2022-23 Operating context

For the better part of two years now, Canadians have endured the disruption and uncertainty occasioned by a once-in-a-century, global pandemic. COVID-19 has wreaked havoc with every aspect of our daily lives and spared no segment of society. Governments at the federal, provincial and territorial level have scrambled to mobilize resources and reprioritize their policies in order to meet the challenges posed by the pandemic and shield their populations from its most harmful effects.

At the federal level, one of the policies that has taken a necessary backseat to COVID related priorities during this time has been the Government’s longstanding commitment to strengthen and modernize the PMPRB’s regulatory framework through amendments to the Patented Medicines Regulations. These amendments were originally slated to come into force in July of 2020. However, in order to avoid the imposition of a new administrative burden on the pharmaceutical industry in the midst of the pandemic, the Government has postponed their coming into force until, most recently, July of 2022.

Internationally, the pandemic has served as catalyst for an unprecedented overhaul of the biopharmaceutical pricing and access landscape, the momentum for which has been building since 2019. Countries are increasingly looking at pharmaceuticals through a national security lens and political imperatives are driving policy priorities like never before. 

While the PMPRB is eager to turn the page on the multiyear effort to reform to its regulatory framework, it recognizes the fluid and rapidly evolving context in which these reforms are taking place. With the regulatory amendments now tentatively slated to come into force in July of 2022, and the possibility of further extension on the horizon depending on the evolving state of the pandemic and emerging policy priorities, the PMPRB is in somewhat of a holding pattern for the foreseeable future in terms of any priority setting exercise.