These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004. Regulation 2 amends Schedule 1 to creates an exception to the general rule that an incapacitated adults cannot be included in a clinical trial unless the conditions in paragraphs 1 to 5 of Part 5 of Schedule 1 have been met; in particular that the adult’s legal representative (as defined) has given informed consent. The exception applies only when the following conditions are met: (i) treatment is required urgently; (ii) the nature of the trial also requires urgent action; (iii) it is not reasonably practicable to meet the conditions in paragraphs 1 to 5 of Part 5 (obtaining consent etc); and (iv) an ethics committee has given approval to the procedure under which the action is taken.
This article critically evaluates the Medicines and Healthcare products Regulatory Agency’s announcement, in March 2008, that GlaxoSmithKline would not face prosecution for deliberately withholding trial data, which revealed not only that Seroxat was ineffective at treating childhood depression but also that it increased the risk of suicidal behaviour in this patient group. The decision not to prosecute followed a four and a half year investigation and was taken on the grounds that the law at the relevant time was insufficiently clear. This article assesses the existence of significant gaps in the duty of candour which had been assumed to exist between drugs companies and the regulator, and reflects upon what this episode tells us about the robustness, or otherwise, of the UK’s regulation of medicines.