The Canadian government is proposing a new “Agile Licensing” framework to expedite pre-market regulation of pharmaceuticals. While Health Minister Jean-Yves Duclos claims this is part of the government’s strategy to offer Canadians “access to quality and affordable medicines,” the policy is likely to cause more harm than good.
Adoption of Agile Licensing would allow companies to market drugs up to six months earlier than under the current system. Fewer pre-market clinical trials would be required as long as firms continue studying their drugs’ effectiveness after they are already in use.
The government suggests this new approach will significantly improve Canadians’ quality of life, estimating the value of this improvement at $302 million over ten years. However, the assumptions behind this estimate are flawed.
