Mifegyne approval gains momentum... initial in-hospital dispensing

President Lee lays out detailed timeline following July directive to introduce abortion pill

Legislative vacuum, opposition resistance and interministerial coordination remain hurdles

The domestic approval and prescribing of Mifegyne, a medication used for pregnancy termination, appears to be drawing closer, with President Jae-myung Lee laying out a detailed roadmap for its introduction in Korea.

According to the roadmap, the drug would initially be prescribed and dispensed within hospitals for 2 years following approval by the Ministry of Food and Drug Safety (MFDS). After the 2 years, the system would shift to hospital prescribing and dispensing at community pharmacies.

The government is now moving toward establishing an approval and safety management framework for Mifegyne, after Lee went beyond his public directive in July to actively consider introducing the drug and specified how it should be prescribed and dispensed, as well as the timing of the transition.

Still, several issues remain unresolved, including the continued legislative vacuum surrounding pregnancy termination and persistent opposition from some political and religious groups.

According to political sources on the 7th, Lee recently addressed the introduction of Mifegyne during a meeting with civil society representatives at the presidential office. He said, “The Ministry of Health and Welfare and women's groups are discussing the matter, and the general direction is to have the drug prescribed and dispensed in hospitals for 2 years, followed by hospital prescribing and dispensing at outside pharmacies thereafter.”

Under this approach, prescriptions and dispensing would initially take place entirely within medical institutions to strengthen safety management. Once the system is established, patients would receive prescriptions from physicians and have them filled at community pharmacies, as is generally the case with prescription medicines.

During a Cabinet meeting on July 14th, Lee had previously instructed relevant ministries to actively consider introducing Mifegyne to Korea.

The intention was to stop overlooking the current situation in which unapproved abortion pills are purchased through unofficial channels overseas, and devise a way to ensure safe use of the drug within Korea’s medical system. The Ministry of Health and Welfare, the Ministry of Gender Equality and Family, and the MFDS have been discussing potential approaches to introducing the drug thereafter.

With the president outlining a specific prescribing and dispensing model, as well as a timeline for the transition thereafter, momentum toward its introduction has accelerated further.

Despite the government's increasingly clear intention to introduce Mifegyne, a legislative vacuum remains, as follow-up legislation has yet to establish matters such as the gestational age limit for pregnancy termination, permitted methods and procedures for medication abortion.

This has also been one reason the MFDS has maintained a cautious stance on approving abortion medications. In addition to reviewing Mifegyne itself for safety and efficacy, authorities must establish safety management standards governing issues such as the gestational age through which it may be used, which medical institutions and healthcare professionals may prescribe it, and how patients would be linked to medical care in the event of adverse outcomes such as bleeding or incomplete abortion.

The president's proposal to require in-hospital prescribing and dispensing for the first 2 years after approval before transitioning to community-pharmacy dispensing also appears intended to address these safety concerns. Under the approach, the drug's use and adverse events could initially be managed within medical institutions, with dispensing later expanded outside hospitals once a safety management system has been established.

Although Lee has proposed 2 years of in-hospital prescribing and dispensing following approval, opposition lawmakers have argued that approving an abortion medication before a complete legal framework is in place would be irrational.

It also remains unclear whether Lee’s timeline has been finalized among the relevant government ministries or whether the proposal is directly linked to the abortion medication currently under review by the MFDS.

"Arbitrarily discussing its use while the legal grounds for the prescription, dispensing, and post-use safety management of abortion pills are not yet complete can be unreasonable. There is also no precedent for specifying the approval method and prescription/dispensing methods for prescription drugs based solely on a presidential directive."