(OTTAWA) A new federal measure that would require hospitals to report adverse reactions to “natural health products” has surprised manufacturers, who say they were taken aback by the proposed change.
The federal government included this measure in the omnibus Budget Implementation Bill 2023, which is still pending in the House of Commons.
The government is proposing to amend the Food and Drugs Act so that natural health products, such as herbal remedies and supplements, fall into the same category as pharmaceuticals in terms of how they are monitored once they are on the market.
According to the government, these changes would allow regulators to take “stronger action” when health or safety issues are detected with respect to natural health products on the market.
These natural health products would actually be governed by the Protecting Canadians from Unsafe Drugs Act, nicknamed “Vanessa’s Law,” which was passed in 2014 to improve the reporting of adverse health effects.
The law is named after Vanessa Young, the daughter of a Tory MP who died in 2000, aged 15, after her heartbeat was disrupted by medication prescribed by her doctor.
Including natural health products in this legislative framework would require hospitals to report any unintended consequences associated with them, so that Health Canada can recall them or order corrective action if necessary.
These provisions had been discussed before, but “there was no indication that it was imminent,” said Aaron Skelton, president of the Canadian Health Food Association. “Both the industry and the association were taken aback when we saw this measure in the budget. »
When first introduced, whether to include natural health products in “Vanessa’s Law” sparked “quite a debate” on Parliament Hill, Senator Judith Seidman recalled recently, who had sponsored the original bill in the Senate. The government of the day had finally decided not to go ahead.
Since then, several high-profile tragedies, which have seen parents and patients abandon conventional medicine in favor of natural remedies, have sparked a new national debate about the regulation of natural health products in Canada.
” It is urgent to take action ”
In 2021, the federal Auditor General found that Health Canada had failed to ensure products were safe and effective, and that gaps in monitoring products on the market were exposing consumers to health risks and security.
“I think there is an urgent need to monitor natural health products after they are marketed and to monitor their safety,” said Senator Seidman, an epidemiologist and health researcher, earlier this month. to a Senate committee.
Vanessa’s Law would also allow Health Canada to require manufacturers to change their labels and recall any unsafe products themselves.
Skelton argues that manufacturers are already responsible for reporting any adverse effects associated with their products and that Health Canada already has the power to stop sales and seize products. The decision to include natural products was not properly studied or debated, he said, before being camouflaged in the omnibus budget bill.
We saw no consultation effort to persuade us that the regulatory powers given by Vanessa’s law would be appropriate for low-risk products, such as natural health products.
Aaron Skelton, President of the Canadian Health Food Association
Patients for Patient Safety Canada says there is little data to help the Department of Health hold companies accountable. “We have no recourse,” said Katharina Kovacs Burns, co-chair of the volunteer organization.
“There’s no reporting of side effects, there’s no follow-up, there’s nothing for natural health products so far — not in the way that there are. has with the other prescription drugs or other therapeutic products that are much more regulated,” she said.
Mme Kovacs Burns said his organization was also not consulted on the legislative change.
In the office of the Minister of Health, Jean-Yves Duclos, it was confirmed Thursday that there had been no formal consultations. Spokesperson Guillaume Bertrand said the government plans to hear from industry and patient groups when it comes up with the actual regulations that will accompany the legislative change.
Minister Duclos had explained earlier this week that the change was intended to address the fact that not all products are equally safe for consumption.
“The goal is to ensure that all health products, of different types and different formulations, are treated the same way, so that Health Canada has the ability, if necessary, to intervene in circumstances where health and safety of Canadians are at stake,” Duclos said at a press conference in Sudbury on Tuesday.
Although natural health products are considered less risky than some prescription drugs, the Canadian Pharmacists Association has repeatedly tried to point out 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 linked to some cases of increased blood pressure, Barry Power of the pharmacists’ association told Senators earlier. this month.
He also pointed to cases of bleeding associated with ginkgo biloba, which is believed to boost memory – a potentially serious side effect for older people who are also using blood thinners.
The measure proposed in the budget is the latest in a series of regulatory changes the government has introduced to tighten the rules on how products are marketed and sold to Canadians, including labeling.