As previously reported, the Patented Medicine Prices Review Board (PMPRB) recently released draft Guidelines operationalizing the amended Patented Medicines Regulations for consultation. The consultation period has been extended (a second time) to February 14, 2020. Submissions are to be sent to PMPRB.Consultations.CEPMB@pmprb-cepmb.gc.ca. The PMPRB continues to consult with stakeholders in the meantime.
The PMPRB has also released the presentations from its Patentee Webinar on January 17, 2020, as well as the earlier Industry Forum held December 9, 2019 and Civil Society Forum held December 10, 2019.
Of note, the Patentee Webinar:
- highlights distinctions between the current and proposed Guidelines;
- provides two case studies of how the maximum rebated price and maximum list price will work in practice;
- provides detail on filing requirements under the new Guidelines; and
- includes further details on transition, including for grandfathered and "gap" medicines, and what to expect after the July 1, 2020 coming into force.
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