A tough pill to swallow

The Fulcrum Nadia Drissi El-Bouzaidi

Will the introduction of an abortion pill help increase access for Canadian women?

In 1969, Canadian pro-choice advocates had a huge victory on their hands with the Supreme Court of Canada’s decision in R v. Morgentaler. The Court ruled that the Criminal Code’s abortion provision was unconstitutional as it violated women’s rights under the Canadian Charter of Rights and Freedoms.

Despite the historic victory, women in Canada who are seeking to end a pregnancy still face numerous barriers.

Sixty years later, abortion is not offered at all in Prince Edward Island, is not covered under New Brunswick’s provincial health insurance, and women in rural and remote areas must traverse vast distances to acquire the procedure.

That being said, last year Health Canada approved mifepristone, an abortion medication that could help fill the gaps in Canada’s lack of abortion services. Mifegymiso, a product developed by Linepharma and comprised of the drugs mifepristone and misoprostol, was first introduced in France and China in 1988—it is now available in over 60 countries worldwide.

The World Health Organization lists it as an “essential medicine”, a minimum medicine needed for basic health-care systems, based on criteria such as safety and cost effectiveness.

However, with one of the lengthiest approval processes in Health Canada’s history, and an extensive list of regulations that experts are calling into question, many are pessimistic about whether Mifegymiso will actually increase access to abortion in Canada.

So while the new frontier of the fight for the right to have an abortion is not a question of legal legitimacy, now it seems to be a question of access.

Abortion access from 1969 to 2016

Since abortion was legalized in 1969, the process has become widely available for thousands of Canadian women. Unfortunately, to this day there still exists restrictions on abortion access.

In 2011, 92,524 women terminated a pregnancy in Canada according to the Canadian Institute for Health Information. Despite this number, abortion services are only offered in one of six Canadian hospitals.

Even though the 1984 Canada Health Act requires provinces to fund abortion clinics, different interpretations of the law have led to limited funding in Nova Scotia and no funding in Prince Edward Island and New Brunswick. PEI is also the only province in Canada that does not offer abortion services at all, forcing women to travel to other provinces.

The progress has been slow in many Canadian provinces, with Manitoba not funding abortions until 2004, and Quebec not fully funding abortions until 2008.

Canada’s history with mifepristone began in the 1990s when both British Columbia and Quebec experimented with early trials of the drug, according to Angel Foster, a University of Ottawa professor in the Faculty of Health Sciences who also holds the university’s endowed chair in women’s health research.

“The drug wasn’t ultimately registered. This has a lot to do with a lot of quirky issues about pharmaceutical drug markets, pharmaceutical industry, the markets for different kinds of pharmaceutical registration processes, the lack of company that was willing to file a separate dossier,” said Foster.

Geography also plays a role in the lack of interest for drug companies to submit a request for approval.

“With about 100,000 abortions a year, distributed over a very large area, it’s not a very large marketplace which can sometimes present challenges to drug companies to invest in bringing a drug to market,” said Foster.

It wasn’t until 2011 that U.K.-based company Linepharma International submitted an application to Health Canada to approve their 200-mg mifepristone tablet. The company resubmitted their application a year later, and after a two-and-a-half-year process, it was approved in July 2015.

But one year later, with a training program being developed and manufacturing adjustments being made, mifepristone has yet to hit the market in Canada.

Regulations, red tape, and a rocky roll-out

Mifegymiso is expected to cost $270 for one dosage, approximately a third of the cost of surgical abortion. Treatment failure was reported in cases for 2 to 4.8 per cent of women, and thereby required a surgical intervention.

While these numbers indicate some improvements, the approval has come with several regulations that have been called into question by critics.

“Mifegymiso is a drug regimen that has the ability to shift the nature of access dramatically in Canada,” said Sandeep Prasad, the executive director of Action Canada for Sexual Health and Rights. “However with these restrictions that Health Canada has imposed, we are doubtful that the promise of Mifegymiso will be realized.”

Foster flagged the lack of availability of mifepristone and “a number of non-evidence based regulations” as two major challenges with Health Canada’s approval of mifepristone.

Health Canada has approved Mifegymiso for use up to 49 days after last menses. However, mifepristone has been approved for up to 10 weeks in certain countries, and this added time can be crucial, according to Prasad.

“Those three weeks make an enormous amount of difference to whether someone can actually access the services that they need,” he said.

“We have overwhelming amount of evidence that shows that mifepristone can be used effectively through 70 days gestation,” said Foster, adding that in many countries it is already approved up to 60 days. “The gestational age limit is actually a major impediment to being able to expand access.”

Critics have also raised concerns over the ambiguously worded monograph which can be interpreted as saying that a woman must take the drugs under a physician’s supervision.

Surpriya Sharma, a senior medical advisor for Health Canada, said these regulations were based on the rules around mifepristone’s use in many other countries.

“So, most cases in most countries, that initial medication is taken in the physician’s office, but we left it broader than that to really be at the discretion of the physician and the patient to decide what’s most appropriate.”

