J Korean Med Sci.  2024 Apr;39(13):e121. 10.3346/jkms.2024.39.e121.

COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries

• Kang CR
• Choe YJ
• Yoon SJ

• KMID: 2554578
• DOI: http://doi.org/10.3346/jkms.2024.39.e121

Abstract

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community’s overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand’s system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

Keyword

Vaccines; COVID-19; Compensation; Vaccination

Reference

1. Goldberg R. Vaccine damage schemes in the US and UK reappraised: Making them fit for purpose in the light of COVID-19. Leg Stud. 2022; 42(4):576–599.

2. Collet JP, MacDonald N, Cashman N, Pless R. Advisory Committee on Causality Assessment. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Bull World Health Organ. 2000; 78(2):178–185. PMID: 10743282.

3. Benbow DI. Virtue ethics and the United Kingdom (UK) Vaccine Damage Payment Scheme (VDPS). J Soc Welf Fam Law. 2022; 44(3):391–410.

4. Korea Disease Control and Prevention Agency. Guideline for Response to Adverse Events Following Immunization. Cheongju, Korea: Korea Disease Control and Prevention Agency;2022.

5. Korea Disease Control and Prevention Agency, COVID-19 Vaccination Response Promotion Team. Guideline for Response to Adverse Events Following Immunization for COVID-19. Sejong, Korea: COVID-19 Vaccination Response Promotion Team;2022.

6. Jeong SM. Current COVID-19 vaccine safety management programs in Korea. J Korean Soc Secur Law Assoc. 2022; 11(2):167–199.

7. Cha SA. A legal review of the scope of causation for vaccine injury compensation – focusing on the case law on presumption of causal relationship. Soc Secur Law Rev. 2023; 12(2):199–316.

8. Health Resources & Services Administration. Countermeasures Injury Compensation Program (CICP) Data. Updated 2023. Accessed May 10, 2023. https://www.hrsa.gov/cicp/cicp-data .

9. Congressional Research Service. Compensation Programs for Potential COVID-19 Vaccine Injuries. Updated 2021. Accessed May 10, 2023. https://crsreports.congress.gov/product/pdf/LSB/LSB10584 .

10. Health Resources & Services Administration. Countermeasures Injury Compensation Program (CICP). Updated 2023. Accessed May 10, 2023. https://www.hrsa.gov/cicp .

11. Shin JG. Current status and implications of Germany’s immunization damage compensation system. J Law Polit Res. 2021; 27(2):31–80.

12. Cha SA. Reporting of adverse events following immunization and compensation for damages caused by side effects of vaccination in Germany. J Korean Soc Secur Law Assoc. 2022; 11(2):201–289.

13. Nationale Lenkungsgruppe Impfen. Aktualisierung des NIPs: Abfrage der Anzahl Anträge und Anerkennungen von Impfschäden bei den Ländern. Updated 2021. Accessed May 11, 2023. https://www.nali-impfen.de/fileadmin/pdf/Zusammenstellung_Impfschaeden_2009-2019_aktuell_2021-02-04.pdf .

14. Lee EJ. Damage compensation system of French vaccination and its implications: focusing on COVID-19 vaccination. J Korean Soc Secur Law Assoc. 2022; 11(2):95–131.

15. Office National d’Indemnisation des Accidents Médicaux. Accidents médicaux indemnisés. 2023. Accessed May 11, 2023. https://www.oniam.fr/accidents-medicaux-indemnis%C3%A9s.Updated .

16. Office National d’Indemnisation des Accidents Médicaux. Référentiel indicatif d’indemnisation par l’oniam. Updated 2022. Accessed May 11, 2023. https://www.oniam.fr/procedure-indemnisation/bareme-indemnisation .

17. Office National d’Indemnisation des Accidents Médicaux. Notre organization. Updated 2023. Accessed May 11, 2023. https://www.oniam.fr/indemnisation-accidents-medicaux/organisation .

