Introduction

Vaccination not only addresses the risk of exposure to infectious diseases but also contributes to broader societal protection. However, almost all vaccines have the potential to cause rare and serious side effects. These can range from mild symptoms such as pain at the injection site, fever, and muscle aches, to severe reactions like anaphylaxis [1]. Therefore, it is essential to establish a compensation system to appropriately address injuries resulting from vaccination, especially when a small number of individuals experience severe adverse events [1]. Many developed countries have integrated a system to compensate for vaccine-related injuries within their public social welfare systems [2]. Some studies provide a comprehensive review of these vaccine injury compensation systems across various countries, comparing and outlining their characteristics to predict future adopters and to guide policy development. However, these studies often do not delve into the background or the current status of the introduction and implementation of these systems [2–4].

In 1992, the Republic of Korea established a national system for compensating vaccine injuries at the administrative level through the Immunization Deliberation Committee. By 1994, this system was incorporated into the Contagious Disease Prevention Act, and the vaccine injury compensation program (VICP) has been operational since 1995 [5]. Meanwhile, Japan had already implemented a legal framework for vaccine injury compensation in 1977, and Taiwan followed with a similar program in 1988. Consequently, the introduction of VICPs in Japan and Taiwan preceded that in the Republic of Korea. Analyzing the current state of VICPs in Japan and Taiwan can provide valuable insights for the further development of the Republic of Korea’s VICP, given the cultural and institutional similarities among these countries. This study aimed to provide a foundation for future collaborations to better prepare for and respond to infectious diseases by understanding the VICPs of East Asian countries.

Materials and Methods

This study conducted a comprehensive review of VICPs in the Republic of Korea, Japan, and Taiwan. To assess the current state of VICPs in these countries, we searched national government websites and relevant literature. The primary databases consulted included PubMed, Embase, Korea Medical Database (KMbase), and the Research Information Sharing System (RISS). Additionally, we explored gray literature such as laws, guidelines, reports, and bulletins through Google. The search terms employed were vaccine AND injury; vaccine AND damage; “vaccine injury” AND compensation; “vaccine damage” AND payment; and “vaccine injury” AND [country name]. Our inclusion criteria encompassed peer-reviewed articles and official reports that discuss no-fault VICPs in specific countries. We excluded publications that dealt with compensation for injuries from vaccine clinical trials or damages due to medical malpractice. For articles in non-English languages, we utilized Google Translate and the automatic translation feature of Google Chrome for non-English web pages. When further clarification was needed, we consulted individuals fluent in the respective languages. Moreover, to ascertain specific details about the VICP that were not available through websites or literature, we sent email inquiries to experts in government agencies in Japan and Taiwan who are knowledgeable about their respective countries’ vaccine injury compensation systems. The inquiries focused on the causality assessment criteria used in each country’s VICP and were designed to be answered within 10 minutes. The findings from this comprehensive review are organized in a summary form. The data summarized include various aspects of the VICP such as historical background, legal basis, administrative entities and procedures, eligibility and scope of coverage, standard of proof, and available benefits.

Results

The Republic of Korea, Japan, and Taiwan provide Expanded Program on Immunization vaccines at no cost and offer additional vaccinations on a fee basis, following recommendations from expert groups [6]. These countries administer national immunization programs (NIPs) for children and the elderly, with the specific vaccine-preventable diseases targeted by the NIP varying by country (Table 1) [6–9]. While the range of vaccines eligible for vaccine injury compensation differs among these countries, injuries resulting from vaccinations administered through the NIP are generally eligible for compensation. Table 2 presents the legal framework, funding sources, administrative bodies and procedures, coverage scope, standards of proof, and benefits available in the VICPs implemented in the Republic of Korea, Japan, and Taiwan. A detailed examination of the current status of each country’s VICP follows.

Historical Background and Legal Basis

Republic of Korea

In the Republic of Korea, a significant outbreak of Japanese encephalitis (JE) occurred in 1983 and 1984, resulting in 55 deaths among 1,336 patients. This led to the implementation of a vaccination program for all children aged 3 to 15 starting in 1985 [10]. Despite this measure, reports of suspected adverse events related to the JE vaccine persisted into the early 1990s, including the death of a child in 1994 after vaccination. Therefore, discussions about introducing a VICP progressed [10]. On January 5, 1995, the Contagious Disease Prevention Act was amended to include Article 52–2, which mandated national compensation for vaccine-related injuries, funded by the national treasury [10]. Today, the VICP is primarily governed by the Infectious Disease Control and Prevention Act. The Enforcement Decree and Enforcement Rules of this Act detail the standards, eligibility, and procedures for compensation [5].

