The PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted.
Updates to the Guidelines
As we reported, the Guidelines were released by the PMPRB on October 23, 2020 and are intended to implement amendments to the Patented Medicines Regulations that were passed in August 2019.
At the time they were released, the Guidelines were scheduled to take effect together with the amendments to the Regulations on January 1, 2021. In December 2020, the government delayed the coming-into-force date of the amendments until July 1, 2021.
Following this change, the PMPRB held Notice and Comment consultation on consequential amendments to the Guidelines:
- First, the PMPRB proposed to update the definition of “Gap” medicines (i.e., those that received a DIN on or after August 21, 2019 and were first sold prior to the coming-into-force date) to reference the new coming-into-force date of July 1, 2021.
- Second, the PMPRB proposed requiring prices of “Grandfathered” and “Gap” medicines to comply with the new Maximum List Price (MLP) under the Guidelines within one reporting period of the MLP being set (i.e., within six months). This was a reduction from the two reporting periods permitted under the October 23, 2020 version of the Guidelines.
In March 2021, the PMPRB issued a decision adopting both recommendations.
Revised compliance period
On April 16, 2021, the PMPRB announced that it had revisited its decision on the number of reporting periods for compliance with the MLP.
Citing the evolving impact of the COVID-19 pandemic, the Board reverted to the original requirement that patentees of “Grandfathered” and “Gap” medicines comply with the new MLP within two reporting periods. As a result, “the operative date for assessing compliance with the MLP will by July 1, 2022.”