1 / 21

Medical Device Congress AdvaMed’s Efforts to Promote Compliance

Medical Device Congress AdvaMed’s Efforts to Promote Compliance. Christopher L. White, Esq. Executive Vice President, General Counsel, and Assistant Secretary, AdvaMed. Harvard University Cambridge, MA March 29, 2007. Introduction. The Device Industry Difference

edward-goodwin
Download Presentation

Medical Device Congress AdvaMed’s Efforts to Promote Compliance

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Medical Device CongressAdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive Vice President, General Counsel, and Assistant Secretary, AdvaMed Harvard UniversityCambridge, MAMarch 29, 2007

  2. Introduction • The Device Industry Difference • AdvaMed Compliance Activities and Priorities • Device Industry Response

  3. I. The Device Industry Difference Close and ongoing collaboration between health care professionals and medical technology companies is necessary for patient safety and medical innovation • Medical technologies require hands-on training and practice to assure safe and effective use and retraining as medical technologies undergo repeated changes (short life cycle) • Physicians bring practical field and other experience vital to continued development and improvement of medical technology

  4. II. AdvaMed Compliance Activities and Priorities • AdvaMed is committed to honest and ethical interactions between medical technology companies and Health Care Professionals (HCPs). HCPs’ decisions should be based on the best technology for the patient, not slick marketing. • Code of Ethics • Respond to Compliance Inquiries • Education, Training, Outreach • Logo License • Other

  5. AdvaMed Compliance Activitiesand Priorities • AdvaMed Code of Ethics is a Voluntary Code • Effective January 1, 2004 • Purpose is to encourage voluntary, ethical interactions between AdvaMed members and health care professionals • Interpret Code 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.

  6. AdvaMed Compliance Activitiesand Priorities • 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

  7. II. AdvaMed Compliance Industry Difference Operationalizing the Code • AdvaMed’s Code includes several Frequently Asked Questions and Answers to assist Members and others in their understanding of the Code. • Companies will communicate principles to their employees, agents, dealers and distributors with the expectation that they will adhere to Code. • Code is intended to facilitate ethical behavior; it is not intended to be legal advice. • Companies have independent obligation to ascertain compliance with all applicable laws and regulations. • AdvaMed’s website maintains link to Member Compliance Officers.

  8. II. AdvaMed Compliance Activities and Priorities • AdvaMed is committed to honest and ethical interactions between medical technology companies and Health Care Professionals (HCPs). HCPs’ decisions should be based on the best technology for the patient, not slick marketing. • Code of Ethics • Respond to Compliance Inquiries • Education, Training, Outreach • Logo License • Other

  9. II. AdvaMed Compliance Activities and Priorities • AdvaMed is committed to honest and ethical interactions between medical technology companies and Health Care Professionals (HCPs). HCPs’ decisions should be based on the best technology for the patient, not slick marketing. • Code of Ethics • Respond to Compliance Inquiries • Education, Training, Outreach • Logo License • Other

  10. II. AdvaMed Compliance Activities and Priorities • Work with Member Company Compliance Officers regarding Code Logo Elements • Sector Specific outreach to Customer Groups • Presenting with Prosecutors to Promote the Code of Ethics and Code Logo

  11. II. AdvaMed Compliance Activities and Priorities • AdvaMed is committed to honest and ethical interactions between medical technology companies and Health Care Professionals (HCPs). HCPs’ decisions should be based on the best technology for the patient, not slick marketing. • Code of Ethics • Respond to Compliance Inquiries • Education, Training, Outreach • Logo License • Other

  12. II. AdvaMed Compliance Activities and Priorities • Code Logo: available to any medical technology company whose CEO signs a licensing agreement • Established policies consistent with the provisions of the AdvaMed Code. • Identified an executive level person in the company who is: (a) responsible for compliance with the company’s policies and procedures consistent with the AdvaMed Code; and (b) informed to answer questions about the AdvaMed Code and the company’s compliance policies and procedures based on the AdvaMed Code. • Provided a copy of the AdvaMed Code or a link to the AdvaMed Code on our company website. • Provided comprehensive training to those employees and contractors whose job requirements make the information relevant on our company policies that are based on the AdvaMed Code and implemented procedures to ensure ongoing training programs for such new employees and contractors. • Instituted processes within the company to a) monitor compliance within the company policies and procedure that are based on the AdvaMed Code; and b) assess the effectiveness of the company’s policies and procedures that are based on the AdvaMed Code. • Established a process to respond to suspected deficiencies or violations of company policies that are based on the AdvaMed Code. • Established a reporting mechanism to facilitate anonymous internal reporting of suspected violations of company policies that are based in the AdvaMed Code. • Established a disciplinary process for violations of those policies and procedures that support the AdvaMed Code.

  13. CODE LOGO COMPANIES II. AdvaMed Compliance Activities and Priorities

  14. II. AdvaMed Compliance Activities and Priorities • AdvaMed is committed to honest and ethical interactions between medical technology companies and Health Care Professionals (HCPs). HCPs’ decisions should be based on the best technology for the patient, not slick marketing. • Code of Ethics • Respond to Compliance Inquiries • Education, Training, Outreach • Logo License • Other

  15. II. AdvaMed Compliance Activities and Priorities • Device and Diagnostics Compliance Group • Code Review Group • Calibrate with Surveys • Emerging Global Activities • Seek Guidance

  16. Device Industry Response • 2006 PWC/Compliance Alliance/King & Spalding Survey: • Nearby 100% Adoption of AdvaMed Code Among Companies Surveyed • Best Practices Noted in Code - Specific Sections • 2007 PWC/Compliance Alliance/King & Spalding Survey

  17. Device Industry Response Operationizaling and Extending Beyond The AdvaMed Code • Charitable Contributions • Consulting Arrangements

  18. Device Industry Response Grants & Charitable Donations • Companies may make donations for charitable purpose if made to charitable organization in support of: • Independent medical research • Indigent care • Patient education and public education • Sponsorship of events if proceeds are charitable • Companies may provide grants for: • Advancement of education for HCPs-in-training • Support of research with scientific merit • Public education about health topics • All grants and donations must be documented.

  19. Device Industry Response Consultants • HCPs serve as consultants. Companies may pay for: • Reasonable compensation for bona fide consulting services • Reasonable and actual expenses incurred • Factors indicative of bona fide consulting arrangements: • Agreement (written, signed, specifying services) • Compensation (fair market value) • Legitimate purpose and need for services • Selection based on consultant’s qualifications and expertise • Venue and circumstances of meetings appropriate, hospitality modest, subordinate to meeting purpose • Written research protocol

  20. Thank you for your Interst in the AdvaMed Code!

  21. Medical Device CongressAdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive Vice President, General Counsel, and Assistant Secretary, AdvaMed Harvard UniversityCambridge, MAMarch 29, 2007

More Related