Korea’s abortion pill plan faces fresh legal questions despite gov't import clearance

The legal interpretation that cleared the way for abortion pills in Korea did not decide whether ending a pregnancy itself is lawful, the Ministry of Government Legislation has told a lawmaker.

With no legal standard on abortion in place for seven years, there are questions over whether the government rushed to bring in the drug first.

In August, the Legislation Ministry answered a query from the Ministry of Food and Drug Safety on whether abortion pills could receive import approval before the Mother and Child Health Act, which sets out the limited cases in which doctors may perform abortions and covers only surgical procedures, is revised.

The Legislation Ministry said such an approval "cannot be seen as violating" the law, and also found that the food and drug ministry's approval is a "nondiscretionary act" if the drug meets the requirements, including safety and efficacy. A nondiscretionary act is one an administrative agency must carry out once the conditions set by law are met.

That interpretation sped up the introduction of abortion pills, which had stalled since the Constitutional Court ruled in 2019 that the criminal ban on abortion was unconstitutional.

This year, on Sept. 16, the Ministry of Gender Equality and Family, the Ministry of Health and Welfare and the Ministry of Food and Drug announced that the pills would be introduced by the first quarter of next year.

The medication the government seeks to introduce is Hyundai Pharm’s Mifegymiso tablets. The regimen consists of mifepristone, which blocks progesterone, a hormone needed to maintain a pregnancy, followed by misoprostol, which induces uterine contractions. It is widely known in Korea by the brand name Mifegyne, which was first launched in France in 1988.

For the first two years, doctors will prescribe and dispense the pills directly.

But the Legislation Ministry struck a different note in materials it recently submitted to the National Assembly.

"We did not judge whether individual abortions using the drug are lawful," the ministry said in a written response to Rep. Joo Jin-woo of the main opposition People Power Party, a member of the Legislation and Judiciary Committee. In other words, its earlier interpretation only stated that importing abortion pills would not violate the law, but did not recognize the legal legitimacy of abortion by medication.

The earlier interpretation focused only on whether the pills could receive import approval rather than on how the law applies, according to Joo.

On questions such as how many weeks into a pregnancy medication abortion should be allowed and for what reasons, the ministry said such issues are "a matter of policy judgment for the ministries in charge." It said its "nondiscretionary act" finding was "interpreted on the premise that 'the submitted materials meet the requirements for approval, such as safety and efficacy.'"

Interpretations by the Legislation Ministry are not legally binding and do not replace the legislative overhaul required by the Constitutional Court's ruling, and a system for induced abortion needs to be overhauled through legislation, according to the Legislation Ministry.

The abortion provisions of the Criminal Act lost effect in 2021, but follow-up discussions at the National Assembly and elsewhere have stalled, and the legal vacuum remains.

Even if the pills are approved, the debate over when and how they should be used will continue. Many in and outside the medical community say the legal uncertainty must be cleared up before the drug is introduced.

"Without a legal basis, it will be difficult for medical staff to actually prescribe abortion pills," Lee Jae-kwan, chairman of the Korean Society of Obstetrics and Gynecology, said.

The society and two other obstetrics and gynecology groups urged the National Assembly last month to move quickly.

"Revisions to the Criminal Act and the Mother and Child Health Act are needed for abortion pills to be safely established," the groups said. The National Assembly Research Service issued an opinion that same month, stating that "the National Assembly should hurry to push legislation that fills the institutional gap."

Some also say the policy is being carried out in the wrong order, where approval came before legislation.

"The Legislation Ministry's interpretation does not legalize medication abortion, and there is no provision in current law that allows it," a lawyer involved in the introduction process said. "The order is backward." A government official said, "Even if the Ministry of Food and Drug Safety grants product approval, actually using it in the field is a different matter."

Joo called for ending the drive to introduce the abortion pills..

"The Lee Jae Myung administration is pushing ahead with introducing abortion pills without any legislation," Joo said. "We must stop the attempt to force through in haste a matter directly tied to people's lives."

BY CHAE HYE-SEON [[email protected]]