As previously reported, regulations further amending the coming into force date of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (Amended Regulations) were registered on December 24, 2021 and push back the coming into force date of the Amended Regulations and certain associated deadlines until July 1, 2021.
The new regulations – officially titled Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 2 – were published in the Canada Gazette, Part II on January 20, 2021. We have prepared an unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments to date.
The Regulatory Impact Analysis Statement explains that the amendments have two objectives: first, the delayed coming-into-force date provides industry, which is simultaneously grappling with the challenges wrought by COVID-19, additional time to prepare for the new reporting obligations; second, the amendments delay the subsection of the amendments relating to third-party rebates in view of the judicial decisions invalidating that subsection (see our articles here and here).
The PMPRB has now invited stakeholders to comment by February 15, 2021 on two proposed consequential amendments to the Guidelines (now intended to be operative July 1, 2021). The first modifies the definition of Gap medicine to extend the requisite date of first sale from January 1, 2021 to July 1, 2021. In the result, a Gap medicine would be defined as a medicine for which a DIN was assigned on or after August 21, 2019 which was first sold in Canada by July 1, 2021.
The second proposed amendment to the Guidelines modifies the compliance timelines for Grandfathered and Gap medicines. Under the current Guidelines, compliance with the Maximum List Price 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.