Federal Action Plan on Antimicrobial Resistance and use in Canada
Health Canada (HC) has held consultation on proposed changes to the Food and Drug Regulations to help address the issue of antimicrobial resistance (AMR) in the veterinary drugs context. Antimicrobial resistance is a serious and growing health threat to humans and livestock in Canada and around the world. The AMR regulatory proposal reflects feedback received during a broad range of consultations with stakeholders over the years, and it will be important to continue this level of cooperation going forward.
The following is a “without prejudice” interpretation of considerations in progress.
The current system of importing Active Pharmaceutical Ingredients (APIs) will stop as it exists. There will be new regulations on the importation and use of APIs. This may not affect horse owners.
Antimicrobial Sales Reporting currently has virtually no information that is of any value. With the new regulatory changes, it will be mandatory to collect sales data from manufacturers, importers and compounders of antimicrobial APIs. This may have no effect on horse owners, but will provide HC with the necessary information to develop meaningful policy.
Own Use Importation veterinary drugs from the USA will be tightened up dramatically. The imported drug will be required to be on an approved list that meets their 7 criteria. (See the Explanatory Notes). This may not affect horse owners.
Veterinary Health Care Products (non-prescription). We cannot comment on this, and do not know if it will affect horse owners.
In addition, there are some other changes that HC has proposed through its Federal Framework for Action to address antimicrobial resistance.
ACTION 1: Establish and strengthen surveillance systems to identify new threats or changing patterns in antimicrobial resistance and use, in human and animal settings.
ACTION 2: Strengthen the promotion of the appropriate use of antimicrobials in human and veterinary medicine.
ACTION 3: Work with the animal agriculture sector partners to strengthen the regulatory framework on veterinary medicines and medicated feeds, including facilitating access to alternatives and encourage the adoption of practices in order to reduce the use of antimicrobials.
ACTION 4: Promote innovation through funding collaborative research and development efforts on antimicrobial resistance both domestically and internationally.
It is possible the only Action items that will affect the horse owner directly are Action 2 and 3.
On or before December 2016, Health Canada (HC) and CFIA may implement the requirement to increase veterinary oversight of antimicrobials drugs deemed to be important to the livestock industry. Horses are not typically medicated by medications added to feed and water therefore affects to the horse industry may not be a major threat.
There is also discussion regarding what veterinary oversight will look like overseeing the dispensing of veterinary antimicrobials not in the feed or water.
In 2017 HC may implement measures to address own use importation of veterinary drugs.
In 2017 HC may strengthen the control over the importation of APIs.
It has been stated that all antimicrobials will become “by prescription only”. This will affect the horse owner in that penicillin and tetracycline products will only be available through a veterinarian and only by prescription. Other antimicrobials are already by prescription, so this will not change.
Links for more information
Official Health Canada consultation – Consultation on new regulations for antimicrobial resistance (AMR) related to veterinary drugs
Federal Action Plan on Antimicrobial Resistance and use in Canada, Building on the Federal Framework for Action
Antimicrobial Resistance and Use in Canada: A Federal Framework for Action
Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance)
2015 Spring Reports of the Auditor General of Canada Antimicrobial Resistance