No-fault compensation schemes for COVID-19 medical products.

No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing. 25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes. 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.

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. Between February, 1977, and December, 2019, 3419 people were certified by the MHLW. 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.

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. In Japan, the scheme for drugs was introduced in 1979 and is authorised by the Pharmaceuticals and Medical Devices Agency (PMDA). 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.

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.