The Need for Regulatory Innovation in Canada: A Series (Issue 1)

Healthcare innovation has a strong position in Canada. From Insulin to Pacemaker to Polio Vaccine, medical products have revolutionized the healthcare system not only in this country but the entire world. In the current times, with the rapid technological advancements and global interconnectedness, the opportunities have been leveraged with a greater impact through collective advances in the field of life sciences and technology. [1]

At present, there is a greater need to provide better transparency and lesser ambiguity in the healthcare sector. The regulations surrounding it are still evolving. One of the main reasons we need regulatory innovation is that it increases the accessibility of innovative medical products to the public.

The Challenge

The major challenge in bringing innovative medical products into the Canadian market is the regulatory flexibility that supports innovative research and health product development. Such flexibility can only be established when strong scientific knowledge and evidence-based data come together for the respective products. This knowledge will also help to regulate the risks, benefits, and uncertainties of the more diverse and complex products. [2]

The following picture provides a representation of the current market estimations in this sector.

 The Opportunity

 Canada envisions to double the size of the health and biosciences sector by 2025 and become a top-three global level hub. For that, they require to leverage and advance innovative technologies, attract and retain capital, skills, and talent; and ensuring a vibrant ecosystem that will unleash the full potential of the sector and lead to improved health outcomes. 

 As per the U.K. Bioindustry Association, Canada is behind the U.S., U.K., and Germany in global health and biosciences hubs. A strategic action to strengthen the sector in every dimension is needed to break into the top three global level hubs.

 By rejecting the status quo and taking ambitious steps, the trajectory can be changed and the exports can be doubled to $26 billion by 2025, which is equivalent to a 9% annual growth rate, unlike the historic 4% growth rate that had been.

 The Issues

 The following are a few issues that need to be overcome for achieving better outcomes in this field.  

1. Complex regulatory, reimbursement, and procurement processes impede the adoption of innovations
2. A risk-averse procurement culture that prioritizes short-term focus on cost rather than broader considerations of value
3. Disconnected digital health systems inhibit the collection, connection, and analysis of data needed to inform innovation decision making
4. Skills shortages and lack of access to executive-level talent hinder the sector’s competitiveness
5. Limited access to capital leads many Canadian firms to exit the market through mergers or acquisitions rather than accrue value domestically

Author:  Madhava Tirukovela

References:

1. Report from Canada's Economic Strategy Tables: Health and Biosciences - Economic Strategy Tables
2. Regulatory innovation for health products: Overview - Canada.ca