Health Economics, Policy and Law
Volume 12 – Issue 4 – October 2017
SPECIAL ISSUE: Healthcare and Health Innovation in Europe: Regulating for public benefit or for commercial profit?
Innovation, informed consent, health research and the Supreme Court: Montgomery v Lanarkshire – a brave new world?
Jean V. Mchale
Published online: 27 April 2017, pp. 435-452
The Supreme Court decision in Montgomery v Lanarkshire ( UKSC11) has been hailed as a landmark not least because the Court enshrines the doctrine of informed consent formally into English law for the first time in relation to medical treatment. This paper explores the decision in Montgomery. It examines what its implications may be in the future for the consent process in relation to health research and innovative treatment and whether it may prove a watershed moment leading to changing dialogues and expectations in relation to consent. First, the paper explores the concept of ‘informed consent’ in clinical research as seen through international, Council of Europe and EU instruments. Second, it considers how English law currently governs the provision of information to research participants in the context of clinical research. It questions whether such an approach will be sustainable in the future. Third, it discusses the decision of the UK Supreme Court in Montgomery v Lanarkshire and asks what might be the impact of this Supreme Court decision in the health research context. It asks whether Montgomery may result in new approaches to consent in health research and innovative treatment.