The company that imports and distributes a medication abortion drug in Canada is seeking to expand access to and lift certain restrictions on the drug, the Huffington Post reports (Raj, Huffington Post, 7/23).
Background
In July 2015, Canada's public health ministry, Health Canada, approved mifepristone, one of the drugs involved in a medication abortion, for use in the country. The approval aligned Canada with roughly 60 other countries where mifepristone has been legal for some time.
Mifepristone in Canada is also referred to by the brand name Mifegymiso (Women's Health Policy Report, 7/11). According to the Huffington Post, the drug is approved for use through 49 days of pregnancy (Huffington Post, 7/23).
While the drug was scheduled to be available via physician prescription as of July 1, the drug will not be available in Canada until this November (Women's Health Policy Report, 7/11). Paula Gelbfarb -- president of Celopharma, the company that distributes Mifegymiso -- said the drug is not yet available because of an ingredient change currently pending government approval.
Distributor seeks to increase gestational age limit
Celopharma is now seeking to expand the gestational age limit for the medication abortion drug, citing FDA's decision to approve mifepristone for abortions up to 70 days of gestation. Gelbfarb said she intends to submit a supplementary application with Health Canada next month.
Gelbfarb did not disclose what new limit the company intended to request. "We are presently trying to gather as much data as we can, supporting data, to substantiate the reason that we feel it's safe and a viable option for women," she said.
Distribution concerns
Gelbfarb said the company is seeking to ease some other restrictions on the drug (Huffington Post, 7/23).
Women's health specialists have flagged concerns about how the rules regarding dispensation of the drug could restrict access to medication abortion when Mifegymiso comes to the market. To prescribe the drug in Canada, doctors must complete an online training course. Further, doctors authorized to prescribe the drug must dispense it themselves, rather than referring a patient to a pharmacy (Women's Health Policy Report, 7/11).
In addition, the first dose of Mifegymiso must be taken "in the presence of your doctor or a member of the medical staff." Advocates say such restrictions limit a woman's choice in determining when to have an abortion.
Sheila Dunn, an associate professor in the department of family and community medicine at the University of Toronto, said the requirement that women take the drug in the presence of a physician conveys the impression that that "a woman can't be trusted to take a drug as she has been advised to take it."
However, Andrew MacKendrick, press secretary for Health Minister Jane Philpott, claims that "patients are not required to take either drug in front of their doctor." He said, "(T)he recommendations for use allow physicians to determine what is best for the individual patient. The product information uses the term 'under the supervision of,' which gives the prescriber the option to observe directly, delegate to another staff or to direct the patient as appropriate."
Nonetheless, Jocelyn Downie, a professor of health law at Dalhousie University, said providers could construe the dispensing requirements in other ways, which would limit women's access. "We have a history of some physicians in Canada treating women who seek abortions very, very badly and inappropriately," she said, adding, "I don't think that you want to leave a lot of discretion around this, because it can be used to justify discriminatory and stigmatizing behavi[o]r."
Separately, Wendy Norman, chair of family planning at the Canadian Institutes of Health Research/Public Health Agency, said physicians do not have the same resources that pharmacies use to effectively distribute medication. According to the Huffington Post, some stakeholders voiced concerns that providers in rural or remote regions of the country might decide not to stock the drug because the restrictions are too burdensome.
Citing the restrictions on pharmacy distribution, Dunn said, "There is a lot of potential for this drug to improve (abortion) access in Canada, but I think we are really missing a huge opportunity for this safe, effective drug that we know many women would choose as their first choice."
Cost concerns
Other stakeholders have raised concerns about the cost of the drug, which is $300 and not covered by health care programs at the provincial or territorial level, the Huffington Post reports. Indicating that she hopes the country's health care system extends coverage to include the drug, Gelfarb stated, "My concern is for access for women all across the country, that is my very big concern."
Noting that it makes "good sense" for the government to cover the "medically necessary procedure," Dunn said, "If there is no other way of funding it, it's going to bias women who don't have coverage through a health insurance plan for this drug ... It's going to bias them for a surgical [abortion], because they don't have to pay for that."
According to the Huffington Post, the health minister's office said there are no plans to lift the restrictions at this time. MacKendrick said Health Canada will "assess the data and consider revising conditions for both the prescribing and dispensing of Mifegymiso" (Huffington Post, 7/23).
