由美、日經驗檢討我國預防接種救濟制度：從H1N1新型流感疫苗談起

Comments on the Relief for Victims of Immunization in Taiwan Based on the Experiences of the U.S.A. and Japan: With Special Reference to H1N1 Vaccine

邱玟惠(Wen-Hui Chiu)

《臺大法學論叢》 40卷2期 (2011/06) Pp. 629-705

https://doi.org/10.6199/NTULJ.2011.40.02.04

摘要

預防接種制度確有其公共衛生政策上之正面意義，因此各國多有針對預防接種受害者特別設置預防接種被害之補償制度。預防接種救濟案件之審議，其目的係在於救濟與否之決定，不在於醫學原因之闡明，因而審議之際如不能理解救濟制度之創設緣由，而以嚴格的因果關係原則審核救濟案件，將偏離救濟制度之本旨。較諸美國與日本之預防接種救濟法制，我國目前之預防接種救濟制度則有因果關係之認定標準上未見緩和、審議小組掌准駁大權、行政法院並未進行實質審理等問題點。針對救濟案件之審查，本文建議：一、在因果關係之審議原則上，應該充分考量預防接種所具有之公共衛生意義，採行柔軟化之因果關係判定原則，亦即放寬因果關係認定之標準以及減輕被害人之證明程度要求，並將之規定於具有法律位階之傳染病防治法中；二、對審議小組成員結構上，應由法界人士占審議成員之半數以上，方能衡諸醫學以外之諸多社會性、法律性及政策性考量，真正落實預防接種救濟制度之設立宗旨；三、對於新式疫苗之特別行政對應上，應倒置舉証責任改由衛生署負擔推翻因果關係之舉證責任。藉此希能發揮救濟制度之創設本旨，由預防接種救濟制度而非民眾個人，負擔此「集體預防接種上不可避免的代價」，以使全社會共享預防接種之族群免疫力。

關鍵字

H1N1新型流感 ； 疫苗 ； 預防接種 ； 受害救濟 ； 因果關係 ； 國家賠償 ； 傳染病防治法 ； 預防接種受害救濟基金徵收及審議辦法 ； 預防接種受害救濟審議小組 ； VICP

並列摘要

Vaccines are widely regarded as one of the greatest achievements in the contemporary public health. Though vaccines are so effective in preventing untold numbers of people from contracting potentially fetal diseases, yet we should not forget that vaccines also carry a modicum of risk, which urges the government worldwide to initiate some compensation or relief strategy for the vaccine victims.
Our government also has enacted Communicable Disease Control Act, which states (§30) ”Vaccine victims may apply for relief compensation” However, some hindrances are still facing us, namely, the difficulty in proving the causation between vaccination and the injury, the review subcommittee on the relief of immunization hazards and the administrative courts did not work fairly.
This article held that (1) On account of the significance of vaccination on the public health and the compliance of the vaccine victims in taking vaccination, the burden of proof on the vaccine victims concerning the causation between vaccination and the injury should be properly alleviated in legislation; (2) The legal experts shall account for at least half of the number of members of the review subcommittee on the relief of immunization hazards in order to realize the fairness and justice of the relief compensation in accord with the goal of Regulations Governing Collection and Review of Relief Fund for Victims of Immunization; (3) We should adapt special administrative relief strategy in response to new vaccines, with special reference to the burden of proof on causation, which should be reversed onto the alleged party because proving the unknown pathogenic mechanism of the new vaccines would certainly fall far beyond the ability of vaccine victims.
With the understanding herein, the herd immunity could be achieved, moreover, the unavoidable harm of mass inoculation could be properly relieved and well compensated.

並列關鍵字

pandemic H1N1 influenza ； vaccine ； immunization ； injury compensation or relief ； causation ； state compensation ； Communicable Disease Control Act ； Regulations Governing Collection and Review of Relief Fund for Victims of Immunization ； Review Subcommittee on the Relief of Immunization Hazards ； VICP

參考文獻

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行政院衛生署（2010a）。〈行政院衛生署公告：預告「預防接種受害救濟基金徵收及審議辦法」部分條文修正草案〉，《行政院公報》，16 卷18 期，頁2695-2699。（Department of Health, Executive Yuan [2010a]. Public notice of Department of Health, Executive Yuan: The draft amendment on partial articles of "Regulations Governing Collection and Review of Relief Fund for Victims of Immunization". Executive Yuan Gazette, 16[18], 2695-2699.）

行政院衛生署（2010b）。〈行政院衛生署令：修正「預防接種受害救濟基金徵收及審議辦法」部分條文〉，《行政院公報》，16 卷32 期，頁4429-4430。（Department of Health, Executive Yuan [2010b]. Order of Department of Health, Executive Yuan: Amendment on partial articles of "Regulations Governing Collection and Review of Relief Fund for Victims of Immunization". Executive Yuan Gazette, 16[32], 4429-4430.）