AUTH/2571/12/12: Anonymous health professional v Pharmacosmos (symposium invitation) – No breach

📅 2012 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2571/12/12
ComplainantAnonymous, non-contactable health professional
CompanyPharmacosmos
MaterialDouble-sided A5 symposium invitation flyer
EventPharmacosmos symposium at the 8th ECCO Congress (European Crohn’s and Colitis Organisation), Vienna, 14–16 February 2013
Key wording at issue“Can we optimize treatment with single high dose intravenous iron in IBD patients? – New data from clinical trials”
Products mentioned in case backgroundMonofer; CosmoFer (not named on the flyer)
Complaint themeConcern about discussing/promoting “new” (potentially unpublished/unlicensed) data
Applicable Code year2012
Clauses considered2, 3.1, 3.2, 4.1, 9.1
Panel decisionNo breach (flyer not promotional; no PI required)
Complaint received20 December 2012
Case completed6 February 2013
AppealNo appeal

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • An anonymous, non-contactable complainant (self-described health professional) complained about a double-sided A5 invitation to a Pharmacosmos symposium at the 8th ECCO Congress (Vienna, February 2013).
  • The invitation headline/topic was: “Can we optimize treatment with single high dose intravenous iron in IBD patients? – New data from clinical trials”.
  • The complainant believed “new” data could not be discussed or promoted until published and licensed.
  • Pharmacosmos marketed Monofer (iron (III) isomaltoside 100) and CosmoFer (iron dextran), both for IV treatment of iron deficiency; both could be administered as total dose infusions (CosmoFer in limited circumstances).
  • Pharmacosmos said the flyer was intended to inform conference attendees about a scientific symposium, did not name a product, and was intended for physicians attending ECCO (though it appeared on a hospital noticeboard).
  • The Panel assessed only the content of the flyer and first determined whether it was promotional.
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Outcome

  • No breach of the Code.
  • The Panel decided the flyer did not directly or indirectly refer to Monofer or CosmoFer and therefore was not promotional.
  • Because it was not promotional, the requirement to include prescribing information did not apply.
  • No breach was ruled for Clauses 3.1, 3.2, 4.1, 9.1 and 2.
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