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A Lethal Guardian: The Canadian Government's Ban on Prescription Drugs

Type: Research Studies
Date Published: April 25, 2005
Research Topics:
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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