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Health Canada responds to concerns about therapeutic product regulatory modernization technical discussions
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Letter to the Editor
2011-09
January 21, 2011
OTTAWA - This letter is in response to concerns voiced by some regarding ongoing stakeholder discussions on proposals to update and strengthen drug safety in Canada.
Despite claims to the contrary, Health Canada is developing proposals to substantially strengthen drug safety legislation and regulations in Canada.
As part of this work, Health Canada has been holding regulatory technical discussions with a broad range of stakeholders, including patient and consumer advocates, academics, health professionals, and industry.
This work is focused on improving safety surveillance once a drug is on the market. But it will not compromise or weaken - in any way - the rigorous, world-class safety standards Health Canada currently applies before a drug can be authorized for sale to Canadians.
Companies will always be required to demonstrate that a therapeutic product's benefits outweigh its risks before it is authorized. In considering improvements to current legislation and regulation, we recognize that clinical trials are effective, but there are rare cases where problems emerge only after a drug's been taken by a greater number of patients following approval.
As a result, ideas are being proposed in these workshops to stimulate discussion with stakeholders on more effective ways to monitor the safety of drugs not only during clinical trials but also after they're authorized for sale.
As part of these proposals, no consideration is being given to lifting current restrictions on direct to consumer advertising. If anything steps will taken to strengthen it in the future.
On the consultation process itself, sessions being held in Ottawa January 19-21 are not the final step.
The Department plans on holding further discussions with health professional and patient and consumer groups.
In all, these discussions are designed to test important concepts before making formal proposals through the Canada Gazette process which allows all Canadians to comment and provide feedback.
Helping Canadians maintain and improve their health is Health Canada's mandate. These discussions and the legislative and regulatory proposals that may arise from them would enhance our capacity to fulfill that important role.
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