| 篇名 |
仿製藥警示缺陷和設計缺陷責任──以美國法為例 |
| 並列篇名 |
Generic Drugs and Liability for Labeling or Design Defect: The Case of American Law |
| 作者 |
趙西巨 |
| 中文摘要 |
美國Hatch-Waxman法案為仿製藥開闢了一條獨特的規制之道。它在仿製藥的易獲得性與安全性和有效性之間尋求著平衡。仿製藥與專利藥的「一致性」要求不允許仿製藥生產商單方面地、獨立地對仿製藥的標示做出修改。對於聯邦法層面的這種「一致性」要求是否可以阻斷受到損害的患者依據州法提起針對仿製藥生產商的藥品警示缺陷或設計缺陷責任訴訟這一問題，來自美國最高法院的Mensing案和Bartlett案均做出肯定回答。不同於專利藥，聯邦法為仿製藥生產商的藥品警示缺陷或設計缺陷責任提供豁免，卻置受害的患者於無侵權法救濟的境地。在仿製藥的低價和易獲得性與受害者的救濟可能性這兩方面，美國的司法和立法在努力探尋著平衡點。
|
| 英文摘要 |
The Hatch-Waxman Act of USA creates a unique mode of regulation for generic drugs, balancing the availability of generic drugs and concerns for their safety and effectiveness. The “sameness” requirement under the Act does not allow generic drug manufacturers to change labeling unilaterally and independently. Does that preempt generic drug consumers’ labeling or design defect claims? In the cases of Mensing and Bartlett, the Supreme Court of USA answered that question affirmatively. As a result, unlike those of brand-new drugs, manufacturers of generic drugs enjoys the immunity from liability for labeling or design defect, therefore depriving suffering patients of state tort remedies. The USA is still struggling to keep a balance between low cost and easy access of generic drugs and increasing remedial possibilities available for generic drug victims. |
| 起訖頁 |
36-51 |
| 關鍵詞 |
仿製藥、警示缺陷責任、設計缺陷責任、美國法、Generic Drugs、Liability for Labeling Defect、Liability for Design Defect、American Law |
| 刊名 |
月旦民商法雜誌 |
| 出版單位 |
元照出版公司
|
| 期數 |
201609 (53期) |
| DOI |
10.3966/172717622016090053003 複製DOI DOI申請 |
| QRCode |
 |
| |
