Proceedings: DIA Annual Canadian Meeting 2018

Plenary Session: Perspectives in Regulatory Cooperation

Megan Bettle
Regulatory Review of Drugs and Devices
Health Canada


his plenary session focused on federal government regulatory modernization efforts as well as updates across other players in the healthcare system and the impacts of these changes on the pharmaceutical industry. Health Canada’s ongoing modernization work is part of a broader initiative to update government regulation.

Key Takeaways

  • Regulatory modernization initiatives in Canada are developing to respond to complex products, technological advances that challenge older regulatory frameworks, and ongoing initiatives to support innovation in the health and biosciences space.
  • Regulatory cooperation can support innovative products coming to market and reduce administrative burden.

Evolving for the Future

David Lee, Health Canada’s Chief Regulatory Officer, began the plenary session with an overview of the regulator’s next steps in regulatory modernization. Canada has strengths in basic medical research, but improvements are needed to support this basic research to bring products to market, including collaboration with industry, downstream stakeholders, and research on the cutting edge of technology. In particular, a modern regulatory system needs to be flexible to deal with novel products that do not fit standard classification systems.

A number of factors are now driving the modernization of drug regulation in Canada. In 2017, the government created a series of economic strategy tables, with a focus on innovation. The Health and Biosciences Economic Strategy Table has released a report with a number of recommendations to help support the growth of this sector. One specific recommendation was the development of agile regulations by adopting international best practices, eliminating duplication across jurisdictions, and decreasing review times. Building on this, a specific review has been launched of the health and biosciences sector, focusing on regulatory barriers to innovation.

Goals of this overall regulatory reform, for which stakeholder engagement is ongoing, include modernizing the current framework (elements of which are decades old), creating more agile regulations, and enabling advanced technologies.

Regulatory Cooperation Within Canada and Internationally

The Treasury Board of Canada Secretariat is a central agency that provides cross-government guidance on best practices in federal regulation. Canada’s whole-of-government regulatory modernization agenda includes enhanced cooperation via three tables, the Canada-US Regulatory Cooperation Council, a federal-provincial-territorial regulatory reconciliation and cooperation table (supporting internal trade), and the Canada-EU regulatory cooperation forum under the Comprehensive Economic and Trade Agreement.

An update to the Cabinet Directive on Regulation focuses on a lifecycle approach, including requirements for government departments to develop plans to review all of their regulations and plan for periodic updates. The targeted health and biosciences regulatory reform mentioned above is part of this broader plan.

Modernization in the Drug Access Chain

The Canadian Organization for Drugs and Technologies in Health (CADTH) is an independent health technology assessment (HTA) agency that is funded primarily by the federal government and provides evidence services to support decision-making in Canadian jurisdictions other than Quebec, including making recommendations to publically-funded drug plans about drug coverage.

Expected pressure points for drug plans include products with novel mechanisms of action, immune-oncology, and both expensive drugs for rare diseases and expensive drugs for common diseases.

While the drug regulatory system is evolving, management of health technologies also needs to evolve. In response to these changes, CADTH is developing a “health technology management” system that focuses on providing support for the implementation of new technologies into the healthcare system and a lifecycle approach, including re-assessment and managed exit for technologies that may no longer have value in the current context.

Business Impacts of Regulatory Initiatives

Throughout the Meeting, discussions of proposed changes from regulators also elicited strong responses from industry and other affected stakeholders. A consistent message was that government needs to consider the overall business impact of regulatory changes, including the challenges resulting from multiple initiatives.

Regulatory cooperation can be good for both economic development and for health and safety. Advice from the industry perspective to move forward with overall modernization included to work with industry associations to understand the specific business issues, to quantify benefits and burdens in terms of costs, and to break complex projects down to more manageable pilots.