Transcript Reg-Coop-in-NAFTAx

Regulatory cooperation in North
America
Stuart Trew
Canadian Centre for Policy Alternatives
• NAFTA “technical working groups” (SPS, labelling, food
standards, etc.)
• Response to “precautionary principle” (2001-2003)
• “Smart regulation” (2003-05) “novel” products to market
• Security and Prosperity Partnership (Regulatory Co-operation
Forum) and the North American Competitiveness Council
(2005-2009)
• Cabinet Directive on Streamlining Regulation & Guidelines on
International Regulatory Obligations (2007)
• Beyond the Border and the Regulatory Co-operation Council
(2011)
• The Red Tape Reduction Act and “one-for-one” rule (2012)
Recent developments in Canadian
regulatory policy
From the Framework for the Application of Precaution in ScienceBased Decision Making About Risk (2003)
•
“The application of precaution is a legitimate and distinctive decision-making approach
within risk management.”
•
“The Government does not yet consider the precautionary principle/approach to be a rule of
customary international law.”
•
CONTRADICTORY: “It is particularily relevant that sound scientific information and its
evaluation be the basis of (i) the decision to act or not to act (i.e., to implement precautionary
measures or note) and (ii) the measures taken once a decision is made.”
•
HIGH (OR VAGUE) BENCHMARK: “sound and credible case that a risk of serious or
irreversible harm exists.”
•
CONSISTENCY WITH TRADE: “Domestic applications of precaution should be
consistent with Canada’s obligations arising from international agreements to which it is a
party.”
Canadian view of “precautionary
principle”
“Both officials and political leaders realize that governments regulate too much.”
“Harmonization with the United States will provide the most benefit to the
greatest number of exporters.”
Cameron Short
Agriculture and AgriFood Canada (2000)
• “[I]t would appear that the relative comprehensiveness of European consumer
protection reflects a policy priority to level the playing field between supplier
and consumer, and to place consumer wellbeing as the key objective in the
commercial transaction. The Canadian equivalent usually appears to be more
engaged with the maintenance of supplier interests.”
Public Interest Advocacy Centre (2009).
Regulation in the interest of business
Canada’s priorities visible in WTO
disputes versus Europe
• “The goal is to align existing federal regulatory systems
or, absent such alignment, encourage the adoption of
other measures that make it easier to conduct business
between the two countries.”
• “Efforts towards regulatory alignment will be conducted
by lead departments and agencies, under broad guidance
from the RCC and in consultation with impacted
stakeholders.”
Beyond the Border: The Regulatory
Cooperation Council (2011-2016)
Some results of
regulatory
cooperation in
North America
Health Canada prioritizes harmonization with International Conference on Harmonization
(U.S., EU and Japanese pharma + regulators) and U.S. specifically.
•
•
•
1994-95: Fee system introduced where pharma pays Health Canada for approvals (double role –
marketer and regulator)
January 2000: Lowered approval time for clinical trial application on new drugs from 60 to 30
days.
RCC (2011): Health Canada and the U.S. Food and Drug Administration will continue to work
closely together to harmonize and align their pre and post marketing surveillance requirements
and standards (including pharmacovigilance issues) through the work of the ICH.
“We hope that the establishment of the RCC will lead to tangible changes to regulations that will
enable our medicines to get to Canadian patients faster.” – PhRMA press statement.
Canada pays 4th highest drug prices while research and development has dropped to historic lows.
Case study 1:
Pharmaceuticals
• July 2016: Canada and U.S. sign food safety recognition
agreement (mutual acceptance of food safety policy) as part of
RCC (arguable whose system is safer).
• Builds on previous adoption of Hazard Analysis at Critical
Control Points (HACCP) quality control system (reliance on
industry self-reporting and risk-management).
• Emphasis on allowing food plants to “innovate” with new
products (as long as plant is certified) and clawing back only
where danger discovered (i.e., people are dying).
• Pesticides and approval processes for agricultural products
“are already highly aligned,” according to RCC action plan,
but plans are to further align crop protection (pesticides).
Case study 2: Food safety
• Canada straddles the EU and U.S. models of regulating
hazardous chemicals, but moved toward industry-friendly
U.S. system as part of SPP/RCC.
• Canada adopted allowed one-person crews on trains
carrying hazardous waste (Lac-Mégantic) as permitted in
U.S.
• RCC calls to “align rail safety standards” (derailments
and explosions of non-traditional fuels too frequent).
• RCC technical working group on chemicals and risk
assessment loaded with industry stakeholders.
Case study 3: Toxics and
transportation
Corporate objectives for CETA’s
RCC
“One way to enhance the status of the RCC in Washington
would be to link it to the U.S.’s global regulatory objectives,
like trade negotiations with the European Union and the
Trans-Atlantic Trade and Investment Partnership (TTIP)
where regulatory cooperation is front and centre.”
• Wants EU to get observer status in North American RCC in
exchange for Canadian observer status in TTIP cooperation
discussions.
• Thinks government should reward regulators who demonstrate
how their proposals reduce trade barriers.
• Proposes incorporation of “supply chain councils” made up of
business to identify regulatory cooperation priorities.
Chamber of commerce proposals
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