November 22, 2011 / 4:34 PM / 6 years ago

Canada regulating pharmaceuticals badly: report

OTTAWA (Reuters) - Canada’s health ministry is not regulating pharmaceutical drugs well enough and is slow to address potential safety issues when it identifies them, an official watchdog reported on Tuesday.

Interim Auditor General John Wiersema said Health Canada sometimes takes more than two years to complete an assessment of the risks of drugs already on the market.

It also said the department had not yet figured out what measures were needed to address the potential for conflicts of interest in its reviews of drug submissions.

“Health Canada has not adequately fulfilled its key responsibilities for monitoring the safety of marketed drugs,” the report said.

There are about 13,000 prescription and nonprescription drugs on a Canadian market that was worth around C$28 billion ($26.9 billion) in 2008.

“The department does not take timely action in its regulatory activities ... in particular, (it) is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues,” the report said.

Wiersema said Health Canada had also not acted on a long-standing commitment to disclose more information about the clinical trials it has authorized.

“This increases the risk that Canadians may be unaware of new treatment options or may unknowingly participate in an unauthorized trial,” he said.

Health Minister Leona Aglukkaq said “it is important to note that the report did not question the safety or effectiveness of drugs authorized by Health Canada.”

In a statement, she added: “During the audit period and since that time, we have taken important steps to improve performance.”

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