American Epilepsy Society
Conflict of Interest Compliance Plan
I. Overview and purpose
Collaborations between health care professionals, biomedical scientists and industry are integral to the process of developing new treatments and conveying knowledge within the medical field. Because such individuals and their professional/scientific organizations provide medical education and participate in the development of new medical innovations, many (health care professionals and biomedical scientists who belong to or have leadership roles in professional scientific organizations) engage in a variety of relationships with pharmaceutical and device (biomedical) companies. Companies also interact with physicians and professional organizations to provide them with information about newly marketed drugs, biologics, and devices (diagnostics) or to engage their services in various capacities, such as advisory boards, speakers bureaus, consultants, and investigators.
The health care professions and the scientific community at large are under increasing public criticism and legal pressure centered on the financial relationships between physicians and their professional organizations with the pharmaceutical, biologics, and medical device industries. At the core are the perceived or actual conflicts of interest that these relationships raise and the resulting impact on the scientific and clinical judgment and prescribing patterns of physicians who attend professional meetings or enter into financial relationships with industry.
Since 2000, federal and state government fraud and abuse investigations, prosecutions and settlements have challenged a variety of industry marketing strategies aimed at physicians and professional organizations, leading the US Department of Health and Human Services (DHHS) to issue compliance guidelines, states to pass laws, and the pharmaceutical and device industries to issue progressively more restrictive marketing codes of conduct, which have changed many industry marketing practices.
As of March, 2009 there remains much confusion among medical professionals and medical organizations about where the line should be drawn between those relationships with industry that are legal and ethically appropriate and those that are not. This is despite the fact that compliance codes are emerging at medical schools, medical centers and professional societies that pertain to medical professionals and their relationships with industry, and participation in research, continuing medical education (CME) and committee work. It is increasingly apparent that medical professionals and medical organizations that fail to become fully knowledgeable about the legal boundaries applicable to their interactions with drug and device companies are putting themselves at significant risk
Because the mission of AES is furthered by interactions with industry, effective management of the relationships is essential. Therefore, this Plan sets in place specific policies and oversight procedures that cover financial relationships between 1) AES and industry (defined as companies marketing services or products of interest to AES members and staff acting on behalf of AES (hereafter referred to as “AES personnel”) and industry. At its core, the Plan requires that AES personnel exercise due diligence before accepting anything of value from, or entering into any relationship with, a drug or device company, in order to prevent and deter illegal or unethical conduct, or conduct that otherwise could be perceived as undermining the scientific and educational independence of AES.
This AES Conflict of Interest and Compliance Plan, therefore, consists of all relevant AES policies and procedures and is supported by legal sources, government guidance and professional codes of conduct concerning industry relationships with medical societies and physicians. This Plan extends these standards to AES personnel and reflects the boundaries that the AES Board of Directors has drawn at a given point of time between permissible and prohibited interactions.
II. The AES Conflict of Interest and Compliance Plan
The Plan consists of this document as well as individual AES policies, which for purposes of this document are grouped into
- AES investment
- Gifts, monies and in-kind services, etc from industry
AES policies and procedures identify which industry relationships are allowed, which are prohibited and which may be permitted after review to confirm their legitimacy. They set out minimum legal standards.
When a relationship between AES and industry is allowed under the policies, the policies should provide the process for contracting and confirming that the contract and the proposed terms are consistent with the applicable anti-kickback personal services safe harbor and otherwise meet sufficient legal standards. This contracting process must by necessity include a system to verify that the terms offered are commercially reasonable and consistent with fair market value and that the finalized contracts are compliant and do not have undesirable and unnecessary clauses that increase the risk to AES.
Plan best practices incorporated into policies:
a. Engagements with drug and device companies should only be accepted or pursued for legitimate and well-defined educational, scientific (including research), and clinical purposes that are consistent with the AES mission, or promotional purposes as explicitly defined by AES policies and procedures.
b. Payments received from industry by AES or AES personnel should only be accepted or requested within a range of fair market values and for work/activities actually completed.
c. All engagements must be memorialized in a commercially reasonable service agreement.
d. AES personnel must exercise extreme caution in participating in any educational activities that relate to off-label uses of therapies.
e. Monies or in-kind services received from industry for AES educational activities cannot influence educational programs or content; ie, there is a firewall between the solicitation and receipt of money and the educational programs and content supported by that money, consistent with ACCME guidelines.
f. Monies or in-kind services received from industry for AES directed or funded research cannot influence what specific research is done, especially when it relates to the donor’s product(s); ie, there is a firewall between the solicitation and receipt of money and the research supported by that money.
A. Conflict of interest
B. AES Investment
1. Specific policies:
2. Investment and Financial Policies
Specific policies exist regarding investment actions. Members of the Finance Committee responsible for reviewing and directing investing strategies should clearly designate possible conflicts of interest, and these should be reviewed by the Chair and/or COI Committee. While acting on behalf of the AES no personal gain or perception of gain to the individual or a particular contributing entity is allowed. Furthermore, there should be no conflict of interest between the company(s) handling investment portfolios and individuals serving on the Finance Committee, including its Chair (Treasurer of AES).