18. Office National d’Indemnisation des Accidents Médicaux. Accidents vaccinations obligatoire. Updated 2022. Accessed May 11, 2023. https://www.oniam.fr/accidents-medicaux-vaccinations-obligatoires .

19. Office National d’Indemnisation des Accidents Médicaux. Rapport d’activité. Updated 2021. Accessed May 11, 2023. https://www.oniam.fr/medias/uploads/RA/ONIAM_RA_2021.pdf .

20. NHS Business Services Authority. VDPS Principles of Medical Assessment. Updated 2023. Accessed May 12, 2023. https://www.nhsbsa.nhs.uk/sites/default/files/2023-05/VDPS%20medical%20assessment%20principles%2020230427.pdf .

21. House of Commons Library. Debate on COVID-19 Vaccines and the Vaccine Damage Payment Scheme. Updated 2022. Accessed May 12, 2023. https://researchbriefings.files.parliament.uk/documents/CDP-2022-0154/CDP-2022-0154.pdf .

22. NHS Business Services Authority. NHS Business Services Authority. Updated 2023. Accessed May 12, 2023. https://www.nhsbsa.nhs.uk/ .

23. Dubé E, Gagnon D, MacDonald NE, Harmon S, Hapuhennedige S. Vaccine injury compensation programs: rationale and an overview of the Québec program. Can Commun Dis Rep. 2020; 46(9):305–308. PMID: 33104084.

24. Murray T. Canada’s long road to a vaccine injury compensation program. CMAJ. 2021; 193(8):E294–E295. PMID: 33619073.

25. Public Health Agency of Canada. Understanding Canada’s Vaccine Injury Support Program. Updated 2022. Accessed May 13, 2023. https://canvax.ca/sites/default/files/VISP%20Webinar%20Presentation%20-%20%20PHAC-RCGT_EN_%20%2020220607_.pdf .

26. du Québec G. Vaccine Injury Compensation Program. Updated 2023. Accessed May 13, 2023. https://www.Québec.ca/en/health/advice-and-prevention/vaccination/vaccine-injury-compensation-program .

27. Public Health Agency of Canada. Vaccine Injury Support Program – Statistics. Updated 2023. Accessed May 13, 2023. https://vaccineinjurysupport.ca/en/program-statistics .

28. Australian Government. COVID-19 Vaccine Claims Scheme (FAQ). Updated 2023. Accessed May 14, 2023. https://www.health.gov.au/sites/default/files/2023-04/covid-19-vaccine-claims-scheme-frequently-asked-questions.pdf .

29. Ministers Department of Health and Aged Care. Australia’s Biosecurity Emergency Pandemic Measures to End. Updated 2023. Accessed May 15, 2023. https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/australias-biosecurity-emergency-pandemic-measures-to-end .

30. The Sydney Morning Herald. Thousands Left Waiting for Compensation After Claims of COVID-19 Vaccine Injury. Updated 2023. Accessed May 15, 2023. https://www.smh.com.au/national/thousands-left-waiting-for-compensation-after-claims-of-covid-19-vaccine-injury-20230413-p5d03y.html .

31. Services Australia. Annual Report 2021–2. Updated 2022. Accessed May 15, 2023. https://www.servicesaustralia.gov.au/sites/default/files/2022-10/annual-report-2021-22.pdf .

32. Korea Legislation Research Institute. A comparison of laws for vaccination compensation among major countries-Japan-. Updated 2021. Accessed May 17, 2023. https://www.klri.re.kr/viewer/skin/doc.html?fn=fam-ip-21-20-1-h.pdf&rs=/doc_convert/FILE_000000000031009tHEz9 .

33. Minister of Health. Labor and Welfare. About the vaccination Health Damage Compensation System. Updated 2023. Accessed May 17, 2023. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/vaccine_kenkouhigaikyuusai.html .

34. Minister of Health. Labor and Welfare. A Concept of the Health Damage Compensation System. Updated 2023. Accessed May 17, 2023. https://www.mhlw.go.jp/content/10900000/001017433.pdf .

