The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines.
The PMPRB has indicated that these changes are intended to account for delays in the coming-into-force date of amendments of the Patented Medicines Regulations (the Regulations). As we reported, the New Guidelines have already been updated once to account for earlier delays to these amendments. Following a further delay, most of the amendments to the Regulations are now scheduled to come into force on January 1, 2022. With respect to these latest changes to the New Guidelines, PMPRB stated:
the changes in dates, terminology and transition measures address the need for further clarity at the Guidelines level where patentees are facing different international price information requirements and a widening "Gap" period due to the further delay to the regulatory amendments. No change to the compliance date is being proposed.
In particular, the PMPRB has proposed three types of changes:
- The definition of "Gap" medicine would be revised to provide for a gap period of August 21, 2019 – January 1, 2022. The gap period is currently identified as August 21, 2019 – July 1, 2021.
- References to the "PMPRB11" basket of comparator countries would be replaced by the term "Schedule Countries".
- The Maximum List Price (MLP) test applicable
to "Grandfathered" medicines and their "Line
Extensions" would be changed.
- At present, the New Guidelines provide that the ceiling be set by the lower of (i) the highest international price (HIP) in the PMPRB11; or (ii) the medicine's ceiling (e.g., the NEAP) under the Guidelines applicable prior to the coming-into-force date of the amendments to the Regulations (the Current Guidelines).
- The proposed change provides for different MLP tests depending
on whether the medicine was first filed with the PMPRB before or
after December 31, 2021.
- The general rule would be that the MLP would be set by the lower of (i) the median international price (MIP) for the Schedule Countries for which the patentee has provided information for the reporting period ending June 30, 2021 under the current Regulations (i.e., the "PMPRB7" countries); or (ii) the medicine's ceiling (e.g., the NEAP) under the Current Guidelines.
- However, if the Grandfathered and their Line Extension medicine was first filed with the PMPRB for the reporting period(s) ending in December 31, 2021, or later, the MLP would be set by the HIP for the Schedule Countries set out in the Regulations for which the patentee has provided information.
For full details of the proposed amendments to the New Guidelines, interested persons should consult the PMPRB's Notice and Comment webpage. The PMPRB has indicated that it will accept feedback submitted in writing by August 15, 2021.
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