Marking the 10th anniversary of the drug side effect compensation system, the Ministry of Food and Drug Safety (MFDS) announced its ‘Five-Year Development Plan for Drug Side Effect Compensation System (2026–2030)’ on June 12. This plan aims to address shortcomings identified during the system’s operation and comprehensively improve compensation scope and procedures. Four key strategies and ten tasks will be implemented step-by-step, focusing on enhancing public-oriented services, establishing a robust compensation system, expanding patient-centered safety nets, and ensuring sustainable operation. The reforms are designed to deliver tangible benefits to both patients and healthcare providers.
Under the new plan, compensation coverage will be expanded to include outpatient care before and after hospitalization, and the reimbursement cap will be raised from 30 million KRW to 50 million KRW. The application process will be simplified by merging consent and pledge forms into a single document, with medical staff assisting patients in completing applications upon discharge. For claims under 2 million KRW with clear causality and consistent expert opinions, compensation will be swiftly provided through written review. A full-time advisory system will be introduced to ensure continuous medical consultation during investigation and assessment.
Education and guidance for healthcare professionals and the public will be strengthened. Medical staff prescribing drugs frequently associated with compensation cases, such as antibiotics, will receive targeted training and information. On-site promotion will focus on fields with high rates of side effects, including liver, neurological, and infectious diseases. Collaboration with patient and consumer organizations will produce tailored promotional content, and a hotline will be established for immediate counseling and application support. Compensation data will be linked to the Drug Utilization Review (DUR) system to prevent recurrence, and accumulated cases will be analyzed to inform future prevention policies.
To ensure sustainability, the MFDS will rationalize the pharmaceutical industry’s contribution procedures. Legislative changes will reduce the frequency of contribution collection from twice to once a year (July), easing administrative burdens. The plan clarifies that civil lawsuits or settlement payments exclude eligibility for compensation, and establishes legal grounds for payment suspension and recovery to prevent double compensation. Procedures for designating excluded drugs and submission requirements will be clarified, and applicants will be able to request reconsideration if dissatisfied with compensation decisions.
This five-year plan represents a significant shift from mere compensation to a comprehensive patient safety strategy. By expanding coverage and increasing the reimbursement cap, the MFDS addresses the financial burden of severe drug side effects. Streamlined procedures and rapid payment improve accessibility for affected patients, while integration with the DUR system and proactive education efforts enhance prevention and recurrence control. These measures reinforce the government’s commitment to safeguarding public health and position Korea’s drug safety management at a global standard.