Regulatory and IP considerations for veterinary drugs in Canada

This article provides an overview of the regulatory regime and associated intellectual property rights for veterinary drug products and provides an update on recent issues, focusing on features that differ from drugs for human use.  

Regulatory classification of products 

Health Canada has published guidance to assist with the classification of products for use in animals and the classification of veterinary drugs and livestock feeds. Products for animal use may fall into one of a number of categories, including:   

• Veterinary drugs, regulated by Health Canada’s Veterinary Drugs Directorate (VDD) under the Food and Drugs Act;  

• Veterinary health products, regulated by the VDD under the Food and Drugs Act;   

• Veterinary biologics, regulated by the Canadian Food Inspection Agency (CFIA) under the Health of Animals Act. A Veterinary biologic means a thing that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state — or its symptoms — in animals and that is (a) a helminth, protozoa or micro-organism, (b) a substance or mixture of substances derived from animals, helminths, protozoa, micro-organisms or plants, or (c) a substance of synthetic origin. Veterinary biologics include products such as vaccines, antibody products and in vitro diagnostic test kits. 

• Veterinary medical devices, which are devices under the Food and Drugs Act but not medical devices as defined in the Medical Device Regulations. Health Canada Guidance provides that the import or sale of devices only for use on animals does not require a medical device establishment licence (the device label must state that it is for use by animals). VDD can be contacted for advice on the classification of products at the veterinary drug/device interface.   

• Livestock feeds, regulated by the CFIA under the Feeds Act.  

Of the classifications listed above, only veterinary drugs are entitled to data protection, the patent linkage regime under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), and certificates of supplementary protection (CSPs) described further below.   

Data protection 

Innovative veterinary drugs benefit from data protection under the Food and Drug Regulations, including a 6-year no filing period and an 8-year no approval period. An innovative drug contains a medicinal ingredient not previously approved in a drug and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. As clarified in recent Health Canada Guidance, prior approval of a drug for human use does not preclude data protection for a drug with the same medicinal ingredient for veterinary use (and vice versa). Eligible veterinary drugs are listed on the Register of Innovative Drugs, under Products for Veterinary Use once approved. 

Patents 

PMNOC Regulations: The eligibility requirements for listing on the Patent Register are similar for drugs for human and veterinary use. A patent list must be submitted with the drug submission, unless the patent issues after the date of filing of the submission. To the extent that VDD permits rolling submissions, sponsors should assume that the initial filing will be treated as the drug submission filing date for the purpose of submitting a patent list.  In general, a patent is eligible for listing on the Patent Register against a veterinary new drug submission (NDS) if the patent claims the approved medicinal ingredient, formulation containing the medicinal ingredient, dosage form or use of the medicinal ingredient. For veterinary drugs, the labelling information and package insert will generally be used to assess the use of the medicinal ingredient. If a subsequent manufacturer compares or refers to the innovative veterinary drug to obtain drug approval, the subsequent manufacturer must address the patents listed on the Patent Register.  

CSPs: CSPs provide an additional patent-like protection term and are intended to partly compensate the innovator for the time required for research and obtaining regulatory approval in Canada. The extension is capped at 2 years. A CSP may issue for an eligible patent that includes a product or product-by-process claim for the medicinal ingredient or combination of medicinal ingredients contained in an approved drug; or a use thereof (whether the claimed use is approved or not). The Patent Act treats a medicinal ingredient for veterinary use and a medicinal ingredient for human use as different medicinal ingredients. Therefore, separate CSPs may be issued for human use and veterinary use even if the medicinal ingredient or combination of medicinal ingredients would otherwise be considered the same. The CSPs may be based on the same or different patents. The Register of Certificates of Supplementary Protection and Applications lists the status of CSP applications and CSPs.  

