Thank you for your continued support for improving our reproductive health and rights.
We are a Japanese group named RHR Literacy Laboratory, working to improve the reproductive health and rights of the Japanese people. We are now collecting messages from international activists, gynecologists, professors, and other specialists on our situations regarding abortion pills and abortion access to share with the public. Please note that we may translate your message into Japanese and publish it with your photo.
The deliberations on the MEFEEGO PACK (Mifepristone +Misoprostol) by the Ministry of Health, Labor, and Welfare was scheduled for March 24, but it was postponed with a sudden notice and they made an excuse that they couldn't "sort out" all the 12,000 public comments they had collected back in February.
And according to the MHLW, the next schedule for the deliberations remains undecided.
The contents that were supposed to be discussed on 3/24 includes whether or not the MEFEEGO PACK needs a "re-examination period" or needs to be registered as a "deleterious medication" that could cause serious complications.
The four items they were planning to discuss on 3/24 are as follows :
1. Whether or not MEFEEGO Pack should be registered as a biological product or a specific biological product
2. Whether or not MEFEEGO PACK itself should be approved in Japan
3. Necessity for a "re-examination period" for MEFEEGO PACK
4. Whether or not MEFEEGO PACK should be designated as a "poisonous" or "deleterious" medication
Regarding these four points, the overall evaluation of MEFI-GOPAC's review report submitted to the government last November indicates the following decision:
Since this item is a drug product containing a new active ingredient and a new route of administration, the reexamination period shall be 8 years. The product falls under neither the category of biological product nor the category of specified biological product. We conclude that the drug substance and formulation of Mifepristone and the formulation of Misoprostol are both classified as deleterious substances.
As a result, the review report concluded that the approval is acceptable with the following two conditions:
［Conditions for approval]
(1) A drug risk management plan must be established and properly implemented. (2) The drug must be administered in accordance with the Maternal Body Protection Act.
(2) Necessary measures should be taken to ensure that the drug is used only by designated doctors under the Maternal Body Protection Law. This includes managing the distribution of the drug in cooperation with relevant organizations, etc. The relevant organizations are those that have been designated under the Penal Code for abortion.
One of the most influential "relevant organization" is the Japan Association of Obstetricians and Gynecologists (JAOG), an interest group of doctors designated under the Maternal Body Protection Law to perform legal abortion. Linepharma clarified in its review report that it is cooperating with the JAOG and that the use of MEFEEGO Pack is subject to the same strict controls as gemeprost（the product name is "PREGLANDIN Vaginal Suppositories"), which is still generally used for mid-term abortions in Japan today. However, gemeprost, used as a vaginal suppository for mid-term abortion, is classified as a deleterious drug in Japan as well as misoprostol, used to treat gastric ulcers.
Such is the current status of abortion pill approval review in Japan, and we would like to hear your opinions as an expert on abortion pills. Thanks in advance for your time.
Kumi Tsukahara, Head
Kazane Kajitani, Staff in charge
RHR Literacy Laboratory
https://www.rhr-literacy-lab.net/
rhr.lit.lab@gmail.com
