/depts/,/depts/programs/,/depts/programs/interactions-with-industry/,

/depts/programs/interactions-with-industry/

201407202

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UWMF,

Leadership,Clinicians,Regulatory,

Departments & Programs,Programs and Initiatives

Interactions with Industry

Interactions with Industry - Departments & Programs, Programs and Initiatives

Summary


Focus

The UW Medical Foundation implemented a policy addressing interactions with industry (Policy on Interactions with Industry or "Policy") designed to provide clear direction on what constitutes a conflict of interest  and how to prevent and/or manage apparent conflicts of interest in our interactions with industry.

At the very heart of this policy is the expectation that all UWMF health care providers make clinical decisions that are transparent, ethical, free of undue economic influence and consistent with the highest professional standards. At the same time, we want to encourage partnerships and interactions with industry which advance our academic missions and adhere to the best traditions of academic medicine.

A key component of the Policy is the formation of an Industrial Interactions Review Committee (“IIRC”), which is charged with oversight of all UWMF health care professional activities within the purview of this policy. The Policy and composition of the IIRC was approved by the UWMF Board of Directors. The IIRC is chaired by Andrew Urban, MD, Associate Professor of Infectious Medicine. The IIRC meets on a quarterly basis to review reports of industry-related activities as required by the Policy, to provide direction relative to requests for consideration of special situations and to provide clarification of the Policy’s requirements.

FAQ

Why preclude meals? Do they really affect patient care decisions?

Evidence suggests that any gifts, including meals, provided by Industry, can influence the decision-making process. Even de minimis gifts, such as pens, mugs and meals have been shown to engender a sense of obligation on the part of the recipient. Moreover, research shows that in cases where a doctor has a pen or pad advertising a particular product, that product gets prescribed more often (AMA guidelines Regarding Industry Interactions: Drug Makers Pay for Lunch as They Pitch, New York Times, July 29. 2006).

A company that manufacturers important devices in my field would like to host a dinner for fellows from several select institutions at our next professional society meeting. The dinner will be at a well-known, expensive restaurant. Can my fellows attend?

In this scenario, the company sponsoring the dinner is buying goodwill and loyalty from specialists who will soon be positioned to make or influence purchasing decisions. The meal would be considered a gift and should not be accepted

At my professional society meetings, registrants are given the conference program material in a tote bag with the name of the society and the name of a pharmaceutical company that likely paid for the tote bags. May I accept the bag?

The policy does not prohibit you from accepting the bag, even with an imprinted company logo. Similarly, it would be acceptable to attend a meeting-wide reception even if it were sponsored by Industry. The UWMF policy cannot extend to sponsorship decisions made by professional societies; however, the practice of Industry support for professional societies in exchange for marketing opportunities (such as printing the company name and logo on conference material) is coming under scrutiny.

Can an Industry representative and UWMF physicians (or other staff) go out to lunch or dinner for a business purpose?

As long as you pay for your own meal, you are not in violation of the Policy. In deciding about such an arrangement however, you may want to consider the public perception that might be created.

Does the policy affect free samples for needy patients?

As we move to eliminate samples from clinics, we are sensitive to the needs of our patients who are uninsured or underinsured and cannot afford to buy drugs. We do not want our policy to have unintended negative consequences for these patients. The IIRC will develop guidelines regarding Pharmaceutical Samples in clinics on or before June 1, 2010, to be effective on July 1, 2010. Until that time, UW Healthcare providers may continue to distribute pharmaceutical samples per their current practices. Some patients may also qualify for medical assistance programs (for ongoing assistance - not just for samples), which are coordinated by the UWMF Patient Resources Department.

Are we allowed to accept scholarships and other educational funds from Industry for resident and student training?

If Industry wishes to support a Department's training of its residents, medical students, such support may be accepted at the level of the Section, Division or Department (not by any particular individual), and then the department may determine how the funds are spent. For more information about this process, see Section XIII of the Policy.

Are we allowed to accept patient education materials from Industry? If so, under what circumstances?

Yes, non-branded, non-promotional patient education materials may be received under the oversight of Vendor Liaison Office (of UWHC). Gifts cannot be made to or on behalf of individual faculty members or staff. Gifts must be made at the Section, Division or Department level with notification to the Chair of the IIRC. See Section II of the Policy.

Under the policy are sales and marketing representatives allowed on the campus and sites that UWMF faculty and staff are employed?

Industry representatives are permitted in both patient areas and non-patient care areas under the specific circumstances outlined in Section XII of the Policy.

Pharmaceutical Representatives' general access is permitted only to public areas which are not designated for patient care. Meetings with health care providers should occur only in non-public areas and must follow specific guidelines including:

  1. Activities may occur in a manner which is consistent with the guidelines set forth in UWHC Policy 11.19, as overseen by the UWHC Vendor Liaison Office.
  2. Meetings shall take place only by invitation from a health care provider or the UWHC Pharmacy Director.
  3. Requests for appointment with health care providers by pharmaceutical representatives shall be made through the VLO.

Alternative processes for implementing the intent of this policy may be adopted for geographically distant clinics and faculty locations.

Medical Device Representatives are generally subject to the same rules as Pharmaceutical Representatives and scheduled through the VLO. They may enter patient care areas if the following conditions are met:

  1. They are appropriately credentialed by the organization owning or operating the clinical entity.
  2. Their visit is requested by appointment and invitation of a UWMF physician or designated department personnel.
  3. Their visit to a patient care area is of direct benefit to the patient(s) currently being treated in the patient care area, or no patients are present.

These requirements do not apply to individuals servicing medical devices which are already in place. For these individuals, credentialing and an existing service or maintenance contract are required.

Is it true that sales and marketing representatives may no longer leave any branded written materials with employees?

Yes, this is true. Branded sales and marketing materials from Industry representatives may no longer be left with departments or with medical staff, faculty or staff. The reason for this is to avoid any expectation on the part of Industry, and to ensure that we do not promote a company or its products to our patients. If information about a product is needed, such information should be obtained online or through a library.

Can an Industry sales representative provide support in the operating room?

A. Yes, in certain circumstances. Industry representatives with appropriate knowledge of a device may be helpful in the operating room, in order to provide technical support or advice. Representatives must be credentialed per the requirements of the facility in question.

I have been invited by a pharmaceutical company to give a talk to community physicians. Am I allowed to do this?

UW Healthcare providers are prohibited from participating as speakers in outside activities that are promotional and funded by pharmaceutical or biologic Industry, such as speaker's bureaus, speaker's training programs, and contracted educational programs. Exceptions may be permitted for unique learning opportunities by obtaining advance approval from the IIRC. See Section IV of the Policy.

Can my department receive grants from Industry for scholarships or other educational funds for students and trainees?

Yes, so long as it is compliant with Section XIII of the Policy. Such support must be specifically for the purpose of education, and should be free of any actual or perceived conflict of interest. In order to be compliant with the policy it must meet the following conditions:

I understand that we no longer allow pharmaceutical sponsors to purchase meals on campus, but what about using gift funds that are derived from unrestricted gifts for research and education to purchase meals?

We do not allow Industry to buy meals for UWMF events.

If I am an invited guest at another educational institution, and am offered an honorarium for my teaching activities, may I accept the payment?

You may accept payments directly from the other educational institution; UWMF is not responsible for their sources of funding. However, you may not accept honoraria directly from Industry.

Resources

Interactions with Industry Policy

Related

Governance