South Korea: Abortion pills can be approved without revising health law, says government

South Korea's Ministry of Government Legislation has issued a landmark interpretation, its first legally binding one, stating that abortion pills can be approved for import even without amending the current Mother and Child Health Act. This decision means that if the drugs meet the necessary requirements for safety and efficacy, the Ministry of Food and Drug Safety is obligated to grant import approval.

The interpretation clarifies that the approval process for abortion drugs is a "discretionary act" (gisok haengwi), meaning the administrative agency must proceed if the legal conditions are met. This ruling comes seven years after the Constitutional Court declared the abortion ban unconstitutional in 2019, a decision that led to the law's invalidation but has not yet been followed by new legislation.

This new interpretation is anticipated to accelerate the review and approval of abortion-inducing medications. Previously, the legal framework surrounding abortion and related medications remained ambiguous following the Constitutional Court's ruling, creating a bottleneck for access to such drugs. The Ministry of Food and Drug Safety had sought clarification from the Ministry of Government Legislation on whether import approval was possible before legislative changes.

The Ministry of Government Legislation's response directly addresses this query, confirming that the import of abortion drugs does not inherently violate the Mother and Child Health Act. The focus will now be on whether the submitted documentation proves the drugs' safety and effectiveness, a standard requirement for any pharmaceutical import.