ADVAMED CODE OF ETHICS PDF

The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies. Based on a survey of policy leaders in Washington, AdvaMed ranked first in 3 of 15 performance categories: "multilateral impact," "bipartisanship," and "information resource. The MedTech Conference gathers more than 3, attendees from 30 different countries to network, conduct business, gain access to capital and share insight into emerging trends and best practices in medtech. The MedTech Conference also gives medtech industry leaders the opportunity to interact with policymakers, members of the media, investors, legal experts, consultants, distributors, and other important stakeholders to help grow and transform their businesses.

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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 these goals.

For example, implantable Medical Technologies are often placed in the human body to replace or strengthen a body part. 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: Promote the Advancement of Medical Technologies. Developing and improving cutting edge Medical Technologies are collaborative processes between Companies and Health Care Professionals.

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.

Encourage Research and Education. 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. 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 to 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.

Code of Ethics Compliance All Companies are strongly encouraged to adopt this Code and to implement an effective compliance program — one which includes policies and procedures that foster compliance with the Code with respect to their interactions with Health Care Professionals related to Medical Technologies. A Company that adopts the Code is strongly encouraged to submit to AdvaMed an annual certification that the Company has adopted the Code and has implemented an effective compliance program.

AdvaMed will publish on its website a list of those Companies that have submitted the annual certification. AdvaMed will publish on its website the contact information supplied by each such Company. Companies are strongly encouraged to follow the seven elements of an effective compliance program, appropriately tailored for each Company, namely: 1 implementing written policies and procedures; 2 designating a compliance officer and compliance committee; 3 conducting effective training and education; 4 developing effective lines of communication including an anonymous reporting function ; 5 conducting internal monitoring and auditing; 6 enforcing standards through well-publicized disciplinary guidelines; and 7 responding promptly to detected problems and undertaking corrective action.

Companies adopting this Code shall communicate the principles of this Code to their employees, agents, dealers and distributors with the expectation that they will adhere to this Code. All Companies have an independent obligation to ensure that their interactions with Health Care Professionals comply with all applicable laws and regulations.

This Code of Ethics is intended to facilitate ethical behavior, and is not intended to be, nor should it be, construed as legal advice. The Code is not intended to define or create legal rights, standards or obligations. Company-Conducted Product Training and Education Companies have a responsibility to make training and education on their products and Medical Technologies available to Health Care Professionals.

Companies may also provide education to Health Care Professionals. In fact, the U. Food and Drug Administration mandates training and education to facilitate the safe and effective use of certain Medical Technologies. Companies should adhere to the following principles when conducting training and education programs concerning Medical Technologies for Health Care Professionals: Programs and events should be conducted in settings that are conducive to the effective transmission of information.

These may include clinical, educational, conference, or other settings, such as hotels or other commercially available meeting facilities.

The training staff used by the Company should have the proper qualifications and expertise to conduct such training. Training staff may include qualified field sales employees who have the technical expertise necessary to perform the training.

Companies may provide Health Care Professional attendees with modest meals and refreshments in connection with these programs. Where there are objective reasons to support the need for out-of-town travel to efficiently deliver Training and Education on Medical Technologies, Companies may pay for reasonable travel and modest lodging costs of the attending Health Care Professionals.

It is not appropriate for Companies to pay for the meals, refreshments, travel, or other expenses for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.

Supporting Third-Party Educational Conferences Bona fide independent, educational, scientific, and policy making conferences promote scientific knowledge, medical advancement and the delivery of effective health care. These typically include conferences sponsored by national, regional, or specialty medical associations and conferences sponsored by accredited continuing medical education providers. Companies may support these conferences in various ways: Conference Grants. Companies may provide a grant to the conference sponsor to reduce conference costs.

They may also provide grants to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows, and others who are Health Care Professionals in training. Companies may provide grants when: 1 the gathering is primarily dedicated to promoting objective scientific and educational activities and discourse; and 2 the training institution or the conference sponsor selects the attending Health Care Professionals who are in training.

Such grants should be paid only to organizations with a genuine educational function and may be used to reimburse only the legitimate expenses for bona fide educational activities. Such grants also should be consistent with applicable standards established by the conference sponsor and any body accrediting the educational activity.

The conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods, and materials. Conference Meals and Refreshments. Companies may provide funding to the conference sponsor to support the provision of meals and refreshments to conference attendees.

Also, Companies themselves may provide meals and refreshments for Health Care Professional attendees if such meals and refreshments are provided: 1 to all Health Care Professional attendees with the limited exception noted below , and 2 in a manner that is consistent with applicable standards established by the conference sponsor and the body accrediting the educational activity.

Meals and refreshments may be provided to fewer than all Health Care Professional attendees if the Company providing such meals and refreshments satisfies all other principles related to meals set forth in Section VIII.

Any meals and refreshments should be modest in value, subordinate in time and focus to the purpose of the conference, and clearly separate from the continuing medical education portion of the conference. Faculty Expenses. Companies may make grants to conference sponsors for reasonable honoraria, travel, lodging, and modest meals for Health Care Professionals who are bona fide conference faculty members.

Advertisements and Demonstration. Companies may purchase advertisements and lease booth space for Company displays at conferences. Sales, Promotional, and Other Business Meetings Companies may conduct sales, promotional, and other business meetings with Health Care Professionals to discuss, for example, Medical Technology features, sales terms, or contracts.

