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
What you need to know
Clinical trials for drugs and devices. Health Canada will expedite applications to get novel devices and therapies into clinical trials and to allow access to these therapies under controlled circumstances. Once the trials produce enough safety and efficacy evidence to support a full market authorization, Health Canada will work with sponsors to expedite the development and authorization of these products.
Medical devices. Medical devices indicated to diagnose, treat, mitigate or prevent COVID-19 will be eligible for expedited review. Health Canada may authorize expanded use of medical devices already on the market if there is an urgent public health need and if there is evidence that the benefits associated with the expanded use outweigh the risks.
Import and sale of medical devices. COVID-19 related medical devices approved for import and sale would be exempt from most of the requirements of Part 1 of the Medical Device Regulations. Additionally, if the device is already approved by a foreign regulatory authority and has not been suspended, information relating to the quality, safety and effectiveness of the device would not be required when applying for authorization to import and sell.
Special Access Program. The Special Access Programs for Drugs and Medical Devices are available to healthcare practitioners to facilitate access to drugs providing supportive treatments to the infection, or diagnostic devices to identify COVID-19 until a vaccine or therapeutic product is commercially available.
Importance of risk benefit analysis. Manufacturers and sponsors of COVID-19 related health products can file a submission or application by contacting the appropriate review bureau at Health Canada. The success of any application or submission under expedited review will turn on the quality and sufficiency of safety and efficacy data. However, given the unique circumstances, a risk-benefit analysis will play a more significant role now than it has previously if Health Canada wishes to meet the urgent public health need.
Government responds to urgent need for COVID-19 health products
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.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.