1 University of Pittsburgh Presentation to Department of Family Medicine Outside Engagements within...

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University of Pittsburgh

Presentation to Department of Family Medicine

Outside Engagements within the Industry Relationship Policy

February 8, 2010Barbara 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

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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.

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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?

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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.

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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. …

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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.

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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;

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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;

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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

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Contacts

Barbara Barnes, MD

412-647-8212; barnesbe@upmc.edu Pamela Grimm, JD

412-647-4915; grimmp@upmc.edu David T. Wehrle, CPA, CIA, CFE412-383-1774; wehrledt@upmc.edu

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For more information…

On the University’s COI Web site:COI/Industry Relationship Policy pages:http://www.coi.pitt.edu/IndustryRelationships/index.htm