden of proof as well as establishing a short and efficient procedure for deliberating their claims. Furthermore, legislators believed that the assurance of compensation to vaccine recipients who had suffered injuries would help to encourage a high rate of vaccination compliance. An examination of the law’s implementation over time revealed that the aforementioned goals were not attained. Conclusions Implementation of the law since its enactment missed the opportunity to fulfill its original purposes to promote public health fundamental principles of fairness and solidarity. In addition, the adversarial proceedings as well as some of the law’s provisions have the potential to undermine public trust in the State’s willingness to grant compensation for injuries that are attributed to vaccines and thereby subvert the law’s pivotal objective of promoting trust and vaccine compliance. We suggest that allowing circumstantial evidence as to an association between vaccine and an injury, transitioning to administrative deliberation, making available to the public details of cases where compensation was awarded, as well as other possible emendations would help it better reflect the values of fairness and solidarity that underlying the law's purpose. These would also promote the level of trust in healthcare authorities which is essential to preserving high vaccine coverage.
... Vaccine injury compensation programs provide a fair and efficient way to compensate individuals for injuries resulting from vaccination and are equitable for all stakeholders [3]. They also reduce the risk of tort liability for manufacturers, which may inhibit the wide supply of life saving vaccines [4]. ...
... Although the Program is unprecedented in scale, it builds on decades of work on vaccine safety and vaccine injury compensation, including in the 25 jurisdictions worldwide that already have vaccine injury compensation programs [3]. For example, the per dose levy funding and scientific advisory panel are similar to elements of the U.S. Vaccine Injury Compensation Program [4], while the composition of the review panels is similar to the vaccine injury claim review system used in Quebec [11]. ...
... The Philippine vaccination program presents a peculiar picture due to the legislation of a specialized law to procure vaccines and allocation of indemnity fund. While other Southeast Asian states such as Vietnam and Thailand have been already implementing a "no-fault-vaccine-injury compensation programs" (Mungwira, et al., 2020), institutionalizing a specific procurement law for COVID-19 vaccines positions the Philippine case as unique compared to other states in the region. Consider the case of Malaysia where vaccine distribution is under the authority of the federal government through the agency of the COVID-19 Immunization Task Force. ...
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One of the most politicized aspects of the global pandemic response is the issue of vaccination. Vaccinating billions of individuals around the world does not only involve scientists, medical experts, and healthcare workers but also require sound governance and policy implementation. Congruent with the assertion that the pandemic is not only a public health but also a political issue, this paper examines the Philippine COVID-19 vaccination program by analyzing the legislation and implementation of Republic Act No. 11525 or the COVID-19 Vaccination Program Act of 2021. With the pandemic and shortage of global vaccine supply being used as justifications to impose stricter regulations and consolidate political power to the national government, RA 11525's restrictive provisions in vaccine procurement serves as a good manifestation of increasing authoritarian tendencies observed among Southeast Asian states during the pandemic. In relation, this paper argues that mainstream theories such as neo-institutionalism and society-based approaches are insufficient to explain the legislation of RA 11525 and its constraining impact to Philippine stakeholders interested to purchase their own vaccines due to each approach's theoretical blindsides. As an alternative, this paper introduces the critical assumptions of the Murdoch School of Political Economy and Modes of Participation (MoP) framework to explain the very restrictive nature of RA 11525. Specifically, RA 11525 prescribed who are the permitted actors to procure, and what are the processes these actors need to comply with because of two fundamental reasons, namely, the global shortage of vaccine supply and the emergency approval of available COVID-19 vaccines.
... However, minimal information is available from several other countries. [15][16][17] Records identified by MEDLINE searching (n=123) Additional records identified by Google searching (n=26) ...
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Background: Vaccines have had a great impact on disease prevention and reducing mortality. Very rarely, vaccines also can result in serious adverse effects. In consideration of this fact, vaccine injury compensation programs have been implemented in many countries to compensate a vaccinee for associated adverse effects. The existing vaccine injury compensation system addresses routine immunization schemes. However, there are rising concerns about the compensation for adverse effects caused by new vaccines such as those developed for coronavirus disease 2019 (COVID-19). This review focuses on vaccine injury compensation programs and highlights the necessity to include all upcoming new vaccines for COVID-19 and other emerging viral diseases in the compensation schemes. Methods: Published articles relating to vaccine compensation injury programs, vaccines, injuries, disabilities, illnesses, and deaths resulting from vaccination were searched in data bases. Through a careful review of the abstracts, 25 relevant articles were selected for analysis. Results : We identified 27 countries on four continents with vaccine injury compensation schemes: 17 countries in Europe, 7 countries in Asia, the United States, a Canadian Province and New Zealand. No programs were identified in Africa and in South America. Program design, funding, and eligibility for compensation vary vastly between countries. We identified 17 countries operating well-established vaccine injury compensation programs. However, minimal information is available on numerous other countries. Conclusion : We conclude that the vaccine injury compensation programs are available in limited number of countries across four continents - mostly in Europe. Lack of standard approach and scope of injury prevention and compensation programs across the countries exists. Some important limitations include limited scientific material, which hindered our research. Therefore, additional data concerning payout for each type of injury and the number of claimants related to a specific vaccine injury worldwide could provide a more comprehensive analysis.
