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


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?
  • 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

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_at_advamed.org
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