Outdated regulatory system inhibits Canadian farmers from accessing natural solutions

Livestock producers and consumers lose as companies with natural, non-antibiotic, non-drug products skip Canada

GUELPH, ON, Dec. 28, 2023 /CNW/ - The regulatory approach of the Government of Canada needs to evolve so Canadian farmers can easily access natural, non-antibiotic, non-drug products that are safe and optimize the health and wellness of their animals.

These products are often readily available to farmers in other countries that either have reduced regulatory burden or a large enough market to justify a high regulatory burden. Farmers and consumers in these countries enjoy the benefits of innovative products that optimize the health of animals, allowing them to better resist disease. Importantly, these products will not contribute to antimicrobial resistance which the World Health Organization (WHO) says is the greatest threat to human and animal health.

"There are significant regulatory challenges for non-drug products in Canada," says Lauren Carde, vice president of operations and regulatory affairs for Paul Dick & Associates (Pda), a full-service consulting firm for the human and animal health industries. "If they don't meet all the requirements for a Veterinary Health Product or a Feed, they are pushed into the drug category, which is really problematic because these products are not drugs and the drug regulations don't make sense for non-drug products."

There are significant challenges with the Veterinary Health Products (VHP) program and the Animal Feed Program which oversee non-drug products for animals in Canada. The VHP program does not permit products that do not have a long history of use, which prevents new and innovative products from pursuing registration this way. New feed ingredients take up to three years to gain approval by the Animal Feed Program because of long regulatory review periods and a lack of service standards. 

Canada is a small player and represents only 2-3% of the total global animal health market. "We have a high regulatory burden and a small market," says Carde. "Our small market size combined with stringent regulatory requirements mean that even our homegrown companies are choosing to skip Canada and are taking their products to other countries instead."

Pda launched a podcast to go deeper into regulatory hurdles facing companies wishing to introduce important non-drug products to Canada. The first episode features an interview with Dr. Steven Theriault, the chief executive officer of Cytophage Technologies, a Canadian bacteriophage company that ultimately decided not to bring their innovative products to Canada because of the regulatory burden.

The podcast is called "Accelerating Success" and is available on all platforms. A position paper with more details about the challenges companies face with the Canadian regulatory system is available at https://pauldickassociates.com/news/f/canadas-regulatory-system-inhibiting-access-to-natural-solutions.

Founded in 2010, Pda is a full-service consulting firm for the animal and human health industries that helps companies be strategic, navigate challenges along the regulatory and product development/ commercialization continuum, and optimally position themselves for success in the marketplace. Clients range from start-up and emerging companies to medium-sized enterprises and large multinationals. Specific areas of focus include, but are not limited to, pharmaceuticals, biologics, natural heath products/ VHPs and supplements, feed ingredients, pet food, diagnostics, wearables, telehealth, big data applications and artificial intelligence.

SOURCE Paul Dick & Associates