The South Korean government has formally moved to introduce mifepristone, the abortion pill, seven years after the Constitutional Court ruled that the country's criminal ban on abortion was unconstitutional. The government plans to complete the product approval process for the drug, which can be used within nine weeks of pregnancy, with a target of domestic introduction as early as the first quarter of next year. For the first two years, doctors will be required to prescribe and dispense the drug directly at medical institutions.
The Ministry of Gender Equality and Family, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety said they reported the plan at the 14th National Policy Coordination Meeting held at the Government Complex Seoul on the 16th.
The plan was drawn up to close the regulatory vacuum that has persisted since the Constitutional Court's 2019 ruling that the abortion ban was unconstitutional. Discussions accelerated after President Lee Jae-myung ordered a review of whether to permit abortion pills in July.
Under the plan announced that day, mifepristone will be used only in early pregnancy, within nine weeks. The drug safety ministry said it will thoroughly review the approval application materials, including the risk management plan for the drug.
Won Min-kyung, minister of gender equality and family, said the measure is significant because it addresses the absence of a substantive state management system following the removal of criminal abortion penalties and allows abortions to be carried out more safely within the national medical system. "The burden on women in socioeconomic circumstances that leave them with no choice but to terminate a pregnancy will also be eased," the minister said.
While the government is moving to introduce the abortion pill after a regulatory vacuum that lasted seven years following the Constitutional Court's 2019 ruling, critics say pharmacy dispensing remains a distant prospect. The government has set direct prescription and dispensing by doctors inside medical institutions as the rule for the first two years, and it has decided to extend that in-clinic dispensing period further if the revision of the Criminal Code and the Maternal and Child Health Act — a prerequisite for pharmacy dispensing — is delayed or if concerns about side effects are not resolved.
According to the gender equality ministry, the health ministry and the drug safety ministry on the 16th, the government will exclude pharmacies from dispensing for the first two years and apply an in-clinic dispensing system in which doctors prescribe and dispense the drug directly at medical institutions. The reason is that with the Criminal Code and the Maternal and Child Health Act still unrevised, the Ministry of Justice has issued a legal interpretation raising the possibility that pharmacists could face punishment, and time is needed to review side effects. Since the Constitutional Court's 2019 ruling, the provisions punishing pregnant women and doctors for abortion have lost effect, but the question of criminal punishment for pharmacists remains unresolved.
As a result, the government's policy of two years of in-clinic prescription and dispensing will not expire automatically after that period, and the timeframe could be lengthened. The health ministry said it expects the Maternal and Child Health Act to be discussed in the National Assembly in the second half of this year and that it will gather views from political circles and various groups to push the revision through. Kwak Soon-heon, director general for health care policy at the health ministry, said, "If the revision of the Criminal Code provisions and the Maternal and Child Health Act is delayed or concerns about side effects are not resolved, the two-year dispensing policy could be extended further."
Securing supplies of the drug at medical institutions and ensuring patient access under in-clinic dispensing are also unresolved problems. During the first two years, when pharmacy dispensing is not allowed, medical institutions that want to prescribe the drug must have systems in place to receive supplies and dispense it on site. The government also believes prescribing physicians need the clinical capacity to confirm gestational age and rule out ectopic pregnancy. The system is likely to operate largely around obstetrics and gynecology practices, but the government has yet to present a specific plan for securing participating medical institutions.
The government set the eligibility limit for the abortion pill at 63 days, or nine weeks, of pregnancy. It said this reflects the fact that the drug now undergoing import approval and review was tested in clinical trials on patients within nine weeks. Hyundai Pharmaceutical, which secured exclusive domestic distribution rights to the oral abortion drug Mifegymiso from British drugmaker Linepharma International, applied in December 2024 for product approval on the condition that it be used within 63 days, or nine weeks, of pregnancy. It was the third application after the first was filed in July 2021. Shin Jun-soo, director general of the pharmaceutical safety bureau at the drug safety ministry, said, "If the review of the company's supplementary documents and the import procedures are completed without setbacks, we will work to make the drug available in the country as early as the first quarter of next year."
The medical community has taken a negative stance on the introduction of the pill. The Korean Association of Obstetricians and Gynecologists issued a statement that day saying the abortion drug is a medication that necessarily requires follow-up surgical treatment and links to emergency care when complications such as incomplete miscarriage or excessive bleeding occur. "If abortion drugs are introduced amid the current legislative vacuum, medical personnel will face the threat of criminal punishment in the course of prescribing and administering them for abortions sought for social and economic reasons," the group said.
