Frequently Asked Questions

 

  1. Can a faculty physician or staff member invite a representative from Industry to a faculty meeting to discuss a new drug or device that is under consideration for clinical use?
  2. Can a supplier who does NOT meet the definition of Industry under the policy conduct sales activities, such as presentations and shows, at my facility without registration?
  3. What is the definition of “medical device” for purposes of this policy?
  4. What facilities have controlled access for Industry representatives?
  5. If the Industry supplier is under a long-term enterprise-wide contract (see list of University and UPMC contracts) or a long-term department contract, do I need to process a supplier visit request for each visit?
  6. Can a faculty physician invite a representative from Industry to a faculty meeting to discuss a new drug? 
  7. What are the guidelines for obtaining legal/business reviews for consulting agreements under the new policy?
  8. For PhD researchers consulting with Industry, will the consulting approval processes apply, or is this only applicable to physicians making clinical decisions?
  9. We are holding our annual departmental retreat; can we solicit funds from drug or device manufacturers to defray our costs?
  10. My spouse (who does not work at the University or UPMC) has been invited to a dinner funded by a drug manufacturer; may I accompany my spouse to this event?
  11. Our department will be using a newly approved medical device, and on-site training by the manufacturer is required. How do we arrange for this in a way that is consistent with the policy?
  12. We are having a fundraising event at which corporate sponsors will be invited to buy tables. Is this permitted under the policy?
  13. Our professional organization’s annual meeting is supported by industry sponsors; may I attend this meeting?
  14. I have been asked to host visiting physicians in the UPMC operating room who are interested in learning how to use a particular vendor’s equipment in patient care. Does this policy permit me to receive a consulting fee for such an event?
  15. Will the prohibition on gifts in the policy prohibit my laboratory from receiving donated drugs for use in basic research?
  16. Our office has multiple anatomical models which have been provided to us for purposes of patient education, and these models also bear corporate logos. Does this policy require use to remove these items from our offices?
  17. A vendor has offered to underwrite the cost of travel, lodging, and other expenses in connection with my attendance at an off-site meeting. May I accept the offer?
  18. How will this policy be enforced?
  19. I have been asked to speak at an event for which industry is providing sponsorship; are there any limitations in the policy on my accepting this invitation?
  20. I have been invited to an event to announce a new product launch by a drug or device company; is this permitted? What if I am invited to participate as a speaker?
  21. A company has invited a faculty member to speak at an event next week; is there a simple, quick way to ensure that the speaking agreement with Industry complies with the requirements of the Industry Relationship Policy?

 

1. Can a faculty physician or staff member invite a representative from Industry to a faculty meeting to discuss a new drug or device that is under consideration for clinical use?

A SOHS or UPMC employee may request, via the appropriate organization’s purchasing department, to schedule a presentation by an Industry representative. If the product will be purchased with University funds under a University account number, see the University’s Purchasing website www.bc.pitt.edu/purchasing for instructions; otherwise, contact UPMC’s Supply Chain Management department http://purchasing.upmc.com or customerservicesupplychain@upmc.edu. The Industry representative must be registered with the appropriate organization’s purchasing department, must have completed required training, and must comply with badging requirements. Any such presentation should allow time for attendees to fully discuss questions related to the data presented, and no gifts may be provided to attendees.

 

2. Can a supplier who does NOT meet the definition of Industry under the policy conduct sales activities, such as presentations and shows, at my facility without registration?

Yes, if the supplier is not in the pharmaceutical, biotechnology, medical device, or hospital equipment supply industries, then the supplier must comply with the existing University and UPMC purchasing policies, but is not subject to the additional requirements of the Industry Relationship Policy.

 

3. What is the definition of “medical device” for purposes of this policy?

For purposes of this policy, the term “medical device" refers to any device that is tracked pursuant to the federal Safe Medical Device Act, which generally includes devices that are implantable or life-sustaining.

 

4. What facilities have controlled access for Industry representatives?

All SOHS facilities and all UPMC clinical facilities are subject to the access restrictions.

 

5. If the Industry supplier is under a long-term enterprise-wide contract (see list of University and UPMC contracts) or a long-term department contract, do I need to process a supplier visit request for each visit?

The Industry vendor need only register as a corporate entity once, but each visit by a representative must be requested and approved prospectively by the responsible purchasing department.

