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Mifepristone, despite its global reputation, may not be available in Canada because no company has applied for its approval. (MARK KEGANS/NYT)
Mifepristone, despite its global reputation, may not be available in Canada because no company has applied for its approval. (MARK KEGANS/NYT)

Experts decry lack of access to best abortion drug – and what it says about Canada’s drug-approval process Add to ...

Elizabeth, a 24-year-old university student in Ottawa, thought she had the flu until, sitting in her bathroom at 6 one morning, she saw the blue line on the pregnancy test. Panicked, she started calling a local abortion clinic, even though she knew no one would answer the phone there for hours.

Elizabeth, who asked to be identified by her middle name, was eventually given an appointment for three weeks later – a seemingly endless wait. She could barely study, worrying about how far along she was, ashamed to find herself pregnant, and worried that she’d have to cross a line of protesters at the clinic. In the end, accompanied by her boyfriend, the procedure went better than she’d imagined. But offered the option of going to her doctor sooner, and taking a pill in privacy, she would have done so “in a heartbeat.” She says, “I could have handled it the way I wanted to.”

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And if she lived in one of 57 other countries, including the United States, Elizabeth would have that option. But Canadian women don’t have access to what is considered around the world to be the safest, most effective choice for an early-stage medical abortion. The drug, called mifepristone, isn’t approved for use here, an omission criticized by an editorial in the Canadian Medical Association Journal last week.

The problem goes beyond one pill: When it comes to contraceptives, Canadian women also have less choice than women in many developing countries. Both medical and legal experts argue that Canadian women should have best-evidence options equal to the rest of the world – and, at the very least, the right to a transparent drug-approval process that explains exactly why they don’t.

“What we are talking about are drugs that are being widely used elsewhere in the world with a very good track record, highly safe and highly effective for access to reproductive health in Canada, and we don’t have them,” says Dr. Sheila Dunn, research director of the Family Practice Health Centre at Women’s College Hospital in Toronto and co-author of the CMAJ piece.

But it’s hard to understand the reasons – and respond to them – when drug-approval decisions are made without public scrutiny. “The Health Canada process has to be fair and above board,” says Dunn. “And we don’t have any way to see what that process is because it is invisible.”

So invisible, in fact, that unless a drug is approved, Health Canada will not even say whether an application has been submitted, and if it’s denied, will not release the reasons for the decision. According to Dunn, Health Canada received an application to approve mifepristone in October, 2012, which is still pending. According to the department’s website, it takes about 18 months on average for a drug to move through the process. (A Health Canada spokesperson said “the existence, or non-existence” of a submission is confidential, citing privacy laws.)

In the United States, by contrast, the federal Food and Drug Administration holds public hearings for some drugs, and publishes expert opinion about their safety. The European Medicines Agency, which already publicly names the products they have turned down, has announced that by next year it also plans to release clinical information submitted for drug approvals – provided the agency doesn’t lose a pending lawsuit from pharmaceutical companies.

In Canada, concerns about access to drugs related to women’s reproductive health aren’t new. A 2004 study by researchers at the University of Toronto found, for example, that Canadian women had significantly fewer contraceptive options than women in the U.S., Britain or France, particularly when it came to new drugs and products – either because they had not been submitted by a drug company, or were working their way through the system. According to the study, the approval process for new drugs at the time was six months longer in Canada than in the U.S., but for six contraceptives analyzed in the Toronto study the mean wait time was nearly 30 months longer. The current example most often cited by experts is an implant contraceptive, Implanon NXT, which is currently available in 86 countries, but not approved for use in Canada.

“We are not able to offer women the best choice for them because it’s not available here,” says University of Ottawa assistant professor Dr. Amanda Black, who chairs the Society of Obstetricians and Gynaecologists of Canada’s Contraception Awareness Program. “Mifepristone is the tip of the iceberg.”

Experts are hesitant to suggest politics is at play when it comes to the delay in approving mifepristone, which the FDA accepted in 2000, despite a significantly more vocal anti-abortion protest movement in the U.S. But “without being privy to internal policies,” says Joel Lexchin, a York University professor who specializes in drug policy and has been critical of Health Canada’s closed-door approach, “it is hard to know whether or not political or religious considerations are a factor.”

Even without outside influence, the current system creates a disadvantage for controversial drugs – such as mifepristone – that would serve a tiny segment of Canada’s already small markets. There’s no prospect of big profits to justify the time-consuming and expensive approval process, which starts at about $350,000 just to make an application. Mifepristone – despite its global reputation as the safer, preferred option – may not be available in Canada because no company has previously applied for approval.

This means that Canadian women who choose to have an early-stage abortion with drugs instead of surgery – perhaps because they don’t want to wait weeks for an appointment, can’t afford to travel to a clinic in an urban centre, or want to avoid public scrutiny at their small town-hospitals – are forced to use a “second-best” drug the World Health Organization doesn’t even recommend, and many doctors are not comfortable prescribing. Often, those women may be poor, or living in northern communities, or belonging to ethnic or faith groups that prohibit abortion. Suzanne Mommersteeg, executive director at Canadians for Choice, says more than 20 per cent of women who contact the organization for information about access to abortion are over the age of 35 and already have children. In those cases, Mommersteeg says, discreet access is particularly important for Muslim women.

When the issues are equity and access, suggests Dr. Wendy Norman, an assistant professor in the medical faculty at the University of British Columbia, who specializes in family planning, then it falls to governments to make the system less onerous for drug companies so that poor or young women with less financial clout, for example, than men who buy Viagra, aren’t denied the best medical options. In France, for instance, the government stepped in when the company applying for approval for mifepristone there tried to withdraw the application because of anti-abortion protests – a proactive measure not adopted by Health Canada, according to experts. (A department spokersperson said the department has no “formal mechanism” for requesting a drug application, and doing so “is at the discretion of the company.”)

But this passive approach, in an area where policy may be influenced by profits and politics, isn’t good enough, Norman argues. “We have a vast area filled with women who don’t have access to adequate and comprehensive reproductive health care,” she says. “Canada is not doing its piece advocating for them.”

 

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