Shire v Genzyme: advisory group slides and narrative ruled promotional, misleading and patient-safety relevant (AUTH/2721/7/14)

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Key facts

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Case number	AUTH/2721/7/14
Parties	Shire Pharmaceuticals Limited v Genzyme Therapeutics Ltd (now referenced as Sanofi Genzyme in later audit stages)
Meeting / activity	Materials for LSDEAG meeting (Lysosomal Storage Disorders Expert Advisory Group)
Date of meeting	26 February 2014
Medicines	Fabrazyme (agalsidase beta) and Replagal (agalsidase alfa)
Therapy area	Fabry disease (enzyme replacement therapy)
Core allegations upheld	Misleading “biosimilar” claims; dose/status messaging inconsistent with SPC; misleading cost comparisons; missing safety balance; disparaging/ambiguous US licensing statements; failure to certify; high standards/discredit
Complaint received	30 June 2014
Corrective statement issued	18 March 2015
Undertaking received	6 February 2015
Case completed	17 March 2016
Sanctions applied (per case page)	Undertaking received; Corrective statement; Audit of company’s procedures; Advertisement; Re-audit
Applicable Code year (case page)	2012

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

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Shire complained about Genzyme materials (a pre-circulated narrative and slide deck) used for a meeting of the Lysosomal Storage Disorders Expert Advisory Group (LSDEAG) on 26 February 2014.
The materials compared Fabrazyme (agalsidase beta) with Replagal (agalsidase alfa) for Fabry disease and included comparative cost messaging and a proposed switch rationale.
Genzyme argued the meeting/materials were exempt under Clause 1.2 (information to national public organisations) and were not promotional; the Panel/Appeal Board disagreed.
The pre-circulated slide deck (presentation 1) differed from the version shown on the day (presentation 2), including an amendment to Slide 4; the revised version was not circulated as a replacement and the change was not disclosed to the audience.
Key issues included use of the term “biosimilar” (likely to be taken in the regulatory sense), dose/status claims inconsistent with the Fabrazyme SPC (notably around 0.3mg/kg), cost comparisons implying equivalence of doses/status, missing safety context in switching/shortage data, and disparaging/ambiguous statements about US licensing/withdrawal.
Material was found to be promotional (linked to tender/procurement context) and therefore required certification, which had not occurred.

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Breach findings were made across multiple clauses, including Clause 2 (discredit), Clause 9.1 (high standards) and Clause 14.1 (certification).
The Appeal Board upheld the key findings that the material was promotional and that the Clause 1.2 exemption did not apply to LSDEAG/SCT in the circumstances.
The Appeal Board required a corrective statement to be sent to meeting attendees/recipients of the pre-circulated materials.
The Appeal Board required an audit of Genzyme’s procedures in relation to the Code, followed by re-audits.
Following audits and organisational changes, the Appeal Board ultimately decided no further action was required (on balance), though concerns remained about training materials that needed addressing.

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