The Federal Government has announced the long awaited changes to the Patented Medicines Regulations, which are set to come into force on July 1, 2020. These amendments will only apply to new medicines that obtain a DIN on or after August 21, 2019.
Notable changes to the Patented Medicines Regulations include:
- The new restrictions will apply only to new medicines. Any medicine which obtains in DIN prior to the amendments being posted in Canada Gazette Part II (scheduled for August 21, 2019) will be excluded.
- The basket of comparator countries is now: Australia; Belgium; France; Germany; Italy; Japan; the Netherlands; Norway; Spain; Sweden: and the United Kingdom. As expected, the United States and Switzerland have been excluded. New in today’s announcement is that South Korea has been dropped from the initially proposed countries.
- PMPRB’s analysis will no longer be limited to unit list price. Parties must now provide confidential information on their actual prices, and the scope of PMPRB’s review is broadened to include:
- Information regarding confidential pricing adjustment such as discounts and rebates given to third party insurers;
- The parmacoeconomic value of the medicine to patients;
- Canada’s GDP and GDP per capita; and
- The expected size of the market for the medicine in Canada.
- To address the increased scope of PMPRB review, a patentee’s reporting requirements have likewise been increased. Patentees must now additionally provide PMPRB with:
- Cost-utility analyses addressing quality-adjusted life year that has been performed in respect of the Canadian Market (e.g., a CADTH or INESS assessment). This includes confidential information redacted from any public report.
- Information on the market size of the medicine. This information would identify the quantity of the medicine that is estimated to be sole, and the period of time that was used to produce the estimate.
- Confidential pricing and rebate information.
It is expected that these new amendments will lead to much discussion and debate leading up to July 1, 2020 and beyond. The PMPRB has indicated it will begin consultation on new Guidelines prior to that date, though no details are yet available.