AUTH/2921/12/16: Grünenthal—Internal Palexia SR video uploaded to YouTube (promotion to the public)

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2921/12/16
CompanyGrünenthal Ltd
ProductPalexia SR (tapentadol prolonged release)
IssueInternal-use video uploaded to YouTube; promotion of a prescription only medicine to the public
How identifiedNotified by global headquarters colleague (Germany) on 23 November 2016
Video availabilityPosted February 2016; viewed 330 times; removed same day it was identified (23 November 2016)
Complaint received20 December 2016
Case completed30 January 2017
Applicable Code year2016
Breach clausesClause 9.1; Clause 26.1; Clause 26.2
No breach clausesClause 2
SanctionsUndertaking received; additional sanctions not stated
AppealNo appeal

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

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What happened

  • Grünenthal voluntarily admitted that a video certified for internal use only about Palexia SR (tapentadol prolonged release) was uploaded to YouTube without the company’s knowledge.
  • The video had been created for internal sales force engagement around the 2015 Palexia SR brand plan and was originally shared via a password-protected link on a secure site.
  • With Grünenthal’s consent, the agency submitted a shortened version for a marketing award (won Gold in January 2016).
  • Without Grünenthal’s or the agency’s knowledge, the production company director sent the shortened video to an actor, who uploaded it to YouTube (posted February 2016).
  • Grünenthal was alerted on 23 November 2016 and had the video removed the same day (by ~1pm). The video had been viewed 330 times.
  • The video included promotional-sounding statements (eg Palexia described as “a jolly good medicine” and “a darned good product”) and suggested persuading a doctor to prescribe it would be a “piece of cake”.
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Outcome

  • Breach ruled: Clause 26.1 (advertising a prescription only medicine to the public).
  • Breach ruled: Clause 26.2 (statements in a public forum encouraging the public to ask a health professional to prescribe a specific POM).
  • Breach ruled: Clause 9.1 (high standards not maintained).
  • No breach: Clause 2 (Panel did not consider the matter warranted the particular censure of Clause 2).
  • Panel also expressed concern that Grünenthal had suggested the video would not be appropriate as a stand-alone item; the Panel reiterated that all material must be capable of standing alone for Code compliance and certification implies the signatory believes it complies with the Code.
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