A new plan to force hospitals to report adverse effects of "natural health products" such as herbal remedies and supplements has come as a surprise to manufacturers, who say they were blindsided by the proposed change.
The federal government included the plan in the 2023 budget bill, which is still making its way through the House of Commons.
It would see natural health products fall under the same category as pharmaceuticals when it comes to how they are monitored once they are on the market.
They would be incorporated into Vanessa's Law, which was passed in 2014 to improve the reporting of adverse health reactions.
It was named after 15-year-old Vanessa Young, the daughter of a Conservative member of Parliament, who died in 2000 after her heart rate had been affected by medication that was prescribed by her doctor.
Putting natural health products under that framework would require hospitals to report on any unintended consequences associated with them, so that Health Canada can recall them or order fixes if necessary.
Vanessa's Law would also let Health Canada demand that manufactures make changes to their labels and recall unsafe products.
The provisions had been discussed before, said Aaron Skelton, president of the Canadian Health Food Association. But "there was nothing that would have indicated to industry that it was imminent," he said.
"The industry and the association were both caught off guard when we saw that included in the budget."
The debate about whether to include natural health products in Vanessa's Law when it was first introduced generated "quite the discussion" on Parliament Hill at the time, Sen. Judith Seidman, who sponsored the original bill in the Senate, told her colleagues at a recent committee hearing.
The government at the time decided against doing so.
Since then, several high-profile tragedies that saw parents and patients eschew conventional medicine in favour of natural remedies have prompted a renewed national conversation about the regulation of natural health products in Canada.
In 2021, the federal auditor general found that Health Canada fell short of making sure products were safe and effective, and that gaps in the monitoring of products on the market left consumers exposed to potential health and safety risks.
"I think post-market surveillance and monitoring for safety around natural health products is urgent," Seidman, an epidemiologist and health researcher, told the Senate committee earlier this month.
The decision to include natural products hasn't been properly studied or debated, Skelton said, and has instead been tucked into an omnibus budget bill.
"We have seen no consultation efforts to persuade us that the regulatory powers conferred in Vanessa's Law would be appropriate for the lowest-risk products, such as natural health products," he said.
Skelton argued manufacturers are already responsible for reporting any ill effects associated with their products, and Health Canada already has the power to stop sales and seize products.
But Patients for Patient Safety Canada says there is little data to help Health Canada hold companies accountable.
"We have no recourse," said Katharina Kovacs Burns, co-chair of the volunteer patient-advocacy organization.
"There's no reporting on side effects, there's no follow up, there's no nothing for natural health products to this point — not the same way that there is with the other prescriptive drugs or other therapeutic products that are much more regulated," she said.
Kovacs Burns said her group was not consulted on the legislative change either.
There were no formal consultations, but the government plans to hear from industry and patient groups when it puts together the regulations that will go along with the change, said Guillaume Bertrand, a spokesperson for Health Minister Jean-Yves Duclos, on Thursday.
Duclos said the change is meant to address the fact that not all products are equally safe for consumption.
"The objective is to make sure that all health products, different types and different formulations, are treated the same way, so Health Canada has the ability, if needed, to intervene in circumstances in which the health and safety of Canadians at stake," the minister said at a press conference in Sudbury on Tuesday.
While natural health products are considered lower-risk than some prescription drugs, the Canadian Pharmacists Association has repeatedly tried to reinforce that there is still some risk in using them.
Ginseng, for example, which is often used in hopes of boosting the immune system, has been associated with some cases of increased blood pressure, the association's Barry Power told Senators at committee this month.
He also pointed to cases of bleeding associated with ginkgo biloba, which is thought to increase memory function — a potentially serious side-effect for older people who also use anticoagulants that thin the blood.
The plan outlined in the budget is the latest in several regulatory changes the government has introduced to tighten rules about how products are marketed and sold to Canadians, including changes to the way products are labelled.
This report by The Canadian Press was first published May 25, 2023.
Laura Osman, The Canadian Press