Anonymous v Pharmacosmos (AUTH/2694/1/14): Monofer website pop-up allowed public to see promotional claims; company later refused PMCPA jurisdiction

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Key facts

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Case	AUTH/2694/1/14
Parties	Anonymous v Pharmacosmos
Product	Monofer (iron (III) isomaltoside 1000)
Channel	Linked websites (pharmacosmos.co.uk and monofer.com)
Core issue	Public visibility of promotional claims via pop-up/overlay; use of “new” for established product/technology
Applicable Code year	2014
Complaint received	16 January 2014
Completed	04 August 2014
Breach clauses	Clause(s) 7.11, 9.1, 23.1 and 23.2
No breach clauses	Clause(s) 2, 4.11, 7.2 and 9.1 (in relation to the SPC allegation)
Undertaking	No undertaking received
Additional outcome	Removed from the list of non member companies covered by the Code; MHRA and ABPI Board informed
Appeal	No appeal (Report from the PMCPA to the Appeal Board)

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

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An anonymous, contactable complainant challenged Monofer (iron (III) isomaltoside 1000) content across two linked sites: the UK corporate site (pharmacosmos.co.uk) and the product site (monofer.com).
On the UK corporate site, the additional monitoring triangle was shown in dark blue rather than black.
The UK site linked to monofer.com, described as an “international” site, but the SPC page referenced UK-specific elements (eg NHS cost in £ sterling and MHRA Yellow Card link), bringing it within the UK Code’s scope.
On entering monofer.com, a pop-up asked users to choose health professional vs public, but the health professional page was visible behind it; the Panel considered the claim “High dose iron in just one visit” readable to the public.
The complainant alleged the SPC on the website was out of date (with potential monitoring/contraindication implications), and that the site described the iron matrix technology as “new” despite Monofer being available for several years.
Before being advised of the Panel’s rulings, Pharmacosmos indicated it no longer wished to accept PMCPA jurisdiction and did not provide the required undertaking and assurance.

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No breach of Clause 4.11 (the UK corporate site was not proven to be promotional material; the Code requirement for the black triangle applied to promotional material).
Breach of Clauses 23.1 and 23.2 (the pop-up plus visible background claims amounted to promotion of a prescription only medicine to the public).
Breach of Clause 9.1 (high standards not maintained in relation to the public visibility of promotional claims).
No breach of Clause 7.2 (complainant did not establish the SPC on the website was out of date).
No breach of Clause 2 (no breach found in relation to the SPC allegation).
Breach of Clause 7.11 (use of the word “new” for technology/product available for several years; acknowledged by the company and removed).
Procedural escalation: no undertaking received; Appeal Board removed Pharmacosmos from the list of non-member companies covered by the Code and informed MHRA and ABPI Board of Management.

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