Canadian officials are batting down critics who say that the country's new, streamlined drug approval process will let unsafe therapies onto the market. The dispute centers on Canada's new standard for drug approval: The benefits offered by a new drug have to outweigh the harm it does. And critics see the shift as a significant retreat from earlier safety standards. The changes come as Health Canada adopts a "progressive licensing" approach, which calls for ongoing trials both before and after approvals to judge the safety of new therapies.
"I think that's a pretty dangerous thing to be doing," Joel Lexchin, a health policy professor at York University and drug safety expert tells the Globe and Mail. "This is part of a general trend in a lot of countries, at least with respect to the drug-approval system, [which] is deregulation, turning over more responsibility to the drug companies."
- read the article in the Globe and Mail
Canadian regulators forging new biosimilar pathway
Canada's drug market slowing