... Before the pandemic, no-fault compensation programs were set up in a few high-income countries; we identified 39 states with such programs for vaccine injuries, and 3 had established the programs for the COVID-19 vaccine. In a prior study in 2018, only 25 states had nofault compensation programs for vaccine injuries, with programs administered at the central government level in 15 states (23). The COVAX No-Fault Compensation Program started in April 2021 to protect the 92 eligible economies (24,25), and the COVAX Facility requested that all participating countries make indemnification and liability agreements with each manufacturer before they shipped the vaccine (16). ...
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Ensuring equitable access to COVID-19 vaccines for all people has been challenging, hence, establishing relevant vaccination policies is required. This study delineates how vaccination policies have affected equitable access to COVID-19 vaccines. A situation survey was conducted in 201 countries and territories through 156 Japanese diplomatic missions abroad to capture the global state of COVID-19 vaccination policies. Questionnaire responses were received from 159 states (79%) as of March 31, 2021, and data from Japan were incorporated into the analysis. All questionnaire items were open-ended, covering the vaccines in use and five vaccination policies such as vaccine eligibility. Results reveal that first, 81 states (51% out of 160) had not started vaccinations as of February 24, 2021, but by March 31, this number had decreased dramatically to 37 (23%); in particular, the number of states in Africa without vaccination decreased from 40 to 16. Second, 43 (27%) states did not recommend the vaccine for pregnant women. Third, the vaccine was free of charge to the public in 116 states (73%), and 43 states (27%) offered no-fault compensation. Finally, vaccination was voluntary in 124 states (78%). In conclusion, the number of countries that had started vaccination increased by March 2021, especially in Africa, although many African countries seemed to lack access to the mRNA vaccine. To fix the uneven distribution, dose donations were accelerated since middle of July. Reviewing worldwide vaccine policies is useful not only for this pandemic but also to strengthen vaccination systems for preparedness for the next pandemic.
... The COVID-19 vaccine pillar has since announced a no-fault compensation system for vaccine injuries, but the negative impact of this scheme on public perception towards the vaccine requires further exploration. 7 Hong Kong Med J 2021;27:377-9 https://doi.org/10.12809/hkmj219639 ...
... Globally, 25 jurisdictions have VICPs. Most of these countries are in Europe, and a recent review study identified 16 nations in Europe with VICPs [3]. Debates around vaccine injury compensation programs have arguably taken on increased significance in the context of the COVID-19 pandemic, as billions of COVID-19 vaccines are intended for global administration, and manufacturers of approved COVID-19 vaccines are being afforded legal indemnity through purchase agreements, which means that they cannot be pursued for compensation for vaccine-related harm [4]. ...
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... However, minimal information is available from several other countries. [15][16][17] Records identified by MEDLINE searching (n=123) Additional records identified by Google searching (n=26) ...
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Background: Vaccines have had a great impact on disease prevention and mortality reduction. Very rarely, vaccines also can result in serious adverse effects. In consideration of this fact, vaccine injury compensation programs have been implemented in many countries to compensate a vaccinee for associated adverse effects. The existing vaccine injury compensation system addresses routine immunization schemes. However, there are rising concerns about the compensation for adverse effects caused by new vaccines such as those developed for coronavirus disease 2019 (COVID-19). The objective of this article is to review the existing vaccine injury compensation programs in different countries. The review also highlights the necessity to include all upcoming new vaccines for COVID-19 and other emerging viral diseases in the compensation schemes. Methods : Published articles relating to vaccine compensation injury programs, vaccines, injuries, disabilities, illnesses, and deaths resulting from vaccination were searched in data bases. Through a careful review of the abstracts, 25 relevant articles were selected for analysis. Results : We identified 27 countries on four continents with vaccine injury compensation schemes: 17 countries in Europe, 7 countries in Asia, the United States, a Canadian Province and New Zealand. No programs were identified in Africa and in South America. Program design, funding, and eligibility for compensation vary vastly between countries. We identified 17 countries operating well-established vaccine injury compensation programs. However, minimal information is available on numerous other countries. Conclusion : We have identified 27 countries operating vaccine injury compensation programs. In Canada, Quebec is the only province with a scheme; however, discussions are ongoing in Canada for nationwide implementation in light of COVID 19. Study limitations include limited scientific material, which hindered our research. Additional data concerning payout for each type of injury and the number of claimants related to a specific vaccine injury worldwide could provide a more comprehensive analysis.
