TORONTO, ON—The process for reviewing and approving new cancer drugs in Canada takes almost twice as long as that in the United States and is longer than the approval times in Europe, concludes a new report from the Fraser Institute, Canada’s leading public policy think-tank.
The result has Canadians waiting significantly longer for new, potentially life-saving cancer drugs.
"Cancer is the leading cause of premature death in Canada. Unfortunately, the review and approval process for new cancer-fighting medications is unnecessarily longer in Canada than other industrialized countries," said Dr. Nigel Rawson, Fraser Institute senior fellow and author of Access to New Oncology Drugs in Canada Compared with the United States and Europe.
"Why are review times longer in Canada than in the United States and Europe? This raises serious questions as to whether the drug evaluation system in this country is beneficial or detrimental to Canadians with cancer."
Access to New Oncology Drugs in Canada Compared with the United States and Europe compares the amount of time that it took to approve each of the 33 new cancer medications that received market approval in Canada, the United States, and the European Community between 2003 and 2011. In addition, the report notes whether or not these new oncology drugs were approved for public reimbursement under provincial government insurance programs.
Of the 33 oncology drugs slated for market approval between 2003 and 2011, 30 were approved in the United States, 26 in the European Community, and just 24 in Canada. With the exception of one medication, Health Canada took longer to approve every new cancer drug than the U.S. FDA, where the median review time was 182 days compared to 356 days in Canada.
Furthermore, 25 of the 30 drugs approved by the American FDA between 2003 and 2011 received an expedited review, compared with only eight of the 24 drugs approved by Health Canada that received a priority review.
"Even then, expedited products in the United States had a median review time of six months, whereas Canadian priority review took close to a year," Rawson said.
"Making matters worse is that once a drug has finally been approved by Health Canada, patients more often than not discover that the medication is not covered under their public drug plan."
By the end of March 2012, only three of the 24 drugs approved in Canada since 2003 were covered to some degree by government insurance in all 10 provinces, while seven others had government-subsidized access in some provinces. Most importantly, almost 60 per cent were not covered under public drug plans in any province.
In order to ensure that Canadians have timely access to new oncology drugs already approved in the United States and Europe, the report suggests that Health Canada be required to monitor approvals in those countries. If a drug is not approved in Canada within a certain period (e.g., 90 days) of the American or European approval dates then Health Canada should be required to report to Parliament on the reasons for the delay.