AUTH/2937/2/17: Anonymous (non-contactable) v Merck Serono — consent requests for email/text communications (No breach)

📅 2017 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2937/2/17
CompanyMerck Serono Limited
ComplainantAnonymous, non-contactable (described as an oncology nurse specialist)
ProductErbitux (cetuximab)
Therapy area / indication mentionedMetastatic colorectal cancer; squamous cell cancer of the head and neck
Main issueAlleged repeated, forceful requests to obtain consent for email/text communications despite refusal
Clauses considered15.2; 15.9
Applicable Code year2016
OutcomeNo breach
Complaint received16 February 2017
Case completed17 March 2017
AppealNo appeal
Additional sanctionsNone stated

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 (described as an oncology nurse specialist) complained about a Merck Serono representative promoting Erbitux (cetuximab).
  • The complainant alleged the representative repeatedly tried to obtain consent for the company’s electronic communication system (email and text), despite being told “no”.
  • The complainant said the representative asked on every visit, was “quite forceful”, and staff felt pressured; the complainant viewed email/text contact as invasive and unwelcome.
  • The PMCPA asked Merck Serono to respond in relation to Clauses 15.2 and 15.9 (Applicable Code year: 2016).
  • Merck Serono said it investigated, had an approved consent-collection process, trained representatives in 2016, and had briefing documents; it also issued additional guidance to field staff after the complaint.
  • Merck Serono stated representatives were not incentivised/bonused and had no KPIs/targets for collecting consent.
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Outcome

  • No breach of the Code was ruled.
  • The Panel found the complainant had not provided sufficient information to identify the particular circumstances and could not be contacted for more detail.
  • The Panel found no evidence that a representative had repeatedly asked for consent as alleged, and the complaint was not proven on the balance of probabilities.
  • No breach of Clauses 15.2 and 15.9 was ruled.
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