AUTH/2662/11/13: Novartis breach for delayed clinical trial results disclosure (Ilaris); no breach for Gilenya legacy trial

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Key facts

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Case number	AUTH/2662/11/13
Complainant	Anonymous, contactable member of the public
Company	Novartis
Issue	Clinical trial disclosure (Ilaris and Gilenya)
Source referenced in complaint	“Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (CMRO, 11 Nov 2013)
Complaint received	18 November 2013
Case completed	24 March 2014
Applicable Code year	2012
Medicines	Ilaris (canakinumab); Gilenya (fingolimod)
Breach clauses	Clause(s) 9.1 and 21.3
No breach clauses	Clause(s) 2, 9.1 and 21.3
Sanction	Undertaking received
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 a published transparency assessment (“Clinical Trial Transparency…”) in Current Medical Research & Opinion (11 Nov 2013), supported by ABPI funding.
The assessment reviewed public sources (27 Dec 2012–31 Jan 2013) and presented disclosure timeliness metrics for medicines including Ilaris (canakinumab) and Gilenya (fingolimod).
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (PMCPA also drew attention to Clauses 1.8 and 21.3 of the Second 2012 Edition).
For Ilaris, the publication suggested 3 evaluable trials were not disclosed within the timeframe (91% disclosed in timeframe; 100% disclosed by 31 Jan 2013 for trials completed by end Jan 2012).
PMCPA assessed the specific evaluable trials covered by the publication (not broader disclosure beyond the publication’s dataset).
One Ilaris trial had no UK involvement and was ruled out of scope of the UK Code.
One Ilaris trial completed 23 Oct 2009 had results posted much later (submitted 30 Aug 2012; posted Dec 2012), which Novartis acknowledged as delayed.
For Gilenya, one evaluable trial was flagged as not disclosed in timeframe, but it had completed in 2004 (pre-Jan 2005) and was assessed against the applicable Joint Position requirements.

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Breach found: Clause 21.3 and Clause 9.1 (for one Ilaris trial with delayed disclosure).
No breach: Clause 2 (Panel considered results had been disclosed, so no discredit in this instance).
No breach: For the other Ilaris trial assessed as within timeframe, and for the Gilenya 2004-completed trial (not required to be disclosed under the applicable Joint Position 2005).
No appeal.

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