Ottawa, 22 November 2011—Health Canada is fulfilling some of its key responsibilities in regulating pharmaceutical drugs for use in Canada, but is struggling with the timeliness and the transparency of some of its activities, says John Wiersema, Interim Auditor General of Canada, in his Report tabled today in the House of Commons.
“Canadians rely on Health Canada to ensure the safety and effectiveness of drugs,” said Mr. Wiersema. “And Health Canada has taken steps to ensure the quality of its drug reviews.”
The audit found that Health Canada has increased the amount of information it discloses on approved drugs. However, it does not provide information on rejected submissions, on drugs withdrawn by manufacturers from the review process or on the status of drugs approved with conditions. Also, it has not delivered on its long-standing commitment to disclose more information about authorized clinical trials.
Health Canada is actively monitoring the safety of drugs already on the market, but is slow to assess the potential safety issues that it identifies. It sometimes takes more than two years to complete an assessment and provide Canadians with updated safety information.
In addition, Health Canada has not determined what measures are needed to address the potential for conflicts of interest in its reviews of drug submissions.
“Health Canada is slow to act on potential safety issues related to drugs already on the market,” said Mr. Wiersema. “It needs to get safety information out to Canadians more quickly, and address the potential for conflict of interest.”
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The chapter “Regulating Pharmaceutical Drugs—Health Canada” is available on the Office of the Auditor General of Canada website.
