Abortion in Japan

Memorandums and information about abortion situations and problems in Japan

Japanese society and the entanglement of government, doctors and women

ARJC Asia & Pacific Regional Webinar: Challenges in Reproductive Justice around Asia and the Pacific held on November 17, 2023

Presentation manuscript by Kumi Tsukahara PhD


Thank you very much for inviting me today. I am Kumi Tsukahara. I’m researching on the issues of abortion in Japan. Today, I would like to give a brief overview of the situation of reproductive health and rights in Japan, focusing on abortion. [1]


In the late 19th century, Japanese imperial government created its first criminal code which banned abortion in 1880, and soon it re-issued a new criminal code in 1907 that regulated abortion more strictly, and it’s still in effect today. In 1948, faced with poverty and a rapidly increasing population after the defeat of the war, Japan established the Eugenic Protection Law (EPL), which provided forced sterilization to the disabled and legalized abortions for several reasons. [2]

In 1952, they added an economic clause, and a single designated doctor gained the authority to decide whether or not to perform legal abortions. By loosely interpreting this clause, the doctors performed a large number of abortions. Abortion became a lucrative business for them. This is the base of our problem. [2]


This graph shows the dramatic change in the number of abortions in Japan. The official numbers of abortions were over 1 million per year for nine straight years. Other nations banning abortions at that time criticized Japan as an “abortion paradise.” [3]

In addition, the forced sterilization articles of the EPL came under attack as discriminatory toward disabled people. So, Japan revised the law in 1996 as the Maternal-body Protection Law (MPL), having only abortion articles remain. [2]


This graph shows the evolution of contraceptive use in Japan and how the approval of the birth-control pill in 1999 did not contribute to an increase in use of contraceptive pill among Japanese. Birth control pills are rarely used even now. I am so concerned that the abortion pills approved this year may follow the same path. [4]


Here is a summary of the legal status quo. The penal code criminalizes and stigmatizes abortion. The MPL allows designated doctors to perform abortion only after obtaining consent from the pregnant woman and her spouse. In reality, 99.9% of abortions performed because of threatened maternal health for economic reasons. [5]


This chart shows the difference in abortion methods between Japan and WHO. Japanese doctors have been using D&C for early abortions since abortion was legalized in 1948. Although the use of aspiration methods has increased just recently, even the latest data show that D&C is used alone or in combination with aspiration in 60% of the early-term surgical abortion procedures. [6]


In April this year, the abortion pill, mifepristone and misoprostol, was finally approved in Japan for termination only up to 9 weeks. All the abortions are exclusively performed legally only by designated doctors, with no health insurance coverage. [6]


Here is a compilation of pictures of abortion methods used in Japan. Abortion by surgeries usually costs 700 – 1500 US dollars. Please refer to the brief explanation about “designated doctors” in the box. [7]


Here is a list of issues regarding the handling of oral abortion pills approved this year in Japan. Abortion pills are so safe and effective that the WHO has included them in their essential drug list as you know. However, in Japan, only designated doctors could prescribe them, hospitalization is required, and the price is very high, equivalent to a surgical procedure. [8]


This year, the UPR of the UN Human Rights Council took place for Japan, the Japanese government received many recommendations regarding SRHR. Several countries called on Japan to abolish the criminal offense of abortion and to implement comprehensive sexual education to guarantee human rights. However, Japan rejected most of the requests. They answered that Japan would respect "the unborn" as a human life and dismissed the guarantee of human rights for women, citing the ethics and morality of the people. This attitude of the government has been the same for almost half a century. [9]


This diagram illustrates the relationship between three interest groups in conventional Japanese society regarding abortion: medical doctors, the government and lawmakers, and women. The medical associations have provided organizational votes and donations to support ruling party legislators, and the government has adopted policies that favor the doctors, as the EPL and the MPL protect their interests. On the other hand, the government has bound women by criminalizing abortion and stigmatizing it. Meanwhile, doctors have monopolized and stigmatized abortion by maintaining outdated and ethically problematic abortion methods. Women have been forced to internalize shame and guilt and remain silent because of stigmatized abortion. [10]
 

To break this vicious cycle, we need to proclaim reproductive rights as a universal human right. Promoting this concept enable women to confront their shame and guilt and raise their voices. Empowered, self-respecting, and united at home and abroad, women can advocate that it is essential for the government and doctors to guarantee women's reproductive health and rights. We demand that doctors respect WHO guidelines and scientific evidence; similar pressure can be applied to them by WHO and FIGO. Meanwhile, empowered women could ask the government to abolish discriminatory abortion-related laws and introduce comprehensive sexual education. The UN and other countries can also put pressure on the Japanese government. [10]


Our basic principle is "justice" based on human rights. Even though the current situation differs from country to country, it is imperative to spread this transnational principle to all people and realize reproductive justice. [10]

Thank you for your attention.


