University of Pittsburgh Presentation to Department of Family Medicine Outside Engagements within the Industry Relationship Policy February 8, 2010 Barbara Barnes, MD Pamela Grimm, JD
Recent Developments re: Reporting of Outside Interests • Pharmaceutical companies have begun posting on their Web sites payments made to speakers and consultants • Enables entities like the University of Pittsburgh/UPMC to review and monitor outside interests of employees for compliance with the Industry Relationship Policy
Outside Engagements with Industry—What is Allowed? True consulting, where payment is reasonable and related to the services provided, is permitted under the Industry Relationship Policy (IRP). Where consulting payments are made without services being provided, or where payment rates are out of proportion to the service provided, the payments may be considered kick-backs. Any consulting agreement, under University/UPMC policies, requires the prior approval of the department chair and/or dean.
Consulting Contract Guidelines A contract detailing the proposed services to be provided must be in writing; Faculty member should provide company with “Guidelines for Contracting with Outside Industry” (see IRP, FAQ # 7); Consultant cannot engage in promotional or marketing activities on behalf of the company; How do you know if it is promotional? Is it organized by the Marketing Dept or the R & D Dept.? Who invites the attendees? Who controls the content?
Consulting Contract Guidelines (cont’d) University’s/UPMC’s name and address cannot appear in the contract; consultant’s personal address must be used instead; Any non-compete clause in the contract cannot interfere with faculty member’s duties at the University/UPMC; Use of University/UPMC resources is not permitted; Use of consulting Addendum helps ensure that contract terms will comply with IRP.
Consulting Contract Guidelines (cont’d) Compensation There must be a direct correlation between services provided and payment received. Contract must include specific, legitimate tasks and deliverables. … 6
Consulting Contract Guidelines (cont’d) Payment must be commensurate with the task performed; Hourly payment of more than $500 is deemed excessive; Consultant cannot be pre-paid for services. 7
Speaking Contract Guidelines A contract detailing the proposed services to be provided must be in writing (e.g., an e-mail invitation is not sufficient); The Speaker’s Agreement Addendum helps ensure that contract terms will comply with provisions of the IRP; Compensation for speaking is limited to a modest honorarium not to exceed $2,500 per event, and reimbursement of reasonable travel expenses;
Speaking Guidelines (cont’d) Presentation must be designed to promote evidence-based clinical care and/or to advance scientific research; Marketing activities and promotional speaking are not permitted; Speakers must make clear that views expressed are their own, not those of the University/UPMC;
Speaking Guidelines (cont’d) Speaker must control content of presentation, and content cannot be subject to company’s approval; Content must reflect a balanced assessment of current science and treatment options, and cannot focus on a single company’s product.
Conflict Management Plan • Dean Levine’s approval and a COI management plan are needed if compensation • exceeds $10,000 in any 12-month period, or • options or equity exceed 5% ownership interest or $10,000
Conflict Management Plan cont’d • Will not be permitted to serve as PI on research of commercial interest to the company • Can serve as a Co-investigator, but role in the study must be diluted
Contacts Barbara Barnes, MD 412-647-8212; email@example.com Pamela Grimm, JD 412-647-4915; firstname.lastname@example.org David T. Wehrle, CPA, CIA, CFE 412-383-1774; email@example.com
For more information… On the University’s COI Web site: COI/Industry Relationship Policy pages: http://www.coi.pitt.edu/IndustryRelationships/index.htm