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Spread of women's health technology faces legal barrier in Japan

This image provided by femtech company Fermata shows menstrual cups and other women's health items.

TOKYO -- People in Japan are becoming increasingly aware of "femtech," or technology to address women's physical and mental health issues. 2020 was called the "first year of femtech in Japan" after a host of domestic firms entered the field, but its growth is facing serious challenges.

    Laws and regulations related to sanitary products including the Standards for Marketing Approval of Sanitary Napkins, set by the Ministry of Health, Labor and Welfare, state that such items "shall be white in color and shall be almost odorless. It shall not contain any foreign matter," and that sanitary napkins are to be generally disposable.

    In Japan, businesses that manufacture and sell medical goods need to obtain approval from their local prefectural government and the health ministry based on the pharmaceutical and medical device (PMD) Act.

    Under the act, the paper sanitary napkins common across Japan are recognized as quasi-pharmaceutical products. Only when they are certified as conforming to this legal classification can they claim to be effective, with expressions such as that they "absorb menstrual blood" and "prevent leaking."

    Meanwhile, increasing numbers of women are using period underwear, which are not mandated to be white. Although these undergarments are gaining popularity, as they can be washed and used repeatedly, they are sold as "miscellaneous goods." This means they cannot be marketed using the same expressions as sanitary napkins, as their status under the PMD law is unclear.

    In some European countries and the United States, femtech is frequently included in employee benefits. This may include menstrual products, but also devices to help women gauge when they have a higher chance of getting pregnant by analyzing vaginal discharge, and pelvic floor muscle training equipment to prevent urine leaks.

    On the other hand, many of these kinds of items cannot get approval under Japan's PMD Act because it has no categories for them. Companies can sell them as "miscellaneous items" instead of medical products, but since this does not guarantee their performance or quality, it may lead to health hazards for consumers.

    Furthermore, Japan's regulations related to sanitary products have seen no significant updates for some 60 years. There is an urgent need to newly define femtech products under the law.

    In October 2020, lawmakers from the ruling Liberal Democratic Party established a parliamentary league for promoting femtech. In March this year, it submitted a proposal to Chief Cabinet Secretary Katsunobu Kato stating that the public and private sectors should work together on an intensive review of the approval of femtech-related products. A government-industry working group, mainly consisting of femtech companies, was launched in June. It plans to advance discussions on the legal status of each item and necessary regulations by June 2022.

    Desperate voices from businesses helped propel this move. It took femtech product maker and supplier Hanamisui more than five years to get approval for a vaginal cleaner. The apparent reason for the delay was that "there weren't any similar items."

    Amina Sugimoto, CEO of the femtech firm Fermata, established in October 2019, said, "The PMD Act is necessary, but it can be a barrier to products that come with new value perceptions."

    But deregulation without careful consideration does not guarantee the safety and security of consumers.

    "Many femtech products are medical device-related, but in Japan, where there is universal health insurance, there may be cases where it is better to visit the hospital," said Reona Matsumoto, representative director of general incorporated association Medical Femtech Consortium, which consists of obstetricians and gynecologists, among other experts. "In some cases, regulations to ensure safety and security are necessary. Femtech needs to be introduced in a way that is suitable for the current situation in Japan."

    In the U.S. and European countries, the femtech market grew to prominence starting with menstruation management, such as monitoring menstruation and period underwear. It then diversified into fertility treatment, including treatment services for companies, and finally to consultation-type medical platforms for women's health problems in general, such as improving their sex lives and menopause-related issues.

    The Japanese femtech market, which has just begun to see the enrichment of menstrual products, seems to be in the early stages of this evolution.

    Major companies have started making moves, for example casual clothing brand operator G.U. Co., a subsidiary of Fast Retailing Co., began selling period underwear in March. Major trading company Marubeni Corp. set up a project team last year toward entering the femtech field.

    According to a survey conducted in February by Sompo Himawari Life Insurance Inc. on 1,000 women in the workforce, only 1.9% recognized the term femtech. After learning about the meaning of the word and its role, more than half said they were "interested" and "hopeful" about the concept -- indicating Japan's femtech market may expand tremendously in the future.

    (Japanese original by Atsuko Motohashi, Business News Department)

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