The Fraser Institute

The Fraser Institute

April 25, 2013 06:32 ET

The Fraser Institute: Health Canada Approvals for New Medicines Slower Than in Europe and U.S.

CALGARY, ALBERTA--(Marketwired - April 25, 2013) - It takes Health Canada nearly a year to grant marketing approval to prescription drugs while new medicines are often approved faster in Europe and the United States, according to a new report from the Fraser Institute, an independent, non-partisan Canadian public policy think-tank.

Federal Delays in Approving New Medicines calculates that Health Canada took a median of 355 days to issue a Notice of Compliance certifying new patented medicines as safe and effective in 2011.

"These new drugs have already passed extensive clinical trials in accordance with international safety standards, and are reviewed by European and American agencies for safety and efficacy. But Health Canada holds them in bureaucratic limbo, often for more than a year," said Nadeem Esmail, Fraser Institute director of health policy studies and co-author of the report.

"This raises important questions about whether the drug evaluation system in this country is beneficial or detrimental to Canadians."

The report shows that every year from 2007 to 2010, Health Canada took longer than its European counterpart, the European Medicines Agency (EMA), to approve new drugs; the largest gap was in 2010, when Health Canada approval was 448 days compared to 319 at the EMA. Health Canada was just 10 days faster than the EMA in 2011.

Health Canada also took longer to approve new medicines than the U.S. Food and Drug Administration (FDA) in four out of five years from 2007 to 2011; the largest gap was again in 2010, when Health Canada approval was 448 days compared to 299 at the FDA.

Critically, Canadians do not have access to new medicines until they have received a Notice of Compliance certifying that Health Canada considers the new medicine safe for public use. A similar process is followed in Europe and the United States.

The report suggests that Canada's federal government could improve access to new medicines through harmonization and mutual recognition with international regulatory agencies.

"Specifically, FDA or EMA approval decisions could be accepted as equivalent to Health Canada decisions, thus reducing the cost of drug approvals in Canada for both taxpayers and drug manufacturers, while simultaneously speeding Canadians' access to new medicines," Esmail said.

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The Fraser Institute is an independent Canadian public policy research and educational organization with offices in Vancouver, Calgary, Toronto, and Montreal and ties to a global network of 86 think-tanks. Its mission is to measure, study, and communicate the impact of competitive markets and government intervention on the welfare of individuals. To protect the Institute's independence, it does not accept grants from governments or contracts for research. Visit

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