Health Canada was reportedly expected to make a decision on whether or not to approve mifepristone—colloquially known as the abortion pill—this month. Last week, however, the federal department announced it wouldn't be making a decision on the pill until later this year.
This is the second time Health Canada has pushed back its decision on mifepristone, also known as RU-486, the first time asking the European drug company Linepharma International to re-submit its application in 2012.
VICE did not receive a direct answer from Health Canada by the time of this writing, but the department's website lists an average timespan of around 18 months, or roughly 550 days, to review a new drug. Mifepristone has already been under review for more than 750 days.
The drug is available in more than 50 countries, including France (since 1988), Australia, and the United States. It is listed on the World Health Organization's List of Essential Medicines.
Taken orally and within nine weeks of a pregnant person's last menstrual period, mifepristone blocks the action of progesterone—a hormone that supports the development of pregnancy. Combined with the ingestion of the drug misoprostol (which is already available in Canada) a couple of days later, the pregnancy is then expelled, mimicking a miscarriage.
Because the drugs can be taken at home, mifepristone advocates say the drug would make abortions safer and easier for Canadians living in remote communities—or on PEI—where surgical abortions are not available. The accessibility of the abortion pill would allow people to have abortions sooner, and the sooner a person has an abortion, the safer it is. (Because some trans men can become pregnant, the language in this piece reflects that women are not the only people who make use of abortion treatments.)
In Canada we have one form of medical abortion, the combination of the drug methotrexate and misoprostol. But methotrexate is used for various treatments and wasn't designed specifically for abortions. Dr. Sheila Dunn, an associate professor and clinician investigator with the Department of Family & Community Medicine at the University of Toronto, studied the use of mifepristone and methotrexate for terminating early pregnancies in the early 2000s. She said that for 25 percent of people who choose to use methotrexate and misprostol, it can take weeks to terminate the pregnancy, whereas after using mifepristone and misoprostol, 95 percent of people expel the pregnancy within 24 hours. Furthermore, methotrexate is generally administered as an injection, making it a far less accessible option than the drugs that can be taken as pills.
Critics have claimed that medical abortions are rife with risks, but research thus far appears to show mifepristone has a pretty decent track record. In the US, where mifepristone has been available since 2000, the US Food and Drug Administration has reported that several people have died from sepsis, a severe illness caused by infection in the bloodstream, after using mifepristone and misoprostol for medical abortions. But sepsis is a known risk related to any type of abortion, and the FDA couldn't verify that using mifepristone and misoprostol specifically caused these deaths. The FDA also states that reports of fatal sepsis in those undergoing medical abortions are very rare (approximately 1 in 100,000). They estimated that 1.52 million people used mifepristone in the US between its introduction in September, 2000 through the end of April, 2011. There were 14 deaths recorded, but even several of those had other contributing factors.
One argument against mifepristone is that its accessibility in rural and isolated communities could result in people who do suffer complications having a lack of medical resources to help them. But Dunn disagrees with this logic.
"If you can have a miscarriage in a community, you can have an abortion in a community," she said. "What you need is access to an emergency department or an emergency facility. It doesn't have to be a downtown, big-city hospital. Many small communities have their own local hospitals that would be well able to deal with this kind of situation."
It seems peculiar that a drug with decades of safe use and substantial research behind it should be subjected to such an inordinately lengthy review process in Canada.
As of this writing, a spokesperson from Health Canada told VICE that the department doesn't provide details about its approval process, and would only say that some paperwork still needed to be filed properly.
With Health Canada's stringent policy of secrecy, which is an issue in and of itself, Canadians are left to speculate. Without a candid explanation from Health Canada, it's possible the delay could be a move by the Harper government to put off approval of a controversial drug until after the upcoming election. It seems a little over the top, but Health Canada's lack of transparency makes it difficult to shut down even the most far-reaching of theories.
Regardless of the reasons, Canadians are being denied a method of abortion accepted world-wide, and we still don't know why.
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