There are no existing therapies or vaccines to effectively treat or prevent COVID-19, a previously unknown disease that has never been identified in humans until now. This reality has prompted Health Canada to expedite the review of any COVID-19 related health product submission and application to facilitate earlier access to a vaccine or therapeutic product for Canadians.1
The Food and Drug Regulations2 provide an existing mechanism for manufacturers of new drugs to file an extraordinary use new drug submission if the new drug is intended for emergency use to treat, mitigate or prevent a life-threatening or other serious disease or its symptoms that result from exposure to a biological substance. However, the regulatory actions Health Canada is taking specifically in response to the COVID-19 pandemic are likely to provide the most efficient and expeditious route to market authorization for any applicable COVID-19 related health products.
At this time, although Health Canada has announced that it will expedite the review process for applicable submissions and applications, it has not provided any legislation or a formal pathway to support the expedited review process for the medical devices, drugs and/or clinical trials that would be in scope of this initiative. For these health product categories, the strategy appears to be driven at present by direct engagement between interested manufacturers and sponsors with the applicable review bureau at Health Canada. In contrast, an Interim Order3 respecting the importation and sale of medical devices manufactured, sold or represented for use in relation to COVID-19 provides more clarity on how regulatory thresholds have been changed to promote access to imported COVID-19 medical devices.
Under the Interim Order, if an application for the authorization to import and sell a COVID-19 related medical device is approved, and the device is deemed by Health Canada to be urgently needed, the importer would be exempt from the requirements of Part 1 of the Medical Device Regulations4, except for the provisions relating to distribution records and recalls. Further, while the Interim Order sets out a list of application requirements for the authorization to import and sell, if the device is already approved by a foreign regulatory authority and has not been suspended, the applicant is further exempt from including any known information in relation to the quality, safety and effectiveness of the device.
The government will also publish a list of marketed medical devices that have been approved for expanded uses based on urgent need and a determination that the health or safety of patients, users or other persons will not be unduly affected by the expanded use. If these medical devices are also approved for import and sale, importers will additionally be exempt from meeting the requirements of Part 1 of the Medical Device Regulations.
We also note that the federal Bill C-13 (COVID-19 Emergency Response Act) includes amendments to the Food and Drugs Act to empower the Governor in Council to make regulations to prevent shortages of therapeutic products. There are also proposed amendments that may permit the Governor in Council to collect more information related to food, drugs, cosmetics and devices.
Interested manufacturers and sponsors of applicable health products are encouraged to contact Health Canada to use this opportunity to bring their products to the Canadian market and respond to the public health need for products to treat or prevent COVID-19.
1 Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19.
2 C.R.C., c. 870.
3 Interim order respecting the importation and sale of medical devices for use in relation to COVID-19.
Read all our coronavirus-related updates on our COVID-19 guidance for organizations resource page.
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