No-fault compensation following adverse events attributed to vaccination: a review of international programmes

Looker, Clare; Kelly, Heath

doi:10.2471/blt.10.081901

Cited by 72 publications

(73 citation statements)

References 11 publications

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“…No-fault compensation schemes are increasingly regarded as an important component of successful vaccination programs. For example, in the United States, the National Vaccine Injury Compensation Program was established as the result of a similar scare relating to diphtheria-pertussis-tetanus vaccination in 1986 [18,19]. However, the current compensation scheme in Japan requires confirmation of causality by the government and may lead claimants to seek further compensation through private litigation [18].…”

Section: Discussionmentioning

confidence: 99%

“…On 30 March 2016, 12 women claiming aftereffects of HPV vaccination held a press conference to bring legal action against the government and pharmaceutical companies in Japan, claiming their responsibility and the need for compensation [20]. While claims of nonsensical adverse events would not be compensated, even under the no-fault compensation program, others who are suffering from unavoidable adverse events could be compensated promptly [2,19]. As a result, it is possible that implementation of this system could attenuate vaccine-related conflict in Japanese society and reduce the risk of lawsuits against the government.…”

Section: Discussionmentioning

confidence: 99%

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Trends of Media Coverage on Human Papillomavirus Vaccination in Japanese Newspapers

Tsuda

Yamamoto²,

Leppold³

et al. 2016

Clin Infect Dis.

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A sensational newspaper article concerning a possible adverse reaction to the human papillomavirus (HPV) vaccine was published in March 2013 in Japan. In June 2013, the Japanese government suspended their proactive recommendation for vaccination, despite the lack of proof for a causal relationship. We searched Nikkei Telecom 21, the largest newspaper database in Japan, for articles published from January 2011 to December 2015 to evaluate the characteristics of newspaper publications about human papillomavirus vaccination. We identified 1138 HPV vaccine-related articles. Compared with those published before March 2013, articles concerning human papillomavirus vaccination after March 2013 were more likely to include adverse reaction-related and authority-related keywords; articles that included efficacy-related keywords decreased significantly. Negative-negative and negative-neutral articles became more frequent, and positive-positive and positive-neutral articles were less frequent. A sensational case report shaped the tone of negative media coverage as a catalyst, regardless of scientific statements from health authorities.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Trends of Media Coverage on Human Papillomavirus Vaccination in Japanese Newspapers

Tsuda

Yamamoto²,

Leppold³

et al. 2016

Clin Infect Dis.

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“…The ministry will consult an expert panel soon to draw up its relief program. [6][7][8] No-fault compensation following adverse events attributed to vaccination is key for vaccine implementation, 9 and the establishment of a new compensation program might be key to calming an anxious public in Japan.…”

Section: Discussionmentioning

confidence: 99%

“…The source of funding for vaccine-injury compensation schemes largely reflects where the decision-making power lies. 9 A typical example is Suginami Ward, Tokyo, which started their own compensation program in April 2013. Suginami Ward is one of the earliest municipalities to have provided funding for the HPV vaccine, having begun doing so in 2009.…”

Section: Discussionmentioning

confidence: 99%

Compensation programs after withdrawal of the recommendation for HPV vaccine in Japan

Kikuchi

Nakada

2015

Human Vaccines & Immunotherapeutics

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HPV vaccinations were recommended with the backing of a Japanese government subsidy program in 2010, and were included in the National Immunization Program in April 2013. However, the Ministry of Health, Labour, and Welfare withdrew the recommendation for the HPV vaccination in June 2013. We investigated HPV vaccine injury compensation programs for both the national and local governments. Approximately 3.38 million girls were vaccinated, and 2,584 complained of health problems. The majority of these received the vaccine shot as a non-routine vaccination. In total, 98 people developed health problems and applied for assistance from 2011 to 2014, but no cases have been processed since October 2014. Several local governments are providing their own compensation program for cases of vaccine adverse reactions, but the number is extremely low (16 of 1,741 municipalities and 1 of 47 prefectures). The local governments that are providing compensation are largely those where HPV vaccine victim support groups are prominent. The confusion regarding the national program for HPV vaccine injury was caused by the discrepancy between the compensation programs for those vaccinated under the immunization law and for those who received voluntary vaccinations. The establishment of a new compensation program might be key to finding a lasting resolution.

