This is one of the three articles in our special report, published 18 August 2023: “Japan’s approval in 2023 of abortion pills”
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Photo: Marion Ulmann presenting medical abortion products and the international experience to the investigators of the Japanese Phase 3 trials – Tokyo, June 2019
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by Marion Ulmann
One of the world’s most common regimens for terminating a pregnancy medically involves taking a combination of two medicines, one called mifepristone (which blocks progesterone, a hormone necessary to continue a pregnancy) and the other called misoprostol (which induces uterine contractions).1 Mifepristone is a synthetic steroid that was discovered in France in 1980.2 By 1985, China had begun clinical trials on the medication, and within three years, became the first country in the world to approve use of mifepristone for medical abortions.3 France followed a few short weeks later.4 The United States granted approval in 2000, Australia in 2012, and Canada in 2015.
In fact, by the end of 2022, 93 countries had approved mifepristone with misoprostol for use in terminating a pregnancy.5
Not until April 2023, however, did a panel from Japan’s Health Ministry approve the two-drug regimen, making the combination of mifepristone and misoprostol legal for medical abortion.6
The question for this article is straightforward: Why is that, despite having the world’s third-largest economy, standing among the world’s largest producers of motor vehicles, electronic equipment, and steel, and being among the most literate countries in the world,7 is Japan so far behind its peers on reproductive rights?
I – Registration of medical abortion
Japanese culture posits a decidedly different view of sexual and reproductive health from its G8 counterparts, a driving factor in explaining the delays in approval.8
The World Economic Forum’s Global Gender Gap Report ranked Japan 116th, near Burkina Faso and Tajikistan,9 and indeed, the country’s cultural mores can be seen clearly in its abortion laws: Japan is one of just 11 countries that requires spousal consent for abortions, and women must consult with doctors to get oral contraceptives.10
A brief review of the country’s demographics helps explain the persistence of these laws and norms. The country’s political positions have long been dominated by men,11 and today less than one quarter of all doctors in the country are women, according to the Health Ministry.12
The result is that Japanese women have had relatively few formal avenues to advance change.
Thus, despite approving emergency contraceptive in 2011, and birth control pills in 1999 (also nearly four decades after much of Europe and the West), available abortion procedures have predictably remained woefully archaic.13
According to a recent CNN article, the Japanese public broadcaster NHK noted that prior to April 2023 when the pill was approved, only surgical abortion was available in Japan through two methods: the “curettage method, which scrapes out the tissue inside the uterus with a metal instrument, and the aspiration method, which sucks out the tissue through a tube.”14 WHO approves and recommends the aspiration method as an outpatient procedure, but curettage was labelled long ago by the World Health Organization (WHO) as “obsolete”. They have called for it to be replaced by the aspiration method or the abortion pills mifepristone & misoprostol.15
Another contributing factor is the fact that the Pharmaceutical and Medical Devices Agency (PMDA), the Japanese equivalent of the US Food and Drug Administration (FDA), ordered that the development of the drug begin from scratch, eschewing the available international data supporting adoptions of the medical abortion regimen.
I met with the PMDA in 2013, and only then did Japan launch the decades-long pharmaceutical development process, conducting 12 clinical trials (more than any other country) for an average of five years each, and holding a specific Phase 3 trial focused on Japanese women.
For comparison, other countries began and completed the process in just two years, a fraction of the time.
II – Public support
So how did adoption ultimately happen? In addition to simultaneous pharmaceutical and clinical developments, advocacy and local support groups played a major role in pushing the country forward, with Japanese women and doctors leading the charge.
In my first meeting with the PMDA, the country’s leaders didn’t see the pressing need for medical abortion, arguing that the available surgical methods were sufficient. And indeed the obstetricians and gynaecologists we met with in 2010 expressed similar ambivalence, content with the available surgical options.
Undeterred, our team focused on making clear the importance of patient well-being, while also making explicit the clear practical benefits: patient discretion, procedural speed and efficacy, and economic prudence.
Japanese women, we argued, deserved to have the right to choose the option of taking two types of pills instead of the arduous and emotionally and physically dangerous and debilitating curettage method.
In time, the argument began to sink in and large-scale social efforts across the country started bearing fruit.
In 2016, for example, I organised a conference that registered only a dozen attendees. Our most recent convening, however, welcomed over 100 of the country’s doctors.
Indeed, my Japanese colleagues and our team have worked diligently for a decade to train hundreds of doctors about the benefits of medical abortion, and increasingly, our attendees demonstrated receptivity to global data that supports the compelling case for the benefits of medical abortion.
Evidence of a social evolution was also obvious on a national scale: prior to the approval for medical abortion, the Minister of Health (MHLW) received more than 12,000 comments regarding the product, with the number of opinions in favour of adoption double the number of those opposed.
III- Future of medical abortion in Japan
Despite the tremendous success of grassroots movement in pushing through the approval, there remain immense obstacles for Japanese women.
The requirement for spousal approval noted above is an obvious hindrance, but there are also additional roadblocks. For instance, according to Bloomberg, access to the two-pill regimen will remain limited to hospitals and the medications will not be covered by insurance, making them prohibitively expensive for many.16 Per Bloomberg: “While the price hasn’t been disclosed yet, the Mefeego pack is estimated to be around ¥50,000 ($354). That’ll make the full procedure — from tests to the drug and hospitalization — cost about ¥100,000, only a little less than surgery, according to the Japan Association of Obstetrics and Gynecologists.”17
Today, Italy is the only other country in the world that demands patients be hospitalised when taking the misoprostol pills, and if, as noted above, the benefits of medical abortion include, among other things, speed, efficiency, and discretion, then key advantages are eliminated by the onerous requirement of hospitalisation.
