rug regulation in Canada doesn’t have to be scary, even at Halloween. October 29, 30, and 31 saw the DIA Annual Canadian Meeting in Ottawa with approximately 130 attendees from industry, regulatory authorities, and other interested parties. This year’s theme, transformation through collaboration, perfectly describes many of the regulatory modernization initiatives being undertaken by the Canadian regulator, Health Canada, and to which drug and device stakeholders are responding.

Key Takeaways

• Collaboration has always been important, but regulators need to do it even better than before.
• A modern regulator needs to have agile domestic frameworks to be able to respond to the technologies of the future.
• There is a need to connect more with small businesses and the developers of emerging technologies to support the development of the transformative products of the future.
• Ongoing multi-stakeholder engagement and collaboration is a best practice for finding the best solutions to complex issues.

As previously discussed in the May 2018 issue of Global Forum, Health Canada has embarked on a modernization exercise, the Regulatory Review of Drugs and Devices, affectionately known as R2D2. The DIA Annual Canadian Meeting provided an opportunity for Health Canada to present some of the progress made, and for the Canadian pharma and medical device industry to provide their views on the impact of the initiatives.

In his opening remarks, Pierre Sabourin, the Assistant Deputy Minister of the Health Products and Food Branch of Health Canada, provided updates on the current status of ongoing transformation and modernization efforts. About a year and a half into the R2D2 initiative, some of Health Canada’s accomplishments include the following:

• Significant enhancements to review capacity.
• The creation of a new digital health unit to support the review of rapidly changing medical technologies.
• Investing to make better use of Real World Evidence across the product lifecycle.
• Development of domestic partnerships, including the launch of a process by which regulatory review and health technology assessment (both done by different organizations) can be conducted in parallel, saving time overall.
• Enhanced international partnerships, including work-sharing with other regulators in the Australia-Canada-Singapore-Switzerland Consortium.

Looking to the future, a regulatory foresight project and a government directive to examine regulatory barriers to innovation in the health and biosciences sector are setting the stage for a much larger modernization of Canadian drug regulation. The plan forward for this modernization is in development.

However, while the regulator looks to modernize, the ultimate goal, as ever, is to ensure the continued availability of safe, high-quality, and effective medicines.

Robert Ghiz, former premier of Prince Edward Island, and current president and CEO of the Canadian Wireless Telecommunications Association, gave a keynote address in which he shared his experience working through transformation in another heavily regulated complex industry as well as working on provincial healthcare initiatives. Ghiz emphasized that advances in wireless technologies will be key to the advancement of new data-driven businesses and services, especially in healthcare, and that there needs to be the right regulatory balance to ensure safety and security while also supporting transformative change. However, multi-stakeholder collaboration will be critical to success.

His advice for Health Canada? Always seek new ways to collaborate for the common good.