On August 21, 2019, the Government of Canada published
amendments to the Patented Medicines Regulations that set
out the long-awaited framework applicable to the price regulation
of patented drugs in Canada. The amendments will come into force on
July 1, 2020, and the text can be found here.
Below is a brief background on the Patented Medicine Prices
Review Board (the "PMPRB" or the "Board"), four
key changes to the Regulations, including differences from
the originally proposed text, and developments to watch for
regarding the amendments.
1. Background on the PMPRB
The PMPRB is a quasi-judicial body established in 1987 under the
Patent Act with the mandate of ensuring that prices
charged for patented medicines sold in Canada are not
excessive.