Interim Guidance

August 18, 2022. Amended on September 27, 2023

During the Interim Period (from July 1, 2022 to the publication of new Guidelines), the price of a patented medicine will not trigger an investigation if:

1) its national average transaction price (N-ATP) remains at or below the NEAP (Non-Excessive Average Price) as projected in the most recent compliance letter from PMPRB staff to the relevant patentee, and;

2) its list price does not increase. For greater clarity, an increase in the list price of a medicine will not trigger an investigation if it was taken in accordance with the Consumer Price Index (“CPI”)-based price-adjustment factors during the first filing period of 2022.

Medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022 (“New Medicines”), are considered reviewed if their list price is below the median international price for the PMPRB11 countries.

The rights holders of these products will receive a Status Report letter once the assessment is completed.

Medicines that do not meet this criterion, are considered “under review” until new Guidelines are in place.

Once new Guidelines are in place, no potential excess revenues will be calculated by staff retrospectively for any New Medicines for sales made during the Interim Period.

FAQs

How can patentees know what the NEAP is that will apply to the price of a medicine during the Interim Period?

In February and March of 2022, patentees received letters from Board Staff which identified the projected NEAP for their medicines. These NEAPs are calculated based on CPI-based price-adjustment methodology increases. These NEAPs will remain in place for the entirety of the Interim Period.

Will the NEAPs continue to apply to the price of medicines if new Guidelines are not in place by the end of 2022?

The PMPRB is committed to completing the consultation process and issuing new Guidelines before January 1, 2023. If it is necessary to extend the Interim Period beyond that date because the Guidelines are not yet in place, the PMPRB will revisit this issue.

How will the PMPRB address the value of free and compassionate goods during the Interim Period?

Nothing has changed in this regard. Subsection 4(4) of the Patented Medicines Regulations provides that, in calculating the average price per package or net revenues, the actual price or actual revenue after any reduction including rebates, discounts, refunds, free goods, free services, gifts or any other benefit of a like nature and after the deduction of federal sales taxes shall be used.

Will HDAP meetings continue on their current timelines for new (and future) medicines?

For the moment HDAP meetings will continue as scheduled. That said, new medicine reviews will not be conducted until such time as new Guidelines are finalized.