Refer to the PPT for this presentation: here

[number] refers to the page of the PPT.

Consent issue casts shadow on safe abortion in Japan

Japan Times, by Kathleen Benoza, 2003, Septmber 28

www.japantimes.co.jp

Main Texts:

As the world observes International Safe Abortion Day on Thursday, there is growing focus on the movement in Japan for safe and accessible abortion practices. The recent approval of the first abortion pill in the nation offers a glimmer of hope, but archaic rules governing consent — rooted in Japan's eugenics history — persist, casting a shadow on safe access.


The 1996 Maternal Health Act, which includes the spousal consent law, evolved from the 1948 Eugenic Protection Act, which opened the path for legal abortion. The former abolished eugenic provisions to create the law Japan follows today.


The current law stipulates that abortion must be carried out in the early stages of pregnancy with the consent of one's spouse.


The health ministry approved the country’s first abortion pill, the Mefeego pill pack produced by British drug manufacturer Linepharma, in late April, providing women in early pregnancy with an alternative to a surgical procedure. The ministry says the spousal consent law is also applicable to abortion pills.


Among the countries with legal abortion, 15 require spousal consent for induced abortions, according to a World Health Organization database. Many of those nations have strong religious influences.


In Japan, exceptions to the consent rule are granted in situations where a spouse's identity is unknown or they are unable to convey their intentions.


There is no provision in the law for unmarried women. The health ministry has clarified that a partner's consent is not required for unmarried women, women who can prove their marriage ended because of domestic violence or those impregnated through rape.


Despite this, because of misconceptions and concerns regarding legal consequences, many doctors continue to insist on obtaining a man's consent.


In some cases, the policy has led to tragedy.


In 2021, a 21-year-old former nursing school student received a suspended prison sentence for leaving her newborn in a restroom at a park. During her trial, the woman said that a hospital demanded male consent for an abortion, which she couldn't obtain.


As the health ministry's assurances are not legally binding, clinics are allowed to have their own practices, especially because only designated doctors appointed by the medical associations in each prefecture can perform abortion procedures at specified medical facilities, said Kumi Tsukahara, director of the Reproductive Health Rights & Literacy Institute.


She argues that this system allows doctors to act in their own interests and engage in practices that should not be permitted under a legitimate framework.


“As long as doctors prioritize avoiding potential issues, the requirement for spousal consent will remain,” Tsukahara said.


Some concepts from the old law, including the requirement for spousal consent, remain unchanged to this day, said Yoko Matsubara, a professor at Ritsumeikan University who specializes in the history of science and bioethics, with a focus on eugenics.


"Doctors have had spousal consent ingrained in their practices,” Matsubara said. “Factors like women's rights or respecting human rights, those elements are not included in the law.”


Matsubara said she believes doctors want to support women with such a life-changing decision, but bypassing the conditions specified in the Maternal Health Act could potentially lead to imprisonment.


Medical practitioners can be imprisoned for up to seven years under the law if they don’t obtain spousal consent. Under the penal code, women who have an abortion without spousal consent or take medication to induce their own abortion can face up to a year in prison.


Due to these provisions, abortion is fundamentally considered a crime, Matsubara said. But with the consent of one's spouse, abortion in the early stages of pregnancy is possible with no questions asked, she said.


When it comes to laws concerning women, lawmaker-initiated legislation is common, said Misako Iwamoto, political scientist and expert on legislative processes in Japan, adding that amending the Maternal Protection Act would require approval by a majority in parliament.


The most recent government report shows that about 16% of lawmakers are women.


Iwamoto said that politicians in Japan tend to place the responsibility for abortion primarily on women, viewing matters such as spousal consent and birth control pills as connected to women's sexual agency.


In July, Japan reviewed recommendations received during the Universal Periodic Review by the United Nations Human Rights Council, which assesses human rights in all U.N. member states every 4½ years.


During the assessment, Japan rejected recommendations both involving the Maternal Health Act and the abortion crime law. Japan's representatives cited the need for thorough parliamentary discussions to amend the Maternal Health Act and emphasized the importance of protecting the fetus as a biological entity before making a decision to abolish the abortion crime law.


