On December 2 2017 the governor in council published the proposed Regulations Amending the Patented Medicines Regulations which are expected to be implemented in 2019. The proposed changes are expected to provide substantial savings over the next 10 years.
The key elements proposed include:
- new price regulatory factors
- Under the new Section 4.4, the PMPRB has three new price regulatory factors: pharmacoeconomic value; market size; and GDP in Canada and GDP per capita in Canada
- Updated international reference pricing basket
- Countries to include Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, South Korea, Spain Sweden, and the UK
- Switzerland and US are to be removed
- Changes to reporting requirements