Merz v Ipsen: Dysport “long-lasting effect” campaign found misleading on appeal (AUTH/3228/7/19)

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Key facts

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Case	AUTH/3228/7/19
Parties	Merz Pharma UK Ltd v Ipsen UK Ltd
Product	Dysport (clostridium botulinum type A toxin)
Main issue	Promotion implying an unsubstantiated duration-of-effect advantage (notably “Dysport – A toxin with a long-lasting effect”) and related in-field messaging
Applicable Code year	2019
Complaint received	24 July 2019 (PDF also states complaint received 25 July 2019)
Case completed	07 October 2020
Panel decision	No breach (initially)
Appeal	By the complainant; successful for Clauses 7.2, 7.10, 9.1; unsuccessful for Clause 7.3
Breach clauses	7.2, 7.10, 9.1
No breach clauses	7.3
Sanctions	Undertaking received; additional sanctions not stated

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

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Merz Pharma UK Ltd complained about Ipsen UK Ltd’s promotion of Dysport (clostridium botulinum type A toxin), focusing on claims implying superior/sustained duration of effect.
The parties had previously completed inter-company dialogue (closed December 2018) in which Ipsen committed to withdraw specific duration-of-effect claims and to brief sales/MSL teams that, without comparative studies, no cross-trial comparisons could be made.
Merz alleged that, despite those undertakings, Ipsen continued a differentiation strategy based on sustained duration of effect, citing reports from three named hospitals and an account from a named senior hospital pharmacist about a March 2019 meeting.
Ipsen denied the alleged in-field statements, said the meeting was about pricing/commercial terms, and stated its post-dialogue materials were within the Dysport SPC and included warnings not to compare with other toxins due to no head-to-head studies.
The Panel initially ruled no breach, finding insufficient evidence on the balance of probabilities that Ipsen promoted a longer duration versus other toxins.
Merz appealed. The Appeal Board focused on the ongoing campaign claim “Dysport – A toxin with a long-lasting effect”, the lack of explanation/context in materials, and the evidence trail around the pharmacist interaction and the absence of detailed call notes.

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Appeal upheld in part: breaches found of Clauses 7.2, 7.10 and 9.1.
No breach of Clause 7.3 (the Appeal Board did not consider it had evidence that the implied benefit amounted to a misleading comparison with Xeomin as alleged).
The Appeal Board considered the main claim would be read in relation to other medicines/neurotoxins and was misleading due to undue emphasis on duration of effect, in the absence of head-to-head evidence showing differences between neurotoxins.

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