NHK NEWS WEB reported on approval of Japan’s first oral abortion pills

NHK NEWS WEB reported on approval of Japan’s first oral abortion pills

“Oral Abortion Pill" Health Ministry Subcommittee Approves Japan's First Approval.
April 21, 2023 9:45 pm

A subcommittee of experts from the Ministry of Health, Labor, and Welfare (MHLW) has approved the first approval in Japan for "oral abortion pills," which are used to perform artificial abortions with medication.
The MHLW is expected to officially approve the drug in the near future.

The drug is named Mefeego Pack, developed by the British pharmaceutical company Linepharma.
The drug is intended to stop the continuation of pregnancy by taking two types of medication in sequence, enable to perform an abortion without surgery or other surgical procedures.
Pregnant women up to 9 weeks gestation are eligible for this procedure.

In January of this year, a panel of experts from the Ministry of Health, Labor and Welfare agreed to approve the procedure, but decided to discuss it again at an upper-level subcommittee meeting, citing the need for careful discussion.
At the panel meeting on January 21, it was agreed to approve the use of the drug on the premise that it should be handled with caution.

Specifically, only doctors designated by prefectural medical associations as "Maternal Body Protection Law designated doctors" will be allowed to administer the drug, and its use will be permitted only in hospitals and clinics that have beds in case a person who has taken the drug lies down.

In addition, while both inpatient and outpatient use is allowed, for the time being, until a system for use is established, patients must remain in the hospital until the abortion is confirmed.

Furthermore, strict standards will be set for the management of the drug, with manufacturers and medical institutions required to report monthly to prefectural medical associations on the number sold and the number used.

In a domestic clinical trial using the drug, 93% of pregnant women seeking an abortion completed the procedure within 24 hours, and although approximately 60% complained of abdominal pain and other symptoms, most of the symptoms were mild or moderate.

The Ministry of Health, Labor, and Welfare is expected to formally approve the procedure, which will make it possible to perform abortions with the drug.

Doctors who have sought approval "expect the operation to be based on international recommendations"
Dr. Sakiko Enmi, an obstetrician and gynecologist and representative of a citizens' group that has been seeking approval for oral abortion pills, said, "The approval comes after more than 30 years of delay, but if there are factors that hinder access, such as high costs and uniform hospitalization management, it will eventually be difficult for patients to access the pills and make it difficult for them to use them. There is also concern that this may end up making it difficult for people to reach and use the drugs. We hope that the system will be operated based on international recommendations and scientific evidence," he said.

She continued, "In Japan, there are many issues, not only abortion methods, but also the high cost, laws requiring spousal consent, and discrimination and prejudice that arise from a false understanding of the issue. I hope that many people will think about safe abortion.

Dr. Ishiwata, President of the Japan Association of Obstetricians and Gynecologists: "It is important to provide accurate explanations”
Isamu Ishiwata, President of the Japan Association of Obstetricians and Gynecologists, said, "I welcome the increase in the use of abortion pills as an alternative to surgery. Looking at the situation overseas, the ratio of abortion pills to surgery is expected to eventually reach about 50-50 in the future. While the availability of medication is considered useful in the case of those who are at risk for anesthesia or surgery, approximately 10% of the patients do not expel spontaneously and require additional surgery or other procedures. It is important to accurately explain the advantages and disadvantages of both abortion pills and surgery," he said.

He added, "We would like to promote correct knowledge of the drugs before they are actually used in the future. To prevent inappropriate use, the government is trying to establish a strict management system, and the medical association is also considering rules for punishing doctors who use the drug inappropriately.

What are oral abortion pills?
Oral abortion pills are two types of pills that are taken to perform artificial abortions. After conducting clinical trials in Japan, the British pharmaceutical company Linepharma applied to the Ministry of Health, Labor and Welfare for approval.

Pregnant women up to 9 weeks' gestation are eligible for the procedure, which involves taking a drug called "Mifepristone," which suppresses hormones to stop the progress of pregnancy, followed 36 to 48 hours later by a drug called "Misoprostol," which causes the uterus to contract.
Together, the two drugs are marketed as "Mefeego Pack.

Unlike surgery, which has been the only option, oral abortion pills do not require anesthesia and have a low risk of damaging the uterus.

Efficacy
In a clinical trial conducted in Japan, of 120 pregnant women who requested an abortion, 112, or approximately 93%, completed the procedure within 24 hours, but five were unable to expel the pregnancy and three had to be removed because parts remained inside their bodies.

Safety and side effects
In the clinical trial, 69 patients (approximately 58%) complained of symptoms such as abdominal pain and vomiting after taking the drug. Four of these patients had severe symptoms such as abnormal uterine bleeding and endometritis, but most had mild or moderate symptoms.

Cost
As abortion is, in principle, a free medical procedure not covered by public insurance, the cost of medical abortion is determined by each medical institution.
According to the Japan Association of Obstetricians and Gynecologists, "The price of the medication is estimated to be about 50,000 yen, and when combined with the consultation fee, the cost is expected to be about 100,000 yen.

The situation of its widespread use in other countries is unknown
The World Health Organization (WHO) has designated this oral abortion pill as an "essential drug" because it is safe and effective.
According to the Pharmaceuticals and Medical Devices Agency (PMDA), which is in charge of drug screening, Mifepristone, a drug that suppresses the function of hormones to stop the progression of pregnancy, was first approved in France in 1988 and was approved in more than 65 countries and regions as of September last year,
Misoprostol, which causes the uterus to contract, is approved in more than 93 countries and regions.
In France, the UK, and other countries, they are also being prescribed for online medical treatment.

Abortion methods in Japan
In Japan, the only abortion methods have been surgical procedures, either the sobriety method, in which a metal instrument is inserted into the uterus and scraped out, or the suction method, in which a soft plastic tube is attached and sucked out manually, or a combination of the two is used.

According to a nationwide survey conducted by the Japan Association of Obstetricians and Gynecologists, as of 2019, the number of abortions performed using both the "soha-ho*1" and "suction" methods was the largest, at about 40% of all abortions, with the "suction" method accounting for about 36% and the "soha-ho" method for about 24%.

The WHO recommends the use of drugs and aspiration methods.<<<<<<<<<<<<<<<<<<<<<<<<<<<<<

Translated from the original in Japanese by Kumi Tsukahara.

*1:D&C after using forceps