As COVID-19 is again spreading uncontrollably, millions of Canadians are clamouring for rapid self-tests. The Omicron variant finally swept aside the suspicions of provincial public health agencies toward rapid tests, as they now hand out the few they have.
Many rapid test manufacturers who sell them globally would like to sell them in Canada. They can’t, however, because our inappropriate regulatory approval framework obstructs them — including Canadian manufacturers.
Consider that mRNA vaccine trials results were announced in late November 2020, and following Health Canada approval less than a month later on Dec. 9, they were in use by mid-December.
Rapid antigen tests, which carry no risk of bodily harm or side effects, were available since summer 2020. Only a dual surge of Delta and Omicron led to a handful being abruptly approved for self-testing, within two weeks in December 2021.
Initially, rapid tests were only authorized for administration by a health professional within the first few days of the onset of symptoms. Yet the potential for asymptomatic screening was already demonstrated in 2020 following the success of the mass testing in Slovakia, and of the pop-up testing by community volunteers in Nova Scotia. Rapid self-tests became available throughout Europe in spring 2021, and in Germany hundreds of rapid tests were approved, including 40 for self-testing, with some costing less than one euro (about $1.40).
For rapid antigen test approval, Health Canada simply adopted the template from the American FDA from July 2020, without considering the Canadian context of a smaller health-care market fragmented by provincial barriers. This led to a paradox, with Health Canada becoming Dr. Jekyll and distributing millions of tests free and then transforming into Mr. Hyde and blocking wider access and availability through misguided, counterproductive regulatory guidelines.
The root cause of this paradox is the refusal to recognize rapid tests as a “screening tool” to identify those at high risk of transmitting the virus. We have known since June 2020 that testing frequency and time-to-result are more important than sensitivity in stopping transmission, because the infectious period is only a few days and is particularly high when people are still asymptomatic. For this reason, cheap, easy-to-use and freely available rapid tests — not centralized polymerase chain reaction (PCR) tests with delayed reporting — are needed, along with other measures, to proactively stop the spread.
Health Canada still insists on regulating rapid tests as a “medical diagnostic” using overly stringent and unworkable criteria derived from PCR testing, rather than on their ability to diagnose contagious patients and cut chains of infection. The consequences are that only a few rapid antigen tests have been approved and remain costly, and that the process favours large multinational companies. Only one of the many Canadian companies received approval, and only for administered tests — yet its kits are now distributed widely and used primarily for self-testing.
To escape from this dead-end and gain access to rapid tests, Health Canada could temporarily (and extraordinarily) authorize ones approved in other jurisdictions, such as Germany or the U.K. In parallel, the approval guidelines should be overhauled, considering rapid tests as a public health screening tool that must be fast, cheap and with low false positives for frequent testing, and abandon the biased comparison to PCR for a true comparison to tried and proven rapid tests.
Further, we must consider the socio-economic ramifications, preparedness for future pandemics, and our dependence on foreign manufacturers that we also faced with vaccines and are trying to correct at the cost of billions. Both PCR and rapid antigen tests have been proven for decades, and new generations of more performant tests have emerged thanks to strategic governmental initiatives — but not in Canada.
Our strategies must be guided by scientific progress, innovation and risk-benefit analysis. Health Canada has a critical role to play, and must adapt to a changing world to allow the Canadian public and manufacturers to participate actively in stopping the pandemic, thanks to widely and freely available rapid tests.
DAVID JUNCKER IS A PROFESSOR AND CHAIR OF THE BIOMEDICAL ENGINEERING DEPARTMENT AT MCGILL UNIVERSITY. DON VINH IS A CLINICIAN-SCIENTIST OF INFECTIOUS DISEASES AND MEDICAL MICROBIOLOGY AT MCGILL UNIVERSITY HOSPITAL CENTRE.
Health Canada could temporarily (and extraordinarily) authorize ones approved in other jurisdictions, such as Germany or the U.K.