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標題: | 預防接種受害救濟中的因果關係 The Causation in Administrative Remedy of National Vaccine Injury Compensation Program |
作者: | 余志磊 Zhi-Lei Yu |
指導教授: | 林明昕 Ming-Hsin Lin |
關鍵字: | 預防接種受害救濟,疫苗,不良事件,因果關係,疫學因果關係,舉證責任轉換,特別犧牲,社會補償,實證醫學,傳染病防治, Vaccine Injury Compensation,Immunization,Adverse Event,Causation,Epidemiologic Causation Theory,Reverse Burden of Proof,Special Sacrifice,Social Compensation,Evidence-based Medicine,Communicable Disease Control, |
出版年 : | 2022 |
學位: | 碩士 |
摘要: | 預防接種之推行除預防個體感染疾病,在公共衛生上亦能防治傳染病,杜絕傳染病之發生、傳染和蔓延。基於特別犧牲及社會安全之實現,傳染病防制法第30條規定了「預防接種受害救濟」制度,對於因預防接種之不良事件而蒙受損害者提供人道的社會補償。現行法「預防接種受害救濟基金徵收及審議辦法」將受害情形與疫苗是否具有因果關係之判斷方式明文化,並以「關聯性」稱之,以取代「因果關係」。
上開因果架構參考自世界衛生組織出版之「預防接種不良事件因果關係評估準則」,該架構基於流行病學及醫學實證文獻為中心發展。然而此一判斷方法並未考量預防接種受害救濟中特別犧牲以及社會補償之法規意旨,亦與法院所採行之因果關係架構──如:相當因果關係、疫學因果關係──不同。 本研究詳盡地介紹預防接種受害救濟因果評估中的實證醫學、「預防接種不良事件因果關係評估準則」之內容、整理出此類因果關係中之三要件,並再訪法學上因果關係之架構以及爬梳法院穩定之實務見解(諸如:預防接種不良事件因果關係評估準則之承認、判斷餘地之適用、客觀舉證責任之轉換)。 本研究亦對實體法、程序事項提出具體可操作之修正,以兼顧實證醫學及法規目的之實踐。第一,雖然預防接種受害救濟訴訟中有判斷餘地之適用,惟參考司法院釋字第533號解釋意旨,應提高審查密度,並進行形式審查;第二,不宜過度嚴格檢視文獻評讀,以使醫學實證文獻得適切地建立抽象因果關係;第三,宜將現行法中醫學實證之定義擴張及於個案報告,以緩和過於嚴格之因果架構,使本就罕見之不良事件受害者得以接受救濟(而法院應理解,個案報告已幾是醫學實證及形式審查之極限);第四,預防接種不良事件因果關係評估準則以及流行病學、實證醫學中之否證原則,仍有排除因果關係存在之適用空間。 綜上所述,本研究希望透過上開見解,適切平衡公共衛生政策之目的、法規本旨及實證醫學觀點,在救濟中以科際整合之手法推進並構築一個平衡的因果關係架構。 The Vaccination program directly benefits immunized individuals from infectious diseases, and indirectly benefits unimmunized individuals through community immunity. Consequently, vaccination programs guard against occurrence, infection and spread of communicable diseases in terms of public health. In accordance with Article 30 of the Communicable Disease Control Act, Vaccine Injury Compensation Program (VICP) provides humanitarian relief compensation for victims suffering from adverse event due to vaccination on the basis of two conceptions: special sacrifice and social security. The existing Regulation, Regulations Governing Collection and Review of Vaccine Injury Compensation Fund, regulates the method of causality assessment between vaccination and alleged injury (§13), adopting the term of “association” instead of causality or causation. The written causation stated above refer to the publication of World Health Organization (WHO): “Causality assessment of an adverse event following immunization (AEFI).” Nevertheless, the methodology of causality assessment in the publication is based on epidemiology and evidence-based medicine (EBM). The causality assessment doesn’t incorporate purposes of VICP, i.e., the assessment in the Regulation did not ensure adequate and sufficient consideration to special sacrifice and social compensation. Furthermore, there are substantial disparities between the causality assessment and causation theories admitted by our Court, e.g., adequate causation theory or epidemiologic causation theory. This study comprehensively introduces the concepts of evidence-based medicine in the causality assessment of VICP and the content of “Causality assessment of an adverse event following immunization (AEFI),” recapitulating the three constituent elements of causation theory in VICP as well. In addition, the study provides holistic reviews of causation theories admitted by the Court and principles established in the VICP judgements (e.g.,” margin of appreciation,” reverse burden of proof, and the admission of WHO’s causality assessment). To take both purposes of VICP and evidence-based practice into account, this research proposes several amendments to the Regulation and the procedural process. (1) Notwithstanding the application of “margin of appreciation” has been admitted by the Court in the VICP litigations, in accordance with the terms of reference of Judicial Yuan Constitutional Interpretation No. 533, the Court is supposed to adopt a more rigorous standard of judicial review by conducting formality examination in VICP litigations. (2) During the practice of EBM, the step of appraising the evidence ought to be performed fairly and properly to allow the abstract causation being established reasonably. (3) Our government shall broaden the current definition of “medical evidence” in the Regulation to include “case report.” By adopting a more lenient standard, more rare cases suffering from AEFI could become eligible for relief compensation. And the Court shall notice that the case report is almost the limit of medical evidence and formality examination in the VICP litigations. (4) The principle of refutation in EBM, epidemiology and WHO’s causality assessment remains applicable to disconfirm the existence of causation in far-fetched cases. In conclusion, this study proposes legal interpretations stated above, aiming to resolve the disagreements between public health policies, purposes of VICP and evidence-based practice. Via interdisciplinary methodology, ultimately, this research advances and constructs a well-balanced causation theory in administrative remedy of VICP. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/87263 |
DOI: | 10.6342/NTU202300531 |
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顯示於系所單位: | 法律學系 |
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