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Stringent Health Canada requirements restrict access to hormonal implants

Hormonal implants are popular among Europeans but are not available in Canada.

AP

Although Canadian women have access to a wide range of birth control options, there's no one size that fits all. What works for one woman may not work for another, either for personal or cultural or medical reasons.

Other safe, highly effective contraceptives are available to women throughout Europe, South America, Asia and the United States, reproductive health experts say – and Canadian women are missing out.

There's the hormonal implant, popular among teens in Europe, and a more effective mini-pill made by Merck, which has never applied to make it available in Canada. Health Canada's long and stringent approval process for contraceptives may be part of the reason why women's options are more limited here than in other countries.

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Take the hormonal implant, a plastic rod inserted under the skin of the upper arm. The matchstick-sized rod releases progestin for three years, keeping eggs from leaving the ovaries.

Hormonal implants are used in 86 countries, including Australia, Denmark, Germany and Britain. Compared with the pill, implants are cheaper over the long term, easier to use and less likely to result in pregnancy.

The implant is also safe for women who cannot take estrogen. Like IUDs, they are reversible and more than 99-per-cent effective.

So why isn't it available here? Merck, manufacturer of an implant called Nexplanon, recently submitted an application to bring the device to Canada, said Dr. Amanda Black, chair of the contraception awareness program at the Society of Obstetricians and Gynaecologists of Canada. But some of Merck's clinical trial data was not recent enough to satisfy Health Canada, she said.

The device had already been on the market for years, so it wasn't financially feasible for Merck to conduct costly new clinical trials to satisfy the regulatory requirements of a small market such as Canada.

The device is unlikely to enter this country unless the public applies significant pressure on both Merck and Health Canada, Black said. "Basically, it's at an impasse."

Research has shown that unintended pregnancy rates decrease with the use of long-lasting reversible contraceptives such as implants and IUDs. But many teens are wary of IUDs because they're uncomfortable with the idea of having a device inserted into their vaginas, said Dr. Ellen Wiebe, medical director of Willow Women's Clinic in Vancouver.

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A device under the skin is another matter. "My colleagues in Europe say it's the teens who love their implants so much," she said.

Wiebe is one of few Canadian physicians with the skills to remove expired implants from immigrant women who had them inserted elsewhere. "So many of them say, 'I wish I could get my implant [here].'"

Another birth control option available in the U.S. and many European countries, but not in Canada, is Cerazette. The drug is similar to the progestin-only "mini-pill" available here, but is more effective because it doesn't dissipate as quickly in the body. "It's probably a much better pill," Black said.

When she attends meetings with family planning experts in Europe, "they're all shocked that we don't have that one." The pill's manufacturer, Merck, has never applied to bring Cerazette to Canada.

Health Canada approval for contraceptives takes more than two years longer than approval for agents in other drug classes, Black said. This lag time, combined with Health Canada's stringent requirements, may deter manufacturers from submitting applications for new contraceptives, she said. "That limits the options Canadian women have."

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About the Author

Adriana Barton is based in The Globe and Mail’s Vancouver bureau. Her article on growing up with counterculture parents is published in a McGraw-Hill anthology, right after an essay by Margaret Atwood. She wishes her last name didn’t start with B. More

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