Health Canada’s Health Products and Food Branch, the body that approves drugs and medical devices for the Canadian market, is not known for moving at a clip that can be detected by standard velocity sensors.
That low-tempo standard operating procedure has led to concerns about whether Health Canada will move quickly on the growing list of COVID-19 vaccines awaiting approval.
On Monday, Jansen Inc. became the fourth company, after Pfizer, Moderna and AstraZeneca, to seek approval in Canada for a vaccine that has shown promising results in massive Phase 3 clinical trials around the world.
Authorities in the United States and the European Union have said they expect to green-light at least one of these vaccines this month.
Health Canada has said the same thing, pointing to the Pfizer vaccine as the most likely candidate. That would be an impressively quick turnaround for a heavily bureaucratic regulatory body known for the slowness of its approval process for new drugs.
In 2013, the Fraser Institute measured the time lags between Canada and the EU and U.S., and found that approvals here tended to take significantly longer.
This fact has became something of a flashpoint during the COVID-19 pandemic.
In September, Ontario Premier Doug Ford and the Conservative Opposition in Ottawa accused Health Canada and the federal government of foot-dragging on the approval of rapid testing kits for detecting the SARS-CoV-2 virus.
Their accusations were based on the fact that other countries, such as Germany, Japan and the U.S., had signed off on the rapid tests, while Health Canada hadn’t.
These tests, which can return a result in minutes, could be used by airlines, schools and businesses to screen out infected customers. The tests could even be self-administered at home; critics of Health Canada note they might have made a difference during the Thanksgiving holiday, which appears to have sparked the nationwide spike in cases.
Deputy Prime Minister Chrystia Freeland shot back at the time by boasting that Canada has an independent regulatory body that doesn’t base its decisions on the drugs and tests that other countries choose to approve, and that Health Canada is not subject to political pressure.
Fair enough. Canadians should be grateful for the independence of a process that is critical to their safety. The disaster of Thalidomide, a prescription drug approved too quickly in the 1950s, and which harmed a generation of Canadians, is not something anyone wants to see repeated.
But Canadians should also note that the Trudeau government, in an effort to speed up the approval of drugs that treat and prevent COVID-19, has put in place an expedited review process that explicitly takes into account a vaccine or other drug having been approved overseas.
The emergency policy, signed by the Minister of Health in September, creates “expedited authorization pathways for the importation, sale and advertising of drugs used in relation to COVID-19.” Those pathways include “allowing consideration of a foreign regulatory approval.”
The policy also allows companies to file “rolling applications,” in which they can submit new evidence on the safety and efficacy of a drug as it becomes available, rather than have to wait to file everything at once.
This is a good and necessary idea. The last thing Canadians want is to be sitting on the sidelines, watching other countries put needles into arms, while Health Canada plods along in the name of its independence.
But it also reinforces the fact that, under normal circumstances, Canadians sometimes have to wait too long for the approval of new drugs, some of which may be lifesaving, that are available in other countries.
And it’s telling that the Trudeau government touts the independence of Health Canada, but is also trying to avoid allowing that autonomy to put it in the awkward position of having to explain why the Pfizer vaccine, or any other, is available everywhere but Canada.
Canadians should be glad Ottawa appears to be trying to speed up the approval process for a COVID-19 vaccine. The future is riding on this: The sooner the vaccines arrive, the sooner the pandemic ends. And the sooner the pandemic ends, the sooner the economy can roar back to life. If only Health Canada felt that need for speed in normal times.
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