Biogen Idec supports patient education grants which provide meaningful opportunities to learn about their disease, gain knowledge about the treatment options and advocate for their health and well being.
Guidelines for Charitable Contributions
Biogen Idec's corporate philanthropic activities are closely aligned with its mission to increase disease awareness, improve patient access to care, and help patients with unmet medical needs. Toward this mission, Biogen Idec may provide a Charitable Contribution to a qualified tax‐exempt healthcare related organization for use in furthering the organization's charitable purposes.
Each Charitable Contribution must adhere to, and be compliant with, as applicable:
- Boigen Idec policies and procedures
- U.S. Food and Drug Administration Final Guidance on Industry-Supported Scientific and Educational Activities
- Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support
- Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals
- American Medical Association Ethical Guidelines for Gifts to Physicians from industry and Ethical Issues in CME
- Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers
- Other applicable laws, regulations, and industry guidance
- Non-profit Organizations - Only qualified independent organizations tax exempt under 501(c)(3) of the Internal Revenue Code may receive a Charitable Contribution. Preference may be given to organizations that are also designated as public charities, as described in Section 509(a) of the Internal Revenue Code.
- No Individuals - Charitable Contributions may not be provided to any individual, including a Healthcare Professional or patient.
- Customer or Organization closely affiliated with an HCP - Charitable Contributions to Customers or tax exempt private foundations that are closely affiliated with, or controlled by, HCPs or other referral sources may be ineligible for charitable contributions.
- No Prior Promotional Services - An organization that has been, or has an officer who has been, involved in a marketing or promotional strategy with Biogen Idec within twelve (12) months preceding the Request may be ineligible for a Charitable Contribution.
Biogen Idec does not intend to receive any significant value or benefit in return for a Charitable Contribution. Biogen Idec never offers a Charitable Contribution with the expectation or intention to influence the organization's programs or advocacy positions or to receive the organization's recommendation or endorsement of its products. Charitable Contributions may not be offered or provided with the intent of, directly or indirectly, implicitly or explicitly, influencing or encouraging the recipient or related party to purchase, prescribe, refer, sell, arrange for the purchase or sale, or recommend Biogen Idec product or as a reward for past such behavior. Biogen Idec employees and agents are strictly prohibited from completing return on investment analyses or from other tracking of business in connection with Charitable Contributions, even when information is offered by the recipient organization.
Charitable Contributions are not appropriate for:
- Political organizations or lobbying activity
- Support of educational activities that are more appropriately eligible for Educational Grant Requests.
- A program or event that provides a promotional opportunity for Biogen Idec (e.g., exhibit space or advertisement) and is more appropriately eligible as an Exhibit or Sponsorship Request.
- Contribution made on behalf of, or in the name of, a Customer or to an organization of the Customer's choice
An organization that receives a Charitable Contribution from Biogen Idec must exercises independent judgment in all its decisions. Biogen Idec may provide support for qualified organizations only if the organization administers funds in an objective, unbiased and balanced manner; and if its programs are not subject to Biogen Idec influence or control.
Patient Education Programs
Biogen Idec may make Charitable Contributions to fund patient Educational Activities, provided that the recipient of the Charitable Contribution is responsible for all aspects of the Educational Activity, making all decisions regarding the disposition and disbursement of the Charitable Contribution and retaining control over the program, including the venue, program structure, content, speakers, educational methods, materials and invitations.
Reasonable restrictions on the purposes for which a Charitable Contribution may be used are acceptable, as are reasonable requirements for reporting on the uses of the donated funds. For example, it is appropriate for Charitable Contributions to be designated to support an organization's specific program, as long as Biogen Idec is not permitted to, and does not, influence or control the program or activity.
Request Submission and Review
- Review - The Grants Office shall review all requests for Charitable Contributions. No Contribution may be paid to an organization without prior Grants Office review. No employee may commit, promise, or use personal resources or expense reports to provide a Charitable Contribution on Biogen Idec's behalf.
- Charitable Contributions Review Committee - The Charitable Contributions Review Committee will be comprised of representatives from the Compliance, Finance, Grants Office, Legal, Medical Affairs and Public Affairs Departments.
- Unsolicited Contributions - Biogen Idec may provide a Charitable Contribution to a qualified organization without the need for a prior Charitable Contributions Request being submitted to the Grants Office by the Qualified Organization.
