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Distributor Guidance

Background

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

Given the increasingly global nature of the medical device and diagnostics industry, and further to the Joint Guidance For Medical Device And Diagnostics Companies On Ethical Third Party Sales And Marketing Intermediary [“SMI”] Relationships, AdvaMed, MedTech Europe and the law firm of Kaye Scholer developed an anti-bribery training tool as an example for member company use in developing and providing distributor training. The tool is designed to facilitate the training of distributors and other third parties involved in the marketing or sale of medical devices and diagnostics, an important component of any effective global anti-corruption compliance program. The tool is offered as a starting point for companies developing anti-bribery training programs. The tool should be further tailored to each company’s third party SMI relationships, policies, business model, region, and any other factors that are relevant to a company’s anti-corruption risk profile. Please see the Distributor Training Tool Terms of Use for more information about how Companies may use the tool.

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.

Related Links

AdvaMed Code of Ethics

        English

        Chinese - Simplified

        Chinese - Traditional

        German

        Italian

        Portuguese

        Spanish

MedTech Europe Code of Business Practice

Article by Aline Lautenberg and Christopher White in Life Science Compliance 

Distributor Guidance

English

Chinese

Other Resources

Third Party Essentials: A Reputation / Liability Checkup When Using Third Parties Globally by the Society of Corporate Compliance and Ethics

        English

        Chinese

        Portuguese

        Russian

        Spanish

Transparency International UK Handbook: How to Bribe: A Typology of Bribe Paying and How to Stop it

Training Slides

Terms of Use - English

English

Chinese

French

German

Italian

Russian

Spanish

Portuguese

Due Diligence Resource

English

Spanish

Illustrative Scenarios

English

SMI Brochure

English

Chinese

Portuguese

Spanish

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