由司法院釋字第767號討論藥害救濟制度

Discussion of the Drug Injury Relief Act by J.Y. Interpretation No. 767

司法院於2018年7月27日作成釋字第767號解釋，係就衛生福利部主管藥害救濟法第13條第9款的規定，關於因為「常見且可預期之藥物不良反應」而遭受藥害的當事人，因為該款規定而不得申請藥害救濟，在大法官間存在意見落差。而此號解釋對於法律明確性原則、比例原則與人民生存權、健康權等概念的操作，也很快在各界引發許多深刻討論。本文探討臺灣、日本、韓國間藥害救濟制度設計的差異，日本與韓國的藥害救濟制度，排除特定藥品（如：抗癌藥物或免疫抑制藥物等）於救濟的範圍內，臺灣雖無明定排除某些高風險的藥品適用藥害救濟法，但依藥害濟救法第13條第9款規定，排除「常見且可預期之藥物不良反應」於救濟的範圍內，亦有類似的規範效果。藥害救濟法為履行憲法增修條文第10條第7、8項所定保障身心障礙者請求補償之權利及重視社會救助等政府義務，特針對因藥物不良反應致死亡、障礙或嚴重疾病之受害者提供及時之救濟，惟基於公共利益，為維持藥害救濟制度之運作乃至全體國民之就醫環境，確有必要增訂不予給付之除外條款。故將「常見且可預期」之藥物不良反應排除於藥害救濟之外實有其必要，無違憲法增修條文第10條第7、8項之精神，也並無欠缺合理之立法目的及正當性考量之情事。

The Judicial Yuan made an J.Y. Interpretation No. 767 on July 27, 2018. In Article 13 (9) of the Drug Injury Relief Act by the Ministry of Health and Welfare, person who has “The common and foreseeable adverse reaction from drug usage” is not eligible for any drug injury relief. This J.Y. Interpretation is in the opinion gap between the Justices of the Constitutional Court. For the principle of clarity and definiteness of law, proportionality, people’s rights to subsistence, and the right of health have also caused many depth discussion. This article explores the differences of drug injury relief among Taiwan, Japan, and Germany. The drug injury relief system in Japan and South Korea excludes certain drugs (such as anticancer drugs or immunosuppressive drugs) within the scope of relief. There is not explicit exclusion of certain high-risk drugs in Taiwan, but there is a similar normative effect in Article 13 (9) of the Drug Injury Relief Act that exclude “The common and foreseeable adverse reaction from drug usage” within the scope of relief.