[Why&Next] Abortion Pill 'Mifjin' Approved... Gaping Holes in Law and Policy

Medical Community: "Safety Verification and Measures Against Illegal Distribution Must Come First"

Protecting Clinical Autonomy and Legal Rights of Healthcare Providers Is Essential

Prescription Authority, Duration of Use, and Counseling Rem

As the government has officially announced the introduction of abortion medication in Korea, updating and establishing relevant regulations and healthcare systems has emerged as a key challenge. While reviewing a drug’s safety and efficacy for approval is one issue, determining when and under what conditions abortion will be permitted is another. This highlights an urgent need to address the long-standing legislative vacuum surrounding this issue.

According to government and healthcare sources on September 23, the Ministry of Food and Drug Safety is currently conducting a supplementary review of the risk management plan for 'Mifgymiso,' for which Hyundai Pharm submitted a marketing authorization application in December 2024. Even after the Ministry’s approval, steps such as importation, quality inspections, and securing supply will remain. However, the government plans to cooperate with the company to introduce the medication within the first quarter of next year.

For the initial two years after its introduction, the medication will be prescribed and dispensed directly by physicians at healthcare institutions. The government plans to center the prescribing system around physicians with the medical expertise necessary to determine gestational age and assess for ectopic pregnancy. Subsequently, the authorities will review data on safety, side effects, and legislative changes in order to revise the operating procedures as needed.

The Korean Society of Obstetrics and Gynecology and other groups agree with the government’s position of a gradual, safety-first approach, but are also calling for detailed, clinically applicable standards before the drug’s introduction. They note there is a need to manage such drugs—previously distributed unofficially—within the national healthcare system. However, they argue there is a clear difference between leaving decisions to doctors’ expertise and shifting legal responsibility onto providers without precise official guidelines.

Pharmacological abortion is not merely taking pills; it requires confirmation of non-ectopic pregnancy, consideration of possible situations including excessive bleeding, incomplete abortion, infection, continued pregnancy, and appropriate post-procedure management. Because emergencies may occur, obstetricians warn that overemphasizing clinical discretion in the absence of clear standards could jeopardize patient safety and expose providers themselves to medical disputes and legal risks.

Kim Jaeyoo, President of the Korea Association of Independent Obstetricians and Gynecologists, stressed, "There is a tendency in some sectors to regard medical abortion as no more than taking a pill, but simply increasing access to medication does not fully guarantee women’s health rights. Clear legal bases, standardized clinical guidelines, emergency response and follow-up systems, and mechanisms to protect providers all need to be established to ensure safe use of the drug."

The Korean Medical Association maintains that introducing such medication without Ministry approval or sufficient safety verification and measures against illegal distribution could threaten the health of pregnant women. The association stated, "Legislation is needed so that medical professionals who refuse abortion-related care on bioethical or religious grounds are not penalized under the Medical Service Act, along with guidelines to protect both patients and healthcare professionals."

Medication under review for use within 9 weeks of pregnancy... Separate from legal gestational limits

The National Assembly Research Service raised concerns about a more fundamental legal gap. In a recent report on "Key Issues and Tasks for Permitting Mifegyne," Yoonjung Jeon, a legislative investigator at the National Assembly Research Service, stated, "While the Ministry of Food and Drug Safety should review the safety, efficacy, and quality of pharmaceuticals, the duration, reasons, and procedures for allowing abortion must be clearly established in law by the National Assembly."

The report particularly emphasized the need to distinguish between "how many weeks a drug can be used" and "how many weeks abortion should be permitted." The Ministry had held the position that legal reforms regarding abortion should precede setting gestational limits for drug usage. Conversely, the Ministry of Government Legislation concluded that the permitted period for drug use under pharmaceutical law and the legal gestational limit for abortion are separate issues. Market approval defines the scope of use for a drug that has been proven safe and effective; it does not set or determine the legal circumstances, reasons, or period for abortion itself.

Currently, the domestic marketing application for Mifgymiso is premised on use before 9 weeks of pregnancy, and the Ministry reviews the application based on the submitted clinical trial data. However, even if the drug is authorized for use within 9 weeks, this does not equate to legally setting abortion’s permitted period at 9 weeks—the scope of legal allowance remains a separate legislative priority.

Issues surrounding consultation and mandatory reflection periods must also be resolved. While some argue for the need to provide ample information about pregnancy maintenance, delivery and parenting support, abortion procedures, and possible side effects, others contend that required counseling or reflection periods could effectively serve as a de facto approval process, limiting autonomy and potentially increasing gestational age at the time abortion is performed.

Investigator Jeon stated, "Rather than handling marketing authorization for abortion medication and legal revision as a sequential process, they should be pursued in parallel. The Ministry of Food and Drug Safety should review safety, efficacy, and quality under the current Pharmaceutical Affairs Act, while the National Assembly should simultaneously revise laws such as the Maternal and Child Health Act to establish legal criteria and healthcare system infrastructure, thereby addressing the systemic void surrounding abortion."

This content was produced with the assistance of AI translation services.