PMPRB and Health Canada held two technical briefings on the soon-to-be published final amendments to the Patented Medicines Regulations (PMR) on August 9th, 2019. This coincided with the pre-release of the final regulatory text and an updated Regulatory Impact Analysis Statement (RIAS). Publication in Canada Gazette II is expected August 21st, 2019.
6 Major Changes from Canada Gazette Part I Were Identified:
1. Amended Regulations will come into force on July 1st, 2020.
2. New Price Control Factors (Pharmacoeconomic, Market Size, GDP) will only be applied to ‘New Medicines’.
- International Price Referencing using the expanded Basket of Reference Countries will apply to both ‘Existing’ and ‘New Medicines’
- ‘New Medicines’ are considered those that receive Health Canada Market Authorization after publication, not implementation, of CGII.
- Line extensions with new DINs will be considered ‘New Medicines’ and subject to the full range of price factors.
3. Pharmacoeconomic Factors will only be applied to ‘High Cost’ drugs – i.e., those with an annual cost per patient above 50% of GDP per Capita (~$26,000 per year).
4. South Korea has been removed from the proposed basket of countries. This results in a total of 11 reference countries considered by PMPRB.
5. Vaccines, patented biosimilars, and patented non-prescription medicines will be under PMPRB’s jurisdiction.
6. Health Canada has conducted and will publish a new Cost Benefit Analysis and Regulatory Impact Analysis Statement based on these changes and recommendations from the David Dodge report.
Additional Items to Note:
PMPRB has indicated that remaining implementation and enforcement questions will be covered in the Guideline consultation process.
- Draft Guidelines are targeted to be published in September.
- Final Guidelines are targeted to be published in February.
Please contact Kimberly Robinson, PDCI’s Director of Pricing and Market Access, for further comment and assistance.