Many medical devices companies have invested in making their marketing actvities aimed at healthcare professionals Eucomed Code of Ethical Business Practices compliant. Although the Eucomed code has a lot of authority in the market and was updated some time ago as to make it enforceable by adding the Compliance Panel and national dispute resolution bodies in 2009, there has not been any formal output of the Compliance Panel so far, until now.

One of the ever problematic issues is what Eucomed allows in respect of sponsoring of conferences, because this is an important competitve instrument. Therefore, the Eucomed secretariat decided to request a formal interpretation of the rules due to the numerous requests by its members and congress organisers about sponsorship invitations regarding third-party congresses and conferences. This interpretation provides significant additional detail on what Eucomed considers ethical sponsoring. The Compliance Panel made six points (full decision here):

  1. The Program must be rigorous from a scientific and/or educational point of view. This means that its content must include current scientific information of a nature and quality which is appropriate to the Healthcare Professionals who are attendees at the Third Party Educational Conference.
  2. The faculty responsible for delivering the Program must be competent and qualified to make the particular delivery involved and must disclose that they are sponsored by a Eucomed Member, if this is the case.
  3. Representatives of Eucomed Members should not act as faculty unless the Program is part of an appropriate Eucomed Member Sponsored Satellite Symposium.
  4. Information on the Program and the identity of faculty should be made available to potential Eucomed Member sponsors sufficiently in advance in order for those sponsors to be able to make a reasoned judgment as to the rigor and quality of the Program, provided however that subsequent changes, deletions and additions to the Program made by the Third Party Conference Organizer are acceptable (including modifications made after a Eucomed Member has committed to sponsor either the Third Party Educational Conference, Healthcare Professionals and/or faculty) to the extent that such changes, deletions and additions are reasonable and do not significantly modify the quality or nature of the Program.
  5. The Program should not include leisure or sports events and should not advertise leisure or sports events or sporting facilities which may be available at the Third Party Educational Conference location.
  6. The Program must involve full days, with both morning and afternoon scientific and/or educational sessions, unless the Third Party Educational Conference is a half day event or commences or ends on a mid-day. Such half-day sessions are permissible, but there should not be any non-scientific or non-educational events or activities organized for the other part of the day. Furthermore, there should be no significant gaps in the Program which would permit Healthcare Professionals to engage in leisure, sports or other non-scientific or non-educational activities. For example, early morning sessions should not be followed by late afternoon or evening sessions with large blocks of free time in between.

Although the Eucomed recommendations and codes are not generally binding, they are generally considered to be the gold standard in business compliance in the medical devices industry in the EU, like the Advamed rules in the US (Eucomed and Advamed cooperate ever more closely on business compliance issues by the way). And how does a company implement all of that? I have written about that extensively in the FDLJ.

About these ads