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International Clinical Trials

Being Pharmacovigilant

On 6th March 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) published its report into GSK’s alleged failure to report certain adverse event data from clinical trials in children of its anti-depressant, Seroxat (paroxetine), to the MHRA in a timely manner. Certain data from those trials – a pooled analysis from all paediatric trials of Seroxat – suggested a causal association between the anti-depressant and an increased risk of suicidal behaviour.

The MHRA’s report concluded that there was insufficient evidence to provide a realistic prospect of a criminal conviction for the alleged breach of pharmacovigilance legislation by GSK, and that there was, at the time of the alleged offences, a “significant gap in the law governing drug safety”. This article examines the MHRA report and its findings, as well as the MHRA’s recommendations for changes in the law on drug safety.

GSK CLINICAL TRIALS AND THE REGULATORY BACKGROUND

According to the MHRA report, between April 1994 and January 2002, GSK carried out nine clinical trials on the use of Seroxat in children and adolescents, a patient population for

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Tim Worden is an Associate in the Intellectual Property (IP) Department at Taylor Wessing. He has experience in both non-contentious and contentious intellectual property and works mostly in the life sciences and healthcare sectors. Tim has advised on a range of IP agreements, regulatory issues in the pharmaceutical industry, IP and IT issues arising out of mergers and acquisitions, venture capital investments and IPOs, patent and trade mark disputes, and data protection and privacy. Tim was previously Legal Counsel and Company Secretary at Eli Lilly and Company Limited. He has a degree in Natural Sciences (Chemistry and Biochemistry) from Cambridge University and a Diploma in Intellectual Property Law and Practice from Bristol University.
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