Health Law Outside the EU: Immediate, Intermediate and Long Term Impacts

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 currently 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

The project will be managed to actively engage with, maintain, and develop contact with user communities from the outset, throughout its lifespan, and beyond. This is to ensure we maximis and continue to gauge the impact of the research long after its conclusion. The impact strategy will be built on the Investigators' wide-ranging expertise and established networks in this area. We will seek to create impact within the following communities in particular: (1) policy/legislative communities; (2) health professionals; (3) non-governmental organisations (NGOs); (4) wider publics and (5) scholars

Policy/Legislative Communities: In WP1, an 'upstream' scoping seminar will be held at the University of Birmingham Brussels office. This will involve early engagement of existing and new contacts at the EU level, including health-related NGOs in order to consider how the project sits within and can contribute to UK health policy. The seminar will flag the research to users and provide the basis for generating impact through early mutual learning, allowing aspects of the project-in-progress to be configured to best meet attendees' needs (who will be among those optimally placed to action and disseminate the project results). Interviews with regulators in WP3 will enable further refinement of impact-generation through engagement with these key stakeholders. Policy briefs will be distributed to policymakers engaged through the project, including e.g. to leaders in the Department of Health, Public Health England, Members of the House of Commons Health Select Committee etc. The Advisory Group includes individuals with high-level policy contacts, and relationships with these policy actors will be carefully nurtured during the course of the project (with a view to helping to contour policy conversations and potentially shaping specific changes). Maintaining contact with the regulators and regulatory challengers after the project will also provide a means of determining and measuring impact, such as if and how their approaches, policies, or strategies have changed as a result of the research.

Health Professionals: Our Advisory Group includes an internationally eminent public health scholars (McKee) who are extremely well-networked in academic, healthcare, and policy communities who will guide engagements with health professional organisations.

NGOs: Impact with NGOs will be initially facilitated by the Brussels seminar (WP1), as noted above. Our Steering Group and interviews with NGOs (WP2) will further develop our engagements and relationships, as will the wider public engagement activities (see next).

Public: We will actively seek opportunities to contribute to media and public debates about Brexit and healthcare e.g. via op-eds in Guardian Comment is Free. We intend to create impact by seeking opportunities to present our research in accessible ways at community group meetings and other forums. The PI and Co-I's all have extensive experience at communicating research to diverse audiences.

Scholars: High quality publications will be produced for journals within which the Investigators have experience in publishing (e.g. Medical Law International Medical Law Review, Journal of Medical Ethics and Science, Technology & Human Values etc.), and the results will also be disseminated through relevant (inter)national conferences and institutional newsletters,.

All the above stakeholders will be reached through other online means; e.g. research findings will be communicated via a project website linked to the websites of Birmingham, Sheffield and QUB Law Schools and via Twitter.