Policy
Since 1991, the Ethics Committee of the American Academy of Ophthalmology has ascribed to the American Medical Association's Council on Ethical and Judicial Affairs' Opinion entitled "Gifts to Physicians From Industry," as updated in June 1998.* However, in the current environment where those relationships resulting in gifts and/or potential influence are being publicly scrutinized for appropriateness, the Ethics Committee has revised the Academy’s Policy Statement. It has incorporated elements of the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Providers and elements of the AMA’s current position on physician-industry relationships.
Background
The public perception of routine relationships between physicians and industry has been transformed by revelations of potentially inappropriate behavior on the part of both physicians and industry; results of clinical research are perceived to be tainted, the validity of physicians’ educational presentations are questioned, and the appropriateness of large-scale industry presence at professional educational meetings is debated. This change in perception has prompted many teaching institutions, professional associations, and the AMA itself to rethink existing policy governing these relationships. Some have called for a total ban on any relationships, while others call for a less severe model by which consensus limits to relationships would be observed by all. In the midst of this ethical debate, and while scientific studies confirm the fact that even seemingly minor and insignificant gift items, such as pens, mugs, and pizza lunches, do have the potential to influence physician behavior, PhRMA released revisions to its 2000 Code on Interactions with Healthcare Providers (to take effect January, 2009). The stated goal of these revisions is to “…reflect PhRMA’s position that appropriate transparency in relationships with healthcare professionals can help build and maintain patient trust in the healthcare system.” In response to the medical profession’s awareness of the potential unethical and undue influence of those relationships, industry is now recommending voluntary compliance by its member companies with stricter parameters on appropriate physician-industry relationships. The policy has been revised, therefore, and it will continue to be revised as the environment changes. The Ethics Committee affirms that in order to uphold the professionalism of ophthalmology, members must adhere to policy governing appropriate behavior that is equal to or greater than that to which industry suggests its members ascribe.
Gifts to Physicians from Industry
Many gifts and financial support given to physicians by companies in the pharmaceutical, device, and medical-equipment industries serve an important and socially beneficial function. For example, companies have long provided funds for educational conferences, seminars, and medical training. Unlike the former educational endeavors, some gifts that reflect customary practices of industry may not be consistent with Principles of Medical Ethics. To avoid the acceptance of inappropriate gifts and the development of inappropriate relationships, physicians should observe the following guidelines:
- Any gifts accepted by individual physicians should benefit patients, should be primarily of educational value, and should not be of substantial monetary value. Accordingly, textbooks, anatomical models, subscriptions to relevant scientific/medical journals, and copies of clinical-practice guidelines are appropriate since they serve a genuine educational function. Accepting drug and product samples for patient use is acceptable. Noneducational items such as pens, notepads, mugs, and materials whose primary purpose is to display company or product logos should not be accepted.
- Modest meals in a physician’s office or clinic setting are acceptable if accompanied by educational or scientific presentations. The meal should be incidental to the educational purpose of the gathering.
- Invitations to participate in entertainment events or recreational activities should not be accepted, even if held in conjunction with a scientific or educational program.
- Cash payments should not be accepted in any form. Payment to ophthalmologists who function as true spokespersons or who serve in an advisory capacity for a given company should be commensurate with the time spent in the activity or presentation.
- The AMA’s Council on Ethical and Judicial Affairs defines a legitimate "conference " or "meeting" as any activity, held at an appropriate location, where (a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering), and (b) the main incentive for bringing attendees together is to further their knowledge on the topics being presented. Appropriate disclosure of financial support and conflicts of interest, whether or not one believes it to be a conflict, is mandatory for the ethical ophthalmologist. Disclosure may be required by policy of an entity for which one serves in a leadership role and is required in any CME-bearing activity.
- Subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a company's representative may create a relationship that could influence the use of the company's products, any subsidy should be accepted by the conference's sponsor, who in turn can use the money to reduce conference registration fees. Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the conference.
- Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging, or other personal expenses of nonfaculty physicians or spouses attending conferences or meetings, nor should subsidies be accepted to compensate for the physician's time. Subsidies for hospitality should not be accepted except for modest meals or social events held as part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging, and meal expenses. It is also appropriate for consultants who provide genuine educational or informational services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging, and meal expenses. Token consulting, advisory arrangements, and spokesperson roles cannot be used to justify the compensation of physicians for their time or their travel, lodging, and other out-of pocket expenses.
- Scholarship or other special funds to permit medical students, residents, and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents, or fellows who will receive the funds is made by the academic or training institution. Carefully selected educational conferences are generally defined as the major educational, scientific, or policy-making meetings of national, regional, or specialty medical associations. No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods, and materials should belong to the organizers of the conference or lectures. Standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) should be followed for any CME-bearing activity.
Summary
To maintain the trust implicit in the physician-patient relationship and in our relationship with the public, ophthalmologists must avoid any appearance of impropriety; disclose potential conflicts to patients, the public, and colleagues; and take the high road to avoid unintended influence by industry. Ophthalmologists should uphold the ideals of the profession by adhering to these guidelines and encouraging colleagues to act accordingly.
References
CEJA Opinion G-I-90 “Gifts to Physicians from Industry”: http://www.ama-assn.org.
The PhRMA Code on Interactions with Health Care Providers: http://www.phrma.org/codes-and-guidelines/code-on-interactions-with-health-care-professionals
The Code of Ethics of the American Academy of Ophthalmology (see Rules 11, 12, and 15).
Approved by: Board of Directors, September 1991
Reaffirmed by: Board of Trustees, September 1997
Revised (per AMA) and Reaffirmed by: Board of Trustees, November 2003
Revised and Approved by: Board of Trustees, January 2009
© 2009 American Academy of Ophthalmology®
P.O. Box 7424 / San Francisco, CA 94109 / 415.561.8500
*From the Council on Ethical and Judicial Affairs (CEJA), American Medical Association, Chicago, IL. Issued as an opinion by the Council on Ethical and Judicial Affairs of the American Medical Association, December 3, 1990 and updated June 1996 and 1998. Reprint requests to American Medical Association, 515 N State St., Chicago, IL 60610 or on the web at http://www.ama-assn.org.
After CEJA published its guidelines on gifts to physicians from industry in a 1991 issue of the Journal of the American Medical Association, it followed up with detailed answers to a number of requests for clarification (Addendum II). These clarifications are presented in Q&A format and are intended to help users of the guidelines better understand how they are to be applied. Reprint requests to American Medical Association, 515 N State St., Chicago, IL 60610 or on the web at http://www.ama-assn.org.