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ABPI-backed study causes Servier Code of Practice breach

Company failed to disclose study results in suitable time

ABPI Code of Practice 

Servier has been 'named and shamed' in the medical press for breaching the Association of the British Pharmaceutical Industry's (ABPI) Code of the Practice after it failed to disclose several clinical study results in a suitable timeframe.

The ruling was inadvertently caused by the ABPI itself after a study backed by the Association became the source of a complaint to Code administrator the Prescription Medicines Code of Practice Authority (PMCPA).

Clinical Trial Transparency: an assessment of the disclosure results of company-sponsored trials associated with new medicines approved recently in Europe was co-authored by Dr Bina Rawal, director of research, medical and innovation at the ABPI, and pharma consultant Bryan Deane.

Published in Current Medical Research & Opinion in November 2013, it surveyed various publicly available information sources for clinical trial registration and disclosure of results searched from December 27, 2012 to January 31, 2013, covering 53 medicines.

On reading the journal article an anonymous member of the public complained to the PMCPA, saying that some companies mentioned in the report had not disclosed clinical trial results in line with the ABPI's Code of Practice.

One of these was Servier for clinical trials involving its antidepressant Valdoxan (agomelatine) – two of which were published later than they should have been.

The results of a further three studies, which involved UK patients (and therefore fell within the PMCPA's remit) were completed in September 2011, August 2011 and December 2008 but had still not been disclosed by November 2013

The PMCPA said Servier's failure to disclose the information meant Servier “had brought discredit upon, and reduced confidence in, the pharmaceutical industry”, and a breach of clause 2 of the Code was ruled.

Servier didn't appeal and was the subject of PMCPA advertisements in several medical journals about the case.

Commenting on the matter, a Servier spokesperson said: "Servier Laboratories Ltd is committed to transparency and worked openly and collaboratively with the ABPI on a study designed to support clinical trial disclosure. The current ABPI Code and the ruling sets out important principles that Servier agrees should be adhered to, and, raised issues of infrastructure and co-ordination that Servier appreciates must be addressed. As a result of the rapidly changing legal and self-regulatory environment Servier was already in the process of updating its internal procedures and the issue has been rectified."

Article by
Thomas Meek

8th September 2014

From: Regulatory



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