New Amendments To PMPRB Pricing Regulations Push Back Deadlines By Six Months

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Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
Further to our June 1, 2020 update, regulations amending the coming into force date of the Regulations Amending the Patented Medicines Regulations
Canada Food, Drugs, Healthcare, Life Sciences
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Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. 


Further to our June 1, 2020 update, regulations amending the coming into force date of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (the "Amended Regulations") were published this morning in Part II of the Canada Gazette.

These new regulations-officially titled Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)-were registered on June 1, 2020 and came into force on that date.

The newly registered regulations generally push back the timelines in the Amended Regulations by six months. As previously announced, the coming into force date of the Amended Regulations has been moved from July 1, 2020, to January 1, 2021. Similarly, section 4.4 of the Amended Regulations previously required the Board to consider excessive pricing based on the three new pharmacoeconomic factors for sales in Canada after June 30, 2020. Under the new amendments, the PMPRB will conduct that assessment for sales after December 31, 2020. Analogous revisions were made to subsection 4.2(4), which sets deadlines for providing the estimated maximum use of a medicine, and subsection 4.1(4), which governs the provision of cost-utility analyses.

We have prepared an unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

Originally published June 10, 2020.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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New Amendments To PMPRB Pricing Regulations Push Back Deadlines By Six Months

Canada Food, Drugs, Healthcare, Life Sciences

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
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