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Canada finally opens up data on new drugs and devices

BMJ 2019; 365 doi: (Published 17 April 2019) Cite this as: BMJ 2019;365:l1825
  1. Joel Lexchin, professor emeritus1,
  2. Matthew Herder, associate professor2,
  3. Peter Doshi, assistant professor3
  1. 1School of Health Policy and Management, York University, Toronto, ON, Canada
  2. 2Health Law Institute, Faculties of Medicine and Law, Dalhousie University, Halifax, NS, Canada
  3. 3University of Maryland School of Pharmacy, Baltimore MD, USA
  1. Correspondence to: J Lexchin jlexchin{at}

Other regulators should take note of Health Canada’s substantive reforms

More than four years after the Canadian parliament passed legislation to make clinical information about drugs and devices publicly available, the federal regulator Health Canada has finalised regulations1 and begun publishing information on its website.2 The proactive release of information about new therapeutic products, including drugs, biological treatments and medical devices, after they have been either approved or rejected will be phased in over the next four years, starting with new chemical entities. In addition, Health Canada will now release on request similar information about drugs and devices already on the market.

This level of transparency represents a fundamental shift in how Health Canada handles clinical trial information, including detailed clinical study reports. Previously, Health Canada maintained that such information must be kept confidential despite clear flexibilities in the law to allow greater transparency.3 As early as 2000, Health Canada’s own science advisory board called the “current drug review process … unnecessarily opaque,” saying it was “inconsistent with public expectation and contributes to a public cynicism about the integrity of the process.”4

Decades of …

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