Marking the 10th anniversary of the drug side effect compensation system, the Ministry of Food and Drug Safety (MFDS) unveiled its ‘Five-Year Development Plan for Drug Side Effect Compensation System (2026–2030)’ on June 12. The plan aims to address shortcomings identified during the system’s operation and comprehensively improve compensation scope and procedures. Four main strategies and ten key tasks will be implemented, focusing on enhancing public service, building a robust compensation framework, expanding patient-centered safety nets, and establishing a sustainable operational foundation. Notably, the plan includes expanding compensation to cover outpatient care before and after hospitalization and raising the medical expense cap from 30 million KRW to 50 million KRW.
Application procedures for compensation will be significantly simplified to improve accessibility. Consent and pledge forms will be integrated into a single document, and medical staff will assist patients in completing applications upon discharge. The decision-making process will be streamlined, allowing for swift compensation of minor medical expenses (under 2 million KRW) with clear causality through written review. A full-time advisory system will be introduced to provide ongoing medical consultation during investigations and assessments. Support for severe cases will be strengthened, with the increased cap helping to alleviate the financial burden of treating serious side effects such as toxic epidermal necrolysis.
Efforts to expand patient-centered safety nets and strengthen prevention systems are also emphasized. Medical professionals prescribing high-risk drugs like antibiotics will receive enhanced guidance and education, with targeted outreach in fields where side effects are more common. Collaboration with patient and consumer organizations will deliver tailored promotional content, and a hotline will be established for direct consultation and application support. Compensation payment information will be immediately linked to the Drug Utilization Review (DUR) system to prevent recurrence, and accumulated case data will be analyzed to inform future prevention policies and regulatory improvements.
To ensure sustainability, the plan rationalizes the pharmaceutical industry’s fee management procedures. Legislative changes will consolidate fee imposition and collection from twice a year to once annually (July), reducing administrative burdens. The plan clarifies that receiving civil settlements or compensation excludes eligibility for government compensation, and legal grounds for payment suspension and recovery will be established to prevent double compensation for the same damage. Procedures for designating excluded drugs and submission requirements will be clarified, and those dissatisfied with compensation decisions can request a review. MFDS Commissioner Oh Yu-kyoung stated, “This five-year plan is a government commitment to safeguard lives and daily well-being, aiming to build a global-standard safety net for drug use.”