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Partners HealthCareApril 10, 2009

Summary of Partners Industry Interaction Requirements—A Medical Device

Company Perspective

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Background on Partners HealthCare

• Boston, MA based integrated health system. • Two academic medical centers and many community

and specialty hospitals, community health centers, a physician network, home health and long-term care facilities.

• Leading biomedical research organization.• Principal teaching affiliate of Harvard Medical School.

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Background on Recommendations

• Recommendations made by an internal commission charged with examining the health system’s policies and practices for interacting with pharmaceutical and medical device companies.

• Commission comprised of physician leaders from across the Partners system.

• Endorsed by Partners HealthCare Board of Directors.

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Purposes of Commission• Formulating principles to guide partners approach to

industry interactions;• Reviewing Partners current range of relationships with

industry; • Considering the potential need for changes in policies

and practices; and• Developing recommendations regarding modifications to

policies, the need for new policies and practices, and the infrastructure required to better support and enforce all activity.

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Overview

• Tightens many current policies.• Introduces several new policies.• Calls for a renewed and rigorous institutional

commitment to education, oversight and enforcement. • Partners will develop a comprehensive implementation

plan.• To be implemented in phases, with target effective date

of as of 10/1/09.• Task force appointed to ensure prompt implementation

and successful rollout.

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Enhancements to Conflict of Interest Disclosure Process Over Past Two

Years • Now reported and analyzed online.• Focus on ensuring disclosures are submitted and

reviewed in a timely manner. • Required participation has been expanded to include

more than 6,000 physicians, researchers, institutional officers and other employees.

• Sanctions for noncompliance are in place.

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Key Recommendations (page 1 of 3) • Prohibition of all gifts, including meals and

funding for meals, provided directly to staff or Partners institutions for their personal use, on a partners site or off-site.

• Requiring that industry representatives have written invitations defining the purpose and terms of visits before having access to partners sites and staff.

• Establishment of a process to identify and manage significant financial interests held by physicians in companies that make products they prescribe or use in their practices.

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Key Recommendations (page 2 of 3) • Acceptance of industry funding for educational

programs and fellowships only if provided through a centrally pooled institutional President’s fund at each hospital or approved by a Partners-wide Educational Review Board.

• Establishment of a robust, tiered approach to evaluate research related conflicts of interest.

• Adoption of a stricter policy holding certain officials to a higher standard because of their influential positions with the organization.

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Key Recommendations (page 3 of 3) • Development of an enhanced infrastructure,

including the creation of a new Conflict of Interest Review Committee, responsible for education, oversight and enforcement of Partners policies and practices in regard to industry interactions.

• Strengthen oversight of permitted outside activities:– A ban on faculty participation in industry

speakers bureaus,– An express prohibition on faculty being listed as

authors on papers ghostwritten by others, and– A more rigorous internal review process for

certain outside activities.

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Implementation and Rollout

• System-wide educational initiatives.• Dedication of financial resources.• Definition of sanctions for non-compliance.• Target effective date of 10/1/09.

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Disclaimers

• This summary may not be comprehensive.• The Partners implementation plan has not yet been

implemented so changes may occur. • Not legal advice - please consult your attorney.• Not compliance advice – please consult your chief

compliance officer.

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Comments Appreciated

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