Notice and Comment - On the change to the definition of Gap medicines and the timeline for compliance

The notice and comment period for this matter is now closed.

The Board announced the decision resulting from this consultation on March 17, 2021.

January 15, 2021 – The Patented Medicine Prices Review Board (PMPRB) invited stakeholders to comment on two proposed consequential amendments to the new PMPRB Guidelines resulting from the decision to delay the coming-into-force date of the Regulations Amending the Patented Medicines Regulations (“Regulations”) a further six months, from January 1, 2021 to July 1, 2021.  The PMPRB proposed to change the definition of Gap medicines and the timeline for compliance with the Maximum List Price (MLP) ceiling for Grandfathered and Gap medicines.  

The deadline to submit written comments was February 15, 2021.

Proposed Consequential Amendments to the January 1, 2021 Guidelines:

Definition of Gap Medicines:

The definition of Gap medicines under the new Guidelines applies to medicines for which a DIN was assigned on or after August 21, 2019 and that were first sold in Canada prior to January 1, 2021. The PMPRB is proposing to extend the date of first sale to the new coming-into-force date of July 1, 2021.

Compliance Timelines for Grandfathered and Gap Medicines:

Under the new Guidelines, compliance with the Maximum List Price (MLP) for Grandfathered and Gap medicines would be assessed after two filing periods, on January 1, 2022. The PMPRB is proposing to reduce this to one filing period so that January 1, 2022 would remain the operative date for assessing compliance. 

About the proposed consequential amendments

On October 23, 2020, the PMPRB published new Guidelines which give effect to the Regulations.  The coming into force of the Regulations has since been delayed by six months and they are now slated to come into force on July 1, 2021.  This is the second six-month delay from the original coming-into-force date of July 1, 2020.

The Regulations were published in the Canada Gazette, Part II in August 2019 and are the first substantive update of the PMPRB’s regulatory framework in more than 30 years.  A year-long consultation on changes to the PMPRB’s Guidelines followed, culminating in the October 23, 2020 publication of the new Guidelines.  The proposed consequential changes to the new Guidelines described above are believed to an appropriate response to the most recent six-month extension in the coming-into-force date of the Regulations, to July 1, 2021.

The new coming-into-force date of the Regulations will be published in the Canada Gazette, Part II on January 20, 2021.

The PMPRB will carefully consider written feedback received from stakeholders prior to the February 15, 2021 deadline before finalizing the proposed consequential changes.

Side-by-side comparison of the proposed consequential amendments:  

Change	January 1, 2021 Guidelines	July 1, 2021 Proposed Guidelines
Definition of Gap Medicines	35. Gap medicines are medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to January 1, 2021	35. Gap medicines are medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to July 1, 2021
Compliance Timelines with MLP	76. Patentees must comply with the MLP within one (1) reporting period of the MLP being set for Line Extension medicines and within two (2) reporting periods for Grandfathered or Gap medicines.	76. Patentees must comply with the MLP within one (1) reporting period of the MLP being set for Line Extension medicines and for Grandfathered or Gap medicines.
Compliance Timelines with MLP	F. Summary of Compliance Timelines Patented Medicine Category Compliance Assessment Grandfathered 2 reporting periods Gap 2 reporting periods (Dec. 2021)	F. Summary of Compliance Timelines Patented Medicine Category Compliance Assessment Grandfathered 1 reporting period Gap 1 reporting period (Dec. 2021)