The Treasury Board Secretariat’s Road to Regulation

The Treasury Board Secretariat (TBS) has launched a consultation seeking input on targeted regulatory review in the health and bio-sciences sectors. The consultation focuses on how regulatory requirements impede growth, understanding which emerging technologies face regulatory barriers and what future technologies or disruptions could challenge the regulatory system.

Roadmap to Treasury Board’s Regulatory Review

• December 2017: The Advisory Council on Economic Growth, chaired by Dominic Barton, advises that regulations should be “agile and adaptive enough to balance health, safety and security considerations without imposing barriers to innovation and competitiveness.”
• March 2018: Budget 2018 announces a regulatory reform agenda, targeting regulatory reviews in three key sectors: health/bio-sciences; agri-food and aquaculture; and transportation and infrastructure.
• June 2018: Health Canada’s Health Products and Food Branch initiates stakeholder engagement with stakeholders to inform the Branch’s main objectives for health product regulation and modernization.

Parallel Initiative: Regulatory Review of Drugs and Devices

Since May 2017, Health Canada has also been undertaking the Regulatory Review of Drugs and Devices initiative (R2D2), the long term initiative to modernize the regulatory system, support timely access to drugs and devices, expand collaboration with health partners and enhance use of real-world evidence. Several regulatory modernization projects are underway, such as public release of clinical information and revisions to Health Canada’s cost recovery framework.

Both regulatory initiatives have similar timeframes – the TBS Regulatory Reform is a three-year process, while R2D2 consultations take place between now and 2021.

Why does Regulatory Review matter?

Given the lens of economic growth and competitiveness on the Treasury Board’s review, this consultation provides an opportunity to provide tangible examples of existing regulatory requirements or practices that impede economic growth, competitiveness, or the adoption of existing and emerging technologies. It is also an additional avenue for industry to raise issues, challenges and opportunities posed by the ongoing R2D2 initiative to the Treasury Board Secretariat, providing an additional perspective to Health Canada’s regulatory approach.