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Long-awaited abortion pill Mifegymiso makes Canadian debut

The first shipment of Mifegymiso that arrived at the Willow Women's Clinic is seen in Vancouver on Friday, nearly two years after the two-drug combination was approved in by Health Canada in July, 2015.

Ellen Wiebe

The abortion pill is finally available in Canada.

The first shipments of Mifegymiso arrived earlier this week at two women's health clinics in Vancouver and Calgary, marking the beginning of a potential sea change in how women in Canada choose to end their pregnancies.

"We were over the moon," said Celia Posyniak, the executive director of Calgary's Kensington Clinic, the first place in the country to provide the medication to a patient. "There's a few of us who've been here for 25 years or more and we've been waiting for it for all that time. Canada was definitely a laggard."

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Mifegymiso is a two-drug combination that Health Canada approved in July, 2015, after an application process that took more than three years, an unusually long time for a medication that is already approved in more than 60 countries, including the United States, China and most of Europe.

Before that, pro-choice advocates spent years trying to find a pharmaceutical company willing to apply to sell mifepristone, the controversial first medication in the package, in Canada's relatively small market. (The second drug needed to complete a medical abortion, misoprostol, was already available in Canada.)

It's too early to say how widely Mifegymiso will be sold in Canada, or whether family doctors who do not already provide surgical abortions will offer the medication to their patients, particularly in small towns and rural regions where abortion services are scarce.

But so far, the early adopters are prominent abortion clinics, as many expected.

The Willow Women's Clinic in Vancouver, the second in Canada to receive a shipment of Mifegymiso, gave out its first two doses of the medication on Friday.

The Bay Centre for Birth Control at Women's College Hospital in Toronto is gearing up to begin offering the medication soon; all of its doctors have already completed the six-hour online course required to prescribe and distribute Mifegymiso.

The Society of Obstetricians and Gynaecologists of Canada (SOGC), which helped design the educational materials, said on Friday that 36 physicians and pharmacists have passed the course and another 65 have registered to take it.

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The course went live on Jan. 3, an SOGC spokeswoman said.

Completing the online training program is one of a slew of stipulations for prescribing Mifegymiso that Health Canada included in the drug's product monograph, the long label that lays out how a medication should be used.

The monograph also says that doctors – as opposed to pharmacists – should give the pills directly to women, and that the pills should not be used in pregnancies that are further along than seven weeks.

Pro-choice doctors and activists have raised concerns that the physician-dispensing rule might discourage family doctors who do not specialize in women's reproductive services from offering the pills.

Celopharma Inc., the Canadian distributor for Mifegymiso, has already applied to Health Canada to extend the upper limit of use to nine weeks, and to allow pharmacists to distribute Mifegymiso directly to women as they do with most prescription drugs, said Paula Tenenbaum, the president of Celopharma.

Meantime, some abortion providers have already decided to prescribe the pills "off-label" to patients whose pregnancies are further along than seven weeks, something Health Canada said is well within a physician's purview.

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"The stance with respect to this product is the same as other products," said Supriya Sharma, chief medical officer for Health Canada. "Information that's contained in the product monograph is really a reflection of the factual and scientific information that we've looked at to authorize the product. Should a practitioner want to go beyond that – the off-label use of that product – that is within the practice of medicine."

Ms. Posyniak said her clinic in Calgary plans to stick to seven weeks, at least at first. The Bay Centre in Toronto has approved an upper limit of nine weeks and the Willow Women's Clinic has settled on 10 weeks.

"The evidence is excellent and that is what the SOGC has on its guidelines, so that's what we went with," said Ellen Wiebe, the medical director of the Willow Women's Clinic and one of the authors of the society's guidelines on medical abortion, which were updated last spring.

The U.S. Food and Drug Administration updated the product monograph for Mifeprex, as the two-drug combination is called south of the border, last year to declare the drug safe and effective up to 10 weeks after the first day of a pregnant woman's last period.

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Kelly Grant is a health reporter with The Globe and Mail. More

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