- UF Guidelines, Policies, and Procedures on Conflict of Interest and Outside Activities, including Financial Interests
- Regulations of the University of Florida- 1.011 Disclosure and Regulation of Outside Activities and Financial Interests
- Disclosure of Outside Activities and Financial Interests Form
- Litigation and Expert Witness Report Form
- Request to use University Equipment, Facilities and Services Form
While the interaction with Industry can be beneficial, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise of pa- tient safety, result in negative socialization of students and trainees, bias of research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because provision of financial support of gifts, even in modest amounts, can exert a subtle but measurable impact on recipients’ behavior, the UFCOP has adopted a policy to govern the inter- actions between Industry and UFCOP personnel.
Policy on Conflicts of Interest and Interactions between Representatives of Certain Industries and Faculty, Staff and Students of the College of Pharmacy at the University of Florida*
The College of Pharmacy at the University of Florida (UFCOP) has as a goal to improve the health of the public through the creation and dissemination of knowledge about the treatment of human disease, and to employ this knowledge in the delivery of effective and efficient clinical care. This mission requires that faculty, students, trainees, and staff of the UFCOP interact with representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (hereinafter “Industry”). While the interaction with Industry can be beneficial, Industry influence can also result in unacceptable conflicts of interest that may lead to increased costs of healthcare, compromise of patient safety, result in negative socialization of students and trainees, bias of research results, and diminished confidence and respect among patients, the general public and regulatory officials. Because provision of financial support or gifts, even in mod- est amounts, can exert a subtle but measurable impact on recipients’ behavior, the UFCOP has adopted the following policy to govern the interactions between Industry and UFCOP personnel.
There is a growing body of evidence demonstrating the adverse consequences of interactions be- tween healthcare providers and Industry, including practices such as receipt of small gifts that have traditionally been considered acceptable by professional standards. While healthcare professionals may not believe that they are personally biased by Industry, detailing by Industry rep- resentatives is designed to sell products and advance the interests of Industry’s shareholders.
This policy has been designed on the basis of the best available literature on conflict of interest and is intended to provide a set of guiding principles that members of the UFCOP as well as rep- resentatives of Industry can use to assure that their interactions result in optimal benefit to clinical care, education and research, and maintenance of the public trust. This policy is designed to affect the behavior and practices of Industry, as much as the behavior of UFCOP. While valuable and meaningful interaction between Industry and UFCOP can occur, the provision of gifts, food, or other blandishments add nothing to the substance of the exchange, and leave both parties sub- ject to questions of integrity and commitment to professional practice responsibilities.
The purpose of this policy is to create a synergistic relationship between the College and industry partners while protecting patients from the negative influence on decision making as the result of gifts and direct financial implications.
The policy development is a dynamic process and the stated components of the policies are to provide clarification of relationships between faculty, staff and students in managing situations that may generate real and perceived conflicts of interest with industry.
1. The institution is committed to transparency to all in its dealings with industry.
2. The care giver’s primary responsibility is to the patient.
3. Research must be free of any potential for bias.
4. Appropriate interactions between industry and faculty/residents/students/staff do exist, but the boundaries of that interaction need continuous monitoring.
5. The goal of policy is to be sure all individuals are aware of their responsibilities with regard to industry relations. To that end all faculty, residents and staff should have specific instruction tailored to their role in appropriate academic-industry interaction.
6. The institution and individuals are accountable for their actions
A. Scope of Policy
This policy applies to all faculty, staff, and students of the UFCOP, and to all healthcare professionals and staff employed and/or contracted by domestic locations of UFCOP, and to all facilities owned or controlled by the UFCOP. While this policy addresses many aspects of Industry interaction, it supplements the existing conflict of interest policies of the University of Florida, particularly as they apply to research conflicts of interest.
In all cases where this policy is more restrictive than a University conflict of interest policy, this policy shall control. This policy applies to interactions with all sales, marketing, or other prod- uct-oriented personnel of Industry, including those individuals whose purpose is to provide in- formation to pharmacists about company products, even though such personnel are not classified in their company as “sales or marketing.”
