A New Turning Point for Abortion Pill Approval

Recent remarks by President Lee Jae-myung have brought the issue of introducing medication for induced abortion back into the spotlight. During a State Council meeting, the President emphasized, "It is not desirable for women to be purchasing abortion pills through direct overseas purchases," and stated that consideration should be given to entrusting the matter to the professionalism and conscience of doctors. These comments have sparked interest in 'Mifegymiso,' which Hyunda Pharm is seeking approval for.

Diverse Opinions Surrounding the Introduction of Abortion Pills

Women's and human rights groups have reacted positively to the resumption of official discussions on introducing medication for induced abortion. On the other hand, some obstetricians and pro-life organizations are concerned that confusion may arise without clear guidelines on the permissible gestational period and prescription criteria. Amidst these controversies, the future response from the Ministry of Food and Drug Safety is drawing attention.

Mifegymiso's Approval Process and Stock Price Fluctuations

Mifegymiso, which Hyunda Pharm is pursuing for introduction, is a drug composed of mifepristone and misoprostol, which works by inhibiting pregnancy hormones and inducing uterine contractions. Hyunda Pharm first applied for product approval in 2021, but the process has been delayed due to multiple requests for supplementary data. Following the President's recent remarks, Hyunda Pharm's stock price has surged, attracting investor interest.

• July 2021: First product approval application
• December 2022: Voluntary withdrawal
• March 2023: Reapplication, followed by another withdrawal
• December 2024: Scheduled for third product approval application

Legal Standards and Future Outlook

Currently, the Ministry of Food and Drug Safety maintains its stance that the permissibility and gestational limits for medication-induced abortion must be established by law. Since the Constitutional Court's decision in 2019, legal standards for induced abortion remain insufficient. In this context, discussions in the National Assembly regarding related legislation have stalled, with no follow-up legislation enacted.

Given the political discord between the ruling and opposition parties, the passage of legislation is expected to be challenging. Therefore, in the short term, it is highly probable that administrative solutions from relevant ministries, based on the President's directive, will take precedence. In light of these circumstances, it is crucial to observe how the discussions surrounding the introduction of abortion pills will unfold.