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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

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Page 1: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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Harvard UniversityCambridge, MAMarch 29, 2007

Medical Device Congress

AdvaMed’s Efforts to Promote Compliance

Christopher L. White, Esq. Executive Vice President, General Counsel, and Assistant Secretary, AdvaMed

Page 2: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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Introduction

I. The Device Industry Difference

II. AdvaMed Compliance Activities and Priorities

III. Device Industry Response

Page 3: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 4: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 5: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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 Activitiesand Priorities

Page 6: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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 Activitiesand Priorities

Page 7: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 8: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 9: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 10: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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• 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

Page 11: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 12: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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.

Page 13: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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II. AdvaMed Compliance Activities and Priorities

CODE LOGO COMPANIES

Page 14: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 15: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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– Device and Diagnostics Compliance Group

– Code Review Group

– Calibrate with Surveys

– Emerging Global Activities

– Seek Guidance

II. AdvaMed Compliance Activities and Priorities

Page 16: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 17: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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• Charitable Contributions

• Consulting Arrangements

III. Device Industry Response

Operationizaling and Extending Beyond The AdvaMed Code

Page 18: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 19: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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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

Page 20: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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Page 21: 1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive

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Harvard UniversityCambridge, MAMarch 29, 2007

Medical Device Congress

AdvaMed’s Efforts to Promote Compliance

Christopher L. White, Esq. Executive Vice President, General Counsel, and Assistant Secretary, AdvaMed


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