"I believe there is a need to change the law to eliminate the abortion crime and establish a law that clearly outlines the regulations doctors must adhere to in abortion procedures,” Matsubara said.

women march for the right to access abortion in Japan Open Access NewsWomen's Health News Japan’s health ministry approves first abortion pill in its history April 24, 2023

Open access 2023/4/24

www.openaccessgovernment.org

I didn't know this article uses my comments without my knowledge.

Kumi Tsukahara, director of the Reproductive Health Rights Literacy Institute, said: “Being able to control one’s own pregnancy is already the minimum requirement for gender equality. Although this discussion is on medicine, we must not lose sight of how this is a human rights issue.”

International Campaign for Women's Right to Safe Abortion, August 18, 2003

Special Report on Japan’s approval in 2023 of abortion pills : three reports

ICWRSA Japan Special Report

1. Japan’s crawl towards medical abortion: Why was Japan the last of the G8 countries to approve mifepristone?
by Marion Ulmann


2. What my Yahoo Japan! articles revealed about the long-delayed approval of abortion pills in Japan
by Masako Furukawa


3. Are medical abortion pills deleterious drugs containing a poisonous ingredient? No!
by Kumi Tsukahara

UN experts say Japan has made strides on business and human rights, but must tackle systemic challenges

TOKYO/GENEVA (4 August 2023) – UN experts today commended Japan’s commitment to implement the UN Guiding Principles on Business and Human Rights (UNGPs), and urged the government to address deeply embedded unfair gender and social norms to ensure full protection for human rights in the country.
UN experts say Japan has made strides on business and human rights, but must tackle systemic challenges | OHCHR

The Approval of the Oral Abortion Pill Mefeego Pack and Remaining Issues

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.

Evidence that Mifepristone is a "deleterious drug"？

I received a response from the MHLW, but......

The abortion drug Mefeego Pack, approved in Japan, has been designated a "deleterious drug" by the Japanese Ministry of Health, Labor, and Welfare. According to them, Mifepristone and Misoprostol are both "deleterious" drugs. When I asked for scientific evidence to support this, I received a response.

However, there is a part of their response that I did not understand, so I will translate it into English below.

A part of their answer I couldn't comprehend:

(i) Mifepristone

(1) The results of embryo-fetal development studies indicate that the non-toxic dose of mifepristone is 0.5 mg/kg/day for mice, 0.5 mg/kg/day for rats, and 0.25 mg/kg/day for rabbits, and that these human equivalent doses are lower than the clinical dose (4 mg/kg/day when the human body weight is 50 kg) These human equivalent doses are lower than the clinical dose (4 mg/kg/day for a 50 kg human body weight).

(See the Mefeego Pack Drug Interview Form "IX. Toxicity Studies (5) Reproductive and Developmental Toxicity Studies," p. 85)

On the interview form referred, I bolded the numbers where they matched.

(1) Female rat fertility and early embryogenesis to implantation study

Mifepristone was administered to female SD rats at a dose of 0.5 mg/animal/day (approximately 2.5 mg/kg/day) for 24 days starting 8 days before mating, and pregnancy status was evaluated the day after the last dose84) . Compared to the control group, there was no effect on the number of mated animals or pregnancy rate, but the number of implantations per pregnant rat was significantly reduced.
　Tamura et al. conducted a female fertility study in which female SD rats were treated with mifepristone at doses of 0, 0.8, 4, or 20 mg/kg/day from 2 weeks prior to mating until 7 days of gestation85). The 20 mg/kg/day group showed persistent keratinization of the vaginal mucosa and arrested sexual cycle. 20 mg/kg/day for the entire period The 20 mg/kg/day group mated 10/10, all were infertile; the 20 mg/kg/day pre-mating only group mated 10/10, with 6/10 pregnant animals and increased preimplantation embryo loss rate.
　The number of pregnant animals in the 20 mg/kg/day post-mating group was 0/10. 4 mg/kg/day pre-mating group showed no effect on the number of mated animals, pregnant animals, or absorbed embryos, while the post-implantation embryo loss rate increased during the entire period and in the post-mating group. Since the cessation of the sexual cycle, the decrease in the number of pregnant animals and the number of implants, and the increase in the number of absorbed embryos were due to the pharmacological effects of mifepristone, 20 mg/kg/day was considered a non-toxic dose.


