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www.lovells.comLovells LLP
Managing Recalls – Issues for Industry in the Global Marketplace
ICPHSO ConferenceToronto, Canada28 October 2009
Rod FreemanPartner Manufacturing, Commercial and Product Liability Group,[email protected]+44(0)20 7296 5256
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Key issues when managing global recalls
Fundamentally, product manufacturers and suppliers want to implement an effective corrective action plan...
– one that delivers the intended results; and
– protects the good reputation of the business
• But when conducting global product recalls, there are a number of obstacles to achieving those objectives that need to be overcome....
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The Economist, September 2007
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RAPEX Notifications from January 2004 to mid-October 2009Consumer Products (excluding food and pharmaceuticals)
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6 10 20 30 40 50 10 20 30 40 50 10 20 30 40 50 10 20 30 40 50 10 20 30 40 50 10 20 30
Date: By year and week
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Issues in managing global recalls
1. Compliance with legal requirements
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Complying with legal requirements
• Especially reporting obligations
– Consider in particular reporting obligations under "new" General Product Safety Directive in the EU
• Obligation to report "immediately"• Separate notifications in each country where products marketed• Need to take care to control the message in each country• Unpredictable outcomes – especially if not managed carefully• Current confusion and uncertainty surrounding Risk Assessments
– Problems in Europe are magnified when you factor in considerations in other parts of the world – US, Canada, Japan, Australia, Brazil, Middle East etc etc
– All this needs co-ordination, and careful management
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Issues in managing global recalls
2. Securing consensus with the authorities
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Securing consensus with the authorities
Importance of implementing a consistent corrective action plan globally
• Consumer relations issues
• Avoidance of confusion
• Product liability risks
• Dealing with the "renegade" national authority
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Issues in managing global recalls
3. Controlling the global message
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Controlling the global message
• Timing is everything
• Staying ahead of the game
• This is your reputation at stake here
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Issues in managing global recalls
4. Protecting confidential information
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Protecting confidential information
• Don't assume that the whole world follows the CPSC
• In the EU, presumption is that information will be make public
• These considerations affect the way you communicate with authorities
• (Bizarrely, the reverse considerations apply to consumer information in Europe (data protection laws), so that both ways the effective conduct of recalls is impeded)
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Issues in managing global recalls
5. Lessons/Best practices
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Lessons and Best Practices
• Understand the complexity of the regimes around the world when conducting global recalls
• Don't assume the world follows the US, don't assume the requirements elsewhere in the world don't matter
• Approach global corrective actions with a global mindset. Focus on the need for co-ordination at every step
• Don't be daunted by the challenge. These challenges can be managed effectively and efficiently with the right approach