Japan

In Japan, specific measures to address health damage caused by vaccination were established in 1970 following Cabinet approval. Subsequently, the Vaccination Act was revised in 1976, and the Health Damage Relief System was implemented in 1977 [11]. In 1948 and 1949, an incident occurred where 924 individuals suffered health damage and 83 died due to an error by a manufacturing company in producing the diphtheria vaccine. Furthermore, between 1989 and 1993, many children contracted aseptic meningitis following vaccinations for measles, mumps, and rubella, affecting about 1,800 victims and leading to a class action lawsuit. These incidents have contributed to the recognition of the causal relationship between vaccines and injuries and have helped diminish the general distrust of vaccines [12]. The primary legal framework for Japan’s VICP is the Vaccination Act, which is divided into 2 main sections: the implementation of vaccinations (chapters 2–4) and health damage relief (chapter 5). The latter provides detailed provisions for compensation for vaccine-related injuries [13]. In Japan’s VICP, there is no legal foundation for establishing a compensation fund; instead, it is funded by the national treasury [11,13,14].

Taiwan

Taiwan initiated its VICP in 1988 by establishing the Compensation Relief Funds (CRFs) and associated regulations. This action was in response to an incident where a child developed polio after receiving an oral polio vaccine [15]. The VICP in Taiwan is grounded in Article 30 of the Infectious Disease Prevention Act and the Regulations Governing Collection and Review of Vaccine Injury Compensation Fund [16]. These legal frameworks dictate the management, funding, eligibility criteria, coverage scope, review committees, and benefits available under the VICP [17]. The primary financial source for compensating vaccine injuries is the CRF, which was established based on the National Vaccine Fund (NVF) introduced in 2010 [9,15]. The government finances the CRF through a premium of 1.5 new Taiwanese dollar (NTD [0.05 United States dollar]) levied on each vaccine procured via the NVF. This premium is paid by the vaccine’s manufacturer or importer, once the vaccine is approved and certified by the Taiwan Food and Drug Administration (TFDA) [18]. The premium rate is subject to adjustment if the fund’s size either exceeds NTD 200 M or falls below NTD 50 M. Additionally, the CRF is not solely dedicated to compensation payments; it also supports research and operational costs associated with managing adverse events following vaccination [18].

Administrative Entities and Procedures

Republic of Korea

The main administrative entity responsible for the VICP in the Republic of Korea is the Korea Disease Control and Prevention Agency (KDCA). The deliberation of compensation claims is handled by the Expert Committee on Vaccine Injury Compensation [19]. This committee consists of up to 25 members, as stipulated by the Regulations for Operating the Vaccination Injury Compensation Expert Committee and Vaccination Injury Investigation Team. Its members include experts in medicine, forensics, law, and vaccination-related fields, as well as high-ranking government officials [20]. Additionally, a Vaccination Injury Investigation Team, comprising up to 10 medical and legal experts, supports the committee by reviewing the causality between the vaccine and the injury [20]. To seek compensation for a vaccine injury, a claimant must submit application documents to the public health center. A city or provincial epidemiological investigator then prepares an investigation report and forwards it to the KDCA [21,22]. The Vaccination Injury Investigation Team evaluates this report and, if necessary, conducts a further detailed epidemiological investigation. Subsequently, the Expert Committee on Vaccine Injury Compensation deliberates on the existence of a causal relationship between the vaccine and the injury, determines the extent of compensation, and makes a decision on whether to award compensation [5]. The results of the deliberation are communicated to the claimant through the public health center and the city or province. Compensation is then disbursed by the KDCA [21]. Appeals against the committee’s decision can be filed at the public health center and are escalated to the KDCA through the city or province for administrative reconsideration. If still dissatisfied, the claimant has the option to initiate legal proceedings [5]. Previously, prior to the implementation of the coronavirus disease 2019 (COVID-19) vaccination, compensation for vaccine injuries could only be claimed if out-of-pocket medical expenses exceeded 300,000 Korean won (KRW). However, with the revision of the Enforcement Decree of the Infectious Disease Prevention Act in January 2022, this financial threshold was removed [22]. Furthermore, in instances where out-of-pocket expenses are below 300,000 KRW and the adverse effect is a general adverse reaction, the responsibility for review has been delegated to local governments at the city or provincial level [5].

