Global%20Codes%20of%20Ethics/Conduct

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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
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Overview

• Where Are We?
• Where Are We Going?

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I. Where are We?

• AdvaMeds Commitment to Compliance Excellence

• 2003 Revised and Reissued AdvaMed
  Code of Ethics
• 2005 AdvaMed Supplementary FAQs
• 2006 AdvaMed Code Logo program
• 2006 AdvaMedOIG 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
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

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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

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I. Where Are We?

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

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I. Where Are We?
CODE LOGO COMPANIES
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I. Where Are We?
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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

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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.
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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

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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

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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

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II. Where Are We Going?
Possible COE Updates include

• Product Evaluations/Samples
• Royalty FAQ
• Consulting
• Research Grants v. Charitable Contributions

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