In Focus: Sara Zborovski is helping companies overseen by Health Canada navigate a fast-changing regulatory environment

August 14, 2020

Sara Zborovski

As a Stikeman Elliott partner who specializes in providing regulatory and commercial counsel to companies overseen by Health Canada, Sara Zborovski has played a critical role in the pandemic response strategies of many prominent businesses. In her practice, Sara helps clients navigate the regulatory landscape implemented by the Food and Drugs Act, Cannabis Act and other legislation and associated regulations governed by Health Canada.

As businesses adapt to a fast-changing legal and regulatory environment, much of Sara’s recent work has involved guiding clients through Health Canada’s expedited review and approval pathway to bring COVID-19-related products to market. She has been highly sought after for her extensive expertise in market access, authorizations and licensing, advertising and marketing, product safety, and recalls.

In Canadian Lawyer Magazine’s “In-House Sector Focus Report on Health Sciences and Technologies,” Sara offered a comprehensive overview of the government’s initiative to create approval pathways, resources and new measures that support domestic manufacturers and businesses to create COVID-19-related drugs, medical devices and personal protective equipment (PPE).

Since then, Sara has worked with international and domestic clients across a variety of industries that are pivoting production to manufacture or distribute COVID-19-related products. In particular in advising on meeting the changing requirements for emerging product category groups. When asked about new market participants, Sara said “companies who were not previously importing COVID-19-related products, were interested in getting into the game to support a significant need.”

In a video interview about Canada’s Healthcare Industry After COVID-19, Sara noted that some recently approved products “might not have fully met Canadian regulatory requirements without the expedited pathways.” In addition to guiding product approvals for clients, Sara has stepped in to advise those who may have previously operated with relatively minimal oversight from government agencies and have increased their risk exposure by entering product category groups that are overseen by Health Canada.

Sara works with clients to develop creative solutions to challenges posed by the evolving regulatory environment and minimize potential risk when entering new markets. On the compliance side, she also advises on developing SOPs and compliance policies, reviews product packaging and labelling and provides strategic advice on advertising and marketing programs, including assistance with pre-clearance agencies and representation before the Pharmaceutical Advertising Advisory Board and Advertising Standards Canada.

Sara also has a wealth of experience assisting clients in designing and implementing product recalls on a national and global basis. She advises manufacturers, importers distributors and retailers regarding possible obligations to recall products, negotiates the terms of recalls, and counsels clients regarding logistics, public relations and other issues that arise in product recalls and highly publicized product safety crises.

Once the pandemic passes, Sara anticipates a continued increase in access to COVID-19-related products, as well as heightened use. Once temporary pathways are no longer in effect, Sara will continue to provide strategic counsel to companies across pharmaceuticals, cannabis, food and beverage, natural health products, medical devices and cosmetics on market access through the old pathways. “Eventually, Health Canada will stop expediting the process,” she said.

Sara Zborovski is well-known in the healthcare and regulatory industries and has achieved significant recognition for her expertise, as evidenced by her ranking in Chambers Canada 2020 as a leading lawyer in Life Sciences, and The Canadian Legal Lexpert Directory 2020 as a leading lawyer in Biotechnology.

For more on Sara’s regulatory practice, click here.