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Clinical trials lawyer welcomes new guidance from regulators

Insurance and compensation guidelines tightened for clinical trial volunteers

Photo of woman taking pills: istock

20 July 2012

Gene Matthews, partner in the product liability team at Leigh Day, has welcomed new guidelines produced by the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) who have jointly published new guidance on insurance and compensation for Phase I clinical trials. Gene, who acted for a number of the men who were left seriously ill after a trial of the experimental drug by TeGenero, a German biotech company, at Northwick Park hospital in London in 2006, is pleased to note that volunteers who suffer personal injury during or after a clinical trial will now be eligible for greater compensation but has described as “laughable” the idea that £5m would provide adequate insurance cover even for a single healthy person who had been severely injured, let alone a group of volunteers.

TeGenero went into insolvency soon after the disastrous drug trial and had insurance cover of only £2m, leaving the volunteers struggling to obtain adequate compensation for their injuries. They were further restricted as the insurance policy only allowed a single “once and for all” payment without allowance for the risk they would develop illnesses long after the initial drug injections. TeGenero was not a member of the UK trade bodies, but it and Parexel, which conducted the trial, were criticised for the conduct of the trials, including for giving doses of TGN1412 almost simultaneously to all the participants.              

The new guidance says individuals should have up to three years to notify insurers of potential claims.

Gene said:

“The compensation paid to the volunteers who participated in the infamous TGN1412 drug at Northwick Park Hospital trial back in 2006 ran into millions of pounds due to the significant injuries they suffered.  The idea that £ 5 million would provide adequate insurance cover for one, let alone a group, of severely injured healthy volunteers who have participated in a first- in- man drug trial is laughable (although some minimum level of insurance is an improvement on the current position).  Healthy volunteers, who through no fault of their own, have suffered the most serious injuries deserve to be compensated quickly and appropriately.”

If you have been left seriously ill, or injured following your participation in a clinical trial please contact Gene Matthews for a free initial consultation on 020 7650 1200.

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