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Home » Food & Drug Regulation: Library » Newsbriefs

E.U., U.S. Device Groups Enter Agreement on Ethics Code

Date Posted: May 5, 2010

Medical device industry associations in Europe and the United States entered into a trans-Atlantic agreement to establish a global code of ethics for the medical device industry.

The agreement, which addresses interactions between medical technology companies and health care professionals (HCPs), was signed by the Advanced Medical Technology Association (AdvaMed), the European Medical Technology Industry Association (Eucomed) and the European Diagnostic Manufacturers Association (EDMA) during a ceremony at the 2010 International Medical Device Industry Compliance Conference in Berlin.

“The signing of this trans-Atlantic statement by AdvaMed and Eucomed, two of the largest medical technology industry trade associations in the world, shows our industry’s unwavering commitment to develop a cohesive international approach to interactions between medical technology companies and healthcare providers,” said  Stephen J. Ubl,  president and chief executive officer of AdvaMed. “We welcome EDMA’s agreement to adopt this statement and urge other associations to do the same. By working to harmonize and extend our collective ethical standards on a global level, we increase transparency into these relationships and demonstrate their critical role in continued medical innovation and improved patient outcomes.”

Under the terms of the agreement, the associations committed to working together to:

  • promote ethical interactions among companies and HCPs by encouraging companies to adopt compliance programs and policies consistent with the codes;
  • provide guidance to the medical technology industry at large on ethical business conduct relating to companies’ interactions with HCPs;
  • support education and compliance of companies with all applicable laws, regulations or professional codes (including national association codes) that may impose more stringent requirements, relating to companies’ interactions with HCPs; and
  • advance ethical collaborations consistent with the codes globally, through regular communication, joint policies (where appropriate), joint activities, and other appropriate collaborations.

While the wording and some of the details of the codes are different, John Wilkinson, president and chief executive or Eucomed, said the agreement demonstrates that the codes share the same goals and spirit.

“Ethical behavior is a prerequisite for continued professional collaborations necessary to the ongoing advancement of medical technology and to the appropriate use of medical technologies in healthcare systems in the best interest of the patient,” Wilkinson said. “It is critical that these medically beneficial and collaborative interactions among companies and HCPs preserve independent decision-making by HCPs and public confidence in the integrity of patient care, treatment and product selection.”

Additional information on the ethics initiative will be in the June 2010 issue of Guide to Medical Device Regulation.

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