The proposed amendments to the were published in the Canada Gazette at the start of the month and are open to comment from industry and the public at large until 14 September 2016. At that point responses will be considered and steps will be taken to allow for the publication of the final revisions in 2017, said Rebecca Gilman, a spokesperson for Health Canada.
“During this time, Health Canada will ensure that any appropriate implementation materials (e.g. guidance, forms, databases, webpages, etc.) are developed for those parties that would be impacted by the regulatory changes,” she told FeedNavigator.
Antimicrobial resistance is a serious and growing public health threat in Canada and around the world, said the agency. It said Canada's Food and Drug Regulations (FDR) currently do not provide the necessary regulatory oversight of antimicrobials for veterinary use to mitigate the risk of AMR.
The amendments to the FDR would
- require veterinary active pharmaceutical ingredients (APIs) imported or sold in Canada to be manufactured in accordance with good manufacturing practices (GMPs);
- require persons who import, fabricate, package, label or test veterinary APIs to do so in accordance with an establishment licence (EL);
- restrict the own use importation of unauthorized veterinary drugs;
- require manufacturers, importers and compounders of veterinary antimicrobials to provide sales volume information by species; and introduce an alternative, less burdensome pathway for manufacturers to legally import and sell certain low-risk veterinary drugs, known as veterinary health products (VHPs), that could reduce the need for antimicrobials.
“The proposed regulatory changes focus on medically important antimicrobials that are used in animals, which are also important in human medicine,” said Gilman. “The steps being taken to improve prudent use of veterinary antimicrobials will have a positive impact on human health.”
Antibiotic resistance concerns
Antimicrobial products have been defined as those drugs that can be used to destroy or inhibit a micro-organism, said Health Canada. Currently in Canada, more than three quarters of the antimicrobials sold are intended for use in animals and 90% are used either for growth promotion or to prevent disease and infection.
The growth and spread of bacteria that are resistant to antimicrobial treatments is a public health threat, the agency said.
It estimated that, in Canada in 2013, about 1.6m kilograms of antimicrobials were distributed for use in animal production alone. “Overuse and misuse of antimicrobials as well as the use of sub-potent antimicrobials resulting from inadequate quality controls are main contributors to the development of AMR [antimicrobial resistance],” it added.
The revisions also aim at expanding the data collated about antimicrobial use to better track the potential for antimicrobial resistance, the agency said. Manufacturers and importers of products that can be used for both people and animals would have to report on a yearly basis the amount of a treatment sold and for what animals.
“This proposal aims to address the lack of information on the type and volume of veterinary active pharmaceutical ingredients that are being imported or used in Canada,” said Gilman. “Sales volume data would be an important tool in supporting our current surveillance programs.”
The proposed regulatory changes are being done to complement other policy work, including labeling changes, that address use of antimicrobials for growth promotion, she said. “The label changes will make these products accessible pursuant to prescription by licensed veterinarians,” she added.
“It is also important to note that, once a veterinary drug has been reviewed and approved by the Department for sale in Canada, the use of the drug is under provincial jurisdiction and the practice of veterinary medicine,” she said. “Any subsequent use of such products for growth promotion would be considered extra-label drug use.”
The proposed regulations are anticipated to cost industry and government CAD$41.6m in net present value over 10 years.
The quantified costs relate to new GMP and EL requirements that would be levied against persons who import, fabricate, package, label or test veterinary APIs; a requirement to submit sales volume and species data of antimicrobials sold in Canada; and costs to Health Canada relating to new compliance and enforcement activities.
The agency said the non-quantifiable benefits of the proposed regulations include domestic and international consumer confidence in the livestock and poultry sectors; a reduction of the incidence of antimicrobial-resistant bacteria; a reduction in environmental residues of antimicrobials; and the introduction of alternative products through the proposed pathway for VHPs.