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

欧盟以外的卫生法：近期、中期和长期影响

基本信息

批准号：
ES/R002053/1
负责人：
Jean McHale
金额：
$ 27.56万
依托单位：
University of Birmingham
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2017
资助国家：
英国
起止时间：
2017 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=ES%2FR002053%2F1
关键词：
Health Law Outside EU Immediate

项目摘要

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

卫生-特别是国民保健制度-是欧洲联盟（欧盟）全民投票的一个关键问题。最近的报告显示，许多人投票“离开”承诺每周额外向NHS提供3.5亿英镑。然而，假设离开的决定将自动改善医疗保健和加强国民保健制度是非常有问题的。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，并在各权力下放国家的医疗保健服务中发挥着重要作用。在诸如药品和医疗器械的批准;病人（无论是游客还是工人）的跨境治疗;公共卫生事项，如食品安全、传染病控制和烟草管制;以及卫生数据、临床研究和人体材料的质量和安全等事项等不同领域，出现了重大的卫生政策和法律问题。要弄清英国脱欧后在这一领域的法律的和政策立场应该是什么，就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，在某些领域，如药品监管，欧盟法律提供了总体法律的框架，我们将需要探讨如何将其取代。在其他领域，如人体组织和器官的监管，欧盟法律在一个主要仍由国内法律的原则主导的领域具有重要但不那么广泛的影响，在这个领域，各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，现状会保持下去吗？自英国加入欧盟之前，欧盟法律就涵盖了卫生政策和实践的变化，将如何管理？需要建立什么机制来确保维持或最好是提高临床护理、监管监督和卫生相关研究的标准？该项目将解决四个主要研究问题。首先，四个权力下放国家、英国和欧盟的法律目前在卫生领域如何互动？第二，英国离开欧盟后，对英国国内卫生法会产生什么影响？第三，英国退出欧盟后，将如何管理卫生政策和做法的变化，需要建立什么机制？最后，对更广泛的国际卫生法/协定有何影响？这些问题将通过侧重于四个相互重叠的实质性领域来回答：公共卫生、流动性、研究、药品和医疗器械（a）公共卫生：这将侧重于在传染性/非传染性疾病/烟草控制等领域对健康的系统性影响（B）流动性：这将包括考虑对保健和护理工作人员的影响、病人的流动性以及保健游客和工作人员治疗费用的报销。(c)研究：这将包括临床试验监管，数据保护和人体材料（包括血液，组织和细胞）使用的监管。(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的框架来取代它们。该项目主要涉及案头研究，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。这些方法将通过在整个项目中进行的宣传和参与活动得到加强。这些将影响正在进行的研究并促进影响。该项目包括3个正在展开的工作包（WP），这些工作包在下放的司法管辖层和广泛的英国层面上逐步分层3个时间要素（即时;中期;长期）的概念工作，每个工作包由项目团队的一名成员管理：McHale（PI），Flear（Co-I）和Hervey（Co-I）。该团队将得到一名全职项目长度的博士后研究员的支持