| 關 鍵 詞： |
疫苗；消費者保護；處方藥；藥品；仿單；指示義務；警告義務；專家中介人；侵權行為整編 |
| 中文摘要： |
處方藥的仿單通常是製造商告知醫療照護提供者之一種適當機制，卻非唯一機制。尤其，應注意若製造商「仿單」資訊的影響力被各種製造商的文獻和商品文件淹沒，或因製造商銷售活動而減弱時，藥品製造商仍可能有指示與警告之欠缺，適用消費者保護法第 7 條至第 10 條之 1 商品責任之規定。在群體疫苗接種之情形，醫師較無對消費者進行個人、具體之風險評估，製造商自應負擔輔以各種方式將資訊達與民眾，清楚地向接種者與其家屬傳達該疫苗的警告說明。此為「專家中介原則」之例外。製造商僅在藥品仿單上記載相關指示及警示副作用，仍有未履行資訊義務之欠缺。
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| 英文關鍵詞： |
Vaccine；Consumer Protection；Prescription Drugs；Pharmaceuticals；Package Insert；Duty to Instruct；Duty to Warn；the Learned Intermediary；Restatement of Torts |
| 英文摘要： |
Package insert for prescription drugs is often an appropriate, but not the only, mechanism for manufacturers to inform health care providers. In particular, it should be noted that if the impact of package insert is diluted by various manufacturers’ promotional activities, the information of instructions and warnings provided by manufacturer may still inadequate. In this case, the product liability provisions of Articles 7 to 10-1 of the Consumer Protection Act shall apply. On the contrary, in a mass inoculation setting, physicians are less likely to inform patient of the individualized medical judgment, manufacturers are under a duty to clearly convey instructions and warning of the danger inherent in its vaccine to consumers by various means. This is an exception to the Learned Intermediary Doctrine. If the manufacturers only provide instructions and warnings through package insert, it still fails to perform its obligations adequately.
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| 目 次： |
壹、緣起－消費者「知情權」
貳、借鏡處方藥品之仿單指示及警告義務
一、默沙東藥廠之「柔沛」案
二、臺灣第一三共公司 Cravit 抗細菌藥案
參、商品責任關於指示及警告之欠缺
一、美國 1998 年侵權行為整編第三版：商品責任
二、疫苗製造商之指示及警告義務與「專家中介原則」
三、指示及警告之充分性
肆、代結語－仿單不等於藥品製造商之指示及警告義務
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