Bill C-265: An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)

This bill primarily affects pharmaceutical manufacturers, medical device companies, drug importers and distributors holding establishment or site licences, as well as hospitals, pharmacies, and medical non-profit organizations across Canada. Manufacturers who produce or supply non-marketed therapeutic products will face new reporting obligations — they must notify the Minister within 90 days of any sale made under this program and could be questioned if the Minister suspects they are using the special access list to avoid the standard regulatory approval process. Licensed importers who bring in these products will similarly need to file importation notices and comply with any ministerial orders on storage, transportation, quality control, and record-keeping. For practitioners and pharmacists, the bill streamlines the process for requesting access to listed products but adds mandatory reporting within 90 days of each request, creating new administrative tasks for clinics and hospitals. The size of the business matters — larger pharmaceutical companies and hospital networks will likely have compliance infrastructure to handle these requirements, while smaller importers or specialty pharmacies may need to invest in new tracking and reporting systems.