Anonymous v Cephalon (AUTH/2409/6/11): Promotional material certified by non‑GMC registered “medical” signatory

📅 2011 | 🖉 Dr Anzal Qurbain
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Key facts

CaseAUTH/2409/6/11
PartiesAnonymous complainant v Cephalon
IssueQualification/registration of a medical signatory who certified promotional material
Applicable Code2008
Complaint received16 June 2011
Case completed26 July 2011
AppealNo appeal
Materials affectedApproximately 45 promotional items certified over ~5 months
Breach clausesClause 14.1
No breach clausesClauses 2, 9.1, 16.1
SanctionsUndertaking received; Additional sanctions: Not stated
Sourcehttps://www.pmcpa.org.uk/cases/completed-cases/auth2409611-anonymous-v-cephalon

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 (ex-employee) alleged a Cephalon medical affairs manager with signatory/approval powers was not a qualified doctor.
  • The individual worked as an interim medical adviser via a recruitment agency (late 2009 to spring 2010), not as a direct employee.
  • Cephalon’s job description required candidates to be medically qualified with current GMC registration and at least 2 years post-registration clinical experience.
  • Cephalon’s SOP required the final medical signature on promotional material to be a registered medical practitioner; the individual completed SOP training but did not disclose the lack of GMC registration.
  • During ~5 months, the individual certified approximately 45 promotional items; these were also reviewed internally by medical and other experienced Code signatories.
  • When Cephalon later conducted pre-employment checks for a permanent role (including GMC status), it discovered the individual was not GMC registered; the offer was withdrawn and the contract terminated immediately.
  • Cephalon commissioned an experienced external pharmaceutical physician to urgently review the materials; Cephalon stated the materials were Code compliant and of good quality.
  • Cephalon could not confirm whether the individual was registered as a medical practitioner in another country; the individual did not indicate this and Cephalon could not match details via GMC searches/communications.
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Outcome

  • Breach found: Clause 14.1.
  • No breach: Clause 16.1 (training), Clause 9.1 (high standards), Clause 2 (particular censure).
  • The Panel accepted that promotional material had been certified by someone Cephalon could not show was a registered medical practitioner, so the certification requirements were not met.
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