“If the product is dispensed at the physician’s office, then that ensures that that visit happens at the physician’s office and allows for the appropriate medical and psychological support for patients as well,” she said.

Mifegymiso will be prescribed and dispensed by physicians, something that’s also done for fertility medication and vaccines, according to Sharma.

Prasad pointed out that physicians prescribing drugs is an anomaly in the Canadian health-care system, and that he believes this regulation is “based in abortion stigma.”

Physicians and pharmacists are also required to take a voluntary training course before they can prescribe Mifegymiso, which Sharma said was instituted after consultations with physicians associations.

“First of all most other countries do have a training program that’s in place. And second of all when we were going through the approval we did consult with physicians associations about the use of the medication and what other supports that might be available in terms of education and we heard that they would very much appreciate having a standardized education program.”

But Prasad is concerned by the barriers put in place by an extensive training process.

“For no other drug apart from methadone do physicians need to register specifically to prescribe that medication and the training requirements are not necessary. It’s sufficient for doctors to be given the information they need to use their clinician judgment for what situation they can actually prescribe this medication to a patient,” said Prasad.

Health Canada also requires women to have an ultrasound before Mifegymiso can be prescribed in order to determine an exact date of pregnancy and to rule out an ectopic pregnancy, according to Sharma.

However, Foster said the requirement for ultrasound to rule out ectopic pregnancy is “not evidence based.”

This requirement “limits the ability of certain kinds of providers to offer the service if they’re not doing ultrasound or don’t have access to an ultrasound on site,” said Foster.

The sum of all of these regulations could end up having the largest impact on women in more remote parts of Canada who want to end a pregnancy.

Rural-urban divide

Due to Canada’s vast landscape, women living in more rural communities stand to gain the most by having an accessible medical abortion option. Unfortunately, the regulations surrounding Mifegymiso could limit those potential impacts.

Christabelle Sethna, a U of O professor of women and gender studies and historian of sex education, contraception, and abortion, said a lack of general access to doctors in these areas means that the regulations “may end up exacerbating disparities that actually exist.”

“If you already have a medically underserviced area, the abortion pill is not necessarily going to help women, because the protocol requires them to access the pill in a way that means that the area is already serviced at a certain level.”

“We know that there are tremendous geographic disparities and abortion access not only between provinces and territories, but within provinces andterritories,” said Foster, adding that women often spend weeks pregnant as they scramble to seek resources to acquire an abortion.

Foster noticed that Health Canada’s cautious roll-out is common practice when it comes to mifepristone.

“In almost all countries where mifepristone has been introduced it takes quite a long time to expand access to services with mifepristone itself.”

Typically abortion providers have first offered the medication as an alternative to aspiration abortion, and in countries with substantial shifts in use patterns of aspiration abortion mifepristone has been incorporated into other settings, said Foster, and then to a broader range of geographic areas.

“I believe that, and hope, that Canada will follow that same sort of trajectory, but there’s been no example globally where mifepristone has been approved and introduced and immediately gone out into rural areas where there’s no existing abortion providers,” said Foster. “So to expect that to happen in Canada is unrealistic.”

Sharma said the regulations were decided solely to limit the potential side-effects and ensure that there is follow-up with a physician.

“People need to understand there can be serious side-effects if those side-effects are left untreated … more than rural or urban, it’s important that there’s the appropriate follow up of anybody that’s taking the medication and that people can have access to these procedures very quickly if the need arises.”

The long road ahead to abortion accessibility

It seems that, despite the approval of mifepristone, Canada still needs to take significant strides before abortion is fully accessible in all regions for women of all backgrounds and socioeconomic statuses. Prasad, Foster, and Sethna all agreed that while significantly fewer Canadian women are carrying unwanted pregnancies to term, women still face numerous barriers.

Sethna said that the strong feelings people have about contraception and abortion has oversimplified the issue.

“Reducing everything to woman versus her fetus makes the larger issues around women’s health disappear,” she said. “The larger issues are inequality in society, unequal pay for women, and the lack of daycare.”

Sethna also mentioned violence against women and the loss of jobs as issues that Canada is lagging behind in when it comes to women’s health.

“I think we as a country see ourselves as leaders in the field, but in fact we are laggards,” said Prasad. “We approved it with many restrictions that will virtually guarantee its poor availability.”

Sethna noted how the tendency to view pills as “magic bullets” also oversimplifies the debate around both the birth control pill and mifepristone.

“A magic bullet is something that is supposed to resolve all issues all at once, and so clearly, the birth control pill was not a magic bullet. It helped, but it didn’t resolve all the issues around unintended pregnancy,” she said, “and this abortion pill is not going to resolve all the issues around abortion and abortion access either.”

While a woman’s right to choose is enshrined in Canadian law, and there’s hope that mifepristone’s approval can help women in more remote parts of Canada, for many the access to an abortion is still out of reach.