Anita Nador
Partner
Co-lead, Global Trade Secrets group; Member, Life Sciences Executive; Lead, Hungary team; Patent Agent; Trademark Agent
Article
6
On October 6, 2022, the PMPRB released new draft guidelines to give effect to the July 2022 amendments to the Patented Medicines Regulations (the "Regulations") set forth by Health Canada. Stakeholders will have a 60-day period (up until December 5, 2022) to submit written feedback. All submissions will be made available to the public.
The PMPRB describes the new draft guidelines as being simpler, more stable and more predictable for rights holders, namely by:
For existing medicines, the PMPRB may also open an investigation if the list price exceeds the highest international prices of the comparator countries (see "PMPRB11", discussed below).
For new medicines, the PMPRB may also open an investigation if the list price exceeds the median international price of the comparator countries (the "PMPRB11"); falls between the median and lowest list price of the PMPRB11 but exceeds the domestic therapeutic class comparator price (dTCC); or the list price exceeds the midpoint between the top of the dTCC and lowest international price for the PMPRB11, and the top of the dTCC is more than 50% lower than the lowest international price.
The PMPRB states in its backgrounder that a concerted effort will be made to only trigger an investigation for new medicines when "at least two of the [s. 85] factors are engaged whenever possible". The factors under s. 85 of the Patent Act are:
As previously reported in our article concerning the amendments to the Regulations, such amendments were first published in August 2019 and were originally intended to come into force on January 1, 2021. However, due to the volume and nature of feedback received from prior draft guidelines and constitutional challenges in both the Federal and Québec courts (see our article), only some of the amendments came into force on July 1, 2022, (see our article) namely the provisions relating to:
The amendments introducing the consideration of pharmacoeconomic factors in to the determination of excessive pricing (i.e., pharmacoeconomic value in Canada, size of the market for the medicine in Canada and Canada's Gross Domestic Product (GDP)), as well as the new price reporting requirements that required reporting of price net of all pricing adjustments (including confidential rebate information) have not been enacted. Such provisions were held invalid by the Quebec Court of Appeal in a decision dated February 18, as reported in our prior article: Two major amendments to the patented medicines regulations.
If you wish to learn more about the PMPRB, get our insights on the draft guidelines or general Canadian commercialization strategies for medicines in light of PMPRB's jurisdiction, the PM(NOC) patent linkage regulations, patent term extensions (CSPs) and patent legislation, please contact one of the authors or a member of our Life Sciences Group.
NOT LEGAL ADVICE. Information made available on this website in any form is for information purposes only. It is not, and should not be taken as, legal advice. You should not rely on, or take or fail to take any action based upon this information. Never disregard professional legal advice or delay in seeking legal advice because of something you have read on this website. Gowling WLG professionals will be pleased to discuss resolutions to specific legal concerns you may have.