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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.
Although other developed countries have similar regulatory
burdens, they take much less time to lift their bans on new
medicines. In 2001, the Canadian government took eight months
longer, at the median, than the United States to lift its
prohibitions. During the three years from 1999 through 2001,
Sweden lifted its bans seven months faster than Canada did, while
the United Kingdom acted almost one-half year faster and
Australia acted three months faster.
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