Photo/Illutration Mifepristone and Misoprostol, abortion pills widely used overseas (provided by Yutaka Osuga, professor at the University of Tokyo)

British pharmaceutical company LinePharma is expected to soon apply to the health ministry to have its abortion pill approved for use in Japan.

The drug company has concluded the final phase of clinical trials in Japan and confirmed that the pill aborts the pregnancy more than 90 percent of the time.

As soon as the company completes an additional clinical trial, it will file the application.

If approved, it will be the first abortion pill in Japan.

Some experts, though, have expressed concerns over the use of such emergency contraception. 

According to the company, 120 women between the ages of 18 and 45, who were in the ninth week of their pregnancy or earlier and wished to terminate the pregnancy, participated in the clinical trial.

They took one tablet of Mifepristone, which suppresses the progestational hormone needed to sustain pregnancy. Two days later, they took four tablets of Misoprostol, which constricts the uterus.

Yutaka Osuga, a professor of obstetrics and gynecology at the University of Tokyo, oversaw the clinical trial and presented the results at an April conference of the Japan Society of Obstetrics and Gynecology.

Osuga said the data was “either equating to or surpassing the data from overseas.”

It came amid a growing need for access to sexual and reproductive health care around the world.

“There has been growing demand in Japan for abortion pills that are widely used and considered safe and effective around the world,” he said.

If the drug is approved, Osuga said women will have more options for abortion according to their own needs.

LinePharma said the company is currently conducting an additional clinical trial for a comparative analysis between Japanese and international patients that examines how the drug differs in participants’ blood concentration.

Abortion pills were first approved in France in 1988. Currently, more than 70 countries and regions have approved the use of this kind of drug with a doctor’s prescription.

The World Health Organization in 2012 issued a guideline that recommended the abortion pill as one of the safest and most effective ways to end a pregnancy.

In Japan, however, abortions can only be performed through operations.

Drug-induced abortions are still illegal in Japan, partly due to the lack of discussion on the subject matter.

According to the health ministry, 156,430 abortion operations were conducted in fiscal 2019.

But amid reports of illegally imported abortion pills causing harmful health effects, such as heavy bleeding, the health ministry responded in 2004 by introducing new import restrictions.

But people continued to purchase the drugs over the internet. In 2018, a woman in her 20s in Miyagi Prefecture took an abortion pill made in India that she bought online and then suffered from heavy bleeding and spasms.

Health care workers and women have urged the ministry to approve abortion pills under the control of doctors based on guidelines by expert bodies such as the WHO.

Kunio Kitamura, an obstetrician-gynecologist who chairs the Japan Family Planning Association, said the public should be educated about bleeding and stomachaches caused by the drug and ways to protect the patient’s health.

To put the drug into practical use, Kitamura said, those who consider taking it should see a doctor to confirm the pregnancy and ensure the completion of abortion, as well as to ensure they are choosing the right option for them and to learn how to take the pill.

The ministry needs to establish detailed rules for the procedure and measures to respond to emergency cases, such as a patient feeling ill while taking the pill, Kitamura said.

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