Code Of Ethics On Interactions With Health Care Professionals

Adopted By The Advanced Medical Technology Association

I. Preamble: Goal and Scope of AdvaMed Code

The Advanced Medical Technology Association ("AdvaMed") represents companies that develop, produce, manufacture, and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities ("Medical Technologies") in order to enable patients to live longer and healthier lives (collectively "Companies," and individually "Company").  AdvaMed is dedicated to the advancement of medical science, the improvement of patient care, and, in particular, the contributions that high quality, innovative Medical Technologies make toward achieving those goals. AdvaMed recognizes the obligation to facilitate ethical interactions between Companies and those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies' Medical Technologies in the United States ("Health Care Professionals").

Medical Technologies

Medical Technologies are often highly dependent upon "hands on" Health Care Professional interaction from beginning to end - unlike drugs and biologics, which act on the human body by pharmacological, immunological or metabolic means.  For example, implantable Medical Technologies are often placed in the human body to replace or strengthen a body part.  Surgical Medical Technologies often serve as extensions of a physician's hands.  In other circumstances, Medical Technologies are noninvasive reagents, instrumentation and/or software to adi in the diagnosis, monitoring and treatment decisions made by Health Care Professionals.  Some Medical Technologies work synergistically with other technologies, or are paired with other products that deploy devices in the safest and most effective manner.  Many Medical Technologies require technical support during and after deployment.

Interactions with Health Care Professionals

The scope of beneficial interactions between Health Care Professionals and Companies is broad and includes interactions intended to:

1. Promote the Advancement of Medical Technologies.  Developing and improving cutting edge medical technologies and collaborative processes between Companies and Health Care Professionals. Innovation and creativity are essential to the development and evolution of Medical Technologies, which often occur outside a Company's laboratory.
2. Enhance the Safe and Effective Use of Medical Technologies.  The safe and effective use of sophisticated electronic, in vitro diagnostic, surgical, or other Medical Technologies often requires Companies to provide Health Care Professionals appropriate instruction, education, training, service and technical support. Regulators often require this type of training as a condition of product approval.
3. Encourage Research and Education.  Companies’ support of bona fide medical research, education, and enhancement of professional skills improve patient safety and increases access to Medical Technologies.
4. Foster Charitable Donations and Giving.  Companies make monetary and Medical Technology donations for charitable purposes, such as supporting indigent care, as well as patient and public education.  This increases access to - as well as the quality of - care and treatment in patient populations that may not otherwise be reached.
   

The purpose of the Code of Ethics

AdvaMed recognizes that Health Care Professionals' first duty is to act in the best interests of patients.  Companies can serve the interests of patients through beneficial collaborations with Health Care Professionals.  To ensure that these collaborative relationships meet high ethical standards, they must be conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance.  AdvaMed recognizes the obligation facilitate ethical interactions between Companies and Health Care Professionals in order to ensure that medical decisions are based on the best interests of the patient.  The ethical principles that govern these interactions are the subject of this Code of Ethics.¹  To that end, AdvaMed restates and amends its Code of Ethics and Frequently Asked Questions (collectively "Code of Ethics" or "Code"). effective July 1, 2009.

Frequently Asked Questions

• Why did AdvaMed develop a code distinct from the PhRMA Code on Interactions with Health Care Professionals?
• Who are "Health Care Professionals?"  Does the term include non-clinical people who make Medical Technology purchasing decisions?  Does it include decision-makers within GPOs?
• Does the Code apply to gifts, meals, refreshments, and other benefits provided by Companies to government employees?
• Does the Code cover interactions with Health Care Professionals whose primary place of work is outside the U.S.?  Does it cover interactions outside the U.S. with Health Care Professionals who work in the U.S.?
• Are combination products covered by the Code?
• Does the Code address arrangements between a Company and a Health Care Professional relating to licensing a new product to the Company?
• What do the terms "modest" and "occasional" mean?
• May a Company's employee or agent pay for meals or refreshments for a Health Care Professional that a Company could not provide under the Code, if the Company neither pays for the meals or refreshments nor reimburses the employee or agent?
• May a Company offer to provide laptop computers with independent value to any purchasing manager whose hospital purchases at least 1,000 units of the Company's medical technology that the Company has just introduced?
• May a Company provide support for a Health Care Professional-sponsored social event, such as an office holiday party?

