Medical Community Calls for "Safety System First" Over Introduction of Abortion Drugs... Prescription to Minors Also a Point of Contention

[Financial News] The government has officially announced the domestic introduction of abortion drugs. This marks the beginning of full-scale efforts to incorporate medical abortion into the institutional medical system, approximately seven years after the Constitutional Court of Korea's 2019 ruling declaring the abortion law unconstitutional. However, there are still many challenges to overcome before actual implementation, including the refinement of relevant laws, prescribing to minors, preventing illegal distribution, and ensuring follow-up care and emergency response.

On the 16th, the government discussed a plan to gradually introduce abortion drugs for pregnancies within the first nine weeks at the National Policy Coordination Meeting. For the first two years of implementation, doctors will be required to prescribe and dispense the drugs directly at medical institutions, and the plan is to expand dispensing to pharmacies after evaluating side effects and safety.
The Ministry of Food and Drug Safety is currently reviewing the safety, efficacy, quality, and risk management plans of abortion drugs for which product approval has been applied. If related procedures, such as manufacturers securing supplies, proceed without setbacks, the goal is to introduce the drugs in the first quarter of next year. The Ministry of Health and Welfare (MOHW) plans to review the phased introduction process as well as the eligibility for health insurance coverage.
The product being pursued for domestic introduction is HYUNDAI PHARMACEUTICAL CO., LTD.'s 'Mifzimiso'. Manufactured by the UK's Rhein Pharma International, it consists of one 200 mg tablet of mifepristone and four 200 μg tablets of misoprostol. Based on clinical trial data and other factors, the company has applied for product approval on the condition that the drug be used within 63 days (9 weeks) of pregnancy. HYUNDAI PHARMACEUTICAL CO., LTD. first applied for product approval in 2021 but voluntarily withdrew the application during the process of supplementing data. They applied again in 2023, but the review process was suspended, and they applied for product approval for the third time in December 2024. The actual timing of distribution is expected to depend not only on product approval but also on import procedures and health insurance coverage.
Addressing the legal vacuum is also a challenge. Although the existing provisions on abortion have lost their effect as the National Assembly missed the deadline for follow-up legislation after the Constitutional Court of Korea's ruling of non-constitutionality, subsequent legislation regulating the permissible scope and procedures for abortion, as well as the responsibilities of medical professionals, has not yet been established. While the Ministry of Government Legislation issued an authoritative interpretation last month stating that the product approval of abortion drugs does not violate the current Mother and Child Health Act, the medical community points out that this does not mean the institutional conditions for safe use in actual clinical practice have been established.
The criteria for prescribing medication to minors is also a point of contention. The Ministry of Gender Equality and Family maintains the position that it will carefully review whether to allow minors to receive prescriptions without parental consent. Minister Won Min-kyong stated that adolescents require psychological and emotional support, and that the issue of parental consent must be reviewed in consideration of the overall youth protection system.

The medical community is demanding that a safety management system be established first.
The Korean Society of Obstetrics and Gynecology and the Committee on Induced Abortion of the Women's Health Foundation pointed out that while they do not oppose the introduction of abortion drugs itself, a system for verifying gestational age and the presence of ectopic pregnancy, follow-up monitoring after administration, and an emergency response system for side effects such as bleeding and infection must be established first.
The stance is that accurate diagnosis is particularly crucial before taking the medication. This is because using the drug without properly verifying the gestational age or missing an ectopic pregnancy can lead to missing the appropriate time for treatment. Furthermore, it is explained that even after taking the medication, it must be confirmed whether the abortion was performed successfully, and medical institutions must be able to respond promptly if any abnormal situations arise, such as persistent bleeding, infection, or an incomplete abortion.
It has been pointed out that the standards medical staff apply during actual clinical practice must also be clearly defined. The concern is that if the scope of prescribing medical institutions and doctors, criteria for pre-medication testing, timing of follow-up care, and the emergency patient transfer system are not specifically established, treatment methods may vary from institution to institution.
Addressing the legal responsibilities of prescribing authorities and medical staff is also cited as a task that needs to be tackled. There are concerns that if the medication is introduced first amidst a legal vacuum following the Constitutional Court of Korea's ruling that the abortion law is unconstitutional, confusion may arise regarding the scope of liability and treatment standards for medical professionals in the event of side effects or emergencies.
Meanwhile, women's groups welcome the government's plan to introduce the drug while demanding improved accessibility. They argue that the current usage limit of within nine weeks should be expanded, regional disparities in access to medical institutions should be reduced, and a comprehensive support system including sex education and counseling should be established. On the other hand, religious groups and some civic organizations are raising voices opposing the introduction, citing concerns over the right to life and the potential for drug misuse.
Prime Minister Han Seong-sook stated, "We take concerns regarding the value of life very seriously," and asked for a broad understanding of the purpose of this measure, which is to protect public health rather than to encourage induced abortion.
[email protected] Jeong Sang-hee Jeong Sang-gyun Reporter