03/30/15 Bob Dickson 1
Partners HealthCare
April 10, 2009
Summary of Partners Industry Interaction
Requirements—A Medical ...
03/30/15 Bob Dickson 2
Background on Partners HealthCare
• Boston, MA based integrated health system.
• Two academic medic...
03/30/15 Bob Dickson 3
Background on Recommendations
• Recommendations made by an internal commission
charged with examini...
03/30/15 Bob Dickson 4
Purposes of Commission
• Formulating principles to guide partners approach to
industry interactions...
03/30/15 Bob Dickson 5
Overview
• Tightens many current policies.
• Introduces several new policies.
• Calls for a renewed...
03/30/15 Bob Dickson 6
Enhancements to Conflict of Interest
Disclosure Process Over Past Two
Years
• Now reported and anal...
03/30/15 Bob Dickson 7
Key Recommendations (page 1 of 3)
• Prohibition of all gifts, including meals and
funding for meals...
03/30/15 Bob Dickson 8
Key Recommendations (page 2 of 3)
• Acceptance of industry funding for educational
programs and fel...
03/30/15 Bob Dickson 9
Key Recommendations (page 3 of 3)
• Development of an enhanced infrastructure,
including the creati...
03/30/15 Bob Dickson 10
Implementation and Rollout
• System-wide educational initiatives.
• Dedication of financial resour...
03/30/15 Bob Dickson 11
Disclaimers
• This summary may not be comprehensive.
• The Partners implementation plan has not ye...
03/30/15 Bob Dickson 12
Comments Appreciated
Comments on this presentation are welcomed. Please
email Bob Dickson your sug...
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Partners HealthCare-Summary of Recommendations on Interactions with Medical Device Companies

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

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Partners HealthCare-Summary of Recommendations on Interactions with Medical Device Companies

  1. 1. 03/30/15 Bob Dickson 1 Partners HealthCare April 10, 2009 Summary of Partners Industry Interaction Requirements—A Medical Device Company Perspective
  2. 2. 03/30/15 Bob Dickson 2 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.
  3. 3. 03/30/15 Bob Dickson 3 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.
  4. 4. 03/30/15 Bob Dickson 4 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.
  5. 5. 03/30/15 Bob Dickson 5 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.
  6. 6. 03/30/15 Bob Dickson 6 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.
  7. 7. 03/30/15 Bob Dickson 7 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.
  8. 8. 03/30/15 Bob Dickson 8 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.
  9. 9. 03/30/15 Bob Dickson 9 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.
  10. 10. 03/30/15 Bob Dickson 10 Implementation and Rollout • System-wide educational initiatives. • Dedication of financial resources. • Definition of sanctions for non-compliance. • Target effective date of 10/1/09.
  11. 11. 03/30/15 Bob Dickson 11 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.
  12. 12. 03/30/15 Bob Dickson 12 Comments Appreciated Comments on this presentation are welcomed. Please email Bob Dickson your suggestions for improvement. Please indicate the specific slide number that you are commenting on so the comment can be easily followed.

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