Clinical trials and the law

The serious condition of six men in Northwick Park Hospital highlights the legal issues surrounding drug trials. Compensation in clinical trials is governed by the EU Clinical Trials Directive brought into force by the Medicine for Human Use (Clinical Trials) Regulations 2004.

If an indemnity cannot be agreed then the claim will be in negligence under the Consumer Protection Act 1987.

Those injured will need their clinical negligence solicitors to investigate the results of the animal trials, the supervision of the trial and whether or not the drug was in fact defective.

Clinical negligence claims solicitor, Paul McNeil said: "The patients may well have signed a document enabling a no-fault compensation scheme to be invoked, in case of a medical accident. Moreover, if negligence or product defect is accepted by the manufacturer at an early stage this may provide some compensation. If not, the families could face a lengthy legal battle."

Please see the MHRA and Parexel websites for further information.

You can find out more information about clinical negligence claims, please visit our clinical negligence section.