Japan is set to approve the nation’s first abortion pill that gives women a method to end pregnancy without surgery, providing controlled access to the medicine decades after it became available in France and US.
A panel for Japan’s health ministry agreed on Friday to approve Line Pharma KK’s two-drug regimen for women who have been pregnant for nine weeks or less. The ministry is proceeding with the next steps for approval, a health official said on Monday.
The drug’s availability in the island nation comes at a time when abortion pills are being targeted in the US, after the Supreme Court overturned the landmark Roe v. Wade ruling in June. Access to reproductive health measures are still limited in Japan, where oral contraceptives aren’t covered by insurance, epidural anesthesia during delivery is available only at select hospitals and abortions require a husband’s consent when a woman is married.
Medication abortions involve two compounds. Mifepristone was initially developed by French researchers, and is designed to be taken with misoprostol. It was approved for use in France in 1988, according to a group of doctors called The Reproductive Health Access Project. In the US, the Food and Drug Administration banned the import of mifepristone in 1989, then allowed its sale in 2000.
The medication is available 25 countries including Canada, Latin America, Asia and Australia, according to Line Pharma. Mifepristone blocks a hormone called progesterone that’s necessary to continue a pregnancy. Misoprostol, taken 36 to 48 hours after the first drug, induces contractions.
Japan’s approval was supported by public comments and petitions. The drug’s use will be limited to places where patients can be hospitalized until sufficient data is collected to evaluate appropriate care, the ministry said. The drugmaker and medical institutions will be required to report sales and usage data to local medical associations, it said.
The number of abortions performed in Japan has been declining since the 1950s. The nation reported 126,174 cases in fiscal 2021, according to health ministry data. Japan’s requirement that married women get consent from their husbands before having an abortion includes an exception for rape cases, according to the Center for Reproductive Rights.
Almost half of all pregnancies globally are unintended, and 6 out of 10 of those end in induced abortion, according to the World Health Organization. Around 45% of all abortions are unsafe, of which 97% take place in developing countries, the WHO said.