Move to boost clinical trials payouts

Volunteers harmed by the testing of new medicines will be eligible for greater compensation under guidelines introduced more than six years after the "elephant man" trial that threatened the lives of six men.

Revised rules issued by the pharmaceutical industry call for joint insurance protection of at least £5m for participants suffering ill effects during a "first in man" clinical trial. However, a leading personal injury lawyer said this was still inadequate.

The guidance, issued by the Association of the British Pharmaceutical Industry and the BioIndustry Association, the leading trade bodies, and the Clinical Contract Research Organisation, the research company, also says individuals should have up to three years to notify insurers of potential claims.

The advice goes some way to addressing the problems raised during the testing of the experimental drug TGN1412 by TeGenero, a German biotech company, at Northwick Park hospital in London in 2006, which left the six participants seriously ill.

While the men recovered following intensive hospital care, their advisers struggled to get what they argued was adequate compensation because TeGenero went into insolvency and its insurance cover was just £2m. Parexel, which conducted the trial for the company, said it acted completely within regulatory, medical and clinical research guidelines.

The six also could not receive compensation for 18 months while doctors monitored their condition, because 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.

Gene Matthews, a partner with Leigh Day, the London law firm that acted for four of the TeGenero participants, said the guidance was an improvement. But he 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.

"Healthy volunteers, who through no fault of their own have suffered the most serious injuries, deserve to be compensated quickly and appropriately," he said.

The participants in the TeGenero trial ultimately received several million pounds in compensation, said Mr Matthews. This included the full £2m insurance cover provided in the policy bought by TeGenero, and further funds from the insurer to Parexel, which took a $1.8m charge.

The new guidance argues that there is little legal protection for healthy volunteers because they are required to give their consent to participate in trials "on the boundaries of scientific knowledge".

But it says the pharmaceutical industry has long proposed such compensation in good faith, and the current interpretation of European law means that both medicines regulators and ethics committees approving clinical trials should ensure there is adequate insurance in place.

TeGenero was not a member of the UK trade bodies, but it and Parexel were criticised for the conduct of the trials, including for giving doses of TGN1412 almost simultaneously to all the participants.

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