Eucomed and AdvaMed have developed the following joint guidance and also specific tools on Third-Party Management and Distributor Relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions.
This guidance has been developed as MedTech companies regularly engage third parties to assist with marketing, sales and distribution of medical technology around the world. These third parties may include distributors, wholesalers, distribution or sales agents, marketing agents, brokers, commissionary commercial agents and independent sales representatives. It is essential that companies’ interactions with such third parties, as well as the behaviour of such third-parties on a company’s behalf (including third party interactions with Health Care Professionals (“HCPs”) and governmental officials) are conducted pursuant to all applicable laws as well as the highest ethical principles.
On 20 January 2012, Eucomed and AdvaMed have approved “Joint Guidance for Medical Device and Diagnostics Companies on Ethical Third Party Sales and Marketing Intermediary (SMI) Relationships.” This guidance complements the Eucomed Code of Ethical Practice and the AdvaMed Code of Ethics.
The guidance encourages companies to adopt a compliance program that integrates individual risk analyses and local laws to ensure ethical interactions between MedTech companies and third-party entities hired for assistance in marketing, sales and/or distribution of their products or services. The guidance recommends elements of a successful third-party compliance program and serves as an important resource for any medical technology company engaging in SMI interactions overseas.
MedTech Europe and AdvaMed have jointly published a brochure to help distributors in their relations with HCPs: Compliance Guide for Medical Technology Sales & Marketing Intermediaries (SMIs).
Distributor Training Slides
The Due Diligence Questionnaire includes a compilation of examples of compliance diligence questions that MedTech companies can use when engaging independent third parties that assist MedTech companies with marketing, sales and distribution.