Taiwan Covid Vaccine NFCS

Introduction

Taiwan had an existing no-fault compensation scheme for vaccines created 1 June 1988, and which incorporated covid-19 vaccines from 22 March 2021.

This scheme was created under national legislation, the Infectious Diseases Prevention and Control Act and the associated Regulations Governing Collection and Review of the Vaccine Injury Compensation Fund.

It is administered by the Taiwan Centers for Disease Control (CDC), who are a public body.

The funding for the scheme comes from a Levy.

Vaccines Covered

This NFCS covers nationally approved vaccines administered by the Government regardless of purchase or donation. Article 2 of the Regulations specifies that covered vaccines are

 'vaccines that have been issued a permit or approved for importation under a special case status by the central competent authority and have been found qualified by testing or document review.'

It includes vaccines approved for emergency use and standard approvals.

Injuries Covered

This NFCS covers both temporary and permanent injuries.

Under this NFCS any injury is potentially covered. The scheme will not cover if the adverse reaction is 'commonly seen, mild and expected after vaccination.'

Charges for making a claim

There is no charge for making a claim under this scheme. 

Claimants

Under this scheme the following categories of individuals are permitted to make a claim.

• Vaccine recipients
• a legal heir if the vaccine recipient has died

Article 5 of the Regulations sets out eligibility to make a claim. There is no mention of representatives being able to claim or what happens for those who lack capacity. It is unclear whether a claimant is allowed to nominate a legal representative to make their claim. There is no mention of funding for legal representation being provided by the scheme.

Losses covered

This scheme pays the following

Live Vaccine Recipient	Dependants of Vaccine Recipient	Legal heir of deceased vaccine recipient
Compensation payments are for general categories and are not broken down into economic and non-economic losses.	No Compensation is provided.	Compensation payments are for general categories and are not broken down into economic and non-economic losses.

Payments consist of a lump sum payment.

It is unclear whether funeral expenses are available under this NFCS. Article 19 of the Regulations state ‘In a case where death of the alleged victim is suspected to be associated with vaccination and pathological autopsy has been performed, the case may be awarded a funeral subsidy of NT$300,000.’ While this is termed a ‘funeral subsidy’ it appears to be intended to cover the expense of the autopsy rather than a contribution towards burial expenses and this may be a translation issue. This subsidy payment appears to be available to both successful and unsuccessful claimants.

Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification. The quantum of compensation awarded is set out in the Attachment Criteria for Compensation and depends on the injury suffered and the conclusion on causality between the vaccine and the injury. The Attachment Criteria for compensation can be downloaded from the Regulations, and is as follows:-

Death 

Type of Compensation	Causality Assessment	Amount of Compensation (NTS$100,000)
Death	Associated	50-600
Death	Indeterminate	30-350

 

Disability - determined by the types and degrees of disability set forth in regulations for the protection of they physically and mentally disabled 

Type of Compensation	Degree of disability	Causality Conclusion	Amount of compensation (NTS$100,000)
Disability	4 - extremely severe	Associated	50-600
Disability	4 - extremely severe	Indeterminate	30-350
Disability	3 - severe	Associated	30-500
Disability	3 - severe	Indeterminate	20-300
Disability	2 - moderate	Associated	20-400
Disability	2 - moderate	Indeterminate	10-250
Disability	1 - mild	Associated	10-250
Disability	1 - mild	Indeterminate	5-200

 

Severe Illness - Illnesses determined by the Catastrophic Illness List from the National Health Insurance or based on severe adverse reactions of medicament as defined in the Regulations for Reporting Severe Adverse Reactions of Medicaments, which do not reach the definition of disability

Type of Compensation	Causality Conclusion	Amount of compensation (NTS$100,000)
Severe Illness	Associated	1-300
Severe Illness	Indeterminate	1-120

Other Adverse Reactions - Other adverse reactions not meeting the definition of severe illnesses. However, commonly seen, mild and expected adverse reactions of vaccination will not be compensated.

