Pangaea Express: PMPRB Decides on 1 Filing Period
After several weeks of consultation, the PMPRB has made their decision regarding the definition of Gap Medicines and the compliance timelines for Grandfathered and Gap Medicines.
The Board clarified the original definition of Gap medicines from "medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to July 1, 2021" to include the requirement that a DIN must also have been assigned on or after August 21, 2019 but prior to July 1, 2021.
The Board also made the decision to proceed with only 1 reporting period to assess compliance for Grandfathered and Gap medicines. This had been changed from the original 2 reporting periods identified in the October 2020 Guidelines. As such, all patented medicines must now comply with the new pricing Guidelines by January 1, 2022.
The amended Guidelines as of March 2021 read:
- Gap medicines are medicines for which a DIN was assigned on or after August 21, 2019 and prior to July 1, 2021 and first sold in Canada prior to July 1, 2021.
- 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.
As the amended Regulations and Guidelines will come into effect mid-year, the compliance report sent to patentees will only be based on 1 reporting period (vs annual reporting) which could affect the newly determined MLP. This decision in timelines could also have implications within the supply chain, as the implementation of all the pricing reductions could leave distributors and pharmacy with devalued stock.
The Board did state they will publish the 48 submissions received along with a brief backgrounder on the Board’s decision in the coming days. Will this publication address any of the challenges and concerns of the various stakeholders?