Japan

The main administrative body responsible for addressing vaccine injuries in Japan is the Health Bureau of the Ministry of Health, Labor, and Welfare (MHLW). The key deliberative entity within this framework is the Disease and Disability Review Board, which is divided into the Vaccination Health Damage Recognition Committee and the Vaccination Health Damage Reexamination Committee [11]. This board is composed of fewer than 30 members, predominantly from the fields of medicine or natural sciences, with some members specializing in law [12]. To seek compensation for a vaccine injury, a claimant must submit the necessary documents to their local municipality. These documents are then assessed by the Vaccination Health Damage Investigation Committee established within the municipality. Following this review, the documents are forwarded to the MHLW via the prefectural governor. The MHLW reviews the recommendations of the Disease and Disability Review Board to determine eligibility for compensation. The final decision is relayed back to the municipality, where the head of the municipality informs the claimant and, if applicable, disburses the compensation [23]. Should the claimant find the decision unsatisfactory, they have the option to request a reconsideration from the prefectural governor [24]. Furthermore, if the claimant feels that the compensation awarded is inadequate, they may initiate legal action against either the head of the municipality responsible for the vaccination or the vaccine manufacturer [12].

Taiwan

Taiwan’s VICP is overseen by the Ministry of Health and Welfare (MOHW). The Taiwan Centers for Disease Control (CDC) handles the administrative and preparatory tasks [15]. The program’s deliberative body, the Vaccine Injury Compensation Program Working Group (VICPWG), comprises 19 to 25 experts from fields such as medicine, pharmacy, public health, anatomy, pathology, law, and social justice. Notably, legal and social justice experts make up more than one-third of the VICPWG’s membership [25]. To seek compensation for vaccine-related injuries, a claimant must apply to their local health bureau. The responsible official at the bureau then compiles an investigation form and forwards it, along with the application documents, to the Institute for Biotechnology and Medicine Industry (IBMI) [15,26]. The IBMI sends the gathered data to the MOHW, where it is reviewed by the VICPWG [15]. Following this review, the case is discussed at a VICPWG meeting, regularly convened by the Taiwan CDC, to assess the connection between the vaccine and the injury and to determine the compensation amount [15]. The final decision is relayed to the IBMI, which then informs the claimant [15]. If the compensation is approved, the claimant must fill out and submit receipt information to the local health bureau, which verifies the details and disburses the compensation [15]. Should the claimant disagree with the decision or be dissatisfied with the compensation amount, they have the right to appeal to the Petitions and Appeals Committee. If dissatisfaction persists following the committee's decision, the claimant may file a lawsuit against the MOHW [15].

Eligibility and Scope of Coverage

Republic of Korea

If an individual experiences illness, disability, or death following a mandatory or temporary vaccination, or after receiving preventive or therapeutic medicine for bioterrorism or other infectious disease outbreaks, they may be eligible to file a claim for vaccine injury compensation [27]. Claims must be submitted within 5 years from the date the injury occurred post-vaccination, or within 5 years from the date of diagnosis of the disability or the date of death [21]. Additionally, individuals who sustain vaccine injuries from non-mandatory vaccinations can seek compensation through the adverse drug reaction relief system managed by the Ministry of Food and Drug Safety [5].

Japan

In Japan, individuals can apply for health damage relief if they experience illness, disability, or death following routine vaccinations for category A and B diseases or temporary vaccinations [13]. Vaccinations targeting category A diseases aim to prevent mass outbreaks and are typically administered to children. Conversely, vaccinations for category B diseases focus on preventing outbreaks on an individual level and are generally given to the elderly [13,28]. There is no deadline for filing compensation claims for vaccine-related injuries from category A diseases. However, the deadlines for filing claims related to category B diseases are as follows: (1) claims for medical expenses must be filed within 5 years of payment, (2) claims for medical allowances must be filed within 5 years from the first day of the month after the treatment, and (3) claims for survivor's pensions, lump-sum survivor's payments, and funeral expenses must be filed within 5 years of the date of death. Additionally, if there is a decision to pay medical expenses, medical allowances, or a disability pension, the claim must be filed within 2 years [23]. For health damage resulting from voluntary vaccinations against category B diseases, the Pharmaceuticals and Medical Devices Agency is responsible for compensation [28].

