AUTH/2665/11/13: Genzyme (Sanofi) – clinical trial disclosure delays for Mozobil; no breach for Renvela (timing pre-Code)

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Key facts

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Case number	AUTH/2665/11/13
Complainant	Anonymous, contactable member of the public
Company	Genzyme (Sanofi)
Issue	Clinical trial disclosure (Mozobil and Renvela)
Trigger/source	ABPI-funded publication on clinical trial transparency (CMRO, 11 Nov 2013) using searches 27 Dec 2012–31 Jan 2013
Products	Mozobil (plerixafor); Renvela (sevelamer carbonate)
Complaint received	21 November 2013
Case completed	24 March 2014
Applicable Code year (case page)	2012
Key ruling – Renvela	No breach (product first approved 19 Oct 2007; relevant trials completed Jan/Mar 2007; disclosure requirement not in ABPI Code until 1 Nov 2008)
Key ruling – Mozobil	Breach Clause 21.3 (2008 Code) and Clause 9.1 for delayed disclosure of one UK-involved trial completed Nov 2010; results not disclosed by Nov 2011
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, contactable member of the public complained about clinical trial disclosure information referenced via an ABPI-funded study published in Current Medical Research & Opinion (11 Nov 2013).
The study (“Clinical Trial Transparency…”) benchmarked disclosure rates for company-sponsored trials linked to 53 new medicines approved by EMA (2009–2011), using public sources searched 27 Dec 2012 to 31 Jan 2013.
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code by listed companies, including Genzyme (now part of Sanofi).
The Panel assessed the specific products/trials covered by the study outputs for Mozobil (plerixafor) and Renvela (sevelamer carbonate), focusing on whether results were disclosed and the timing (not the content quality of disclosures).
Sanofi argued much activity was outside UK scope (registration/disclosure managed by non-UK teams), but provided details of the limited UK-involved studies.
Renvela: product first approved 19 Oct 2007; two non-disclosed trials with UK involvement completed Jan/Mar 2007 (before ABPI Code introduced a disclosure requirement on 1 Nov 2008).
Mozobil: product first approved and commercially available 28 Dec 2008; one trial had UK sites/investigators and completed 18 Nov 2010; results were not disclosed by Nov 2011 (deadline missed).

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Renvela: No breach of Clauses 9.1 and 2 of the 2006 Code (disclosure requirement not yet in the ABPI Code at the relevant time).
Mozobil: Breach of Clause 21.3 of the 2008 Code (failure to disclose trial results within the required timeframe).
Mozobil: Breach of Clause 9.1 (delay meant high standards had not been maintained).
Mozobil: No breach of Clause 2 (results had been disclosed by the time of the ruling; Panel considered Clause 2 covered by the other breach rulings in the circumstances).
For other Mozobil/Renvela studies in the publication with no UK involvement, the Panel ruled no breach as the matter did not come within the scope of the Code.

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