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 I.Where Are We? II.Where Are We Going?

3 AdvaMed’s Commitment to Compliance Excellence I. Where are We? 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  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 I. Where Are We?

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

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

7 CODE LOGO COMPANIES I. Where Are We?

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99 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 II. Where Are We Going?

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

11 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 II. Where Are We Going? Other External Factors Bearing on AdvaMed Code

12 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” II. Where Are We Going?

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

15 Thank You! Christopher White Exec. Vice Pres., General Counsel and Secretary