On June 12, the Ministry of Food and Drug Safety (MFDS) announced a new five-year plan (2026–2030) to advance Korea’s drug side effect compensation system, marking the 10th anniversary of its implementation. The plan aims to address shortcomings identified during previous operations and comprehensively improve compensation scope and procedures. Four main strategies and ten key initiatives will be rolled out, focusing on enhancing user experience, establishing a robust compensation framework, expanding patient-centered safety nets, and ensuring sustainable system management. These efforts are expected to create a safer environment for drug use among patients and the public.
A major highlight of the policy is the expansion of compensation to include outpatient treatments before and after hospitalization, with the reimbursement cap raised from 30 million KRW to 50 million KRW. Application procedures for compensation will be simplified by integrating consent and pledge forms into a single document, and medical staff will assist patients in preparing application documents upon discharge. For claims under 2 million KRW with clear causality and consistent expert opinions, compensation will be processed swiftly through written reviews. Additionally, a full-time advisory system will be introduced to provide ongoing medical consultations.
Compensation for drug side effect treatments will become more realistic and inclusive, covering outpatient diagnosis and treatment before hospitalization and follow-up care after discharge. Support for severe cases will be strengthened, significantly reducing the financial burden for treatments such as toxic epidermal necrolysis. Education and guidance for medical professionals, especially those prescribing high-risk drugs like antibiotics, will be enhanced, and on-site promotions will be expanded. A dedicated hotline for consultations and applications will be established, and the Drug Utilization Review (DUR) system will be linked to prevent recurrence. Accumulated case data will be analyzed to inform future prevention policies.
To ensure sustainability, the MFDS will rationalize the pharmaceutical industry’s contribution procedures, reducing the frequency of levies from twice to once a year. Legal grounds will be established to clarify exclusion criteria, prevent double compensation, and enable suspension or recovery of payments when necessary. Procedures for designating excluded drugs and requirements for submitted documents will be clarified, and appeals for payment decisions will be allowed. MFDS Commissioner Oh Yu-kyoung emphasized that this plan represents the government’s commitment to safeguarding citizens’ lives and daily well-being, aiming to build a globally competitive drug safety system.