The Patented Medicine Prices Review Board (PMPRB) has released its new draft guidelines and launched a 60-day consultation period with stakeholders and interested members of the public. This consultation follows Health Canada's July 2022 amendments to the Patented Medicines Regulations, which provided the PMPRB with new tools to protect Canadians from excessive prices for patented medicines.
The PMPRB ensures that prices charged by pharmaceutical companies for patented drugs sold in Canada are not excessive.
The PMPRB also reports on pharmaceutical trends and R&D spending by pharmaceutical patentees.
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 to the PMPRB is December 5, 2022.
