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

健康——特别是国民保健制度——是欧盟全民公决的一个关键问题。最近的报道显示，许多人投票“离开”，因为他们承诺每周向NHS提供3.5亿英镑的额外资金。然而，认为脱欧决定将自动改善医疗保健和加强NHS的假设是非常有问题的。英国脱欧给立法者和政策制定者带来了巨大挑战。几十年来，欧盟法律一直影响着英国的卫生政策，并与各下放国家的卫生保健服务密切相关。在药品和医疗器械批准等不同领域产生重大的卫生政策和法律问题；无论是作为游客还是作为工作人员的患者的跨境治疗；公共卫生事项，例如食品安全、传染病控制和烟草管制；以及健康数据、临床研究、人体材料的质量和安全等事项。要分析脱欧后在这一领域的法律和政策立场，需要详细分析权力下放国家、英国和欧盟的法律目前相互作用的方式。例如，在药品监管等某些领域，欧盟法律提供了总体法律框架，我们需要探索如何取代这一框架。在其他领域，如对人体组织和器官的监管，欧盟法律在很大程度上仍然由国内法律原则主导的领域具有重要但广泛得多的影响，在这些领域，各个权力下放的司法管辖区有明显不同的方法——在《大废除法案》之后，现状会保持不变吗？在英国加入欧盟之前就已被欧盟法律涵盖的卫生政策和实践的变化将如何管理？需要建立什么样的机制来确保临床护理、监管监督和健康相关研究的标准得以维持，或者在理想情况下得到改善？本项目将解决4个主要研究问题。第一，目前四个地方分权国家、英国和欧盟的法律在卫生领域是如何相互作用的？第二，英国脱欧对英国国内卫生法有何影响？第三，如何管理英国退出欧盟后卫生政策和实践的变化，需要建立哪些机制？最后，这将对更广泛的国际卫生法律/协定产生什么影响？这些问题的回答将侧重于四个相互重叠的实质性领域：公共卫生、人员流动、研究、药品和医疗设备(a)公共卫生：这将侧重于传染病/非传染性疾病/烟草控制等领域对健康的系统性影响。(b)人员流动：这将包括审议对卫生和护理工作人员的影响、患者流动以及保健游客和工作人员治疗费用的报销。(c)研究：这将包括临床试验管理、数据保护和包括血液、组织和细胞在内的人体材料的使用管理。(d)药品和医疗器械：-这将涉及考虑取消现有的欧盟结构，以及在国内一级需要什么样的法律框架来取代它们。该项目主要涉及基于桌面的研究，并增加了对关键利益相关者的有限数量的定性半结构化访谈。这些方法将通过整个项目的传播和参与活动得到加强。这些将塑造正在进行的研究并促进影响。该项目包括3个展开的工作包（WPs），在下放的司法管辖区和广泛的英国层面上，逐步将3个时间要素（近期、中期、长期）的概念工作分层，每个都由项目团队的一名成员管理：McHale （PI）、Flear （Co-I）和Hervey （Co-I）。该团队将由一名全职博士后研究员支持

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