Japan Covid Vaccine NFCS
Introduction
Japan had an existing no-fault compensation scheme for vaccines included in its national immunisation programme created in 1976 through the passing of Act No. 69 of June 19, 1976, which introduced supplementary provisions on vaccine injury no-fault compensation to the Immunization Act 1948 (Act No. 68 of June 30, 1948). The provisions regulating the NFCS are contained in Chapter V of the Immunization Act. According to media reports (see here and here), in February 2021 the Japanese health minister announced at a budget meeting that the NFCS would cover injuries resulting from COVID-19 vaccination.
The first COVID-19 cases were adjudicated by the Scheme in August 2021 (see report here).
The scheme is administered by Japanese Ministry of Health, Labour and Welfare (MHLW) and mayors of relevant municipalities (see Immunization Act, Article 15).
The funding for the NFCS is shared between municipalities, prefectures and central government (see Immunization Act, Articles 25-27).
Note that Japan also has a separate NFCS administered by the Pharmaceuticals and Medical Device Agency for 'voluntary vaccinations' that are not part of the national immunisation programme (see Mungwira et al. 2020).
Vaccines Covered
Vaccines for a pre-specified list of diseases are covered by this NFCS. The vaccines covered by the scheme are classified as vaccines against ‘Category A’ diseases and vaccines against ‘Category B’ diseases.
‘Category A’ diseases specified by the Immunization Act are the following (see Art. 2(2)):
- diphtheria;
- pertussis;
- polio (acute myelitis);
- measles;
- rubella;
- japanese encephalitis;
- tetanus;
- tuberculosis;
- Hib infection (Haemophilis influenza type B);
- pneumococcal infectious disease (limiting to one that is of infants);
- human papilloma virus infection; and
- Beyond the diseases listed in the preceding items, diseases provided for by Cabinet Order as diseases against which vaccinations are deemed a required necessity to prevent an outbreak and a spread from person to person, or to prevent a outbreak or a spreading as the condition of a person infected can become serious or will likely become serious.
‘Category B’ diseases specified by the Immunization Act are the following (see Art. 2(3)):
- influenza; and
- Beyond the diseases listed in the preceding items, diseases provided for by Cabinet Order as diseases against which vaccinations are deemed a required necessity to prevent individuals from developing the disease or the condition from getting worse, and to contribute to preventing the disease from spreading.
Under the Act, vaccinations are furthermore classified as either ‘routine’ or ‘temporary’ vaccinations (see Immunization Act, Article 5 and Article 6).
COVID-19 vaccination has been classified as a special ‘temporary vaccination’ following a revision of the Immunization Act in December 2020 (Yamamoto et al. 2021; Tsuji 2021).
Injuries Covered
This NFCS covers all diseases, disability, deaths caused by covered vaccinations.
There is no specified disablement threshold in the statute.
Charges for making a claim
It is not specified whether there is a charge for making a claim under this scheme.
Claimants
Under this scheme the following categories of individuals are permitted to make a claim:
- Live vaccine recipient or a caretaker in case of those under eighteen years of age who are in a state of disability due to vaccination;
- Surviving family of a person who died of a given vaccination.
It is not specified whether under this scheme the claimant is allowed to nominate a legal representative to make their claim.
Losses covered
This scheme pays the following:
|
Live vaccine recipient |
Dependents of vaccine recipient |
Surviving family of a deceased vaccine recipient |
|
Compensation payments are for general categories and are not broken down into economic and non-economic losses. |
No Compensation is specifically provided to the dependents of the vaccine recipient. |
Compensation payments are for general categories and are not broken down into economic and non-economic losses. |
The following items are compensated under Article 16(1) of the Immunization Act (which refers to injuries caused by routine vaccination against ‘category A’ diseases or a temporary vaccination against ‘category B’ diseases):
- medical expenses and medical benefits: A person who undergoes a medical treatment of a disease due to a given vaccination;
- child disability assistance pension: A person who takes care of those under eighteen years of age who are in a state of disability due to given vaccination, as specified by Cabinet Order;
- disability pension: A person who is eighteen years of age or more, who is in a state of disability as determined by Cabinet Order as a result of being vaccinated;
- lump sum payment: A surviving family of a person who died of a given vaccination, specified by Cabinet Order; and
- funeral rite expenses: A person who performs funeral rites for a person who died due to a given vaccination.
Article 16(2) (for injuries caused by a routine vaccination against category B diseases) covers the same items, except at point (iv) it covers a ‘pension for a surviving family or lump sum payment for a surviving family’.
Payments consist of a mixture of periodic payments and/or a lump sum payment.
Funeral rite expenses are covered under this Scheme.
Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification. The lump sum compensation for a surviving family in case of death following vaccination is currently ¥44.2 million, while funeral rite expenses are covered up to ¥209,000. Compensation is not capped, but the maximum quantum that can be awarded depends on the consequences of the injury in an individual case and the amounts provided under the scheme for each compensated category (see Ro et al. 2021, Table 5).
Time limits for claims
The scheme does not set a time limit between vaccination and the adverse event occurring.
It is not known whether there are other time limits for claims under this scheme.
Evaluating claims – standard of proof required
According to the National Research Council (US) Division of Health Promotion and Disease Prevention (1985) ‘judgments are based on available clinical information, interval between vaccination and onset of illness, and report in literature of similar adverse reactions.’
Appeals and the right to litigate
It should remain possible to pursue litigation in court (see National Research Council (US) Division of Health Promotion and Disease Prevention, 1985), but indemnification may be negotiated by vaccine manufacturers in procurement agreements (see Yamamoto et al. 2021).
Litigation may affect the award paid by NFCS. See Immunization Act, Article 18.
No information is available on appeals to NFCS decisions.
Useful information and links
It is not known whether the scheme produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc).
Links to legislation:
Immunization Act (Act No. 68 of June 30, 1948) [in English]: https://www.japaneselawtranslation.go.jp/en/laws/view/2964/en#je_ch5at2
Immunization Act (Act No. 68 of June 30, 1948) [in Japanese, includes the 2020 supplementary provisions on COVID-19]:
https://www.mhlw.go.jp/web/t_doc?dataId=79015000&dataType=0&pageNo=1
Academic literature:
Tsuji, Y. (2021). COVID-19 Vaccination in Japan: Remedies for Injured Patients. 16 Health L. & Pol'y Brief 40. Available at: https://heinonline.org/HOL/LandingPage?handle=hein.journals/heallaw16&div=8&id=&page=.
Yamamoto, N., Takahashi, Y., & Hayashi, S. (2021). Legal and regulatory processes for Japan's COVID-19 immunization program. Vaccine, 39(43), 6449–6450. https://doi.org/10.1016/j.vaccine.2021.09.002.
Mungwira, R. G., Guillard, C., Saldaña, A., Okabe, N., Petousis-Harris, H., Agbenu, E., Rodewald, L., & Zuber, P. L. F. (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.
Ro D., Ro D., & Kim SY. COVID-19 vaccine injury compensation programs. J Glob Health Sci. 2021 Dec;3(2):e21. https://doi.org/10.35500/jghs.2021.3.e21.
National Research Council (US) Division of Health Promotion and Disease Prevention. Vaccine Supply and Innovation. (1985) Washington (DC): National Academies Press (US). Appendix E, Vaccine-Injury Compensation in Other Countries. Available at: https://www.ncbi.nlm.nih.gov/books/NBK216811/?report=reader#_NBK216811_pubdet_
Media reports:
https://www.independent.co.uk/news/world/asia/japan-covid-vaccine-pay-families-death-b1806799.html
https://mainichi.jp/english/articles/20210820/p2a/00m/0na/024000c