The majority of physicians who operate in clinics do not have access to ultrasound machines on-site. The mandatory ultrasound requirement will therefore require multiple appointments, likely at different locations. This has the potential to result in delays in administering Mifegymiso within the 7-week gestation period. In their April 2016 Medical Abortion guidelines, the Journal of Obstetrics and Gynaecology in Canada provides alternative means to confirm gestational age and rule out ectopic pregnancy when ultrasound is not available to the physician. The article notes that “in the absence of readily accessible ultrasound, gestational age can be estimated using last menstrual period (LMP), clinical history, and physical examination, in women who are certain of the date of their LMP. Ultrasound is needed when uncertainty remains.”
The language of the decision would suggest that the physician would be required to observe the patient taking the first dose of Mifegymiso. This requirement has been interpreted as demeaning to women. Health Canada has indicated that this is not what they intended through this restriction but lack of clarity in the Summary Basis of Decision’s wording would seem to imply this expectation.
Many stakeholders have noted that it is virtually unheard of for physicians to have to dispense drugs, noting that the physician-only dispensing requirement makes Mifegymiso more heavily regulated than medications in the Controlled Substances Act, and would subject individuals to onerous and demeaning requirements including taking the first of the two medications in Mifegymiso on-site in front of a physician. Due to a lack of precedent or existing infrastructure to do so, it is unlikely that physicians will stock the drug, particularly if they are located in rural areas.
Pharmacists and Physicians who are not currently abortion providers who wish to dispense Mifegymiso will be required to take a 6-hour training (3 hours for physicians who are currently providers). No other similar drug requires this amount of training. Following that training, the physician will be added to a confidential registry. This confidential directory undermines effective referrals. Action Canada for Sexual Health and Rights is working with Celopharma to develop measures to mitigate the impact of the registry restriction through greater public information.
Evidence from other countries (including the United States) indicates that Mifepristone can safely be used beyond the mandated 49 days of gestation. In March 2016, the United States Food and Drug Administration revised its approval of Mifeprex, the American equivalent of Mifegymiso, to terminate pregnancies of up to 70 days.
Provinces and territories have yet to agree to cover the cost of Mifegymiso either in the formulary or through full cost coverage. At $300/regimen, this makes it unaffordable for those with limited access to resources. Currently, Mifegymiso is under review by CADTH to determine whether it will be listed on provincial and territorial formularies. Even if covered via provincial and territorial formularies, many people in Canada will still have to pay out-of-pocket for the drug. Approximately 1/3 of people in Canada are not covered by provincial/territorial health plans (social assistance) or private insurance. Meaning that 1/3 of people living in Canada have no drug coverage at all. In addition, not all private insurance plans will necessarily include overage for Mifegymiso. All this despite the fact that Mifegymiso is 3-4 times less than costs associated with surgical abortion – saving significant amounts of money for health care systems, especially when evidence shows that medical abortion is preferred to surgical 50% of the time.