It's Christmas Eve and this is the dead line, written by Kumi Tsukahara
On the 25th of last month, the Japanese Ministry of Health, Labor, and Welfare (MHLW) announced its intention to make an erectile dysfunction (ED) treatment drug available over the counter. The MHLW has decided to gather public comments on the matter until December 24. The drug in question is called Cialis, and its active ingredient is tadalafil.
We oppose the conversion of tadalafil (Cialis tablets) to an OTC drug. The package insert for this drug warns: “Since there have been reports of serious adverse cardiovascular events, such as myocardial infarction and other serious cardiovascular events, including deaths, patients need detailed examination for cardiovascular disorders before administration of this drug.” There is a wide range of contraindications, including: “When administered, the drug should be limited to patients who require clinical tablet therapy based on an objective diagnosis of erectile dysfunction and its underlying disease, including a review of their medical history and various tests.” The warning states, “When administering this drug, patients should have their medical history investigated and various tests performed to diagnose erectile dysfunction and its underlying disease, and only patients who require clinical tablet treatment based on an objective diagnosis could reach them.” In the UK, it is only available as a prescription drug. The efficacy of this medicine is to help men with ED to become sexually available, but it is not urgently needed.
On the other hand, the emergency contraceptive levonorgestrel, the only available EC in Japan, which has been under consideration for a long time for OTC use but has not yet been available, is truly an “emergency” medication for women who want to prevent unwanted pregnancy. The earlier they take it, the higher the contraceptive success rate. For women, an unwanted pregnancy is an event that poses a tremendous risk to life and health. This medicine should be sold in pharmacies before ED drugs under a “short-cut” scheme so that women can purchase it at pharmacies.
The EC is also on the WHO Essential Medicines List, meaning it is very safe. WHO strongly recommends making over-the-counter emergency contraceptive pills available without a prescription based on the systematic review of the literature relevant to the question, “Should ECPs be made available without a clinician’s prescription?” conducted by WHO in 2021.
Japan has a history of speedy approval of Viagra, an ED drug lots of older men needed, without even conducting domestic clinical trials, while not approving a contraceptive pill necessary for women for decades. At that time, the MHLW rushed to approve the birth control pill after receiving a flood of domestic and international criticism for its blatant double standard. I believe the approval of tadalafil as an OTC product instead of levonorgestrel is a similar double standard. We are firmly opposed to this proposal.
The deadline for public comments is December 24, and the MHLW will announce the results next year. Japanese feminist activists have started a campaign to send comments advocating that the MHLW should prioritize the OTC conversion of EC over ED drugs.
