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	Implied, unsubstantiated benefit/superiority regarding duration of effect (including claim ‘Dysport – A toxin with a long-lasting effect’) and alleged continuation after inter-company dialogue undertakings
Complaint received	24 July 2019 (PDF text also states complaint received 25 July 2019)
Case completed	7 October 2020
Applicable Code year	2019
Panel decision	No breach of Clauses 7.2, 7.3, 7.10, 9.1
Appeal	By complainant (Merz)
Appeal Board decision	Breach Clauses 7.2, 7.10, 9.1; No breach Clause 7.3
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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What happened

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Merz complained about Ipsen’s promotion of Dysport (clostridium botulinum type A toxin), alleging Ipsen continued to promote an unsubstantiated impression of superior duration of effect after inter-company dialogue had closed.
Earlier inter-company dialogue (concluded in 2018) focused on claims in a leavepiece ‘Why choose Dysport?’ (DYS-UK-002956), including: ‘Dysport extends time to retreatment in some patients’ and ‘Dysport offers sustained effect of treatment up to 24 weeks in some patients for upper and lower limb spasticity’.
Ipsen undertook to withdraw materials containing those claims (and similar 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 maintained a strategy differentiating Dysport on “sustained duration of effect”, citing reports from three named hospitals and an account (confirmed by a senior hospital pharmacist as accurately summarised) of a March 2019 meeting where Dysport was said to have a longer duration of effect and Xeomin was described as inferior.
Ipsen denied the alleged conversation, said the meeting was about pricing/commercial terms, and stated its current campaign used the claim ‘Dysport – A toxin with a long-lasting effect’ supported by SPC wording and data on file; briefing documents also warned: ‘no comparison should be made with other toxins as we do not have any prospective head to head studies’.
The Panel initially ruled no breach, citing limited evidence that representatives promoted longer duration versus other toxins.
Merz appealed. The Appeal Board focused on the ongoing headline claim ‘Dysport – A toxin with a long-lasting effect’, the lack of explanation/qualification in materials, absence of head-to-head evidence, and the pharmacist email exchange as evidence on the balance of probabilities.

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Outcome

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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 without head-to-head evidence.

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Key facts

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