藥害救濟制度探究

傳統訴訟救濟制度以咎責為其基礎，在處理藥品傷害事件時，卻經常面臨病患遭受嚴重不良反應的傷害卻無人可咎責，以致完全無法獲得任何補償的窘境，再者，訴訟咎責的特性，亦使得醫護人員為維護自身名譽，而採取防衛性醫療與訴訟策略，如此不但不利於醫療的進步與發展，更使醫病關係惡化，造成雙輸的局面。有鑑於傳統訴訟制度在處理藥害救濟時的局限性，我國乃效法其他醫療先進國家，制定藥害救濟制度，提供受害病患無過失補償。本文首先以藥害相關之民、刑事訴訟案例呈現傳統訴訟制度於藥害救濟領域的瓶頸，藉此引入我國藥害救濟制度建立的必要性與整體樣貌之說明，接著審視藥害救濟制度施行後的藥害案件申請狀況，並挑選實際案例，詳細探究其申請與後續救濟的過程，以尋求制度面臨的困境與改善、進步的空間。本文進一步研究美、德、北歐、日本等醫藥先進國家的藥害救濟處理模式，分析、歸納出其制度的特色與共通之概念與精神，並與我國現行制度相互對照，據以提出對於我國現行制度改良之具體建議，盼能提供立法者與主管機關未來調整制度之參考。

關鍵字

藥害救濟；藥品責任；無過失補償；嚴格責任

並列摘要

While dealing with drug injury cases, the traditional fault-based litigation and compensation schemes have got its limitations and difficulties, due to it is usually not being easy to identify the liable person and establish the causal link between an injury and a malpractice successfully. Furthermore, lawsuits against health care professionals may also lead to defensive medicine, which is adverse to the development of medicine, and can also jeopardize patient-provider relationship. Therefore, it is critical to provide a drug injury relief scheme free from fault seeking basis; which is the approach assumed in Taiwan. The present thesis present criminal and private lawsuit cases pertained to drug injury disputes to demonstrate the limitation of fault-based scheme in the field of medicine. Upon that, the necessity and features of the drug injury relief system in Taiwan is introduced and described. Certain statistic data of application status is reviewed and followed by real case study aiming to identify issues and root causes of the current relief system, as well as the potential solutions. In order to learn from the experience of medical advanced countries, the present thesis study drug injury relief schemes of the U.S., Nordic, Japan and Germany. According to the analysis and induction of these schemes, specific advices for improvement of the current Taiwan system are concluded and put forward.