No-fault compensation schemes for COVID-19 medical products
Authors: Yasuhiro Fujiwara, Yutaka Onda, Shuichiro Hayashi
Journal: The Lancet (2021)

No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing.1Wouters OJ Shadlen KC Salcher-Konrad M et al.Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment.Lancet. 2021; 397: 1023-1034Summary Full Text Full Text PDF PubMed Scopus (775) Google Scholar 25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes.2Mugwira RG Guillard C Salana A et al.Global landscape analysis of no-fault compensation programmes for vaccine injuries: a review and survey of implementing countries.PLoS One. 2020; 15e0233334PubMed Google Scholar Although the USA is covering COVID-19 vaccine-associated adverse events with the US Countermeasures Injury Compensation Program (CICP) for the duration of the public health emergency declaration, the country is having challenging issues as CICP does not have the ease of access to, and levels of compensation provided by the US National Vaccine Injury Compensation Program available at normal times, exacerbating long-standing inequities based on income, race, and ethnicity.3Van Tassel K Shachar C Hoffman S COVID-19 vaccine injuries—preventing inequities in compensation.N Engl J Med. 2021; 384: e34Crossref PubMed Scopus (15) Google Scholar Japan has a long-established no-fault compensation scheme for people who have adverse drug reactions from vaccines or drugs. The vaccine health damage relief system (a no-fault compensation scheme authorised by the Immunisation Act of 1976 is managed by the Japanese Ministry of Health, Labour and Welfare (MHLW) and prefectural governments.4Enami T Otsubo H The current state of immunization administration in Japan.JMAJ. 2010; 53: 111-117Google Scholar Between February, 1977, and December, 2019, 3419 people were certified by the MHLW.5Health BureauMinistry of HealthLabor and WelfareFlattening 31 years. Summary of forecast.https://www.mhlw.go.jp/wp/yosan/yosan/19syokanyosan/dl/gaiyo-03.pdfDate: December, 2018Date accessed: April 29, 2021Google Scholar In fiscal year 2019, the MHLW received 134 health damage relief claims of which 88 were certified; the annual MHLW budget for these claims in 2019 was US$10·8 million.5Health BureauMinistry of HealthLabor and WelfareFlattening 31 years. Summary of forecast.https://www.mhlw.go.jp/wp/yosan/yosan/19syokanyosan/dl/gaiyo-03.pdfDate: December, 2018Date accessed: April 29, 2021Google Scholar Japan is unique in that it has a no-fault compensation scheme for drugs financed mainly by contribution from pharmaceutical companies. France, Germany, New Zealand, Taiwan, Denmark, Norway, Sweden, and Finland have similar systems.6Maeda H Kurokawa T Involvement of anticancer drugs in the relief system for adverse drug reactions in Japan.Jpn J Clin Oncol. 2013; 43: 1273-1281Crossref PubMed Scopus (5) Google Scholar In Japan, the scheme for drugs was introduced in 1979 and is authorised by the Pharmaceuticals and Medical Devices Agency (PMDA).7Tominaga T Miyazaki S Oniyama Y Weber AD Kondo T The Japanese postmarketing adverse event relief system; a confluence of regulatory science, the legal system, and clinical pharmacology.Clin Pharmacol Ther. 2017; 102: 277-282Crossref PubMed Scopus (3) Google Scholar In fiscal year 2019, the PMDA received 1590 relief claims, 1285 of which were certified, and US$22·6 million was paid within the same fiscal year.8Relief Business CommitteeBusiness performance so far in the second year of Reiwa. About recent major efforts.https://www.pmda.go.jp/files/000239139.pdfDate: Dec 4, 2020Date accessed: April 29, 2021Google Scholar The COVID-19 pandemic presents an opportunity not only for vaccines, but also for covering drugs under no-fault compensation schemes. YF reports speaker fees from AstraZeneca, Chugai Pharmaceuticals, Daiichi Sankyo, Bristol-Myers, SRL, and Santen Pharamceuticals. All other authors declare no competing interests. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deploymentThe COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. Full-Text PDF