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Background Despite the proposed ethical link between mandatory immunization and Vaccine Injury Support Programs (VISPs), relatively few jurisdictions, even those with mandatory immunization, have implemented such programs. Although it may be assumed that individuals injured by a vaccine in a non-VISP country receive less support than in countries possessing such programs, the extent of the discrepancy is not clear; nor is the nature of any discrepancy. Methods In our 2018 survey of 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, we asked respondents about mandatory immunization and the availability of VISPs. Responses were supplemented with desktop research and review of scholarly literature for further information regarding VISP availability and details. Results Although only two of 14 (14%) surveyed jurisdictions with mandatory immunization had formal VISPs, responses from additional countries suggested the presence of less formal avenues of compensation for serious Adverse Events Following Immunization (AEFIs); similarly, we found five of 15 (33%) of countries without mandatory immunization had implemented formal VISPs, but another three such countries suggested similar informal methods of compensation. Conclusions From our data, it is evident that at least some countries with mandatory immunization may discharge their (perceived or actual) ethical obligation to provide financial assistance to vaccine-injured individuals through more informal avenues rather than structured VISPs, although the extent and impact of this practice is by its nature difficult to assess. Further, the nature of VISPs may vary significantly from jurisdiction to jurisdiction, and simple VISP/non-VISP classification of jurisdiction may fail to capture nuance in support for AEFI victims in many jurisdictions. Future assessments of VISPs should consider the possibility of these more informal avenues of support for vaccine injuries.
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Improvements in vaccine safety surveillance and investigative capacity lead to identification of rare reactions attributable to vaccination. As a result, the issue of fair compensation for those who experience vaccine injuries is gaining growing attention. Although vaccine injury compensation programmes (VICP) have been developed in a few countries for more than 50 years, no global policy guidance to guide vaccine injury compensation in all countries wishing to adopt such compensation schemes is currently available. To update the landscape analysis of no-fault compensation programmes and characterize VICP implementing countries, we conducted a survey of all 194 Member States from the World Health Organization and received feedback from 151. This analysis describes the economic and vaccine safety surveillance characteristics of Member States implementing VICPs. This analysis describes the characteristics of 25 Member States implementing a compensation programmes. Characteristics examined include economic, vaccination and safety surveillance indicators. Twenty of the 25 Member States (80%) with compensation programmes are categorized as high-income countries, 20/25 (80%) met the Global Vaccine Action Plan (GVAP) safety indicator of reporting at least ten annual reports of adverse events following immunization per 100,000 population, 21/25 (84%) met the GVAP coverage indicator by achieving greater than 90% third dose of Diphtheria, Tetanus and Pertussis vaccine (DTP3) and 17/25 (68%) assessed vaccine hesitancy in 2017. All Member States with VICP have a national immunization technical advisory group. This study identified growing interest in the implementation of no-fault compensation programs beyond high-income countries. Global policies guiding compensation should be developed for countries regardless of the maturity of their immunization programmes. Research in context As a result of improved vaccine safety surveillance, World Health Organization (WHO) Member States are facing situations where known untoward serious vaccine reactions are documented, including in low- and middle-income settings. This has led to increased interest for the development of national no-fault compensation policies for vaccine injuries. As of 2010, compensation schemes for vaccine related injuries had been identified and characterized in 19 out of 194 WHO member states. All these programmes were in the industrialized world with none in low- and middle-income countries. Previous reviews have described the characteristics of the existing programmes based on the six common elements identified by Evans in 1999 with less emphasis on characteristics from countries implementing these no-fault compensation programmes. This manuscript aimed to identify predictors of countries implementing no-fault compensation programmes for vaccine injuries and update the inventory of existing programmes as part of a more comprehensive global landscape evaluation of existing programmes. This information will be useful for country self-evaluation and future compensation policy formulation as discussion to develop policies guiding the implementation of vaccine injury compensation continues to gain growing attention.
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On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, "Adverse Effects of Vaccines: Evidence and Causality," the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations. The Secretary amends the Table through the changes in this final rule. These changes will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.
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In 2005, China introduced an administrative no-fault one-time compensation scheme for adverse events following immunization (AEFI). The scheme aims to ensure fair compensation for those injured by adverse reactions following immunization. These individuals bear a significant burden for the benefits of widespread immunization. However, there is little empirical evidence of how the scheme has been implemented and how it functions in practice. The article aims to fill this gap. Based on an analysis of the legal basis of the scheme and of practical compensation cases, this article examines the structuring, function, and effects of the scheme; evaluates loopholes in the scheme; evaluates the extent to which the scheme has achieved its intended objectives; and discusses further development of the scheme. © The Author 2017. Published by Oxford University Press; all rights reserved.
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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).
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This report was commissioned by the No-Fault Compensation Review Group in Scotland. It provides an up-to-date analysis of existing no-fault schemes in New Zealand, Sweden, Denmark, Norway, and Finland, as well as limited schemes which operate in Virginia and Florida in the United States. Drawing on such analysis, the report considers a number of specific elements such as the advantages and disadvantages of no-fault schemes; choice of model; equality of coverage; cost and affordability; access to justice; and linkages to patient complaints processes, professional accountability and patient safety. The report was designed to assist the Group in its deliberations on whether a no-fault compensation scheme for medical injury should be established in Scotland. The Group’s report setting out its findings and recommendations was published in 2011.