Pangaea Express: PMPRB To Make Significant Changes
The PMPRB published an announcement today to express that the Board “will be making significant changes to the draft Guidelines in response to the feedback it has received.”
The amended Patented Medicines Regulations will still come into force on July 1, 2020 and the PMPRB will ensure a “fully operational set of Guidelines” to be in place by that time and will include transitional measures to ensure all patentees are able to comply with the Pricing Regulations.
There were 116 submissions in total from manufacturers, industry associations, patient groups, payers, distributors and other healthcare related agencies. Though the March 18th Policy Forum had to be cancelled due to the COVID-19 pandemic, it does appear that the PMPRB read and listened to the detailed and extensive input from all stakeholders.
At this time, the PMPRB plans to publish revised draft Guidelines this spring, that will have only a limited time-frame for feedback before being finalized. However, they are acknowledging that they may need to adjust any next steps given the evolving situation with COVID-19.
While we don’t know exactly what changes will be made, there have been reports that the PMPRB may apply cost-effectiveness measures to fewer treatments and may focus on drugs that are of particular risk of being excessively priced. (1) Of course, this is only speculation and we will know much more in the coming weeks before the impending date of July 1, 2020.