AUTH/2674/11/13: Member of the public v GlaxoSmithKline (Benlysta) – clinical trial disclosure (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2674/11/13
Complainant	Anonymous, contactable member of the public
Company	GlaxoSmithKline
Product / topic	Benlysta (belimumab) – clinical trial disclosure
Source of allegation	ABPI-funded transparency study published in Current Medical Research & Opinion (11 Nov 2013) with product-level data via linked website
Allegation	Failure to disclose clinical trial results in line with the ABPI Code for licensed products
Applicable Code	Second 2012 Edition
Clauses considered	2, 9.1, 21.3
Panel finding	No breach
Key reasoning	The apparently undisclosed evaluable trial was ongoing; therefore results were not yet required to be published under Clause 21.3
Complaint received	18 November 2013 (site listing) / 21 November 2013 (report text)
Case completed	20 March 2014
Appeal	No appeal
Sanctions	None

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 study: “Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe” (Current Medical Research & Opinion, 11 Nov 2013), funded by the ABPI.
The study searched public sources (27 Dec 2012 to 31 Jan 2013) and assessed disclosure for new EMA-approved medicines (2009–2011). Product-level detail was available via a linked website.
The complainant alleged companies (including GlaxoSmithKline) had not disclosed clinical trial results for licensed products in line with the ABPI Code, alleging breaches of Clauses 2, 9 and 21 (considered as 2, 9.1 and 21.3 under the applicable Code).
For Benlysta (belimumab), the study suggested 1 evaluable GSK trial had not been disclosed (reported disclosure percentage 88%).
GSK responded that the apparently undisclosed evaluable trial was a Phase II extension study in the US, started by Human Genome Sciences in 2004 (acquired by GSK in 2012), and was ongoing with expected completion May 2016; results would be disclosed May 2017 (one year after completion).

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No breach of Clause 21.3 (Second 2012 Edition) because the trial was ongoing and there was not yet a requirement to publish results.
Consequently, no breach of Clauses 9.1 and 2.
No appeal.

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