Ferring voluntary admission: uncertified symposium flyers sent to 436 UK delegates (AUTH/2586/3/13)

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Key facts

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Case number	AUTH/2586/3/13
Company	Ferring Pharmaceuticals Ltd
Issue	Two symposium invitation flyers for an overseas congress mistakenly mailed to UK delegates; materials deemed promotional and not certified
Audience / reach	436 UK registered delegates (EAU Congress)
Event	EAU Annual Congress, Milan, 17/18 March 2013
Products referenced/linked	Degarelix (Firmagon) mentioned; nocturia content linked to Desmospray (desmopressin) UK indication
Complaint received	11 March 2013
Case completed	25 April 2013
Applicable Code year	2012
Breach findings	Clause 14.1 (x2)
No breach findings	Clause 3.2
Sanctions	Undertaking received; Recovery of items
Appeal	No appeal

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

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Ferring Pharmaceuticals voluntarily admitted that two invitation flyers for Ferring-sponsored symposia at the European Association of Urology (EAU) Congress in Milan (17/18 March 2013) were sent in error to UK delegates.
The flyers were sent by Ferring’s global corporate office (Geneva) on 5 March 2013 without UK approval, to a list that mistakenly included 436 UK registered delegates.
Ferring said some symposium sessions included data about indications and dose regimens not licensed in the UK, so the flyers were not intended for UK recipients; it attempted to stop/recall mailings where possible.
The PMCPA Panel treated the voluntary admission as a complaint and assessed the invitations under the ABPI Code (2012), noting UK companies are responsible for UK-scope activities by overseas colleagues.
The Panel considered distribution of invitations to UK delegates for an overseas meeting was within the scope of the Code and noted that meetings involving travel outside the UK must be certified in advance.
Flyer 1 (prostate cancer) referenced the GnRH antagonist degarelix (Firmagon) and comparative data vs LHRH agonists; the Panel considered it promotional.
Flyer 2 (nocturia) did not name a product but discussed nocturia in a way the Panel considered closely linked to the UK indication for Desmospray (desmopressin); the Panel considered it promotional in this regard.

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No breach of Clause 3.2 (the invitations did not promote products inconsistently with their marketing authorisations, based on the admission being limited to the invitations).
Breach of Clause 14.1 (x2) because both promotional invitations were issued without the required certification.
The Panel made no decision on the actual meetings because the voluntary admission related only to the invitations.

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