To ensure ongoing patient and clinician access to innovative, reliable and effective medical technologies, medical device and diagnostics companies often need to engage with distributors and other third parties to assist with marketing, sales and distribution of advanced medical technology overseas. These third parties are often distributors, but may also include wholesalers, distribution or sales agents, marketing agents, brokers, commissioning commercial agents and independent sales representatives (sales and marketing intermediaries or "third party SMIs).
Company interactions with third party SMIs, as well as third party SMIs’ behaviour on a company’s behalf (including third party SMI interactions with healthcare professionals - HCPs - and government officials) have to follow all applicable legal and ethical principles, including the Eucomed and EDMA Codes of Ethics.
In order to ensure such compliance, MedTech Europe and AdvaMed have developed a joint guidance on third-party management and distributor relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions. In addition, MedTech Europe and AdvaMed have developed a Compliance Guide for Medical Technology Sales & Marketing Intermediaries (SMIs)
In order to substantiate specific elements in the guidance, MedTech Europe and AdvaMed have developed other materials which may be valuable for any company developing or updating their SMI program, such as:
1. Distributor Training Slides
AdvaMed, Eucomed and the law firm Kaye Scholer have developed an anti-bribery training tool for member companies. 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. Click here for more information.
2. Distributor Due Diligence Resource
This document includes a compilation of Third Party Sales and Marketing Intermediary compliance diligence questions, example certifications, and an example of compliance diligence privacy notice for Eucomed and AdvaMed member companies to consider when engaging third-party SMIs. Click here for more information.