President Lee Jae-myung ordered a review of "ways to allow use at the discretion of medical staff even before the law is revised" regarding the introduction of medication abortion. Attention is focusing on whether there will be a change in the stance of the Ministery of Food and Drug Safety, which has delayed the approval review on the grounds that "amendments to the Mother and Child Health Act must come first."
At a Cabinet meeting on the 14th, President Lee said, "If the government evades responsibility by leaving this outside the law, the public will be put at risk," adding, "If we keep arguing over how many weeks abortion should be allowed, the term could end."
He also said, "One option is to allow doctors to make judgments at their discretion even before that standard is set," and "Wouldn't it be enough to make it possible to use the medication safely even before the Mother and Child Health Act is revised?"
◇ Legislative void enters year seven after Constitutional Court ruling… Only illegal distribution has grown
The Constitutional Court in 2019 issued a decision of constitutional inconsistency on the crime of abortion. The court called for alternative legislation by the end of 2020, but the National Assembly has since failed to narrow differences over the gestational age limit for permitting abortion. All related bills were scrapped in the 21st National Assembly, and in the 22nd, amendments to the Mother and Child Health Act remain pending in committee.
While the legislative void has continued, the illegal market has grown. According to the Ministery of Food and Drug Safety, from 2021 through last August there were 2,641 cases of illegal sales of medication abortion detected. Considering transactions that went undetected, the actual distribution scale is estimated to be larger. Many of the drugs distributed online are overseas generics, making it difficult to verify authenticity and to receive medical protection in cases of counterfeit harm or side effects, critics said.
The Ministry of Health and Welfare has acknowledged the need to improve the system but maintained a cautious stance. Minister Jung Eun-kyeong said at the Special Committee on Budget & Accounts last year that "since there are safety issues after the constitutional inconsistency decision, this is an issue that must be resolved," adding, "We will review the fetal right to life and women's health rights in a balanced manner."
By contrast, the Ministery of Food and Drug Safety has adhered to the position that "amendments to the Mother and Child Health Act must come first." It said core review items such as efficacy, effectiveness, and the risk management plan (RMP) can be evaluated only when the gestational age and scope for permissible abortion are defined by law.
On the same day, responding to related questions from ChosunBiz, the Ministery of Food and Drug Safety said, "Only when the law defines whether medication abortion is allowed and the permitted period can we review certain approval requirement data," adding, "We plan to discuss this with related ministries, including the Ministry of Gender Equality and Family and the Ministry of Health and Welfare."
As the Ministery of Food and Drug Safety maintains this stance, Hyundai Pharm's item approval review is effectively on hold. After securing exclusive domestic rights in 2021 to Linepharma's "Mifegymiso" from the United Kingdom, Hyundai Pharm applied for item approval the same year but voluntarily withdrew in 2022 over supplemental data submission issues. It reapplied in 2023, but the review was halted due to requests for additional data, and after reapplying for item approval in December 2024, it is still awaiting the result.
In the National Assembly, controversy continues over the Ministery of Food and Drug Safety's legal interpretation. It became known that, of six legal opinions the agency commissioned from outside law firms between 2021 and 2023, four held that "approval review is possible even without amendments to the Mother and Child Health Act," leading to criticism at the Health and Welfare Committee last year that "delaying approval is rather an abuse of discretion."
◇ Medical community objects, pharmacists welcome it… Government's choice in focus
Reactions from the medical community and pharmacist groups over the president's remarks were split.
The Korean Association of Obstetricians and Gynecologists pushed back, calling for the remarks to be withdrawn. On the 14th, the association said, "Early approval without established safety guidelines and a distribution system would drive the public into a dangerous human testing ground," arguing that management by OB-GYN specialists is essential from verifying gestational age before administration to confirming complete expulsion after dosing.
It particularly stressed that mifepristone, the main ingredient in medication abortion, is managed as a prescription drug in the United States and is prescribed after ruling out ectopic pregnancy and accurately confirming gestational age.
That same day, the Pharmacists for a Healthy Society issued a welcoming commentary, saying, "This should not stop at approving medication abortion, but should lead to discussions on guaranteeing sexual and reproductive health rights."
The best-known medication abortion drug, "Mifegyn," was designated an essential medicine by the World Health Organization (WHO) in 2005 and is now used in about 100 countries. The WHO recommends use within 12 weeks of pregnancy, and the Korean Society of Obstetrics and Gynecology recommends use up to 9 weeks and 6 days.
However, even if Mifegyn is approved domestically, it will not be freely available for purchase at pharmacies like an over-the-counter drug. As in major countries overseas, it is likely to be used as a prescription drug under a system of physician prescription, medical care, and follow-up management.
Attention is on whether, after the president's directive, the government will stick to its existing principle or present a new administrative solution to push forward the approval process for Mifegyn even before the law is revised. The Ministry of Health and Welfare said in the National Assembly in March that it would complete consultations with related ministries within the first half, and attention is on whether a specific implementation direction will be presented in the work report on the 16th.