Regional and Bilateral Initiatives
Government of Canada - European Commission
Framework on Regulatory
Co-operation and Transparency |
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A. GENERAL
I. Introduction
The Government of Canada and the European Commission (Commission)
Seeking to address new challenges and opportunities by enhancing
regulatory co-operation, and to work towards preventing and eliminating
unnecessary barriers to trade and investment while ensuring better
quality and effective regulations to achieve public policy objectives,
Committed to ensuring high levels of protection via regulation
for their essential public interests including human, animal,
plant life or health, and the environment,
Confirming that this Framework, as a non-legally binding document,
cannot affect commitments under bilateral, regional and multilateral
environment, health, safety or other international agreements
to which either the Government of Canada and/or the European Communities
may be a party,
Recognizing that regulation impacts society, and that a strong
regulatory environment is one that balances social, environmental
and economic interests, and increases public confidence and trust
in government institutions, regulators and their decision-making
practices,
Recognizing also that increased regulatory dialogue between the
Commission and the Government of Canada has the potential to enhance
the bilateral relationship and that the Commission and the Government
of Canada share many of the same broad objectives and values when
developing sound policies and regulations to protect the public
and the environment,
Recognizing further that it is desirable that this dialogue take
place within a Framework, while at the same time noting that the
voluntary Framework should not be considered legally binding for
either the Government of Canada, the European Commission, or the
European Communities,
Noting that this Framework provides a useful instrument to exchange
views on various regulatory activities including those which may
subsequently be subject to discussion in the relevant agreements
under the World Trade Organization, and that this Framework is
without prejudice to the rights and obligations derived from those
agreements,
Taking into account the shared commitment to regulatory reform
as reflected in the EU “Better Regulation Package”
and the Government of Canada’s “Smart Regulation”
initiative,
Noting the potential for further co-operation in trilateral,
multilateral and regional fora on issues of mutual concern and
interest to regulators and policy makers in the areas of standardization
and regulation,
Desiring to build on the long and fruitful co-operation between
the European Union and Canada since the 1976 Framework Agreement
for Commercial and Economic Co-operation, the 1996 Joint Action
Plan and the 1998 EU-Canada Trade Initiative, as well as the various
bilateral sectoral agreements,
Desiring to implement the Joint Statement of the EU-Canada Summit
of December 2002, where leaders recognised that “regulatory
co-operation is considered a priority by our respective business
communities” and having “agreed to intensify our regulatory
dialogue”
Seeking to implement the Joint Action Plan for Regulatory
Co-operation and Dialogue adopted at the EU-Canada Summit
in May 2003, where four broad "ways and means" were
identified, notably,
- a senior level regulatory policy seminar
on the respective internal regulatory approaches and procedures
which was held in June 2003 with the objective of achieving
a common understanding on the potential for EU-Canada regulatory
co-operation;
- a review of existing areas of bilateral co-operation
between regulators in specific sectors to assess the need and
appropriate means for improved co-operation;
- a review of stakeholders’ concerns and market
access barriers,
- the development of a Framework for Regulatory Co-operation,
Noting the leaders’ commitment at the EU-Canada summit
of March 2004 to negotiate a new Trade and Investment Enhancement
Agreement (TIEA) between Canada and the European Communities and
its Member States to further stimulate our bilateral economic
relationship, and their agreement to make regulatory co-operation
a key element of the future agreement,
have established this Framework to enhance regulatory co-operation,
and to work towards preventing and eliminating unnecessary barriers
to trade and investment while ensuring effective regulations to
achieve public policy objectives.
II. Objectives
1. The objectives of this Framework include:
- To offer high level political support to the process of co-operation
between policy makers, technical experts and regulators of the
Government of Canada and the Commission;
- To support existing, and encourage new, co-operation between
regulators by providing ideas for how such co-operation could
take place;
2. The objectives of regulatory co-operation include
A. Regulatory Governance
to achieve a better understanding of each side’s regulatory
systems and obtain from each other the benefit of expertise and
perspective for enhancing the efficacy of regulations, identifying
alternative instruments, recognizing the associated impacts of
regulations, and to deepen our understanding of the manner in
which regulations are implemented and compliance is achieved.