 

6. Can a faculty physician invite a representative from Industry to a faculty meeting to discuss a new drug?

A SOHS or UPMC employee may request, via the UPMC Supply Chain Management, to schedule a presentation by an Industry representative. The Industry representative must be registered with UPMC, must have completed required training, and must comply with badging requirements. Any such presentation should allow time for attendees to fully discuss questions related to the data presented, and no gifts or food may be provided to attendees by the representative. 

 

7. What are the guidelines for obtaining legal/business reviews for consulting agreements under the new policy?

Before submitting a consulting or speaking agreement for review, a faculty member or UPMC physician employed by UPMC should first verify that the proposed agreement meets Guidelines for Contracting with Outside Industry and can be shared with any outside company requesting consulting services. The Guidelines include specific requirements for a detailed description of services to be provided, along with details of the proposed compensation and expected maximum time commitment. Some proposed services are never appropriate for consulting arrangements, such as changes in the physician’s prescribing practices. The proposed agreement should be submitted to the department chair (in the case of faculty), as well as the department administrator or to the vice president of UPMC Physician Services Division (in the case of CMI physicians) or to the appropriate UPMC administrative unit. After confirmation by the immediate supervisor that the proposed time commitment is acceptable, the contract will be reviewed by PSD legal area to determine compliance with the contracting guidelines and UPMC policies.

In case of SOHS faculty members, the proposed agreement should be submitted to their department chairs, deans, or administrators for approval. In addition, prior review and written approval from the faculty member’s dean is required if consulting relationships with any one company (including the parent and subsidiary companies) will pay the faculty member in excess of $10,000 in any one 12-month period. The same Guidelines for Contracting With Outside Industry should be used to evaluate these proposed consulting relationships, and any questions regarding specific issues may be referred to the Office of General Counsel at the University.

 

8. For PhD researchers consulting with Industry, will the consulting approval processes apply, or is this only applicable to physicians making clinical decisions?

The consulting approval process applies to all faculty in the Schools of the Health Sciences. In case of SOHS faculty members, who are not also UPMC employees, the proposed agreement should be submitted to their department chairs, deans, or administrators for approval. In addition, prior review and written approval from the faculty member’s dean is required if consulting relationships with any one company (including the parent and subsidiary companies) will pay the faculty member in excess of $10,000 in any one 12-month period. The same Guidelines for Contracting With Outside Industry should be used to evaluate these proposed consulting relationships, and any questions regarding specific issues may be referred to the Office of General Counsel at the University.

9. We are holding our annual departmental retreat; can we solicit funds from drug or device manufacturers to defray our costs?

No. Departmental meetings are an administrative expense and should be paid for from departmental funds. Contributions from Industry to pay for internal meetings present the same issues as direct provision of meals and are not permitted. Solicitation of philanthropic gifts from industry for support of research or for support of educational programs may be coordinated through the Medical and Health Sciences Foundation.

 

10. My spouse (who does not work at the University or UPMC) has been invited to a dinner funded by a drug manufacturer; may I accompany my spouse to this event?

Yes, provided that you pay for your own meal. Although the invitation is to your spouse, the same principles that apply to the direct prohibition of Industry providing you with gifts or free meals would apply in this case.

 

11. Our department will be using a newly approved medical device, and on-site training by the manufacturer is required. How do we arrange for this in a way that is consistent with the policy?

Training on new medical devices may be provided on-site, as long as the Industry representative has first registered with UPMC Supply Chain Management, completed the necessary training, and is following badging requirements. Appointments will normally be made for such purposes as in-service training of personnel for research or clinical equipment already purchased, or the evaluation of new purchases of equipment, devices, or related items.

 

12. We are having a fundraising event at which corporate sponsors will be invited to buy tables. Is this permitted under the policy?

Fundraising social events that are open to the general public, with ticket payments going to a general philanthropic goal (e.g., a scholarship fund, a general purposes fund for a particular school, etc.) are not prohibited by the policy. Departments should coordinate closely with the Medical and Health Sciences Foundation in the planning and marketing of such events.

 

13. Our professional organization’s annual meeting is supported by industry sponsors; may I attend this meeting?

Provided that the meeting is designed to promote evidence-based clinical care, and/or advance scientific research, and industry support is prominently disclosed, attendance would not be prohibited by the policy. Attendees must pay their own expenses and may not receive gifts or compensation for attendance. Any meals provided must be incidental to the event and modest in cost. Logo incidentals of nominal value (such as meeting folders, binders, or canvas bags) that are provided as a matter of course to all attendees may be accepted for use at the conference, but should not be utilized on SOHS or UPMC clinical areas.

