Health Canada eases restrictions on abortion pill Mifegymiso


Kathryn  Blaze Baum | The Globe and Mail

Ottawa is making it easier for women to get the abortion pill, relaxing rules around who can prescribe the drug and at what stage of pregnancy a woman can take it – changes that catapult Canada among the world’s most liberal jurisdictions in terms of obtaining the medication.

Health Canada announced on Tuesday that Mifegymiso can now be prescribed by a wider range of health professionals, dispensed at pharmacies and administered up to nine weeks into pregnancy, instead of the previous limit of seven weeks. Prescribers no longer have to complete special training, nor must they register with the Canadian distributor of the drug – a requirement that raised concerns about doctors’ privacy. In addition, the patient is no longer obligated to provide written consent.

The changes are the result of a six-month review of guidelines that had generated confusion among health professionals about the rules for Mifegymiso, a two-drug combination that gained federal approval in 2015.

“Today is a significant step forward for abortion rights in Canada,” said Sandeep Prasad, executive director of Action Canada for Sexual Health and Rights. “The restrictions that were lifted with this decision will help to ensure that we are getting closer to realizing the promise of Mifegymiso. … We need to shout this from the rooftops.”

Some form of the abortion drug has been approved in more than 60 countries, yet it took decades for Mifegymiso to hit the Canadian market. The rollout was stymied initially by an unwillingness among pharmaceutical companies to apply to sell the first pill in the package, then by an unusually long application process.

When the medication finally became available in Canada, it marked the beginning of a potential sea change in how women choose to end their pregnancies in a country with vast geographic disparities when it comes to accessing surgical abortion. Mifegymiso retails for about $300 and is covered in some provinces.

Health Canada’s initial guidelines said only physicians should prescribe the medication and that doctors, as opposed to pharmacists, should give the pills directly to patients. This raised concerns about getting Mifegymiso to women who live in rural areas far from a doctor’s office, or who are not in the care of a physician but rather see a nurse practitioner, for example. The guidelines – also known as the product monograph, which lays out how a medication should be used – limited prescriptions to women who were seven weeks along or less.

“There are people that are very passionate and feel that we were being too restrictive and there were people who were equally passionate about saying that we’re too permissive,” said Dr. Supriya Sharma, chief medical adviser to Health Canada. “Those opinions are valid … but when it comes down to the decisions that we have to make, as with any product, it really has to be grounded in science, evidence and law. That’s what we have to hang our hat on.”

Dr. Sharma said the scientific evidence submitted by the drug sponsor, Linepharma, and its Canadian distributor, Celopharma, showed that the drug combination is slightly less effective at nine weeks than seven and that side effects at both stages are roughly comparable. She said extending the timeline gives women “more flexibility,” and noted that nine weeks is the upper limit in countries such as France, Britain and Australia. The United States has set the restriction at ten weeks.

As was true of the previous monograph, Health Canada continues to advise that, in order to guard against potentially fatal complications for the patient, health professionals should schedule an ultrasound to ensure that the pregnancy is not ectopic (outside the uterus). The guidelines also say the ultrasound should be used to determine how far along a woman is in her pregnancy.

Marie-Claire Bissonnette, a spokeswoman for the anti-abortion group Campaign Life Coalition, said the changes display a “cavalier response” to women’s reproductive health, valuing accessibility over safety. “[Mifegymiso] replaces a surgical procedure,” she said. “It’s not an Aspirin and it should be taken seriously.”

While Health Canada’s guidelines are not binding, the department was aware that some provinces and territories were uncomfortable with the idea of straying from the federal monograph, Dr. Sharma said. Now, though, the path to access is clear: “In general, for most individuals looking at it from the outside, [Mifegymiso] is now being treated like any other medication,” she said.

Wendy Norman, a family doctor and University of British Columbia professor who is leading an independent research project on the uptake of Mifegymiso, said Tuesday’s development is a big win for primary care providers. By swapping the word “physician” for “health professionals” in the guidelines, Health Canada is effectively saying that prescriptions should be allowed to come from any provider whose provincial or territorial regulatory body includes prescribing in the scope of practice.

“For nurse practitioners, this was the biggest barrier to come down,” said Prof. Norman, adding that she meets regularly with Health Canada about Mifegymiso. “Canada, now, is a leader in improving safety and access to abortion for women.”

Posted on 2017-11-07
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