Policy 20: Pharmaceutical/Medical Device Industry Conflict of Interest Policy

Adopted: November 2008

Background

Collaboration between academic medicine and the pharmaceutical and medical device industries has contributed to important advances in medical therapy and public health. However, some of the collaborations have created situations in which the care of patients may have been compromised. The most egregious situations make for sensational headlines, but the less publicized activities such as free meals, free educational offerings, excessive consultant fees, and reimbursement for presentations promoting specific products are more pervasive and are now being scrutinized by the media, state and federal policy makers, patient advocacy groups, and patients themselves.

A large and compelling body of evidence supports the contention that decision making by physicians and other health care professionals is influenced by relationships with the pharmaceutical companies and medical device manufacturers and by the promotional and marketing techniques used by these companies. Individual physicians, the AMA, the AAMC, other medical and health care-related associations and organizations, and the NIH have recommended that the nature and extent of these relationships be disclosed in order for the public to regain and maintain trust in medical education, biomedical and psychosocial research, and clinical care. Bipartisan bills in the U.S. Senate (S. 2029) and the House (H.R. 5605) may require annual electronic reporting by drug, device, and medical supply companies of payments or other transfers of value to any physician or medical practice beginning March 31, 2011. Moreover, the AAMC recommends that all U.S. medical schools have conflict of interest policies in place by 2010.

Purpose

The purpose of this policy is to define the ethical standards that will be expected of the School of Medicine and its administrators, faculty, and staff when interacting with pharmaceutical companies and medical device manufacturers. Two fundamental principles of the policy are (1) to ensure professional integrity and preserve public trust while continuing to advance medical knowledge through collaborations between academic medical centers and industry and (2) to require easy public access to disclosure about the nature and extent of all such collaborations.

Policy

1. Sales representatives from pharmaceutical companies, nutritional support companies, medical device manufacturers, and medical supply and equipment companies (hereinafter referred to as "sales representatives") are permitted on the premises of the Boonshoft School of Medicine or Wright State Physicians, Inc. only by appointment and for specific activities approved in advance by a department chair or departmental administrator.
2. Sales representatives may not interact with students, residents and other trainees on the premises of the Boonshoft School of Medicine or Wright State Physicians, Inc. without faculty presence.
3. For the specific activities with advanced approval that are conducted on the premises of the Boonshoft School of Medicine or Wright State Physicians, Inc. (See 1 above), sales representatives may provide peer-reviewed literature and technical information about their products. They are not permitted to provide meals or refreshments, promotional items such as pens and notepads, or medical textbooks or similar gifts to faculty, students, residents, and staff.
4. Sales representatives may provide free samples of medications or nutritional products for patient use only with the approval of the respective department chair or departmental administrator explicitly for distribution to low-income patients who are unable to afford prescriptions or as a therapeutic trial prior to writing a full prescription.
5. Pharmaceutical companies, nutritional support companies, medical device manufacturers, and medical supply and equipment companies (hereinafter referred to as "industry sponsors") may provide unrestricted educational grants with the approval of the respective department chair as long as the following conditions are met:
   • Grants are used for speaker honoraria, photocopying handout material, rental of meeting room space and audiovisual support, and provision of modest food and meals.
   • Grants cannot be conditional or related in any way to pre-existing or future business relationships with industry sponsors.
   • The content of the educational program and related materials is under the total control of the Boonshoft School of Medicine.
   • Grant support by industry sponsors can be acknowledged in the text of program announcements, brochures, and handouts by using phrases such as "This program was sponsored in part by an educational grant from ______."
   • When industry sponsors provide support for CME programs sponsored by the Boonshoft School of Medicine, all relevant ACCME guidelines and procedures for commercial support of educational activities must be followed.

6. Industry sponsors may provide funding for Boonshoft School of Medicine faculty members to test new products or devices or to provide existing product feedback, to conduct clinical research, to serve on scientific advisory boards, or to serve as experts to teach the use of new technologies as long as the following conditions are met:
   • Ensure that collaborations with industry sponsors for which funding or other items of value are received are performed pursuant to a written agreement or memorandum that is established in advance with a description of the deliverables.
    

   • If the faculty member is collaborating with an industry sponsor on behalf of the Boonshoft School of Medicine or Wright State Physicians, Inc., the written agreement should be between the industry sponsor and the Boonshoft School of Medicine or Wright State Physicians, Inc.
   • If the faculty member is acting as an individual, such engagements must comply with CBA Article 22 concerning Outside Employment and with Wright State Physicians, Inc. Honorarium Policy and must be approved by the faculty member's department chair. In addition, the agreement or memorandum must include the industry sponsor's acknowledgement that the faculty member is not an agent or representative of the Boonshoft School of Medicine or Wright State Physicians, Inc.

    

   • Ensure that funding or compensation is at fair market value and based on the provision of tangible services and not on the decision to use a specific device, implant, product or drug in a patient.
   • Maintain documentation of the funding or compensation received and the services provided, including reasonable estimates of the time and effort involved in or committed to providing the services.
   • Ensure that disclosure of the nature and extent of all industry-sponsored activities are prominently displayed in all patient care areas and on the Boonshoft School of Medicine and Wright State Physicians, Inc. web sites and that disclosure about industry-sponsored activities involving specific devices, implants, products or drugs that will be recommended for an individual patient be disclosed in writing to the patient and documented in the patient's record prior to obtaining informed consent for a procedure or treatment that involves that specific device, implant, product or drug.
   • Faculty members must also follow relevant guidelines in the Wright State University Research Conflict of Interest and Financial Disclosure Policy regarding extramural non-federal and federal funding for research.
7. Meals, sporting event, theater, or other tickets, golf outings, gift baskets, travel and any other free goods or services should not be accepted from sales representatives or industry sponsors.
8. Boonshoft School of Medicine faculty members are subject to relevant Wright State University and Wright State Physicians, Inc. policies in regard to potential conflicts of interest. These include:
   • WSU Faculty Handbook
   • WSU Ethics Policy
   • WSU Research Conflict of Interest and Financial Disclosure Policy
   • WSU Responsible Conduct of Research
   • For faculty covered by the CBA: Article 22 Outside Employment
   • Medical Student Policy and Procedure Guide
   • Wright State Physicians, Inc. Honorarium Policy (DOC)

Implementation

Bargaining unit faculty members in matrixed departments are subject to the guidelines for behavior contained in CBA Articles 3 and 5, and the procedures for implementation in CBA Articles 14 and 16.

All other School faculty members must submit a conflict of interest disclosure statement annually and any time upon entering into a new or revised industry-sponsored activity that potentially affects their role as administrator, teacher, researcher, or clinician in the Boonshoft School of Medicine or with Wright State Physicians, Inc. (A PDF copy of the disclosure statement is available for review.) Details about conflicts that potentially affect a faculty member's professional activities are made available in relevant clinical areas and on the web sites of the Boonshoft School of Medicine and Wright State Physicians, Inc. The written procedures for disclosing information in clinical areas and any subsequent modifications must be approved by the Dean of the School of Medicine.

If, in the opinion of the Dean of the School of Medicine, the conflict of interest adversely affects the faculty member's professional role or if the faculty member fails to report or incompletely or inaccurately reports a potential conflict of interest, then the faculty member may be subject to disciplinary action.

Conflict of Interest Disclosures are public information and are available on the Web.

Frequently Asked Questions About The Conflict of Interest Policy

Please direct additional questions to: som_cme@wright.edu.