Why did AdvaMed develop a code distinct from the PhRMA Code on Interactions with Health Care Professionals?

The AdvaMed Code of Ethics is intended to address the unique interactions that occur between Companies and Health Care Professionals, just as the PhRMA Code reflects the nature of interactions between pharmaceutical companies and Health Care Professionals.  Distinguishing features in AdvaMed's Code arise primarily from the fact that Companies interact with Health Care Professionals because of the complexity and "hands on" nature of Medical Technologies and the importance of having Health Care Professionals understand how to use the technologies safely and effectively.

Who are "Health Care Professionals?"  Does the term include non-clinical people who make Medical Technology purchasing decisions?  Does it include decision-makers within GPOs?

The phrase "Health Care Professionals" is intended to be a broad one.  It includes individuals or entities: 1) which are involved in the provision of health care services and/or items to patients; and 2) which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies' Medical Technologies in the United States.  The phrase Health Care Professional includes both persons providing services (such as licensed physicians) and persons who do not provide services directly but who are involved in the decision to purchase, lease, or recommend a Medical Technology.  These individuals include, for example, purchasing agents, physician's practice managers and management within group purchasing organizations ("GPOs").

Does the Code apply to gifts, meals, refreshments, and other benefits provided by Companies to government employees?

Yes, the Code applies to gifts, meals, refreshments, and other benefits provided by Companies to government employees if the employees are Health Care Professionals.  Companies also should be aware that there may be specific legal restrictions on providing gifts and other benefits to government employees, and that these restrictions may, in some cases, be more restrictive than the Code.

Does the Code cover interactions with Health Care Professionals whose primary place of work is outside the U.S.?  Does it cover interactions outside the U.S. with Health Care Professionals who work in the U.S.?

The Code applies to interactions with Health Care Professionals to the extent that they provide services or Medical Technologies in the United States.  This would include interactions with Health Care Professionals who work in the United States, even if the interaction occurs outside the country (such as at a conference or other event).  Of course, there are other laws and ethical requirements that may pertain to interactions with Health Care Professionals located both inside and outside the United States.

Are combination product covered by the Code?

Yes, interactions related to combination products (e.g., those that are both biologics and devices or drugs and devices) are covered by the Code.  Interactions related to combination products also may be subject to the ethical codes of other trade associations.

Does the Code address arrangements between a Company and a Health Care Professional relating to licensing a new product to the Company?

If these arrangements involve providing services to a Company, they are a type of consulting arrangement addressed in Section VI.

What do the terms "modest" and "occasional" mean?

"Modest" means moderate value, but may differ depending on regional differences. "Occasional" means infrequent.

May a Company's employee or agent pay for meals or refreshments for a Health Care Professional that a Company could not provide under the Code, if the Company neither pays for the meals or refreshments nor reimburses the employee or agent?

No. The Code should be viewed as applying to a Company's employees and agents even if they pay for benefits themselves. Depending on the circumstances, it may be appropriate for an employee or agent of a Company to engage in certain activities with a Health Care Professional if each pays his or her own ways.

May a Company offer to provide laptop computers with independent value to any purchasing manager whose hospital purchases at least 1,000 units of the Company's medical technology that the Company has just introduced?

No. A Company may not provide any item of value to a Health Care Professional that takes into consideration the value or volume of the business that is or may be generated by the Health Care Professional unless permitted by law (e.g., appropriate discounts).

May a Company provide support for a Health Care Professional-sponsored social event, such as an office holiday party?

No, such support would be inappropriate.