C. Gifts, Monies and In-Kind Services from Industry or Individuals
- The policies governing these activities include:
The AES leadership and those responsible for financial relationships shall clearly disclose a conflict of interest statement on a yearly basis. No individual by themselves may enter into a financial relationship on behalf of AES without approval of the Executive Board of Directors and Executive Office. This group will oversee the possible conflict and determine whether real or perceived conflict of interest exits prior to any financial relationship between individuals, industry or other sponsor. This includes opportunities to fund specific programs, research, endowments and all activities within the organization.
1. Specific policies:
E. Oversight of the Plan- Conflict of interest Committee (COIC)
Oversight of the AES Conflict of Interest and Compliance Plan is the responsibility of the AES Board of Directors, as supported by the Conflict of Interest Committee (COIC) of the Board of Directors, chaired by the Second Vice President.
The chair of the COIC shall serve as the Compliance Officer of the American Epilepsy Society.
The COIC and Compliance Officer must publicize how they can be contacted for reports of conflict on interest and compliance issues
The COIC Committee shall review and update the Compliance Plan of the AES on an annual basis, or as needed, to assure that the Plan conforms to recent legal and ethical standards and expectations regarding conflict of interest involving all AES personnel and their activities.
The Conflict of Interest Committee is charged with developing, adopting and modifying the policies and procedures in the Plan and should be recused when appropriate if they have financial relationships to companies whose business is relevant to the work of AES. Therefore, oversight of the Plan involves review of Board members’ conflict-of-interest statements and determination of when Board members should be recused from activities pertaining to oversight of the Plan and other matters coming before the Board.
The COIC shall evaluate all issues of conflict of interest and non-compliance as they arise. The COIC must promptly report only to the Executive Committee of the Board of Directors (BOD) any issue which the COIC deems as serious violation of the Compliance Plan. The report should include its recommendations for remedial action.
The COIC shall make all reasonable efforts to assure confidentiality and protect the rights of persons who reported issues involving conflict of interest and non-compliance.
The COIC shall review mandatory annual reports from all AES committees, councils, and administrative staff, concerning conflict of interest and compliance. The report must include:
-measures taken to remedy conflict of interest or non-compliance, including recusal or dissociation of persons with conflict of interest.
-listing of all contracts and agreements, except those under the responsibilities of the Council on Education. Listing must be accompanied by statement that all contracts conform to the Compliance Plan.
The COIC shall document all of its reports and recommendations. Time of discovery, review, discussion, recommendations and resolutions of all issues must be documented.
The COIC shall provide an annual written report only to the Executive Committee of the BOD. The report should contain all activities undertaken by the COIC for that year, including recommendations of the COIC for revising the Compliance Plan, and measures for remedying conflict of interest and non-compliance.
Procedures established by the Conflict of Interest Committee ensure that AES is adhering to the Plan and track all engaged relationships, including an inventory of contracts and a mechanism for triggering notifications when those contracts have expired and may need to be renewed. The Committee also manages an internal anonymous reporting/hot-line system and provides regular training about the Plan to AES staff and Board members, which should be documented when completed.
III. Resources: Relevant legal sources, government guidance and professional codes of conduct:
A. Conflict of Interest:
- Federal and State Anti-kickback Laws
– OIG 2003 Compliance Guidance for Pharmaceutical Companies
- Federal Stark Law
- Federal and State False Claims Acts
– Violations of Anti-kickback/Stark Laws
– Whistleblower Provisions
- 1997 FDA Guidance on Industry-Supported Scientific and Educational Activities
- National and State Medical Society Ethical Codes
– AMA (Ethical Opinion E-8.061 and clarifying guidelines on gifts and CME)
– American College of Physicians
- PhRMA Code on Interactions with Health Care Professionals issued in 2003 – updated effective January 1, 2009 http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf
- AdvaMed Code of Ethics on Interactions with Health Care Providers issued in 2004 – updated effective July 1, 2009 http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf
- International and EU Codes
- Massachusetts regulations
– M.G.L. c. 111N: Pharma and Device Manufacturer Conduct (effective 1/1/09)
– Mass DPH Proposed Regulations finalized March 2009
- Schachter SC, Mandell WM, Harshbarger S, Grometstein R. Managing relationships with industry. San Diego, CA: Elsevier; 2008
- 1997 FDA Guidance on Industry-Supported Scientific and Educational Activities
- FDA Regulation of Information on Off-Label Uses
– 1997 Food and Drug Administration Modernization Act – permitted limited company distribution of journal articles with off-label info -- expired in 2006
– Current FDA Guidance - Jan. 2009 “Good Reprint Practices”
- Federal Public Financial Disclosure
– Terms of Settlement with federal government
– Proposed: The Physician Payments Sunshine Act of 2009
- Voluntary Company Public Disclosure of Grants and other Financial Relationships (eg, Pfizer 2008 Policy)
- April 2007 Senate Finance Committee Report on company grant-making practices
– clarifying guidelines on gifts and CME)
– American College of Physicians
- ACCME Accreditation Standards and Standards for Commercial Support :