The coming-into-force date of the Regulations Amending the Patented Medicines Regulations ("the Amendments") has been delayed by 6 months until July 1, 2021.
What does this mean? Assuming the final PMPRB Guidelines do not change, Appendix F requires grandfathered[1] and gap[2] medicines to comply within two reporting periods (i.e. July 1, 2022). All other medicines will have one reporting period to comply (i.e. January 1, 2022).
What is impacted? First published in the Canada Gazette, Part II in August 2019, the Amendments introduced three major changes to the PMPRB's regulatory framework:
- Introducing new mandatory economic factors when determining whether the price of a patented medicine is excessive (pharmacoeconomic value, market size, and gross domestic product ("GDP") and GDP per capita);
- Changing the basket of countries used by the PMPRB as a benchmark (removing Switzerland and the United States, adding Australia, Belgium, Japan, the Netherlands, Norway, and Spain); and
- Introducing a new price calculation required of patentees to calculate the sale price of a patented medicine ("New Price Calculation").
The Amendments were challenged in the Federal Court and the Quebec Superior Court. Both Courts struck the New Price Calculation. The Federal Court challenge is now under appeal.
Initially, the Amendments were slated to come into force on July 1, 2020. However, in June, 2020 the coming-into-force date was delayed until January 1, 2021. The Amendments have now been delayed a further 6 months and will now come into force on July 1, 2021. The reason cited for the second delay by Health Canada is the COVID-19 pandemic.
According to Health Canada, this delay will provide industry with additional time to prepare for the new reporting obligations and allows industry further time to familiarize themselves with the PMPRB's final Guidelines, which were published on October 23, 2020.
The amendment to the coming-into-force date was registered December 29, 2020 and will be published in Canada Gazette II on January 20, 2021.
[1] All dosage forms and strengths of medicines for which the patentee was assigned a DIN prior to August 21, 2019 regardless of whether those dosage forms and strengths have been approved for new indications (without a DIN change) after August 21, 2019.
[2] Medicines for which a DIN was assigned on or after August 21, 2019 and first sold in Canada prior to the coming-into-force date.