They say the abortion medication ‘Mifjin’ will be introduced··· who can get a prescription, from when, and where - 경향신문

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

If you search online for ‘Mifjin’ (abortion medication), you can still find posts offering it for sale. The price is around 300,000-500,000 KRW. No one knows whether it is genuine or counterfeit, or when it expires. The Ministry of Food and Drug Safety detected 3,189 cases of illegal online sales or brokerage advertisements for abortion medicines from 2021 through May of this year. Although the World Health Organization (WHO) designated it an essential medicine in 2005 and 101 countries allow it, in Korea it has been traded under the table.

The plan to introduce abortion medication announced by the government on the 16th is a declaration to bring this underground market into the national healthcare system. After the Constitutional Court's 2019 decision finding the abortion crime nonconforming to the Constitution, the Criminal Act provisions on self-abortion and physician abortion lost effect on January 1, 2021. However, because the National Assembly did not enact replacement legislation, abortion medication still could not be prescribed at medical institutions thereafter. The government has therefore decided, seven years after the court decision, to proceed with introducing the medication without waiting for legal amendments.

The target for introduction is the first quarter of next year. Still, authorization by the Ministry of Food and Drug Safety and import and supply procedures remain, and matters such as whether minors will need guardian consent and which physicians are qualified to prescribe have not yet been decided. Based on the government announcement, here is a summary of who can receive a prescription, from when, and where.

Q. What exactly is the medicine being introduced, and how is it different from emergency contraception?

It is ‘Mifegymiso’, for which Hyundai Pharm has applied for import approval. It is commonly referred to as Mifjin, and the product to be imported is made by Linepharma International in the United Kingdom. It is not a single-pill product. It is a combination of two different medicines taken in sequence. The first drug, mifepristone, blocks the action of the pregnancy-maintaining hormone progesterone, and the second drug taken afterward, misoprostol, induces uterine contractions. Shin Jun-Su, Director General for Drug Safety at the Ministry of Food and Drug Safety, explained that the first drug, mifepristone, is a new drug, while the second, misoprostol, has been used since 1988 as a treatment for gastric ulcers.

It works differently from emergency contraception. Emergency contraception delays or suppresses ovulation to prevent a pregnancy from being established, and it has no effect on pregnancies that have already implanted. In contrast, abortion medication terminates an established pregnancy. Grouping the two together leads to completely different timing of use and prescribing procedures.

Under the authorization application, it is for use within 63 days of pregnancy (9 weeks). The government explained that the company applied for use within 9 weeks based on clinical trial data. In other words, the government did not set the gestational limit; the company submitted clinical trials conducted on patients within 9 weeks, and the application reflects that scope. The Ministry of Food and Drug Safety will review it within that range. This is shorter than the WHO usage criterion of 12 weeks. The government explained that each country sets its limit based on its medical environment and clinical results.

Q. From when do you start counting the 9 weeks of pregnancy?

According to the WHO clinical practice guideline on abortion care, the count is generally based on the first day of the last menstrual period. If the date of the last period is uncertain, clinicians determine gestational age by examination or ultrasound. However, this description follows WHO guidance; in this announcement, the government did not separately present a concrete method for calculating gestational age.

Q. Can minors receive a prescription? Is parental consent required?

Nothing has been finalized. The Ministry of Food and Drug Safety stated that the authorization application does not include a separate age criterion. However, the mere absence of an age criterion in the application does not mean minors will be able to use it without restriction. Minister Won Min-Kyung of the Ministry of Gender Equality and Family said the question of guardian consent requires careful consideration within the broader youth protection framework and will be reviewed cautiously. In the end, the age issue is more likely to be addressed in guidance to be drawn up by the Ministry of Health and Welfare and the Ministry of Gender Equality and Family than in the Ministry of Food and Drug Safety authorization.

On July 23, members of the ‘Rights Guarantee Network for Safe Abortion for All’ hold a press conference in front of the Seoul Central District Court in Seocho-gu, Seoul, regarding the verdict in a case that applied the charge of ‘murder’ to a woman who underwent a late-term abortion. Yonhap News

Q. Exactly when will prescriptions start?

The government has set a target of the first quarter of next year, that is, sometime between January and March. No specific date has been fixed. The Ministry of Food and Drug Safety said its review of the application is largely underway, with supplementation and review of certain documents, including the risk management plan (RMP), remaining. Approval alone will not immediately place the medicine in hospitals. Actual prescribing can begin only after import procedures and labeling are prepared, import safety and quality testing is completed, and the company secures supply.

