JAPAN – Linepharma abortion pills (mife+miso combi-pack) to be considered for approval 27 Jan

Although abortion pills have been used in many other countries for as long as 30 years, they have not yet been approved in Japan.

In late December 2021, the pharmaceutical company Linepharma applied for approval to manufacture and market the pills in Japan as a combi-pack of oral mifepristone & misoprostol, with the name Mefeego Pack. The Health, Labor and Welfare Ministry recently announced that experts in Japan will deliberate on 27 January 2023 whether to approve this combi-pack to induce abortion. In Japan, the practice of abortion has been limited mostly to surgical methods, including D&C, and if the mife-miso method is approved, it will provide another option for women. This method is on the World Health Organization’s Essential Medicine’s List and is approved for use at home up to 12 weeks.

In pre-introductory clinical trials in Japan, 93% of 120 pregnant women seeking abortion at up to 63 days of gestation were able to abort within 24 hours using these combined medications. Although 60% of the patients had symptoms such as abdominal pain and vomiting, most of them had mild or moderate symptoms, which are well known and for which simple treatment is provided.

The following topics are also on the agenda of the meeting (without further details):
1. whether or not the drug Mefeego Pack should be designated as a biological product or a specific biological product
2. whether or not manufacturing and marketing authorisation should be granted
3. whether or not a designated re-examination date should be indicated
4. whether or not the pills should be designated as a poison or a deleterious drug.

Why this fourth question? Preglandin (or Cervagem) are brands of an abortifacient pessary that contains the prostaglandin gemeprost. They are currently used for abortion after 12 weeks of pregnancy in Japan. They are officially designated as a “deleterious drug” in Japan and are therefore kept under strict control (and very expensive!). But the reason why they are probably designated that way is because prostaglandin is deleterious for anyone who is pregnant because it can cause an abortion! For anyone who wants an abortion, it is not “deleterious”. There is concern among the women’s groups in Japan that Mefeego Pack could be labelled similarly, but this would be completely inappropriate, given the approval by WHO of the same abortion pills in all other countries’ combi-packs as being very safe, safe enough for self-use at home up to 12 weeks of pregnancy! WHO could also be asked if it is still an appropriate label for gemeprost too. It may be an out-of-date label!

SOURCES: The Japan News, by The Yomiuri Shimbun, 22 January 2023 + VISUAL by Linepharma; E-mail from Kumi Tsukahara, 24 January 2023 ; see also earlier Campaign newsletter reports on these issues from Japan.