The Fraser Institute

The Fraser Institute

September 25, 2013 06:22 ET

Patient Suffering Could Be Reduced by Accepting European or U.S. Prescription Drug Approvals

CALGARY, ALBERTA--(Marketwired - Sept. 25, 2013) - Canadian patients are denied the health benefits of many new medicines for months, if not years, waiting for their government to duplicate approvals already provided in other jurisdictions, concludes a new study published today by the Fraser Institute, an independent, non-partisan Canadian public policy think-tank.

The Case for Mutual Recognition of Drug Approvals points out that nearly all newly-patented prescription drugs approved by Health Canada were also approved by the United States and the European Union - but much earlier. For example, 30 of a group of 31 drugs approved by Health Canada in 2011/2012 were approved by a median of 386 days earlier in the U.S. In Europe, all 31 were approved by a median of 267 days earlier.

"Important new cancer drugs like Avastin and Jevtana were only available to patients in Canada more than a year after receiving marketing approval in either the United States or Europe," said Nadeem Esmail, Fraser Institute director of health policy studies and co-author of the study.

"Such needless delay unquestionably had a negative effect on those patients whose lives could have been extended by these drugs."

The study's authors found that most of the delay in receiving access to new drugs in Canada resulted from pharmaceutical companies submitting their applications for approval significantly later in Canada than they do in Europe and the U.S. Several reasons for this difference in submission may exist, including Canada's relatively weaker intellectual property protections, small market size, drug pricing controls, as well as the extra financial burden associated with additional regulatory hurdles.

The European Union, with a population of over 500 million, tests and approves new medicines through the European Medicines Agency or through individual national approval and a European mutual recognition process. Drug approval in the United States, for a population of over 300 million, is carried out by the Food and Drug Administration. In Canada, with a population of nearly 35 million, new medicines are approved only after testing by Health Canada.

Given that Health Canada's process for approving drugs is not significantly different from those used in Europe or the United States there is little justification for forcing patients to wait for access to medicines already approved for use in the United States and Europe.

"If Canada accepted European and American approvals instead of duplicating their processes, patients in Canada could have received access to 152 new pharmaceutical therapies a median of 494 days earlier between 2005 and 2011/12."

Esmail and co-author Bacchus Barua point out that relieving Health Canada of its mandatory drug regulation function will not prevent the agency from providing safety warnings or requiring a withdrawal of a drug from the Canadian marketplace. Canadian approvals could also still be done on a non-mandatory basis, with drugs approved in the U.S. or Europe being subject to a labeling requirement.

More importantly, such an approach opens up new possibilities for the federal agency. First, more support could be provided for surveillance of drugs that have already been approved. Secondly, funding better communications about prescription drugs and their side effects to both patients and physicians would allow everyone to make more informed decisions.

"The result of accepting European and FDA approvals for market access in Canada would be faster access to the important health benefits created by new drugs, paired with a higher level of information about the potential risk/benefit tradeoffs associated with each for Canadian patients and physicians," 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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