Life Science Compliance Update

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January 07, 2016

EDMA and Eucomed Adopt Code of Business Practice Brings Changes to Medical Congresses

Members of both the European Diagnostic Manufacturers Association (EDMA) and the European Medical Technology Industry (Eucomed) approved a new Code of Ethical Business Practice. Both associations are members of MedTech Europe who are working to set high ethical standards for the medical technology industry all throughout Europe.

This new Code will replace the EDMA and Eucomed codes of business practice and will be known as the MedTech Europe Code of Business Practice. This decision to adopt a common and wide-reaching code was prompted by the fact that EDMA and Eucomed each had different codes, which created inconsistencies in the rules that were applied to the industry. Once EDMA and Eucomed began to heavily collaborate, both organizations saw the need to align their codes to create greater consistency industry-wide.

The new Code will regulate all aspects of industry's relationship with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs), and will introduce a common independent enforcement mechanism. The new code, establishing the new minimum standard by which industry members operate in Europe, will become binding for EDMA and Eucomed members by January 1, 2017, and the ban on direct sponsorship for doctors begins January 1, 2018.

Lisa Boch-Anderson, MedTech Europe's communications director, claims that the new Code will regulate all aspects of relationships with medical professionals. Boch-Anderson stated that MedTech Europe will be taking transparency to a new level, "[w]e will be banning direct sponsorship of medical professionals' being sent to events. The pharmaceutical sector has introduced transparency, but we opted for transparency plus – not only making it transparent, but ending direct sponsorship all together."

In addition to the direct sponsorship ban, educational grants to hospitals will become public and will be able to be found in a database hosted by MedTech Europe's website. According to Boch-Anderson, "hospitals will look after their own educational needs; we won't be pinpointing specific doctors." Part of the reason for the distinction is so that there is "a level of independence."

The code includes a Eucomed independently managed conference vetting system which reviews the compliance of third-party educational conferences with both Eucomed Code of Ethical Business Practice. The decisions rendered by the Compliance Officer are binding on Eucomed and Mecomed members. Which means that members of Eucomed and Mecomed may not directly sponsor or cover expenses of Healthcare Professionals to attend a third-party conference which is found to be not compliant with the system.  

While the Code does set out minimum standards appropriate to the activities, it is not meant to supersede any national laws or regulations, or any professional codes that may have more stringent requirements. MedTech Europe cautions members to be "mindful of the fact that they may be liable for the activities of third party intermediaries who interact with Healthcare Professionals or Healthcare Organizations in connection with the sale, promotion, or other activity involving Member Companies' products."

Leadership of both associations and MedTech Europe are pleased with the new Code. Rob Ten Hoedt, Chairman of MedTech Europe and Eucomed, said, "We are proud that the European medical technology industry has adopted one of the most modern and progressive codes of conduct, with strict, clear and transparent rules." Jurgen Schulze, Vice Chair of MedTech Europe and President of EDMA is also pleased, stating, "This is a landmark vote that reflects both how our industry is changing and how our partnership with healthcare professionals and healthcare organizations has evolved."

A group of European cardiologists, including the Editor-in-Chief of EuroIntervention, is one of several groups upset with the new regulation, stating that they believe the updated Code "may significantly impact the future of CME, create major restrictions for smaller meetings, and have a severe impact on larger conferences." They estimate that the new guidelines will reduce attendance at CME events by as much as thirty to fifty percent.

Gregg Stone, MD, of Columbia University Medical Center in New York, NY, believes that industry support of CME for physicians plays an important role in improving patient outcomes. Dr. Stone stated,

For those of us who have dedicated our lives to running high-quality, independent CME-accredited courses, we are concerned that these new rules will be counterproductive, and limit attendance at independent meetings, while paradoxically making it relatively easier to attend direct industry-sponsored events. Only time will tell if this initiative is a step backward or achieves its stated goals of greater transparency and fairness without slowing the remarkable progress we've collectively realized. In the meantime, we strongly encourage all physicians in Europe to continue to annually attend major physician-directed interventional meetings to ensure ongoing quality improvement and enhance patient care.

In addition to the new Code, which can be found here, MedTech Europe has issued a Guidance Document with questions and answers on the new Code.

The Guidance Document provides a quick summary of clarifications of the new changes in regulation, as well as some common questions, such as the definition of "Healthcare Professional." The Guidance Document is broken up into eight chapters, each of which highlights important distinctions of the new Code, including "Chapter 1: General Criteria for Events," "Chapter 2: Third Party Organized Educational Events," "Chapter 3: Company Events," "Chapter 4: Grants and Charitable Donations."

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