Commercial Support

Commercial Support (99-08-B)

A commercial supporter is defined as any entity providing funds or resources to a continuing medical education provider.

(ACCME 96-B-7)

Commercial Acknowledgment in Enduring Materials (00-03-J)

1. Product specific advertising of any type is prohibited in enduring materials.
2. Commercial support must be acknowledged in order to comply with the Standards for Commercial Support and references to a company or institution are allowed.
3. This acknowledgment must be placed only at the beginning of the enduring materials.
4. The institutional acknowledgment may state the name, mission, and areas of clinical involvement of the company or institution and may include corporate logos and slogans, if they are not product promotional in nature.
5. No specific products may be referenced, even if they are not related to the topic of the enduring material.

(ACCME 95-B-02)

Funds from Government Entities (00-03-K)

Funds from Government entities are not considered commercial support.

(ACCME 97-B-17)

Delegating Responsibility for Educational Grants (00-03-O)

The accredited provider may delegate the responsibility for receiving and disbursing funds from educational grants to an educational partner. However, the letter of agreement regarding the grant must be between the accredited provider and the commercial supporter and the accredited provider must maintain and be able to produce as documentation a full accounting of funds.

(ACCME 99-A-14)

Standards for Commercial Support (00-03-T)

Element SCS3c reads in part “the accredited provider shall require the speaker to disclose that the product is not labeled for the use under discussion.” Compliance is documentation that demonstrates the provider has a practice in place to make this requirement known to the faculty.

(ACCME 99-C-07)

Faculty as Learners (00-03-U)

If faculty members are “bona fide” faculty, in that they are listed on the agenda as facilitating or conducting a presentation/session, but they participate in the remainder of an educational event as a learner, their expenses can be reimbursed and honoraria can be paid as allowed by the Standards for Commercial Support.

(ACCME 99-C-21)

Standards for Commercial Support (00-12-A)

PREAMBLE

The purpose of continuing medical education (CME) is to enhance the physician's ability to care for patients. It is the responsibility of the accredited provider of a CME activity to assure that the activity is designed primarily for that purpose.

Accredited providers often receive financial and other support from non-accredited commercial organizations. Such support can contribute significantly to the quality of CME activities. The purpose of these Standards is to describe appropriate behavior of accredited providers in planning, designing, implementing, and evaluating certified CME activities for which commercial support is received.

STANDARDS

1. General Responsibilities of Accredited Providers

   Accredited providers are responsible for the content, quality and scientific integrity of all CME activities certified for credit. Identification of continuing medical education needs, determination of educational objectives, and selection of content, faculty, educational methods, and materials is the responsibility of the accredited provider. Similarly, evaluation must be designed and performed by the accredited provider.

   1. Basic Design Requirements for CME Activities

      In designing educational activities, the accredited provider must assure that the activities have the following characteristics: They must be free of commercial bias for or against any product; If the activities are concerned with commercial products, they must present objective information about those products, based on scientific methods generally accepted in the medical community.

   2. Independence of Accredited Providers

      The design and production of educational activities shall be the ultimate responsibility of the accredited provider. Commercial supporters of such activities shall not control the planning, content or execution of the activity. To assure compliance with this Standard, the following requirements must be adhered to:

      1. Assistance with Preparation of Educational Materials
         The content of slides and reference materials must remain the ultimate responsibility of the faculty selected by the accredited provider. A commercial supporter may be asked to help with the preparation of conference related educational materials, but these materials shall not, by their content or format, advance the specific proprietary interests of the commercial supporter.
      2. Assistance with Educational Planning
         An accredited provider may obtain information that will assist in planning and producing an educational activity from any outside source whether commercial or not. However, acceptance by an accredited provider of advice or services concerning speakers, invitees or other educational matters, including content, shall not be among the conditions of providing support by a commercial organization.
      3. Marketing CME Activities
         Only the accredited provider may authorize a commercial supporter to disseminate information about a CME activity to the medical community. However, the content of such information is the responsibility of the accredited provider, and any such information must identify the educational activity as produced by the accredited provider.
      4. Activities Repeated Many Times
         Accredited providers that offer commercially supported educational activities that repeat essentially the same information each time they are given, must demonstrate that every iteration of that activity meets all of the Essential Areas, Elements and Policies.
      5. Educational Activities or Materials Prepared by Proprietary Entities
         When accredited providers offer educational activities consisting of concepts or materials prepared by proprietary entities, such activities must adhere to the Essential Areas, Elements and Policies in all respects, especially with regard to the provisions concerning the independence of the accredited provider in planning, designing, delivering, and evaluating such activities.

2. Enduring Materials

   The accredited provider is responsible for the quality, content, and use of enduring materials for purposes of CME Credit. (For the definition, see OSMA Standards for Enduring Materials.)

