"If the (abortion) drug is approved and introduced, we are preparing to establish safe usage standards, including clinical practice guidelines with the medical community, so that it can be used safely."
Jeong Eun-kyeong, Minister of Health and Welfare, presented her position on the introduction of the abortion-inducing drug "Mifegyne" during a preliminary briefing on the ministry's second-half work plan on the 16th. Mifegyne is the brand name for mifepristone, developed by French pharmaceutical company Roussel Uclaf in 1980 and first approved by French health authorities in 1988. It received approval from the U.S. Food and Drug Administration (FDA) in 2000 and was designated an essential medicine by the World Health Organization (WHO) in 2005. It is currently used in more than 100 countries around the world.
In Korea, however, it cannot be sold. Although Hyundai Pharmaceutical signed a domestic distribution contract in 2021 with British pharmaceutical company Linepharma International for "Mifegymiso," an artificial abortion drug composed of two ingredients, mifepristone and misoprostol, there has been no word on approval for more than five years. Hyundai Pharmaceutical is known to have applied for product approval to the Ministry of Food and Drug Safety three times from December of that year through 2024. However, the matter remained at a standstill as the ministry maintained its position that specific standards for safe drug use—such as the permissible gestational weeks for abortion and the permissibility of drug-induced abortion—must be established first.
The social debate surrounding abortion dates back to April 2019, when the Constitutional Court ruled that the self-abortion and doctor-performed abortion provisions under the criminal law were unconstitutional. At the time, the court ordered the National Assembly to revise the relevant law by the end of 2020, but follow-up legislation was never enacted, and the criminal law provisions lost their effect as of January 2021. The provisions penalizing abortion disappeared, but a strange situation in which women seeking abortion cannot legally take the drug with a doctor's prescription has continued for more than five years. Recently, however, the long-running abortion debate has resurfaced after President Lee Jae-myung instructed at a Cabinet meeting that a plan to permit the use of the abortion-inducing drug Mifegyne be reviewed.
President Lee pointed to the reality of women taking drugs of unverified safety through direct overseas purchases as a reason to review the introduction of Mifegyne. In fact, a considerable number of cases of abortion drugs being traded through dark channels such as social media (SNS) like Telegram and secondhand marketplaces have been identified. According to data submitted by the Ministry of Food and Drug Safety to the office of Rep. Nam In-soon of the Democratic Party of Korea, a total of 3,189 cases of illegal online sales brokerage and advertising of abortion drugs were caught from 2021 through May of this year. This amounts to an average of 1.6 cases caught per day, and both inside and outside the medical community, the actual scale of illegal distribution, including undetected cases, is believed to be far larger.
Although it is commonly referred to as "Mifegyne" online, this is only the name of a specific product. Generally, drug-induced abortion uses two ingredients together: mifepristone and misoprostol. While mifepristone blocks the action of the hormone progesterone needed to maintain pregnancy, misoprostol induces uterine contractions and prompts the expulsion of pregnancy tissue. The problem is that it is difficult to guarantee safety when drugs purchased through dark channels such as the internet are taken arbitrarily. Even if it is a drug approved 40 years ago and used in more than 100 countries, the process of accurately confirming the gestational weeks and whether the pregnancy is intrauterine is essential before taking it. Ectopic pregnancy is not an indication for abortion drugs, but its early symptoms are similar to those of a normal pregnancy, so the diagnosis can be missed.
Even if it is a genuine pregnancy, abdominal pain and bleeding can occur after taking the drug, and if excessive bleeding, infection, or incomplete miscarriage occurs, additional drug administration or surgery may be needed. Taking the drug arbitrarily without diagnosis, prescription, and follow-up care by a specialist is tantamount to being exposed to dangerous situations defenselessly. Moreover, products distributed online cannot be guaranteed to be genuine regardless of their outer packaging. Not only is it difficult to confirm the manufacturing date, expiration date, and storage condition, but the possibility that they contain no active ingredient or a different ingredient than labeled cannot be ruled out.
Following President Lee's instruction, the Ministry of Health and Welfare's declaration of its willingness to introduce the drug has fueled growing expectations regarding product approval for "Mifegymiso." However, the process may not be smooth because the backlash from the medical community is so fierce. The Korean Association of Obstetricians and Gynecologists immediately issued a statement criticizing it as "an extremely dangerous and irresponsible idea." The reason is that if the drug is distributed indiscriminately without thorough preparation, not only heavy bleeding and infections but also emergency surgery due to incomplete miscarriage may become unavoidable. There is merit to the argument that this is not a matter that ends simply with approving a single drug, and that the permissible gestational weeks for prescription, pre-examinations, contraindications, post-administration follow-up observation, and standards for linking to emergency surgery must first be established.
There is also a considerable counterargument that the current situation of delaying formal introduction is actually more dangerous. Considering women who are driven to unverified online sellers due to the absence of legal treatment and prescription channels, the argument holds that swiftly bringing abortion drugs within the institutional framework is a realistic solution to reduce illegal distribution and side effects. Rep. Nam In-soon pointed out, "While the Ministry of Food and Drug Safety consistently took a passive attitude and effectively delayed approval, women had no choice but to use illegal drugs of unverified safety," adding, "The harm ultimately led to risks to women's health and safety."
