Author: Dara Jospé, Nicolas Charest and Jason Markwell

About Dara Jospé, Nicolas Charest and Jason Markwell

Dara Jospé practises law in the area of life sciences, health and food regulation. She advises manufacturers on all stages of the lifecycle of a pharmaceutical product, from conception until it reaches the consumer. In all cases, Dara develops low-risk and creative ways to adjust to the legal prohibitions and policy restrictions while keeping business interests and the safety of patients in mind.

Breaking News from the WTO: Limited TRIPS Waiver for COVID-19 Vaccines

Close up of Vials and Syringes with Covid-19 vaccine are displayed on a tray during vaccination.

On June 17, the 2022 Ministerial Conference of the World Trade Organization (“WTO”) issued a decision [PDF] pursuant to the Agreement on Trade-related Aspects of Intellectual Property Rights (“TRIPS Agreement”) and allowed certain members to use patented inventions for the production and supply of COVID-19 vaccines in specific circumstances (“Ministerial Decision”).

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Key Takeaways from Ongoing PMPRB Litigation

Flags of Quebec and Canada

UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.

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This article provides an update on each of these cases and highlights the growing body of jurisprudence questioning the PMPRB’s price control reasoning.

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The 2022 PMPRB Outlook for Pharmaceutical Patentees in Canada

pharma pills

UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
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In December 2021, the Patented Medicine Prices Review Board (the “PMPRB”) and the Minister of Health issued two updates regarding the Regulations Amending the Patented Medicines Regulations (the “Amendments”) and the new PMPRB Guidelines (the “New Guidelines”). These notably include a further deferral of the coming-into-force date of the Amendments. The updates, along with the Federal Court of Appeal’s (“FCA”) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General), 2021 FCA 157 (“Alexion”), may have important implications for pharmaceutical patentees in Canada as they implement or revise their pricing strategy for 2022 and beyond.

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Mind the GAP: The PMPRB Changes Definition of GAP Medicines and Reduces Compliance Timeline

On January 15, 2021, the Patented Medicines Prices Review Board (“PMPRB”) initiated a consultation on two proposed amendments to the new PMPRB Guidelines (“Guidelines”): (1) the definition of Gap medicines; and (2) the compliance timeline for Grandfathered and Gap medicines. 

According to the PMPRB, the two amendments were required due to the change in the coming-into-force date of the Regulations Amending the Patented Medicines Regulations (“Regulations”), which was pushed from January 1, 2021 to July 1, 2021.

And so, on March 17th, the PMPRB rendered its decision.

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Changes to the PMPRB Delayed Due to COVID-19

UPDATE: On April 14, 2022, the Minister of Health announced that the federal government will not proceed with amendments to the Patented Medicines Regulations introducing new pharmacoeconomic factors and requiring that price and revenue information be reported net of all adjustments. The federal government will proceed with amendments establishing a new basket of comparator countries, with a coming-into-force date of July 1, 2022. For more information, see our Life Sciences Bulletin on the Minister’s announcement.
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The Patented Medicine Prices Review Board (PMPRB) has delayed the coming into force of the amended Patent Medicines Regulations to January 1, 2021.

The Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) were set to come into force on July 1, 2020 and provide the PMPRB with additional price regulatory factors to assess whether the price of a patented medicine sold in Canada was “excessive”. But on June 1st, 2020, the Canadian government delayed their coming into force, citing an increased demand on the pharmaceutical industry in light of COVID-19.

Then, on June 19th, 2020, the PMPRB released its Draft Guidelines 2020. These changes were the result of extensive stakeholder feedback received during public consultations. While the new Guidelines have the same conceptual structure as those released back in November 2019, there are now some substantial quantitative changes.

In particular, in the new Draft Guidelines 2020, the thresholds for identifying high-priority drugs has changed: The PMPRB will classify new patented drugs as either high or low priority based on their anticipated financial impact. If they have a high treatment cost (now above $90,000 annually per patient) or large anticipated marketed size (now above $50M in sales) then they will be subject to a more comprehensive price review. This comprehensive review will take into consideration new additional price regulatory factors, including a drug’s pharmacoeconomic value, market size and the gross domestic product (GDP) and GDP per capita in Canada.

The Draft Guidelines are available for public comment until July 20, 2020. We have extensive experience in this area and are available for a consultation if you are interested in responding.

Learn more about our patent practice and our life sciences practice.