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Mifegyne, an abortion medication (active ingredient: mifepristone). / Photo courtesy of AP, Yonhap News Agency

Discussions on introducing Mifegyne, an oral abortion pill, have resumed following instructions from President Lee Jae-myung, but concerns are mounting over the lack of legal standards and medical safety nets. Prescription criteria, the scope of medical personnel liability, and post-ingestion emergency response systems are expected to emerge as central points of contention moving forward.

According to government sources on July 23, People Power Party lawmakers Jo Bae-sook, Kim Mi-ae, and Paik Jong-heon held an emergency academic seminar at the National Assembly titled "Problems of the Lee Jae-myung Administration's Lawless Allowance of Abortion Drugs." Participants argued that allowing drug use at physician discretion without clear legal parameters regarding permitted abortion windows could exacerbate confusion in clinical settings and increase legal disputes.

The debate was sparked on July 14 during the 30th Cabinet meeting when President Lee instructed officials to review ways to enable access to abortion medications even before relevant legislation is revised. President Lee suggested leaving decisions to physician discretion, noting that codifying gestational limits into law is not the sole approach. His rationale centered on avoiding leaving individuals stranded outside institutional protections as they turn to dubious channels like direct overseas purchases.

Following his remarks, inter-agency consultations led by the Office for Government Policy Coordination were launched, involving the Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety (MFDS). However, positions remain divided among government ministries, political circles, the medical community, and women's rights groups over whether the legal scope and gestational limits of abortion must be codified in law first.

Currently, no abortion drugs are approved in South Korea. Hyundai Pharm signed an agreement with the UK-based Linepharma International in 2021 and applied for item approval for Mifegymiso, a combination of mifepristone and misoprostol, but voluntarily withdrew the application over difficulties submitting supplementary data. It reapplied in 2023 and 2024, with the third submission currently under review.

While approval has remained stalled for an extended period, illegal online distribution has persisted. According to the MFDS, instances of illegal online sales, brokering, and advertising of abortion drugs rose from 414 cases in 2021 to 682 cases last year. Between January and May of this year alone, 218 cases were detected.

With the issue officially brought to the fore by the President, experts unanimously agree that upcoming discussions must extend beyond item approval to specify actionable standards for clinical settings. These include defining eligible medical institutions, clinical departments, and authorized healthcare professionals, as well as establishing protocols to verify gestational age and intrauterine pregnancy. Key points of disagreement also surround whether to mandate in-person consultations and ultrasound examinations, alongside the extent to which telemedicine or pharmacy dispensing should be permitted.

Safety management systems post-ingestion are also deemed necessary. Systems are required to designate handling institutions and enable immediate patient transfers for emergency treatment or surgery in cases of excessive bleeding, infection, incomplete abortion, or continued pregnancy. Furthermore, with farming and fishing communities facing a shortage of obstetrics and gynecology clinics, finding facilities for prescriptions and follow-up care may prove difficult even if the medication is approved, underscoring the need for measures addressing regional medical accessibility.

"Abortion pills can be introduced as soon as the MFDS grants approval," said Gong Hye-won, secretary general of the Center for Sexual Rights and Reproductive Justice. "While the government maintains that legal standards such as permitted gestational limits under the Mother and Child Health Act must be established first, the medication should be introduced first, followed by discussions on the overall healthcare system covering prescription, administration, and follow-up care." She added, "Medication-based abortion is an effective method used in early pregnancy, and usage methods vary based on gestational age and circumstances. Considering regions with limited accessibility, prescriptions should not be overly restricted to OB-GYN specialists alone."

Meanwhile, the MFDS stated that relevant discussions among related ministries are underway, adding, "We will disclose specific details once the outcome of these discussions is finalized."

                                                                                                                 Lee Se-mi