B. Good regulatory practice to create better regulations
to advance bilateral co-operation between regulators and policy
makers in order to promote transparency and predictability in
the development and establishment of regulations, improve the
planning and development of regulatory proposals, avoid unnecessary
regulatory differences, and minimize administrative costs.
C. Facilitate trade and investment
to facilitate bilateral trade and investment by building on
existing co-operative arrangements, reducing unnecessary differences
in regulation, and identifying new appropriate modalities for
co-operation in specific sectors.
D. Promote competitiveness and enhance the climate
for innovation
to contribute to the improvement of competitiveness and efficiency
of industry by reducing duplicative regulatory requirements and
pursuing compatible regulatory initiatives where possible while
ensuring a high level of protection to citizens and the environment.
3. Activities within the Framework will:
- Contribute to achieving high levels of safety for the protection
of human, animal or plant life or health, the environment, consumers;
- Be fully consistent with any applicable domestic and international
legal requirements, including rules and policies on transparency
of government activities to the public at large, and preserve
the integrity of the domestic regulation development process;
- Encourage, as appropriate, co-operation on a bilateral, trilateral,
plurilateral or multilateral basis, which includes taking into
account work carried out in multilateral and international institutions
such as the Organization for Economic Co-operation and Development
(OECD), the United Nations (UN), or other relevant international
bodies involved in regulatory activities and;
- Not duplicate or overlap with any existing formal or informal
arrangements for regulatory co-operation, unless so mutually agreed
to by regulators.
III. Field of Application
- This document represents the Framework under which regulators
of the Government of Canada and the services of the Commission
are encouraged to co-operate on a voluntary basis as broadly as
possible. “Regulators” refers to officials –
in regulatory departments in Canada and the services of the Commission
- having policy competence for specific sectoral issues in each
jurisdiction.
- The Framework concerns regulatory activities during the planning
and development of regulations for such measures that are covered
by the WTO Agreement on Technical Barriers to Trade and the Agreement
on the Application of Sanitary and Phytosanitary Measures where
the Government of Canada and the Commission have jurisdiction,
including the development of regulations for submission as legislative
proposals.
- The Framework concerns any regulations, and amendments to existing
regulations, which regulators of either side believe may have
significant effects on bilateral trade and investment, and/or
where regulators on both sides agree that co-operation would be
of mutual benefit, and that have been identified under the procedure
in section V.
B. Operational
IV. Elements of Regulatory Co-Operation
The Government of Canada and the Commission seek to fulfil the
objectives set out in section II by encouraging bilateral regulatory
co-operation in the following areas:
A. Regulatory Governance
-
With a view to achieving a better understanding of good regulatory governance
and working toward promoting best practices in the development of regulatory
proposals, regulators and policy makers should engage in ongoing bilateral
discussions, including in the area of regulatory reform (such as Better
Regulation and Smart Regulation) and their effects on the Canada-EU relationship;
identify lessons learned; explore, where appropriate, alternative approaches
to regulation; and exchange experiences with regulatory tools and instruments,
including regulatory impact assessments and compliance strategies.
B. Good regulatory practice to create better regulations
Consultation and Exchange of Information
- Regulators are encouraged to consult with their counterparts
on a bilateral, trilateral, plurilateral or multilateral basis,
as appropriate, and exchange information during the regulation
development process. Such consultation and exchange may occur
throughout the development process, beginning as early as possible
in that process.
- Regulators may share non-public information to the extent that
such information may be shared with foreign governments in accordance
with their applicable rules. A Model Confidentiality Arrangement
is attached (Annex I html pdf).
Selection of Regulatory Approaches
- Regulators are encouraged to exchange information with counterparts about
contemplated approaches to regulatory requirements and choice of regulatory
instrument, at the earliest stage possible, in order to:
- Better understand the rationale behind regulatory choices and examine
the possibilities for greater convergence on how to state the objectives
of regulations and to define the scope of regulations. The interface between
regulations, voluntary standards and conformity assessment should also
be addressed in this context;
- Compare methods and assumptions used in analyzing regulatory proposals,
including, where appropriate, analysis of technical and/or economic practicability,
and benefits in relation to the objective pursued, of any major alternative
regulatory requirements and approaches considered. Such information exchange
should also include compliance strategies, and impact assessments, including
a comparison of the potential cost-effectiveness of the regulatory proposal
to that of major alternative regulatory requirements and approaches considered;
- Examine opportunities to minimize unnecessary divergences in regulations
through means such as achieving harmonized, equivalent or compatible solutions
or to consider the use of mutual recognition, as appropriate, in specific
cases.
