This document summarizes recommendations from a commission at Partners HealthCare regarding interactions with medical device and pharmaceutical companies. The commission proposed tightening policies around gifts, payments, and conflicts of interest. Key recommendations included prohibiting all gifts to staff, requiring written invitations for industry visits, establishing oversight of financial interests and outside activities, and creating an enforcement infrastructure. The recommendations were endorsed by Partners HealthCare and will be implemented over time with the goal of improving oversight and reducing undue industry influence.

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Partners HealthCare
April 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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