This policy does not apply to pharmacy companies (e.g., Walgreens, CVS, Publix, Wal-Mart, McKesson, etc.) that provide funding to support UFCOP events (i.e., Orientation, Homecoming BBQ, Parents and Family Day, Open Houses, Career Days, Professional White Coating Ceremony, and similar events), that are held for the benefit of professionalization, socialization, and ed- ucation of students and their families, faculty, staff, alumni, pharmacists, and friends of the College. The funding for these events may not be used as a forum for the companies to endorse or promote specific pharmaceutical products. These companies may advertise to assist students in their evaluation of career pathways in the pharmacy profession.
B. Statement of Policy
It is the policy of the UFCOP that clinical decision-making, education, and research activities be free from influence created by improper financial relationships with, or gifts provided by, Indus- try. For purposes of this policy, “Industry” is defined as all pharmaceutical manufacturers, and biotechnology, medical device, and hospital equipment supply industry entities and their repre- sentatives. In addition, pharmacists and their staffs should not be the target of commercial blandishments or inducements – great or small – the costs of which are ultimately borne by our pa- tients and the public at large. These general principles should guide all potential relationships or interactions between UFCOP personnel and Industry representatives. The following specific lim- itations and guidelines are directed to certain specific types of interactions. For other circumstances, UFCOP personnel should consult in advance with their deans or department chairs to obtain further guidance and clarification. Charitable gifts provided by industry in connection with fundraising done by or on behalf of UFCOP shall be subject to other policies adopted by the University of Florida Foundation on fundraising.
C. Specific Activities
1. Gifts and Provision of Meals
UFCOP personnel shall not accept or use personal gifts from representatives of Industry, regardless of the nature or dollar value of the gift. Although personal gifts of nominal value may not violate professional standards or anti-kickback laws, such gifts do not improve the
quality of patient care, may subtly influence clinical decisions, and add unnecessary costs to the healthcare system. Gifts from Industry that incorporate a medication product (e.g., pens, notepads or office items such as clocks) introduce a commercial, marketing presence that is not appropriate to a non-profit educational and healthcare system. Meals or other hospitality funded directly by Industry intended to provide a forum to influence patient care decisions on the use of medications by faculty and students may not be offered in any facility owned and operated by the UFCOP. UFCOP individual personnel may not accept meals or other hospitality funded by Industry, whether on-campus or off-campus, or accept complimentary tickets to sporting or other events or other hospitality from Industry.
This provision does not prohibit acceptance of items bearing Industry logos provided as part of an off-site educational program (such as a meeting of a professional society), including name tag lanyards, totes, etc., where the items are provided incidental to attendance, the items are of nominal value, and the items are not used on UFCOP premises.
2. Consulting Relationships
The UFCOP recognizes the obligation to make the special knowledge and intellectual competence of its faculty members available to government, business, labor, and civic organizations, as well as the potential value to the faculty member, the University, and UFCOP. However, consulting arrangements that simply pay UFCOP personnel a guaranteed amount without any associated duties (such as participation on scientific advisory boards that do not regularly meet and provide scientific advice) shall be considered gifts and are consequently prohibited.
In order to avoid gifts disguised as consulting contracts, where UFCOP personnel have been engaged by Industry to provide consulting services, the consulting contract must provide specific tasks and deliverables, with payment commensurate with the tasks assigned. All such arrangements between individuals or units and outside commercial interests must be reviewed and approved prior to initiation in accordance with appropriate University policies (e.g., the University’s outside employment activity report form).
For UFCOP personnel, consulting relationships with Industry may be entered into only with the prior permission of a faculty member’s dean and department chair. In addition, prior re- view and written approval from the faculty member’s dean is required if consulting relation- ships with any one company (including the parent and subsidiary companies) will pay the faculty member in excess of $10,000 in any twelve-month period. The dean and chair should evaluate the content/effectiveness of the consultation to insure compliance with specific tasks and deliverables commensurate with payment for the tasks assigned. The UFCOP reserves the right to require faculty and employees to request changes in the terms of their consulting agreements to bring those consulting agreements into compliance with UFCOP policies.