Taiwan

In Taiwan, compensation claims for vaccine injuries must be submitted within 5 years of the occurrence of the injury or within 2 years from when the injury is recognized as vaccine-related. Eligible vaccine injuries for compensation include death, disabilities, severe illnesses, and other adverse reactions [9,15]. The Taiwan VICP provides compensation for injuries caused by vaccines that are either licensed by the TFDA or imported with a business license and have passed inspection or a written review [9,15]. The coverage extends to injuries from routine and compulsory vaccines, self-paid vaccines, specially imported vaccines, off-label vaccines, and vaccines used for post-exposure prophylaxis. For self-paid vaccines, injuries are covered because they have been approved by the TFDA and have undergone the necessary inspections and reviews. In the case of specially imported vaccines, coverage is provided for injuries even if the vaccines are not certified, provided they pass inspection or a written review. For vaccines used off-label, such as those administered outside the recommended age range specified in the manual, injuries are covered if the vaccines are used for preventive purposes. Regarding post-exposure prophylaxis, vaccines used for preventive purposes, including those for measles, varicella, hepatitis A, rabies, and tetanus, are also covered [29].

Standard of Proof

Republic of Korea

In the Republic of Korea, the causality assessment criteria for the VICP are divided into 5 categories: (1) definitely related, (2) probably related, (3) possibly related, (4) probably not related, and (5) definitely not related [5]. The category “probably not related” encompasses 2 scenarios: (a) insufficient data on the vaccine and adverse reactions, and (b) cases more likely attributed to causes other than the vaccine [5]. Compensation for vaccine injuries is provided for cases categorized as “definitely related,” “probably related,” and “possibly related” [5]. However, specifically for COVID-19 vaccine injury claims, support for medical expenses is available even when causality is unclear, provided the injury is unlikely to be due to causes other than the vaccine [22].

Japan

In Japan, the process of determining causality is conducted from a medical standpoint for each case, based on the presence of symptoms that are medically rational, temporally proximate, and cannot be attributed to other causes [30]. Furthermore, compensation for vaccine injuries is granted even when it cannot be conclusively denied that the symptoms resulted from vaccination [30]. According to an email inquiry conducted with experts at the National Institute of Infectious Diseases, Japan prefers the term “relief fund” over “compensation.” This terminology is used because medical expenses are covered unless it can be definitively proven that the damage is 100% vaccine-related. The causality assessment criteria for the VICP include 4 categories: (1) definitely related, (2) probably related, (3) cannot determine if the event is related due to insufficient information, and (4) not related. Compensation is provided for cases that fall into the first 3 categories, with the exclusion of cases categorized as “not related.”

Taiwan

In Taiwan, the criteria for causality assessment in the VICP are outlined in Article 13 of the Regulations Governing Collection and Review of Vaccine Injury Compensation Fund [17]. The regulations define 3 categories of causality: (1) associated, (2) indeterminate, and (3) unassociated. Compensation is awarded when the results of the causality assessment are either “associated” or “indeterminate” [9]. According to an email inquiry conducted by experts at the Taiwan CDC, the causality assessment criteria were updated in 2018 to align with World Health Organization standards, incorporating these 3 categories. Moreover, the criteria used to assess causality between adverse events following immunization surveillance and vaccine injury compensation are very similar. However, a comprehensive review of data is undertaken when evaluating causality for vaccine injury compensation.

Available Benefits

Republic of Korea

The types of compensation provided by the Republic of Korea’s VICP include medical expenses, fixed nursing expenses, lump-sum compensation for the disabled, lump-sum death compensation, and funeral expenses. Medical expenses are compensated for, excluding amounts covered by medical insurance or medical benefits. Fixed nursing expenses are set at 50,000 KRW per day, but only for inpatient care. For lump-sum compensation for the disabled, 55% of the lump-sum death compensation is awarded for mild cases, and 100% for severe cases, as defined by the Act on Welfare of Persons with Disabilities. If the disability level is recognized under other laws, 10% of the lump-sum death compensation is paid. The lump-sum death compensation itself is calculated by multiplying the monthly minimum wage, as defined by the Minimum Wage Act, by 240 at the time of death. Funeral expenses are covered up to 300,000 KRW [5,21].

