On December 18, 2008, the Board of Directors of the Advanced Medical Technology Association (“AdvaMed”), a medical technology association, approved a significant update to its Code of Ethics on Interactions with Health Care Professionals (the “Revised Code”). The Revised Code clarifies and distinguishes between appropriate activity between health care professionals (HCPs) and AdvaMed member companies.
Effective July 1, 2009, the Revised Code contains a number of key revisions and expands into important new areas, including an explicit prohibition on providing entertainment or recreation to HCPs and a prohibition of gifts of any type, including all non-educational branded promotional items, regardless of value.
AdvaMed also broadened the definition of “HCPs” to include not only those individuals who purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a medical technology product, but also all those who are involved in the provision of health care services and/or items to patients in the United States. AdvaMed also added a new term, “Medical Technologies,” which encompasses medical products, technologies and related services and therapies to diagnosis, treat, and monitor or manage patient conditions.
Additionally, the Revised Code provides clarity in such areas as consulting agreements, company-conducted training of HCPs, grants, and compliance programs. Specifically, with respect to consulting services, companies may pay HCPs for consulting services only if such payments are fair market value for the services provided and based on the consultant’s past, present, or future business relations with the company. In addition, sales personnel may not control the decision to hire a particular HCP. Of further note, the Revised Code provides guidelines that allow for companies to enter into royalty arrangements with HCPs in exchange for substantial contributions that improve medical technology. but may provide input on the same.
Compliance with the Revised Code is not mandatory. To that end, AdvaMed strongly encourages companies to adopt the Revised Code and to submit to AdvaMed an annual certification that the company has adopted the Revised Code and implemented an effective compliance program. AdvaMed will publish a list of companies that have submitted this certification on its website.
In essence the Revised Code “reflects the medical technology industry’s ongoing commitment to openness, transparency and high ethical standards,” said Michael A. Mussallem, chairman and CEO of Edwards Lifesciences, and chairman of AdvaMed. He continued by saying that “our [the medical technology industry’s] primary focus is helping patients and we want to ensure that the public understands that collaboration between physicians and the industry’s scientists and engineers is critical for developing and delivering medical innovations.”