Regulatory Change to Address Antimicrobial Resistance

On May 17th 2017, Health Canada announced changes to the Food and Drug Regulations regarding the use of antimicrobial drugs in animals. These changes, along with other ongoing initiatives, aim to address the increasing health concern posed by antimicrobial resistance. Microorganisms (such as bacteria, fungi, viruses and parasites) could develop resistance after exposure to antimicrobial drugs and render medicines ineffective against infections. This resistance increases the risk of infections in many important medical procedures such as organ transplantation, chemotherapy, diabetes management and major surgery.

The new regulations for veterinary drugs include:

  • Restricting the personal importation of specific veterinary drugs for food-producing animals;
  • Requiring companies to follow stricter quality guidelines for their active pharmaceutical ingredients;
  • Requiring manufacturers, importers and compounders of veterinary drugs to report annual sales of medically important antimicrobial drugs to Health Canada; and
  • Introducing what is described as a more “flexible and risk-appropriate framework” that aims to make importation simpler for low-risk veterinary health products, including products that may be used as alternatives to antimicrobial drugs.

About 80% of medically important antimicrobials sold in Canada are used in livestock.  These regulatory changes are intended to assist in addressing the transfer of antimicrobial-resistant bacteria to humans through the food chain.

The Regulations have been published in the Gazette and can be found here:

This article was written with the helpful contribution of Heesoo Kim (Summer Law Student).

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