American Epilepsy Society
Conflict of Interest Compliance Plan
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.