PMPRB Notice and Comment – Consultation on new Draft Guidelines
Ottawa, ON – Patented Medicine Prices Review Board (PMPRB)
The Patented Medicine Prices Review Board (PMPRB) released its new draft Guidelines today and launched a 60-day consultation period with stakeholders and interested members of the public. This consultation gives effect to Health Canada’s July 2022 amendments to the Patented Medicines Regulations, which strengthen and modernize Canada’s pricing framework for patented drugs, and further the Board’s longstanding commitment to modernize and simplify its administrative framework.
The Guidelines explain the procedures typically used by staff at the PMPRB when monitoring the prices of patented medicines. In particular, they explain the criteria staff will consider in determining whether the price of a patented medicine warrants a more in-depth review in the form of an investigation. The opening of an investigation may lead to a recommendation to the PMPRB’s Chairperson to hold a public hearing into whether the price of the patented medicine is excessive under section 85 of the Patent Act.
The deadline for providing written submissions through the PMPRB consultation portal is December 5, 2022.
During this consultation period, the PMPRB intends to engage its stakeholders through two webinars. Members of the regulated industry will be invited to attend a dedicated Industry Webinar and will be notified of the webinar information in the coming days. All members of our stakeholder community will be invited to participate in a Public Webinar. Information on this webinar will be made available on the consultation page in the coming days.
The PMPRB remains committed to hearing from all Canadians who have an interest in and opinion on how it carries out its regulatory mandate and looks forward to receiving constructive and meaningful feedback from this consultation process with a view to issuing final Guidelines by end of year.
For updates on PMPRB activities, you can visit our website or follow us on Twitter @PMPRB_CEPMB.
Consistent with our commitment to transparency, the PMPRB intends to make the written submissions publicly available on our website.