法學期刊.
  • 社群分享
論著名稱: 從科際整合角度評析司法院釋字第 767 號-常見且可預期之不良反應不得申請藥害救濟案
編著譯者: 邱玟惠
出版日期: 2019.01
刊登出處: 台灣/月旦醫事法報告第 27 期 /144-163 頁
頁  數: 13 點閱次數: 449
下載點數: 52 點 銷售明細: 權利金查詢 變更售價
授 權 者: 邱玟惠
關 鍵 詞: 可容許之風險仿單吿知後同意常見且可預期藥害救濟法
中文摘要: 司法院釋字第 767 號固然引發了行政法上諸多議題之討論,本文認為,將本號解釋中所援引之「醫師之告知」與「藥物仿單之記載」,作為病人合理預見藥物風險之手段,於形式上,符合法律明確性原則。然本文由科際整合角度出發,說明「告知後同意」原則本起源於人格權利或是利益之保護,而「藥物仿單之記載」之內容,則係依據藥物臨床試驗之結果,界定其使用上之一般可能危險性,具有以「可容許之危險」作為阻卻侵權行為違法性之法律意義,其程度與內容是來自於藥物使用利弊之權衡結果,而不良反應是否屬於「常見且可預期」,則是依據其發生之頻率及是否能夠預見,「藥物仿單之記載」與「常見且可預期」兩者間並無必然之絕對關係。解析此兩跨領域觀念之來源及應用後,應可理解藥害救濟法第 13 條第 9 款之規定,其形式上或已符合法律明確性原則,然與實質上是否即能具有法律之明確性,恐尚有距離。此外,臺灣之藥害救濟目前以 1% 不良反應發生率作為藥害基金救濟與否之區分點,應是基於廠商營業自藥物獲取利潤、民眾使用藥物獲得疾病治療之利益,由此兩者共同負擔不良反應之損害。至於此 1% 區分點之適當與否,則應可依據立法政策、醫藥產業發展趨勢、藥害救濟基金制度之永續經營等之觀點,作適當之調整。
英文關鍵詞: permissible riskinstructionsinformed consentcommon and foreseeableDrug Injury Relief Act
英文摘要: J.Y. Interpretation No. 767 regarded the disclosures from physicians and the descriptions on the drug label as the ways which enable the patients gain the reasonable foreseeability about the adverse reaction of the drug taken, and consequently led to them being barred from relief by Drug Injury Relief Act. However, the informed consent doctrine is proposed to protect the personal rights of patients rather than exempting them from relief. Moreover, the description of adverse effects on drug label is the record of the result and conclusion of clinical trial, which represents itself as a permissible risk to exempt the pharmaceutical factory from illegality and is not necessarily compatible with the “common and foreseeable adverse reaction from drug usage” stipulated in Drug Injury Relief Act. The contemporary application of 1% as the cut-off criteria to “common” adverse reaction when apply the Drug Injury Relief Act is a trade-off between the gains and losses of patients and pharmaceutical factory. However, this cut-off level would be subject to change according to the health policy, the development trends of pharmaceutical industry and the sustainability of Drug Injury Relief System.
目  次: 壹、案例事實
貳、司法院釋字第 767 號解釋文及理由要旨
一、解釋文
二、理由要旨
參、評析
一、不宜以「告知後同意」之踐行作為「受規範者得預見」之說理
二、藥物之仿單之意義在於「可容許風險」
三、「常見」定義為不良反應發生率大於或等於1%發生率者之法律意涵
肆、結論
相關法條:
相關判解:
相關函釋:
相關論著:
    返回功能列