When any new drug is invented and ready for distribution in Canada, the Canadian government responds by enforcing an automatic ban on its use. This ban is removed for patients who need the drug immediately only under extraordinary circumstances. The general ban is only lifted after the manufacturer has paid a user fee and waited for Health Canada to undertake a lengthy review to certify the safety and efficacy of the medicine. This ban is harmful to Canadians’ health and is implicated in the deaths of hundreds of Canadians annually.
Although we cannot estimate the precise number of fatalities due to this untimely lack of new medicines, international evidence going back three decades supports the conclusion that any decrease in negative health outcomes resulting from avoiding the harmful side effects of new medicines is off-set many times over by the lost positive outcomes that would have occurred had the government allowed patients and health professionals to use new drugs sooner.
The time it takes Health Canada to lift its ban on new drugs is very long and, in fact, is increasing as time goes on. In 2002, the median time to remove this ban in Canada was two years. Yet, in 1997, it took just over 16 months. Therefore, the time to remove the prohibition has lengthened by 50% over the five-year period measured.