【醫療行政法】H1N1疫苗接種救濟案：預防接種救濟審議小組之合法組成、預防接種救濟因果關係之認定【學習式判解評析】   全文下載

Comment on the composition of Review Subcommittee and causation determination in the Relief of Immunization Hazards

原告OOO以其子XXX於2009年11月23日接種H1N1新型流感疫苗後，眼睛及臉部腫大，經多院治療、驗血仍無法找出病因，嗣後出現頭痛症狀、於學校宿舍昏倒，後經退輔會臺北榮民總醫院（下稱臺北榮民總醫院）診斷為ADEM（急性瀰散性腦脊髓炎，Acute Disseminated Encephalomyelitis），持續治療住院，發生左手左腳偏癱、視力模糊，腦部切片檢查確定為ADEM，嗣後於2012年8月25日死亡，於2012年9月10日向被告（衛生福利部）申請預防接種受害救濟。案經被告預防接種受害救濟審議小組（下稱審議小組）2012年10月30日第105次會議審定結果，與本次預防接種無關，不符合預防接種受害救濟之給付要件。被告以2012年11月29日署授疾字第1010101518號函（下稱原處分）送核定之審定結果，請財團法人藥害救濟基金會依審定結果辦理。該基金會據以2012年12月4日藥濟調字第1011672號函知原告陳俊傑，原告陳俊傑不服，遂提起本件行政訴訟。

The plaintiff’s son developed ocular and facial edema soon after receiving H1N1 invaccination on Nov. 23th in 2009, however no definite diagnosis was made after investigations in several hospitals. The patient then developed left hemiparaplegia and blurred vision, acute disseminated encephalomyelitis was diagnosed by brain biopsy in Taipei Veteran Hospital. And he died on Aug. 20th in 2012. The plaintiff claimed for vaccine injury relief against Ministry of Health and Welfare, yet was the claim was rejected on the basis of no causation by review subcommittee on the Relief of Immunization Hazards on Oct. 30th in 2012. The plaintiff then filed this administrative action.

This article briefs the decisions of high and supreme courts and criticizes the reasoning, and holds that “impartiality” should be the essential requirement in the composition of review subcommittee on the relief of immunization hazards, every member should be impartial regardless experts in the fields of medical and health, anatomy and pathology, law, or members of the community. And 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.