Bill C-97(1) was introduced in the House of Commons on 8 April 2019. It includes proposed amendments to the Food and Drugs Act to introduce a new framework for advanced therapeutic products, including a new licensing framework.

The proposed amendments define an 'advanced therapeutic product' as a product or class of products set out in Schedule G. Thus far, Schedule G does not contain any entries, but the proposed amendments allow the minister to make additions to Schedule G if they believe that the product or class of products "represent[s] an emerging or innovative technological, scientific or medical development".

It is unclear what the full details and scope of this framework will encompass. However, it is expected that advanced therapeutic products may include the regulation of newer technologies, such as cell and gene therapies, 3D printing and novel drug delivery methods. The proposed amendments align with Health Canada's March 2019 report: What we heard: A summary of scanning and consultations on what's next for health product regulation. The report identifies various emerging technologies that Health Canada will be considering further, and which Health Canada recognises are challenging current regulatory classification schemes.

For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

Endnotes

(1) Bill C-97, an act to implement certain provisions of the budget tabled in Parliament on 19 March 2019 and other measures.