(2) Embryo-fetal development studies in mice, rats, and rabbits

A study on embryo-fetal development of pregnant CD1 mice, SD rats, and HY rabbits was conducted using repeated oral administration of mifepristone during organogenesis.86),87),88) In all three species, an increase in the number of absorbed embryos (≥ 0.5 mg/kg/day in mice, ≥ 1 mg/kg/day in rats, ≥ 2 mg/kg/day in rabbits) was observed. 2 mg/kg/day or more in rabbits) were observed in all three animal species. However, no teratogenicity was observed in mice or rats. Some morphological abnormalities were observed in fetal rabbits, but the frequency of occurrence of these fetal abnormalities varied, and they were also seen in the control group, so the relationship to dosing was not clear. The non-toxic dose for the mother was considered to be 0.5 mg/kg/day for mice, 0.5 mg/kg/day for rats, 0.25 mg/kg/day for rabbits, and for embryos and fetuses, 2 mg/kg/day for mice and rats and 1 mg/kg/day for rabbits.

The first thing I couldn't understand was that at the end of (1), it says the non-toxic dose is 20 mg/kg/day, so isn't 4 mg/kg/day (i.e., the value for a 50 kg person given 200 mg of Mifepristone). This is smaller than the non-toxic dose, so Mifepristone should be non-toxic at least for this?

　Also, (2) is a "repeated dose" experiment, but in humans, Mifepristone is only given once. There is no way it can be administered repeatedly. Wouldn't it be better to compare the results with those in which all animals were given only one dose in accordance with the human dosage?

　Furthermore, (2) is an experiment looking at the effects on the embryo/fetus, and suddenly there is talk of a "non-toxic dose to the mother animal".


It is strange. I'll inquire again next week.

A big but awkward step forward

My report

In Japan, the Mefeego Pack, a combi-product of one Mifepristone and four Misoprostol tablets, was launched on May 16, 2023, and the Japan Women's Foundation's Dr. Miho Uchida's clinic began offering "oral abortion pills" for the first time in Japan on Thursday, May 25, 2023.

As far as we could confirm on May 27, 11 hospitals or clinics joined the providers listed on the website of the manufacturer Linepharma K.K. as institutions that can handle this drug, however on Monday morning, all the other clinics that followed the lead of Dr. Uchida's Fides Ladies Clinic disappeared from the list.

As of the time of our review over the weekend, there was no detailed information on the abortion pill offerings on the websites of these ten medical institutions, so we assume that either Linepharma has decided to withhold the listings until they provide more detailed information, or that each of the clinics, aware of their lack of preparation, has voluntarily suspended their listings.

Anyway, because abortion pills are provided outside the insurance system and not covered by any public funds, women must pay the equivalent of the most expensive legal surgical abortion in the world. At Dr. Uchida’s clinic, the total fee for medical abortion is the same for the surgery is set at 99,000 yen.

In Japan, written consent of the spouse is still legally necessary as a pre-condition for any method of abortion. In addition, the patients cannot take abortion pills very early in the pregnancy, as the doctor prescribes the medications only after they could confirm the pregnancy in the uterine by transvaginal ultrasound which means usually after 6th week. However, according to Dr. Christian Fiala of Austria, who spoke at the #Action for Safe Abortion Japan online event on May 28, taking abortion pills very early is effective when an echo test is unavailable. If nothing happens, he says, then one should suspect an ectopic pregnancy and go to a higher-level medical facility. Very early MA also serves as a screening for ectopic pregnancy.

Japanese abortion patients should take both medications in front of a physician, and after taking the misoprostol, they are forced to stay in the medical institution until the pregnancy expels. Many obstetrics and gynecology facilities in Japan are not dedicated to abortion services and often house expectant mothers, new mothers with babies, infertility treatment, and gynecology patients in the same waiting room, which is an uncomfortable place for abortion patients to be. Now, however, abortion patients are required to remain in the hospital for up to eight hours (doctors say 90 % of the cases finish in 8 hours, but what about the remaining 10%!?) after taking the misoprostol. The Ministry of Health, Labor, and Welfare and the Japanese Association of Obstetricians and Gynecologists state that this in-hospital waiting rule is "temporary" and will be lifted once safety is sufficiently confirmed, but the criteria for lifting are unclear.


The JAOG also states that patients who come to the hospital to take Mifepristone on the first day at any time, and Misoprostol two days later at 9:00 a.m. should remain in the hospital until the pregnancy expells and that if the expulsion is not completed by 5:00 p.m., surgery will be performed next day or later. However, whether the patient will be hospitalized for a fee or sent home at their own risk is not explained clearly.


Because the Japanese health insurance system or any public funds do not cover abortion costs, women must pay the equivalent of the most expensive legal surgical abortion in the world. Some people may have to pay for hospitalization, backup surgeries, and multiple hospital visits out of their pocket.


