Global Codes of Ethics/Conduct Roundtable Discussion

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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. Overview. Where Are We? - PowerPoint PPT Presentation

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  • Global Codes of Ethics/Conduct Roundtable Discussion International Medical Device Compliance Congress and Best Practices Forum

    May 27, 2008ParisChristopher L. White, Esq., Executive Vice President, General Counsel, and Assistant Secretary

  • OverviewWhere Are We?

    Where Are We Going?

  • AdvaMeds Commitment to Compliance ExcellenceI. Where are We? 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

  • AdvaMed Code of EthicsVoluntary CodeEffective January 1, 2004Purpose is to encourage voluntary, ethical interactions between AdvaMed members and health care professionalsCode should be interpreted in light of principle that AdvaMed Members:Encourage ethical business practices and responsible industry conductShall not use unlawful inducement to sell, lease, etc. their productsHealth 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 adoptionI. Where Are We?

  • *AdvaMed Code of EthicsPreambleMember-Sponsored Product Training and EducationSupporting Third Party Educational ConferencesSales and Promotional MeetingsArrangements with ConsultantsGiftsProvision of Reimbursement and Other Economic InformationGrants and Charitable Donations Also, includes a series of Frequently Asked QuestionsI. Where Are We?

  • *Code of Ethics Logo

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

  • CODE LOGO COMPANIESI. Where Are We?

  • *I. Where Are We?

  • * 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 websitesII. Where Are We Going?

  • 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 companiesII. Where Are We Going?

  • *

    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

  • Spring 2008: Reconstituted Code of Ethics Work Group Formed to Review and Develop Proposed Revisions to Code of Ethics (COE)

    Current Activities:Code Review ProcessEnforcementII. Where Are We Going?

  • 2008 COE Work Group Member Companies:II. Where Are We Going?CovidienCR BardEdwards LifesciencesEndocareGambro BCTGEHill-RomHospiraIntegra LifeSciencesJohnson & JohnsonKensey NashMedtronicRoche DiagnosticsAbbott LaboratoriesAlcon LaboratoriesAdvanced Medical OpticsAmerican Medical SystemsBausch & LombBaxterBDBeckman CoulterBiometBiotronikBoston ScientificCardinal HealthConvatecRTI BiologicsSiemensSmith & NephewSmiths MedicalSorin GroupSt. Jude MedicalStrykerTerumo MedicalWL GoreZimmer

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

  • Thank You!

    Christopher WhiteExec. Vice Pres., General Counsel and Secretary [email protected]

    Let me share with you some background on our Code of Ethics. First, it is a voluntary code. Unlike physician societies, we do not license manufacturers. Even so, surveys show that nearly all of our industry has embraced our Code. The Code is broad and runs between the healthcare professional and industry. By healthcare professional, I mean not only physicians, but anyone who influences product selection, including hospital executives and hospital materials management. *The Code of Ethics includes eight sections around those arrangements most common in the industry. Ill share with you the details of three sections that come up most commonly. Please reference our website for a more detailed description of the Code. Also, I have brought with me a trifold describing each section of our code in brief terms*****