Commercial Support is a financial or in-kind contribution provided by a commercial interest, that is used to off-set part, or all, of the costs of a CME activity. (SCS 3.1) The primary regulations governing the application for, acceptance of, and proper use for this support are the ACCME Standards for Commercial Support.
When we talk about Commercial Support, we are talking about "unrestricted educational grants". These are grants requests submitted to the Independent Medical Education (IME) departments of commercial interests. These requests are then graded by the supporter and a decision is made whether or not to contribute to the activity.
Providers cannot allow commercial supporters to directly (SCS 1.1) or indirectly (SCS3.2) control the content of CME. The Provider is required to decide what commercial support will be accepted and how it will be spent (SCS 3.3). Because of this, the Academy will ask potential partners if they plan to seek commercial support when the begin applying for CME accreditation. You do not have to provide a final list, but commercial support cannot be applied for without advanced agreement by the Academy.
Potential supporters will review much of the same information reviewed by the Academy during the planning of an activity. You will be required to submit a budget, , , , agenda, information about the venue, and policies on honoraria and management of conflict of interest.
Definitions
- Commercial Bias: An undue influence promoting the proprietary interests of a Commercial Interest.
- Commercial Interest: [From the ACCME] A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. (Revised August 2007) The ACCME does not consider providers of clinical service directly to patients to be commercial interests.
- Letter of Agreement (LOA): A document specifying the terms and conditions of a commercial support agreement, signed by the provider (the Academy), the company (commercial interest) and any un-accredited partners.
- PACME/MSS Working Group: A joint work group between the Pharmaceutical Alliance for CME and the Medical Specialty Society group, working on improving interactions between societies and commercial interests.
- Standards for Commercial Support (SCS: 1) The ACCME Standards for Commercial Support (SCS). 2) Standards to ensure the independence of CME Activities from Commercial Interests.
Separation of Commerical Support and Marketing
To reduce the risk of impropriety, commercial supporters are required to have firewalls in place between their marketing and grants departments. For this reason, Providers [such as the Academy] and educational partners [such as a potential or current joint sponsor] should not engage in discussions with supporters' marketing and sales personnel regarding educational priorities, strategies, or grants [PhRMA Code].
The following ACCME standards govern the separation of support and marketing:
[ACCME SCS 4.1] Arrangements for commercial exhibits or advertisements cannot influence planning or interfere with presentation, nor can they be a condition of the provision of commercial support for CME activities.
[ACCME SCS 4.3] Educational materials that are part of a CME activity, such as slides, abstracts and handouts, cannot contain any advertising, trade name or product-group message.
Due to ACCME SCS 4.3, the Academy requires that your final program/syllabus be devoid of marketing information if it contains handouts, abstracts, or other adjuncts to the CME activity.
You are, however, free to create an "Exhibitors and Advertisements" book to accompany your educational materials - as long as this is a separately bound book.
When to Apply
Each potential supporter determines their own review process, and grant review timeline. Failure to meet these deadlines will mean that your request will fall on deaf ears, or in some cases, future requests may be less likely to be approved.
A partial list of deadlines follows. If a commercial interest does not appear below, that does not mean that you cannot apply; it means that the Academy does not have their specific policy in our records.
Letter of Agreement (LOA)
After a grant request has been submitted to, and approved by, a commercial supporter, a Letter of Agreement (LOA) is drafted. The LOA should detail the terms and conditions of the support agreement, and be signed by the provider (the Academy), the company (commercial interest) and any un-accredited partners.
The Academy must review all LOAs prior to them being signed to ensure that they comply with the ACCME Standards for Commercial Support.
[From the ACCME] Question: "Can you tell us what elements must be included in the written agreement?" (SCS 3.4, 3.5, 3.6)
Answer: When there is commercial support there must be a written agreement that,
- Itemizes how the Provider will use the commercial support in the development and presentation of the CME activity
- Itemizes the organizations involved in the activity (e.g., joint sponsors, education partners, managers)
- Specifies the organizational name of the commercial interest(s) that supplied the funds
- Specifies what funds or in-kind services will be given by the commercial supporter to support the provider's activity
- Is signed by the commercial interest and the accredited provider prior to the activity taking place.
Tips and Recommendations
The PACME/MSS Working Group recommends that the term "Sponsor" or "Sponsorship" be eliminated from the lexicon regarding the relationships or financial agreements between industry and medical specialty societies, academic institutions or other entities of like interest.
- Do not offer, or agree to, quid pro quo: do not offer any goods, or favorable treatment (outside of standard acknowledgements) in exchange for educational support.
- Some supporters will not fund live activities at venues with 4 or 5 star ratings.
- . Some supporters require this document, but all commercial supporters like to read them. A formal NA will draw linkages for the supporter and explain to them why this activity is important and how it intends to change physician practice.
- Do not volunteer your list of speakers & faculty to a commercial supporter. Some supporters have a policy of automatically rejecting support requests for live activities where one or more faculty members has been a speaker for the commercial interest. If a supporter wants to see a list of speakers, they will ask for it after the request has been submitted.
- Ensure that your budget includes detailed information about food and beverage: what is the price-per-person for each meal?
- Do not request support in return for perks or benefits (such as free exhibit space).
- If a supporter asks you to note, relative to your budget, how their funds will be used, limit the disbursement of funds to educational and administrative sections, when possible (try to avoid expenses for food, entertainment, and professional networking.)
-
- Keep track of how you will use funds from each supporter. Avoid overlap (do not use support from multiple commercial interests to fund the same line-item of an activity.)