France approved the abortion pill, mifepristone, in 1988. The U.S., where even the mention of the word "abortion" sparks massive political battles, approved the drug in 2000. So have almost 60 other countries, including most of Europe, China, India, Russia, Australia, and South Africa.
The drug has been used safely for more than a quarter century, by millions of women around the world.
The World Health Organization includes mifepristone on its list of essential medicines - efficacious, safe and cost‐effective medicines considered necessary to provide basic health care.
The drug's manufacturer, Linepharma International, formally asked for approval in October 2011. (Why it didn't do so earlier is a long story but suffice to say that, like the U.S., Canadian officials should have proactively invited the drugmaker to make the product available in this country instead of sitting on its hands.)
One year later, in October 2012, at Health Canada's request, Linepharma filed additional material.
Since then...Who knows? Health Canada says it cannot comment on the status of specific drugs for reasons of confidentiality. (Which, in passing, is a crock, but a bit beside the point.)
What we do know is that mifepristone has still not been approved in Canada and probably won't be any time soon.
Health Canada: Needs. More. Time.
To review paperwork.
There can be only two possible explanations for this kind of dithering:
1) Gross incompetence : If you're a drug regulator and you can't review and approve (or reject) drugs promptly, then you're failing pretty fundamentally to do your job;
2) Political interference : It is no secret there is a core of anti-abortion MPs in the caucus of the ruling Conservative party and that the government is, shall we say, not enthusiastically pro-choice.
Neither lack of competence or being used for partisan purposes places the country's drug regulator in a very flattering light.
And it is particularly troubling for those who now hope drug reviews are a scientifically-based process that Health Canada won't make a decision on mifepristone until the fall – which, coincidentally no doubt, is after the next federal election.
Abortion may be topic that some of this country's politicians prefer to be swept under the rug. Health Canada may legitimately be struggling to approve drugs in a timely fashion given cuts to its budget.
Regardless, the failure to approve mifepristone promptly is a gross disservice to Canadian women, and to health professionals who strive to provide the best possible care.
Canada does not have any legal restrictions on abortion. Nevertheless, outside a handful of major cities, access to surgical abortion ranges from spotty to non-existent. Fewer than one in five hospitals perform abortions; only some provinces pay for abortions under medicare; some provinces, like New Brunswick and Prince Edward Island, have virtually no access.
Yet, about one in three women in Canada will have an abortion.
Having prompt, affordable access is an essential medical service, and a right. Having a pill that could be prescribed by physicians or nurse-practitioners is a much-needed alternative to surgery.
Mifespristone blocks production of the hormone progesterone, which nourishes the fetus and is required to sustain a pregnancy. It is taken in conjunction with misoprostol, a drug that induces contractions.
An abortion results; physically, the process is the same as a miscarriage.
Mifespristone has a good safety profile, despite the trumped-up claims of anti-abortion zealots. Fewer than three per cent of women who take the drug need further treatment; in about one per cent of cases it is ineffective.
The biggest worry in taking the abortion pill is that it is associated with a higher risk of bacterial infection and sepsis (blood poisoning). This issue has been studied extensively, and it does not seem to be caused by the drug per se, but by bleeding. Surgical abortion, miscarriage, menstruation, tampon use, childbirth, and obstetrical surgeries all create conditions that increase the risk of infection but, again, these are rare occurrences.
To put it in perspective, the abortion pill is safer than Viagra.
In European countries, about 60 per cent of abortions are now induced using mifespristone. The drug, long known by its laboratory name RU-486, is sold under the brand names Mifeprex and Mifegyme.
In the U.S., only about 20 per cent of abortions are drug-induced because onerous rules in many states require women using the drug to make up to three physician visits, which is costly and time-consuming. The pill itself costs, about $300, about the same as a surgical abortion.
In Canada, fewer than four per cent of abortions are drug-induced. In this country, women who don't want a surgical procedure – and often those who have an ectopic pregnancy (when the fetus develops outside the uterus, typically in the Fallopian tube) – can be prescribed the chemotherapy drug methotrexate, but it is less effective and has more side effects than mifepristone. It is also prescribed off-label – meaning it was not formally approved as an abortifacient.
In other words, in Canada, a woman who wants a drug-induced abortion can access a non-approved, not particularly effective drug but she cannot access a safer, more effective drug with a proven track record.
That, in a nutshell, sums up the absurdity of the Canadian drug regulatory environment, a place where kowtowing to political masters seems to take precedence over patient convenience and safety.
André Picard is The Globe's public health columnist.