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Article Japan: Abortion Pill Regimen Likely to Be Approved

On January 27, 2023, an expert panel (Drug Division 1 of the Pharmaceutical Affairs and Food Sanitation Council) of Japan’s Ministry of Health, Labour and Welfare (MHLW) reportedly decided to approve Mefeego Pack — a commercial package containing mifepristone and misoprostol pills used for inducing an abortion. The decision was posted for public comments on the government website in February 2023. After the collection of public comments, the Pharmaceutical Affairs Section of the council will meet in March or later to reexamine the issue of medical abortion in light of the public comments . Final approval of the pills by the council, which is likely before the summer of 2023, would lead to official approval by the MHLW. (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, Act No. 145 of 1960, amended by Act No. 47 of 2022, art. 14, item 11.)

Background to the Issue of Abortion in Japan

In Japan, the Maternal Health Act allows abortions to be performed for economic reasons. (Maternal Health Act, Act No. 156 of 1948, as amended, art. 14.) However, medical abortions for economic reasons have not been allowed, although Gemeprost is approved for termination of second trimester pregnancies for medical reasons.

According to a BBC report, “Medical abortions, using pills rather than surgery, were made legal in France 34 years ago [1988]. Britain approved them in 1991, and the US in 2000. In many European countries this is now the most common form of terminating a pregnancy.” The World Health Organization (WHO) states that abortion by these pills is noninvasive, has proven cost-effective, and “offers several advantages.” Nevertheless, British pharmaceutical company LinePharma’s application for approval of Mefeego has remained pending with the MHLW for more than 14 months, since December 2021, though drugs are usually approved within one year

The BBC report states, “Japan, a country with a poor record on gender equality, has a history of being extremely slow to approve drugs related to women’s reproductive health.” Previously, for example, the Japanese government maintained a ban on oral contraceptives for decades, despite oral contraception being “one of the most widely used contraceptive methods in the world.” The government finally approved it in 1999 after its exceptionally swift approval of Viagra was internationally and domestically mocked and criticized.

The abortion pill regimen will most likely be approved with restrictions on its use that are at odds with the practices of other countries. The WHO states that “a medical abortion can also be safely self-managed by the pregnant person outside of a health care facility (e.g., at home), in whole or in part” in the first 12 weeks of pregnancy, but Japan is poised to restrict the use of the pills to the first nine weeks of pregnancy. Further, in accordance with the opinion of the Japan Association of Obstetricians and Gynecologists, the pills will most likely be allowed for use only by outpatients or by inpatients in facilities with beds until sufficient usage experience is accumulated and an appropriate usage system is established.

In December 2021, Katsuyuki Kinoshita, the head of the Japan Association of Obstetricians and Gynecologists, reportedly commented that around 100,000 yen (about US$735) would be a “fair” price for the abortion drugs, which is about 135 times the global average. In response, social media commentators have accused the association of trying to make an inordinate profit from the pills. (LinePharma has not disclosed the price of the packet yet.) Subsequently, medical experts explained that Kinoshita most likely meant the entire procedure, including doctor visits, would cost 100,000 yen. According to the nonprofit organization Planned Parenthood, medical abortion in the U.S. costs “up to around $800, but it’s often less.” Nevertheless, the accusation that the price of the abortion drugs has been inflated continues to be repeated in media sources.

Sayuri Umeda, Law Library of Congress
March 15, 2023

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