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 to engage third party intermediaries to assist in the marketing, sale and/or distribution of the companies’ products or services.
Eucomed and AdvaMed, the US Advanced Medical Technology Association, have worked together to draft a guidance document to help companies develop and adopt effective compliance programmes for third-party sales and marketing intermediary (SMI) relationships.
Both organisations recognise that joint, harmonised, ethical guidance with respect to company interactions with third-party SMIs can be helpful to ensure integrity in medical decision-making.
The new guidance identifies the following elements of an effective SMI compliance programme:
- 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.
Eucomad and AdvaMed encourage companies to implement an effective SMI programme in addition to an overall (Healthcare Professionals) compliance programme, applicable to all relevant personnel.
