Falling between the gaps post the declaration of Helsinki: innovative medical treatment in England - the case for comprehensive legal regulation

This article explores and contrasts the current legal regulation of innovative treatment and health research in England. First, it explores what actually constitutes ‘innovative’ treatment and considers the piecemeal regulatory structures which exist in relation to innovative treatment in England. Secondly, it contrasts this with the current regulation of clinical research post-Nuremberg and the Declaration of Helsinki. Thirdly, it explores the impact of the Access to Medical Treatments (Innovation) Act 2016 and what this might mean for future regulation in this area. Fourthly, the paper suggests that it is time for a radical reconsideration of new ‘innovative’ or ‘experimental’ procedures and explores alternative approaches which could be utilised. It concludes by arguing that the regulation of innovative treatment in England is currently inadequate and provides insufficient safeguards for patients and that legislative reform is required.