| 關 鍵 詞： |
管轄法域；上市審查；相互認可；簡免審查；國家賠償 |
| 中文摘要： |
為確保醫療器材（簡稱醫材）的安全性與有效性，世界各國多要求具有相當風險的醫材上市前通過審查。在我國，需審查醫材技術相關資料才能上市的醫材以第 2 等級者為大宗。倘他管轄法域已對特定醫材完成上市前審查，我國衛生主管單位直接認可其結果固然可使業者直接受益於縮短審查時間和降低備審成本，亦使國民間接受惠於更快接受新式醫材以及較低商品成本可能反應出的較低價格。不過，減免醫材上市前審查難免有降低對人民健康及安全的保護程度之疑慮。為此，基於各國法律和法規，以及學術文獻，本文比較我國和下列管轄法域的醫材上市審查減免條款：約旦、南美共同市場、與阿拉伯聯合大公國。本文並探討我國認可歐洲聯盟（簡稱歐盟）及美國醫材上市審查結果對我國國民之影響，以及倘我國國民受通過減免條款上市的瑕疵醫材損傷而提出國家賠償之勝訴可能。首先，本文指出，我國對歐盟及美國減免條款僅為單方面條款，故預期業者傾向先取得歐盟及美國醫材上市證明，再申請我國者，從而可能使我國國民晚於歐盟和美國者接受新式醫材的利益。其次，我國減免條款有待釐清其中蘊含多重解釋之處，並有待改進其中不合理之處。本文並指出，基於後列因素，我國減免條款確實難免降低對擬上市醫材的安全性和有效性審查強度之疑慮：一、歐盟醫材指令本質上給予業者審查庭挑擇之機；二、實地調查結果證實有部分歐盟民間審查公司採行「不會在醫材核准上市的過程放置障礙」之執業方針；以及，三、美國食品藥物管理局出版的內部調查報告顯示該局對第 2 等級醫材審查之品質確有需要提升之處。無論如何，本文分析後認為，前揭受害國民不太可能取得國家賠償，因為減免條款於施行前業已完成公告和聽取公眾意見之正當程序。最後，本文提出補強我國醫材上市減免條款之幾項建議。
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| 英文關鍵詞： |
Jurisdiction Region；Premarket Review；Mutual Recognition；Abridge Review；State Compensation |
| 英文摘要： |
To ensure the safety and effectiveness of a medical device (MD,) most countries in the world require that the MDs of certain level of risk must pass premarket review before being granted to go public. In Taiwan, among the types of MDs requiring premarket review on the technical information of MD, most of them are categorized as class II.
Should a MD under premarket review be awarded a listed license from at least one of the competent authorities of other jurisdiction regions to grant an abridged review by our nation’s competent authority in health? It will directly benefit the manufacturers of MD by reducing the reviewing times and costs, and will indirectly benefit the publics by sooner accessing the MDs of new functions and lower prices resulted from lower costs.
Nevertheless, abridged review cannot avoid being questioned of diminishing the strength of protecting the public health and safety. These motivated this study to compare based on the laws, regulations, and academic publications providing with the abridged regulations of the following jurisdiction regions: Jordan, the Southern Common Market, and the United Arab Emirates. This study also explored and discussed the potential influence arising from our nation’s abridged regulations recognizing the results of premarket review of MDs from the European Union (EU) and the United States of America (USA,) and the possibility of the injured citizens by the defective MDs approved by the abridged regulations to award compensation according to the State Compensation Act. Firstly, our nation's abridged regulations recognizing the reviews from the EU and the USA are unilateral, and thus the MD manufacturers would tend to obtain the listed licenses from the EU and the USA before applying for ours. Consequently, the opportunity of accessing the MDs of new technology of our public would need to be held until the public of the EU and the USA have. Secondly, our abridged regulations consist of ambiguity allowing multiple interpretations and unreasonable requirements, which ought to be amended. This study also found that indeed our abridged regulations cannot avoid the risks of reducing the reviewing strength regarding the safety and effectiveness of MDs due to the following factors: 1) the EU directive of MD essentially provides the manufactures the opportunity of forum shopping; 2) academic reports of investigation reveals that some private companies authorized by the EU competent authorities on premarket review of MDs implement the policy of “not putting obstacles in the way of approving the device”; and 3) the report of internal investigation by the U.S. Food and Drug Administration shows that the reviewing quality on class II MDs requires improvements. However, this study analyzed and concluded that those who are injured by the defective MDs putting on the market by the abridged regulations would not win claims for compensations based on the State Compensation Act, since those abridged regulations were announced and enforced by due process. Finally, this study presented some suggestions for amending the abridged regulations on premarket review of MD.
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| 目 次： |
壹、探討之背景
貳、我國對醫材上市之自主審查制度
參、我國認可他國醫材上市審查結果制度
肆、美國和歐盟的第 2 等級醫材上市審查制度
伍、外國認可他國醫材上市審查結果制度和我國情形之比較
陸、我國第 2 等級醫材上市前審查認可他國醫材結果對我國國民之影響
柒、以減免條款上市的醫材有瑕疵而傷害國民，受害者成功獲得國家賠償之可能性
捌、改進我國減免條款之建議
玖、結語
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