Japan’s approval of oral abortion pills: A new era of opportunities and challenges in aligning with global standards

On 28 April 2023, an oral abortion pill was approved for the first time by the Japanese government and is expected to be used to induce abortion care shortly. ¹ The prescription of this medication requires an in-hospital waiting period, and for the time being, until an appropriate system for its use is established, it may only be prescribed at medical institutions where inpatient or outpatient care is available. In addition, only obstetricians and gynecologists certified by prefectural medical associations as designated physicians under the Maternal Health Act (MHA) can prescribe this medication to their patients. ² Induced abortions have been performed so far under the MHA in cases where there is a risk of serious harm to the mother’s health due to physical or financial reasons or when the pregnancy is the result of violent acts or coercion, under the condition that the consent of the spouse is obtained within 22 weeks of conception. ² It was, therefore, difficult for Japanese mothers to decide whether or not to deliver a baby based solely on their judgment.

The number of abortions in Japan reported in the fiscal year 2021 was 126,174, and early pregnancy terminations have been primarily conducted through curettage and vacuum aspiration, and it has been reported that more than half of abortions in Japan performed are by curettage. ³ However, the World Health Organization (WHO) recommends using vacuum aspiration or abortion pills instead of curettage when performing surgeries associated with abortion or miscarriage. This is because, although rare, there have been reports of significant risks associated with curettage, including heavy bleeding, infections, and uterine wall or intestine perforation. ⁴ In response, the WHO-recommended plastic manual vacuum aspirator has been approved in Japan, and insurance coverage was applied to miscarriage surgeries using this method in 2018. The approval of the oral abortion pill this time is a catch-up to global standards following the ongoing trend of abortion care.

The approved medication this time was Mefeego Pack, which WHO also designates as an essential medicine for its safety and efficacy. It involves the administration of mifepristone, an anti-progesterone that inhibits the action of progesterone, essential for the maintenance of pregnancy, on the reproductive tract, followed by the intake of misoprostol 36 to 48 h later, which promotes uterine contractions. The target population for this treatment is those with pregnancies less than 9 weeks along, and it is expected to be generally ineligible for insurance coverage. Indeed, the use of oral abortion pills is growing rapidly worldwide thanks to its reported efficacy of more than 97%. ⁵ For example, in the United States, the Food and Drug Administration approved its use in 2000, and it was reported that in 2020, 53% of abortions in the country were by oral pills. ⁶ In many European countries, medical abortion is even more prevalent; for instance, in the United Kingdom, 87% of abortions in England and Wales were medically induced, according to the UK Government statistics for 2021. ⁷ Concerns about side effects such as bleeding and failed abortion exist, but these frequencies are less than 0.05%, ⁵ and this method is expected to become more common in Japan in the future, given that it imposes less burden on the mother than surgical procedures.

However, there are two concerns at the current stage. The first is the issue of cost. As induced abortions are typically not covered by public insurance and are treated as elective care in Japan, the cost of medication-induced abortions will be determined by individual medical institutions. Therefore, the Japan Society of Obstetrics and Gynecology has reported that the price of the medication is expected to be around $370, and when combined with consultation and hospitalization fees, the total cost could reach a substantial sum of approximately $740. The second is the barrier to access to medical services for performing abortions. In Japan, obstetrician-gynecologists who meet the criteria to be designated under the MHA to prescribe Mefeego Pack are facing a severe shortage, and there is even a trend of obstetrics and gynecology hospitals in rural areas closing down. As a result, it may be difficult, especially in rural areas, to access appropriate medical services nearby. Furthermore, the social stigma surrounding abortion, independent of the method used to induce it, could potentially lead to psychological distress and fears of being stigmatized, causing those seeking abortions to hesitate to visit hospitals. ⁸ Therefore, prompt efforts to address these issues are required.

One potential solution to these problems is the introduction of online medical consultations. This is because telemedicine is less constrained by distance and time, allowing it to expand access to healthcare in rural areas and bridge the gap between rural areas and specialized healthcare providers. ⁹ Indeed, telemedicine can reduce labor costs, travel expenses, and other costs; an average saving of around $230 per abortion has been reported in the United Kingdom, where the process involves assessment and counseling by telephone or virtual consultation, followed by prescription by a doctor and delivery by post or collection. ¹⁰ Likewise, in countries such as France and the United States, similar methods of remote consultation are used, rather than prescribing abortion pills directly online, and as shown in Forward Midwifery, where services are offered for as low as $150, this approach can be a viable option for those with low or no income.^11,12 In addition, telemedicine provides a simple and private way to access abortion care, helping to lower the psychological barriers to visiting a hospital for an abortion. ⁹ Therefore, with an appropriate healthcare system, telemedicine abortion is a potentially cost-effective, safe, and secure means of providing care; thus, the Japanese government must raise awareness of these advantages.

On the other hand, it is also important to recognize that online medical consultations possess certain limitations. Abortion often involves intense psychological suffering, for which the physical presence of a healthcare provider or in-person care may be preferable. ¹³ In this context, alternatives must be considered, such as the provision of services by other trained health professionals or the establishment of medical centers in isolated regions. Nevertheless, despite these inherent challenges, telemedicine offers clear advantages in terms of accessibility and cost-effectiveness,^{9 –11} and these strengths may be especially advantageous in Japan, where rising healthcare costs and uneven distribution of healthcare providers, particularly physicians, are major issues,^14,15 and therefore, an active discussion is needed for its introduction.

Fortunately, online medical consultations have evolved and become widely accepted over the 3 years of the COVID-19 pandemic. Expanding appropriate prescription of abortion medication not only protects the health of women who have no choice but to choose abortion but also safeguards the right to self-determination whether or not to give birth. Of note, approximately 73 million abortions are performed worldwide annually, and global estimates suggest that 45% of induced abortions are unsafe. ¹⁶ Therefore, it is essential for Japan and other countries to build a consensus for telemedicine abortion based on recommendations and scientific evidence within international coordination and to find ways to prudently expand its practical use so that any person can choose an oral abortion.