Japan

In Japan, compensation for vaccine injuries resulting from routine vaccinations for category A diseases includes coverage for medical expenses, a monthly medical allowance, an annual nursing pension for children with disabilities, annual disability pensions, a lump-sum death payment, and funeral expenses. For injuries from vaccinations for category B diseases, compensation covers medical expenses, a monthly medical allowance, annual disability pensions, an annual survivor's pension, a lump-sum survivor’s payment, and funeral expenses (Table S1) [23]. A nursing pension for children with disabilities is provided to caregivers of children under the age of 18 who have been disabled due to vaccination. Adults over the age of 18 who are disabled due to vaccination receive a disability pension; this requires a recognized transition from the nursing pension for children with disabilities. The lump-sum death payment and the lump-sum survivor’s payment are awarded to the spouse or a surviving family member who shares the same livelihood as the deceased individual. If the deceased was the family breadwinner, the survivor’s pension is paid to the surviving family members [23].

Taiwan

The compensation guaranteed by Taiwan’s VICP is determined by the “level of causal relationship” and the “severity of the injury” [9]. In cases of death, disability, severe illnesses, and other qualifying adverse reactions, if the causality assessment results are “associated” or “indeterminate,” the compensation amount is set within specified lower and upper limits based on the severity of the injuries and is paid as a lump-sum payment (Table S2) [9]. To determine the compensation amount, certain criteria must be met: for disabilities resulting from vaccination, a disability certificate specifying the type of disability must be issued; severe illnesses must be included on the Catastrophic Illness List from the National Health Insurance; and other adverse reactions must be covered under specific policies [15].

Discussion

This study conducted a comprehensive review of the historical background, legal foundations, administrative bodies and procedures, eligibility and coverage scope, standard of proof, and benefits available under the VICPs in the Republic of Korea, Japan, and Taiwan. Each country’s VICP has evolved uniquely, influenced by its own cultural history and shaped by distinct policies and laws [1]. The structure and approach of the VICP vary from country to country, yet each is effectively integrated with the nation’s social welfare system [2]. The review reveals both similarities and differences in the VICPs of the Republic of Korea, Japan, and Taiwan. In all 3 countries, the government plays a pivotal role in facilitating investigations into vaccine-related injuries and managing compensation procedures according to legal statutes. Regarding the funding sources for compensation, the national treasury provides the funds in the Republic of Korea and Japan, whereas in Taiwan, compensation is financed through a fund generated by premiums collected on vaccines. For VICPs to fulfill their purpose of providing compensation, it is crucial to establish a sustainable balance in the funding mechanisms for these programs [1].

Second, VICPs in the Republic of Korea, Japan, and Taiwan are implemented at all levels of the government. These countries have established administrative systems that handle VICP claims and prepare for deliberations at the municipal level, while the central government is responsible for the final deliberations and decisions regarding compensation. Additionally, the central government agency, which is the primary entity operating the program, establishes an expert committee to deliberate on compensation for vaccine injuries. If individuals are dissatisfied with the decision, they have the right to file an appeal, leading to an administrative reconsideration. Should they remain unsatisfied with the outcome, they can pursue legal action. Providing government-led, fee-free administrative support to claimants throughout the compensation process can help make the system more user-friendly and accessible.

Third, VICPs in the Republic of Korea, Japan, and Taiwan compensate for vaccine injuries corresponding to their NIPs. However, the vaccines covered by each NIP vary. Additionally, the scope of vaccines covered by VICPs differs. In the Republic of Korea and Japan, VICPs cover injuries from vaccines included in the NIP. Injuries from vaccines not included in the NIP can be compensated through an adverse drug reaction relief system. In Taiwan, the VICP covers injuries from all vaccines administered for preventive purposes within the country.

