AUTH/2803/11/15: Complainant v Alexion — conference programme booklet alleged to promote an unlicensed medicine (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2803/11/15
Parties	Complainant v Alexion
Material	Conference programme booklet (sponsor/exhibitor entry)
Event	British Society for Paediatric Endocrinology and Diabetes (BSPED) meeting, Sheffield, 25–27 November 2015
Allegation	Promotion of an unlicensed medicine
Medicines mentioned	Strensiq (asfotase alfa), Kanuma (sebelipase alfa), Soliris (eculizumab)
Key disputed wording	“development of two late-stage therapies” (Strensiq and Kanuma)
Authority request (clauses)	Clauses 2, 3.1, 3.2, 9.1
Applicable Code year	2015
Complaint received	26 November 2015
Case completed	28 January 2016
Outcome	No breach
Appeal	No appeal

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

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A contactable complainant (anonymous) alleged Alexion Pharma UK’s entry in the programme booklet for the British Society for Paediatric Endocrinology and Diabetes (BSPED) meeting (Sheffield, 25–27 Nov 2015) promoted an unlicensed medicine.
The complainant highlighted wording stating Alexion was developing “two late-stage therapies, Strensiq (asfotase alfa) for hypophosphatasia (HPP) and Kanuma (sebelipase alfa) for Lysosomal Acid Lipase Deficiency (LAL-d)”.
Alexion said its stand materials were educational/disease awareness and that the booklet text was a corporate statement describing global development status.
Alexion stated Strensiq and Kanuma received UK marketing authorisations on 28 Aug 2015 (before the Nov 2015 meeting) and provided links/evidence including SPCs and approved materials.
The Panel noted the booklet also referenced Soliris (eculizumab), Strensiq and Kanuma and their indications, and stated Alexion was evaluating potential indications for Soliris in additional severe and rare disorders.

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No breach of the Code was found.
No breach of Clause 3.1 (the Panel accepted there was no pre-licence promotion because UK marketing authorisations were in place).
No breach of Clause 3.2 (the Panel considered the complainant had not alleged a breach of this clause).
No breach of Clauses 9.1 and 2.
However, the Panel expressed concern that the entry might go beyond a corporate piece and could be seen as promotional copy that would then need to meet promotional requirements (eg prescribing information, avoiding exaggerated claims). The Panel requested Alexion be advised of these concerns.

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