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Availability of Veterinary Medicines

Access to and the availability of veterinary medicines is critical to keeping our pets and food-producing animals healthy.

Availability of Veterinary Medicines

Availability of Veterinary Medicines

Factors Impacting Availability

Canada currently faces a number of challenges with respect to maintaining and improving access to the veterinary medicines needed to keep our animals healthy..

  • Size of the Canadian Animal Health Market
    • Canada is lower tier commercial market globally
    • equivalent to 10% of the US market
    • equivalent to only 2.5% of the global market
    • this makes it more difficult for companies to get a return on the investment required to register a new product in Canada, particularly if the costs of entry into the market are high
  • Regulatory Environment and International Harmonization
    • As a lower tier commercial market, Canada needs to make sure that our regulatory requirements for veterinary medicines can align as closely as possible to those of the major animal health markets globally (e.g. the United States, the European Union, etc.), a concept known as international harmonization
    • This is important because products developed for the large global markets often face different requirements for licensing in Canada.  One example of this are substances that are regulated as drugs in Canada, but are considered feed additives in the European Union.
    • Maximizing international harmonization of regulatory requirements with trusted regulators in other jurisdictions is one way to lower the overall costs of registering products in Canada.
  • Rising Regulatory Fees
    • Regulatory fees are the service fees charged by the federal government to both license new products and maintain existing products on the Canadian market.
    • The government sets regulatory fees through ministerial orders (rather than regulations)
    • Under the Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124), Health Canada’s service fees for licensing of veterinary drugs are set to rise by up to 500% between 2020 and 2027.

What is a DIN?

A Drug Identification Number (DIN) is a computer generated eight digit number assigned to a drug product by Health Canada prior to that product being marketed in Canada.

All licensed drug products in Canada have a unique DIN.

DIN Status

Marketed = a product that is currently being sold in Canada

Dormant = a product that was
previously marketed in Canada but for which there have been no sales for at least 12 months

Cancelled = a product that has left the Canadian market and is no longer available. DINS can be cancelled both before (pre-market) and after (post-market) a product is actually sold in Canada

Availability of Veterinary Medicines

Impact of Declining Access to Veterinary Medicines

A recent decline in the number of veterinary drugs available on the Canadian market is negatively impacting animal welfare, the quality of veterinary medicine practiced in Canada, and the sustainability and competitiveness of the Canadian livestock industries.

Current strategies used by veterinarians and producers to access products not available in Canada, such as use of compounded products, off-label drug use, own-use importation and online purchases from other countries, can result in serious risks to animal health, environmental safety and food safety in Canada, potentially leading to major impacts on trade and the closure of international borders to Canadian livestock exports.

Animal health products like veterinary medicines are critical tools for the sustainable production of safe food. The health of animals is inextricably linked to human health and the well-being of the planet.

The ability of the animal health industry to innovate and develop new products within the Canadian regulatory environment will in large part dictate Canada’s success in achieving the desired outcomes of the Pan-Canadian Action Plan on Antimicrobial Resistance and our collective efforts to achieve the UN Sustainable Development Goals by 2030.

As of the end of 2023, a total of 399 DINs were sitting in dormant status and are at risk of permanently leaving the Canadian market. They serve as red flags for products which are at high risk of moving to a cancelled DIN status and becoming permanently unavailable in Canada. The Canadian marketplace already faces significant challenges due to the nature of our highly regulated yet very small market, and Canada is falling behind our global competitors with respect to product availability.

Proposed Solutions

  • Reduce fees for regulatory reviews of products already approved and licensed by trusted regulatory authorities in other jurisdictions by implementing recognition of foreign decisions
  • Permanently adopt temporary COVID regulatory flexibilities that have proven to be both effective and more cost efficient and reflect these cost efficiencies in revisions to regulatory fees
  • Align Canadian regulatory requirements for studies and testing of products more closely with those of trusted regulators to reduce costs of entry into the Canadian marketplace.

 

CAHI is advocating for a solution

CAHI remains committed to working with our regulators and politicians to address this growing concern.  CAHI strongly urges the Government to develop and implement a strategy to increase the availability of veterinary medicines in the Canadian market.

Quarterly Update

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