19

Aug2022
On August 18, 2022, PMPRB announced its decisions regarding Price Regulation of patented medicines during the ‘Interim Period’, between July 1, 2022 and when a final set of price regulatory guidelines is published. The PMPRB has decided to move forward with earlier proposals drafted June 30th, 2022, and ... Read More

20

Jul2022
On June 30, 2022, PMPRB issued a Notice and Comment which published its Proposed Interim Guidance and invited stakeholder comments until July 18, 2022. This Interim Guidance outlines PMPRB’s intentions for regulating the prices of patented medicines in the “interim period” between the coming-into-force date ... Read More

30

Jun2022
PMPRB Launches Consultation on its Proposed Interim Guidance Today, June 30, 2022, PMPRB published a proposed set of Interim Excessive Price Guidelines and has invited stakeholders to comment on the approach before July 18, 2022. This Interim Guidance outlines PMPRB’s intentions ... Read More

25

Apr2022
On April 14, 2022, Health Canada announced that the government will:  Proceed only with the proposed amendments to the Regulations pertaining to schedule of reference countries (the PMPRB11 replacing the PMPRB7).   Not proceed with new excessive price factors (cost effectiveness, market size, GDP) nor the reporting of third-party ... Read More

04

Apr2022
On March 31, 2022, PMPRB published its 2020 Annual Report on its website. Key statistics reinforce concerns about Canada’s continued attractiveness for new medicine investment and launch since drug pricing reform began in 2017. Statistical Highlights201820192020Total # of Patented Medicines for Human Use Reported ... Read More

25

Mar2022
On September 29, 2021, the Attorney General of Canada applied for leave to appeal to the Supreme Court of Canada concerning the Federal Court of Appeal’s (FCA) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). On March 24, 2022, the Supreme Court of Canada ... Read More

22

Feb2022
On February 18, 2022, the Quebec Court of Appeal ruled that two of the three major proposed changes to the PMPRB price regulations are unconstitutional: As more information becomes available, PDCI will share further insights and implications for ... Read More

14

Feb2022
This is a reminder to patentees of their filing requirements respecting revenues and development expenditures. These filing requirements are contained in section 5 of the Patented Medicines Regulations. The Annual Form 3 filing to the PMPRB is due on March 1, 2022. As ... Read More

17

Dec2021
On October 28th, 2021, PMPRB provided their first update to the Notice & Comment that was issued on July 15, 2021. The primary takeaway is PMPRB will be providing patentees two reporting periods for compliance, a change from PMPRB's earlier position expecting one reporting period for ... Read More

29

Jun2021
This morning, June 29th, 2021, Health Canada announced an additional 6-month delay in implementation of the Patented Medicines Regulations and Final PMPRB Guidelines.  The changes will now come into force on January 1, 2022. The reasons cited by Health Canada for the delay are the ongoing COVID-19 pandemic and need ... Read More