Japan's abortion situations-- Past, Present, and Future
Linepharma's Mefeego Pack, containing one Mifepristone and four Misoprostol tablets, has been called "Japan's first oral abortion pill. "Japan's first abortion pill" was Preglandin (ingredient name: gemeprostol), a transvaginal mid-term abortion pill approved in 1984. Since then, for a long time in Japan, early-term abortions were mainly performed by curettage, while this archaic vaginal suppository was for later abortions.
Until recently, Japanese people were not much interested in oral abortion pills: in a 2014 survey of Japanese women in general, a majority said they had never heard of abortion pills, and more than one-third said that they could not distinguish them from emergency contraceptives, whereas less than 10% of respondents correctly recognized that abortion pills were not on sale in Japan and put on sale in foreign websites. The U.S. medical consulting firm that conducted the survey was also involved in the 2017 approval of the manual aspirator Women's MVA System. Japan's Galapagosized abortion care was slowly beginning to change due to these external pressures.
Japan is one of the few countries where abortion came before contraception. Although abortion was legalized soon after the Second World War and later was simplified so that it could be performed virtually at the discretion of a single doctor. In contrast, oral contraceptives did not come until 1999 and are not still very popular.
The conventional lack of interest in oral abortion pills in Japan is due in part to a lack of education, which has led to a lack of awareness on the part of women to control their pregnancies, as well as a social problem in which the barriers to accessing contraceptive information and methods are too high. For example, both contraceptives and emergency contraceptives require a "doctor's prescription" in Japan and are extremely expensive. For young women who have never been pregnant, going to an obstetrician/gynecologist can be very uncomfortable, and even the cheapest monthly birth control pills cost 2,000 to 3,000 yen, while an emergency contraceptive pill costs 10,000 to 20,000 yen.
Nevertheless, abortion pills gathered attention in April 2021 when news broke that Linepharma would apply for approval of "Japan's first oral abortion pill. Female journalists indeed showed a high level of interest personally, and I believe women's movements like ASAJ wielded influence by providing information and lobbying lawmakers on abortion pills around 2020.
In December 2021, Linepharma K.K. applied for approval of a combination pack for oral abortion consisting of two drugs, Mifepristone and Misoprostol. The following year, the Pharmaceuticals and Medical Devices Agency (PMDA) conducted a review and issued a report in November stating that the approval was appropriate.
Linepharma's oral abortion drug, named "Mefeego Pack," was finally approved on April 28, 2023, after deliberations by the First Division of the Pharmaceutical Affairs and Food Sanitation Council of the MHLW at the end of January 2023, a month of public comment, and deliberations by a higher-level Pharmaceutical Affairs Subcommittee. In addition to being strictly controlled as a "deleterious" drug, the conditions of approval stated that the drug "must be administered under the confirmation of a designated doctor under the Maternal Body Protection Law" and "must be used for the time being in a hospitalized facility (hospital or clinic) where hospitalization is possible, and after Misoprostol administration, the patient must remain in a hospital or on standby until the patient expels the pregnancy.
Only the designated doctors under the Maternal Body Protection Law can perform abortions in Japan. There is no coverage by health insurance, and individual medical institutions can determine the method and fee of abortion. In addition, women have to get spousal consent before taking abortion pills. Furthermore, even if they ease regulations in the future, there is still a risk of violating the crime of self-abortion under criminal law if the person performing the abortion takes the abortion pill by themselves.
Mefeego Pack became available on May 16, 2023, and medical institutions wishing to handle it can take Linepharma's e-learning course to register. However, it is not yet ready for accessible use. I pointed out six problems below:
First, there is a lack of providers: as of June 15, 2023, only 14 medical institutions appear on Linepharma's website, "Find Hospitals and Clinics Where You Can Ask About Abortion Pills." Since this is a free medical service, they may be waiting to see how other hospitals will operate, but some parts of Japan have no medical institutions offering the service. It seems unlikely that the system will spread rapidly.
Second, the fees are likely to be high. Only two of the 14 locations listed above clearly indicate their prices on the websites. One sets the flat fee of 128,000 yen for surgical or medical abortions, while the other charges 89,000 yen, including the cost of a preliminary medical examination. Although Linepharma has not disclosed the wholesale price of the abortion pill, the Japanese Association of Obstetricians and Gynecologists assumes the cost of the medicine is about 50,000 yen to justify the price at medical institutions as about 100,000 yen, including the pill, consultation, examination, and treatment in case of failure. It is said to be slightly cheaper than surgery, but the price is left to the judgment of individual medical institutions and cannot be predictable.
Third, hospitalization or waiting in the hospital "until the pregnancy expels" is mandatory, although only for a while. Since the conventional abortion procedure for early pregnancy in Japan has been a one-day operation, if "hospitalization" is required for those who wish to take the medicine, there will be people who give up. It is also unclear whether they can stay in a private room or whether the patient can be with a chaperone. If it takes longer to complete the abortion, the cost of hospitalization may increase.
There are also concerns about whether the patient will experience emotional distress from encountering other expectant mothers and newborns because of the long time spent in the medical facility. Another problem is that, unlike surgery, you are awake, but they don't offer mental health care.
Furthermore, in the case of in-hospital waiting, there is no indication of rules for what to do "if the pregnancy has not been expelled" by the end of clinic hours. The advantage of the abortion pill is that it "de-medicalizes" abortion. There should be an option to take the Misoprostol alone, which expels the pregnancy product, at home.
Fourth, there is no option to complete the abortion with the medication alone as much as possible by giving additional doses of Misoprostol; the WHO's 2022 "Guidelines for Abortion Care" states that you can consider "repeated doses of Misoprostol application if necessary to complete the abortion..." However, giving additional Misoprostol is not an option for Japanese doctors who only perform the surgery if it fails. Giving additional Misoprostol should be an option, as this would increase the number of people who could complete the abortion with the drug alone.
Fifth, ultrasound (echocardiography) is a requirement for taking the medication in Japan. After the Corona disaster, "self-administered abortion," where the patients have the medicine at home very early in the pregnancy without requiring an echo, has become widespread in other countries. The International Federation of Gynecology and Obstetrics (FIGO) encouraged "online prescription of abortion pills and self-administered abortion in early pregnancy" as a temporary measure in March 2020, when WHO declared the COVID-19 pandemic, and after confirming that this method was used safely and effectively, in March 2021 it "made this method permanent The statement "this method should be made permanent" was issued in March 2021.
Although ultrasound can confirm pregnancy around the 6th week, the latest pregnancy test reacts at 4 to 5 weeks. Recently, medical abortion (VEMA), performed at a very early stage when ultrasound cannot confirm the pregnancy, has shown promise as a beneficial method that hastens the completion reduces risks, and serves as a screening test for ectopic pregnancies.
Sixth, abortion pills are also effective in treating patients with comorbid abortions, but this is not an option in Japan. Only to offer the highly invasive "surgery" is nonsense when you can use the pill for comorbid miscarriages.
Since there are no uniform guidelines for the handling of abortion pills in Japan, there should be a wide range of discretion for individual doctors. They should put the patient first, demonstrate "professional autonomy," and improve access to abortion pills.