Patented Medicine Prices Review Board (PMPRB): The PMPRB’s mandate is to ensure that the pricing of patented medicines sold in Canada is not excessive, and to report on pricing trends in the pharmaceutical industry. While the pricing of veterinary drugs falls under PMPRB jurisdiction, pricing information need only be reported upon request by the PMPRB and pricing is only subject to in-depth review if a complaint is received from an approved individual or organization. A rights holder (a patentee or CSP-holder) must file annual information including the identity of any licensee in Canada, and rights holders’ revenues from sales and expenditures on research and development in Canada.  

Regulatory submissions  

Veterinary drug submissions are evaluated by the VDD. Health Canada provides a series of guidance documents that set out requirements of new drug submissions for veterinary drugs, including quality requirements for NDSs and abbreviated NDSs (ANDSs) and clinical and human safety requirements for ANDSs. This section highlights criteria that are unique or of particular relevance to veterinary drug submissions.  

Human safety requirements: Veterinary drugs are subject to human safety requirements for use in food-producing animals, or where the proposed use potentially results in human health concerns, such as antimicrobial resistance or occupational exposure.  

Labels: Labels for veterinary drugs must have “adequate directions for use of the drug product", including among other things, indication, intended species, warning statements and withdrawal periods /milk withholding times. Warning statements must consider species and include information on potential human health risks (i.e., food safety, user safety and microbiological safety). 

International collaboration: The VDD cooperates with regulators in other countries to facilitate timely access to veterinary drugs. Collaborative reviews are available with regulators in the United States (simultaneous), the United Kingdom (simultaneous), and Australia and New Zealand (joint). Bilateral confidentiality arrangements are in place to facilitate information sharing with regulators in Australia, the European Union, France, New Zealand, Switzerland, the United Kingdom and the United States. 

Priority review: Health Canada will grant priority status for a veterinary drug submission for a serious or severely debilitating disease or condition or urgent unmet health need in animals. The sponsor must provide substantial evidence that the drug is (i) “effective at treating, preventing or diagnosing a disease or condition for which no veterinary drug is presently marketed in Canada” or; (ii) “significantly more effective, or pose a significantly lower risk, such that the overall benefit-risk profile is improved over existing veterinary drug therapies, preventatives or diagnostic agents marketed in Canada.” 

Use in same species: Similar to drugs for human use, a generic veterinary drug is eligible for an ANDS if it satisfies certain criteria for equivalence with a reference product. For a veterinary drug, among other criteria, the ‘conditions of use’ must be within those of the reference product, e.g., the drug is for use in the same species.  

Eligibility for biowaiver: To be approved by the ANDS pathway, a generic drug must be bioequivalent to a reference product. A biowaiver may be available, including in the following circumstances specific to veterinary drugs:   

• Feed premixes with water-soluble medicinal ingredients;  

• Topical solutions administered via the dermal, otic, ophthalmic or nasal route and intended for systemic or local therapeutic effects, in all animal species; and 

• Certain dosage forms administered topically and intended only for local therapeutic effects in all animal species.  

Regulation of Veterinary Health Products 

VDD oversees import and sale of veterinary health products. A veterinary health product is used to maintain or promote the health and welfare of animals and includes substances listed in List C: Veterinary health products. It is not used in the diagnosis, treatment, mitigation or prevention of disease. Under the VHP Notification Program, a sponsor is required to notify Health Canada about their veterinary health product before importing it into Canada, at least 30 days before selling it in Canada and at least 30 days before making a change to an existing veterinary health product. Health Canada publishes a List of Notified Products. 

Competition  

The Competition Bureau has expressed concerns in recent years regarding the lack of competition in the pet health sector. In October 2024, the Bureau published an analysis addressing reports that, while pharmacists and veterinarians are permitted to dispense veterinary drugs, exclusive distribution practices have prevented pharmacists from obtaining supply. The Competition Bureau recommended that provincial and territorial governments consider mandating the supply of pet medications to pharmacists, providing them the opportunity to compete with veterinarians. Recent reports suggest that exclusive distribution practices may be changing, allowing access for pharmacies.