Q. At which hospitals can it be prescribed? Is it limited to obstetrics and gynecology?

Qualifications for prescribing physicians are under discussion with the medical community. The government takes the view that the capability to determine gestational age and rule out ectopic pregnancy by ultrasound and other means is more important than the formal name of a specialty. The intent is not to limit prescribing strictly to a particular specialty, but in practice it is expected to require the level of an obstetrics and gynecology specialist. The actual scope of medical institutions available will become clear once detailed criteria are issued.

Q. How will prescribing and dosing proceed? Must the medicine be taken at the hospital?

For the first two years after introduction, it will operate under an in-house dispensing model in which a physician prescribes and dispenses the medicine directly at the medical institution. First, through a consultation, gestational age and the presence or absence of ectopic pregnancy are confirmed. The dosing method applied for is to take the first drug, mifepristone, followed by the second drug, misoprostol, 24 to 48 hours later. Within 7 to 14 days thereafter, the patient is to return to the hospital to confirm the result of the abortion and check for adverse events.

However, in-house dispensing is different from in-house ingestion. The principle is that the medicine is provided at the hospital, but whether both drugs must be swallowed on the premises and how long one must remain after dosing have not yet been decided.

Q. Why is it not dispensed at regular pharmacies? Will that be possible after two years?

This is both the core element and the limitation of the plan. The reason is the law. The Constitutional Court's decision of nonconformity concerned the crimes of physician abortion and self-abortion, and the Ministry of Justice issued an interpretation that a pharmacist could still be criminally liable under the Criminal Act. To avoid exposing pharmacists to criminal liability, pharmacies have been excluded from the distribution channel.

Pharmacy dispensing will not automatically be permitted after two years. The government plans to decide on expansion based on safety assessments and the status of amendments to the Criminal Act and the Mother and Child Health Act. If the laws are not amended or safety concerns remain, the in-house dispensing period may be extended.

Activists from the ‘Rights Guarantee Network for Safe Abortion for All’ hold a press conference at Gwanghwamun Square in Jongno-gu, Seoul, on September 23 last year to mark the ‘International Safe and Legal Abortion Day’ on 9.28. Kwon Do-Hyun, staff reporter

Q. How much will it cost? Will National Health Insurance cover it?

The price has not yet been set. The government said there is a possibility it will initially be prescribed as a non-covered service not reimbursed by National Health Insurance. Coverage can be reviewed only if the pharmaceutical company applies for reimbursement. In other words, the government expects the company to supply the medicine on a non-covered basis at first.

In that case, each medical institution sets the price. However, the government plans to prepare a scheme for the Health Insurance Review and Assessment Service to receive, compare, and disclose the prices. Separately from the drug cost, whether National Health Insurance can be applied to ultrasound examinations performed beforehand will be reviewed.

Q. Will it be difficult for people in provincial areas or with low incomes to use it?

It is true that the burden is greater in areas without obstetrics and gynecology clinics, because patients must visit hospitals multiple times for consultation, dosing, and follow-up, and pharmacies cannot be used. The government said this was the greatest concern raised in discussions with women's organizations, and that it will monitor utilization after introduction to assess access by group and region, including adolescents, low-income people, and women living in rural and fishing communities, and will prepare improvement measures. However, this announcement did not include plans to secure prescribing medical institutions or concrete support measures.

Q. Will the medicine reliably terminate a pregnancy? Are there side effects?

The domestic authorization details have not yet been finalized. Based on information published by the WHO and the United States Food and Drug Administration (FDA), there are cases in which medication alone does not complete the abortion and additional procedures such as aspiration are required. One must not assume the process is complete simply because there was bleeding; a follow-up visit at a hospital to confirm the result is essential. Abdominal pain and bleeding are reactions that occur as the medicine works, and nausea, vomiting, diarrhea, and fever may accompany them. Rarely, heavy bleeding requiring transfusion or infection may occur. The regimen has no effect on ectopic pregnancy.

Q. Does terminating a pregnancy with medication make it harder to become pregnant later?

The Royal College of Obstetricians and Gynaecologists (RCOG) explains that if abortion is completed without complications, it does not affect future fertility. The FDA also notes that a person can become pregnant again soon after terminating a pregnancy with medication.