Alberta may circumvent Health Canada to gain access to COVID-19 tests and drugs, premier says
Dr. Theresa Tam says Health Canada has 'significant concerns' about the quality of some tests
Albertans should have access to COVID-19 tests, medicines and vaccines approved by trusted regulators in other countries, Premier Jason Kenney says.
On Monday, Kenney said products approved by European or American health regulators should be available for use in Alberta even while awaiting Health Canada's approval.
"The direction I've given our officials is if we see a highly credible regulator, medications in a peer jurisdiction like the European Union, Australia or the United States that has approved a test or a vaccine or medication, we should pursue that," he said on CBC's Power and Politics. "We should not wait for Health Canada to catch up."
His comments were an affirmation of a similar tweet he posted on Sunday in response to a story Health Canada was reviewing a blood test already in use in the U.S. to detect COVID-19 antibodies.
Agreed, <a href="https://twitter.com/jackmintz?ref_src=twsrc%5Etfw">@jackmintz</a>.<br><br>I have directed our officials to consider use of COVID19 tests, vaccines, or medications that have been approved by the high standards of at least one credible peer country’s drug agency, e.g. <a href="https://twitter.com/EMA_News?ref_src=twsrc%5Etfw">@EMA_News</a>, <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a>. We won’t wait for Health CDA to play catch up <a href="https://t.co/eYFSf7bbx2">https://t.co/eYFSf7bbx2</a>—@jkenney
Public health experts have said that widespread, rapid testing for COVID-19 antibodies could help identify which people have already developed immunity for the deadly novel coronavirus. It could help guide decision making about reopening businesses or schools.
Canada's chief public health officer, Dr. Theresa Tam, said Health Canada already has a mechanism to quickly evaluate the safety and effectiveness of health products approved in other developed countries.
She also said Health Canada has "significant concerns" about the quality of some of the existing rapid antibody test kits and that products require an independent Canadian review.
The U.S. Food and Drug Administration waived its usual initial review process to allow blood antibody tests to reach the market quickly during the pandemic, the Associated Press reported.
More than 70 companies have now signed up to sell the rapid test kits in the U.S. However, in Texas, the federal government seized 20,000 test kits purchased by the city of Laredo after determining the results were unreliable.
On Monday, Kenney also criticized Tam's response to the pandemic.
He said the Canadian government was wrong to keep national borders open to travellers from countries hit earlier by COVID-19.
"This is the same Dr. Tam who is telling us that we shouldn't close our borders to countries with high levels of infection and who in January was repeating talking points out of the PRC [People's Republic of China] about no evidence of human to human transmission," Kenney said.
Can Alberta evaluate health products alone?
University of Calgary professor Lorian Hardcastle, an expert in health law, said Kenney's statements are problematic on several fronts.
She said the premier extrapolated an issue about Canadians' access to one test to create the impression the federal agency is slowing access to potential drugs or vaccines. There are no approved drugs or vaccines for COVID-19 yet, she said.
She said standards differ between countries, and a product approved elsewhere may not meet Health Canada requirements.
Hardcastle also questioned whether provinces have the constitutional authority to regulate drugs and health products. Alberta would need to develop its own agency, regulations and expertise, she said. Importing drugs is also under federal government control, which creates a logistical hurdle, she said.
"Provinces don't have any experience in testing the safety of drugs and approving drugs," she said. "To send the message to Albertans that Alberta could all of a sudden do a better job of getting Canadians better access to devices and drugs, I think is very false."
University of Alberta health law professor Timothy Caulfield was also baffled by how Alberta might regulate drug or vaccine approval on its own.
Kenney's comments inappropriately bolster misinformation circulating on social media contending that regulators are withholding proven COVID-19 treatments from the public, he said.
An ineffective test kit hitting the market could be more problematic than a delay for a valid one, he said.
"There is a reason we have a regulatory system," Caulfield said. "There's a reason we want good evidence before we deploy them."
Provincial government press secretaries did not answer questions Monday about how the province would assess the efficacy or safety of drugs or devices unapproved by Health Canada or whether Alberta has the jurisdiction to do so.
Dr. Lynora Saxinger, an infectious diseases professor at the University of Alberta, said in an email Monday labs already can and do adopt medical tests without Health Canada approval.
However, the labs need to validate the tests before they can use them, and smaller centres may have fewer resources to do that necessary confirmation work.
With files from The Associated Press