Decision resulting from the consultation on the definition of Gap medicines and the timeline for compliance

On January 15, 2021, the PMPRB initiated a Notice and Comment period, which closed on February 15, inviting stakeholders to make submissions on two proposed consequential amendments to the new PMPRB Guidelines (“Guidelines”). The first such amendment relates to the definition of Gap medicines in the Guidelines and the second to the number of filing periods patentees have under the Guidelines to comply with the new Maximum List Price (MLP) ceiling for Grandfathered and Gap medicines.  The amendments were required in order for the Guidelines to adjust to the change in the coming-into-force (“CiF”) date of the Regulations Amending the Patented Medicines Regulations from January 1, 2021 to July 1, 2021.

In the interest of timely communication with its stakeholders, the Board’s decision on the two proposed amendments appears below. The 48 submissions received during the month-long comment period, and a brief backgrounder on the Board’s decision, are now available.  

Definition of Gap Medicines

Under the Guidelines, Gap medicines are those for which a DIN was assigned on or after August 21, 2019 and were first sold in Canada prior to January 1, 2021. In its January 15 notice to stakeholders, the PMPRB proposed to extend the date of first sale to the new CiF date of July 1, 2021. Following a careful review and analysis of all of the comments received from stakeholders on this proposal,  the Board decided to proceed with this amendment to the definition of Gap medicines, and to clarify the original intent behind the proposal by further specifying that a DIN must have been assigned to the medicine on or after August 21, 2019 but prior to July 1, 2021. 

Compliance Timelines for Grandfathered and Gap Medicines

Under the new Guidelines as published on October 23, 2020, compliance with the Maximum List Price (MLP) for Grandfathered and Gap medicines was to be assessed after two filing periods, on January 1, 2022. Following the government’s decision to extend the coming into force of the Amended Patented Medicines Regulations a second time to July 1, 2021, the Board  consulted on a proposal to have this done after one filing period only so as to retain January 1, 2022 as the operative date for assessing compliance. Upon further review however, the Board has decided that compliance with the MLP for these medicines will be assessed after two filing periods, as was originally provided for in the new Guidelines. Accordingly, upon coming into force of the amended Patented Medicines Regulations on July 1, 2021, the operative date for assessing compliance with the MLP will be July 1, 2022.

For ease of reference, the following table compares the wording of the relevant provisions in the Guidelines to that of the proposed amendments and to the provisions as they now are as a result of the Board’s decision: