South Korea: Drug for medical abortion can be approved without legal changes, says institute

A South Korean state-funded research institute has asserted that the drug mifepristone, used for medical abortions, can be approved for use even without specific legal amendments defining its scope. This finding directly challenges the Ministry of Food and Drug Safety's (MFDS) seven-year delay in approving the medication, a delay the ministry attributed to the need for legislative changes following a constitutional court ruling that found the abortion ban unconstitutional.

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it is not the case that a drug can only be approved after its permissible scope is legally defined.

The Korea Legislation Research Institute (KLRI), a national policy research institution, stated in a report that "it is not the case that a drug can only be approved after its permissible scope is legally defined." The report emphasized that under the Pharmaceutical Affairs Act, the criteria for drug approval are safety, efficacy, and quality, determined by submitted clinical data. It pointed out that since there are no explicit restrictions on mifepristone in the Pharmaceutical Affairs Act, the MFDS should review and approve it if it meets the standards upon application by a pharmaceutical company.

The KLRI report also refuted the MFDS's claim that approval requires a law specifying the allowance and gestational limits for medical abortions. "The efficacy and usage of drugs are determined by the scope supported by clinical trial data, not by the permissible limits set by criminal law," the report stated, adding that the "delay in approval can be seen as a selective policy outcome."

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The efficacy and usage of drugs are determined by the scope supported by clinical trial data, not by the permissible limits set by criminal law.

Several countries have adopted medical abortion drugs before or alongside legislative changes. Japan, for instance, approved the manufacturing and sale of mifepristone in April 2023, maintaining its system of requiring prescriptions only from designated doctors and spousal consent. The UK has allowed remote consultations and at-home use of medical abortion drugs since August 2022, and recently passed an amendment to decriminalize abortion. These examples illustrate that healthcare systems can be improved first, followed by criminal law revisions.

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Easy abortions are already happening outside of regulation.

Addressing concerns about side effects like incomplete miscarriage and infection, the report noted that over 3,000 illegal sales posts were detected over five years without a single quality inspection. "Easy abortions are already happening outside of regulation," it argued. The institute stressed that to manage adverse drug reactions, the drug must be known and regulated through approval and risk management plans. "Allowing medical abortions while establishing specific guidelines is necessary," said KLRI researcher Choi Ji-yeon, advocating for the drug's inclusion within a national management system to control misuse and adverse events. She also called for long-term reforms to criminal law, the Mother and Child Health Act, and the integration of the drug into health insurance and medical delivery systems.

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Allowing medical abortions while establishing specific guidelines is necessary.