Diffusion of women’s health technology faces legal hurdle in Japan

TOKYO – The Japanese are more and more aware of “femtech”, or technology to treat the physical and mental health problems of women. 2020 has been dubbed “Japan’s first year of femtech” after a host of domestic companies entered the field, but its growth faces serious challenges.

Sanitary product laws and regulations, including sanitary napkin marketing approval standards set by the Ministry of Health, Labor and Welfare, state that these items “shall be white in color and should be almost odorless. They must not contain any foreign element. material ”, and that sanitary napkins should generally be disposable.

In Japan, companies that manufacture and sell medical products must obtain approval from their local prefectural government and the Ministry of Health on the basis of the Pharmaceutical and Medical Device Act (PMD).

By law, paper sanitary napkins common in Japan are recognized as quasi-pharmaceutical products. It is only when certified as conforming to this legal classification that they can claim to be effective, with phrases such as “absorbs menstrual blood” and “prevents leakage”.

Meanwhile, more and more women are wearing menstrual underwear, which doesn’t have to be white. Although these underwear are gaining in popularity because they can be washed and used repeatedly, they are sold as “miscellaneous”. This means that 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 can include menstrual products, but also devices to help women assess when they are most likely to get pregnant by testing for vaginal discharge, and pelvic floor muscle training equipment to prevent leakage. urine.

On the other hand, many of these types of items cannot be approved under Japan’s PMD law because there is no category for them. Companies can sell them as “sundries” instead of medical products, but as this does not guarantee their performance or quality, it can pose risks to the health of consumers.

In addition, Japanese health product regulations have not seen a significant update for about 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 created a parliamentary league to promote femtech. In March of this year, he submitted a proposal to Chief Cabinet Secretary Katsunobu Kato, stating that the public and private sectors should work together on a comprehensive review of the approval of products related to fem technology. A government-industry task force, made up mostly of femtech companies, was launched in June. He plans to advance discussions on the legal status of each item and the necessary regulations by June 2022.

Desperate corporate voices have helped propel this movement. It took over five years for femtech manufacturer and supplier Hanamisui to gain approval for a vaginal cleanser. The apparent reason for the delay was that “there were no similar articles”.

Amina Sugimoto, CEO of femtech Fermata, founded in October 2019, said: “The PMD law is necessary, but it can be a barrier to products that come with new perceptions of value.

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

“Many femtech products are related to medical devices, 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 the general association incorporated Medical Femtech Consortium, which consists of obstetricians and gynecologists, among other experts. “In some cases regulations to ensure safety and security are needed. Femtech needs to be introduced in a manner appropriate to the current situation in Japan.”

In the United States and European countries, the femtech market has grown in importance starting with period management, such as period monitoring and menstrual underwear. It then branched out into fertility treatments, including treatment services for businesses, and finally to consultation-type medical platforms for women’s health issues in general, such as improving their sex life and menopause-related problems.

The Japanese femtech market, which is just beginning to grow richer with menstrual products, appears to be in the early stages of this development.

Large companies have started to budge, for example the operator of casual clothing brand GU Co., a subsidiary of Fast Retailing Co., started selling vintage underwear in March. The large trading company Marubeni Corp. last year set up a project team to enter the femtech field.

According to a February poll by Sompo Himawari Life Insurance Inc. of 1,000 working women, only 1.9% recognized the term femtech. After learning about the meaning of the word and its role, more than half of them said they were “interested” and “hopeful” for the concept, indicating that the Japanese market for femtech technology could grow considerably in the future.

(Japanese original by Atsuko Motohashi, Department of Economic News)