Author
Dr. Nigel SB Rawson, Ph.D.
Introduction
Before any new drug can be sold in Canada, it must be approved as safe and effective by Health Canada. Research shows that the wait for new drug approval in Canada has tended to be longer than in other jurisdictions. However, Health Canada’s performance has been improving in recent years and the regulatory delays affecting access to new drugs have shortened substantially in Canada. Some experts have been critical of Health Canada’s efforts to achieve more timely regulatory approval of new drugs and have argued that shorter review times will result in lower quality assurance for drug safety. This paper presents new evidence to examine whether, in fact, faster drug approvals have resulted in increased discontinuations of new drug products from the market for a safety reason.
Objective
To compare review times of new drugs approved Canada and Europe over a 10-year period (2003-2012) and the rate of drugs discontinued for safety reasons.
Data
Data were obtained from Health Canada and the European Medicines Agency.
Results
Over the 10-year period from 2003 to 2012, 186 new therapeutic drug products were approved by Health Canada compared with 189 by the European Medicines Agency. The median approval delay for the new drugs approved in Canada was 391 days compared with 338 days for new drugs approved in Europe. However, the rate of discontinuation of these new drugs for safety reasons was 1.6% in both jurisdictions. A comparison of jurisdictional experience between consecutive five-year periods showed that the Canadian median review time exceeded the European median by more than 100 days in drugs approved between 2003 and 2007 (503 days versus 349 days), but between 2008 and 2012, the Canadian median delay was only 15 days longer than the European median (353 days versus 338 days). Between the 2003-07 and 2008-12 periods, major decreases were seen in the Canadian median review times for drugs in the biotechnology (467 days), cardiovascular (218 days), endocrine and metabolic (202 days), and “other” categories (252 days). Despite shorter review times in Canada in 2008-12, none of the drugs approved during this period in either jurisdiction had been discontinued for a safety reason as of the end of June 2014, at which time they had a minimum of 18 months post-approval time. The rate of discontinuation in drugs approved in the 2003-07 period among products with a minimum of 18 months of post-approval time was also virtually the same in Canada (2.2%) and Europe (2.1%), in spite of the longer approval times in Canada during the period.
Conclusions
The wait for new drug approvals in Canada has been persistently longer than in Europe. However, new drug approval times in the two jurisdictions in the last five years grew closer than in the previous period due to Health Canada reducing its regulatory delays. Contrary to the suggestion that decreasing drug review times increases the risk of safety issues, the evidence shows that faster drug approval times in Canada were associated with a reduction in the rate of drugs discontinued for safety reasons versus the previous period (falling from 2.2% in 2003-07 to 0% in 2008-12). In addition, despite Europe having faster drug approval times than Canada throughout the decade, the rate of discontinuation for safety reasons was no higher in Europe than in Canada in any period. This means that the added drug approval delay in Canada achieved no extra assurance of safety but imposed a cost on Canadian patients who were forced to forego the potential health benefits that could have been gained from earlier access to new drugs.
