Canadian Drug Approval Delays Blamed for 'Hundreds of Deaths'

Canadian free-market policy organisation the Fraser Institute has issued a scathing report on the country's drug approval procedures, which it claims are "implicated in the deaths of hundreds of Canadians annually."

The report, titled "A Lethal Guardian," highlights the Canadian government's practice of enforcing an automatic ban on all drugs pending marketing approval. Although the ban is lifted for some patients in extraordinary circumstances, safety and efficacy studies by Health Canada are now delaying launches of life-saving drugs by a median of two years.

The study's authors also claim that despite a similar regulatory burden in comparable markets, countries such as the UK lift the ban by an average six months faster than Canada. Further, the study suggests that Health Canada's adoption of user fees on marketing applications will not improve accountability or hasten safe drug approvals as hoped.

Although the study declines to place precise estimates on the loss of life alleged to have occurred as a result of the delays, it recommends improvements to local recognition of approvals in other regulated markets, with Health Canada removing bans following similar action by agencies in markets such as the US, the UK and Australia.

In this scenario, Health Canada would retain the right to impose labels stating that a drug is unapproved. Manufacturers would then be obliged to pay a fee to have the labelling removed after thorough safety and efficacy studies by health authorities.