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

2 Introduction I.The Device Industry Difference II.AdvaMed Compliance Activities and Priorities III.Device Industry Response

3 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 I.The Device Industry Difference

4  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. II.AdvaMed Compliance Activities and Priorities Respond to Compliance Inquiries Education, Training, Outreach Logo License Other Code of Ethics

5  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. II.AdvaMed Compliance Activities and Priorities

6 I.Preamble II.Member-Sponsored Product Training and Education III.Supporting Third Party Educational Conferences IV.Sales and Promotional Meetings V.Arrangements with Consultants VI.Gifts VII.Provision of Reimbursement and Other Economic Information VIII.Grants and Charitable Donations II.AdvaMed Compliance Activities and Priorities

7 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. II.AdvaMed Compliance Industry Difference

8  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. II.AdvaMed Compliance Activities and Priorities Respond to Compliance Inquiries Education, Training, Outreach Logo License Other Code of Ethics

9  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. II.AdvaMed Compliance Activities and Priorities Code of Ethics Respond to Compliance Inquiries Education, Training, Outreach Logo License Other

10 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 II. AdvaMed Compliance Activities and Priorities

11  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. II.AdvaMed Compliance Activities and Priorities Code of Ethics Respond to Compliance Inquiries Education, Training, Outreach Logo License Other

12  Code Logo: available to any medical technology company whose CEO signs a licensing agreement II.AdvaMed Compliance Activities and Priorities 1.Established policies consistent with the provisions of the AdvaMed Code. 2.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. 3.Provided a copy of the AdvaMed Code or a link to the AdvaMed Code on our company website. 4.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. 5.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. 6.Established a process to respond to suspected deficiencies or violations of company policies that are based on the AdvaMed Code. 7.Established a reporting mechanism to facilitate anonymous internal reporting of suspected violations of company policies that are based in the AdvaMed Code. 8.Established a disciplinary process for violations of those policies and procedures that support the AdvaMed Code.

13 II.AdvaMed Compliance Activities and Priorities CODE LOGO COMPANIES

14  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. II.AdvaMed Compliance Activities and Priorities Code of Ethics Respond to Compliance Inquiries Education, Training, Outreach Logo License Other

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

16 III.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 Charitable Contributions Consulting Arrangements III.Device Industry Response Operationizaling and Extending Beyond The AdvaMed Code

18 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. III.Device Industry Response

19 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 III.Device Industry Response

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