Anonymous v Bristol-Myers Squibb: Daklinza leavepiece at integrated care conference (AUTH/2861/7/16) – No breach

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2861/7/16
PartiesAnonymous, non-contactable complainant v Bristol-Myers Squibb Pharmaceuticals Limited
MedicineDaklinza (daclatasvir dihydrochloride)
Therapy areaChronic hepatitis C virus (HCV) infection in adults (in combination with other medicinal products)
AllegationPromotion of a prescription only medicine to the public via leavepieces placed on seats at a conference session
SettingIntegrated care conference (June 2016)
MaterialCertified 4-sided promotional leavepiece referencing NICE approval and including prescribing information
Distribution method1200 copies delivered to organisers; placed on seats in five non-sponsored sessions (agreed verbally)
Clauses consideredClause 2; Clause 9.1; Clause 26.1
DecisionNo breach of Clauses 26.1, 9.1 and 2
Complaint received29 July 2016
Case completed2 September 2016
AppealNo appeal
Applicable Code year2016

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 alleged Bristol-Myers Squibb (BMS) promoted Daklinza (daclatasvir dihydrochloride), a prescription only medicine, to the public at a 2-day integrated care conference in June 2016.
  • The complainant said a Daklinza promotional piece was placed on every seat in a keynote lecture theatre session on day 1, which they believed was open to non-medical attendees and the public.
  • The complainant alleged this brought the industry into disrepute and amounted to advertising a POM to the public.
  • BMS said the conference was a trade-only event aimed at health professionals and “other relevant decision makers” (eg, NHS payors/commissioners), with consumers and direct patients refused entry.
  • BMS provided that 1200 copies of a certified 4-sided Daklinza leavepiece (focused on recent NICE approval and including prescribing information) were distributed by organisers onto seats in five pre-identified, non-sponsored sessions (agreed verbally).
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Outcome

  • No breach of the Code was found.
  • The Panel ruled the distribution did not constitute advertising a prescription only medicine to the public.
  • The Panel noted concern that the distribution arrangements were agreed verbally with no written details or documented compliance assessment, but this did not change the no-breach outcome.
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