疫苗接種與消費者保護法之適用──兼論處方藥品製造商之指示及警告義務

Vaccination and the Consumer Protection Laws: Including the Study on the Duty to Instruct and Warn of Manufacturers of Prescription Drugs

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。

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.