Medical experts, drug ministry divided over abortion pill

Members of the Joint Action for Reproductive Justice, a coalition of pro-choice groups, participate in a press conference in Gwanghwamun, central Seoul, in this March 8 photo, calling on the government to include abortion in the public health care system. Korea Times photo by Hong In-ki

By Lee Hyo-jin

Medical experts and the drug ministry are sharply divided over Mifegymiso, an abortion pill regimen which has been under regulatory review for market approval in Korea, making it unlikely for the drug to hit the shelves this year.

If approved, it will become the first legal abortion pill in the country, following the landmark ruling of the Constitutional Court in April 2019 that found the ban on abortion was unconstitutional because prohibiting it in the early stages of pregnancy was a violation of a woman's right to self-determination

In March of this year, local drug firm Hyundai Pharmaceutical signed an exclusive agreement with the U.K.-based drug maker Linepharma International to sell the product in Korea under the local name, Mifegymiso.

Mifegymiso is a combination of two drugs: one tablet of mifepristone and four tablets of misoprostol.

Mifepristone, also known as RU-486 or Mifegyne, is a medication used to terminate an early pregnancy. It is used in 76 countries, including the United States, China, Vietnam, along with several European countries. The World Health Organization (WHO) added the pill to the list of essential medicines in 2005.

Hyundai Pharmaceutical filed an application with the Ministry of Food and Drug Safety for the authorization of Mifegymiso, July 2, with the approval process initially expected to be completed by mid-November.

However, the drugs have yet to be approved.

The ministry's move to waive a bridging clinical trial for the pills to speed up the approval process has been met with fierce opposition from the Korean Association of Obstetricians and Gynecologists.

A bridging clinical trial is a supplementary study performed in a new region or country upon introducing new drugs in order to get more clinical data on their efficacy, safety and dose regimen for local patients.

If the trial is conducted, the introduction of the abortion pill could be delayed for more than two years.

While the drug regulator is considering skipping the trial, given the fact that mifepristone and misoprostol are being widely used in other countries, the doctors argue that the government should mandate it in order to guarantee the safety of the pills.

Minister of Food and Drug Safety Kim Gang-lip speaks during a National Assembly session, Nov. 25. Korea Times photo by Oh Dae-keun

"If we proceed with the bridging clinical trial, it will take an additional two to three years for approval. During a recent meeting of the Central Pharmaceutical Affairs Advisory Committee, we reviewed ways to waive the trial requirement," Food and Drug Safety Minister Kim Gang-lip said during a National Assembly audit, Oct. 8.

"We will analyze existing clinical data submitted by the drug firm along with WHO guidelines, in addition to real-world data, as the pills have been used in 76 countries for 30 years," he added.

Although Kim said that a final decision was yet to be made, his remarks were interpreted by industry insiders to mean that the authorities are likely to exempt Hyundai Pharm from conducting a bridging study.

The drug ministry's move reflects growing calls among pro-choice groups for a swift approval of a legal abortion pill regimen in order to prevent the illegal trading of such pills. According to data from the Korean Pharmaceutical Association, there have been nearly 4,000 cases of the unlawful trading of abortion medicine online between May and November of this year.

On the other hand, the obstetricians' association has expressed concerns over possible unexpected side effects of Mifegymiso on Korean women if the drug is introduced without a bridging study. It criticized the ministry for deprioritizing women's safety in its push to approve the pill.

In addition, these doctors argue that it is too early to authorize any abortion pills, as drug-assisted terminations of pregnancies are in a legal gray area, due to the absence of revisions to related laws, after the so-called Anti-Abortion Law was abolished.

At a press conference on Nov. 23, Moon Eun-hee, director of the pharmaceutical policy division at the ministry, said that the approval process of Mifegymiso does not necessarily require a revision to criminal laws, as "the Constitutional Court's previous ruling has decriminalized abortion, including abortion via medication."

But the obstetricians' association called the statement "a wrong interpretation of the laws."

"The purpose of the Constitutional Court's ruling was to recognize women's right to self-determination, and to respect the freedom of the doctor profession by abolishing or revising criminal law. The ruling itself is irrelevant regarding allowing drug-assisted abortions," it said through a statement, Nov. 24.

"As the introduction of abortion pills is not as urgent as approving a coronavirus vaccine, the drug authorities should continue further discussions after related bills allowing drug-assisted terminations of pregnancies are passed," it added.

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