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- RCC – Progress to Date
- Outstanding challenges
- Comparing models of regulatory cooperation
- What regulatory cooperation is and isn’t
- Cooperative arrangements
- Forward path
- Stakeholder dialogue
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- RCC Action Plan contains two
components:
- specific issue resolution; and
- ongoing alignment
- Progress being made in individual initiatives
- Most misalignment not due to fundamental differences – rather lack of
synchronization and collaboration in routine regulatory system
development and renewal
- Consideration of ongoing alignment remains at an early stage
- Common critical path developed to focus attention on this task in the
coming months
- Work underway to enable deeper regulatory cooperation
- Considerable interest in additional work
- Timely to consider the path forward
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- Fundamental shift in regulatory relationship still required to secure
benefits
- Lower costs for industry and consumers
- Combined regulatory expertise and effort
- More effective and efficient collective regulatory system
- Product availability improvement for consumers
- An issue-based “Action Plan” was a good place to start
- Senior-level dialogue between agencies with similar mandates
- Built common understanding of some systemic issues
- Socialized concept of deeper cooperation and alignment
- Regulatory cooperation needs to be institutionalized – the “new normal”
- Need to engage in a dialogue on systemic alignment – regulators and
stakeholders
- Regulator discussions in working groups in the coming months
- Opportunity for input this summer by stakeholders: industry and
consumers
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- Several other “advanced” models of cooperation exist – don’t correlate
precisely to Canada-U.S. situation, e.g.:
- Australia-New Zealand Trans-Tasman Agreement
- Built on successive trade agreements
- Several joint institutions developed replacing traditional agency
roles:
- e.g. a therapeutics regulatory agency (ANZTPA)
- e.g. a food standards organization (FSANZ)
- European Union
- As customs union, provides for supra-national law-making and
institutions
- Regulatory cooperation takes place through centralized rules and
control
- Canada-U.S. partnership model will be about sovereign regimes but with
deeper cooperation, given…
- Similar desired outcomes, targeting high levels of protection and
outcomes
- Recognition that two effective regulatory systems already exist
- Tradition of cooperation and strong relationships between our
regulators
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- Our analysis is that there are four key areas where regulatory
cooperation could deliver significant benefits:
- Cooperation in product reviews and approval
- Collaborate on aligning submissions, analysis, and approval processes.
- Cooperation in regulatory system reliance
- Reduce and eliminate duplicative requirements by recognizing success of
each others’ work.
- Cooperation in regulatory standard-setting
- Partner on regulatory standards development, conformance (i.e.,
testing), and implementation / enforcement.
- Cooperation in managing import risk at the perimeter
- Move Canada/U.S. border activity to the external perimeter and
collaborate on efforts abroad.
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- Work in the coming months on systemic alignment/cooperative arrangements
- Common Canada-U.S. critical path agreed to across all working groups
- Implement deeper stakeholder-working group engagement
- webinars – to help reach out to non-traditional groups and regional
firms
- Consider regulatory cooperation moving forward
- - input from stakeholders this summer
- Government discussions before the end of the mandate on securing
Canada-USA regulatory cooperation
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- Upcoming formal solicitation of views
- Prompting questions in 3 areas:
- Evolution of the action plan
- Stakeholder role
- Ongoing cooperation
- Formal and informal input
- In writing to the Federal Register Notice via Regulations.gov and the
Canada Gazette
- Opportunities for discussions at your events
- Several month process
- to allow time for thoughtful input from stakeholders and consideration
- Will be used to inform further government to government discussions this
fall / winter
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