AdvaMed and MedTech Europe have developed joint compliance guidance and tools on Distributor Relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions. We believe clear, established compliance programs will safeguard the integrity of medical decision making and promote further public confidence in our industry.
To ensure and improve ongoing patient and clinician access to innovative, reliable and effective medical technologies, it is often necessary for medical device and diagnostics companies (“Companies”) to engage third parties to assist with marketing, sales and distribution of advanced medical technology overseas. These third parties may include distributors, wholesalers, distribution or sales agents, marketing agents, brokers, commissionary commercial agents and independent sales representatives (“Third Party Sales and Marketing Intermediaries" or "Third Party SMIs”).
It is essential that Companies’ interactions with Third Party SMIs, as well as Third Party SMIs’ behaviour on a Company’s behalf (including Third Party SMI interactions with Health Care Professionals (“HCPs”) and governmental officials) are conducted pursuant to all applicable legal and ethical principles that comply with standards equivalent to those in our organizations’ individual Codes of Ethics (“Codes”).
AdvaMed and MedTech Europe encourage Companies to adopt a Third Party SMI Management Compliance Program in addition to an overall (HCP) compliance program, applicable to all relevant personnel, including a Company’s senior leadership.
Guidance on Ethical Relationships with 3rd Party Distributors
This guidance complements the AdvaMed Code of Ethics, as well as MedTech Europe’s Code of Ethical Business Practice. The new guidance encourages companies to adopt a compliance program that integrates individual risk analyses and local laws to ensure ethical interactions between medical device companies and third-party entities hired for assistance in marketing, sales and/or distribution of their products or services. SMI arrangements can be complex and implicate a variety of U.S., overseas and local laws. The guidance recommends elements of a successful SMI compliance program and serves as an important resource for any medical technology company engaging in SMI interactions overseas. The guidance identifies the following elements of an effective SMI compliance program:
- Comprehensive anti-bribery policy;
- Established process for evaluating risk profiles of third-party SMIs;
- Risk-based pre-engagement and renewal due diligence program;
- Contract terms providing adequate controls and implementation of the policy;
- Training and education for third-party SMIs and the company employees that manage these relationships;
- Routine, risk-based assessment of third-party SMI relationships; and
- Appropriate corrective measures when needed.
Distributor Training Slides
Distributor Due Diligence Resource
This document includes a compilation of example Third Party Sales and Marketing Intermediary compliance diligence questions, example certification, and an example compliance diligence privacy notice for AdvaMed and MedTech Europe Member Companies' consideration when engaging Third Party SMIs.
Illustrative Scenarios & Compliance Program Controls
This document, Illustrative Medical Technology Scenarios and Compliance Program Controls For Third Party Sales & Marketing Intermediary Relationships, includes hypothetical scenarios and examples of steps companies might take to minimize corruption risk related to engagements with sales and marketing intermediaries.