Manufacturers, patient groups support Ottawa's new drug safety proposals
Last Updated: Thursday, April 10, 2008 | 12:40 PM ET
CBC News
Federal government proposals to change the way drug safety is monitored in Canada have drawn praise from manufacturers and patient groups.
On Tuesday, consumer safety legislation was tabled in the House of Commons that includes requirements for health-care institutions to report adverse drug reactions, demands continuing surveillance of drugs after they've been approved and raises fines for unsafe drugs from $5,000 to a minimum of $5 million.
While some experts say the new rules will improve the government's ability to protect the public, critics say it has the potential to expose Canadians to more risk.
Dr. Joel Lexchin, a York University professor in Toronto, says he's concerned that the bill would give the federal health minister the ability to fast-track drug approvals.
"Eighty-five-year-old women that are already on five drugs, maybe they'll be fine, but they might also have serious side-effects," he told CBC News.
Right now, the government can accelerate drug approvals by issuing what's called "a notice of compliance with conditions."
Russell Williams, president of Canada's Research-Based Pharmaceutical Companies, says that Canada's move is in line with other countries and shouldn't be viewed as fast-tracking.
"This issue is about ensuring that patients in Canada have the same timely and safe access to medicines as patients have in Europe and in the U.S," he said.
Louise Binder, chair of the Canadian Treatment Action Council and a member of other patient groups that advocate for timely access to medical treatments, says she's living proof that sometimes that's necessary.
"I happen to have HIV. If I had had to wait for years and years of clinical trials to prove that some of the anti-retroviral drugs were good — I and many other Canadians would be dead."
Binder says it's impossible to run clinical trials that are large enough to prove a drug is safe for everyone.
She believes the government's proposal to aggressively track drugs after they're approved makes more sense.
Russell agrees. "Although the rules in place are stringent, the federal government is recognizing the need to continually evaluate the benefit/risk profile of medicines throughout their life cycle," he said.
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