On June 12, the Ministry of Food and Drug Safety (MFDS) announced a five-year development plan for the drug side effect compensation system, marking its 10th anniversary. The new plan aims to address shortcomings identified during previous operations, focusing on improving compensation scope and procedures. Four main strategies and ten key tasks will be implemented in stages: enhancing user-oriented services, establishing a robust compensation system, expanding patient-centered safety nets, and securing sustainable operations. These measures are designed to strengthen support for patients and ensure safer drug usage nationwide.
Under the new plan, compensation coverage will be expanded to include outpatient treatments before and after hospitalization, and the reimbursement cap will be raised from 30 million KRW to 50 million KRW. Application procedures will be simplified by consolidating consent and pledge forms into a single document, improving accessibility. For claims under 2 million KRW with clear causality and consistent expert opinions, compensation will be processed swiftly via written review. A full-time advisory system will be introduced for ongoing medical consultations, and compensation payment information will be immediately linked to the Drug Utilization Review (DUR) system to prevent recurrence of similar side effects.
The MFDS will strengthen guidance and education for medical professionals and the public, and establish a hotline for direct consultation and application support. Tailored promotional content will be provided in collaboration with patient and consumer organizations, while on-site outreach will be expanded for medical staff in high-risk fields such as antibiotics and liver, neurological, and infectious diseases. Legal revisions will enable analysis and research of accumulated compensation cases, and the frequency of industry levies will be reduced from twice to once a year to ease administrative burdens for pharmaceutical companies.
Looking ahead, the MFDS plans to clarify procedures and documentation requirements for designating drugs excluded from compensation, and allow requests for reconsideration of compensation decisions. Commissioner Oh Yu-kyoung emphasized that the five-year plan represents a government commitment to protecting citizens’ lives and daily well-being, beyond mere compensation. By building a globally competitive safety net, the ministry aims to create a secure environment for drug use in Korea. These policy changes signal a significant advancement in patient-centered healthcare and social safety infrastructure.