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UK pharma firm to seek first Japan approval for abortion pill, but challenges remain

Mifepristone pills, marked "MF," and misoprostol pills, marked "ML," which have been used widely outside Japan as induced abortion medication, are seen in this photo provided by Tokyo University professor Yutaka Osuga.

TOKYO -- British drug company Linepharma is set to seek Japan's first ever regulatory approval for an induced abortion pill for practical use. However, though the pill has been in regular use in the United States and Europe for some two decades, there remain challenges surrounding drug pricing and abortion methods, among other factors.

    "There are hardly any side effects, and it's extremely safe. Women will be able to have an abortion independently without surgery by a doctor," said Yutaka Osuga, an obstetrics and gynecology professor at the University of Tokyo who has been participating in clinical trials for the abortion medication.

    Currently, abortions in Japan are surgical, performed by doctors designated under the Maternal Health Act and selected by prefectural medical associations. Abortions within the first trimester are done through the curettage method, in which metal instruments are used to scrape out the embryo, placenta, and other contents of the uterus. This method is used alongside evacuation, which entails sucking out the contents of the uterus through a straw-shaped instrument. According to the Ministry of Health, Labor and Welfare, 156,430 surgical abortions were carried out in Japan in fiscal 2019.

    Abortions induced using medication are intended for women who are within the first nine weeks of pregnancy. First, an individual must take one mifepristone abortion pill, and then take four tablets of misoprostol two days later. The drugs block hormones that sustain a pregnancy, the uterine lining breaks down, and the womb empties as it contracts. Painkillers are needed as well, as women also experience bleeding and pain during the process. Surgical intervention is needed if the uterus does not empty completely.

    According to Linepharma, the final stage of clinical trials in Japan was finished by the end of 2020, with successful abortions confirmed in 93.3% of cases. The firm said that once additional clinical trials comparing the shift of concentration levels of active pharmacological substances in the blood with that of non-Japanese are completed, it will file an application as early as this year with the government's Pharmaceuticals and Medical Devices Agency (PMDA) to have the drug approved for use.

    France approved abortion medication in 1988, the first country in the world to do so. The abortion pill also became widespread throughout the United States, Europe, and China from 1990 to the early 2000s. The medication has now been authorized in over 65 countries.

    In guidelines issued in 2012, the World Health Organization (WHO) stated that the curettage surgical method -- commonly used in Japan -- risks bruising the inside of the womb, and has safety issues. The WHO advised the use of the suction method or abortion medication, and specified the abortion pill as essential medication that should be distributed at affordable prices. Half of women who have abortions in the United Kingdom and France, as well as 70-80% of those in Nordic countries, are said to choose medication as their abortion method.

    Meanwhile, in 2004, Japan's health ministry subjected induced abortion pills to restrictions on importation by individuals, claiming that health issues resulting from medication manufactured by overseas firms had been reported. In November 2010, a Tokyo woman in her 20s had her papers referred to prosecutors by the Metropolitan Police Department on suspicion of criminal abortion for allegedly having an abortion at home by taking pills she had imported personally. However, online sales of abortion pills showed no signs of abating, which prompted the National Consumer Affairs Center to issue a warning in March 2013 that "individual importation and usage of the pill without due consideration is dangerous."

    Following a rise in demand, the Japan Association of Obstetricians and Gynecologists presented its views on induced abortion medication in September of the same year. The association said it was in favor of the national government starting discussion on the pill's approval. It has also been asking the government to consider conditions for managing the medication, such as only allowing doctors designated by the Maternal Health Act to handle the pills.

    As to why authorization of abortion pills has been so late in Japan, professor Osuga commented, "The drug is not well known among the public, and doctors did not actively introduce it. There may also have been concern among conservatives that it would cause the number of abortions to increase."

    Kunio Kitamura, director of the Japan Family Planning Association and a gynecologist who has pushed for domestic authorization of abortion pills for many years, said, "A massive amount of money, time, and coordination with concerned parties is necessary to introduce the new drugs. It may also be that pharmaceutical companies were worried about religious and profitability issues."

    Japanese pharmaceutical companies have also begun clinical trials for induced abortion pills, so their introduction is becoming more realistic. However, how they will be introduced for regular use remains a challenge to be discussed moving forward.

    It usually takes about one year from the time of filing to obtain health ministry approval for a new drug. In the meantime, the PMDA and a ministry deliberative body discuss how to safely manage, distribute, and take it. In other countries, the abortion medication is prescribed together with painkillers at medical institutions, and many countries also allow people to take the pills at home. However, due to the bleeding, it may be life-threatening for individuals with preexisting medical conditions, and some observers have said it should only be taken under medical supervision.

    There are also many countries that require women taking induced abortion medication to visit the hospital several times: when confirming the pregnancy, when taking the pills, and when confirming a successful abortion. Some people have expressed concern that the pills in fact impose a greater burden on doctors and patients than the quick surgeries.

    Kitamura said, "In addition to the safe management of the woman's body, the drug's effects, as well as methods to deal with bleeding, and other forms of education and emotional care are crucial. We must discuss and create rules for administering the drug."

    There are also monetary challenges. In Japan, abortion is not covered by public health insurance. Normally, patients pay 100,000 to 200,000 yen (about $925 to $1,850) for surgical abortions. Osuga said, "It's possible that medication abortions and surgical abortions will be set at around the same cost from the standpoint of running hospitals. It's necessary to consider offering public assistance to make the price affordable."

    When asked at a March 22 House of Councillors Committee on Health, Labor and Welfare session whether the government plans to cover abortion under public medical insurance, health minister Norihisa Tamura said, "If the mother's life and health are endangered, insurance will be applied, but I suppose this would not apply to general abortion, considering the objectives of insurance."

    Meanwhile, Kumi Tsukahara, who researches abortion issues, said that in around 30 countries, including the U.K., France, and New Zealand, abortion pills are effectively prescribed free of charge, as they are covered by insurance or subsidized by the government. In Australia, the U.K., France and other countries, prescriptions for the pills can be obtained online.

    The International Federation of Gynecology and Obstetrics (FIGO) issued a statement in March saying, "(online) telemedicine medical abortion service was proven to be effective, safe, inexpensive and satisfactory." FIGO stated that abortion should be provided by all governments "with safety, privacy and dignity at the forefront."

    (Japanese original by Satoko Nakagawa, Lifestyle and Medical News Department)

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