On January 15, 2021, PMPRB invited stakeholders to comment on two key amendments to the final guidelines that were originally to come into affect for January 1, 2021 but were delayed to July 1, 2021. PMPRB received 48 submissions in response to the definition of Gap Medicines and the change in timeline for compliance. On March 17, 2021, Health Canada published the decision resulting from the consultation.

KEY TAKEAWAYS:

• PMPRB has amended the definition of Gap medicines timeline and extended the date from January 1, 2021, to July 1, 2021.
• Patentees must comply to the new MLP within 1 reporting period instead of 2 reporting periods.
  • All patented medicines will require compliance by January 1, 2022.
  • Patentees will file the PMPRB11 for the upcoming semi-annual filing on or prior to July 30, 2021 which will be a factor for the new MLP.

PDCI strives to support timely transparency around public policy consultations and invites organizations and individuals to share their submissions so ideas may be shared publicly. PDCI publicly publishes consultation responses that stakeholders have submitted and give consent to publish. See our sharing repository here.

PDCI continues to prioritize the ongoing changes and complications for patentees.
Please e-mail Jennifer Mathews, Manager Pricing Data, at Jennifer.mathews@pdci.ca
if you have any questions relating to the implications or Form 2 filing requirements for your patented portfolio.