Introduction
Original Regulations
Recent developments
On 14 April 2022, the minister of health announced that the amendments to the Patented Medicines Regulations (the Regulations), originally released on 18 August 2019, would come into force on 1 July 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 1 July 2020, and would have introduced:
- new price regulatory factors based on pharmacoeconomic value, market size and gross domestic product (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 18 February 2022. The Federal Court had similarly struck down the provisions relating to the expanded reporting of confidential-third party rebates (for further details, see "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 "Patented Medicine Prices Review Board (PMPRB) 11" – consists of Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and the United Kingdom. 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 30 July 2022 for the 1 January 2022 to 30 June 2022 reporting period.
The PMPRB has also announced that the revised guidelines for reporting will not be available by 1 July 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 operationalise the final amended Regulations.
For further information on this topic please contact Daphne Lainson or Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.