의약품의 ‘허가사항 외 사용(Off-Label-Use)’으로 인한 손해배상책임 - 의사의 책임을 중심으로

When pharmaceutical manufacturers wish to make and sell drugs, they must obtain permission from the Ministry of Food and Drug Safety. Also, the manufacturers must indicate the permission's details on their pharmaceutical labels. When medical professionals such as doctors use a medicine beyond the permission from Ministry of Food and Drug Safety, the act is referred to as ‘off-label use.’ If a doctor engages in off-label use, it is regarded as an act of negligence, provided that there is no valid reason for such use. If the government fails to conduct administrative guidance for pharmaceutical manufacturers, despite being aware of their off-label use, it should be held liable for damages inflicted on citizens, despite the knowledge of their off-label use. If the manufacturers fail to warn customers of the danger of off-label use on their labels, they should be held liable for their products. If a pharmacist has prepared a medicine despite the doctor's prescription suggesting off-label use, the pharmacist should be held liable for the consequences. However, the most important thing is to prevent such consequences, as the lives and health infringed by off-label use can never be fully compensated, no matter who takes responsibility.