"The approval of the abortion pills in Japan means that women now have more options," says Dr. Uchida. ”From now on, Japanese women no longer have to risk their lives to use foreign abortion pills by self-determination. Now a qualified doctor can fully explain the options and risks of abortion and make the best choice for her is a step forward for Japan from the perspective of 'reproductive rights'."


But it will likely take a little longer for Japan to achieve reproductive rights that guarantee women themselves to make the best choices for themselves.

Product information for MEFEEGO Pack, a combi-pack product of Mifepristone and Misoprostol for Japanese market

One of the misteries that occationally happens in MHLW sites

The site I could find easily yesterday suddenly disappeared! It was a product information of MEFEEGO Pack with the sign of "Deleterious product." I searched the site of the Ministry of Health, Labour and Welfare and found a new URL for the product information with the "deleterious" sign:
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/841049_249910AX1028_1_02


Along the process, I also found a new "Report of Deliberations" issued on April 26, 2023 by the Drug Evaluation and Administration Division of the Pharmaceuticals and Consumer Health Bureau of MHLW. The two-page report was added on top of the "Report of Examination" provided at the time of gathering pubic comments during last February.
https://www.pmda.go.jp/drugs/2023/P20230501001/841049000_30500AMX00126_A100_1.pdf


The translated content of this added document includes as follows:(original in Japanese)

Report of Deliberations
April 26, 2023
Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau
［Marketing Name］ Mefeego Pack
［Generic Name] Mifepristone, Misoprostol
[Applicant's Name] Linepharma K.K.
［Date of Application] December 22, 2021
［Results of deliberation］
The First Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council held on January 27, 2023 approved this item and decided to submit it to the Pharmaceutical Affairs Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council.
At the Pharmaceutical Affairs Subcommittee meeting held on April 21, 2023, it was decided that approval is acceptable on the assumption that the following handling will take place.

  • For the time being, the patients should be admitted to a facility with beds that can accommodate them or be treated on an outpatient basis (in-hospital standby is mandatory) until an appropriate system for emergency use has been established. Regarding the "period of time until the appropriate system for use is established," a notice will be issued stating that sufficient post-marketing surveillance and research will be conducted to evaluate the appropriate medical coordination system, and the results will be used as the basis for consideration and decision making.
  • Regarding distribution and use management, a procedure manual should be established to require the manufacturer/distributor and each medical institution to report monthly to prefectural medical associations the volume of sales and the volume of use (number of abortions), respectively, and the manufacturer/distributor should be required to stipulate this as a "necessary measure" in the conditions of approval. Prefectural medical associations will be required to supervise the reporting by checking the consistency of the content of both reports.
  • In order to enhance the provision of correct information, the applicant should prepare materials for designated doctors under the Maternal Body Protection Law (proper use guide), and the MHLW should provide appropriate information for the public(e.g., by creating a website).


This item is not classified as either a biological product or a specified biological product, the reexamination period is eight years, and both the active ingredient and formulation of Mifepristone and the formulation of Misoprostol are classified as deleterious drugs.


［Conditions for approval]
1. A drug risk management plan should be established and properly implemented.
2. Take necessary measures to ensure that the drug is used only by designated doctors under the Maternal Body Protection Law, including the implementation of distribution and other controls in cooperation with related organizations.

The phrase "classified as a deleterious drug" was suddenly added without any explanation, which was not included in the "Review Report" issued by the Pharmaceuticals and Medical Devices Agency on November 9, 2022.


It is quite absurd that the word "deleterious drug" disappeared while public comments were being gathered, yet after two rounds of secret deliberations, when it was finally approved, it turned out to be a "deleterious drug" again.

On Approval of Mefeego Pack to Japan

Original Note by Kumi Tsukahara

On Approval of Mefeego Pack to Japan - What We Can Learn from the Experience of Preglandin Suppository, the Only Approved 2nd-trimester Abortion Drug in This Nation

Transvaginal Abortion Suppository Seen as Promising in the 1970s-1980s


In December 2021, Linepharma K.K., with a British parent company, filed for approval of the oral abortion drug Mefeego Pack, the first oral abortion pill in Japan, but it is not the first abortion drug. Preglandin Vaginal Suppository (chemical name: gemeprost) was the first modern abortion medication in Japan and abroad. Ono Pharmaceutical Co., Ltd. developed and got approval for manufacturing and marketing from the Japanese government in 1984. Since then, this drug has been the primary treatment for second-trimester abortion in Japan.