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“…With this, the victim, already very vulnerable, remains in loss, because they are not having their right sought in amplitude. A legal compensation system for AEFI, such as the one existing in Germany, Japan and France 54 , and preferably an extra-judicial one, could make a difference, as it would avoid such distortions and distinctions, bringing responsibility to State and laboratories and keep the vulnerable group from depending on the greater or lesser knowledge of their legal representatives to trigger the correct liable subject. Nowadays, since there is no standard system of compensation for post-vaccination damages, the individual is subject to the defense strategy of his/her lawyer or public defender, which is sometimes incomplete and not always the most adequate, causing insecurity, which, according to the UDBHR, is unacceptable and unfair.…”

Section: The Passive Pole Of the Demandmentioning

confidence: 99%

Judicialização de eventos adversos pós-vacinação

2017

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Science has made important contributions to improving people's well-being, achieving remarkable advances that protect them from illnesses. Vaccines are one such example, and serve as a tool to improve the lives of the global population. Vaccines have risks the consequences of which are not fully known, however, making surveillance systems that neutralize or reduce adverse events vital. In Brazil, vaccination policy is "compulsory", restricting the autonomy of the individual, who as a "victim" of adverse events then needs to seek redress through legal action, as the State does not have a national compensation policy. With the support of Bioethics and human rights, this article aims to analyze Brazilian judicial decisions, demonstrating that judicialization is not the best way to solve problems arising from adverse events caused by vaccines, and that there is a lack of preparation among the professionals involved, as well as contradictions, insecurities and injustices in decisions. Keywords: Bioethics. Vaccines. Cost-benefit analysis. Legal responsibility. Human Rights. Resumo Judicialização de eventos adversos pós-vacinaçãoA ciência trouxe importantes contribuições para a melhoria do bem-estar do ser humano, surpreendendo com criações que buscam protegê-lo das enfermidades. Vacinas são exemplo, funcionando como instrumentos de melhoria de vida da população mundial. Entretanto, vacinas apresentam riscos cujas consequências não são completamente conhecidas, sendo importante a presença de sistemas de vigilância que neutralizem ou diminuam os eventos adversos delas provenientes. No Brasil, a política de vacinação é "compulsória", restringindo a autonomia do indivíduo, que, quando "vítima" dos eventos adversos, precisa judicializar suas demandas, pois o Estado não possui política nacional de compensação de danos. Este artigo visa, com o apoio da bioética e dos direitos humanos, analisar as decisões judiciais brasileiras, demonstrando que a judicialização não é o caminho mais justo para dirimir problemas surgidos pelos eventos adversos das vacinas, havendo despreparo dos profissionais envolvidos, contradições, inseguranças e injustiças nas decisões. Palavras-chave: Bioética. Vacinas. Análise custo-benefício. Responsabilidade legal. Direitos humanos. Resumen Judicialización de eventos adversos post-vacunaciónLa ciencia ha aportado importantes contribuciones a la mejora del bienestar del ser humano, llegando a sorprender con creaciones que buscan protegerlo de las enfermedades. Las vacunas son un ejemplo de ello, funcionando como un instrumento de mejora de la vida de la población mundial. Sin embargo, las vacunas presentan riesgos cuyas consecuencias no se conocen por completo, siendo importante la presencia de sistemas de vigilancia que neutralicen o disminuyan los eventos adversos provenientes de éstas. En Brasil, la política de vacunación es "obligatoria", restringiendo la autonomía del individuo, que cuando es "víctima" de los eventos adversos, necesita judicializar sus demandas, pues el Estado no posee una ...

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No-fault compensation following adverse events attributed to vaccination: a review of international programmes

Cited by 72 publications

References 11 publications

Trends of Media Coverage on Human Papillomavirus Vaccination in Japanese Newspapers

Trends of Media Coverage on Human Papillomavirus Vaccination in Japanese Newspapers

Compensation programs after withdrawal of the recommendation for HPV vaccine in Japan

Judicialização de eventos adversos pós-vacinação

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