By Kuo-Hsun Hong & Jin-Hong Tsai, Partner and Associate of Formosan Brothers, Attorneys-at-Law

Since the start of Taiwan’s COVID-19 vaccination effort on March 22, 2021, the total number of vaccines administered has surpassed ten million. Reports of suspected serious adverse reactions from the vaccines have also been on the news from time to time.

According to the Ministry of Health and Welfare’s “Reports of Adverse Reactions to the COVID-19 Vaccines,” up to September 2, 2021, there have been a total of 3400 reports of “suspected serious adverse reaction to vaccination,” among which 712 are reports of death. Although whether such serious adverse reactions were indeed caused by vaccinations are yet to be determined case by case, but since adverse reactions are linked to vaccinations in terms of time sequence, their causes are therefore temporarily attributed to the vaccines. If one has a serious adverse reaction after vaccination, how should he/she seek relief under the law?

With respect to serious adverse reactions after vaccination, legal relief primarily includes: claims for “vaccination injury compensation” and “state compensation.” In terms of state compensation, in principle, the person claiming for compensation shall provide the essential facts. That is, such person shall prove that: an employee of the government was at fault (e.g., proving that a competent authority released a non-compliant vaccine by mistake during the vaccine examination or inspection process; proving that a competent authority provided wrong information by mistake when it was promoting vaccination policy, etc.),  health was indeed impaired and such impairment has a causal relationship with the wrongdoing (that it was indeed because of the vaccination of non-complaint vaccine that health was impaired), and the scope of the injury (e.g., the amount of salary lost due to disability, the necessary medical expenses, homecare expenses, mental harm, etc.). It is indeed a difficult process.

In addition to claiming state compensation, a person could also claim for “relief compensation as a vaccine victim” pursuant to Paragraph 1 of Article 30 of the Communicable Disease Control Act. In brief, if someone has a suspected serious adverse reaction after vaccination, as long as such person suspects that the adverse reaction is related to the vaccination, for example, if the two are “associated by time sequence (vaccination occurs before the reaction)” or “associated medically,” he/she may submit a claim to the local Department of Health where the vaccine was administered. A review committee will review the claim with respect to the correlation between the adverse reaction and the vaccination and decide whether the claimant could be compensated and the amount of compensation.

Since causality between vaccination and adverse reaction is difficult to be determined and difficult to be ruled out 100% (Was the adverse reaction actually caused by the vaccine? Or was it caused by the vaccine recipient’s own disease, or other factors not related to vaccination? That is, was the occurrence of the adverse reaction and the vaccination only a coincidence in time?), which is a characteristic of vaccine injury, the Regulations Governing Collection and Review of Vaccine Injury Compensation Fund (hereinafter the “Regulations”) classifies the relationship between vaccination and adverse reactions into three types: “unassociated,” “associated,” and “indeterminate.”If an adverse reaction is determined to be “associated” with vaccination, the claimant will be able to receive compensation. However, even if the relationship between an adverse reaction and the vaccination is “indeterminate,” that is, “one can neither  confirm nor 100% rule out the possibility that the adverse reaction was induced by the vaccination either,” the claimant may still claim compensation pursuant to the Regulations, with the difference being the amount of compensation is smaller than the “associated” type. Only when the adverse reaction is confirmed to be “unassociated” with vaccination, i.e., when the review committee can “100% rule out the possibility that the adverse reaction was induced by the vaccination,” the claimant will not receive any compensation.

When the correlation between adverse reaction and vaccination cannot be determined due to the limitation of existing medical science, the Regulations provides that the compensation will be funded by the “Vaccine Injury Compensation Fund.” This is the characteristics of this type of “relief system” (other examples are Drug Injury Relief Act” and “Childbirth Accident Emergency Relief Act”) – through a fund not belonging to either party of the vaccination process, a limited statutory compensation amount (the amount is not high, but the claimant does not need to bear the burden of proof for the extent of injury suffered), and a review process conducted by a third party (review conducted by a group of impartial members of society who are formally objective and professional), this type of incidents may receive the most fair, professional, and speedy processing possible. The “relief system” can slightly reduce the burden on victims of special injury incidents which often result in serious injuries but are difficult to be attributed to any party, preventing the circumstance that the victims cannot receive any compensation simply because they cannot prove the causality between vaccination and their adverse reactions.

In summary, if, unfortunately, a serious adverse reaction occurs after one receives vaccination, in terms of the level of difficulty in legal relief (with respect to burden of proof), claiming “relief compensation as a vaccine victim” pursuant to the Regulations bears less burden of proof, but the statutory amount for relief is fixed and not high. And the amount of compensation a victim may receive in actuality fully depends on the decision of the review committee; the amount may not be comparable to the injury suffered by the victim. On the other hand, if the victim would like to claim “state compensation” for all the injury suffered, he/she needs to bear a greater burden of proof. If it is difficult to determine the causality using existing medical science, the case may receive zero compensation due to lack of sufficient proof. Therefore, if one unfortunately suffers adverse reaction after vaccination, it is better to solicit professional medical or legal advices in subsequent relief effort to protect his/her own rights.
(This article was published in the Expert’s Commentary Column of the Commercial Times：https://view.ctee.com.tw/legal/32661.html）

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