MFDS, ob-gyn doctors interpret laws differently over Mifegymiso approval

The Ministry of Food and Drug Safety (MFDS) and the Korea Association of Obstetricians & Gynecologists (KAOG) have expressed widely different views of the laws over an introduction of an abortion drug Mifegymiso (mifepristone/misoprostol).

The clash between the two sides erupted after an MFDS official said it could authorize an abortion drug even though law revisions were not complete.

The government and a group of obstetricians and gynecologists have divided opinions on introducing the abortion drug Mifegymiso.

In April 2019, the Constitutional Court ruled that Korea’s banning of abortion was unconstitutional and ordered to amend related laws. However, the National Assembly and the health authorities have failed to come up with revision bills.

At a briefing on Tuesday, Moon Eun-hee, director of the Pharmaceutical Policy Division at the MFDS, said the process of Mifegymiso review does not necessarily require a revision of the criminal law. “The Constitutional Court’s decision to decriminalize abortion includes drug-assisted abortion. So, it is not judged that the criminal law should be amended to introduce an abortion drug,” she said.

The Pharmaceutical Affairs Act prohibits the use of expressions that can suggest drug-assisted abortion in labels. However, if the government allows displaying the efficacy of Mifegymiso as “termination of pregnancy within a certain period,” the drug will be able to bypass the law, Moon said.

On Wednesday, the MFDS held an advisory meeting with external experts to manage an abortion drug safely. After the meeting, however, KAOG lambasted the MFDS for abusing the power to approve an abortion drug when law revisions were incomplete.

The group of ob-gyn doctors directly refuted the MFDS’ argument that authorization of an abortion drug was possible without an amendment to the criminal law.

“The essence of the Constitutional Court’s ruling was to recognize pregnant women’s right to self-determination on abortion and to respect the professional freedom and professionalism of doctors by abolishing or revising the criminal law, which only stipulates that abortion is subject to punishment,” KAOG said in a statement. “The court’s decision has nothing to do with allowing drug-assisted abortion.”

Also, the MFDS misinterpreted the law because it was not possible to display “abortion” in the label of a drug when the Pharmaceutical Affairs Act was not revised, the doctors’ group said.

Under the current law, it is impossible to display abortion as a drug’s effectiveness in the label because the article of the law prohibits the use of phrases or designs that suggest abortion in drug labeling, KAOG said.

“The MFDS misunderstood the law to think that such an expression was not a suggestion of abortion.”

KAOG said it could not understand why the MFDS was rushing to approve Mifegymiso in a situation where there will be a “legislative vacuum” if legislation for allowing abortion does not pass the National Assembly.

“Unless the government has a political purpose amid the upcoming presidential election, it has to discuss (Mifegymiso) approval after a drug-assisted abortion bill gets passed,” KAOG said. “If the MFDS overstretches to authorize the import and distribution of an illegal medicine, we will have to sue the government for abusing power.”

KAOG also demanded the government allow only ob-gyn doctors to prescribe an abortion drug.

Suppose a doctor who cannot confirm pregnancy status without an obstetric ultrasound prescribes Mifegymiso. In that case, they could misdiagnose an ectopic pregnancy and fail to confirm a safe termination of the pregnancy, KAOG argued.

Mifegymiso must be taken under the guidance of an ob-gyn doctor because the number of repeated visits to the clinica can differ depending on the number of weeks of pregnancy, it went on to say.

KAOG also expressed concerns that if Mifegymiso gets approved when no law permits a drug-assisted abortion, ob-gyn doctors have no legal basis for refusing a pregnant woman’s request for a drug prescription.

“To approve an abortion drug without waiting for the National Assembly’s legislation when abortion has not been decriminalized is to aid doctors to commit a crime,” KAOG said. “The MFDS should not make doctors potential criminals.”

KAOG emphasized that Mifegymiso must go through a bridging trial to get the permit.

As an introduction of an abortion drug is not as urgent as a Covid-19 vaccine, the MFDS could start reviewing Mifegymiso after a bill allowing drug-assisted abortion gets passed, it added.