35. Minister of Health. Labor and Welfare. About the Health Damage Compensation System. Updated 2020. Accessed May 17, 2023. https://www.mhlw.go.jp/content/10906000/000588416.pdf .

36. Minister of Health. Labor and Welfare. Disease·Disability Review Committee: Infectious Disease·Vaccination Review Subcommittee - New Coronavirus Infectious Disease Vaccination Health Damage Examination Second Subcommittee Deliberation Results. Updated 2023. Accessed May 17, 2023. https://www.mhlw.go.jp/content/10900000/001102618.pdf .

37. Taiwan Centers for Disease Control. 2022 CDC Annual Report. Updated 2022. Accessed May 18, 2023. https://www.cdc.gov.tw/En/File/Get/SRjt-YHFqBdlrd5t_kA8nQ .

38. Taiwan Centers for Disease Control. Vaccination Victim Relief Instructions Booklet. Updated 2021. Accessed May 18, 2023. https://www.cdc.gov.tw/File/Get/YnyBgkKCGRl64UsjdcA1lw .

39. ThinkWell. Taiwan country brief – Sustainable Immunization Financing in Asia Pacific. Updated 2018. Accessed May 18, 2023. https://thinkwell.global/wp-content/uploads/2018/09/Taiwan-Country-Brief-081618.pdf .

40. Wang PC. Updates on vaccine injury compensation program in Taiwan and program evaluation. Epidemiol Bull. 2015; 31(18):149–158.

41. Attwell K, Drislane S, Leask J. Mandatory vaccination and no fault vaccine injury compensation schemes: an identification of country-level policies. Vaccine. 2019; 37(21):2843–2848. PMID: 31000414.

42. Ministry of Health Singapore. Vaccine Injury Financial Assistance Programme for COVID-19 Vaccination. Updated 2023. Accessed May 20, 2023. https://www.moh.gov.sg/covid-19/vaccination/vifap .

43. D’Errico S, Zanon M, Concato M, Peruch M, Scopetti M, Frati P, et al. “First do no harm.” No-fault compensation program for COVID-19 vaccines as feasibility and wisdom of a policy instrument to mitigate vaccine hesitancy. Vaccines (Basel). 2021; 9(10):1–14.

44. Dollars and Sense. Vaccine Injury Financial Assistance Programme (VIFAP): How Much Will MOH Be Insuring for Serious Side Effects Related to COVID-19 Vaccination? Updated 2021. Accessed May 20, 2023. https://dollarsandsense.sg/vaccine-injury-financial-assistance-programme-vifap/ .

45. National Health Security Office. No-Fault Compensation System in the Thai Universal Coverage Scheme. Updated 2020. Accessed May 23, 2023. https://eng.nhso.go.th//assets/portals/1/files/Infographics/646_NoFaultCompensation(Article41)_Info.pdf .

46. National Health Security Office. One billion baht paid to COVID-19 vaccine recipients experiencing side effects. Updated 2022. Accessed May 23, 2023. https://eng.nhso.go.th/view/1/home/News/409/EN-US .

47. Fairgrieve D, Borghetti JS, Dahan S, Goldberg R, Halabi S, Holm S, et al. Comparing no-fault compensation systems for vaccine injury. Tulane J Int Comp Law. 2023; 31(1):75–118.

48. Yang TG. Comparative Study of the Legal System on Vaccine Injury Compensation in Major Countries – Japan. Sejong, Korea: Korea Legislation Research Institute;2021.

49. Mungwira RG, Guillard C, Saldaña A, Okabe N, Petousis-Harris H, Agbenu E, et al. Global landscape analysis of no-fault compensation programmes for vaccine injuries: a review and survey of implementing countries. PLoS One. 2020; 15(5):e0233334. PMID: 32437376.

50. Crum T, Mooney K, Tiwari BR. Current situation of vaccine injury compensation program and a future perspective in light of COVID-19 and emerging viral diseases. F1000 Res. 2021; 10:652.