Abortion pill ‘Mifjin’ Q&A… When and where can you get a prescription? [Flat]

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If you search for ‘Mifjin’ (an abortion pill) on the internet, you can still find posts about selling it. The price is in the 300,000500,000 won range. No one knows whether it is genuine or counterfeit, or when it expires. From 2021 through May of this year, the Ministry of Food and Drug Safety detected 3,189 cases of illegal online sales or brokerage ads for abortion medicines. Although the World Health Organization (WHO) designated them essential medicines in 2005 and 101 countries allow them, in Korea they have been traded covertly.

The government plan announced on the 16th to introduce abortion medications is a declaration to draw this clandestine market into the national healthcare system. Following the Constitutional Court decision in 2019 finding the abortion provisions unconstitutional, the Criminal Act articles on self-induced abortion and physician-performed abortion lost effect on January 1, 2021. However, because the National Assembly did not enact replacement legislation, abortion medications 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 drugs without waiting for legal revisions.

The target for introduction is the first quarter of next year. However, Ministry of Food and Drug Safety approval and import and supply procedures remain, and matters such as whether minors need parental consent and which physicians may prescribe have not yet been determined. Based on the government announcement, we have summarized who can get a prescription, from when, and where.

Q. What exactly is the drug being introduced, and how is it different from the morning-after pill?

It is ‘Mifegymiso tablets’, for which Hyundai Pharm has applied for an import license. Commonly called ‘Mifjin’, the product coming to Korea is made by Linepharma International in the United Kingdom. It is not a one-pill drug. It is a combination in which two drugs with different actions are 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-soo, Director-General of the Pharmaceutical Safety Bureau at the Ministry of Food and Drug Safety, explained, “The first drug, mifepristone, is a new drug, and the second, misoprostol, has been used since 1988 as a treatment for gastric ulcers.”

It acts differently from the morning-after pill. The morning-after pill delays or suppresses ovulation to prevent pregnancy from occurring; it has no effect on an already established pregnancy. By contrast, abortion medication terminates an established pregnancy. If you group the two into the same category, the timing of use and the prescription process will be completely mismatched.

Under the application, it is for use within 63 days (9 weeks) of pregnancy. On the reason, the government explained, “Based on clinical trial data, the company applied for use within 9 weeks of pregnancy.” In other words, it is not that the government set the gestational limit; the company applied within that range because its clinical trials were conducted in patients up to 9 weeks. The Ministry of Food and Drug Safety will review within that scope. This is shorter than the WHO usage criterion (12 weeks). On this, the government said, “Countries are to set it based on their medical environments or clinical results.”

A vehicle promoting the safety of mifepristone use passes in front of the meeting hall of the American Pharmacists Association at the Phoenix Convention Center in Arizona, United States, on March 25, 2023 (local time). Getty Images

According to WHO clinical guidance on abortion care, it is generally calculated from the first day of the last menstrual period. If the date of the last period is uncertain, clinicians determine gestational age through an examination or ultrasound. However, this is an explanation based on WHO guidance; in this announcement the government did not separately present a specific method of calculating gestational age.

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

Nothing has been decided yet. The Ministry of Food and Drug Safety said the application did not include a separate age criterion. However, the mere absence of an age criterion in the application does not mean minors can use it without restriction. Won Min-kyung, Minister of Gender Equality and Family, said, “Whether guardian consent is required needs careful consideration in light of the overall youth protection system, and we will review and proceed prudently.” In the end, age criteria are likely to be addressed in guidance to be developed by the Ministry of Health and Welfare and the Ministry of Gender Equality and Family, rather than in approval by the Ministry of Food and Drug Safety.

Q. Exactly when will prescriptions start?

The government's target is the first quarter of next year, that is, between January and March. The date has not been fixed. The Ministry of Food and Drug Safety said the review of the application has progressed considerably, with supplementation and review of some materials, including the Risk Management Plan (RMP), still remaining. Approval alone will not immediately place the drugs in hospitals. Import procedures, preparation of labeling, import safety and quality testing, and the company securng supply must all be completed before actual prescribing begins.

Q. At which hospitals can you get a prescription? Is it limited to obstetrics and gynecology?

Qualifications for prescribing physicians are currently under discussion with the medical community. The government's position is that the capability to determine gestational age and rule out ectopic pregnancy, such as by ultrasound, matters more than the name of a medical specialty. It does not intend to limit prescribing to a particular specialty, but, in practical terms, it expects that at least obstetrician-gynecologists will be able to do so. The actual scope of medical institutions that will be available can be known only after detailed criteria are issued.

Q. How will prescribing and taking the drugs work? Do the pills have to be taken at the hospital?

For the first two years after introduction, it will operate on an in-house dispensing model in which a physician at a medical institution directly prescribes and dispenses the drugs. First, a consultation confirms gestational age and whether there is an ectopic pregnancy. The dosing method in the application is to take the first drug, mifepristone, and then, 2448 hours later, take the second drug, misoprostol. It then provides for a return visit within 714 days to confirm the result of the abortion and check for adverse effects.

However, in-house dispensing is different from in-hospital ingestion. While the principle has been set that the drugs are dispensed at the hospital, it has not yet been decided whether both pills must be taken on-site or how long one must remain after taking them.

Q. Why are regular pharmacies not dispensing it? Will that be possible after two years?

This is both the core and the limitation of the plan. The reason is the law. The Constitutional Court decision of nonconformity concerned physician- and self-abortion, and the Ministry of Justice issued an interpretation that pharmacists could still be punished under the Criminal Act. If pharmacists dispense it, they could incur criminal liability, so pharmacies were removed from the distribution route.

Dispensing at pharmacies will not automatically be allowed after two years. The government will decide on any expansion after reviewing safety monitoring results and the status of revisions to the Criminal Act and the Mother and Child Health Act. If the laws are not revised or safety concerns are not resolved, the in-house dispensing period may be extended.

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

The price has not yet been set. The government said, “At the initial stage of introduction, it may be prescribed as a non-reimbursable service not covered by National Health Insurance.” Coverage review begins only if the pharmaceutical company applies for reimbursement. In other words, the government expects the company to supply the drug as non-reimbursable.

In that case, prices are set by medical institutions. However, the government plans for the Health Insurance Review and Assessment Service to collect, compare, and disclose prices. Separately, it will review whether National Health Insurance can cover ultrasounds and other pre-prescription exams.

Q. Will it be difficult for residents outside major cities or for low-income people to use it?

Because patients must visit hospitals multiple times for consultation, dosing, and follow-up, and because pharmacies cannot be used, the burden is heavier in areas without obstetrics and gynecology services. The government said this was the biggest concern raised in discussions with women's groups, and it would monitor utilization after introduction to assess accessibility by demographic and regionsuch as adolescents, low-income people, and women living in rural and fishing communitiesand develop improvements. However, this announcement did not present measures to secure prescribing institutions or specific support plans.

Q. Will taking the pills definitely terminate the pregnancy? Are there side effects?

Domestic labeling has not yet been finalized. Based on information released by WHO and the U.S. 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. Do not assume it is finished merely because there has been bleeding; you must have the outcome confirmed at a hospital. Cramping and bleeding are reactions that occur as the drugs act, and nausea, vomiting, diarrhea, and fever may accompany them. Rarely, heavy bleeding requiring transfusion or infection may occur. The drugs are not effective for ectopic pregnancy.

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

The Royal College of Obstetricians and Gynaecologists (RCOG) in the United Kingdom explains that if abortion is completed without complications, it does not affect the ability to become pregnant in the future. The FDA also advises that you can become pregnant again not long after a medication abortion.