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Global Codes of Ethics/Conduct Roundtable Discussion

International Medical Device Compliance Congress and Best Practices Forum

May 27, 2008Paris

Christopher L. White, Esq., Executive Vice President, General Counsel, and Assistant Secretary

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Overview

I. Where Are We?

II. Where Are We Going?

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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

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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?

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AdvaMed Code of EthicsI. 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?

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Code of Ethics Logo

• Available to any medical technology company whose CEO signs a licensing agreement (requiring defined compliance controls)

I. Where Are We?

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CODE LOGO COMPANIES

I. Where Are We?

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I. Where Are We?

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• 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?

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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.

Deferred Prosecution Agreements• AdvaMed Code made legally binding on on signatory companies

II. Where Are We Going?

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• 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

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• 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?

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2008 COE Work Group Member Companies:

II. Where Are We Going?

•Covidien•CR Bard•Edwards LifesciencesEndocare•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

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Possible COE Updates include:

• Product Evaluations/Samples

• Royalty FAQ

• Consulting

• Research Grants v. Charitable Contributions

II. Where Are We Going?

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Thank You!

Christopher WhiteExec. Vice Pres., General Counsel and Secretary

cwhite@advamed.org