However, it has been kept as a secret that gemeprost had a high success rate in clinical trials for first-trimester abortion in Japan between 1977 and 1980.


This report reveals the past of vigorous control over Preglandin (gemeprost) for the benefit of a few doctors to call attention to the fate of the newly approved oral pills - Mefeego Pack - will be.


Gemeprost was developed under the name of ONO-802, which has several trade names in other countries, including Cervagem in Sweden and Singapore. When I searched for "ONO-802" up to 1980 in PubMed, I found 11 research articles from 1977 to 1980. Nine of these studies were conducted by Japanese, with two English reports and seven Japanese. Two other studies were conducted abroad and reported in English. Ten out of the eleven studies were related to first-trimester abortions.


For example, Karim et al. of the National University of Singapore, who reported the first clinical trial in 1977, found that 50 women 5 to 14 days over their expected menstrual period received one 1 mg tablet vaginally and were sent home with instructions to insert four suppositories, one every 4 hours and that 46 (98%) successful abortions were confirmed by a pregnancy test two weeks later [1]. The same year, Tominaga Yoshiyuki et al. of Tottori University in Japan reported for the first time as a Japanese that a 0.5 mg or 1 mg vaginal suppository was administered 3 to 5 times every 3 hours to 32 patients within four months of pregnancy, and 30 patients (93.8%) had successful abortions [2].


The women reported various side effects in the 10 studies, but they were considered only transient and treatable. Even in cases where abortions were unsuccessful, the cervical dilating effect of gemeprost was favorably reported as facilitating backup surgical procedures. In addition, there have been several successful cases in which women have self-administered the drug vaginally.


In the late 1970s, no medicines were available anywhere in the world for first-trimester abortion. It was 1982 when the clinical trials of RU-486 (Mifepristone) began in Switzerland, while ONO-802 had reported high success rates in 10 early pregnancy trials by 1980, and all the researchers involved saw it as a promising abortion drug for early pregnancy.


International Attention


In July 1982, an international symposium on Cervagem (gemeprost) was held in Singapore, led by Karim, and scholars participated in the symposium from the United Kingdom, Singapore, Hong Kong, Norway, Sweden, and Japan. The next year, a book entitled "Cervagem" was published, containing a total of 10 presentations and 3 questions from the symposium. Chapter 7, jointly authored by K. Sato, K. Kinoshita, and S. Sakamoto of Japan, is entitled ‘Clinical Study of Cervagem (ONO-802) for Abortion in the First and Second Trimester in Japan.’ It reported the results of clinical trials conducted with ONO-802(gemeprost) at 12 Japanese universities from December 1977 to July 1978 in the first and second trimesters of pregnancy, respectively.


In “Cervagem”, researchers from May-Barker in the U.K. revealed the fact that in 1974 they began working with Japanese researchers at Ono Pharmaceutical Company “to find an effective drug for early miscarriage,” and believing that “this drug should also be a powerful cervical dilator.” ONO-802 is itself an ‘abortion drug’ that artificially causes miscarriage through uterine contractions, and at the same time, it has attracted attention as a ‘cervical dilator’ to ripen and open the cervix as a pre-treatment for surgical abortion.


On the other hand, the Japanese, who had been using laminaria tents mainly for cervical dilation since the 1950s, had no idea of using ONO-802 for cervical dilation, or rather, the method of opening the cervical canal with laminaria before intravaginal administration of this drug is still the current standard practice in Japan.


Lies told in Japan and Abroad


However, in April 1981, the year before the international symposium on Cervagem, Ono had already applied for approval of Preglandin to the Ministry of Health and Welfare of Japan as a dedicated second-trimester abortion drug for use only after the 12th week of pregnancy. The only data submitted with the application were the results of a clinical trial on the second-trimester pregnancy. The results were published in Japanese in the 1981 issue of Obstetrics and Gynecology (No. 10) as “Therapeutic Miscarriage and Cervical Dilation of ONO-802 Vaginal Suppository in the Second Trimester of Pregnancy,” co-authored by 31 doctors from 12 universities in Japan. They entirely omitted the data for the first-trimester abortion which had been already published in the English book.


In August 1982, four months after the international symposium, the Central Pharmaceutical Affairs Council declared that approval was 'appropriate'. In response, the Nihon Keizai Shimbun (Nikkei Asia) reported in its morning edition on September 28 that “The government will soon grant manufacturing approval, and that the MHW intends to approve it as an indication drug that only designated doctors under the Eugenic Protection Law can prescribe limited to the case of a therapeutic abortion in the second-trimester pregnancy,” and added, “Ono has been conducting clinical trials in more than ten foreign countries with the cooperation of WHO. However, since Ono has NO clinical trial data on abortions in the first-trimester pregnancy and on its effects on artificially delivered third-trimester fetuses.” As I mentioned earlier, this is contrary to the fact: clinical trials have been conducted abroad mainly on abortion in the first trimester of pregnancy. For some reason, data on the first trimester of pregnancy was concealed.


