Ask ACCME


Standards for Commercial Support, 1: Independence


1) What is a commercial interest? (SCS1.1)
See ACCME's definition of a commercial interest.

2) Why will ACCME not allow commercial interests to act as joint sponsors? (SCS 1.2)
Joint sponsors are educational partners and are expected to routinely have a role in making decisions about the elements specified in SCS 1.1.  For further information on this topic, please click here to view ACCME policy on joint sponsorship.

3) ACCME defines a ‘commercial interest’ as "any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients." If an accredited provider believes that its organization is now defined as a commercial interest, what action(s) does the ACCME recommend in order to ensure independence and continued eligibility for accreditation? (SCS1.1)
The ACCME expects that providers will make changes to their organizational structure so that the CME program is independent from the organization that markets, re-sells, or distributes health care products and services.  In this way, the following decisions are made free of the control of the commercial interest: (a) identification of CME needs; (b) determination of educational objectives; (c) selection and presentation of content; (d) selection of all persons and organizations that will be in a position to control the content of the CME; (e) selection of educational methods; and (f) evaluation of the activity. 

The independence of the CME program from the commercial interest can be accomplished in different ways.

An example of an organizational structural change would be when an accredited provider that is a corporation sets up two additional wholly owned corporations:  one corporation that markets, re-sells, or distributes health care products or services and the CME corporation that does not market, re-sell, or distribute health care products or services.  The corporation that is the CME provider: 1) is not owned or controlled by a commercial interest; 2) has separate management; 3) is the employer of record; 4) has a governance structure separate from the governance structure of the commercial interest; and 5) receives any funds from a commercial interest only as commercial support.

4) How will the change in the definition of a commercial interest announced in August 2007 affect already accredited providers that might be owned by a commercial interest? (SCS 1.1)
The ACCME will work individually with accredited providers that might be affected by this definition as they transition to an independent corporate structure that is acceptable in the context of the ACCME’s Standards for Commercial Support.  It is ACCME’s expectation that any accredited provider that is, or is currently owned by, a commercial interest will transition to a different corporate structure (or will withdraw from accreditation) by August 2009.

The ACCME will answer your questions or provide you with the information your organization needs to make informed decisions. We ask that you communicate in writing directly with the ACCME as you evaluate your corporate structure. If you intend to change that structure, when you arrive at final conclusions on next steps, we invite you to provide your proposed solution to the ACCME prior to taking any definitive action. We are available to review your plans before they are implemented. You can submit them in writing to this email address: mkopelowmd@accme.org.

5) The August 2007 definition of ‘commercial interest’ seems to lump the people that secure the ads for the journal [i.e., publishers] into the camp of "promotion." Are entities that publish journals commercial interests? (SCS1.1)
No.  The ACCME has never intended that organizations (e.g., text-book/journal publishing company, specialty society) or people in organizations that are responsible for the production, layout, administrative, and operational aspects of a medical journal or text-book be defined as commercial interests. These organizations or people may sell advertising space to entities that are commercial interests, but that does not make them involved in the marketing of a commercial interest’s product. The person or organization that creates or buys the advertising space on behalf of a commercial interest is involved in marketing.

However, the people that are publishers and the people that are executives of accredited providers that generate income from the sale of advertising and promotional space have financial relationships with commercial interests as a result of these transactions.   The ACCME does consider these financial relationships to create conflict of interest in CME if, or when, the publisher and/or executive have control of CME content. As for all such conflicts in CME the accredited provider will be expected to have mechanisms in place to identify and resolve these conflicts of interest as necessary.  (See ACCME Standards for Commercial Support, Standard 2 for more information.)

6) Can an accredited provider ask a commercial interest for suggestions related to topics or speakers for CME? (SCS1.1)
No.  There is no reason for the CME provider to request suggestions for speakers or topics from commercial interests -- since it is unacceptable to act upon their suggestions. The ACCME believes that CME can receive commercial support from industry without receiving any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content. If the provider implements the suggestions of the commercial interest then this creates the situation where the independence of CME from the commercial interest is seriously undermined.  The provider must ensure that the content of the CME remains beyond the control of any commercial interest.  The process to develop the CME must be independent of any commercial interest.  Accredited providers must not allow commercial interests to directly (SCS 1.1) or indirectly (SCS3.2) control the content of CME.

