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Global Codes of Ethics/Conduct Roundtable Discussion

Global Codes of Ethics/Conduct Roundtable Discussion International Medical Device Compliance Congress and Best Practices Forum May 27, 2008 Paris. Christopher L. White, Esq., Executive Vice President, General Counsel, and Assistant Secretary. Overview. Where Are We?

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Global Codes of Ethics/Conduct Roundtable Discussion

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  1. Global Codes of Ethics/Conduct Roundtable Discussion International Medical Device Compliance Congress and Best Practices Forum May 27, 2008 Paris • Christopher L. White, Esq., • Executive Vice President, General Counsel, and Assistant Secretary

  2. Overview • Where Are We? • Where Are We Going?

  3. I. Where are We? AdvaMed’s Commitment to Compliance Excellence • 2003 – Revised and Reissued AdvaMed Code of Ethics • 2005 – AdvaMed Supplementary FAQs • 2006 – AdvaMed Code Logo program • 2006 – AdvaMed–OIG communications on entities where physicians have both an ownership interest and generate substantial revenues • 2008 – AdvaMed Supports Kohl Legislation; ”appropriate” disclosure of device company- physician relationships • Code Revisions Currently Underway

  4. AdvaMed Code of Ethics I. Where Are We? • Voluntary Code • Effective January 1, 2004 • Purpose is to encourage voluntary, ethical interactions between AdvaMed members and health care professionals • Code should be interpreted in light of principle that AdvaMed Members: • Encourage ethical business practices and responsible industry conduct • Shall not use unlawful inducement to sell, lease, etc. their products • “Health Care Professionals” defined as: • Individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Members’ products in the U.S. • Independent surveys show wide industry adoption

  5. I. Where Are We? AdvaMed Code of Ethics • Preamble • Member-Sponsored Product Training and Education • Supporting Third Party Educational Conferences • Sales and Promotional Meetings • Arrangements with Consultants • Gifts • Provision of Reimbursement and Other Economic Information • Grants and Charitable Donations Also, includes a series of Frequently Asked Questions 5

  6. I. Where Are We? • Code of Ethics Logo • Available to any medical technology company whose CEO signs a licensing agreement (requiring defined compliance controls) 6

  7. I. Where Are We? CODE LOGO COMPANIES

  8. I. Where Are We? 8

  9. II. Where Are We Going? • Industry Scrutiny in the Orthopedic Sector • Novel deferred/non-prosecution agreements • Monitors installed within each company • Strict compliance controls • Companies required to post all MD payments on websites 9

  10. II. Where Are We Going? • Deferred Prosecution Agreements • AdvaMed Code made legally binding on • on signatory companies 10. The Company shall adhere to the AdvaMed Code of Ethics on Interactions with Health Care Professionals. The AdvaMed Code can be found at www.advamed.org. The principles set forth in the AdvaMed Code are expressly incorporated as compliance requirements under this DPA.

  11. II. Where Are We Going? Other External Factors Bearing on AdvaMed Code • Critical Media • Federal (and State) Physician Payment Disclosure Legislation • Inquiries from Senator Grassley into transparency of companies’ charitable giving • Whistle blower laws • Other US and Global Codes Continue to Evolve Beyond Existing Footprint • IOM Public Hearing on industry conflicts of interest • AAMC issues report on industry funding of medical education 11

  12. II. Where Are We Going? • Spring 2008: Reconstituted Code of Ethics Work Group Formed to Review and Develop Proposed Revisions to Code of Ethics (COE) • Current Activities: • Code Review Process • “Enforcement”

  13. 2008 COE Work Group Member Companies: II. Where Are We Going? • Covidien • CR Bard • Edwards Lifesciences • Endocare • Gambro BCT • GE • Hill-Rom • Hospira • Integra LifeSciences • Johnson & Johnson • Kensey Nash • Medtronic • Roche Diagnostics • Abbott Laboratories • Alcon Laboratories • Advanced Medical Optics • American Medical Systems • Bausch & Lomb • Baxter • BD • Beckman Coulter • Biomet • Biotronik • Boston Scientific • Cardinal Health • Convatec • RTI Biologics • Siemens • Smith & Nephew • Smiths Medical • Sorin Group • St. Jude Medical • Stryker • Terumo Medical • WL Gore • Zimmer

  14. II. Where Are We Going? Possible COE Updates include: • Product Evaluations/Samples • Royalty FAQ • Consulting • Research Grants v. Charitable Contributions 14

  15. Thank You! Christopher White Exec. Vice Pres., General Counsel and Secretary cwhite@advamed.org

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