Lee slams abortion pill legal limbo as 'irresponsible'

President Lee Jae Myung on Tuesday criticized the government for leaving the abortion pill mifepristone in legal limbo, calling the situation "irresponsible," and stressing that women should be able to receive the medication through proper medical channels despite legal uncertainty.

"Even if it creates some difficulties for the government, women should be able to receive the medication appropriately," Lee said during a Cabinet meeting at the presidential office. "Leaving the situation as it is now is irresponsible."

Mifepristone is an oral medication used to terminate early pregnancies. First approved in France in 1988, it is now legally available in more than 100 countries. The World Health Organization designated it an essential medicine in 2005. The drug has not been approved in Korea and cannot be purchased legally, leaving women to obtain it through illegal channels, including overseas online purchases.

Debate over approving mifepristone in Korea gained momentum after the Constitutional Court ruled in 2019 that the country's abortion ban was unconstitutional. The criminal provisions of abortion lost effect in 2021, but the National Assembly has failed to pass follow-up legislation defining when and how abortions may be performed, leaving a legal vacuum for more than five years.

Hyundai Pharm first applied for approval of its combination drug containing mifepristone and misoprostol — medications used together to induce an abortion — marketed as Mifjimiso, in July 2021. The company withdrew the application in 2022 to supplement additional data before filing again. The Ministry of Food and Drug Safety has not completed its review, saying legislation must first define the permissible gestational limit and prescribing guidelines.

External legal opinions obtained by the ministry, however, reportedly concluded that the drug could be approved under the current Pharmaceutical Affairs Act regardless of revisions to the Mother and Child Health Act. Critics in the National Assembly also argued that the ministry improperly linked what should be a scientific review of the drug's safety and efficacy to unresolved political and legislative issues.

Lee said the prolonged legislative vacuum has left women in legal limbo.

"Mifepristone is not approved here, so women appear to be buying it directly from overseas," he said. "Because the debate over the legal scope of abortion has not been resolved, women who need the medication are obtaining it through overseas purchases, so accidents are occurring, too."

He questioned whether the Ministry of Food and Drug Safety could approve the drug before revisions to the Mother and Child Health Act are completed.

"Couldn't the ministry approve the medication even before the Mother and Child Health Act is revised?" Lee said. "Other countries are already using it. The government may avoid responsibility by leaving it outside the legal system, but the public is put at risk."

Lee also expressed frustration over the prolonged debate on setting a legal gestational limit for abortion.

"At this rate, my term could end before we settle the question of how many weeks should be allowed," he said. "Even before that issue is resolved, couldn't doctors be allowed to exercise their own judgment? If the remaining issues are mainly legal ones, couldn't the medication be approved until those questions are settled?"

No legal gestational limit for prescribing mifepristone has been established. Cho Won-cheol, minister of government legislation, suggested allowing the drug to be prescribed only between five and 10 weeks of pregnancy, but Lee said debate over setting a gestational limit could continue indefinitely.

"Doctors make life-and-death decisions every day," Lee said. "We should let them decide whether prescribing the medication is appropriate. I'm not sure a law specifying an exact week limit can ever be 100 percent certain."

He added, "Even before replacement legislation is enacted, doctors could be allowed to decide whether to prescribe the medication. That would be better than leaving the current situation unresolved despite its imperfections."

Prime Minister Han Seong-sook proposed further discussions after the relevant ministries prepare policy proposals.

"This is a highly sensitive issue," Han said. "The relevant ministries should prepare an agenda so we can discuss it again and come up with a compromise."

Lee instructed the relevant ministries to begin consultations.

"Let's come up with a compromise," he said. "This is not something we should simply leave unresolved."

BY HAN YOUNG-HYE [[email protected]]