Health Canada has approved more than 10,000 prescription drugs for use across the country, but the federal health department does not have the power to recall a single one if it is found to be unsafe.

That little-known but long-standing regulatory flaw — first raised after the thalidomide tragedy of the 1960s, when more than 100 Canadian babies were born with malformed limbs — was recently highlighted again in a government-commissioned report on faulty birth control pills.

Related: Health Canada and Thalidomide: 'If the government had acted, this would never have happened’

Canadian laws empower regulators to recall bad toys, tools, cleaning supplies, clothing and food, but not bad drugs. That job is left almost entirely up to manufacturers and distributors.

“People overestimate what the drug regulatory agency is doing,” said Trudo Lemmens, Chair in Health Law and Policy at the University of Toronto.

Health Canada cannot order but only “negotiate” with manufacturers for a drug recall — a process that can last months or years.

“It doesn’t make any sense,” said Dr. David Juurlink, a clinical pharmacologist and drug safety researcher at Sunnybrook Health Sciences Centre. “Why should there be a negotiation with the company?”

As reports of adverse drug reactions skyrocket — new Canadian data obtained by the Toronto Star shows a nearly 800 per cent increase from 1998 to 2011 — doctors, health policy experts and consumers are calling on Ottawa to revise the archaic Food and Drugs Act, which lays out the regulator’s roles in keeping Canadians safe.

“Although one would hope a commercial company would act appropriately, I don’t know that you can always rely on them to do so,” says Dr. Joel Lexchin, a health policy professor at York University who has just completed a second study of drugs withdrawn from the Canadian market for safety reasons, to be published shortly in Open Medicine.

“Safety around drugs is something that should be a public responsibility, not the responsibility of a private, for-profit company,” Lexchin said. “To use Stephen Harper’s phrase, this is a no-brainer.”

Mercédes Benegbi was born with no arms, her fingers attached to her shoulders. She has undergone several surgeries to correct toes that grew inside her feet instead of straight out.

The 51-year-old Montreal woman is one of 96 officially recognized Canadian-born survivors of thalidomide, a sedative prescribed for morning sickness in pregnant women that caused congenital malformations in babies.

“If such a tragedy could not change this … I don’t know what it will take,” Benegbi told the Star.

“It’s a shame for our country.”

The drug stayed on the market in Canada for three months after countries in Europe ordered it withdrawn. It was an unforgiveable delay, says Benegbi, who is executive director of the Thalidomide Victims Association of Canada.

Worse, perhaps, is that even after the regulatory agency realized the limits of its laws in protecting Canadians from dangerous drugs, nothing has been done to fix the problem.

“Although the Food and Drugs Act of 1953 provided authority to define by regulations the conditions of sale of a drug, no direct authority was provided to prohibit the sale of a drug,” L. I. Pugsley, the former deputy director-general of Health Canada’s Food and Drug Directorate wrote in a 1967 edition of the Medical Services Journal.

Health Canada temporarily banned the sale of thalidomide, but the law was never amended so that the regulator could act more swiftly and unilaterally to prevent future tragedies.

Three weeks ago, the Star reported on Diane-35, a controversial acne pill that has been the subject of worldwide safety reviews after France suspended sales. France found the drug was being prescribed mostly off-label for birth control, putting women at increased risk of severe and sometimes fatal blood clotting. Diane-35 is suspected of causing fatal blood clots in at least 13 young Canadian women, most of them teenagers.

Though Health Canada concluded the benefits of the drug outweigh its risks, the department has since confirmed it could not order the drug to be pulled from shelves even if it wanted to.

“The Food and Drugs Act does not provide Health Canada the legislative powers to compel a recall,” department spokesman Sean Upton said.

There has been little public pressure to change the Act, primarily because so few Canadians realize how the system actually works.

The public has “several critical misunderstandings” about the government’s regulatory responsibilities, according to a government-commissioned review of Health Canada actions in the recent recall of Alysena-28, a generic birth control that contained too many placebos and too few doses of active medication.

“These include the assumption that Health Canada is responsible for, and has the authority to, order drug recalls,” the report states.

“It is alarming and I don’t think it’s well understood,” said Matthew Herder, assistant professor at Dalhousie University’s Faculty of Medicine, who participated in federal government discussions on modernizing the Food and Drugs Act several years ago.

The department’s lack of authority to pull drugs from the market was news even to Dr. Jennifer Blake, chief executive officer at Society of Obstetricians and Gynecologists of Canada.

