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e-4448 (Health)

Initiated by Susan Natsheh from Owen Sound, Ontario

Original language of petition: English

Petition to the Government of Canada

  • Canada has held to the highest regulatory standards by ensuring all medical products were proven safe and effective prior to authorization through randomized controlled trials;
  • Canada created ‘Agile Regulations’ permitting approval of novel therapeutic products that fulfill a minimal level of evidence showing their benefits outweigh their risks and their risks will be adequately managed and controlled, replacing the pre-market requirements for proven safety with post-marketing monitoring of harm;
  • These novel medical products, classified as Advanced Therapeutic Products (ATPs), may include potentially high-risk products such as gene editing, 3D bioprinting, and nanotechnology;
  • Proposed amendments to Canada’s Food & Drugs Act published in the Canada Gazette, Part I, Volume 156, Number 51: ‘Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)’ seek to further strengthen the ATP framework; and
  • Amendments of concern are those granting potential expedited access to drugs for public health emergencies, emerging infectious diseases, or the prevention and diagnosis of serious diseases or conditions, thereby permitting use of potentially harmful products in healthy adults, children, and livestock.
We, the undersigned, citizens of Canada, call upon the Government of Canada to stop the authorization of any therapeutic product for use in healthy Canadians and livestock that has not first been proven safe and effective through rigorously conducted randomized controlled trials, and permit re-examination of the Agile Regulations and all proposed regulatory changes to the Food and Drugs Act by qualified, independent health professionals and public representatives free from conflicts of interest.
Open for signature
May 25, 2023, at 9:02 a.m. (EDT)
Closed for signature
June 24, 2023, at 9:02 a.m. (EDT)
Photo - Dean Allison
Niagara West
Conservative Caucus