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Letting the genie out of the bottle: 23andMe expands to Canada

Guest post from Olivia Lee, law student turned medical student at the University of Ottawa, and former policy intern with Genome Canada.

On Wednesday October 1st, 23andMe, American pioneer in direct-to-consumer genetic testing services, announced that it now offers exclusive health and ancestry services to the Canadian market through 23andMe.ca. The announcement comes a year after the US Food and Drug Administration (FDA) issued a warning letter to the company, instructing it to cease providing unreliable health information that could potentially lead consumers to misinformed decisions regarding their health. Effectively forced to limit its services to genealogical information, the company has set sights north of the boarder to Canadian consumers, 20 000 of whom have already sought 23andMe’s genomic based “health reports.” Its expansion into a market without genetic discrimination laws nor specific direct to consumer genetic testing regulations seems to be a promising solution for a company looking to overcome regulatory setbacks.

23andMe’s official arrival onto the Canadian market comes at the same time that a law that would prohibit genetic discrimination is being reviewed by Federal law-makers.
Bill S-201, which seeks to limit insurers and employers from having access to genetic test results was introduced last year in the Senate and has recently been referred to the Standing Senate Committee on Human Rights. In response, various stakeholders, including the Office of the Privacy Commissioner (OPC) and the Canadian Life and Health Insurance Association (CLHIA), have released position statements to inform the legislative debate. While the Privacy Commissioner recommends to life and health insurers not to request and rely on genetic tests results, which may be an unreasonable breach of privacy, CLIHA continues to hold that insurers need to have access to genetic tests of which applicants are aware, in order to properly assess risk.

While The Genetic Information Nondiscrimination Act (known as GINA) in the United States protects American consumers from having to submit genetic test results to insurers and employers, no such legislation currently exists in Canada. As such, Canadian consumers should be particularly well informed about their insurance policy before opting to purchase 23andMe’s services. While receiving such genomic-based information may encourage some consumers to be more engaged with their health care, there will also be instances when physicians and genetic counsellors will be faced with the challenge of interpreting these test results and informing patients about their true implication. This could be a daunting challenge for these professionals since some results may have very little relevance for clinical decisions.

As 23andMe paves the way for more direct to consumer genetic testing companies to penetrate the Canadian market, legislators can no longer leave concerns for genetic discrimination on the backburner. In the meantime, it is critical to inform consumers as well as health professionals about the nature of direct to consumer genetic tests, and their implications.

Letting the genie out of the bottle: 23andMe expands to Canada

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