Health Canada is proposing regulatory changes to pharmaceutical product approvals under the guidance of Health Minister Jean-Yves Duclos, former Minister of Industry with a background in economics.
The regulations are being made under the Food and Drugs Act Agile Licensing. More broadly, this licensing will expedite the drug approval process that some criticize as prioritizing industry over the health and safety of Canadians.
It makes the rolling submissions (like those instituted with the emergency use authorization of the novel COVID-19 injections) permanent by essentially granting pharmaceutical companies the ability to submit safety data on a rolling basis. This means that rigorous safety testing is not necessarily conducted prior to market rollout, but rather collected in real-time.
Retired pediatric physician Dr. Susan Natsheh joined Rebel News to discuss the impact that these changes would have on the Canadian public.
The regulations refer to innovation with “advanced therapeutic products,” something Natsheh says have not been well defined.
“That’s part of the amendment that they’re trying to decide upon is which products will fit into these categories. What we do know is that they’re novel products and in a number of documents there are suggestions of products which may be included.”
One such document was produced by Health and Biosciences called Targeted Regulatory Review – Regulatory Roadmap.
“They list products such as artificial intelligence, nanotechnology and gene editing as examples of therapeutic products that will be included under these advanced regulatory products,” explains Natsheh.
A key component of this is what Natsheh refers to as a back-door pathway; changes that were brought forward by Duclos when he was the Minister of Industry in 2019, which allowed products to be put on the market without first proving safety or efficacy.
“This new pathway allows for novel therapeutic products which have unknown side effects and implications to bypass that traditional route and access the public as long as the Minister of Health and Health Canada has evidence to support the conclusion that the associated benefits of the products outweigh the risk.”
Of course the motive is to expedite products to market faster – but physicians are left wondering if the public or the manufacturers benefit from the expedition of novel drugs.
This legislation also pertains to veterinary products which means that novel products have the potential to enter the food supply.
Natsheh says the uncertainties are concerning, given that they could manifest into harms.
And how will potential harms be managed?
The “quest for economic gain should not compromise our health regulations which are a safety net for the Canadian public against harms from therapeutic products,” says Natsheh.
“They did everything [over the last three years] out of an abundance of caution to keep us safe but now it seems like they’re introducing these regulations which I consider to be de-regulations; they are pulling apart the very essence of our safety net to protect the Canadian public.”
If you agree with Dr. Natsheh that upholding the true meaning of the words safe and effective means that novel products are not rammed through to Canadian markets by the same companies who will profit from their use and sale, then consider signing the petition sponsored by conservative MP Dean Alison to send a message to the government that disregarding robust safety nets is not acceptable.
After all, it is said that Canada should institute more independent oversight throughout the regulatory process to minimize conflicts of interest, not less.
*It has been reported that the link to confirm a signatory email address in order to sign the petition listed above does not work. If that is the case, please e-mail [email protected] to notify them.