On March 18, 2020, the federal Minister of Health approved the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The Interim Order, which allows for an expedited review of Health Canada applications for COVID-19 related medical products and expedited market access, was enacted under section 30.1(1) of the federal Food and Drugs Act. This section empowers the Minister to make an interim order where the Minister believes that immediate action is required to deal with a significant risk to health, safety or the environment.
The Interim Order will remain in effect for 14 days and may be extended for up to one year. After one year, the Interim Order may be renewed if required.
Expedited Review by Health Canada of COVID-19 Related Health Product Submissions and Applications
The Interim Order enables Health Canada to expedite the review of submissions and applications, at no cost, for health products that are presumed to diagnose, treat, mitigate or prevent COVID-19. This will provide Canadians with increased access to new investigational treatments, once available.
These efforts by Health Canada align with other federal initiatives, including the National Research Council Canada's (the NRC) Pandemic Response Challenge Program. Through this program, the NRC will receive $15 million to form dedicated research teams to accelerate the development of diagnostics and medical countermeasures in the fight against COVID-19. The program is currently structured around three main research areas: (1) rapid detection and diagnosis; (2) therapeutics and vaccine development; and, (3) digital health. An additional $15 million will be dedicated to the NRC Biomanufacturing Facility, which will be operationally capable of producing up to 100,000 doses of vaccine per month within 6 months, once a suitable vaccine becomes available.
Despite the expedited pathway, Health Canada's Special Access Program (the SAP) remains available to healthcare professionals prior to approval. The SAP allows doctors to gain access to non-marketed drugs and medical devices that have not yet been licensed for sale in Canada including unapproved diagnostic devices and drugs that can identify or support treatment of COVID-19.
The appropriate contact information for COVID-19 related applications or submissions to Health Canada's Review Bureau can be found here.
Expedited Access to COVID-19 Related Diagnostic Laboratory Test Kits and Other Medical Devices
Under the same Interim Order, the Minister of Health has also approved expedited market access to COVID-19 related diagnostic laboratory test kits and other medical devices.
The Interim Order will enable Health Canada to take a simplified approach to approving the importation and sale of medical devices. This will in turn enable healthcare manufacturers to submit their own test kits and related medical devices with faster approval processes. In fact, it has already allowed for immediate access to two new diagnostic test kits: (1) the Roche Molecular Systems Inc. cobas SARS-CoV-2 diagnostic device; and (2) the ThermoFisher Scientific TaqPath" COVID-19 Combo Kit.
Health Canada has set out the particulars required in all applications for the authorization of importation or sale of a COVID-19 medical device, detailed in section 4(1) of the Interim Order. Additionally, Health Canada may also look to approvals by foreign regulatory authorities to expedite approval in Canada. The Minister of Health is required to issue authorization for the importation or sale of COVID-19 related devices where the following criteria are met:
- The applicant has submitted an application to the Minister that meets the mandatory information requirements set out in subsection 4(1) (and if applicable for Class III and IV devices, subsection 4(2)) of the Interim Order;
- The applicant has submitted all additional information or material requested by the Minister, including samples, as permitted under section 9 of the Interim Order;
- The Minister has sufficient evidence to support the conclusion that the benefits associated with the COVID-19 medical device outweigh the risks, having regard to the uncertainties relating to the benefits and risks and the urgent public health need; and
- The Minister determines that the health or safety of patients, users or other persons will not be unduly affected.
Expedited Market Access to Certain Supplies that may Mitigate the Spread of COVID-19
Health Canada has also implemented an additional interim measure, which will allow for expedited market access to certain products that can help to mitigate the spread of COVID-19. In particular, Health Canada is facilitating access to products including hand sanitizers, disinfectants and personal protective equipment (PPE), such as medical masks and gowns, as well as medical swabs, that may not currently meet the organization's regulatory requirements.
Health Canada currently classifies hand sanitizers as natural health products or non-prescription drugs, depending on the product's ingredients. Disinfectants are classified as non-prescription drugs. Class I PPE and swabs are regulated as medical devices. Each of these products are typically subject to regulatory requirements, such as licensing and bilingual labelling. Under the interim measure, Health Canada will allow certain products to be sold in Canada, including:
- Products that are already authorized for sale in Canada, but are not fully compliant with Health Canada requirements, including products that have English-only labels or packaging that differs from what was authorized; and,
- Products that are not authorized for sale in Canada, but are authorized or registered in other jurisdictions that maintain similar regulatory frameworks and quality assurances as Canada.
Additionally, Health Canada is expediting approvals of products, as well as establishment and site licenses related to these types of products.
Under the interim measure, importers and manufacturers are subject to certain notification requirements in order to market products that would otherwise not meet Health Canada requirements:
- Importers who currently have a Drug Establishment License (DEL) or Site License (SL) to conduct activities related to hand sanitizers and disinfectants are requirement to notify Health Canada in advance to advise that they intend to import products. Importers must maintain records that will facilitate product recalls, if necessary.
- Domestic companies that do not currently have a DEL or SL to conduct activities related to hand sanitizers and disinfectants may submit an application for expedited review to Health Canada. Applications will be granted based on an attestation to the requirements.
- Domestic companies that do not currently have a Drug Identification Number or a Natural Product Number for disinfectants or hand sanitizers may submit an application for expedited review to Health Canada.
- Medical Device Establishment License applications for Class I Medical Devices related to COVID-19 may be submitted to Health Canada for expedited review. Authorization will be granted based on an attestation to the requirements.
- Requests to import or manufacture medical devices that may not fully meet regulatory requirements must be submitted to Health Canada.
A list of products that do not fully meet labelling, licensing or packaging requirement, but that Health Canada has nonetheless permitted to be currently sold in Canada under this interim measure, can be found here.
The authors would like to acknowledge the support and assistance of Melissa Morton , articling student at law.
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