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European Pharmaceutical Contractor
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Managing a pharmaceutical or device company is hazardous enough but things keep getting riskier! In this article, we discuss risks your business faces both externally with the potential impact of the new Clinical Trials Directive and internally in terms of your facilities.
Increased litigation is something UK society is beginning to accept as the norm in many areas, but it appears to be especially true of general health issues - just ask any NHS Manager. Although they are kept from the courts by the use of alternative dispute resolution agreements, allegations arising from injury from clinical trials are increasing. A newspaper headline: "pill trial man to sue over illness" (Scottish Mail on Sunday, 15th June 2003), is evidence of this. The story ran as follows:
"A volunteer in trials of the male pill plans to sue the makers, claiming the contraceptive left him with a life threatening illness. The man, 44 years old and a father of two, suffers from fibrosis and has lost nearly half the power of his lungs. He claims he has medical evidence to link his illness with the experiments that involved the use of female hormone implants. The man claims the sponsor failed to tell him of the possible health risks before he took part in the trials nearly two years ago. He said, 'If doctors can't halt the fibrosis in my lungs, I'm a dead man. I wish I had never volunteered for the trials' ".
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