한국, 일본, 대만에서의 의약품 부작용 피해구제 제도 현황 조사

Current Status of Adverse Drug Reaction Relief System in Korea, Japan and Taiwan

Abstract The adverse drug reaction relief system is no-fault compensation system which provides compensation for severe injuries that were caused by adverse reaction even after proper use of medicines. The purpose of this study is to evaluate current status of the adverse drug reaction relief system in Japan, Taiwan, and Korea. We investigated the relief system in above three countries through websites, literatures, reports, spot investigation and e-mail questionnaires. Although great similarities for the relief system were recognized among the three countries, the difference among the countries and the unique characteristics of each country’s relief system was also identified; for example, the relief for injuries by offlabel uses, details of relief benefits, the relief payment for the adverse drug reactions, and the compensation for medical expenses which is classified as non-reimbursement treatment. Therefore, it is possible to establish more valuable no-fault compensation system in Korea through application of advantage and experience for the relief system in Japan and Taiwan.