Health Council of Canada weighs in on drug safety in Canada
OTTAWA, Nov. 7, 2012 /CNW/ – Today the Health Council of Canada is
appearing before the Standing Senate Committee on Social Affairs,
Science and Technology to make recommendations on the post-approval
monitoring of prescription pharmaceuticals in Canada.
Health Council representatives include Dr. Ingrid Sketris, Councillor
and pharmacist, and John G. Abbott, CEO.
“We’re pleased to see the Senate Committee tackle this important issue”
said Abbott. “We hope our input can contribute to a better
understanding of the need for improved vigilance to protect Canadians
once medications are in the marketplace.”
The committee will be discussing issues such as (but not limited to) the
process to approve prescription drugs, the post-approval monitoring of
these drugs, and unintended consequences or adverse reactions
associated with prescription drugs. In 2010, the Health Council issued
a discussion paper on drug safety called, Keeping an Eye on Prescription Drugs: Keeping Canadians Safe. The paper showed that the number of people exposed to unsafe drugs has
been increasing, and that Canadians are often not aware of the risks
associated with certain prescription drugs.
“Because drugs are approved based on pre-marketing clinical trials with
selected populations and relatively short durations, it is extremely
important to continue monitoring to determine the benefit/risk balance
after a drug becomes available for sale,” said Sketris. “We need to
develop a better, more efficient and open way to ensure better patient
The Health Council’s paper found that Health Canada has limited
authority to deal with post market safety issues. They cannot require
companies to conduct post market studies after the product has been
approved unless significant new safety issues have been identified. And
although they have the authority to order drugs to be withdrawn from
the market, they rarely exercise this power or tend to do so slowly.
Recent media reports show this to be a continuing issue.
The Health Council paper made a number of recommendations to improve
post-market monitoring of drugs in Canada. These will be the subject of
discussion at today’s senate hearing.
About the Health Council of Canada
Created by the 2003 First Ministers’ Accord on Health Care Renewal, the Health Council of Canada is an independent national agency that
reports on the progress of health care renewal. The Council provides a
system-wide perspective on health care reform in Canada, and
disseminates information on leading practices and innovation across the
country. The Councillors are appointed by the participating provincial
and territorial governments and the Government of Canada.
SOURCE Health Council of Canada