News Release

2005-68
June 28, 2005
For immediate release

Achieving a Mandatory System for Reporting Serious Adverse Reactions

OTTAWA - Health Minister Ujjal Dosanjh today announced Health Canada's intention to hold consultations on developing a mandatory system for reporting adverse reactions.

"We are committed to increasing the safety of health products available to Canadians," said Minister Dosanjh. "Consistent adverse reaction reporting by health-care professionals will provide consumers, governments and health-care professionals with important information that will enhance the safety of health products available to Canadians."

To begin this process, a discussion paper entitled, Designing a Mandatory System for Reporting Serious Adverse Reactions , has been posted on Health Canada's web site. The Department invites all interested stakeholders and the public to review the document and provide feedback. Face-to-face consultations with stakeholders and the public will be held later this summer.

The discussion paper contains information on the current reporting system, the known barriers to reporting, and the fact that only a small number of adverse reactions are in fact reported. The discussion paper provides basic information to generate discussion on how to best develop and implement a mandatory reporting system.

"We need to deal with the under-reporting problem in a fair, balanced and responsible way," the Minister added. "By consulting with our provincial counterparts, health professionals and Canadians, we will arrive at a solution that protects Canadians and deals effectively with the various issues around reporting."

Currently, adverse reaction reporting by health professionals is voluntary, unlike the mandatory reporting of serious adverse reactions that is required of manufacturers. Yet health professionals are in an ideal position to observe adverse reactions experienced by their patients and to report them in a clear and scientific way.

"The design for reporting adverse reactions cannot put an undue burden on our health care professionals," said Minister Dosanjh. "We must take time to consider the issues raised in this discussion paper in order to arrive at the best possible solution that has the welfare of Canadians at its heart."

The discussion paper and instructions on how to send written feedback can be found at www.hc-sc.gc.ca/dhp-mps/advers_react_neg/index_e.html
Details about the summer consultations will be made available once they are finalized.

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