Mechanism to Protect the Rights and Interests of the Designated Doctors


However, it took two more years after the news report until the government approved the drug due to lengthy procedures to impose even stricter restrictions. Besides the above requirements, the MHW also specified that the use of the drug must be limited to second-trimester therapeutic abortion to treat a maternal injury or illness, designated it as a deleterious drug, and established its management and handling guidelines, to supervise its quantity, lot numbers, and date of delivery in the aim to prevent illegal use or resale of the drug. After such exceptionally strict regulations, finally, Preglandin was approved as the first abortion drug in Japan on May 30, 1984.


The Nikkei Sangyo Shimbun (Nikkei Business Daily) explained the background of this “exceptional measure” as follows:


“The simplicity of inducing miscarriage without general anesthesia by just inserting a suppository of Preglandin into the vagina every three hours stirred up anxiety in various quarters. Religious groups were concerned that the number of easy abortions would increase, and the designated doctors feared that laypersons and other non-designated doctors could perform abortions."


The newspaper reporter exposed that such a strict and rigorous regulation was so “unusual” that MHW wanted to create a system that would protect the interests of a specific group of designated doctors, the Japan Mothers Protection Association（Current JAOG）.


What Separates Preglandin from Mefeego Pack


Preglandin was filed for approval in 1981, and 40 years later the oral abortion drug of Linepharma was filed for approval in December 2021. During these 40 years, a vast amount of research has accumulated on abortion pills. However, the Japanese designated doctors are once again trying to protect their interests by insisting that only they can prescribe the drug, hospitalization is required, spousal consent is needed, and the fee would be about 100,000 yen（more than US$700）.

However, there is a major difference between the two drugs: at the time of the application for Preglandin in the 1980s, only 125 people participated in the clinical trials, and the safety of this drug had not yet been established, as the problems of uterine rupture later arose. On the other hand, the combi pack that was approved in Japan has been used millions of times even in the U.S. alone. It has myriad evidence of safety and certainty so the WHO has selected abortion pills into the Essential Medicines List since 2005 and included them on its Core List in 2019.


In addition, the situation of women has changed dramatically over the past 40 years: in Japan in the 1980s, pseudo-religious aborted fetal offerings (mizuko kuyo) enjoyed extraordinary prosperity. The religious right made great use of the argument of mizuko kuyo, which considers abortion to be a “crime of women,” and denounced them verbally to impede abortion. For this reason, the view of abortion in public opinion at that time was far harsher than it is today.


The atmosphere of the era of abortion condemnation, in fact, even affected the psychology of some abortion pill developers. Yoshiyuki Tominaga of Tottori University, who is introduced as the “father” of Preglandin testified that he was horrified by the “frighteningly great" effects of this drug and anguished over whether such a medication was allowed to be introduced into the world. On the other hand, Tominaga also stated that “more women would be saved if it were allowed in the early stages of pregnancy as well”. Such views centered on women's health and well-being did not catch Japanese people's attention at the time and were forgotten.


Ten years later, ‘reproductive health and rights’ was proposed at the International Conference on Population and Development in Cairo, Egypt, in 1994, and at the World Conference on Women (Beijing Conference) the following year, “the freedom to decide whether or not to have children, when to have them, and how many to have,” was reaffirmed. In countries where abortion pills had been introduced earlier, the time to finish abortion is becoming shorter, and the stigma of “abortion” is diminishing as women who had used the pills began speaking out about their experiences. Then came the Covid-19 pandemic. The international specialists on reproductive healthcare reaffirmed abortion as essential medical care. Now the International Federation of Obstetrics and Gynecology has issued a statement calling for online prescription and home use of abortion pills to be made permanent. The United Nations has also made it clear that abortion restrictions are a violation of human rights.


In the 21st century, the world's view of abortion has changed dramatically. Knowing this, we should keep a close eye on how Mefeego Pack will be used in Japan.


