Abortion medication ‘Mifjin’ entering the formal system, tasks to resolve before introduction next year [Flat]

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On the 16th, Minister Won Min-kyung of the Ministry of Gender Equality and Family gives a briefing on plans to introduce abortion medication at Government Complex Seoul in Jongno-gu, Seoul. Yonhap News

The government is moving to introduce abortion medication for the first time in seven years since the Constitutional Court in 2019 found the abortion ban inconsistent with the Constitution. It plans to allow women up to 9 weeks (63 days) of pregnancy to use the medication at medical institutions through a physician prescription and dispensing within the first quarter of next year.

The Ministry of Gender Equality and Family, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety reported this plan to introduce abortion medication at the 14th National Policy Coordination Meeting held at Government Complex Seoul on the 16th.

Hyundai Pharm, which holds the domestic rights to Mifjin, applied to the Ministry of Food and Drug Safety for marketing authorization in December 2024, and a supplementary review is under way. Shin Jun-su, Director General of the Pharmaceutical Safety Bureau at the Ministry of Food and Drug Safety, said, “There remain items needed for approval and review, such as a risk management plan, and after approval the company must proceed with importing supply,” adding, “We plan to work with the company so that introduction can take place by the first quarter of next year to the extent possible.”

For the first two years of rollout, the government plans to operate the system through ‘in-house dispensing’, in which a physician prescribes the drug and the medication is prepared directly within the medical institution. Kwak Soon-heon, Director General for Health Care Policy at the Ministry of Health and Welfare, explained, “Although there was a Constitutional Court decision of inconsistency with the Constitution regarding the abortion ban under the Criminal Act, there is an authoritative interpretation that pharmacists can still be punished under the Criminal Act,” adding, “For the initial two years, we intend to introduce it in a way that ensures safety by having physicians dispense directly.”

The marketing authorization for Mifjin is being reviewed for use in women up to 9 weeks of pregnancy, but specific criteria such as the eligible age for prescription have not yet been established. Minister Won Min-kyung of the Ministry of Gender Equality said, “Adolescents will likely need special psychological and emotional support,” adding, “We will prepare guidelines to address those aspects appropriately.”

Introducing ‘Mifjin’, an early medication abortion drug, is one of the policy tasks of the Lee Jae Myung administration. Discussions on introducing abortion medication have continued since the 2019 Constitutional Court decision of inconsistency, but domestic marketing authorization has been repeatedly delayed. Hyundai Pharm has applied to the Ministry of Food and Drug Safety for authorization since July 2021, but applications were voluntarily withdrawn or reviews were halted during the process of supplementing data. In July, President Lee Jae Myung directed officials to review the possibility of permitting abortion medication, accelerating discussions on introduction among the relevant ministries.

The Ministry of Health and Welfare and the Ministry of Gender Equality plan to prepare clinical guidelines for use while the Ministry of Food and Drug Safety reviews authorization. For now, it appears prescriptions could be issued at any medical institution that can confirm gestational age and rule out ectopic pregnancy. The Ministry of Health and Welfare said it is discussing detailed criteria with academic societies so that physicians who have the capability to confirm gestational age and ectopic pregnancy by ultrasound and other means can prescribe the drug.

If approved as applied for to the Ministry of Food and Drug Safety, women using abortion medication would need to visit a medical institution at least twice. According to the application, Mifjin is to be used by sequentially taking drugs containing mifepristone (Mifjin) and misoprostol. First, mifepristone, which blocks the action of hormones necessary to maintain pregnancy, is taken, followed 24 to 48 hours later by misoprostol, which induces uterine contractions. Within 7 to 14 days thereafter, the patient returns to a medical institution to confirm that the termination has been completed properly.

Health insurance coverage will not apply in the initial phase, so prescriptions are expected to be non-reimbursable. Even if a drug receives marketing authorization from the Ministry of Food and Drug Safety, health insurance coverage does not take effect immediately. Only when a pharmaceutical company separately applies for benefit determination is coverage decided after appropriateness review by the Health Insurance Review and Assessment Service. Separately from drug reimbursement, authorities said they will review whether health insurance can be applied to pre-procedure items such as ultrasound.

A joint statement by the Korean Society of Obstetrics and Gynecology, the Korean Association of Obstetricians and Gynecologists, and the Direct Election Korean Association of OB-GYN Practitioners on the introduction of abortion medication. Korean Society of Obstetrics and Gynecology website

Three organizations, namely the Korean Society of Obstetrics and Gynecology, the Korean Association of Obstetricians and Gynecologists, and the Direct Election Korean Association of OB-GYN Practitioners, issued a statement after the government announcement, saying, “We agree with the government policy direction and, as specialist OB-GYN bodies spanning academia and clinical practice, will actively cooperate for safe introduction and use management.”

They also set out institutional tasks that should be refined through discussions with the medical community. First, they argued that relevant laws such as the Mother and Child Health Act and the Criminal Act should stipulate the right of clinicians to refuse to prescribe if they do not wish to. The groups said, “We should respect the choice of physicians who, based on personal beliefs, do not participate in prescribing abortion medication, but the law must clearly set out procedures to ensure women are promptly connected to the care they need.”

They also called for revision of Article 14 of the current Mother and Child Health Act, which requires spousal consent for abortion. The organizations said, “In light of the Constitutional Court decision of inconsistency, the right of women to self-determination, and the new form of care represented by early termination through medication, this provision has lost consistency with reality,” adding, “It needs to be revised so that frontline medical staff are not left to make judgments amid legal uncertainty.”

They also stressed the need to establish safety management systems, compensation mechanisms, and protections for medical personnel so that, before Criminal Act revisions are completed, clinicians involved in prescribing and administration are not exposed to criminal uncertainty.

Kwak said, “The relevant laws are the Mother and Child Health Act and the Criminal Act. For the Mother and Child Health Act, there are about six member-sponsored amendment bills, which appear likely to be discussed in the National Assembly in the second half of this year,” adding, “We will collect opinions from the National Assembly and various groups and take part in deliberations on legal amendments.” On clinicians refusing to prescribe, he said, “We are also discussing ways to respect the right of clinicians to choose.”

“Introducing the drug alone is not enough... access to medical institutions and support systems must be established”

Women advocates welcomed the official introduction of abortion medication but pointed out that the in-house dispensing model could reduce access. Na Young, head of SHARE (Center for Sexual Rights and Reproductive Justice), said, “Compared with using other regimens, medication abortion can be done more safely and effectively, which is positive,” adding, “For more than five years the Ministry of Food and Drug Safety delayed decisions on introduction, and we welcome that this time the government is pushing it forward quickly.” However, she said, “If in-house dispensing is the premise, access could be considerably limited,” and, “It is also important to secure sufficient access so patients can use the drug safely.”

There were also calls to establish support systems for those who have difficulty accessing medical institutions, including adolescents. Heo Min-suk, a legislative researcher at the National Assembly Research Service, said, “In the case of minors, there may be situations where it is difficult to obtain parental consent, and some people may worry about medical costs,” adding, “There should be separate counseling or support channels for such people, along with systems to provide swift assistance when needed.” The researcher added, “It should not end with a two-year pilot operation; the government should present concrete plans on how to create a legal basis and make the system take root during that period.”

▼ Reporter Lee Hye-in hyein@khan.kr · Reporter Woo Hye-rimsaha@khan.kr