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Contracts With Doctors: Not Just a US Compliance Issue anymore

Contracts With Doctors: Not Just a US Compliance Issue anymore. First International Medical Device Compliance Congress and Best Practices Forum May 26-27, 2008 Paris, France. Pascal Cabanel Chief Legal Counsel - Stryker EMEA. TRANSPARENCY. EQUIVALENCE .

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Contracts With Doctors: Not Just a US Compliance Issue anymore

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  1. Contracts With Doctors: Not Just a US Compliance Issue anymore First International Medical Device Compliance Congress and Best Practices Forum May 26-27, 2008 Paris, France Pascal Cabanel Chief Legal Counsel - Stryker EMEA

  2. TRANSPARENCY EQUIVALENCE DOCUMENTATION SEPARATION Contracts with Doctors - Key Principles

  3. Contracts with Doctors - Key Principles Separation: Industry must not grant undue advantages or co-operation to HCPs ; Doctors must not be misused to influence purchasing decisions and activities should not be contingent upon sales transactions Transparency: Requires disclosure and approval to hospital Administrator /Superiors and other institutions of Doctors Equivalence: Performances and considerations must stand in an adequate relation to each other Documentation: Written agreement - all related documents, reports, invoices etc. to be retained in order to support the substance of the service rendered and any reimbursement of costs

  4. SEPARATION Procedure • Needs Assessment & Budget • Request for Approval • Purpose & Project • Qualification & Selection • Certification • Due Diligence • Initiator • Consultant • Written Contract • Training

  5. SEPARATION Contract • Be specific on the services to be provided • Prefer project based / short term contracts • Include specific provisions about: • Compliance with any applicable laws & Code of Conduct • Doctors’ representations • Independent Contractor - Taxes • Intellectual property • Work-product / Documentation expected • Remuneration, Expenses, Payment • Check consistency with the regulations of the country where the Doctor is licensed to practice / is located

  6. TRANSPARENCY Authorization • Interference • Employed Doctors - Government Officials • Use of Hospital’s facilities / equipment • Enforcement • Intellectual Property • Counterpart • Local Requirements • e.g.: France, Germany, Belgium • Declaration and/or Representations

  7. EQUIVALENCE Arm’s length • Fair Market Value • Independent appraisal • Local Laws & regulations • Loss of revenue • Benchmark • Per Diem / Per Hour • Differentiation • Services provided • Qualification required

  8. DOCUMENTAION Contract Management • Contract Procedure • Contract Approval • Contract Data Base • Data Base - Consolidation • Retention of Doctor’s work-product and other supporting documents • Payment authorization • Audit

  9. Contracts With Doctors: Not Just a US Compliance Issue Questions ? Pascal Cabanel Chief Legal Counsel - Stryker EMEA

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