“Also, what was news to me is that drug manufacturers don’t have to inform Health Canada (about the problem) until after they’ve made a decision to recall,” which is what happened with Alysena-28. Apotex notified wholesalers and distributors first. Patients who were taking the faulty drug didn’t learn about the problem for another five days, when media began reporting the story.

A class-action lawsuit against Apotex claims the faulty pills caused “40 unwanted pregnancies and four abortions,” according to the review.

Twenty-three adverse reaction reports citing unplanned pregnancy were filed with Health Canada.

The government-commissioned review, released in September by Risk Sciences International in Ottawa, urged the federal department to strengthen its recall authority for pharmaceutical products.

The report criticized the drug regulator’s lack of “robust oversight.” It noted that the Canadian Food Inspection Agency Act and the Canadian Consumer Product Safety Act both include defined powers for the government to order recalls of products that pose an unacceptable risk.

“The Canadian public expects Health Canada would have the ability to go in, and, like a restaurant inspector, shut it down,” Blake said. “I think that’s exactly what we want them to have.”

A total of 23 prescription medications — notably the painkiller Vioxx, the anti-depressant Serzone and the diet drug Meridia — approved for use in Canada since 1991 have been withdrawn permanently for safety reasons, according to Health Canada and data compiled by Lexchin at York University.

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In most cases, companies were credited with pulling the drugs voluntarily, typically after international post-market studies showed evidence of serious harm. In all cases, Health Canada’s power was and remains limited to simply “requesting” the manufacturer review the evidence and consider pulling the product from shelves.

The pharmaceutical industry supports updating the Food and Drugs Act, but not unilateral authority for Health Canada to pull unsafe drugs.

As it stands, the regulator and a manufacturer can negotiate a variety of options. An advisory or safety warning may be issued. This is typically the first step. Product monographs and labeling may also be revised. Withdrawing a drug from the market is a last-resort measure.

“Patient safety is the first priority of Canada’s research-based pharmaceutical industry,” said Russell Williams, president, Rx&D in a written statement to the Star. Recalls are only one of several “escalating responses” drug companies take when a drug problem has been identified, he said. “To this end any proposed legislation should direct Health Canada to continue to pursue the possibility of mutually acceptable voluntary undertakings before resorting to the power to recall. In exceptional circumstances where there is disagreement, a rapid means of dispute resolution should be available.”

Lexchin’s upcoming study in Open Medicine analyzes the length of time that passed after a drug was approved for sale in Canada, the issuance of its first serious safety warning and its ultimate withdrawal from market.

In nearly half of the cases, there was no prior public safety warning.

While Health Canada has no recall power, there are regulations within the Act that allow the minister to take some action on problem medications, but it’s a drawn-out process that exposes the public to potentially dangerous drugs while the government evaluates them.

This has happened at least twice.

First in 2005 with Adderall XR, a drug used to treat attention deficit hyperactivity disorder in children.

Based on a preliminary review of international data that Adderall’s use was associated with increased risk of sudden or cardiac death and stroke, Health Canada took the rare step of invoking a regulation that empowers the minister to suspend “for a definite or indefinite period” an unsafe drug’s marketing approval.

The drug returned to market four months later, after Shire BioChem Inc. asked Health Canada to appoint a new, independent drug committee to re-assess the data.

The committee found there was “insufficient evidence” that Adderall carried a greater risk of fatality or stroke in children than other ADHD treatments.

A Toronto Star investigation has since analyzed nearly 600 adverse reaction reports associated with the medications and found Health Canada failing to act on red flags in its own database.

More recently, Health Canada used another regulation to review safety evidence for Miacalcin and its generics — a nasal spray it approved in 1983 to treat osteoporosis in post-menopausal women.

The European Medicines Agency advised doctors to stop prescribing the nasal spray in July 2012 after it was linked to an increased risk of cancer.

In January 2013, Health Canada invoked a regulation that permitted it to ask manufacturers of the spray to turn over their benefit-risk assessments of the drug. For a drug to retain market approval, clinical evidence must show that its benefits outweigh its risks. Just last month, the drug was withdrawn.

Between 3.5 per cent and 4.5 per cent of drugs Health Canada approves for market end up withdrawn, Lexchin’s research has found. It’s a figure that’s on par with the United States, where the Food and Drug Administration also lacks the legal authority to recall drugs.

Does this mean the system, if flawed, is working? Are there more drugs that should be removed, and quickly?

“That question you really can’t answer from this data,” Lexchin said.

“It can really only be answered by getting access to Health Canada information that looks at how they make decisions about withdrawing drugs. And you won’t get it. It’s confidential.”