Merz: employee delivered Bocouture from Northern Ireland to Republic of Ireland (unlicensed) after shipping error (AUTH/3264/10/19)

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Key facts

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Case	AUTH/3264/10/19
Parties	Anonymous v Merz
Product	Bocouture (botulinum toxin type A)
Issue type	Cross-border activity; delivery/supply into jurisdiction where product was not licensed; training/standards
Geography	Northern Ireland and Republic of Ireland
Complaint received	24 October 2019
Case completed	13 February 2020
Applicable Code year	2019
Clauses considered	Clauses 2, 3.1, 9.1, 15.2
Breaches found	Clause 9.1; Clause 15.2
No breach findings	Clause 2; Clause 3.1; and no breach for allegations about threatening/controlling communications and PV support withdrawal (not proven)
Sanctions	Undertaking received; additional sanctions not stated
Appeal	No appeal

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

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An anonymous complainant alleged unethical cross-border activity involving Bocouture (botulinum toxin type A) between Northern Ireland (licensed) and the Republic of Ireland (not licensed).
A UK-registered health professional (working in both jurisdictions) ordered Bocouture for delivery to a Northern Ireland clinic, but (per Merz’s deviation report) intended to use it to treat patients in the Republic of Ireland where it was unlicensed.
Following a shipping error (Xeomin shipped instead of Bocouture) and an urgent request, a Merz employee collected Bocouture from a Northern Ireland warehouse and personally delivered it to the health professional at a clinic in the Republic of Ireland.
The complainant also alleged Merz staff used controlling/threatening communications to steer purchasing via preferred wholesalers and suggested clinics would not receive support for product concerns/adverse event queries if product was not bought via preferred partners.
Merz raised a deviation/CAPA and ran multiple training/briefing sessions (May, July, September, and an annual GDP update in October) covering licensing status, GDP/ABPI considerations, and referral of Republic of Ireland Bocouture queries to medical information.

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No breach of Clause 3.1: the complainant did not provide evidence that Bocouture was promoted contrary to the Code (promotion prior to a licence) and Merz stated it was not promoted in the Republic of Ireland.
Breach of Clause 15.2: personally delivering Bocouture to the Republic of Ireland where it was not licensed was ruled to be a failure to maintain a high standard of ethical conduct for representatives.
Breach of Clause 9.1: Merz failed to maintain high standards by not providing important training earlier, given the cross-border working context.
No breach of Clause 15.2 regarding the alleged controlling/threatening communications (not proven on the balance of probabilities).
No breach of Clause 9.1 regarding alleged withdrawal of support for product concerns/adverse event queries (not proven; Panel noted wording could have been clearer).
No breach of Clause 2: Panel did not consider the circumstances warranted a Clause 2 finding.

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