Effective January 1, 2009
Policy on the separation of individuals who conduct marketing or promotional activities for ineligible companies from those who participate in IAS–USA activities.
The ACCME defines ineligible companies as “those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.”
The IAS–USA endeavors to provide independent, expert certified continuing medical education (CME), information, and guidelines for health care practitioners involved in the management of people with HIV, HCV, or other viral infections. As of January 2009, as part of this commitment, the IAS–USA will no longer allow medical professionals involved in commercial marketing efforts to contribute to general IAS–USA educational and informational programs. The IAS–USA defines a promotional or marketing effort as any activity in which the ineligible company controls key elements, such as selection of speaker(s) and authors or topic determination that could be used to serve the entity’s commercial interests.
Under this policy, individuals may not participate in IAS–USA programs for 12 months after taking part in a promotional or marketing effort sponsored by the pharmaceutical or medical device industry. Among the promotional and marketing efforts covered by the IAS–USA policy are:
- lectures or appearances that are coordinated by commercial companies, including company lectures and industry-sponsored “speakers’ bureaus,” or those for which a commercial firm pays honoraria directly to the faculty member, and satellite events that are organized and sponsored by industry
- advertising and marketing campaigns, including “advertorials”
- appearances or presentations at company-sponsored exhibit booths during professional events
This policy applies to participation in IAS–USA activities as speakers, moderators, CME course cochairs, authors, and members of the Board of Directors, advisory boards, program development committees, and guidelines panels. This policy does not apply to the research-driven annual Conference on Retroviruses and Opportunistic Infections, however, because of the nature of the research presented. Any exception to this policy must be approved by the IAS–USA Board of Directors.
This provision of IAS–USA policies erects another firewall between IAS–USA program activities and potential commercial influence. With this policy—one of the strictest of any CME provider—the IAS–USA reaffirms its commitment to ensuring independence, objectivity, and scientific rigor in its programs and publications.
In drafting the new policy, the IAS–USA recognizes the distinction between speaking activities that serve academic or informational purposes and “speakers’ bureau” activities that primarily serve commercial interests. By “speakers’ bureau” or “company lecture,” the IAS–USA means a relationship in which a company controls any elements such as speaker selection, topic choice, audience selection and recruitment, and content of presentation and for which speaker honoraria, fees, or costs are paid directly by the company or through an agent or individual acting on behalf of the company. For example, an activity for which a commercial firm selects and invites a speaker is considered promotional regardless of whether the speaker uses company slides or his or her own slides.
The IAS–USA recognizes that although the distinction between promotional and nonpromotional events is well defined in the United States, particularly by US Food and Drug Administration (FDA) laws and regulations, such rigorously defined distinctions do not necessarily exist outside of the United States. Moreover, local customs and perceptions of promotional versus independent activities vary outside the United States. In countries where there is no Accreditation Council for Continuing Medical Education (ACCME) structure or equivalent arbiter of the independence of educational content from the marketing objectives of ineligible companies, individuals who participate in IAS–USA activities must agree not to accept direct payment from ineligible companies for lectures or presentations, other educational events, or company satellite conferences. The ACCME defines ineligible companies as “those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.” Any personal compensation (eg, honoraria or speaker fees or travel) for participation in such events must be coordinated through an independent third party, such as the speaker’s academic or medical institution or a charity. Other clearly promotional activities are included in the policy as described above.
IAS–USA program staff will work with prospective activity participants to determine whether they meet the policy’s compliance criteria. Individuals who have had no association with an industry promotional or marketing effort in the previous 12 months are eligible to serve in IAS–USA programs, providing they also comply with existing IAS–USA policies on conflict of interest and disclosure. Individuals who are currently associated with an industry promotional or marketing effort will not be eligible to serve in IAS–USA programs until 12 months from the date their industry association ends. This policy does not exclude individuals who serve as consultants on company advisory boards, receive support to conduct scientific or clinical research, or participate in certified CME activities, with or without commercial support.
This policy went into effect on January 1, 2009. Individuals associated with promotional or marketing efforts who were confirmed for IAS–USA programs before this policy took effect were allowed to participate in IAS–USA programs through 2009 but will not be allowed to participate in 2010 and beyond until they are 12 months beyond their last promotional or marketing activity.
The above-described provision expands IAS–USA policies designed to ensure CME programming that is objective, balanced, scientifically rigorous, and free of commercial control. The IAS–USA independence policy also requires that:
- Any IAS–USA program that receives support from ineligible companies must have support from several companies with competing products. Absolutely no single-company commercial support is permitted for any IAS–USA activity
- These grants are pooled and used to support the specific national efforts as designated and controlled by the IAS–USA.
- Individuals who participate in marketing or promotional activities for commercial firms or ineligible companies (eg, paid lectures for industry) may not participate in IAS–USA general educational and informational activities.
- Before medical professionals can create or present content for IAS–USA programs, they must disclose all relationships, financial or otherwise, with all ineligible companies and other outside entities.
- The content and recommendations of all IAS–USA activities are subject to independent peer review.
- When enduring materials are considered for renewal, their need for additional peer review is based on the nature of the changes required. As well, staff monitor participant comments about bias in the activity evaluations. If bias is noted in participant evaluations, IAS–USA staff follow-up with the peer review prior to the activity renewal.
- IAS–USA does not invite or accept any advertising revenue (eg, in any venue, including the journal and the website) or commercial exhibit revenue (eg, at CME courses or Conference on Retroviruses and Opportunistic Infections) nor participate in any product or company promotion.
Through its policies, the IAS–USA reinforces its commitment to standards that meet or exceed those set by others in the field, including the American Medical Association and the ACCME. The IAS–USA will continue to reevaluate its policies and programs to ensure that they uphold the organization’s mission.