| 英文摘要 |
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. |
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