Policy & Regulation
Aim is to curb illicit distribution and manage drugs through national health care system For first 2 years, doctors would directly prescribe and dispense the medication

The government is moving to formally introduce medication abortion. This would be the first policy improvement in 7 years since the Constitutional Court ruled the criminalization of abortion unconstitutional.
The Ministry of Gender Equality and Family reported a plan to introduce medication abortion jointly with the Ministry of Health and Welfare and the Ministry of Food and Drug Safety at the 14th National Policy Coordination Meeting, held on the 16th at the Government Complex Seoul.
The measure is a follow-up to a government policy agenda and President Lee Jae-myung’s directive in July to review the possibility of allowing medication abortion. The aim is to bring drugs that have been distributed illicitly into the national health care system to protect women’s safety and right to health.
The Ministry of Gender Equality and Family reported that gaps in legislation have persisted since the Constitutional Court’s April 2019 ruling that the criminalization of abortion was unconstitutional, and that delays in introducing the medication have led to problems involving women’s health and safety.
According to the ministry, unverified drugs and substitutes are being widely distributed illegally, and women’s right to choose surgery or medication based on their health status is restricted. Socioeconomic burdens, including higher costs resulting from delays, were also cited as reasons for the urgent introduction.
The Ministry of Food and Drug Safety said the medication abortion drug currently undergoing review for import approval was submitted for use within 63 days (9 weeks) of pregnancy, based on clinical trial data. The ministry plans to thoroughly review the approval application materials, including those on safety, efficacy, quality and the risk management plan for the drug.
The Ministry of Health and Welfare said it would manage use of the medication under a principle that doctors directly prescribe and dispense it at medical institutions for the first 2 years after its introduction, and would consider plans for gradual expansion after reviewing adverse effects and safety.
Won Min-kyung, minister of gender equality and family, said, “Pregnancy and childbirth are decisions that have a profound impact on every aspect of women’s lives, but institutional shortcomings have meant that individuals’ rights to safely access the health care system have not been guaranteed.”
Won said, “We expect that abortion will be carried out more safely under the national health care system and that the burdens on women facing socioeconomic circumstances that leave them with no choice but to have an abortion will also be reduced.”
Jeong Eun-kyeong, minister of health and welfare, said, “We will work to create conditions for safe use after the medication abortion drug is approved,” while Oh Yu-kyung, minister of food and drug safety, said, “We will thoroughly review the approval application materials for the medication abortion drug, with public safety as our top priority.”

Biobook Team
biobookmedia@biobook.co.kr
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