1. www.lovells.comLovells LLP Managing Recalls – Issues for Industry in the Global Marketplace ICPHSO Conference Toronto, Canada 28 October 2009 Rod Freeman Partner Manufacturing, Commercial and Product Liability Group, London rod.freeman@lovells.com +44(0)20 7296 5256

2. www.lovells.comLovells 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....

3. www.lovells.comLovells The Economist, September 2007

4. www.lovells.comLovells

5. www.lovells.comLovells LLP Issues in managing global recalls 1. Compliance with legal requirements

6. www.lovells.comLovells 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

7. www.lovells.comLovells LLP Issues in managing global recalls 2. Securing consensus with the authorities

8. www.lovells.comLovells 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

9. www.lovells.comLovells LLP Issues in managing global recalls 3. Controlling the global message

10. www.lovells.comLovells Controlling the global message Timing is everything Staying ahead of the game This is your reputation at stake here

11. www.lovells.comLovells LLP Issues in managing global recalls 4. Protecting confidential information

12. www.lovells.comLovells 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)

13. www.lovells.comLovells LLP Issues in managing global recalls 5. Lessons/Best practices

14. www.lovells.comLovells 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