Title: Health Law Outside the EU: Immediate, Intermediate and Long Term Impacts
Funder: Economic and Social Research Council

Abstract: Health - in particular the NHS - was a key issue in the European Union (EU) referendum. Recent reports show many voted 'leave' on the promise of an extra £350 million a week being given to the NHS. However, the assumption that the decision to leave will automatically improve healthcare and enhance the NHS is highly problematic. Brexit brings huge challenges for legislators and policymakers. EU law has affected health policy in the United Kingdom (UK) for decades and is entwined in the delivery of healthcare across the devolved nations. Significant health policy and law questions arise in regard to such diverse areas as drug and medical devices approval; cross border treatment of patients whether as tourists or workers; public health matters, e.g. food safety, communicable disease control and tobacco regulation; and matters such as health data, clinical research, and quality and safety of human materials. Unpicking what the post-Brexit legal and policy position in this area should be requires detailed analysis of the manner in which the laws of the devolved nations, UK and EU currently interact. For example, in some areas such as pharmaceutical regulation EU law provides the overarching legal framework and we will need to explore how this will be replaced. In other areas, such as the regulation of human tissue and organs, EU law has an important but much less extensive impact in an area still largely dominated by domestic legal principles where there are distinctly different approaches across devolved jurisdictions- will the status quo remain post the Great RepeaL Bill? How will changes to health policy and practice, covered by EU law since before the UK joined, be managed? What mechanisms need to be put in place to ensure that standards of clinical care, regulatory oversight and health-related research are maintained, or ideally improved? This project will address 4 main research question. First, how do the laws of the four devolved nations, UK and EU curently interact in the field of health? Secondly, what will the impact be upon domestic health law in the UK when the UK leaves the EU? Thirdly, how will changes to health policy and practice upon UK withdrawal from the EU be managed and what mechanisms will need to be put in place? Finally, what will be the impact on broader international law/agreements on health? These questions will be answered by focusing on four overlapping substantive areas: public health, mobility, research, pharmaceuticals and medical devices (a) Public Health: this will focus on systemic impacts on health in areas including communicable/non-communicable diseases/ tobacco control etc. (b) Mobility: this will include consideration of the impact on the health and care workforce, patient mobility and reimbursement of treatment costs both for health tourists and workers. (c) Research: this will include clinical trials regulation, data protection and regulation of use of human material including blood, tissue and cells. (d) Pharmaceuticals and Medical Devices:- this will involve consideration of the removal of existing EU structures and what legal frameworks will be needed at domestic level to replace them. The project involves primarily desk-based research, with the addition of a limited number of qualitative semi-structured interviews of key stakeholders. These methods will be augmented through dissemination and engagement events placed throughout the project. These will shape the research-in-progress and facilitate impact. The project comprises 3 unfolding Work Packages (WPs), which gradually layer the conceptual work for the 3 temporal elements (immediate; intermediate; long-term) at the devolved jurisdictional levels and at the broad UK level, with each being managed by a member of the project team: McHale (PI), Flear (Co-I) and Hervey (Co-I). The team will be supported by a full-time project-length post-doctoral Research Fellow


Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: GENERIC HEALTH RELEVANCE