Health Canada announced this afternoon, “…Health Canada will be moving forward with the implementation of the new basket of comparator countries and reduced reporting requirements for those medicines at lowest risk of excessive pricing. These [Amendments to the Patented Medicines Regulations] will come-into-force on July 1, 2022. The Government will not proceed with the Amendments related to the new price regulatory factors, nor with the requirements to file information net of all price adjustments.” Continue reading PMPRB
Two consultations were announced today:
- the Patented Medicine Prices Review Board announced a consultation on updated guidance relating to Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions, all arising from the six month extension to the coming-into-force of the new Regulations.
- The government announced a consultation on the copyright framework relating to artificial intelligence and the Internet of Things, including data mining, authorship and ownership of works created by AI, infringement and liability regarding AI, and repair and interoperability issues related to technological protection measures.
Several IP related amendments have been published in the Canada Gazette:
- College-related for the coming into force of the College on June 28th (see earlier post):
- By-laws of the College of Patent Agents and Trademark Agents (Board),
- By-laws of the College of Patent Agents and Trademark Agents (College),
- Code of Professional Conduct for Patent Agents and Trademark Agents Regulations,
- Order Fixing the Number of Directors Under the College of Patent Agents and Trademark Agents Act
- Amendments to the Federal Courts Rules that came into force on June 17th (see earlier post):
- PMPRB-related (see earlier post on delaying Patented Medicines Reporting Requirements that were to come into force on July 1st): Regulations amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)
Various amendments relating to the Patented Medicines Prices Review Board are to come into force on June 30, 2021 including amendments to sections 79 to 103 of the Patent Act. In addition there are some changes being made for consistency with the Patent Act and to encompass CSPs. This is in addition to the amended Patented Medicines Regulations expanding reporting requirements are scheduled to come into force July 1, 2021 after being delayed several times. Continue reading PMPRB
Implementation of the new Patented Medicines Prices Review Board regulations that were due to come into force on January 1, 2021 have been delayed by six-month. The coming-into-force was previously delayed from July 1st and the regulations have been subject to several legal challenges.
Proposed “Regulations Amending the Patented Medicines Regulations” have been published in the Canada Gazette for a 75 day consultation. According to the Regulatory Impact Analysis Statement, “This proposal would amend the Patented Medicines Regulations (“Regulations”) so that the PMPRB’s regulatory framework includes new price regulatory factors and patentee price information reporting requirements that will help the PMPRB to protect Canadian consumers from excessive prices.”