3. Drug or Device Samples
The provision by manufacturers of “free” samples of prescription drug or device products is a marketing practice designed to promote the use of these products and to gain access to pre- scribers to influence their behavior6. Studies from the literature quite convincingly demonstrate the effectiveness of this technique to boost sales. At the same time, this practice provides invaluable assistance to some patients to quickly begin a course of treatment or to determine which therapeutic option is most beneficial for that patient. Free samples also have been responsibly incorporated into the evidence-based decision making of some individual
and group practices. While societal benefits result from the availability of medications at the point of care, sampling is also accompanied by regulatory and security concerns, poses potential safety risks for patients, and encourages prescribing of new, high cost medications whose safety and efficacy may not be different from existing treatments. In addition, the manufacturers’ cost of producing the specially packaged samples and distributing them to clinicians via personal couriers (company representatives), introduces a substantial expense into the overall consumer drug cost. Since pharmacists are not prescribers of legend medications, this policy is most applicable to physicians. However, pharmacists work in consulting roles to physicians in the selection and delivery of medications. Use of sample medications should be limited where feasible and possible.
4. Site Access
As institutions dedicated to advancing the public interest, the UFCOP should not allow use of their facilities or other resources for marketing activities by Industry. The University and UFCOP always reserve the right to refuse access to their facilities or to limit activities by Industry representatives consistent with their non-profit mission. However, interaction with representatives of Industry is appropriate as it relates to exchange of scientifically valid information and other data, interactions designed to enhance continuity of care for specific patients or patient populations, as well as training intended to advance healthcare and scientific investigation. To balance these interests, UFCOP will develop a registry to assist in the management of site access by Industry representatives for appropriate purposes. Sales or marketing representatives of Industry may access UFCOP facilities only if the company with which they are associated has registered with department or administrative unit and they have been specifically invited to meet with an individual healthcare provider or a group of healthcare providers for a particular purpose. Individual pharmacists/faculty or groups of pharmacists/ faculty or other healthcare professionals may request a presentation by or other information from a particular company through the respective department or administrator. Management will provide names of registered Industry representatives to the University upon request.
Representatives without an appointment as outlined above are not allowed to conduct busi- ness in patient care areas (inpatient or outpatient), in practitioners’ office areas, or other areas of UFCOP facilities.
On-campus vendor fairs intended to showcase Industry products may be permitted if approved by the appropriate departments or administrative unit but only in campus buildings in which no clinical care is delivered or in which no research is conducted. Such events must comply with the “no gifts” provisions of Sections 1 and 3 of this policy. In such situations, vendors would not be permitted to distribute free samples, free meals, raffle tickets, or any other gifts to attendees.
5. Support of Continuing Education in the Health Sciences
Industry sponsored presentations should meet the following principles:
a. Full disclosure of corporate sponsorships and/or industry relationships must be present prior to any presentation.
b. A responsible faculty member must be present and review content prior to ensure that and the content is presented in a balanced and unbiased manner.
c. Industry representatives can only be permitted in patient care areas after the approval of a sponsoring faculty member with the industry representative demonstrating compliance with HIPAA guidelines.
Industry support of continuing education (“CE”) in the health sciences can provide benefit to patients by ensuring that the most current, evidence-based medical information is provided to healthcare practitioners. In order to ensure that potential for bias is minimized and that CE programs are not a guise for marketing, all CE events hosted or sponsored by the UFCOP must comply with the ACPE standards for educational programs whether or not CE credit is awarded for attendance at the event. All such agreements for Industry support must be negotiated through and executed by the Division of Continuing Education and must comply with all policies for such agreements. Any such educational program must be open on equal terms to all interested practitioners, and may not be limited to attendees selected by the company sponsor(s). Industry funding for such programming should be used to improve the quality of the education provided and should not be used to support hospitality, such as meals, social activities, etc., except at a modest level. Industry funding may not be accepted for social events that do not have an educational component. Industry funding may be accepted to sup- port the costs of internal department meetings or retreats (either on- or off-campus) for educational purposes but without advertisement of specific products.