14. I have been asked to host visiting physicians in the UPMC operating room who are interested in learning how to use a particular vendor’s equipment in patient care. Does this policy permit me to receive a consulting fee for such an event?

No. Consistent with UPMC Conflict of Interest Policy No. HS-LE0002 and University Policy 02-06-01, Outside Employment, employees cannot use University or UPMC resources to generate personal income/revenue. Moreover, UPMC tax-exempt facilities cannot be used by for-profit entities for marketing activities. For acceptable models for CME sponsorship, see UPMC Section IV, 5 or SOHS Section C, 5 of the Policy.

15. Will the prohibition on gifts in the policy prohibit my laboratory from receiving donated drugs for use in basic research?

No. Materials donated for research use may be received by the University under an appropriate Material Transfer Agreement.

16. Our office has multiple anatomical models which have been provided to us for purposes of patient education, and these models also bear corporate logos. Does this policy require use to remove these items from our offices?

No; these items are acceptable because they primarily entail a benefit to patients; they are intended for patient education and may be retained. In accepting any new models from Industry, care should be taken to indicate to the offering company that such items need to be directly shipped, unless a manufacturer’s representative is invited to the office in accordance with the policy’s requirements. Logos or company advertising on the models should be removed or otherwise covered.

17. A vendor has offered to underwrite the cost of travel, lodging, and other expenses in connection with my attendance at an off-site meeting. May I accept the offer?

Subsidies from vendors should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses. There also should be no payment directly to a physician for attending the meeting if the physician’s participation was passive. It is appropriate for a speaker or other active conference participant to accept a reasonable honorarium and to accept reimbursement for reasonable travel, lodging, and meal expenses.

18. How will this policy be enforced?

With respect to violations by Industry representatives, enforcement shall be the responsibility of the UPMC Supply Chain Management and the University’s Purchasing Department. With respect to UPMC employees and SOHS personnel, violations of the policy shall be handled first by the individual’s dean and department chair (in the case of SOHS personnel) or the individual’s immediate supervisor and the UPMC Ethics and Compliance Office (in the case of UPMC personnel), or both (for dual status personnel). Existing policies of the University and UPMC related to employment actions shall apply to any action taken, including any provisions in those policies for appeal of decisions.

19. I have been asked to speak at an event for which industry is providing sponsorship; are there any limitations in the policy on my accepting this invitation?

Faculty may participate as speakers at industry-sponsored educational meetings, but both the event and the lecture must meet the requirements of the policy. As for the event, it should be an activity that is designed to promote evidence-based clinical care and/or to advance scientific research; the financial support of Industry must be disclosed; Industry must not pay attendees’ travel and attendance expenses, or provide gifts or other compensation for attendance; and any meals provided must be modest (i.e., the value of which is comparable to the Standard Meal Allowance as specified by the United States Internal Revenue Service). If the event meets these requirements, faculty members may participate as speakers, provided that they prepare their own content (without any control or approval of the content by industry), and the talk reflects a balanced assessment of alternative treatment options and is not focused on a single company’s product. Faculty members may accept a modest honorarium (not to exceed $2,500 per event) and reimbursement of reasonable travel expenses. Please note that reimbursement of travel expenses for speakers is a part of the compensation that faculty receive for speaking, and therefore, reimbursement of travel expenses for speakers—so long as industry does not pay the travel expenses of those who are simply attendees—does not violate the policy.


20. I have been invited to an event to announce a new product launch by a drug or device company; is this permitted? What if I am invited to participate as a speaker?

No, as described in FAQ 19 above, such an event would not be designed to promote evidence-based clinical care; it would be a promotional event for one company’s product. Because the event is promotional, attendance as a speaker would not be appropriate.

21. A company has invited a faculty member to speak at an event next week; is there a simple, quick way to ensure that the speaking agreement with Industry complies with the requirements of the Industry Relationship Policy?

Instead of editing an Industry-proposed agreement you may wish to use the Speaker’s Agreement Addendum to override impermissible terms of the Industry-proposed agreement. If you use this approach you should still first ensure that the speaking engagement is for an acceptable event (i.e., it will promote evidence-based clinical care or advance scientific research). That being the case, both parties should sign and date the Speaker’s Agreement Addendum.