Abstract
As legislators and policy makers grapple with the challenges arising from the decision in the June 2016 Referendum to leave the EU, this special edition of Medical Law International provides the first collection of legal academic papers to consider the implications of Brexit for UK Health law. The special edition begins with Tamara Hervey and Elizabeth Speakman’s framing paper, “The immediate futures of health law after Brexit: Law, ‘a-legality’, and uncertainty” which examines some of the key legal questions for the UK as a whole and the devolved administrations from the perspective of the limits of ‘legal centralism’. Hervey and Speakman suggest that the ways in which UK health law, policy and practice are currently determined by the UK’s membership of the EU, coupled with the short time frame within which the future EU-UK relationship must be determined, mean that law will be less of a determinant in immediate post-Brexit futures than it is at present. The paper argues that the uncertainties surrounding the Brexit process signify that in health policy and practice, we should expect a period of ‘a-legality’, where the legal position of actors does not necessarily determine or explain their actions. The uncertainties of Brexit and the conceptual implications flowing from this also feature in Graeme Laurie’s paper “How do We Make Sense of Chaos? Navigating Health Research Regulation through the Liminality of the Brexit Process”. Laurie examines Brexit using the anthropological lens of liminality, a concept which explains the impact of change and transformation on human experience. A central feature of liminality is its attention to process, namely, the identification of milestone thresholds within a series of events involving change. The pivotal role of law in the period up to 29th March 2018, one year before Exit Day, are seen as ‘liminal’ moments in European legal and human history. Liminality, Laurie argues, has a degree of predictive power regarding certain influencing factors on transformational processes and outcomes. He explores how liminality can be seen as particularly valuable as a means of better understanding Brexit with reference to its impact upon the regulation of human health research.
Leaving the EU will involve the UK no longer being part of or having direct impact on certain EU bodies, and not being able to directly influence the development of certain international norms and standards. Do these changes raise challenges and problems or could they lead to opportunities? Jonathan Montgomery, in his paper “Bioethics after Brexit: An opportunity to rationalize bioethics governance in the United Kingdom,” examines bioethics governance in Europe and in the UK. He discusses the relationship of UK bioethics with EU and Council of Europe institutions and the role of soft power. He explores strategies which may be utilised in the future by the UK which may mitigate the loss of influence which may result from Brexit. The practical problems of the UK no longer being in a position to be a “maker” of such standards and norms are explored by Mark Flear in his paper “Charting a roadmap towards membership and formal voice in global bioethics standard-setting: health research and the case of the International Council on Harmonisation”. Mark Flear considers the extent to which third countries, including the UK, can participate in the framing of norms and standards at a global level. He examines this question by using the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) technical guidelines relating to good clinical practice (GCP) for clinical trials as a case study. He explores the pathway to becoming a Regulatory Member of the ICH, and highlights the limitations of what, formally speaking, this offers the UK as a third country of the EU.
Many areas of UK domestic health law are affected, directly and indirectly, by EU law. The practical implications of this conscious decoupling are explored in the two final papers of the special edition. Emma Cave’s paper “The EU Clinical Trials Regulation 2014: Fetter or Facilitator” examines the impact of Brexit on clinical trials for medicinal products. This is an area in which domestic law has been underpinned to a great extent by EU law itself since the EU Clinical Trials Directive was implemented in 2004. A new EU Clinical Trials Regulation is due to come into force in 2019 accompanied by a major new EU clinical trials computer database which the UK will lose access to unless there is an agreement. Cave explores the implications of Brexit for the regulation of medicinal product trials in the UK, considering both the situation if the UK secures a Withdrawal Agreement or leaves without doing so. Finally, Jean McHale in her paper “Health Law, Brexit and Medical Devices: A Question of Legal Regulation and Patient Safety” explores how medical device regulation has been impacted by EU law and the challenges of the existing regulatory system. The paper discusses the ongoing reform of the existing EU Medical Devices Directives in the form of two new EU Medical Devices Regulations which are due to come into force in 2020 and 2022 respectively, and the challenges for regulatory alignment and for patient safety in the UK in the future.