Type of Compensation	Causality Conclusion	Amount of compensation (NTS$100,000)
Other Adverse Reactions	Associated/indeterminate	1-20

Loss of earnings are not paid/paid under this scheme.

Compensation under this scheme is capped, with a top value of NT$600,000,000

There is no minimum claim value under this NFCS.

There are certain payments which appear to be a contribution towards the costs of medical care and autopsy services. These are available when the situations set out in Article 19 have occurred regardless of whether the claim is found to be associated with the vaccination. Article 19 states:-

1. In a case where severe adverse reactions suspected to be associated with vaccination are not considered so following review, the case may be awarded a subsidy up to NT$200,000 after giving considerations to reasonable costs of examination and medical care incurred by the alleged victim for the purpose of clarifying the association between the victim’s symptoms and vaccination.

2. In a case where death of the alleged victim is suspected to be associated with vaccination and pathological autopsy has been performed, the case may be awarded a funeral subsidy of NT$300,000.

3. In a case where a pregnant woman’s stillbirth or miscarriage is suspected to be associated with vaccination, and the fetus or embryo has been autopsied or examined, the case may be awarded a subsidy of NT$100,000 if the gestation was 20 weeks or longer, or NT$50,000 if the gestation was less than 20 weeks.

Time limits for claims

An injury will only be eligible for compensation if it occurs within ‘a reasonable time’ of the vaccination. This is not specified any further.

A claim under the scheme must be brought within 5 years from the onset of the adverse event or 2 years from the knowledge that the vaccine caused the adverse event.

Evaluating claims – standard of proof required

Claims are evaluated by a Vaccine Injury Compensation Working Group. The Working Group meets at least every 60 days and is comprised of 19-25 members including experts in medicine and pharmacy, health, anatomy and pathology, law, and impartial members of the community, etc. However, legal experts or impartial members of the community (non-medical experts) must take up more than 1/3 of total members. Article 9 of the Regulations defines four functions of the Working Group.

1. Review of vaccine injury compensation claims
2. Assessment of causality between vaccination and alleged injury
3. Determination of the amount of compensation for each vaccine injury
4. Determination of other matters related to vaccine injury compensation.

The Scheme has an interesting causality assessment, set out in Article 13 of the Regulations, with three categories, associated, unassociated and indeterminant, where associated and indeterminant  claims are compensated, but at different quantum.

Unassociated: The assessment result will be “unassociated” if any of the following situations applies:

1. Clinical examination or the laboratory test result substantiates that the injury was caused by something other than vaccination.
2. Medical evidence shows no causality or medical evidence does not support causality.
3. Medical evidence supports causality. However, the injury did not occur during a reasonable period of time following vaccination.
4. It is determined in consideration of medical principles and following a comprehensive review that there is no support for causality between the alleged injury and vaccination.

Associated: The assessment result will be “associated” if the following situations all apply:

1. Medical evidence, clinical examination or the laboratory test result supports causality between vaccination and the alleged injury.
2. The alleged injury occurred within a reasonable period of time following vaccination.
3. After a comprehensive review, it is determined that a significant association exists.

Indeterminate: The case is free of the situations described in the preceding two subparagraphs and causality cannot be determined following a comprehensive review.

“Medical evidence” referred to in the preceding paragraph is defined as evidence from a population-based study or pathogenesis study that is published in a domestic or foreign journal.

“Determined following comprehensive review” referred to in Paragraph 1 is defined as professional medical judgment made after giving considerations to the medical history of the alleged victim before and after vaccination, the alleged victim’s family history, adverse reactions experienced by the alleged victim in the past after receiving analogous vaccines, medications taken by victim, victim’s exposure to toxins, biologic coherence and other relevant factors.

Appeals and the right to litigate

It is not clear how the scheme interacts with product liability litigation, there is no mention in the legislation, so it seems likely that an affected individual could litigate.

If a claimant rejects the Working Group’s decision they can ask for an internal review or they can ask the courts for a review.

Useful information and links

The CDC produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc)

Legislation

Infectious Diseases Prevention and Control Act

Regulations Governing Collection and Review of the Vaccine Injury Compensation Fund