UFCOP facilities (clinical or non-clinical) may not be rented by or used for Industry funded and/or directed programs, unless there is a CE agreement for Industry support that complies with the policies of the acceptable CE programs. Dedicated marketing and training programs designed solely for sales or marketing personnel supported by Industry are prohibited.
6. Industry Sponsored Meetings or Industry Support for Off-Campus Meetings
UFCOP faculty, personnel, or students or staff may participate in or attend Industry- sponsored meetings, or other off-campus meetings where Industry support is provided, so long as: (a) the activity is designed to promote evidence-based clinical care and/or advance scientific research; (b) the financial support of Industry is prominently disclosed; (c) if the UFCOP representative is an attendee, Industry does not pay attendees’ travel and attendance expenses; (d) attendees do not receive gifts or other compensation for attendance; (e) meals provided are modest (i.e., the value of which is comparable to the Standard Meal Allowance as specified by the United States Internal Revenue Service) and consistent with the educational or scientific purpose of the event. In addition, if a UFCOP representative is participating as a speaker: (a) all lecture content is determined by the UFCOP speaker and reflects a balanced assessment of the current science and treatment options, and the speaker makes clear that the views expressed are the views of the speaker and not the UFCOP; (b) compensation is reasonable and limited to reimbursement of reasonable travel expenses and a modest honorarium not to exceed $2,500 per event.
7. Industry Support for Events
a. When college sponsored events take place, industry support is permissible if support is recognized on all printed materials and acknowledged at the beginning of presentations.
b. When industry sponsored events take place, UFCOP involvement is permissible as long as there is no perceived endorsement by the College by the nature of participating in the event. Presentations by industry on site must be sponsored by the administration, faculty/department, or recognized student organization. Student organizations must have faculty input and approval prior to either engaging in an invitation for either a college or industry sponsored educational event.
8. Industry Support for Scholarships, Residencies or Fellowships or Other Support of Students, Residents, or Trainees
The UFCOP may accept Industry support for scholarships, residency support or discretionary funds to support trainee or resident travel or non-research funding support, provided that all of the following conditions are met:
a. Industry support for scholarships, residencies, and fellowships must comply with all University or requirements for such funds, including the execution of an approved budget and written gift agreement through the University of Florida Foundation, and be maintained in an appropriate restricted account, managed at the department as determined by the Dean. Selection of recipients of scholarships or fellowships will be completely within the sole discretion of the department which the student or trainee is enrolled or, in the case of graduate medical education, the associate dean for graduate studies. Written documentation of the selection process will be maintained.
b. Industry support for other trainee activities, including travel expenses or attendance fees at conferences, must be accompanied by an appropriate written agreement and may be accepted only into a common pool of discretionary funds, which shall be maintained under the direction of the dean or department or center director (as specified in the funding agreement) for the relevant department. Industry may not earmark contributions to fund specific recipients or to support specific expenses. Departments or divisions may apply to use monies from this pool to pay for reasonable travel and tuition expenses for residents, students, or other trainees to attend conferences or training that have legitimate educational merit. Attendees must be selected by the department based upon merit and/or financial need, with documentation of the selection process provided with the request. Approval of particular requests shall be at the discretion of the Dean.
