Marking the 10th anniversary of Korea’s drug side effect compensation system, the Ministry of Food and Drug Safety announced its ‘Five-Year Development Plan for Drug Side Effect Compensation System (2026-2030)’ on June 12. The plan aims to address shortcomings in the current system by improving compensation scope and procedures. Four main strategies and ten key tasks will be implemented, focusing on enhancing public-oriented services, building a robust compensation framework, expanding patient-centered safety nets, and establishing sustainable operational foundations. These efforts are designed to strengthen support for victims and increase public trust in the system.
Specifically, the compensation scope will be expanded from inpatient treatment costs to include outpatient care both before and after hospitalization, provided the side effect is recognized as related. The reimbursement cap will be raised from 30 million KRW to 50 million KRW, significantly reducing the financial burden for severe cases such as toxic epidermal necrolysis. Application procedures will be simplified by merging consent and pledge forms, with medical staff assisting patients in completing paperwork upon discharge. For claims under 2 million KRW, compensation will be processed quickly through written review, and a full-time advisory system will be introduced for ongoing medical consultation.
To further strengthen patient safety, education and guidance for medical professionals and the public will be enhanced. Outreach will focus on doctors prescribing high-risk drugs like antibiotics, and tailored promotional content will be provided in collaboration with patient and consumer groups. A dedicated hotline will be established for immediate counseling and claims, and compensation data will be linked to the Drug Utilization Review (DUR) system to prevent recurrence of similar side effects. Accumulated case data will be analyzed to inform future prevention policies.
For sustainable operation, the pharmaceutical industry’s levy procedures will be streamlined, reducing the frequency of collection from twice to once a year. Legal grounds will be clarified to exclude compensation in cases of civil lawsuits or settlements, and procedures for designating excluded drugs and submitting required documents will be specified. Disputes over compensation decisions can be appealed for reconsideration. Commissioner Oh Yu-kyoung emphasized that this plan represents the government’s commitment to safeguarding citizens’ lives and daily well-being, promising to build a globally competitive safety net for drug use.