Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 3
The special circumstances mentioned in Paragraph 1, Article 3 of the Act, refer to the disease prevalence rate that exceeds the criteria announced by the central competent authority or that the prevalence rate is difficult to calculate, and that the methods, medical products, and special dietary foods needed for diagnosis and treatment are indeed difficult to obtain.
中文原文 罕見疾病防治及藥物法施行細則第3條
本法第三條第一項所稱情況特殊，指疾病盛行率難以推算，或已逾中央主管機關公告之基準，而其診斷治療所需之方法、藥物、特殊營養食品，取得確有困難之情事。