[i] Karim et al., ‘Menstrual induction with vaginal administration of 16, 16 dimethyl trans-delta2-PGE1 methyl ester(ONO 802),’ Prostaglandins Vol.14 No.3,1977.
[ii] Tominaga et al., Abstract of ‘Basic and clinical study on medical abortion with vaginal administration of 16, 16 dimethyl trans-delta2-PGE1 methyl ester,’ in Japanese, Japan Society of Obstetrics and Gynecology, Vol.29 No.10, 1977.

ASAJ's Request on "Notes on the Use of Mefeego Packs”

For more available, accessible and affordable abortion pills!

#Action for Safer Abortion (ASAJ) issued a request on May 8, 2023 to the following people and held a press conference on the same day at 11:00 am. This is a private, tentative translation of said request.

May 8, 2023

Mr. Katsunobu Kato, Minister of Health, Labour and Welfare
Mr. Masanobu Ogura, Minister of State for Special Missions, Cabinet Office
Ms. Yumiko Watanabe, Director-General of the Administration for Children and Families
Dr. Yoshiro Matsumoto, President, Japan Medical Association
Mr. Isamu Ishiwata, President, Japan Association of Obstetricians and Gynecologists


#Action for Safer Abortion (ASAJ)
https://www.asaj2020.org/
safeabortion2020@gmail.com

Request on "Notes on the Use of Mefeego Packs

We are a group working for the decriminalization of abortion and improved access to safe abortion. We are submitting a request (*) regarding the document on proper use, etc. published on the website of the Ministry of Health, Labor and Welfare (MHLW) in relation to the approval of the manufacture and sale of drugs for oral abortion.
(*)https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/topics/infertility_treatment_00001.html, Viewed April 28, 2023

(1) "For the time being until the appropriate system for the use of this drug is established
"For the time being," the MHLW recommends that the period of time spent on evaluation be kept to the minimum necessary, and that subsequent hospital stays be made only when a woman wishes to do so.

(2) Cost Burden
Abortion is a medical treatment that affects the lives, livelihood and health of many people living in Japan.
The Ministry of Health, Labor and Welfare (MHLW) should make abortion either covered by insurance or subsidized by public funds.
Doctors should set accessible fees for abortions using oral abortion pills.


(3) Spousal Consent
Spousal consent should not be required for the use of abortion pills. Maternal Body Protection Laws that require spousal consent for abortion violate reproductive rights.

(4) Provision of Information
The Ministry of Health, Labor and Welfare (MHLW) should provide scientifically based information on oral abortion pills and supervise medical institutions to ensure that they do not disseminate incorrect information.

The end.

Q&A:What is the abortion procedure?

Explanation of the abortion methods by Japan Association of Obstetricians and Gynaecologists

What if the abortion procedure? - JAOG

This is my personal translation from original Japanese version.

Question: What is the abortion procedure?


Answer: There is a big difference between early pregnancy (less than 12 weeks) and pregnancy from 12 to 22 weeks. There is a big difference in the abortion procedures and the subsequent proceedings.


An abortion is performed when the Maternal Body Protection Law applies, and when the pregnancy must be terminated. The procedures differ between early termination (less than 12 weeks) and later termination.


In early termination (less than 12 weeks), the uterine contents are removed by curettage (scraping out the contents) or aspiration (sucking them out with an instrument). In most cases, the contents of the uterus are removed instrumentally under intravenous anesthesia after dilating the uterine opening beforehand. The procedure usually takes only 10 to 15 minutes, with minimal pain and bleeding, and if there are no physical problems, the patient can go home on the same day.


For pregnancies of 12 to 22 weeks, the cervix is dilated in advance, and uterine constrictors *1 are used to artificially induce contractions that cause a miscarriage. Although it varies from person to person, the procedure is physically demanding and usually requires several days of hospitalization. If the abortion is performed after 12 weeks of pregnancy, it is necessary to report the stillbirth to the local government office and obtain a permit for the burial of the aborted fetus.


Most abortions are not covered by health insurance. For abortions performed after 12 weeks of gestation, the financial burden is greater due to the cost of hospitalization as well as the surgical fee. Therefore, if you must choose to have an abortion, it is better to make the decision as early as possible to minimize the various burdens.


Since only "designated doctors" designated by the Maternal Body Protection Law are allowed to perform abortion surgeries, you should undergo the procedure at a medical institution that has a doctor who is designated by the Maternal Body Protection Law. While some foreign countries have marketed early pregnancy abortion pills, they are currently not approved in Japan. There have been reports of heavy bleeding, and the Ministry of Health, Labor and Welfare has issued a warning.

  • Adapted from "Adolescent Gynecological Consultation Manual for School Doctors and School Teachers.

"

*1:gemeprost vaginal pessaries

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