Ethics & Compliance

Ethics and conducting business in a compliant way is critical for both large and small companies. The adoption of new anti-bribery laws in a number of countries, increasing enforcement and new pressures coming from socially responsible investors and the general public frame the daily activities of any business. As a result, responsible companies have recognised the need for and value of guarding and promoting their reputation for integrity and responsibility as stakeholders become less tolerant of lapses.

For medical technology companies, interacting with Healthcare Professionals (HCPs) is a key component of their day to day activities. HCPs are an integral part of the R&D process and a source of innovation and creativity during the development of medical devices. HCPs are also the prime users of technologies and play an instrumental role in the successful adoption of innovative medical devices throughout Europe and beyond. Companies are also required to provide HCPs with appropriate instruction, education, training, service and technical support to ensure delivery of modern, safe and effective medical technology and care to patients.

The medical technology industry represented by Eucomed is committed to ensuring that its collaboration with HCPs adheres to the highest ethical and professional standards.

The role of Eucomed is to support its members by providing guidance on how to conduct their business responsibly. This is achieved by:

• Promoting the need and value of a culture of integrity and ethical business practices across the healthcare sector to continue to work for the patients’ best interests
• Supporting the adoption of ethical behaviours by providing a clear framework assessing the appropriateness – or otherwise – of the day-to-day collaboration between the medical technology industry and HCPs
• Ensuring that compliance is fully understood by all healthcare stakeholders, particularly – but not exclusively – within the industry
• Seeking collaboration with other major actors from the healthcare industry to harmonise ethical business practices

Eucomed has, amongst other activities, already published a Code of Ethical Business Practice, providing clear guidelines in the following areas:

• Eucomed Guidelines on Interactions with Healthcare Professionals (CZ, DE, ES, IT, PL, RO), September 2008
• Q&A on the Eucomed Guidelines On Interactions with Healthcare Professionals, December 2011 (v7) (CZ, DE, ES, IT, PL, RO), October 2009
• Eucomed Guidelines on Competition Law (CZ, DE, ES, IT, PL)
• Code of Ethical Business Practice: Procedural Framework (amended version (III) approved on 15 June 2011)
• Eucomed Compliance Panel Internal Procedural Rules, 26 June 2010
• Joint AdvaMed-Eucomed guidance for medical device and diagnostics companies on ethical third party sales and marketing intermediary [“SMI”] relationships, 18 January 2012

The Code is intended to provide ethical standards and principles for the medical technology industry within Europe. It is designed to supplement, but not replace, any national laws or regulations or other professional or business codes which may apply to Eucomed members.

In March 2010, Eucomed created a Compliance Panel to provide guidance on interpretation of the Eucomed Code and ensure consistency of interpretation of nationally applicable codes with the Eucomed Code. Where no national dispute resolution mechanism exists, the Panel may also act as a first and last instance decision-maker where disputes have been raised.

More information

Aline Lautenberg
Senior Legal Counsel
E: aline.lautenberg@eucomed.org
T: +32 2 761 22 82