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PMCPA Case

Servier: delayed clinical trial results disclosure for Valdoxan (AUTH/2671/11/13)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2671/11/13
ComplainantAnonymous, contactable member of the public
CompanyServier
ProductValdoxan (agomelatine)
IssueClinical trial results disclosure (timeliness and completeness for UK-involved studies)
Complaint received21 November 2013
Case completed11 April 2014
AppealNo appeal
Applicable Code year(s) referenced in rulings2008 Code and 2011 Code (depending on study timing)
Breach clausesClause 21.3 (x3); Clause 9.1 (x2); Clause 2
No breach clausesClause 2, 9.1 and 21.3 (in relation to certain studies/scenarios, including Study 29 and out-of-scope/exempt studies)
SanctionsUndertaking received; Advertisement
Notable study-level findingsStudies 25 & 26 disclosed late; Studies 30 & 31 not disclosed at time of ruling; Study 29 no breach (different formulation; encouragement only under Joint Position 2008)
Post-consideration noteServier later stated first approval/commercial availability was Ukraine (Feb 2007); March 2009 related to EU. Servier did not appeal Panel’s breaches for Study 25.

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

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What happened

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  • An anonymous, contactable member of the public complained about clinical trial disclosure performance reported in an ABPI-funded paper in Current Medical Research & Opinion (published 11 Nov 2013) and linked product-level data for Valdoxan (agomelatine).
  • The ABPI study assessed whether company-sponsored trial results were disclosed within a defined timeframe (searched 27 Dec 2012 to 31 Jan 2013) for new medicines approved by EMA in 2009–2011; product-level detail was available via a website link (not in the journal article itself).
  • For Valdoxan, the study reported 32 “evaluable” trials, with 20 disclosed in timeframe (63%), and 29 disclosed by 31 Jan 2013 for trials completed by end Jan 2012 (83%).
  • The Panel focused only on studies with UK involvement (UK patients and/or UK company involvement).
  • Servier accepted at most a “technical” breach of Clause 21.3 and argued the broader transparency context and its cooperation with ABPI should mean the matter was closed without condemnation or sanctions.
  • The Panel assessed whether results were disclosed and whether disclosure was timely under the applicable Code editions and relevant Joint Positions.
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Outcome

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  • Breach of Clause 21.3 (2008 Code) for late disclosure of Study 25 (completed Sep 2008) and Study 26 (completed Apr 2009).
  • Breach of Clause 9.1 (2008 Code) for the delay in disclosure of Studies 25 and 26 (high standards not maintained).
  • No breach of Clause 2 (2008 Code) in relation to Studies 25 and 26 because results had been disclosed by the time of the ruling (on balance).
  • Breach of Clause 21.3 (2011 Code) for Study 30 (completed Aug 2011) where results were still not disclosed within 12 months of completion.
  • Breach of Clause 21.3 (2008 Code) for Study 31 (completed Dec 2008) where results were still not disclosed within one year after first approval (as assessed by the Panel).
  • No breach of Clause 21.3 (2011 Code) for Study 29 (completed Sep 2011; different formulation) because the Joint Position 2008 only encouraged posting results for investigational products that failed in development if of significant medical importance, and the Panel could not conclude the criteria were met.
  • Breach of Clause 9.1 for continued non-disclosure of Studies 30 and 31 despite Servier knowing from the ABPI/CMRO publication that data were missing and having ~9.5 months before the complaint was received.
  • Breach of Clause 2 for failure to disclose Studies 30 and 31 (brought discredit upon and reduced confidence in the industry).
  • No breach findings were also made where studies could not be identified and/or were out of UK Code scope (no UK involvement) or exempt (completed before 5 Jan 2005).
  • No appeal.
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