AUTH/2672/11/13: Member of the public v Merck Sharp & Dohme (clinical trial disclosure – Brinavess, Sycrest, Victrelis) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2672/11/13
Parties	Anonymous contactable member of the public v Merck Sharp & Dohme
Issue	Clinical trial disclosure (Brinavess, Sycrest, Victrelis) – alleged non-disclosure/non-timely disclosure of results
Complaint received	18 November 2013 (site listing). The PDF text also references 21 November 2013.
Case completed	20 March 2014
Appeal	No appeal
Applicable Code year	2008
Clauses cited/alleged	Clauses 2, 9 (Panel considered 9.1) and 21 (Panel considered 21.3)
Decision	No breach of Clauses 2, 9.1 and 21.3
Products mentioned	Brinavess (vernakalant hydrochloride), Sycrest (asenapine), Victrelis (boceprevir) (Elonva also referenced in the company response but not part of the complaint)
Core rationale	Key studies were out of scope for MSD under the UK Code (no UK involvement and/or not MSD-sponsored), or disclosure was not required under the applicable Joint Position (exploratory trial), or disclosure appeared to have occurred within the relevant timeframe.

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

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An anonymous, contactable member of the public complained about alleged non-disclosure or non-timely disclosure of clinical trial results, based on an ABPI-funded transparency study published in Current Medical Research & Opinion (11 Nov 2013).
The study reviewed public sources (27 Dec 2012–31 Jan 2013) and reported disclosure rates for trials linked to new medicines approved by EMA in 2009–2011; product-level detail was available via a linked website.
The complainant alleged companies (including Merck Sharp & Dohme) had breached Clauses 2, 9 and 21 of the Code in relation to Brinavess (vernakalant), Sycrest (asenapine) and Victrelis (boceprevir).
MSD argued the assessment used “current” standards retrospectively; noted evolving Joint Positions and Code requirements; and raised jurisdiction/scope points (UK involvement, sponsor responsibility, and product transfers/mergers).
The Panel assessed whether each allegedly “missing/late” study was within the scope of the UK Code (eg, UK company involvement or UK sites) and whether disclosure obligations applied under the relevant Joint Position/Code timing.

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No breach of the Code was found.
For Brinavess, the “undisclosed” evaluable studies were sponsored by Cardiome (not MSD) and appeared outside the scope of the Code for MSD; one related to a non-licensed presentation.
For Sycrest, the Panel considered MSD responsible for Organon/Schering-Plough studies under the Code, but found: (a) a 2005 flavour-preference study could be exploratory and not required to be disclosed under Joint Position 2005; (b) several studies had no UK involvement and were out of scope; (c) the one study with UK sites (completed Dec 2007) appeared disclosed in Dec 2009, within the required timeframe (before Aug 2010).
For Victrelis, the study in question had no known UK involvement and was therefore out of scope of the UK Code; results were posted shortly after the study’s cut-off date.

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