Once more, Health Canada has delayed its decision on whether or not to approve the medical-abortion drug mifepristone. A hoped-for ruling in January will now come at the end of the year. Some proponents of the drug are hinting darkly that political interference from the Harper government is to blame, a possibility they suggest is supported by the fact this latest delay will conveniently postpone Health Canada's decision until after the general election scheduled for the fall.
That's a bit much. Mifepristone has caused controversy in nearly every country that has approved it. There are always people who think the pill, which prompts a spontaneous abortion in the first three months of pregnancy, has either been approved too slowly or should not have been approved at all.
There simply is no concrete evidence that Health Canada is exercising anything other than due caution. Marion Ulmann, the COO of Linepharma International, the company trying to bring the drug to Canada, agrees. She said this week after the new delay came to light that "the registration procedure has gone uneventfully."
At the same time, and with due respect to Ms. Ulmann's diplomacy, it is nonetheless puzzling why Health Canada has taken so long to make a decision – more than 750 days, according to one researcher.
Mifepristone has been approved in 60 countries, including the U.S. and most of Europe, and has been used routinely for years. Multiple studies have demonstrated that it is safe and effective. There are serious side effects and risks, including that of death, but they are extremely rare. According to one study, the risk of death is lower than that associated with many popular over-the-counter and prescription drugs, including acetaminophen and Viagra.
Presumably, Health Canada has this information. Presumably, too, it is aware that Canadian women have unequal access to abortion across the country, even though the procedure is funded by medicare. There are many small cities and towns, not to mention the entire province of PEI, where there are no abortion clinics.
Mifepristone could level the playing field. Women could get the pill from their doctor, rather than having to travel to a large city or even out of province for the procedure. It would also give them a larger degree of privacy.
The drug's success in other countries, and the benefit it would bring to women here, is turning Health Canada's unusual slowness into an issue of a woman's right to an established medical treatment. This, in turn, is exacerbated by the complete secrecy that Health Canada maintains around its approval process.
We need an explanation for the delay. The longer regulators dither in this unaccountable manner, the more people will wonder if there is more going on than meets the eye.