As expected, amendments to the Patented Medicines Regulations (“Regulations”) were published in Canada Gazette II this morning. The amendments officially change the coming into force date of the new amending Regulation to January 1, 2021. These Regulations were originally published in Canada Gazette II on August 21, 2020 with an implementation date of July 1, 2020.
Today’s amending Regulation also changes other dates to remain consistent with the new coming into force date. Issuance of a DIN prior to August 21, 2019 remains the cut-off date for patented medicines to be exempted from application of the new economic factors. Significantly, the changes also clarify that excess revenues cannot be accrued against sales prior to January 1, 2021, based on the new “economic” pricing factors (s. 4.4 of the amended Regulations, s. 85(1)(e) of the Act). The full text of the amendments is available in Canada Gazette II.
Health Canada issued official confirmation of the delayed coming into force date with key stakeholders, and PMPRB will send an official notification to all parties who participated in the consultation process.
A revised set of draft Guidelines is expected next week, followed by a 30-day consultation period and acceptance of written comments.
PDCI will be hosting a free webinar presenting an analysis of the new Draft Guidelines on June 23rd from 10:30 to noon.
Please register at this link.
As with past consultations, PDCI will host a web page for interested stakeholders to post their submissions commenting on the proposed Guidelines. PMPRB may ultimately post stakeholder submissions received on its website, however PMPRB postings may not be immediately available. More details will follow.
Please contact Kimberly Robinson, Director of Pricing and Market Access at PDCI Market Access Inc. if you have questions.