Notes
Slide Show
Outline
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U.S.-Canada
Regulatory Cooperation
– Charting the Path Forward –

June 20, 2013
Washington, DC
Bob Carberry / Andrei Greenawalt
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Outline
  • 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 –
Progress to Date
  •  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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Outstanding Challenges
  • 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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Comparing Models of Regulatory Cooperation
  • 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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What Regulatory Cooperation
Is and Isn’t
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Four Key Areas of
Regulatory Business
  • 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..."
  • 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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Stakeholder Dialogue –
Launching this summer
  • 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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Regulatory Cooperation Council


www.actionplan.gc.ca/RCC

www.trade.gov/RCC