On April 22, 2022, the Patented Medicine Prices Review Board ("PMPRB" or the "Board") announced that it will be preparing a "new and different set" of draft guidelines, and will communicate a process for public consultation for those new guidelines in the coming months. New guidelines are needed because the Board's current revised guidelines reflect amendments which have been found to be unconstitutional.
What You Need to Know:
- The PMPRB will publish this spring new draft guidelines for the remaining amendments to the Patented Medicines Regulations. The remaining amendments do not include the controversial economic drug pricing factors (pharmacoeconomic value, market size in Canada, and GDP and GDP per capita in Canada), nor the net price reporting requirements, which were found by the Quebec Court of Appeal to be unconstitutional.
- To make time for public consultation, the new guidelines will not be finalized before the July 1, 2022 coming into force of the amendments. There will be a temporary period when no guidelines will apply. The government will seek input on what price tests should apply during this temporary period. Once the new guidelines are finalized, the Board has stated it will provide patentees with a reasonable period of time to comply with the guidelines.
- Health Canada intends to proceed with amending the basket of comparator countries scheduled to the Patented Medicines Regulations. These amendments to the schedule of countries would: (i) maintain France, Germany, Italy, Sweden, and the UK; (ii) add Australia, Belgium, Japan, Netherlands, Norway, and Spain; and (iii) remove Switzerland and the US.
In the meantime, the industry challenge to the amendments as ultra vires Parliament's regulation-making authority under the Patent Act remains pending before the Federal Court of Appeal (Court File No. A-215-20). On April 21, 2022, the Court directed the parties to advise whether any portions of the appeal are now moot, or will be rendered moot upon publication of the remaining amendments in the Canada Gazette. Given the government's decision not to proceed with the economic factors or requiring net pricing reporting, the scope of the appeal may become focused on the new basket of comparator countries.
To view the original article click here
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
We operate a free-to-view policy, asking only that you register in order to read all of our content. Please login or register to view the rest of this article.