9. Frequent Speaker Arrangements (Speakers Bureaus) and Ghostwriting
While one of the most common ways for the UFCOP to disseminate new knowledge is through lectures, “speakers bureaus” sponsored by Industry may serve as little more than an extension of the marketing department of the companies that support the programming. Be- fore committing to being a speaker at an Industry-sponsored event, careful consideration should be given to determine whether the event meets the criteria set forth in Section 6 of this policy, relating to Industry Sponsored Meetings. UFCOP personnel may not participate in, or receive compensation for, talks given through a speaker’s bureau or similar frequent speaker arrangements if: (a) the events do not meet the criteria of Section 6; or (b) if the content of the lectures given is provided by Industry; of Industry or event planners contracted by Indus- try; or (c) the content of the presentation is not based on the best available scientific evidence; or (d) the company selects the individuals who may attend or provides any honorarium or gifts to the attendees. Under no circumstances may UFCOP personnel be listed as co- authors on papers ghostwritten by Industry representatives. In addition, UFCOP personnel should always be responsible for the content of any papers or talks that they give, including the content of slides.
Speaking relationships with company or company event planners are subject to review and approval of the participant’s administrator, department chair, or dean as delineated in Section 2, Consulting Relationships.
10. Other Industry Support for Research
The UFCOP, through the Office of Sponsored Research, have established policies and con- tract forms to permit Industry support of basic and clinical research in a manner consistent with the non-profit mission of the University. True philanthropic gifts from Industry may be accepted through the University of Florida Foundation. All industry sponsored research should follow guidelines and polices developed by the University for Florida Division of Sponsored Research. Investigators should comply with research ethical guidelines and complete respective UF conflict of interest documentation in a timely manner. All issues are to be referred to the Associate Dean of Research in the College of Pharmacy.
Gifts of a philanthropic nature from industry to UFCOP may be accepted by the Dean in consultation with an appropriate department chair/dean based on the congruence of the donor’s corpo- rate mission with the mission of UFCOP. Whenever there is ambiguity in this regard, the issue shall be decided on by the Dean.
Exemption Request: Faculty, Staff, and Students of the College of Pharmacy at the University of Florida may request an exemption to any of the specific activities specified in Part C of the Policy. The procedure for faculty, staff, and students will be to request an exemption by submit- ting a written request to either the department chair (for faculty), Senior Associate Dean for Pro- fessional Affairs (for students), Chief of Staff (for staff). The request will be notated with a sign of support or disapproval and then will be forwarded to the Dean for a decision.
D. Reporting and Enforcement
For questions and issues of general industry conflict and industry supported research, the Associate Dean for Research and Graduate Studies should be consulted. The UFCOP faculty, students, and staff who do not comply with these policies are subject to disciplinary action as defined in University policies in conflict of interest.
The UFCOP personnel shall report their outside relationships with Industry using the combined Conflict of Interest Form, at least annually and more often as needed to disclose new relation- ships. Alleged violations of this policy within the UFCOP shall be investigated by the Dean’s Office. Suspected violations of this policy shall be referred to the individual’s department chair who shall determine what actions, if any, shall be taken.
Violations of this policy by UFCOP employees may result in the following actions (singly or in any combination), depending upon the seriousness of the violation, whether the violation is a first or repeat offense, and whether the violator knowingly violated the policy or attempted to hide the violation:
1. Counseling of the individual involved
2. Written reprimand, entered into the violator’s employment or faculty record
3. Banning the violator from any further outside engagements for a period of time
4. Requiring that the violator return any monies received from the improper outside relationship
5. Requiring the violator to complete additional training on conflict of interest
6. Removing the violator from supervision of trainees or students
7. Termination for cause
Any disciplinary action taken hereunder shall follow the established procedures of the University. Industry representatives who violate this policy may be subject to penalties outlined in the Health Science Center policies, as well as other actions or sanctions imposed at the discretion of the Vice President of Health Science Center.
Violation of any of the above procedures by representatives shall result in disciplinary action which may include but shall not be limited to the following:
• First violation: Verbal and written warning to representative; written notification to district manager or representative’s supervisor.
• Second violation: Suspension of representative and all other company sales/marketing representatives from the UFCOP for six months.
• Third violation: Suspension of representative and all other sales and marketing representatives of the company from the UFCOP for one year or more. A review of multi-source products obtained from the company will be conducted. Representatives found trespassing as defined in this policy will be escorted from the premises and their companies notified as appropriate.