7) What is the Provider to do if a commercial supporter of an activity says the content of the activity is not accurate -- or unreasonably favors their product? (SCS1.1)
There is no CME reason for commercial supporters to review and comment on CME content prior to its delivery to learners. The ACCME believes that CME can receive commercial support from industry without receiving any advice or guidance, either nuanced or direct, on the content of the activity or on who should deliver that content.

As has always been the case, issues could be brought directly to the ACCME by commercial supporters if commercial supporters believe that a provider does not meet ACCME’s expectations under the ACCME Standards for Commercial Support (e.g., freedom from bias, balance, or the ACCME Content Validation Policies). This will contribute significantly to the ACCME’s ability to enforce its policies

NEW (03/2009) 8) Can employees of commercial interests serve as planners or speakers in our accredited CME activities?
If the content of CME that the employee of the commercial interest controls relates to the business lines and products of its employer – NO.
If the content of CME that the employee of the commercial interest controls DOES NOT relate to the business lines and products of its employer – YES.

NEW (03/2009) 9) Can we offer accredited CME activities on research that was controlled in some way by a commercial interest, either through funding, collaboration, or involvement of the commercial interests’ staff in the research itself?
Yes, as long as the CME activity complies with the ACCME’s Accreditation Criteria, including the ACCME® Standards for Commercial SupportSM.  It is understood and accepted that industry conducts its own research and that industry partners, as funder or collaborator, in research projects.  An important step in the translation of discovery to practice is the dissemination of the results of this research.  There are several layers of internal and external controls already in place to manage the conduct of research (e.g., Institutional Review Boards, Government agencies) and the dissemination of results (e.g., editors, peer review, international standards.)  The ACCME does not intend to interfere with these carefully managed phases. 

However, when an organization chooses to base its CME content on research the organization assumes responsibilities related to CME, including compliance with the ACCME® Standards for Commercial SupportSM. The CME content (not the research that has already taken place or is taking place) cannot be controlled by a commercial interest. As an example, industry employees cannot deliver oral presentations and cannot author enduring materials that are accredited CME if the CME content relates to business lines or products of their employer.

NEW (03/2009) 10) One of our CME courses is an intensive hands-on course that trains physicians to perform vascular interventions in a laboratory setting. The training is primarily about newer medical devices and equipment, their use, and practical training in how to perform the procedures. The course director has asked a couple of companies to provide both training equipment/devices to use and company personnel to operate the equipment. We will track this loaned equipment as in-kind commercial support. The course director has independently designed the activity, determined the procedures to be taught, instructs the technologists on their roles, and is present to oversee and participate in the instruction. The course director verifies that the training and comments provided by the device technologists are technical only about the use of the equipment, and do not favor a commercial product or compare products. Is this situation allowed under the ACCME® Standards for Commercial Support?
Education on devices is a special use-case in accredited CME. Some equipment contains "labeling requirements" set by the FDA that include the requirement for instruction prior to use.  Each set of circumstances need to be taken on a case-by-case basis as the conflicts of interest of industry employees are irreconcilable in CME, so they can never take the usual role as teacher or author in accredited CME.  Industry employees can demonstrate the operational aspects of the use of a device under the umbrella of a provider’s ACCME accreditation - but they must only demonstrate the operational aspects. They can do this without contributing in any way to any decision making about the elements of SCS 1 of the ACCME® Standards for Commercial SupportSM.  It is also critical that the employees never expand their input into areas of clinical medicine while involved in accredited CME (e.g., never talk about indications for use, never talk about comparisons between competing products or comparisons between the device and/or invasive surgery and/or medical treatment.) This special use-case, if it is going to remain compliant, requires careful supervision by the accredited provider’s faculty and staff and proper professional behavior by industry staff.

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