- RMS submission - Requesting organizations must submit an application via the Request Management System (RMS). The RMS submission process facilitates communication with the Grants Office, and requires requestors to provide detailed information describing the purpose for which the Charitable Contribution is requested. Charitable Contributions that do not originate with an external Request must be entered into the RMS by the Grants Office.
- Application Deadline - Applications must be submitted at least sixty (60) days in advance of the date the funding is requested. Biogen Idec makes every effort to review Requests in a timely manner. However, Biogen Idec makes no commitment regarding the amount of time it will take to review a specific Request. Any Request not approved before the date funding is requested will be denied.
- No Guarantee of Funding - Submission of a Request does not assure funding, and Biogen Idec reserves the right to revoke an approved charitable Contribution at any time before both Biogen Idec and the requesting organization execute the Letter of Agreement.
- Changes in Request - Requestors must notify the Grants Office in writing with changes to the Request. The Grants Office reserves the right to revoke or change the level of the Charitable Contribution as a result of any change in the Request.
- No Recommendation or Endorsement - Donor recognition is a universal part of fundraising, but should be conducted with appropriate limitations. For example, donors can be recognized in print materials, in private or public ceremonies, and with banners or other visible displays. However, recognition should not be provided in a manner that implies Biogen Idec influence over the organization's programs or advocacy positions. Any donor recognition should not be placed or distributed in such a way as to suggest the organization's recommendation or endorsement of any Biogen Idec product.
- PAP Programs and Anonymous Contributions - Recipients of Charitable Contributions to support Patient Assistance Programs (PAP), as described below, must not be informed of the Charitable Contributions made by donors to the PAP, including by Biogen Idec. Other Charitable Contributions that are provided for the benefit of patients may require an anonymous Charitable Contribution, as appropriate.
Patient Assistance Programs (PAP)
Charitable Contributions for Patient Assistance Programs (PAP) are provided to only independent, bona fide pre-approved Patient Assistance Organizations for large scale, national programs. Priority will be given to programs that provide broad opportunity for participation in the Patient Assistance Program.
- Advisory Opinion - The Patient Assistance Organization must obtain or demonstrate reliance upon an advisory opinion from the Office of Inspector General (OIG) that demonstrates the PAP contains the safeguards necessary to reduce risk of fraud and abuse to the federal healthcare programs. More information about the OIG's advisory opinion process is available here.
- Independence - Neither Biogen Idec nor any affiliate, employee, or agent may exert any direct or indirect influence or control over the Patient Assistance Organization or PAP. The Patient Assistance Organization has absolute, independent, and autonomous discretion to the use of the Charitable Contribution.
- Designated Funds - When making Charitable Contributions to Patient Assistance Organizations, Biogen Idec employees and agents may designate distribution of funds for one or more broad disease categories; however, Biogen Idec employees and agents may not recommend or designate distribution of funds for specific therapies, even if asked to do so by the organization or anyone acting on its behalf. Disease categories should be defined by diagnoses or broadly recognized illnesses or diseases, and not by reference to specific symptoms, severity of symptoms, or drug administration method.
- Review - The factors to consider in reviewing Patient Assistance Programs include:
- The Patient Assistance Organization awards assistance in a truly independent manner that severs any link between Biogen Idec's funding and the recipient (i.e., the assistance provided cannot be attributed to Biogen Idec)
- The Patient Assistance Organization uses objective criteria for patient participation and financial eligibility determinations
- The Patient Assistance Organization awards assistance without regard to Biogen Idec's interests or the recipient's choice of product, provider, practitioner, supplier, or health plan
- The Patient Assistance Organization provides assistance based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner
- Recipients have complete freedom regarding their choice of products, practitioners, providers, suppliers, health plan, and treatment regimens
- Recipients are not informed of the Charitable Contributions made by donors to the PAP, including by Biogen Idec, except for disclosures the Patient Assistance Organization is required to make publicly available, such as in an annual report or on the Patient Assistance Organization's publicly available website
- Recipients are unable to link their benefits to any particular donor
- The organization does not refer recipients to specific products
- Pre-approved Charitable Contributions - PAP programs may be pre-approved in advance by the Charitable Contributions Review Committee. Biogen Idec may provide a Charitable Contribution to a pre-approved PAP without the need for a prior Request by the Patient Assistance Organization.