Sharing Information on Regulatory Proposals
- Regulators should endeavour to
- share proposed technical or sanitary and phytosanitary regulations, where
such measures may have an impact on trade, with their counterparts at as
early a stage as possible so that comments and proposals for amendments
may be taken into account,
- provide, upon request by their counterparts, copies of the proposed regulation
and allow sufficient time for interested parties to provide comments in
writing
Monitoring of Forthcoming Regulatory Proposals
- Regulators are encouraged to periodically exchange information of ongoing
or planned regulatory proposals. Such information could include annual work
programs listing the new regulations, and the amendments to existing regulations,
that are likely to be proposed or adopted in the next year.
- When annual work programs are exchanged and upon request by their counterparts,
regulators are encouraged to supplement the annual work programs, to the extent
possible, with information regarding regulatory approaches under consideration,
including potential benefits, costs and other impacts for all parties, domestic
and non-domestic, where assessed and available.
Identification and Selection of Issues to be Addressed through Regulation
- Regulators are encouraged to:
- Data collection. Examine the appropriateness and possibility
of collecting the same or similar data about the nature, extent and frequency
of problems potentially warranting regulatory action where it would expedite
making statistically significant judgments about those problems. Periodically
conduct comparisons of data collection practices.
- Data collection methodologies. Examine the possibility
and appropriateness of using the same or similar assumptions and methodology
as those used by their counterparts for analyzing the data and determining
the magnitude and causes of specific problems and, on this basis, to consider
possibilities to bring them closer. Periodically compare analytical assumptions
and methodologies.
- Compliance Strategies. Exchange information on the administration
and implementation of regulations, as well as on the means to obtain and
measure compliance.
Research
- Technical experts and regulators are encouraged to conduct co-operative
research agendas in order to reduce duplicative research; generate more information
at less cost; gather the best data; establish where appropriate a common scientific
basis; address the most pressing regulatory problems in a more consistent
and performance-oriented manner; with the intention to minimize unnecessary
differences in new regulatory proposals, while more effectively improving
health, safety and environmental protection.
Post-implementation review of regulations
- Technical experts and regulators are encouraged to conduct post implementation
reviews of regulations or policies and to:
- Compare methods and assumptions used in such reviews.
- Where applicable, make summaries of the results of post-implementation
reviews available to regulators of the other side.
C. Facilitating Trade and Investment
- Regulators are encouraged to co-operate wherever possible during
the regulation making stage, including by utilising any of the
provisions described in section IV, with the aim of reducing unnecessary
regulatory differences and minimising instances of duplicate regulatory
requirements that adversely impact trade between our two regions
while ensuring a high level of protection and working towards
effective regulations for the sake of public interests.
- Regulators are also encouraged to co-operate in the identification
of the appropriate approaches to reducing any adverse effects
of existing regulatory differences on bilateral trade and investment
in identified sectors, including where appropriate, through greater
convergence, mutual recognition, minimising the use of trade distorting
regulatory instruments, and use of international standards including
such standards and guides for conformity assessment,
D. To boost competitiveness and enhance the climate
for innovation
- The dialogue on good governance could include issues such as
how to create a proper balance between diverging objectives of
regulatory policies, including how to take into account the competitiveness
and efficiency of industry while ensuring a high level of protection
for citizens and the environment.
V. Procedural Aspects of the Framework
- The Government of Canada and the Commission should engage in
ongoing dialogue to meet the objectives of the Framework. Such
an exchange may take place between regulators through websites
(for example by creating “networks”), via teleconferences,
joint seminars or workshops, and specific meetings including in
the margins of the Trade and Investment Sub Committee (“TISC”)
or any other committee established to this effect, including those
established under the proposed EU-Canada Trade and Investment
Enhancement Agreement.
- Regulators in the Commission and in the Government of Canada
may agree between themselves on the ways and means by which they
wish to co-operate in their area of competence.
- Both sides, represented by the regulators concerned, should
work jointly to identify specific sectors or proposals for regulatory
co-operation set out in section IV, and areas in which regulatory
co-operation could be further expanded or established ex novo.
