從證據法角度討論COVID-19疫苗傷害因果關係之證據種類與證據力爭議：法律政策與科學不確定性之互動

Controversy over the Types and Strength of Evidence for Assessing the causality of COVID-19 vaccine injuries: The Interaction Between Legal Policy and Scientific Uncertainty

臺灣在2021年起大規模接種COVID-19疫苗，而2021-2022年間預防接種受害救濟申請案例暴增為8,564件。截至2023年6月8日，臺灣衛生福利部預防接種受害救濟審議小組（VICP）審議完成COVID-19疫苗案件共2,689例，其中303例獲得救濟佔11.26%，而2,386例則是不予救濟佔88.73%。相較之下，日本、香港、紐西蘭、芬蘭、挪威通過救濟比例皆遠高於臺灣，似乎顯示臺灣VICP採納證據標準稍嫌嚴格。
本文由證據法角度分析臺灣現行制度下疫苗不良事件因果關係判斷標準及所採用證據種類，檢視臺灣VICP審議COVID-19疫苗案件現況，發現VICP引用醫學證據的方式有以下特徵：一、致病機轉明確實驗室檢驗結果擁有最高證據力；二、選擇性採納人口群醫學證據；三、是否採納醫學個案報告標準不明確、不一致；四、過度重視統計學常態而忽略極端值（離群值）；五、VICP原則上認為接種者體質（既有健康風險）阻斷因果關係；六、VICP傾向採取診斷立場判斷COVID-19疫苗傷害因果關係。
為增進疫苗傷害救濟制度效能與客觀性，優化VICP使用科學證據方式之明確性與一致性，並滿足社會大眾合理期待，本文提出一些解決疫苗傷害因果關係爭議可能方案如下：一、因果關係分類更加細緻化、彈性化；二、適用民法「蛋殼頭蓋骨理論」承認多重因果關係；三、以舉證責任轉換、證明度降低方式採信疑似接種受害人事實主張；四、以法律規範目的判斷預防接種不良事件因果關係；五、科學不確定時可採納部分人口群及案例報告證據；六、適度承認新疫苗極端值案例因果關係；七、政府根據新證據主動職權撤銷以往行政處分。

Taiwan began large-scale vaccination against COVID-19 in 2021, and since then, the number of applications for vaccine injury compensation has surged to 8,564 between 2021 and 2022. As of June 8, 2023, the Vaccine Injury Compensation Working Group (VICP) in the Ministry of Health and Welfare has reviewed a total of 2,689 cases of COVID-19 vaccine applications. Of these, 303 cases (11.26%) received compensation, while 2,386 cases (88.73%) were not granted compensation.
This study analyzes the criteria used to assess the causality of adverse events following immunization under Taiwan's current system and examines the reasons behind the Vaccine Injury Compensation Working Group's (VICP) acceptance or rejection of compensation applications. How VICP cites medical evidence exhibits the following characteristics: Firstly, medical evidence with clear pathogenic mechanisms is given the highest evidentiary weight. Secondly, population-based or cohort studies are selectively utilized by VICP. Thirdly, VICP selectively adopts case report evidence without clear and consistent standards. Fourthly, there is an overemphasis on statistical normality, while outliers are often ignored. Fifthly, pre-existing medical conditions are often used to preclude any causal link between vaccination and adverse events. Finally, VICP is prone to consider the vaccine injury causality from a diagnostic point of view.
To enhance the effectiveness and objectivity of the vaccine injury compensation system, ensure clarity and consistency in the utilization of scientific evidence by the VICP, and meet the reasonable expectations of the public, this article proposes several solutions to address the dispute over the causality of vaccine injuries. Firstly, creating additional causality types to provide more flexibility in assessing causality. Secondly, applying the ''Eggskull Theory'' to acknowledge multiple causes of adverse reactions. Thirdly, shifting the burden of proof through the application of evidence rules. Fourthly, assessing causality in accordance with the purpose of legal norms. Fifthly, utilizing population-based studies and case reports to provide more support for the applicants. Sixthly, recognizing the causality of extreme value cases for new vaccines. Finally, based on new evidence and revised decisions, the government can proactively grant compensation to victims who were previously not compensated.