Stakeholder Panel Industry perspectives on EMARS II

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Stakeholder Panel - Industry perspectives on
EMARS II

• Presentation to EMARS II Launch Event
• Vienna, 17 March 2009
• Rod Freeman
• Partner, Product Safety and Product Liability
  Group
• Lovells
• London

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Key points that should drive the development of
market surveillance systems

• Effective market surveillance is dependant on a
  high level of co-operation between enforcement
  authorities and economic operators.
• An effective, and efficient market surveillance
  regime will support the objectives of key
  industry players, who will in turn support such a
  system.
• Conversely, an ineffective, or unbalanced market
  surveillance system will undermine the market and
  will naturally meet with resistance from
  industry.
• For these reasons, the objectives of EMARS II are
  entirely consistent with the broad long term
  interests of manufacturers, importers and
  distributors of products marketed to citizens in
  the EU/EFTA region.

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Priorities for industry in the context of market
surveillance in the EU/EFTA region

• Predictability
• expectations need to be clear
• Consistency
• both internationally, and at a national level
• Level playing field
• market surveillance actions should be seen to be
  fair
• Technical expertise
• market surveillance decisions/actions/policies
  should be based on reliable data and a realistic
  view of the market
• Responsiveness and effectiveness
• market surveillance activities need to be
  proportionate and effective in meeting reasonable
  objectives

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Priorities for Industry some specific issues

• How to ensure best practice is implemented in day
  to day activities
• challenges are particularly acute in Member
  States where responsibilities are decentralised
• Risk assessments
• practical implementation of "new" risk assessment
  methodology
• Counterfeits and non-branded accessories
• good level of co-operation with brand-owner
  needed
• Confidentiality
• businesses need to be confident of an appropriate
  level of respect for commercially confidential
  information

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Priorities for Industry some specific issues
(2)

• Encouragement of dialogue between market
  surveillance personnel and economic operators
• eg informal dialogue is encouraged in some Member
  States, but not others
• Further development of policies and procedures
  for product recalls needs good level of input
  from economic operators
• eg how in practice can problems of poor return
  rates be addressed?
• Challenges arising from unequal availability of
  resources amongst market surveillance operators
• perception that lack of resources can lead to
  unnecessarily precautionary decisions

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Importance of EMARS II

• Virtually all of the proposed actions of EMARS
  II, to varying degrees, address the priorities of
  economic operators in relation to the market
  surveillance regime
• The complexity of the European regime gives rise
  to many challenges for all stakeholders in
  ensuring effectively co-ordinated market
  surveillance
• But much has already been achieved, with EMARS I
  making a substantial contribution.

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Importance of EMARS II involvement of economic
operators

• Development of "best practice" principles and
  guidance
• important to ensure "buy-in" from economic
  operators, so they understand and support the
  objectives
• same considerations apply to the development of a
  revised corrective actions guide, and to the
  development of "SOPs"
• Development and application of guidance on risk
  assessment
• the experience of industry experts can provide
  important input into the practical application of
  these principles
• Involvement of economic operator stakeholders
  should be integral to these processes

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EMARS II other considerations

• Feedback to law and policy makers at a Commission
  level
• An important output of EMARS ought to be feedback
  and recommendations to Commission on gaps and
  areas for improvement in existing regime, eg
• the development of risk assessment methodologies
• the development of other guidance materials
• practical operation of the RAPEX regime
• The international dimension
• What role can/should EMARS II play in developing
  "best practice" at an international level
  especially having regard to rapid ongoing changes
  in the US, China etc.

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