The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine. The Bureau concluded that there
July 2019
Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products
By Christopher A. Guerreiro on
As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health…
Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products
Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between …
Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis
The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the…