Pangaea Express: PMPRB Not Moving Forward July 15 with Proposed Changes

On December 17, 2021, the PMPRB posted an update that read, “The Board has decided not to proceed with the changes that were proposed in the July 15, 2021 Notice and Comment. The Board would like to thank stakeholders for their written submissions, which are now available on the PMPRB website.”

The PMPRB’s July 15, 2021 Notice and Comment contained three amendments to:

• -the definition of Gap medicines
• -the references to the comparator countries
• -the international price tests for Grandfathered medicines and their line extensions

At this point, what we know is that these amendments will not be incorporated into the October 2020 Guidelines. If the Regulations continue to be implemented January 1, 2022 or at some point thereafter, there will still need to be a change in the definition of Gap medicines to reflect the period of time from August 21, 2019 to the implementation of the Regulations.

There were 66 written submissions received from stakeholders during the consultation period on the change to the definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions.

IMC stated in their response, “The July 15, 2021 proposal to change the international price tests for existing medicines and their line extensions from the highest of the international schedule to the median is arbitrary, inconsistent with the PMPRB’s role as a regulator of excessive ceiling prices, and will harm both patentees and other elements of the pharmaceutical supply chain in Canada (e.g., distributors, pharmacies, and generics).”

BIOTECanada wrote, “The existing proposed Guidelines were already complicated to interpret, and these latest changes add significant, and unnecessary complexity including the use of two separate sets of comparator countries; one from an active set of Regulations and one from an expired set of Regulations that Health Canada elected to replace. This complexity also appears to be the product of a misalignment between Health Canada and the PMPRB.”

The Canadian Association of Pharmacy Distribution Management (CAPDM) referenced the impact to the supply chain as, “The estimated impact on distributors alone is projected to be a $40-60 million funding reduction per year. This is double to triple the previous negative impact of the earlier PMPRB guidelines. In order to offset this loss, CAPDM foresees distributors members having to cut costs by reducing service levels and/or postponing or foregoing investments to maintain the critical drug distribution infrastructure which could ultimately lead to reduced patient access to the medication they require.” This sentiment was reinforced by others involved in the supply chain.

Pangaea will continue to monitor further announcements regarding the coming into force of the Regulations Amending the Patented Medicines Regulations for January 1, 2022.

For more information, please contact Suzanne Solman or Marla Weingarten.