Further to our June 1, 2020 update, regulations amending the coming into force date of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (the “Amended Regulations”) were published Wednesday, June 10th, in Part II of the Canada Gazette.
These new regulations—officially titled Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)—were registered on June 1, 2020 and came into force on that date.
The newly registered regulations generally push back the timelines in the Amended Regulations by six months. As previously announced, the coming into force date of the Amended Regulations has been moved from July 1, 2020, to January 1, 2021. Similarly, section 4.4 of the Amended Regulations previously required the Board to consider excessive pricing based on the three new pharmacoeconomic factors for sales in Canada after June 30, 2020. Under the new amendments, the PMPRB will conduct that assessment for sales after December 31, 2020. Analogous revisions were made to subsection 4.2(4), which sets deadlines for providing the estimated maximum use of a medicine, and subsection 4.1(4), which governs the provision of cost-utility analyses.
We have prepared an unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments.