Merck Serono breach over MS nurse call frequency driven by 6-contacts/day target (AUTH/2754/5/15)

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2754/5/15
ComplainantAnonymous, non-contactable nurse (described as senior MS nurse specialist)
CompanyMerck Serono Limited
IssueCall/contact frequency; visits often without appointment; additional attendees
Product mentionedRebif (interferon beta-1a)
Incentive/targetTarget of 6 contacts/day (stated as March 2015 “short-term fix”; emails suggested continuation beyond March)
Applicable Code year2015
Complaint received05 May 2015
Case completed24 July 2015
AppealNo appeal
Breach clausesClause 15.2; Clause 15.4
SanctionsUndertaking received; Additional sanctions: Not 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 a senior MS nurse specialist in an NHS trust) complained that Merck Serono representatives visited very frequently, often without an appointment.
  • The complainant said visits were made more inconvenient by additional attendees (described as managerial, medical, marketing and administrative staff) and that requests to stop bringing extra visitors were ignored and visits increased.
  • The complainant alleged the additional visitors threatened patient confidentiality and were against trust policy; colleagues reportedly had similar experiences.
  • Merck Serono said competitive pressure led to a time-limited incentive (1–31 March 2015) targeting 6 contacts/day with MS customers; it said most calls were solicited and accompanied visits were infrequent and pre-arranged.
  • The Panel reviewed CRM data, market research and internal emails and concluded the contact frequency increased and that internal communications implied the 6 contacts/day expectation continued beyond March.
  • The Panel was concerned that KAMs were not given comprehensive, consistent guidance distinguishing “call” vs “contact” rates and how to meet targets compliantly.
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Outcome

  • Breach found: Clause 15.4 (frequency/timing/duration/manner of calls must not cause inconvenience).
  • Breach found: Clause 15.2 (representatives must maintain a high standard of ethical conduct and comply with the Code).
  • No breach found (trust policy allegation): The Panel found no evidence that a trust policy had been breached because the complainant did not provide the policy and the burden of proof was not met.
  • No appeal.
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