Health Canada is planning to speed up reviews of some medications by piggybacking on the decisions of foreign regulators, including possibly the U.S. Food and Drug Administration, which has been in turmoil since Donald Trump returned to the White House a year ago.
Ottawa has not yet revealed which foreign drug authorities or which classes of drugs will be subject to the change, outlined in a draft ministerial order designed to quicken the pace of pharmaceutical approvals in Canada.
However, neither the office of Health Minister Marjorie Michel nor Health Canada ruled out including the U.S. FDA on the forthcoming list.
“Health Canada will make decisions on which regulatory authorities it can rely on based on established partnerships and comparable regulatory standards,” said André Gagnon, a spokesman for Health Canada. “The department will also be able to modify the list of trusted regulatory authorities as appropriate.”
The draft ministerial order, which was published just before the holidays, is part of Prime Minister Mark Carney’s commitment to cut red tape in the federal government.
It is also a response to increasingly vocal complaints from the pharmaceutical industry and some patients about how long it takes Health Canada to authorize new drugs, including cheaper generic copies of medicines already on the market.
But some experts warn that relying on the decisions of foreign drug regulators could water down Health Canada’s standards and open the door to reducing the number of scientific reviewers on staff.
Matthew Herder, director of the Health Law Institute at Dalhousie University, said he would be particularly concerned if the current incarnation of the FDA made Canada’s list of trusted foreign regulators. The Trump administration has cut thousands of jobs at the agency and installed some leaders who are skeptical of vaccines.
But Prof. Herder noted that even before the upheavals of the past year, the FDA and other major regulators, such as the European Medicines Agency (EMA), sometimes differed from Health Canada in their assessments of new pharmaceuticals.
“If you look at decisions by the EMA versus FDA versus Health Canada, you actually see a lot of nuance,” Prof. Herder said. “And in a time as volatile as we’re living in, I actually think you want redundancies in the system, not one gatekeeper effectively, which is what this could lead to.”
The draft ministerial order says that Health Canada could rely on foreign regulators in three ways. In one scenario, the Canadian regulator could deem parts of a drugmaker’s submission as already completed if the drug has been approved by a trusted foreign regulator.
In another, Health Canada could draw on elements of in-progress reviews by another drug authority so long as companies file in Canada within 120 days of applying to the other regulator. Finally, Canada could carry out more joint reviews with foreign regulators.
Some of Canada’s peer countries, including Australia, Switzerland, Britain and Singapore, have pathways to approval that rely to some degree on the decisions of foreign regulators, according to the draft order.
Health Canada has been grappling with an increase in the number and complexity of pharmaceutical submissions. On the generics side alone, the regulator saw a 43-per-cent increase in new applications since 2016.
Innovative Medicines Canada (IMC), the industry group for brand-name drug makers, said it was generally supportive of efforts to make the Health Canada approval process faster and more efficient.
Meanwhile, the Canadian Generic Pharmaceutical Association urged Health Canada to prioritize timely reviews and approvals of cheaper generics to help lower the prices patients pay for medications.
Both groups will participate in a public consultation, which runs until Feb. 28, and are watching to see which foreign regulators and drugs Health Canada puts on its initial list.
The order mentions three possible classes of drugs as examples of what could be included at the outset: drugs for pets, drugs for food-producing animals and drugs authorized for children, including pediatric formulations.
The Canadian Veterinary Medical Association said it was “encouraged” by the draft order, as the group had been lobbying for Health Canada to collaborate with foreign regulators to speed up approvals and address drug shortages. However, the association said it still needed to see the final details of the order.
Adam Houston, an adjunct professor of health law at the University of Ottawa, hopes a streamlined process will persuade pharmaceutical companies to apply to sell in Canada child-friendly formulations of certain drugs that are authorized elsewhere, such as drugs for tuberculosis.
“Health Canada is pretty good at being the bouncer at the nightclub,” Prof. Houston said, in that it keeps out drugs that are unsafe or ineffective. “But if there’s something really good that we want to have, they can’t drag you inside.”