Top photo: KCOG members in 2018
A conflict developed this month between an abortion rights group and a gynaecologists’ association over whether or not is it necessary to conduct a “bridging trial” of the combi-pack of medical abortion pills whose brand name is Mifegymiso (mifepristone + misoprostol), a widely used brand of abortion pills that is due to arrive in Korea soon.
A “bridging trial” is intended to obtain clinical data on the safety of a new medication for Koreans when it is believed that clinical trial results from other countries do not apply to Koreans due to “differences in ethnic factors” (sic).
Hyundai Pharm had applied for marketing approval for Mifegymiso in July this year. According to industry sources, the Ministry of Food and Drug Safety (MFDS) held a meeting of the Central Pharmaceutical Affairs Council on 2 September 2021 to review to safety data.
The advocacy group Joint Action for Reproductive Justice (JARJ) attended the drug approval review meeting as a reference witness. JARJ argued that as Mifegymiso’s safety and efficacy have already been proved sufficiently in other countries, the MFDS should waiver a bridging study and approve the abortion pills swiftly to guarantee women’s access to safe abortion.
They also argued that misoprostol is already authorised as a gastric ulcer treatment in Korea, and poses almost no risk in efficacy and safety. And that mifepristone had already been approved in several Asian countries, including China, Taiwan, Vietnam and Mongolia, which made a bridging study unnecessary since they were all Asian.
JARJ also noted that the authorities had caught 2,365 illegal advertisements for the sale of unauthorised abortion pills in 2019, which potentially left Korean women unsafe.
“A bridging study is a tool to review ethnic factors, not national factors,” said Lee Dong-geun, Secretary-General of the Association of Pharmacists for Healthy Society (APHS). Lee is also an executive member of JARJ. “Excessively demanding a bridging study could be a waste of resources, and it could further delay access to an abortion drug that has been delayed for more than 30 years.”
Lee noted that mifepristone was recognised as a safe drug by the WHO and has been used in Asia for a long time. Raising concerns about the drug’s effect on Koreans only was excessive. “Just like the regulator exempts a bridging study for orphan drugs and anti-cancer drugs, it should waiver a bridging trial for Mifegymiso considering that there is no other medicine that can induce medical abortion.”
In contrast, the Korean College of Obstetrics & Gynecology (KCOG) said a bridging trial for Mifegymiso was necessary because it is an accepted part of introducing a new medicine in Korea, usually when it is imported. It is possible to apply for a local permit without an additional clinical trial only with bridging clinical data. “We sternly warn that attempts to ignore such a process could endanger people’s right to health,” KCOG said.
KCOG also rejected the argument that bona fide abortion pills are needed to curb illegal distribution of abortion pills. KCOG said the government should enforce the law strictly to protect people’s safety first. KCOG also claimed that many women suffer from adverse reactions after using abortion drugs illegally and called on the government to conduct a fact-finding investigation to identify the risks before introducing Mifegymiso. Also, the government should draw up measures to prevent misuse of abortion pills and illicit trading that could also occur even after Mifegymiso gets approval.
The Constitutional Court of Korea ruled in 2019 that criminalising abortion in Korea was unconstitutional and ordered lawmakers to revise the law by the end of 2020. However, the government and the National Assembly have been slow to do this, KCOG said. “Rather than rushing to introduce a risky medicine, the government and the parliament should expedite the revision of the law,” it said.
These inaccurate claims are disturbing from ob-gyns. Are abortion pills seen as a threat to ob-gyn income from surgical abortion services, as has happened in several other countries, including Japan and Spain? In 2018, it was the KCOG that discontinued performing abortions, except legally allowed procedures, in spite of existing demand, as their protest against the government’s latest law reform, which imposed harsher punishments on doctors who did abortions illegally. Yet it was women needing abortions who suffered.
SOURCES: Korea Biomedical Review by Kim Chan-hyuk, 13 September 2021 ; Korean Herald, by Claire Lee, 29 August 2018