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27 September 2017
On September 7 2017 the Canadian government published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement (CETA). According to an order in council, the new regulations will come into force on September 21 2017.
The amended regulations mark a significant change to the environment for pharmaceutical companies in Canada, with long-lasting consequences for innovators in terms of exclusivity and drug product lifecycle management.
This update reviews the drafts(1) of:
There are no differences between the draft and the final regulations.
When in force, the amended regulations will immediately apply to all submissions for which a notice of allegation is served on or after the effective date of the regulations (September 21 2017). Any notice of allegation served before that date will be governed by the existing regulations.
The amendments to the regulations are accompanied by a regulatory impact analysis statement outlining the background and objectives and describing the changes. The objectives are stated to include:
According to the précis published with the order in council announcing the amended regulations, the regulations were amended in order to:
The new scheme includes the following key specific amendments:
The regulations will allow for protection to take effect at the end of the relevant patent's term, which will be calculated by subtracting five years from the period beginning on the filing date of the patent application and ending on the day on which the authorisation for sale is issued, for a maximum of two years.
The final regulations have two amendments, discussed below, over the draft regulations (for further details please see "CETA draft regulations on patent linkage and term restoration published for public comment").
The CSP regulations include the following key provisions:
Health Canada is expected to update its guidance documents in light of the amendments to the PMNOC regulations and release new guidance documents relating to the CSP regulations. The Federal Court is also working to settle guidelines that will apply to actions covered by the amendments to the PMNOC regulations.
For further information on this topic please contact Urszula Wojtyra or Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or email (firstname.lastname@example.org or email@example.com). Alternatively, please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) For further details please see "CETA draft regulations on patent linkage and term restoration published for public comment".
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