- Information Received from PAP - Biogen Idec may receive and evaluate the aggregate number of patients assisted by Contributions to the Patient Assistance Organization, if applicable. However, Biogen Idec may not receive or review (i) information regarding individual patients, (ii) information regarding the number of patients assisted by specific therapy, (iii) or any data that would allow it to correlate the amount or frequency of its Contributions with the number of subsidized prescriptions for its products or the amount or frequency of the use of its products.
Executed Letter of Agreement
A written agreement that clearly indicates terms and conditions of the Charitable Contribution must be executed prior to the Contribution to the organization. Biogen Idec reserves the right to revoke an approved charitable Contribution at any time before both Biogen Idec and the requesting organization execute the Letter of Agreement.
The organization must provide Biogen Idec with a written disclosure statement for any contribution in excess of $75 that includes the amount of the contribution that is deductible for federal income tax purposes and provide a good faith estimate of the value of the goods or services that Biogen Idec received.
The term "Charitable Contribution" means a voluntary donation or gift to, or for the use of, a Qualified Organization that is made without getting, or expecting to get, anything of equal value, of promotional benefit or significant donor recognition.
Continuing Medical Education or CME:
The term "Continuing Medical Education" or "CME" means Educational Activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician and/or healthcare professional uses to provide services for patients, the public or the profession. The content of CME is the body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine and the provision of health care to the public. Examples of CME include:
- A course in management would be appropriate CME for physicians responsible for managing a health care facility
- A course in educational methodology would be appropriate CME for physicians teaching in a medical school
- A course in practice management would be appropriate CME for practitioners interested in providing better service to patients
- CME that discusses issues related to coding and reimbursement in a medical practice falls within ACCME's definition of CME
Not all continuing educational activities which physicians may engage in however are CME. Physicians and/or healthcare professionals may participate in worthwhile continuing educational activities which are not related directly to their professional work and these activities are not CME. Continuing educational activities which respond to a physician's and/or a healthcare professional's non-professional educational need or interest, such as personal financial planning or appreciation of literature or music, are not CME.
The term "Customer" means any Healthcare Professional and/or a healthcare professional's extended staff, and any other person, entity, or affiliate of such entity, in a position to purchase, pay for, prescribe, refer, lease, order, arrange for, recommend, or determine the determine the formulary placement of Biogen Idec products including, but not limited to, physicians, nurse practitioners, pharmacies, pharmacists, medical directors, hospitals, and other healthcare institutions, pharmacy benefit managers, group purchasing organizations, wholesalers, distributors, third party payors (including managed care organizations), and any individual employed by such entities. For purposes of this policy, "Customer" does not include patients, caregivers and/or relatives of patients, unless such individual is otherwise covered by this definition. A healthcare professional is a provider of medical or other health services.
The term "Disaster Relief" means a Charitable Contribution for flood relief, hurricane relief, or other disaster relief to a Qualified Organization.
The term "Educational Activities" means any project, program, activity or instruction that is designed to impart, develop, maintain or increase the knowledge and skills of the general public.
The term "Educational Grant" means monetary support for an unbiased, fair balanced educational program provided and made available to the medical, scientific or patient community. Programs supported by Educational Grants should enhance awareness and education regarding certain disease(s) in the medical or scientific community that are of interest to the Company.
Patient Assistance Organization:
The term "Patient Assistance Organization" means an independent non-profit organization providing services, including but not limited to: (i) information about diseases; (ii) referrals to patient advocacy organizations; (iii) advocacy for the rare-disease community; and (iv) financial assistance programs that help patients obtain medications and/or treatments or provide other therapy support that they could not otherwise afford.
Patient Assistance Program (PAP):
The term "Patient Assistance Program" or "PAP" means a financial assistance program that provides copay assistance or in-kind provision of drugs, biologics or medical devices for the care of patients who are financially needy.Patient Assistance Organization.
The term "Qualified Organization" means a community chest, corporation, trust, fund, or foundation organized or created in or under the laws of the United States, any state, the District of Columbia, or any possession of the United States (including Puerto Rico) that is organized and operated only for one or more of the following purposes: religious, charitable, educational, scientific, literary, or that work to prevent cruelty to children or animals.
The term "Sponsorship" means funding provided to a healthcare related organization in exchange for a commercial benefit. Sponsorships provide Biogen Idec the ability to receive something of material value in return for support of the event.