President Lee calls for review of Mifegyne approval

Prime Minister Han, "The issue is highly sensitive... We will prepare an agenda with relevant ministries."

KAOG “rejects introduction without safety verification,” calls for action

Pharmacists’ society “Discussion necessary to protect health and rights”

President Lee Jae-myung speaks during a Cabinet meeting on July 14

President Jae-myung Lee has instructed relevant ministries to prepare a balanced approach to the approval of the abortion medication Mifegyne (mifepristone).

During a cabinet meeting on July 14, President Lee mentioned Mifegyne, stating, “The current ban has led women who need the drug to purchase it through overseas direct purchases, exposing them to safety risks. It does not seem right to neglect the situation as is.”

President Lee asked the Ministry of Food and Drug Safety (MFDS), the Ministry of Gender Equality and Family, and the Ministry of Government Legislation for detailed information on actual use patterns and developments following the Constitutional Court's ruling. Lee said, "The appropriate standard may vary depending on a woman's health condition. It doesn’t seem that setting a strict legal cutoff by gestational week needs to be a definitive standard. Entrusting the decision to physicians' conscience and professional judgment could also be one option,” calling on the ministries to explore a pragmatic compromise.

Prime Minister Seong-sook Han responded that the matter is highly sensitive and said the government would prepare an agenda in consultation with the relevant ministries before revisiting the issue.

President Lee's remarks immediately drew opposition from medical groups.

The Korean Association of Obstetricians & Gynecologists (KAOG) issued a statement on July 14 criticizing the President's directive to seek practical solutions for introducing Mifegyne into Korea. In the statement, KAOG stated, “Introducing the drug without supporting legislation and adequate medical safety verification would threaten women's health. If the policy is pushed forward, the association will launch a strong campaign, including a nationwide refusal movement.”

KAOG added, “If the drug is distributed without sufficient preparation, women could face severe bleeding, infections, and incomplete abortions requiring emergency surgery. Permitting early access before establishing safety guidelines and a proper distribution system would effectively turn the public into subjects of a dangerous medical experiment.”

In contrast, public health advocacy groups welcomed the President's comments. The Korean Pharmacists for Democratic Society (President: Kyung-Lim Jeon) said, “President Lee has repeatedly expressed support for the need to introduce medical abortion drugs and included the issue among his 123 national policy initiatives, yet the Ministry of Health and Welfare and the MFDS have made little progress toward approval. As a result, women requiring abortion care have been left in a regulatory gray area.”

“Simply approving abortion medication would not be sufficient to enable the practical approach emphasized by the President. We welcome the President's position, and the  discussion should move beyond punishment and focus instead on protecting sexual and reproductive health and rights.

Mifegyne is an oral medical abortion drug developed by the French pharmaceutical company Exelgyn. It received an essential medicine designation from the World Health Organization (WHO) and is currently approved in more than 80 countries. In Korea, however, it has yet to receive marketing approval.

Hyundai Pharm previously secured Korean commercialization rights for the combination product ‘Mifegymiso Tab’ from the UK's LinePharma and has pursued marketing approval with the MFDS. However, the application process has repeatedly stalled for years because of unclear regulatory requirements and requests for additional data, resulting in multiple voluntary withdrawals and resubmissions.