Serono breached Clause 15.4 after internal call-rate document implied up to 9 unsolicited visits per year

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/1843/6/06
PartiesAnonymous v Serono
IssueRepresentative call rates / implied frequency of unsolicited calls
Material“Activity Standards and Definitions” (updated 1 January 2006)
Key concernWording “For Sept–Dec 04” implied per-cycle call frequency, potentially leading to up to 9 calls/year (3 cycles/year)
Company positionDocument altered/out of date; typo; other SOPs/training limited unsolicited calls to 3 per year; revised table issued 17 January 2006
Panel findingDocument had to stand alone; typo gave wrong impression about call rates
BreachClause 15.4
SanctionUndertaking received
Complaint received31 May 2006
Case completed14 August 2006
AppealNo appeal
Applicable Code year2006

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

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What happened

  • An anonymous complainant submitted Serono’s internal document “Activity Standards and Definitions” (updated 1 January 2006) setting out representative activity targets across therapy areas (reproductive health, multiple sclerosis, myalgic encephalomyelitis and dermatology).
  • The document described minimum activity requirements and included “frequency per cycle” figures (eg three calls for some doctors in one area; two in another). The complainant stated there were three cycles per year.
  • Serono said the complainant’s copy had been altered and that the document was out of date and superseded by SOPs, cycle materials, training and performance objectives that limited unsolicited calls to three per year.
  • However, both Serono’s original and the complainant’s version contained the wording “For Sept–Dec 04” in some therapy areas, implying the stated call frequency applied per Sept–Dec cycle.
  • The Panel considered that this wording could imply up to 9 calls per year (3 cycles/year × 3 calls/cycle) and that the document had to “stand alone”.
  • Serono argued “For Sept–Dec 04” was a typographical error and should have read “As agreed with Manager”, and said a revised table was issued on 17 January 2006.
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Outcome

  • Breach found.
  • The Panel ruled that the typographical error gave the wrong impression about call rates and therefore breached the Code.
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