Summary of recommendations issued by Partners HealthCare on April 10th.

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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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