Academic journal article Bulletin of the World Health Organization

No-Fault Compensation Following Adverse Events Attributed to Vaccination: A Review of International programmes/Indemnisation Sans Egard a la Faute Consecutive a Des Evenements Negatifs Lies a la Vaccination: Evaluation Des Programmes internationaux/Compensacion Sin Admision De Responsabilidad Tras Las Reacciones Adversas Atribuidas a la Vacunacion: Revision

Academic journal article Bulletin of the World Health Organization

No-Fault Compensation Following Adverse Events Attributed to Vaccination: A Review of International programmes/Indemnisation Sans Egard a la Faute Consecutive a Des Evenements Negatifs Lies a la Vaccination: Evaluation Des Programmes internationaux/Compensacion Sin Admision De Responsabilidad Tras Las Reacciones Adversas Atribuidas a la Vacunacion: Revision

Article excerpt

Introduction

The public health benefits of vaccination are clear. The World Health Organization estimates that, in 2008, more than 2.5 million deaths were prevented by vaccination. (1) Immunization programmes have led to the eradication of smallpox, the elimination of measles and poliomyelitis in many regions, and substantial reductions in morbidity and mortality from Haemaphilus influenzae type b, diphtheria, whooping cough and tetanus. However vaccines are not without risks and it is commonly accepted that, regardless of proper design, manufacture and delivery, adverse events occur following vaccination although serious adverse events are rare. (2)

At a population level, it is considered that these small risks are balanced by the benefits of widespread population immunization. However this means that an individual occasionally bears a significant burden for the benefit provided to the rest of the population. Although these vaccine-related adverse events occur occasionally due to negligence, more often there is no clearly attributable fault.

Without evidence of clear negligence, it is difficult to obtain compensation through traditional legal mechanisms. Recognizing this, several countries have implemented vaccine-injury compensation programmes. (3) These programmes reflect a belief that it is fair and reasonable that a community that is protected by a vaccination programme accepts responsibility for and provides compensation to those who are injured by it. In 1999, Evans conducted a thorough review of 13 compensation programmes. (3) We aimed to update this review examining similar programme elements to those described both by Evans and by Mariner in her 1985-6 study. (4)

Search strategy

We used a recta-search engine (Supersearch MetaLib[R]) to identify key published resources on vaccine-injury compensation schemes. Databases searched were: Web of Science[R], Scopus v.4 (Elsevier), Medline (ISI), CINAHL[R]Plus (EBSCO), PsycINFO[R] (CSA), PubMed, Academic Search Premier (EBSCO), Expanded Academic ASAP (Gale), JSTOR, LegalTrac (Gale) and Law Journal Library (Hein).

Keywords entered were vaccine AND injury AND compensation; "vaccine injury"; vaccine AND damage AND compensation; vaccine AND compensation; "vaccine policy"; "vaccine injury" AND international; and "vaccine injury" AND [country name]. We scanned reference lists of key full text papers. We used citation tracking in PubMed, Google Scholar, ScienceDirect and EBSCOhost to forward track key papers and identify articles cited in mainstream journals. We performed a grey literature search in Google using the same keywords. We searched web pages of international organizations, bilateral agencies, nongovernmental organizations, consultancy firms and universities involved in funding, delivering or evaluating immunization services. We perused national government web sites to find details of specific country's schemes. Finally we contacted key individuals involved in vaccine compensation programmes throughout the world.

Evolution of programmes

We identified 19 countries with current vaccine compensation schemes (Fig. 1). In 1953, the German Supreme Court ruled that people who were injured by compulsory vaccination (in this case smallpox) were entitled to compensation. Germany enacted a compensation programme in 1961. (5) France implemented a similar scheme in the 1960s. (6) Concern over injuries caused by medicines and the inadequacies of traditional litigation processes increased after the thalidomide tragedy in the 1960s. In the 1970s, concerns over adverse events related to diphtheria--tetanus--pertussis vaccination led to programmes being established in Austria, (7) Denmark, (8) Japan, (9) New Zealand, (10) Sweden (11) Switzerland

(12) and the United Kingdom of Great Britain and Northern Ireland (UK). (13) In the 1980s, Taiwan (China), (14) Finland, (15) the United States of America (USA) (16) and Quebec (Canada) (17) implemented programmes. …

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