Fourth, the Republic of Korea, Japan, and Taiwan have independently established standards to evaluate causality between vaccination and injuries. Under the guidance of government-led expert committees, these countries assess the causal relationship between vaccines and injuries for compensation purposes, relying on epidemiological and medical evidence. A causal relationship is generally recognized when there is a temporal association between the administration of the vaccine and the subsequent injury, and it is improbable that the injury was caused by factors other than the vaccination [29–31]. However, Japan and Taiwan employ relatively lenient standards in recognizing claims for vaccine injury compensation. In these countries, compensation may be granted even in cases where a causal link between the vaccination and the injury cannot be definitively established. In contrast, the Republic of Korea applies a more relaxed standard specifically for COVID-19 vaccine injury compensation. Here, medical expenses are covered even if causality is difficult to establish, provided that the likelihood of the injury being caused by other factors is not greater than that of it being caused by the vaccine [22].

Fifth, in the Republic of Korea, Japan, and Taiwan, compensation is typically paid as a lump sum, with the amount determined by considering the level of disability. In Japan, however, pension payments are also taken into account. Additionally, the compensation calculation considers the type of vaccination and the characteristics of the target population. In Taiwan, compensation amounts vary and are set within minimum and maximum limits, based on the level of causal relationship and the severity of the injury. When comparing the available benefits for compensation, it is evident that the VICPs in Japan and Taiwan offer more detailed items and standards than the VICP in the Republic of Korea.

Finally, this review examined the VICPs in Japan and Taiwan, noting their cultural and institutional similarities, and offers insights into the current situation in the Republic of Korea with a focus on key issues. Over the long term, the VICP could become an integral part of social welfare and be implemented as a policy. Therefore, to facilitate future policy changes, it will be essential to thoroughly discuss and study these key issues and explore ways to introduce the necessary expertise to build a social consensus.

Conclusion

This study conducted a comprehensive review of VICPs in the Republic of Korea, Japan, and Taiwan. Each country’s VICP operates uniquely, influenced by its economic capacity and legal framework. Therefore, understanding the current state of VICPs in these nations is crucial for guiding policy reviews [4]. Given that these systems may change based on national circumstances and societal needs, ongoing research into these systems is necessary [32]. Variations in the VICPs across these countries can enhance existing programs, and modifications to the VICP are vital to adapt to evolving conditions [33]. Thus, this study’s exploration of the similarities and differences in VICPs in the Republic of Korea, Japan, and Taiwan offers valuable insights for the future development and management of domestic systems. Additionally, this study aids in fostering future collaborations with East Asian countries to better prepare for and manage infectious diseases.

HIGHLIGHTS

• There are differences in the financial resources allocated for compensation for vaccine injuries. The Republic of Korea and Japan fund compensation through the national treasury, whereas in Taiwan, it is financed by a fund that is supported by premiums levied on vaccines.

• Vaccine injury compensation programs (VICPs) in the Republic of Korea and Japan cover vaccine injuries that fall under the national immunization program; however, Taiwan’s VICP extends coverage to injuries from all vaccines administered for preventive purposes within the country.

• The Republic of Korea, Japan, and Taiwan have each established independent standards for evaluating the causality between vaccination and injuries. Japan and Taiwan apply relatively relaxed criteria when recognizing eligibility for vaccine injury compensation.

• In the Republic of Korea, Japan, and Taiwan, compensation is paid as a lump sum, with the amount determined based on the level of disability. In Japan, pension payments are also taken into account. In Taiwan, compensation amounts vary and are set within lower and upper limits, depending on the level of causal relationship and the severity of the injury.

Supplementary Material

Article information

Ethics Approval

Not applicable.

Conflicts of Interest

Jong-Koo Lee has been the editor-in-chief of Osong Public Health and Research Perspectives since October 2021. The other authors have no conflicts of interest to declare.

Funding

This research was supported by a grant from the KDCA (2023).

Availability of Data

All data generated or analyzed during this study are included in this published article. For other data, these may be requested from the corresponding author.

Authors’ Contributions

Conceptualization: CRK, YJC, JKL; Data curation: CRK; Funding acquisition: JKL; Literature review: CRK, YJC; Methodology: all authors; Supervision: CKR, YJC, JKL; Validation: all authors; Visualization: CRK; Writing–original draft: CRK; Writing–review & editing: all authors. All authors read and approved the final manuscript.

Additional Contributions

The authors are grateful to Hajime Kamiya (Japan’s National Institute of Infectious Diseases) and Yung-Ching Lin (Taiwan CDC) for providing information on the specific status of VICPs in each country.

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