Prime Minister Han Seong-sook speaks during a national policy coordination meeting at the Government Complex Seoul in central Seoul on Sept. 16.NEWS1
The government is moving to formally introduce abortion medication for pregnancies up to nine weeks, with doctors required to prescribe and dispense the drugs directly at medical institutions for the first two years.
“We intend to introduce medication abortion in phases for pregnancies of up to nine weeks,” Prime Minister Han Seong-sook said during the 14th national policy coordination meeting at the Government Complex Seoul in central Seoul on Wednesday. “Safety is the most important consideration. We need to establish a system that allows women who need it to receive care within a safe medical system rather than relying on unverified methods.”
“We also take concerns about the value of life very seriously,” Han added. “This measure is not intended to encourage abortion, but rather to protect public health. I ask for broad understanding of that purpose.”
The Ministry of Gender Equality and Family, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety presented the proposal at a meeting chaired by Prime Minister Han.
With follow-up legislation stalled since the Constitutional Court ruled the abortion ban unconstitutional in April 2019, the government decided to move ahead with introducing the medication under the existing legal framework before relevant laws are amended.
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.
A box containing a Mifepristone tablet is seen at Blue Mountain Clinic in Missoula, Montana, on Feb. 28, 2023.REUTERS/YONHAP
Abortion pills were first approved in France in 1988, according to the Gender Equality Ministry. They were introduced in Britain in 1991, the United States in 2000 and Japan in 2023, and were permitted in about 100 countries as of 2024. The World Health Organization has also included the drugs on its Model List of Essential Medicines.
The Ministry of Food and Drug Safety is reviewing an application for import approval, which seeks authorization for use within 63 days, or nine weeks, of pregnancy based on clinical trial data and other evidence. The ministry will assess the medication’s safety, efficacy and quality, as well as a risk management plan covering the collection and evaluation of adverse events after launch, safety monitoring and educational materials for patients and medical professionals.
The Health Ministry intends to require doctors to directly prescribe and dispense the oral regimen at medical institutions for the first two years after its introduction. The government will then assess any adverse effects and safety concerns before considering whether to expand access beyond medical facilities.
“Safety is being undermined by the illegal distribution of drugs whose safety has not been verified and the proliferation of substitutes,” the government said in explanatory materials released on Wednesday. It cited restrictions on women’s ability to choose between surgical and medication-induced abortion based on their health conditions, as well as higher costs when abortions are delayed, as reasons for introducing medication.
The Ministry of Gender Equality and Family office in Jongno District, central Seoul, on Sept. 3NEWS1
“Formalizing the use of the medication would make it possible to monitor its use and ensure safe administration and follow-up care,” the Gender Equality Ministry said.
The pharmaceutical company first applied for approval in July 2021. The Drug Safety Ministry has delayed its review for over five years. Discussions gained momentum after President Lee Jae Myung instructed officials on July 14 to examine the possibility of allowing the medication.
The Ministry of Government Legislation concluded on Aug. 19 that abortion pills could be approved even though the Mother and Child Health Act does not explicitly recognize medication as a method of terminating a pregnancy. The ministry interpreted the existing law as allowing approval if the medication meets requirements for safety, efficacy and other criteria.
The medical community has called for a safety management system to be established first. The Korean Society of Obstetrics and Gynecology has called for in-clinic prescriptions by obstetricians and gynecologists, along with a reporting system after use, to ensure that conditions such as ectopic pregnancies can be identified and emergencies properly handled.
This article was originally written in Korean and translated by a bilingual reporter with the help of generative AI tools. It was then edited by a native English-speaking editor. All AI-assisted translations are reviewed and refined by our newsroom.
