Abortion pill sold via internet lacks formal regulatory approval

An abortion pill illegal in Korea may not be approved for some time despite it being sold here via the internet and despite a clamoring by activists for the regulators to allow it into the country.

Mifegyne

Hyundai Pharm submitted an application in July last year with Ministry of Food and Drug safety to sell Mifegyne, the brand name for mifepristone, which is commonly known as RU-486.

The Korean company has an exclusive agreement with London's Linepharma International for the sale of the abortion-inducing drug in Korea.

Mifegyne violates the Pharmaceutical Affairs Act and is currently being evaluated by authorities.

In 2021, laws against abortion in Korea lost their effect after the Constitutional Court ruled that two articles in the Criminal Act were unconstitutional, but some matters related to the procedure remain unresolved.

Experts point out that a legal vacuum remains as a legislative amendment is required to actually make abortion legal in Korea.

Mifegyne was developed in 1980 and is sold in 76 countries, including the United States and China. The World Health Organization considers it safe.

"Currently, 95 percent of abortions in Korea are done before 10 weeks of pregnancy, and it is known that taking Mifegyne within 70 days of pregnancy has a success rate of more than 99 percent," said Han Jung-yeol, an obstetrics and gynecology professor at Inje University Ilsan Paik Hospital.

The ministry is still in the process of approving Mifegyne as it believes additional clinical trials should be done by the country before introducing it.

"There is no need to postpone the approval of Mifegyne, but additional clinical trials are necessary to see if there are any medical complications from taking the pill," said Na Sunghun, an obstetrics and gynecology professor at Kangwon National University Hospital in an interview with the Korea JoongAng Daily.

Despite being technically illegal, Mifegyne is in high demand online. Websites conduct 24-hour consultations anonymously and "prescribe" the drug based on these consultations. The price ranges from 200,000 won ($162) to 450,000 won, depending on the number of weeks a woman has been pregnant.

There are concerns that knockoff Mifegyne is being sold online.

In May 2020, a group was caught after selling fake Chinese abortion pills, receiving a total of 130 million won from 300 women. The group committed a crime by deceiving women looking for abortion pills, saying the pills are approved by the FDA, and conducting medical consultations without a license.

Women who took this pill said they suffered various side effects including excessive bleeding.

"The government is postponing the approval of Mifegyne for the sake of safety, but it should be aware that this is threatening the safety of women. Pregnant women may prefer taking abortion pills over surgical abortions as it is non-invasive. Prohibiting it violates women's right to health."

"Insurance coverage for abortion is another important issue. Legally permitting abortion in the country will not change anything if the cost is still high. Abortion was treated as a crime for a long time in the country, and I believe amending the insurance coverage will help change people's mind positively," said Kim Sun-hye, professor of women's studies at Ewha Womans University.

"Mifegyne should be sold at an affordable price for easier access, but getting a proper diagnosis from the doctor is crucial," Na said.

On Sunday, an event to commemorate the first anniversary of the court's ruling on abortion was held in Jongno District, central Seoul. Participants in the event asked the government "to pass related bills and implement systems including health insurance coverage and the introduction of abortion pills."

"In the past, women attempted abortion even though the surgery was dangerous. It has been already 30 years since a safe way was found, but Korea is still not capable of adopting it," said Lee Dong-geun, Secretary General of a civic group called Good Pharmacists.

BY CHOI SEO-IN, CHO JUNG-WOO [cho.jungwoo1@joongang.co.kr]