3. Identifying Products, Reporting on Research, and Discussion of Unlabeled ses of Products

4. Generic and Trade Name Presentations
   Any generic and trade name presentation must give a balanced view of therapeutic options. Faculty use of generic names will contribute to this impartiality. If trade names are used, those of several companies should be used rather than only that of a single supporting company.
   1. Reporting Scientific Research
      Objective, rigorous, scientific research conducted by commercial companies is an essential part of the process of developing new pharmaceutical or other medical products or devices. It is desirable that direct reports of such research be communicated to the medical community. An offer by a commercial entity to provide a presentation reporting the results of scientific research shall be accompanied by a detailed outline of the presentation which shall be used by the accredited provider to confirm the scientific objectivity of the presentation. Such information must conform to the generally accepted standards of experimental design, data collection and analysis.
   2. Unlabeled Uses of Products
      When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an educational activity, the accredited provider shall require the speaker to disclose that the product is not labeled for the use under discussion or that the product is still investigational.

5. Exhibits and Other Commercial Activities

   1. Exhibits
      When commercial exhibits are part of the overall program, arrangements for these should not influence planning or interfere with the presentation of CME activities. Exhibit placement should not be a condition of support for a CME activity.
   2. Commercial Activities During Educational Activities
      No commercial promotional materials shall be displayed or distributed in the same room immediately before, during, or immediately after an educational activity certified for credit.
   3. Commercial Supporters at Educational Activities
      Representatives of commercial supporters may attend an educational activity, but may not engage in sales activities while in the room where the activity takes place.

6. Management of Funds from Commercial Sources

   1. Independence of the Accredited Provider in the Use of Contributed Funds
      The ultimate decision regarding funding arrangements for CME activities must be the responsibility of the accredited provider. Funds from a commercial source should be in the form of an educational grant made payable to the accredited provider for the support of programming. The terms, conditions and purposes of such grants must be documented by a signed agreement between the commercial supporter and the accredited provider. All support associated with a CME activity, whether in the form of an educational grant or not, must be given with the full knowledge and approval of the accredited provider. No other funds from a commercial source shall be paid to the director of the activity, faculty, or others involved with the supported activity.
   2. Payment to Faculty
      Payment of reasonable honoraria and reimbursement of out-of-pocket expenses for faculty is customary and proper.
   3. Acknowledgment of Commercial Support
      Commercial support must be acknowledged in printed announcements and brochures, however, reference must not be made to specific products.
   4. Accountability for Commercial Support
      Following the CME activity, upon request, the accredited provider should be prepared to report to each commercial supporter, and other relevant parties, information concerning the expenditure of funds each has provided. Likewise, each commercial supporter should report to the accredited provider information concerning their expenditures in support of the activity.

7. Commercially Supported Social Events

   Commercially supported social events at CME activities should not compete with, nor take precedence over the educational events.

8. Policy on Disclosure of Faculty and Provider Relationships

   1. Disclosure Policy for all CME Activities
      An accredited provider shall have a policy requiring disclosure of the existence of any significant financial interest or other relationship a faculty member or the provider has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. All certified CME activities shall conform to this policy.
   2. Disclosure in Conference Materials
      CME faculty or provider relationships with commercial supporters shall be disclosed to participants prior to educational activities in brief statements in conference materials such as brochures, syllabi, exhibits, poster sessions, and also in post-meeting publications.
   3. Disclosure for Regularly Scheduled Activities
      In the case of regularly scheduled events, such as grand rounds, disclosure shall be made by the moderator of the activity after consultation with the faculty member or a representative of the supporter. Written documentation that disclosure information was given to participants shall be entered in the file for that activity.

9. Financial Support for Participants in Educational Activities

   1. Expenses of Non-Faculty Attendees
      In connection with an educational activity offered by an accredited provider, the provider may not use funds originating from a commercial source to pay travel, lodging, registration fees, honoraria, or personal expenses for non-faculty attendees. Subsidies for hospitality should not be provided outside of modest meals or social events that are held as part of the activity.
   2. Scholarships for Medical Students, Residents and Fellows
      Scholarships or other special funding to permit medical students, residents, or fellows to attend selected educational conferences may be provided, as long as the selection of students, residents or fellows who will receive the funds is made either by the academic or training institution, or by the accredited provider with the full concurrence of the academic or training institution.

Commercial Exhibits (00-12-G)

Commercial exhibits are promotional activities, and as such, accredited providers are not obligated to fulfill all the requirements of the OSMA’s Standards for Commercial Support with respect to these promotional activities, but are obligated to use sound fiscal and business practices with respect to these exhibits.

(Reference ACCME Policy 97-A-16)