Deadline Extended: PMPRB Notice and Comment – New Price Tests for Grandfathered Medicines

On July 15th, 2021, the PMPRB invited stakeholders to comment on three amendments to the regulations with responses due by August 15th 2021. PMPRB announced today that the deadline has been extended to August 31, 2021. PMPRB also communicated they will be publishing a Q&A addressing questions that have been asked by stakeholders.

Amendment 1: Changes the definition of Gap Medicines by extending the cut-off date. Gap Medicines will be defined as medicines that received a DIN on or after August 21, 2019 and that received a DIN and first sale prior to January 1st, 2022.

Amendment 2: Changes terminology in the Guidelines. References to ‘PMPRB11’ will be changed to “Schedule Countries”.

Amendment 3: Changes the Maximum List Price (MLP) calculations for all Grandfathered Medicines and their Line Extensions.

Amendment 3 will have major implications for Grandfathered and Line Extension Medicines. The Maximum List Price of Grandfathered Medicines will now be set to the lower of the 2021 N-NEAP and the Median International Price of the current basket of 7 countries. The median will be calculated from the January-June 2021 semi-annual filing that is due July 30th. The proposed new MLP will be calculated in the same manner as the new guideline’s methodology.

This change is likely to negatively affect the prices of a large number of Grandfathered medicines. PDCI would encourage patentees to assess the impact of this proposed change on their patented portfolio and to provide PMPRB with comments and feedback promptly.