Compliance … A Critical Perspective Peter Ellingworth Chairman ABHI International Medical Device Compliance Congress Paris May 2008

International Medical Device Compliance Congress Paris May 2008’ The Issues New corporate climate External environment is changing Government investigations and heavy fines Media scrutiny Confidence in the industry? International Medical Device Compliance Congress Paris May 2008’

Key to achieving the goals Adopting a compliance programme fully integrated into the business Compliance being an “enabler” not an “inhibitor” of performance The way we conduct business is as important as the results we deliver International Medical Device Compliance Congress Paris May 2008’

International Medical Device Compliance Congress Paris May 2008’ Code of Practice Evolve to reflect the prevailing ethical environment Provide clear guidance Harmonise practice on a pan-European basis Ensure a level playing field Send out a clear message Effective enforcement International Medical Device Compliance Congress Paris May 2008’

The Results Open and transparent business relationships Protect the interests of industry and healthcare professionals Enhance industry reputation Promote confidence in the industry Stave off government intervention