AUTH/3723/1/23: Complainant v Lundbeck — market research alleged to be disguised promotion (No breach)

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Key facts

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Case number	AUTH/3723/1/23
Parties	Complainant v Lundbeck
Issue	Allegations about market research (alleged disguised promotion; alleged clinical-record style data capture)
Medicine referenced	Abilify Maintena (aripiprazole LAI)
Activity type	Awareness, Trial and Usage (ATU) tracking market research (online questionnaire)
Time period of MR waves considered	Annually 2018–2021 (waves 1–4)
Complaint received	9 December 2022
Case completed	4 April 2024
Applicable Code year (per PMCPA page)	2021
Clauses considered	Clause 9.1 (2016); Clause 12.2 (2016); Clause 9.1 (2019) (x2); Clause 12.2 (2019) (x2); Clause 5.1 (2021); Clause 25.4 (2021)
Decision	No breach of the Code
Appeal	No appeal
Sanctions	None
Related case	Otsuka Europe Ltd proceeded under Case AUTH/3722/1/23

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

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An anonymous, contactable complainant alleged that annual, repeated market research (2018–2021) commissioned by Lundbeck A/S (Global) and Otsuka Europe Ltd had a promotional purpose.
The research related to Abilify Maintena (aripiprazole LAI), which Lundbeck co-promoted with Otsuka (the marketing authorisation holder).
Allegations focused on (a) repeated mention of the brand name “Abilify Maintena” and (b) questions that appeared to require HCPs to transcribe patient clinical record data (suggesting a clinical study rather than market research).
Lundbeck stated the activity was an Awareness, Trial and Usage (ATU) tracking project to understand awareness/usage across the schizophrenia therapy area, drivers of prescribing, and patient profiles considered suitable for LAI antipsychotics, repeated in waves to track change over time (including COVID-19 impacts).
The market research was an online questionnaire; UK participants were recruited by a third-party agency via panel matching, target lists, and randomised panel recruitment; participants were anonymous to the companies.
The Panel reviewed the questionnaires and noted brand mentions were alongside other products and lists were scripted to be randomised; patient-identifiable information was explicitly prohibited and the questionnaire required anonymised information only.

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Clause 9.1 (2016 Code) — Requirement that high standards must be maintained at all times
Clause 12.2 (2016 Code) — Requirement that market research activities must not be disguised promotion
Clause 9.1 (2019 Code) (x2) — Requirement that high standards must be maintained at all times
Clause 12.2 (2019 Code) (x2) — Requirement that market research activities must not be disguised promotion
Clause 5.1 (2021 Code) — Requirement that high standards must be maintained at all times
Clause 25.4 (2021 Code) — Requirement that market research activities must not be disguised promotion

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