On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the "Regulations"), originally released on August 18, 2019, would come into force on July 1, 2022 in a substantially amended form.
The government will be moving forward only with the new basket of comparator countries and the reduced reporting obligations for certain patented medicines at the "lowest risk" of excessive pricing.
The amended Regulations were originally scheduled to come into force on July 1, 2020, and would have introduced:
- New price regulatory factors based on pharmacoeconomic value, market size and GDP/GDP per capita in Canada, and related reporting obligations;
- Expanded reporting of price and revenue information to include confidential third-party rebates;
- A new basket of foreign reference countries for price benchmarking; and
- Reduced reporting obligations for patented veterinary, over-the-counter (apart from non-prescription schedule D drugs such as vaccines and insulin) and generic medicines.
The confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations were declared invalid by the Quebec Court of Appeal on February 18, 2022. The Federal Court had similarly struck down the provisions relating to the expanded reporting of confidential-third party rebates ("Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations"); the appeal of this decision remains pending.
With the announcement by the Minister of Health, going forward, innovators will be required to report price and sales data using the new basket of reference. The new basket—or the "PMPRB11"—consists of Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and the United Kingdom (the "PMPRB11"). The former "PMPRB7" had included the United States and Switzerland, and did not include Australia, Belgium, Japan, the Netherlands, Norway or Spain. The next reporting of price and sales data is due on or before July 30, 2022 for the January 1 to June 30, 2022 reporting period.
The PMPRB has also announced that the revised Guidelines for reporting will not be available by July 1, 2022, and that:
...once a final set of new guidelines is issued and the price tests that apply to the new basket of countries are known, rights holders will be provided with a reasonable period of time to take the necessary steps to come into voluntary compliance with them on a go forward basis.
The PMPRB has promised to proceed with "an expedited written consultation" on the price tests to be applied during the interim period when neither the old nor the new Guidelines are in effect, as well as a consultation on a new and different set of final Guidelines to operationalize the final amended Regulations.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
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