Dr. Susan Natsheh, MD, makes an urgent appeal to Canadians to get informed about amendments being proposed to Canada’s Food and Drugs Act. These amendments would compromise the safety standards used for approval of potentially high-risk therapies in Canada. Dr. Natsheh explains how you can make a difference below.
1. Take 5 minutes to express the concerns above to Health Canada.
○ Submit a ‘General Comment’ about “Agile Licensing” at the top of this Canada Gazette webpage by April 26, 2023
– AND –
○ Send that same comment to: Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, 3000A, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: email@example.com)
2. Contact your MP to express your concern about “Agile Licensing”! Demand an immediate re-examination of all Agile Licensing regulations and proposed amendments and demand an investigation into the individuals involved in creating this industry-favoring backdoor that places Canadians at risk of product harm by rushing novel products to the market without first proving their safety and efficacy.
○ Find your Member of Parliament HERE:
Here is sample letter / text for submission to the Gazette/Mr. Bruno Rodrigue:
Attn: Bruno Rodrigue
Office of Legislative and Regulatory Modernization
Health Products and Food Branch
Department of Health, 3000A
11 Holland Avenue
Ottawa, Ontario K1A 0K9
I am contacting you to express my concerns about these proposed regulatory changes and the attempt to push innovation over safety.
Historically Canada has held to the highest regulatory standards by ensuring all medical products were PROVEN SAFE and effective prior to being released to the public, using Randomized Controlled Trials to ensure that the benefits outweigh the risks.
I am opposed to the Part I, Volume 156, Number 51: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) and any other regulatory changes that would remove the requirement that all drugs, medical devices, veterinary and similar products are first PROVEN safe through rigorously conducted randomized controlled trials BEFORE market authorization. I am also opposed to changes that centralize the process and increase the control of a single individual, such as the Minister of Health.
No civilized society would ever sacrifice the safety of their citizens on the altar of innovation.
All Canadians deserve to have a government and bureaucracy that are committed to putting their interests first and maintaining the highest safety standards. Therefore, I insist on an immediate re-examination of the Advanced Therapeutic Products Pathway and all proposed regulatory changes to the Food and Drugs Act, by qualified independent health professionals and public representatives who are free from conflicts of interest and who will ensure that all products are proven safe before being given market authorization.
Health Canada has a fiduciary responsibility to protect Canadians from pharmaceutical abuse and not to promote innovation.
I further insist that the safety of Canadians be re-prioritized by setting prudent, transparent, objective, safety criteria for ALL products and devices that cannot be manipulated for political or economic gain.