2014-081
September 18, 2014
Health Canada recognizes that confidence and transparency are important in the decisions made that affect the health and safety of Canadians.
That is why it has recently changed the way it operates to make more information publicly available than ever before through the Openness and Transparency Framework, announced by Minister Ambrose in April 2014.
Not only has Health Canada begun regularly posting practical, world-leading drug safety review summaries online, but it has also accelerated the implementation of additional transparency initiatives related to this framework.
For example, the inspection report of GSK's Quebec facility was made public earlier this year, and Health Canada plans to regularly post information on inspections of companies and facilities including inspection dates, findings, and actions that result. Annual reports that summarize these results are also already being made available which contain statistics on the overall inspection program and examples of observations.
With regard to Apotex specifically referenced in earlier Toronto Star reports, Health Canada contacted the company shortly after learning that safety issues had been identified to request that they stop selling these products. Apotex did not agree. The company subsequently identified actions it had undertaken to mitigate these safety concerns, and agreed to additional safety testing to confirm the safety of its products. Health Canada has also since conducted a follow-up inspection. At no time have we received evidence that the drug products' safety has been compromised.
New powers proposed in Vanessa's Law (Bill C-17) will give the Minister of Health the tools to better respond to drug safety issues including powers to order mandatory recalls of unsafe drugs so that Health Canada does not have to negotiate with companies when safety issues are identified, tough new fines for companies who put Canadians at risk, and the authorities required to publish even more data on drug reviews and clinical trials.
Health Canada has strong measures in place to ensure that the drugs in Canada are safe, it is making more information publicly available than ever before, and will never hesitate to take action to protect the health and safety of Canadians.
Dr. Supriya Sharma
Senior Medical Advisor
Health Products and Food Branch
Health Canada
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