Cephalon: Lisbon congress hospitality and an internal “feedback” note that normalised excessive entertainment (AUTH/2361/10/10)

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Key facts

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Case number	AUTH/2361/10/10
Parties	Anonymous ex-employee v Cephalon (UK) Limited
Complaint received	05 October 2010
Case completed	01 December 2010
Applicable Code year	2008
Activity	Sponsorship of 13 health professionals to attend a European pain congress in Lisbon (September 2009) and circulation of an internal congress feedback document
Products mentioned	Effentora (fentanyl); Abstral (fentanyl) referenced
Main issues upheld	Excessive hospitality beyond subsistence; poor standards/ethical conduct; discredit to industry; internal document treated as briefing material; failure to comply with applicable codes
No breach findings (selected)	Clause 3.2 (off-label promotion) not proven; Clauses 7.1/7.2 (implied comparisons) not proven; Clause 16.1 no breach; Clause 15.10 no breach
Breach clauses	1.7, 2 (x2), 9.1 (x2), 15.2, 15.9, 19.1
Sanctions	Undertaking received; Additional sanctions: Advertisement
Appeal	No appeal

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

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An anonymous ex-employee complained about Cephalon’s sponsorship of 13 health professionals to attend a European pain congress in Lisbon (September 2009).
The complaint was triggered by an internal “congress feedback” document circulated within Cephalon (including sales teams) describing hospitality in a “party” tone (eg “took them clubbing”, “a few bars and to a club until 3am – a few good photos to prove it!!!”).
The feedback document concluded: “All the customers were really looked after and spoke positively about Effentora – lets make sure they start Rxing now!”.
Receipts showed restaurant and bar spend across multiple evenings; early morning bar bills included spirits and cocktails; one dinner booking required payment for 20 covers although only 15 attended.
Cephalon could not locate the required “job bag”/certification paperwork for the meeting arrangements.
Allegations also included off-label promotion (sublingual Effentora before licence) and misleading implied comparisons with Abstral; the Panel did not find evidence to uphold those points.

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Breach found for the internal feedback document being, in effect, briefing material that advocated conduct likely to lead to a breach (Clause 15.9).
Breach found because the impression created by the feedback document (party atmosphere, recorded on camera) failed to maintain high standards and brought discredit on the industry (Clauses 9.1 and 2).
Breach found because, cumulatively, hospitality went beyond subsistence and was not secondary to the main purpose of attending the congress (Clause 19.1), with associated breaches of Clauses 9.1 and 2.
Breach found for representatives not maintaining a high standard of ethical conduct (Clause 15.2).
Breach found for failure to comply with all applicable codes, laws and regulations (Clause 1.7).
No breach found for alleged off-label promotion (Clause 3.2), implied comparisons (Clauses 7.1 and 7.2), staff being not conversant with the Code (Clause 16.1), or company responsibility principle (Clause 15.10).

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