- The functioning of this Framework, and progress on identified
regulatory projects, should be followed-up on an ongoing basis
at least annually by the Canada-EC Regulatory Co-operation Committee
established for this purpose. In particular, this committee should
follow the overall progress of the Framework, discuss horizontal
issues, plan seminars focused on regulatory issues, identify areas
for improvement, disseminate best practices, and facilitate implementation
of the framework in areas of mutual concern. This does not prejudice
the role of the TISC or any other committee established under
the TIEA.
- Regulators may establish working groups – if they so
desire- in their area of competence voluntarily agreed to with
their counterparts in Canada and the European Communities to address
issues of common concern.
- Projects undertaken under the Framework will be listed in an
implementation plan to facilitate follow-up. It is understood
that the plan will evolve as required and agreed to by both sides
to allow for the continuous identification of opportunities to
achieve the objectives established under the Framework.
ANNEX I
ARRANGEMENT
BETWEEN THE
DIRECTORATE GENERAL OF……………..OF
THE EUROPEAN COMMISSION
AND
THE DEPARTMENT OF…………………OF
CANADA
ON THE SHARING OF NON-PUBLIC INFORMATION
The Directorate General of …… of the European Commission
and the Department of ………of Canada (“the
Parties”) have recognized a need to further strengthen their
relationship as encouraged by the voluntary Framework for Regulatory
Cooperation between the Government of Canada and the Commission
("the Framework").
The Parties consider that one of the aims of the Framework includes
exchanging between each other the benefit of information, expertise,
research and ideas for alternative approaches to regulation, which
may make it desirable to facilitate the sharing of non-public information
in the interest of better regulatory cooperation. Non-public information”
is understood to consist of any information not in the public domain.
In order to permit such an exchange of information, the Parties
have recorded in this Arrangement the protection they will provide,
consistent with applicable legislation or regulations, to non-public
information, which they may exchange between each other in respect
of regulatory activities covered by the Framework.
This Arrangement does not contain legal obligations for the Parties.
In particular, it does not require them to exchange any information
and they may limit the scope of the information exchanged under
this Arrangement as appropriate.
The exchange of information under this Arrangement may be subject
to prior authorization from persons or organizations that originally
provided the information to either Party and that may become the
subject of an exchange under this Arrangement.
The Parties undertake to use any information which has been exchanged
under this Arrangement, and is not otherwise in the public domain,
only for the purposes of the Framework and not for any other purpose.
Either Party will take due account of any suggestion made by the
other Party with regard to the functioning of the exchange of information
envisaged in this Arrangement.
The Parties will inform each other in due time of any changes in
the applicable legislation or regulations which may affect the exchange
of information envisaged in this Arrangement.
When a request is received by either Party for disclosure to third
parties of non-public information exchanged under this Arrangement,
the Party receiving the request will consult with the other Party
before disclosing the information concerned. Each Party will take
into account, to the extent possible, the views provided by the
other Party in arriving at a decision whether to disclose the non-public
information concerned.
The Directorate General of ………..of the European
Commission will not disclose to third parties non-public information,
including confidential commercial information, that was provided
to its officials or representatives by the Department of ………of
Canada, subject to Regulation (EC) No 1049/2001 or any other applicable
domestic law of the European Communities. In case the Directorate
General of ………..of the European Commission is
under a legal obligation to disclose certain non-public information
that was obtained from the Department of …….. of Canada,
it will immediately inform the Department.
The Department of ………of Canada will not disclose
to third parties non-public information, including confidential
commercial information, that was provided to its officials or representatives
by the Directorate General of………… of the
European Commission, subject to the Access to Information Act, the
Privacy Act or any other applicable domestic law of Canada. In case
the Department of ………of Canada is under a legal
obligation to disclose certain non-public information that was obtained
from the Directorate General of ………..of the European
Commission it will immediately inform the Directorate General.
The foregoing represents the understanding reached between the
Parties, not binding in international law, on the matters referred
to in this Arrangement.
Signed at ______________ on this _____ day of ____________, 200X,
in the English and French languages, each version being equally
valid.
___________________________ For the Directorate General of……………..of
the European Commission |
____________________________ For the Department of ………of Canada |
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