August 11 2021 New consultation on PMPRB guidelines Smart & Biggar | Healthcare & Life Sciences - Canada Healthcare & Life Sciences On 15 July 2021 the Patented Medicines Prices Review Board (PMPRB) announced a consultation(1) on proposed changes to the new guidelines(2)(3) (which, like the amendments to the Patented Medicines Regulations, are now due to come into effect on 1 January 2022).(4)(5) The amendments relate to:the definition of "gap medicine" – the PMPRB has proposed to revise the definition of "gap medicine" to align with the further delay in the coming into force of the amendments. Under the new definition, "gap medicines" are medicines for which a drug identification number was assigned on or after 21 August 2019 and prior to 1 January 2022 and was first sold in Canada prior to 1 January 2022;comparator countries – the PMPRB has proposed to refer to the comparator countries set out in the regulations as "schedule countries", rather than the "PMPRB11".international price tests for grandfathered medicines and their line extensions – for both grandfathered medicines and line extensions, the new guidelines had set the maximum list price (MLP) at the lower of either the highest international price (HIP) for the PMPRB11 countries for which the patentee has provided information or the medicine's price ceiling under the old guidelines (the non-excessive average price (NEAP)). The PMPRB is proposing to set the MLP as the lower of either the median international price for the schedule countries for which the patentee has provided information for the reporting period ending 30 June 2021 (schedule as per SOR/2008-70, section 6) or the NEAP. For grandfathered medicines and their line extension medicines first filed with the PMPRB for the reporting period(s) ending 31 December 2021 or later, the MLP is to be set by the HIP for the schedule countries for which the patentee has provided information.The PMPRB will accept written feedback on the proposed changes until 31 August 2021 (this has been extended from the previous deadline of 15 August 2021).For further information on this topic please contact Abigail Smith at Smart & Biggar by telephone (+1 416 595 2768) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.Endnotes(1) Further information is available here.(2) Further information is available here.(3) For further information please see "Few significant changes made in final PMPRB Guidelines".(4) For further information please see "PMPRB Update: jurisdiction extends to CSPs effective June 30; coming into force of Patented Medicines Regulations and Guidelines delayed to January 2022".(5) On 28 October 2021, the PMPRB provided an update on this consultation, announcing that patentees will have at least two reporting periods to comply with any forthcoming changes to either the current guidelines or the new guidelines that were published in October 2020. The PMPRB otherwise continues to review the feedback it received during the consultation.