There is also little evidence to justify hospitalisation: medical abortion results in menstrual bleeding similar to any woman’s normal menstrual cycle. Unpleasant, but entirely familiar. Bluntly put, requiring that patients be admitted appears to be an attempt by conservative Japanese doctors and politicians to make the process more complicated and expensive than it needs to be.18
Further evidence of this claim is that the PMDA has placed severe restrictions on the centres permitted to dispense the medical abortion regimen. These facilities must be certified and have the requisite amenities required for in-patient hospitalisation.
Consequently, less than 1% of all medical facilities have received the required approval.
In contrast to the United States or Canada or the United Kingdom, where medical abortion pills can be prescribed via telemedicine, or in Australia and Canada where the medications are available in pharmacies, Japan exemplifies a country crawling towards progress.
Indeed, while my colleagues and I are working globally on the next frontier of bringing medical abortion to “over-the-counter status”, in Japan this remains an unrealistic short-term goal. But the Japanese population has proven determined, and with support from the international community, our hope is that progress for Japanese women is still very much in sight.
About the author:
Marion Ulmann was the General Manager of Linepharma International and Board member of Linepharma KK, Japan. She oversaw the development and registration of medical abortion in Japan. She has been instrumental in registering medical abortion pills in more than 20 countries around the world (including Canada, Australia and in Latin America).
References
1 Mayo Clinic, https://www.mayoclinic.org/drugs-supplements/mifepristone-oral-route/description/drg-20067123; Planned Parenthood, https://www.plannedparenthood.org/learn/abortion/the-abortion-pill; Agence France, “Japan approves abortion pill for the first time,” The Guardian, April 29, 2023, https://www.theguardian.com/world/2023/apr/29/japan-approves-abortion-pill-for-the-first-time
2 Robin Herman, “In France, A New Method of Abortion,” The Washington Post, September 27, 1988, https://www.washingtonpost.com/archive/lifestyle/wellness/1988/09/27/in-france-a-new-method-of-abortion/f3527ac1-cc4a-4cb0-9a89-f06dd2aa0900/; Macnaughton H, Nothnagle M, Early J. Mifepristone and Misoprostol for Early Pregnancy Loss and Medication Abortion. Am Fam Physician. 2021 Apr 15;103(8):473-480. PMID: 33856168.; E. J. Corey, Barbara Czakó, László Kürti, Molecules and Medicine, 2007
3 Ibid.
4 Ibid.
5 See Gynuity Health, https://gynuity.org/assets/resources/mife_by_country_and_year_en.pdf
6 Kanoko Matsuyama, “Japan’s First Abortion Pill Is Here — and Elusive,” Bloomberg, June 19, 2023, https://www.bloomberg.com/news/newsletters/2023-06-19/japan-s-first-abortion-pill-is-here-and-elusive?in_source=embedded-checkout-banner
7See US News and World, Japan, https://www.usnews.com/news/best-countries/japan
8 Moe Shiojiri, “Japan Severely Lags on Reproductive Rights,” The Diplomat, March 9, 2023, https://thediplomat.com/2023/03/japan-severely-lags-on-reproductive-rights/; Yamamura,S.;Terajima,T.; Navarrete, J.; Hughes, C.A.; Yuksel, N.; Schindel, T.J.; Sriboonruang, T.; Anantachoti, P.; Patikorn, C. Reproductive Health Services: Attitudes and Practice of Japanese Community Pharmacists. Healthcare 2021,9,1336. https://doi.org/ 10.3390/healthcare9101336
9 Kanoko Matsuyama, “Japan’s First Abortion Pill Is Here — and Elusive,” Bloomberg, June 19, 2023, https://www.bloomberg.com/news/newsletters/2023-06-19/japan-s-first-abortion-pill-is-here-and-elusive?in_source=embedded-checkout-banner; World Economic Forum, Global Gender Gap Report, 2022, https://www.weforum.org/reports/global-gender-gap-report-2022/
10 Jessie Young and Era Ishikawa, “Japan approves first abortion pill, decades after other countries,” CNN, April 24, 2023, https://www.cnn.com/2023/04/24/asia/japan-abortion-pill-approved-intl-hnk/index.html
11 Justin McCurry, “‘I decided I could do better than them’: the women taking on Japan’s male-dominated politics,” The Guardian, April 7, 2023, https://www.theguardian.com/world/2023/apr/07/i-decided-i-could-do-better-than-them-the-women-taking-on-japans-male-dominated-politics
12 Kanoko Matsuyama, “Japan’s First Abortion Pill Is Here — and Elusive,” Bloomberg, June 19, 2023, https://www.bloomberg.com/news/newsletters/2023-06-19/japan-s-first-abortion-pill-is-here-and-elusive?in_source=embedded-checkout-banner
13 Jessie Young and Era Ishikawa, “Japan approves first abortion pill, decades after other countries,” CNN, April 24, 2023, https://www.cnn.com/2023/04/24/asia/japan-abortion-pill-approved-intl-hnk/index.html
14 Ibid.
15 Ibid.
16 Kanoko Matsuyama, “Japan’s First Abortion Pill Is Here — and Elusive,” Bloomberg, June 19, 2023, https://www.bloomberg.com/news/newsletters/2023-06-19/japan-s-first-abortion-pill-is-here-and-elusive?in_source=embedded-checkout-banner
17 Ibid.
18 Ibid.