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What’s New/Significant
The Advanced Medical Technology Association (AdvaMed) recently announced revisions to its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals (the Code). The revisions to the Code become effective January 1, 2020.
Rationale
These are the first changes to the Code since 2009 and consist of enhancements to existing provisions of the Code as well as the addition of several new sections.
Key revisions include new sections for: (i) conflicts of interest in consulting arrangements; (ii) jointly conducted education and marketing programs; (iii) communication on safe and effective use of medical technology; and (iv) provision of technical support in the clinical setting. There are also provisions that clarify or expand: (i) support for third-party educational and other conferences; (ii) the definitions of “health care providers” (HCPs) and “medical technology”; (iii) standards for travel and meals; and (iv) third-party support, including support for independent third-party research.
Definition of HCP
The Code clarifies the definition of an HCP to include any person or entity that is (i) licensed or authorized in the U.S. to provide health care items or services to patients or (ii) involved in the decision to purchase, prescribe or recommend a medical technology. This definition applies to manufacturer interactions with nonclinical or administrative personnel involved in purchasing, recommending or ordering decisions and also applies to interactions with U.S. HCPs both within and outside the United States.
Joint Education and Marketing Programs with HCPs
The updated Code provides a list of principles for companies that jointly sponsor education and marketing programs with HCPs, including: (i) that the company has a bona fide, legitimate need to participate in the program for its own educational or marketing benefit; (ii) establishment of controls that ensure such programs are not intended to serve as unlawful inducements to HCPs; (iii) that the company and HCPs make equitable cost contributions to the program; (iv) that HCPs follow company policies on providing product information; and (v) as with other financial arrangements with HCPs, the joint marketing program is subject to a written agreement.
Communication of Off-Label Information
The updated Code describes the appropriate means and contexts for communicating off-label information, such as in peer-reviewed scientific and medical journal articles, reference texts, and clinical practice guidelines; presentations at educational and medical meetings; and discussions with consultants and HCPs, among others.
The Code also encourages companies to adopt policies and controls governing the dissemination of on-label and off-label information about company products.
Personnel in Clinical Settings
The updated Code includes principles governing the presence of medical device personnel in clinical settings. Company personnel should: (i) be present in the clinical setting only at the request of and under the supervision of an HCP; (ii) make transparent to other providers and patients that they are acting on behalf of their company; (iii) not interfere with the independent clinical decision-making by the treating HCPs; (iv) comply with applicable hospital policies and requirements, including patient privacy and credentialing; and (v) not provide support that would eliminate an overhead expense that the HCP would otherwise incur.
Product Consignment
Companies providing consignment products for use in HCP clinical settings should ensure that consignment arrangements are subject to a written agreement that specifies the terms of consignment, the number of products consigned, segregation requirements and rental space terms. Controls should also include taking periodic inventory of consigned products and reconciling discrepancies in inventory.
Consulting Arrangements and Conflicts of Interest
The updated Code includes additional provisions related to permissible consulting arrangements, including that companies must ensure HCP consultants are appropriately vetted, have the necessary qualifications to meet the specific objective of a consultancy, provide bona fide services, and are paid fees based on fair market value (FMV), the determination of which is based on objective criteria and not on an HCP’s past, present or anticipated business. The updated Code also provides examples of potential conflicts of interest that companies need to address.
Third-Party Support for Grants, Donations and Sponsorships
The updated Code contains a checklist of factors to be considered by companies when reviewing third-party funding requests. An expanded section on research grants makes clear that such requests should be accompanied by clinical protocols that outline objectives and milestones; document the nature and scope of research activity, budget and duration of research; and provide for independent approvals. New language also defines and provides guidance for satellite symposia, which are company-organized and company-funded programs appended to third-party programs (such as medical conferences) but that such third parties do not control.
Company-Sponsored Training and Education Meetings
The updated Code includes a new section on sales/promotional programs and company-conducted trainings that provides more specificity as to the types of meetings that are appropriate to conduct, including meetings that address product features, sales terms, health economics information or purchase contract arrangements; plant/facility tours; meetings to demonstrate equipment; and meetings to explore product development or clinical testing needs. HCPs in attendance at such meetings must have an objective, legitimate need to attend.
Travel, Meals and Lodging
The updated Code encourages companies to develop meal policies, including establishing a per-meal spending limit, which may take into account geographic differences and guidelines as to appropriate settings for the provision of meals. Meals intended to build goodwill or for entertainment or recreational purposes continue to be prohibited.
The updated Code further specifies the need for an objective, legitimate reason for the HCPs’ out-of-town travel, such as the need to deliver training and education on a company’s products, the inability to effectively deliver the content of the program through means other than an in-person meeting or the need to demonstrate equipment. The updated Code provides principles for evaluating appropriate venues, which should be centrally located, easily accessible and conducive to the exchange of information. Venue should not be the main or primary attraction for an HCP to attend a meeting, and luxury venues or those associated with recreational or entertainment attractions should be avoided.