I'd like to thank the committee for inviting Health Canada to discuss the issue of antimicrobial resistance with a particular focus on our implementation efforts as part of the federal framework and action plan on AMR.
Thank you, Dr. Njoo, for the overview of the strategy in the first presentation.
I am pleased to be here today to discuss with you this global public health issue and the actions we are taking to address it from the veterinary drug, as well as human drug perspectives. The activities I will cover today are important and tangible deliverables under the stewardship, surveillance, and innovation pillars described in the previous presentation.
I'll begin by emphasizing the important role that Health Canada plays in protecting human and animal health and ensuring the safety of Canada's food supply.
Through the veterinary drugs directorate and therapeutic products directorate, we review and authorize all new antimicrobial drugs used in animals and humans. We monitor the safety of marketed products, and we require companies to amend product labelling with new information, including information related to AMR as it becomes available.
It is important to remember that Health Canada provides market authorization for the sale of drugs, while the use is regulated by the provinces and territories under the practice of medicine and veterinary medicine. There are also provincial and territorial rules pertaining to the distribution and dispensing of drugs.
As Dr. Njoo discussed, the inappropriate antimicrobial use and overuse in humans, animals, and plants is leading to increases in the emergence and spread of AMR. Health Canada's goal is to promote the responsible use of antimicrobials to reduce the development and spread of resistant bacteria, as well as help preserve the availability of effective antimicrobials for future generations.
I'll now focus on our efforts to address AMR in the animal context, as this is one of my key responsibilities within the veterinary drugs directorate and also because in Canada an estimated 70% of all medically important antimicrobials, which means those that impact human medicine, are sold for use in food-producing animals.
We have made significant progress in building an evidence-based approach to assessing the antimicrobial resistance risks from antimicrobials approved for sale in Canada. Since 2004, our ongoing actions include the implementation of specific requirements for the assessment of new veterinary antimicrobial drug submissions for antimicrobial resistance risks when used in food-producing animals.
The categorization of antimicrobials into four categories is based on their importance in human medicine. For example, category I antimicrobials are of very high importance in human medicine; category II are high importance, and category III are of medium importance. This categorization has helped us to better manage the risks. For example, all category I antimicrobials have specific warnings on the labels recommending against extra label drug use.
The surveillance data from the Public Health Agency of Canada's antimicrobial resistance surveillance program supports the veterinary drugs directorate's market and post-market safety assessments of veterinary antimicrobial drugs.
To encourage the prudent use of antimicrobials in animals, the veterinary drugs directorate works collaboratively with stakeholders, such as the provincial and territorial authorities, veterinarians, industry, and food animal producers.
In addition, we are also making significant progress on important regulatory and policy changes to increase the oversight and promote the responsible use of antimicrobials in animals.
Final regulatory changes to the food and drug regulations were published in the Canada Gazette, part II, on May 17 of this year. These changes focus on four key measures.
First, we are increasing oversight on the personal importation of unapproved veterinary drugs for food-producing animals. This means that, moving forward, only those drugs that Health Canada has determined do not pose a risk to public health or food safety may be imported and only in limited quantities. For example, our eligibility criteria do not allow for the importation of prescription drugs or medically important antimicrobials.
Second, we are increasing oversight on the importation and quality of active pharmaceutical ingredients for veterinary use by requiring compliance with good manufacturing practices and establishment licences to conduct these activities.
Third, we are requiring that manufacturers and importers report annual sales of medically important antimicrobials for veterinary use, to support our surveillance programs. This information will help provide a better understanding of the volume of antimicrobials available for use in animals in Canada and support the analysis of patterns and trends of antimicrobial resistance.
Fourth, we are introducing an alternative, less burdensome pathway for companies to import and sell low-risk veterinary health products, such as vitamins, minerals, and botanicals, as additional health management tools. We know that promoting the health and welfare of animals can help reduce the need for antimicrobials down the road.
These regulatory changes will come into force through a phased approach, starting in November of this year, and we will continue to work with stakeholders to help prepare everyone so that we have a smooth transition.
To complement the regulatory changes, we are also working with provincial and territorial authorities and other stakeholders to make important policy changes to promote the responsible use of antimicrobials in animals. These include two key measures.
First, we are proposing to move all medically important antimicrobials from over-the-counter to prescription status. This means that a prescription will be needed from a veterinarian before one is able to purchase the drug.
Veterinarians who prescribe for animals under their care possess the scientific and clinical training to assess the health of animals, diagnose disease conditions, determine the need for antimicrobial drug treatment, and choose the most appropriate course of treatment. Consequently, involving the veterinarians in antimicrobial treatment decisions is a very important component of enhancing antimicrobial stewardship. This is also an internationally recognized best practice. Already, since 2004, new medically important antimicrobials approved by Health Canada are required to be sold pursuant to a prescription. With this proposal, we will establish the same level of oversight for those remaining medically important antimicrobials that, in some cases, were approved decades ago.
Second, we are removing growth promotion claims from the labels of medically important antimicrobials. This is in line with international best practices or principles that these important drugs should not be used to promote weight gain in animals and should be reserved only for treating and preventing diseases.
These two measures will be rolled out concurrently, since they will both require changes to labelling. For example, companies that need to add the “Pr” symbol to labels to identify them as a prescription drug as well as remove growth promotion claims will be able to do so at the same time.
We are proposing to roll out these changes between now and 2018 so that, for example, provinces and territories, which have oversight on the distribution and dispensing of the drugs, will have enough time to make needed changes and also so that end users, such as farmers, are aware and prepared. These changes require extensive consultation and collaboration, and we are making significant progress on this.
Both the regulatory and policy measures are important elements of the federal antimicrobial resistance action plan and have been developed over many years of collaboration with stakeholders and experts in Canada. We all have a role to play, and the prudent use of antimicrobials in animals is a shared responsibility across governments, industry, veterinarians, and the agriculture sectors. We continue to collaborate with all stakeholders to ensure an effective and smooth implementation of these measures that I've just described.
Switching now to the human drug context, I'd like to share with you an update on the progress being made for human use antimicrobials. Under the stewardship pillar, work began in 2015 and will wrap up in late 2018 to include standard antimicrobial stewardship statements to all currently marketed antibiotics to encourage the prudent prescribing and use of these drugs.
Specifically, we are adding text to remind physicians to check for susceptibility of bacterial infections prior to prescribing an antibiotic. We are also adding text to the patient medication information leaflet to inform patients that they should take their antibiotic exactly as directed by their doctor and should not share their medication.
In order to manage the large number of antibiotics on the market, the prudent use statements are being added in a phased approach, starting with antibiotics that have the highest prescribing in adults and children, as well as those of last resort. This is being followed by antibiotics important for treating resistant pathogens in the community, and then all remaining antibiotics.
Beyond labelling changes, we're working with the Public Health Agency of Canada on awareness and education materials about the responsible use and exploring how best to reach physicians and patients.
In conclusion, Health Canada is continuing to take concrete steps to address AMR risks related to the use of antimicrobial drugs with a “one health” approach. Our main goal is to ensure that safe and effective antimicrobials remain available on the market for treating infections for generations to come.
The department is committed to both ongoing collaboration with its partners and stakeholders on limiting and controlling the emergence and spread of antimicrobial resistance and ensuring the continued protection of the health and safety of Canadians and their food supply.
I thank you for your time, and I would be pleased to answer any questions you may have.