AUTH/2912/12/16: Astellas Pharma Europe – Betmiga videos posted online by third parties (public promotion via Vimeo) | PMCPA Case

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Key facts

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Case number	AUTH/2912/12/16
Company	Astellas Pharma Europe Ltd
Product	Betmiga (mirabegron)
Issue	Videos with product claims posted online by third parties; potential promotion of a prescription-only medicine to the public
Channels	Vimeo (open access) and a UK event awards website linking to YouTube via a secure link
Complaint type	Voluntary admission (treated as a complaint under Paragraph 5.6 of the Constitution and Procedure)
Complaint received	05 December 2016
Case completed	03 April 2017
Applicable Code year	2016
Breach clauses	9.1, 26.1, 26.2
No breach clauses	2 (and for video 3: no breach of 26.1, 26.2, 9.1, 2)
Sanctions	Undertaking received
Appeal	No appeal

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

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Astellas Pharma Europe voluntarily admitted that three videos containing Betmiga (mirabegron) product claims had been posted online by third parties, potentially promoting a prescription-only medicine (POM) to the public.
Two videos (“Manifesto” and an “International launch campaign”) were found on Vimeo (open access) following a keyword alert (delivered 1 Nov 2016; accessed 2 Nov 2016).
A third video (“Astellas Betmiga launch”) was identified on 14 Nov 2016 via a UK event awards website; it appeared to link to a YouTube video accessible only via a secure link.
Videos 1 and 2 were created by a UK agency for internal launch purposes/awards submission; they were not approved in Zinc because they were intended for internal/limited use.
An ex-employee of the agency uploaded videos 1 and 2 to Vimeo to showcase past work; the ex-employee removed them after being contacted.
Video 3 was created by another agency (ceased trading) for an awards entry; Astellas could not confirm permissions or whether the video was removed at source, but it was removed from the awards website in Nov 2016.

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Videos 1 and 2 (Vimeo): ruled to be promotion of a POM to the public; breaches of Clauses 26.1, 26.2 and 9.1.
Video 3 (awards website / secure YouTube link): in the particular circumstances, not considered promotion to the public; no breach of Clauses 26.1, 26.2, 9.1 or 2.
No breach of Clause 2 was ruled overall (Panel did not consider the circumstances warranted particular censure).
Astellas had taken immediate steps to remove the material once discovered.

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