It is appropriate to pay for reasonable travel costs of attendees when necessary e. However, it is not appropriate to pay for meals, refreshments, travel, or lodging of guests of Health Care Professionals or any other person who does not have a bona fide professional interest in the information being shared at the meeting.

Companies may pay consultants fair market value compensation for performing these types of services, provided that they are intended to fulfill a legitimate business need and do not constitute an unlawful inducement.

Companies should comply with the following standards in connection with consulting arrangements with Health Care Professionals: Consulting agreements should be written and describe all services to be provided. When a Company contracts with a consultant to conduct clinical research services, there should also be a written research protocol.

Consulting arrangements should be entered into only where a legitimate need for the services is identified in advance and documented. A Company may pay for documented, reasonable and actual expenses incurred by a consultant that are necessary to carry out the consulting arrangement, such as costs for travel, modest meals, and lodging.

The venue and circumstances for Company meetings with consultants should be appropriate to the subject matter of the consultation. These meetings should be conducted in clinical, educational, conference, or other settings, including hotel or other commercially available meeting facilities, conducive to the effective exchange of information.

Company-sponsored meals and refreshments provided in conjunction with a consultant meeting should be modest in value and should be subordinate in time and focus to the primary purpose of the meeting. Companies should not provide recreation or entertainment in conjunction with these meetings. Companies should consider implementing appropriate procedures to monitor compliance with this section.

Provisions on Payment of Royalties. Arrangements involving the payment of royalties to a Health Care Professional should meet the contractual standards set forth above. Health Care Professionals, acting individually or as part of a group in which they are an active participant, often make valuable contributions that improve products or Medical Technologies.

They may develop intellectual property, for example, patents, trade secrets, or know-how, under a product or technology development or intellectual property licensing agreement. A Company should enter into a royalty arrangement with a Health Care Professional only where the Health Care Professional is expected to make or has made a novel, significant, or innovative contribution to, for example, the development of a product, technology, process, or method.

A significant contribution by an individual or group, if it is the basis for compensation, should be appropriately documented. The calculation of royalties payable to a Health Care Professional in exchange for Intellectual Property should be based on factors that preserve the objectivity of medical decision-making and avoid the potential for improper influence.

For example, royalties paid in exchange for Intellectual Property should not be conditioned on: 1 a requirement that the Health Care Professional purchase, order or recommend any product or medical technology of the Company or any product or technology produced as a result of the development project; or 2 a requirement to market the product or medical technology upon commercialization.

Companies may, however, elect to enter into separate consulting agreements with Health Care Professionals for marketing services if such services meet the requirements set forth in this Section VI above. Prohibition on Entertainment and Recreation Company interactions with Health Care Professionals should be professional in nature and should facilitate the exchange of medical or scientific information that will benefit patient care.

Such activities include, for example, theater, sporting events, golf, skiing, hunting, sporting equipment, and leisure or vacation trips. Such entertainment or recreational events, activities, or items should not be provided, regardless of: 1 their value; 2 whether the Company engages the Health Care Professional as a speaker or consultant; or 3 whether the entertainment or recreation is secondary to an educational purpose.

Such exchanges may be productive and efficient when conducted in conjunction with meals. Accordingly, modest meals may be provided as an occasional business courtesy consistent with the limitations in this section. The meal should be incidental to the bona fide presentation of scientific, educational, or business information and provided in a manner conducive to the presentation of such information.

The meal should not be part of an entertainment or recreational event. Setting and Location. Meals should be in a setting that is conducive to bona fide scientific, educational, or business discussions. However, in some cases the place of business may be a patient care setting that is not available for, or conducive to, such scientific, educational, or business discussions. A Company may provide a meal only to Health Care Professionals who actually attend the meeting. A Company may not provide a meal for an entire office staff where everyone does not attend the meeting.

A Company may not pay for meals for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting. Other principles.

Depending on the type of business interaction or meeting, additional principles may apply, as described in other sections of this Code of Ethics. Educational Items; Prohibition on Gifts A Company occasionally may provide items to Health Care Professionals that benefit patients or serve a genuine educational function for Health Care Professionals.

Companies also may not provide Health Care Professionals with gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents. This section is not intended to address the legitimate practice of providing products for evaluation and demonstration purposes, which is addressed in Section XII. Provision of Coverage, Reimbursement and Health Economics Information As Medical Technologies have become increasingly complex, so have payor coverage and reimbursement policies.

Consequently, a Company may provide such information regarding its Medical Technologies if it is accurate and objective. A Company also may collaborate with Health Care Professionals, patients and organizations representing their interests, to achieve government and commercial payor coverage decisions, guidelines, policies, and adequate reimbursement levels that allow patients to access its Medical Technologies.

Collaborating with Health Care Professionals, their professional organizations, and patient groups to conduct joint advocacy on coverage, reimbursement and health economics issues; supporting Health Care Professionals and their professional organizations in developing materials and otherwise providing direct or indirect input into payor coverage and reimbursement policies.

For example, a Company should not provide free services that eliminate an overhead or other expense that a Health Care Professional would otherwise of business prudence or necessity have incurred as part of its business operations if doing so would amount to an unlawful inducement.

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