On January 9th, 2019, the Board of Directors for the Advanced Medical Technology Association (AdvaMed) approved an updated version of the association’s Code of Ethics on Interactions with U.S. Health Care Professionals (Code). The updated Code takes effect on January 1, 2020 and replaces the current version, which has been in effect since July 2009.
The updated Code reflects an important development for the industry, adding new topics, incorporating other guidance previously issued by AdvaMed, and enhancing guidelines on existing topics that are focused on the types of collaborations and interactions that are increasingly common among medical technology manufacturers and health care professionals (HCPs). The press release announcing the updated Code states the revisions are intended to reflect “evolving legal standards, care delivery models and best practices over the last decade.”
Among other key changes, the updated Code addresses the following new topics:
- Expanded Scope and Cornerstone Values: The scope of the Code has been expanded to apply to all interactions with HCPs linked to medical technology, including in relation to combination products and whether occurring inside or outside the United States. The Code also adds a new section identifying the cornerstone values that should underpin interactions with HCPs (innovation, education, integrity, respect, responsibility, and transparency) and directs companies to review all interactions with HCPs in light of these cornerstone values.
- Communications Regarding Safe and Effective Use of Products: The updated Code states that “[a]ccess to truthful, non-misleading information relating to Medical Technologies, including information on both on- and off-label uses, is critical to a [HCP’s] ability to exercise his or her medical judgment in the best interest of patients[.]” The updated Code provides examples of appropriate communications of such information, including properly disseminated peer-reviewed scientific literature or clinical practice guidelines; presentations at educational meetings regarding clinical trial results; and/or discussions with HCPs to solicit feedback regarding unmet patient need, research, and similar topics. Under this section of the Code, such communications containing information about unapproved or uncleared uses should (i) be identified as such and (ii) be provided by authorized company personnel, and all communications, whether on- or off-label, should be truthful and non-misleading.
- Jointly Conducted Education and Marketing Programs: The updated Code addresses jointly conducted education and marketing programs designed to highlight both a company’s products and treatment options available and an HCP’s ability to treat medical conditions. The updated Code highlights certain principles that companies should observe when conducting such programs, including that the company and the HCP “should serve as bona fide partners, and contributions and costs should be shared fairly and equitably between the parties.”
- Principles for Company Representatives Providing Technical Support in the Clinical Setting: The updated Code identifies several principles for companies to adopt when their representatives provide technical support in the clinical setting, including principles related to: (i) HCP supervision; (ii) transparency; (iii) maintenance of HCP independent clinical decision-making; (iv) compliance with hospital/facility policies and requirements (e.g., patient privacy and credentialing); and (v) mitigation of potential expense relief.
- Consigned Products: The updated Code states that consignment arrangements should generally be subject to an agreement addressing the terms of the consignment (e.g., number of products, requirements to segregate consigned products from other products, and space rental terms). The Code also encourages companies to consider implementing controls such as taking periodic inventory of consigned products and returning or removing expired product. These additions are consistent with guidance on consigned products set forth in AdvaMed’s prior standalone guidance on sample products, loaned products, and consignment products.
In addition, the updated Code also expands existing guidance related to the following topics:
- Consulting: The Code expands its previous guidance on consultant arrangements. This includes providing clarification on the meaning of “legitimate need,” identifying examples of appropriate qualifications to consider when selecting a consultant, and explaining the restrictions on the involvement of sales personnel in selecting consultants. There is new guidance on how to establish “fair market value,” which states that a third party may assist in developing an approach to assess fair market value and that, in all instances, a company’s fair market value methodology should incorporate objective criteria and, ideally, should be documented.
- Third-Party Programs: The Code adds several new defined terms regarding support of third-party programs and substantially expands the existing guidance on such programs into one comprehensive section entitled “Educational & Research Grants, Donations, and Commercial Sponsorship.” The consolidated section provides that companies may support “Third-Party Programs” through “Educational Grants” and/or “Commercial Sponsorships,” (all of which are defined in the updated Code) and identifies principles that should underpin such support, including that sales personnel should not unduly influence decisions, support should not be provided to individual HCPs, and any benefits received by the company in exchange for its support should not be passed to any HCP. There is also new guidance on “Satellite Symposiums,” which are defined, in part, as “Company-organized and funded program[s] that [are] appended to a Third-Party Program agenda but that the Third-Party Organizer does not control.” This section also sets forth new guidelines for supporting independent third-party research and supporting charitable programs.
In addition to the foregoing expansions, the updated Code also:
- provides additional considerations for what might be permissible and impermissible travel and lodging expenses;
- encourages companies to develop meal policies; and
- expands the existing language regarding demonstration and evaluation products, including by incorporating AdvaMed’s prior standalone guidance on sample products, loaned products, and consignment products.
Medical device manufacturers should consider the updates to the Code and determine whether any changes to company policies, procedures, and practices are warranted, and whether such changes impact compliance with state laws such as those in California and Nevada.